Disclosure of Unanticipated Outcomes

By Lizabeth F. Brott, JD, Vice President, Risk Management, ProNational Insurance Company
Kay Thomas, RN, CPHQ, Risk Management Consultant, Medical Assurance, Inc.

On July 1, 2001, the new Joint Commission Standard on disclosure of unanticipated outcomes went into effect. It is important to point out the Standard is actually broader than just disclosure of negative unanticipated outcomes and appears to encompass disclosure of unanticipated positive outcomes, as well. Standard RI.1.2.2 provides “Patients, and when appropriate, their families are informed about the outcomes of care, including unanticipated outcomes.” The intent provision of RI.1.2.2, further states that the “responsible licensed independent practitioner or his or her designee clearly explains the outcome of any treatments or procedures to the patient and, when appropriate, the family, whenever those outcomes differ significantly from the anticipated outcomes.”

Of course, it is the negative unanticipated outcomes which tend to create malpractice liability exposures for health care providers and are the focus of this article.

While the Joint Commission does not provide a specific definition of an “unanticipated outcome,” the intent provision of RI.1.2.2 can be restated to define an “unanticipated outcome” as an outcome that differs significantly from the expected outcome of the treatment or procedure. The American Society of Healthcare Risk Management’s white paper, entitled Perspective on Disclosure of Unanticipated Outcome Information, suggests that the Joint Commission views unanticipated outcomes as similar to incidents which would constitute reviewable sentinel events.

Research may support disclosure
A number of studies have been published suggesting that disclosure may actually strengthen the physician-patient relationship and, at the same time, have a positive impact on medical malpractice claims. In a study published in JAMA in 1992, researchers interviewed malpractice plaintiffs who had filed claims involving perinatal injuries. The plaintiffs volunteered numerous reasons for filing lawsuits; 20 percent said they wanted more information, while another 24 percent said they recognized a cover-up. Further, 32 percent believed their physician would not talk openly with them, 48 percent felt their physician attempted to mislead them, and 70 percent said they were not warned about long-term neurodevelopmental problems.

A subsequent study reported by the Risk Management Foundation of the Harvard Medical Institutions explored what patients want or expect from their physicians when mistakes occur. Almost all patients in the study indicated they wanted their physician to acknowledge an error, regardless of the severity of the injury. Patients were also significantly more likely to sue or report a physician if they were not told of an error. This number increased with the severity of the mistake.

A number of risk management experts also point to the much publicized experience of the Veterans Affairs Medical Center in Lexington, Kentucky. In 1987, following two large malpractice judgments, the Center decided to approach cases differently. When an investigation determined a patient injury was a result of malpractice or error resulting in loss of substantial function or earning capacity, the patient and/or family was notified. All details were disclosed to the patient or their family along with offers of restitution. Patients and families were also advised to retain legal counsel and the Center’s attorney then worked with the plaintiff’s attorney to reach an equitable resolution. A subsequent seven-year review of the Center’s malpractice claims showed that while their number of claims were higher than most similar Veterans Affairs medical centers, the Center’s overall dollars spent for liability payments were lower than most, and substantially lower than several other centers.

What to disclose
There is considerable debate about exactly what should be disclosed to patients and their families. While the studies support disclosure, the question is--how much disclosure? The Lexington Veterans Affairs Center took the full disclosure approach, acknowledging error, attributing cause, and encouraging patients to obtain legal counsel. And while their claims results are encouraging, there are a number of reasons cited in subsequent articles as to why full disclosure may not necessarily produce similar results in the private sector.

First, Veterans Affairs’ patients are provided free comprehensive medical care. The Veterans Affairs system can also cover the costs of remedial treatment and even monthly disability payments if a patient’s injury is treatment related. Secondly, the average medical malpractice judgment in the private sector is much higher than that experienced by Veterans Affairs centers. And finally, the Veterans Affairs medical centers and their physicians are covered by the Federal Tort Claims Act (FTCA). Under the FTCA, all claims are filed in federal court and decided by a judge (not a jury); physicians are not named individually in claims; and the federal government pays all settlements and judgments.

Unfortunately (or maybe, fortunately), the JCAHO does not state specifically what should be disclosed to patients or their families. The scoring guideline for RI.1.2.2 merely indicates that hospitals will be scored on whether the patient and/or the family were informed when appropriate.

The National Patient Safety Foundation is specific in their recently issued Statement of Principle entitled Talking to Patients about Health Care Injury. The Statement encourages disclosure of both errors and steps taken to avoid future similar injuries.

