Expect the unexpected: Create a policy for unforeseen outcomes

JCAHO now requires a policy on what and when to tell patients

Now is the time to decide what you will do when a patient has an unexpected outcome — and new information from the American Society for Healthcare Risk Management (ASHRM) might help with developing a policy.

Whatever resources you use, you have to move quickly. New patient safety standards that went into effect July 1 require hospitals to initiate specific efforts to prevent medical errors and to tell patients when they have been harmed during their treatment. Dennis O’Leary, MD, president of the Joint Commission on Accreditation of Healthcare Organizations (JCAHO), says the new rules from his organization represent a major milestone in the nation’s continuing pursuit of improvements in patient safety.

"Health care executives, physicians, and nursing leaders must radically change their thinking about medical mistakes," O’Leary says. "We need to create a culture of safety in hospitals and other health care organizations in which errors are openly discussed and studied so that solutions can be found and put in place. These new standards are intended to do just that."

Geri Amori, PhD, ARM, FASHRM, president of Communicating HealthCare, a risk management consulting firm in Shelby, VT, also is president of ASHRM. She says she doesn’t think most health care providers have policies in place for the disclosure of unanticipated outcomes. "Most people are still formulating their policies," she says. "The Joint Commission doesn’t require you to have written policies and procedures — just a stated policy on how you’ll handle these unanticipated outcomes. It’s not an entire program you have to develop, but you have to go beyond just thinking about it and put it on paper."

You should tell when patient is harmed

The new standards underscore the importance of strong organization leadership in building a culture of safety, O’Leary says. Such a culture should strongly encourage the internal reporting of medical errors and actively engage clinicians and other staff in the design of remedial steps to prevent future occurrences of these errors. He says the additional emphasis on effective communication, appropriate training and teamwork found in the standards’ language draw heavily upon lessons learned in both the aviation and health care industries.

A second major focus of the new standards is on the prevention of medical errors through the prospective analysis and redesign of vulnerable patient care systems, such as the ordering, preparation, and dispensing of medications. Finally, the standards make clear the hospital’s responsibility to tell a patient if he or she has been harmed by the care provided. O’Leary notes that JCAHO’s accreditation process has long placed a high priority on patient safety. "However, these standards will clearly raise the bar," he says. "When the new standards are implemented, over 50% of all of JCAHO’s hospital standards will relate directly to patient safety."

The new standards are based both on JCAHO’s own six-year experience in overseeing the management of sentinel (adverse) events in accredited organizations and on the opinions of a special panel that included patient safety experts as well as leaders from governments, hospitals, insurance companies, universities, and consumer advocacy groups. Broad field input was also solicited in finalizing the standards.

Don Nielsen, MD, president of the American Hospital Association (AHA), says the new standards echo AHA policy for its members — about 5,000 hospitals and health care systems nationwide — but AHA policy even goes further, advising hospitals to tell patients about mistakes that don’t cause any harm.

ASHRM document can help

A new document from ASHRM can be a key resource for a risk manager 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 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 policies. Amori says ASHRM didn’t seek to answer all the questions but rather to give risk managers a base from which to reach their own conclusions.

"It seems like common sense that you should tell patients what happened to them, but it hasn’t always been that way," she says. "We used to feel like it was our right to hide information and hope they never knew. We don’t feel that way any more — or at least most of us don’t. Some still feel that very strongly."

Amori says the risk management profession has seen a shift in recent years toward more disclosure of unanticipated outcomes and other information, but the new Joint Commission standard is forcing people to get off the fence and take a stand, one way or the other. "We’re making formal the idea that we’re all going to play by the same rules," she says. "The Joint Commission wants you to talk it out, state what you’re going to do and put it in a formal document. Now it has to be based on good solid thinking, not just spur-of-the-moment decisions."

The Joint Commission Patient Safety Standards include RI.1.2.2, which states that "Patients and, when appropriate, their families are informed about the outcomes of care, including unanticipated outcomes." This requirement does not necessarily mean that the patient must be told of every negative event, Amori says. In some cases, informing patients of unanticipated outcomes could harm their recovery, but Amori says those will be rare circumstances.

In most cases, the patient should be informed of any significant unanticipated outcomes and especially those that constitute an injury to the patient. Health care providers have been reluctant in past years to provide full accounting for fear of inviting a lawsuit, but Amori says that can no longer be a reason to keep information to yourself.

"It won’t be easy," she says. "I’m not saying a few institutions won’t take hits because of it, but it will be worth it because we’re doing the right thing." Amori points out that "unanticipated outcome" doesn’t have to mean something negative, such as an injury to the patient. Some unanticipated outcomes could be positive, such as when a patient requires a less extensive surgical procedure than anticipated. The ASHRM document provides a discussion of just what constitutes an unanticipated outcome. (For an excerpt from the ASHRM discussion, see "Unanticipated outcome’ can include good news," in this issue.)

Grena Porto, RN, ARM, DFASHRM, director of clinical risk management and loss prevention services at VHA Inc. in Berwyn, PA, and past president of ASHRM, says the Joint Commission standard and the ASHRM document should help risk managers look at unanticipated outcomes from the patient’s perspective. Porto also consults and speaks frequently on the issue of dealing with adverse events. She cautions that the patient’s perception must be considered carefully when deciding what is and isn’t "unanticipated."

"It’s unanticipated in terms of the patient’s own expectations," she says. "With an infection after surgery, the provider may say it’s not an unanticipated outcome because we know a certain percentage will get infections. But we need to shift to what the patient thinks and remember that the health care system is there to serve the patient, not to serve our needs."

Porto says she hopes the Joint Commission standard will help risk managers do what they know is right. She hears from a lot of risk managers that they know they should disclose and that the risk of a lawsuit isn’t increased, but a lot of institutions have an ingrained reluctance to reveal information to the patient. She suggests that the health care provider must create an overall culture that supports the assumption that patients should know everything about their health care — a culture that allows people to report problems without fear. Disclosing unanticipated outcomes will be very difficult in an institution that is still blame-oriented, she says.

The policy also needs to include a great deal of input from the front line health care worker, she says. "This is not something that can be handed down from on high by the CEO and just be implemented," she says. "It will take lots of preparation. They don’t teach this in medical and nursing schools, so you’re sending people out to do something they haven’t done before. You can’t do a half-hour lecture and assume they’re good to go."

Porto says the training should involve role playing and demonstrate a support system, such as peers that staff can turn to for advice and reassurance. "Don’t underestimate the value of being able to talk to a peer immediately, that day, to discuss their feelings and be reminded that disclosure to the patient is probably the right thing," she says.

Health care providers also may need to set up different mechanisms for how to disclose unanticipated outcomes that are minor and those that are severe. (For more advice on how to talk to the patient, see "It’s not what you say, it’s how you say it," in this issue.)

There are different ways to formulate a policy, but Porto says the important thing is to think about it thoroughly and calmly, before the crisis happens. "Whatever you do, don’t just turn people loose without any training or resources and tell them to give information to patients," she says. "It’ll be a disaster if you do."