While studies indicate patients certainly seem to want full disclosure by their physicians, at this point there is little evidence--at least in the private sector--that full disclosure will not actually contribute to increased malpractice claims and payments. While disclosure to the patient and his/her family is essential following an unexpected outcome, it is important to make a distinction between disclosure of an unanticipated outcome and an admission of liability.

Risk Management Suggestions

• Create a written plan for disclosure of unanticipated outcomes. (While not required by the JCAHO, a written plan will assist in developing a uniform approach among employees and medical staff.)
   
• Be sure to define an “unanticipated outcome” in the plan.
   
• The licensed independent practitioner (LIP) should provide disclosure except when the LIP and the organization decide that it may be more appropriate for a designee to provide disclosure. An LIP is more likely to be able to respond to patients’ questions. Additionally, LIPs may be uncomfortable with someone else’s explanation to the patient.
   
• In many instances there may be an ongoing investigation; however, prompt disclosure is important. Disclosure should take place as soon as practicably possible following the unanticipated outcome. The patient and family should be provided the facts known at the time of disclosure and told they will be informed as additional facts become known.
   
• Include at least one “friendly” witness to the disclosure conversation whether it be another physician, the hospital’s patient advocate, etc. The patient and/or family should have input as to who attends the meeting. Determination as to who should be included should be made on a case-by-case basis. Be careful about including the risk manager or hospital legal counsel as their very presence may suggest litigation.
   
• All health care providers involved in the disclosure should meet in advance to prepare for the conversation. Consideration of patient issues including, but not limited to, the need for interpretation services or other cultural needs should be discussed. In addition, strategies on how to handle special patient requests (such as recording of the meeting) should be considered. Note that recording of the meeting is highly discouraged unless approved by both the physician’s and organization’s legal counsel.
   
• Disclosure should include a statement of the facts without pointing fingers or admitting liability (e.g., “While performing the procedure the common bile duct was lacerated” as opposed to “I made a mistake while performing the procedure and lacerated the common bile duct”).
   
• If patients attempt to place blame, explain that it is premature to place blame, if there is any. If the unanticipated outcome is a known complication of the procedure or treatment, be sure to remind the patient of the informed consent discussion.
   
• If the error is obvious (e.g., operating on the wrong body part), disclosure of the unanticipated outcome--in and of itself--will, most likely, attribute blame. The hospital and caregiver(s) should notify their professional liability carriers as soon as possible, but such notification should not delay disclosure.
   
• Disclosure should include discussion of the patient’s current condition and plan for continued treatment, both in the near future and long term.
   
• Disclosure should conclude with an offer to be available for further questions.
   
• Documentation should conform with hospital policy and procedure and good risk management documentation principles. Risk management may be consulted for input. Document the disclosure conversation thoroughly in the patient’s chart. A number of malpractice cases have involved allegations that the injury was never disclosed. The documentation should be thorough enough to rebut subsequent allegations of finger pointing, admissions of liability, etc. The chart should contain documentation when determination is made, based upon the patient’s condition, that it is in the best interest of the patient to withhold certain facts at that time. Documentation should support the determination. Disclosure should then occur as soon as possible based on the patient’s condition.
   
• Provide in-service training on your disclosure plan. Review what should be disclosed. Emphasize the importance of informed consent so when unanticipated outcomes occur that are known complications, caregivers can point to the informed consent discussion. Encourage staff to be sympathetic and express concern for the patient. Encourage offers of assistance to patients in contacting family members, etc.
   
• If the unanticipated outcome is also a “sentinel event,” be sure to follow normal procedures in response to a sentinel event. Documentation of the sentinel event investigation (i.e., root cause analysis, etc.) should be maintained separate of the documentation of disclosure in the medical chart.
   
• Lastly, be sure to consult with your professional liability carrier if you need assistance.

References
American Society for Healthcare Risk Management, “Perspective on Disclosure of Unanticipated Outcome Information,” Apr. 2001.
Hickson, Gerald B., et al., “Factors that Prompted Families to File Medical Malpractice Claims Following Perinatal Injuries,” JAMA, Mar. 1992, pp. 1359-1363.

Joint Commission on Accreditation of Healthcare Organizations, “Comprehensive Accreditation Manual for Hospitals,” Update 1, Feb. 2001 & Update 3, Aug. 2001.

Kraman, Steven S., and Ginny Hamm, “Risk Management: Extreme Honesty May Be the Best Policy,” Annals of Internal Medicine, Dec. 1999, pp. 963-967.

National Patient Safety Foundation, “Talking to Patients about Health Care Injury,” Mar. 2001.

Witman, Amy D., and Steven Hardin, “Patients’ Responses to Physicians’ Mistakes,” Forum, Risk Management Foundation of the Harvard Medical Institutions Inc., Apr. 1997, pp. 4-5.