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To disclose or not disclose: That is the question

by Barb Boose No Comments
In the 2008 DreamWorks comedy “Ghost Town,” character Bertram Pincus discovers the surgeon failed to disclose his momentary death during a routine colonoscopy. “Have you any idea how much I am going to sue you for?” he sputters.

This scene, while humorous, illustrates how an incomplete or evasive response is counterproductive and highlights the consequences when health care professionals are not prepared to meet their legal, regulatory and ethical obligations to disclose adverse events.

When things do not turn out as planned during a patient encounter, regardless of fault, most physicians and other health care providers want to show compassion and disclose what happened.1 Significant anecdotal experience – such as the examples at www.sorryworks.net/disclosepolicy.phtml – demonstrates that full disclosure combined with apology in these situations results in reduced lawsuits, payouts and costs while improving patient satisfaction and quality. Yet it is estimated that only one in four errors is disclosed to affected patients.2 Escalating lawsuits and jury verdicts, the high cost and limited access to professional liability insurance, and fear of shame and damage to professional reputations have left providers in denial and struggling with how to respond. These fears are intensified by a sense that insurers, attorneys and other advisers are pressuring them to remain silent to avoid premature admissions of liability in subsequent adversarial proceedings.

Health care disclosure lawsuits are generally analyzed using a paradigm of informed consent and autonomy. Judges have routinely held that physicians have a fiduciary responsibility to disclose adverse events to patients and may invoke civil liability when failure to timely disclose negatively affects a patient.

Lucian L. Leape, M.D., professor of health policy at Harvard University, asserts, “Full disclosure is the right thing to do. It is not an option; it is an ethical imperative…Patients are entitled to a full and compassionate explanation when things go wrong.”3 This position is consistent with the ethical principles of veracity, beneficence and patient autonomy.

Professional codes of ethics also call for disclosure as part of the patient relationship. For example, American Medical Association Ethical Opinion 8.12 – Patient Information states:

Situations occasionally occur in which a patient suffers significant medical complications that may have resulted from the physician’s mistake or judgment. In these situations, the physician is ethically required to inform the patient of all the facts necessary to ensure understanding of what has occurred. Only through full disclosure is a patient able to make informed decisions regarding future medical care…

Concern regarding legal liability which might result following truthful disclosure should not affect the physician’s honesty with a patient.4

Government agencies and health care organizations have followed industry trends toward transparency, including disclosure. For example, the Joint Commission on Accreditation of Health Care Organizations requires accredited hospitals to develop a policy on disclosure of unanticipated outcomes.5 Its Patient Safety Standard RI.1.2.2 provides that “Patients, and when appropriate, their families are to be informed about the outcomes of care, including unanticipated outcomes.” The Patient Safety and Quality Improvement Act (PSQIA) of 2005 established a confidential system for providers to voluntarily report adverse events without fear of litigation.6 Starting in October 2008, the Center for Medicare and Medicaid Services (CMS), many states and some private insurers halted payments to hospitals for additional care resulting from “reasonably preventable” errors called “never events.”7 Sixty-three percent of Leapfrog hospitals adopted that group’s “never event disclosure policy,” which requires an apology to the patient, a root cause analysis and public reporting.8

According to the American Society for Healthcare Risk Management, 35 states have laws making a professional’s statements of apology, sorrow or regret following an adverse outcome non-admissible. The theory behind these “I’m sorry” or “apology” statutes is that “if patients were treated with openness and sympathy—and offered prompt compensation—when doctors make mistakes instead of showing the detachment doctors frequently feel required to project to protect themselves from malpractice suits, they would be less likely to sue and, if there were less patients suing, there would be a corresponding decline in malpractice insurance costs.”9

Unfortunately, the vast majority of these state apology statues protect only the portion of discussions related to apology and regret and not broader disclosure—the primary basis for liability. Attempts to set a federal standard protecting disclosure conversations have not been successful.10 Thus, even with apology statutes, patient disclosure conversations can be used against a provider in most jurisdictions.

Important considerations for developing and implementing a disclosure protocol

1. Disclosure is an ongoing process that does not mean there was an error or require an admission of fault.
Adverse outcomes can occur even when the applicable standard of care has been met. In most cases, a root cause analysis and investigation must be conducted before discussing the cause. Disclosure is not designed to assign fault but to enable care providers to discuss medically relevant information with patients so they are fully informed about their care. Therefore, providers should have an initial disclosure discussion with patients regarding what is known; actively investigate the cause; keep patients informed as information becomes available; and resolve the situation when it is appropriate. Documentation of these steps should be maintained in the patient record. For more information on the “I’m Sorry Works Disclosure Process,” see www.sorryworks.com.

2. Advanced planning, written protocols and training for adverse outcomes are crucial.
Well thought-out protocols should be developed and reviewed throughout health care organizations to ensure that the response after an adverse outcome is timely, orderly, compassionate and appropriate. These comprehensive written policies should address who will talk to the patient, when and where conversations should take place, and the scope of disclosure. They may also address complex matters such as conflicts of interest, compliance investigations and media inquiries. Professional liability insurers should be consulted and contracts reviewed to ensure there is not a contractual basis to later deny coverage or cancel a contract because a disclosure conversation is later interpreted to be an admission of liability or failure to cooperate with defense counsel.

Timely and effective communication with patients and families is important. A study in the September Journal of General Internal Medicine found that disclosure and apology increased physician ratings but did not guarantee patients would not bring suit. Rather, the patient’s perception of what was said was more important than the act of apologizing and disclosing itself in deciding whether or not to sue.11 This is an important point, since many providers have not been trained and lack skills to effectively present bad news to patients who are upset, frustrated and disappointed (Leape, 2009). Therefore, administrators, providers and staff would benefit from didactic training (including practice disclosure conversations) to prepare for how to apologize and disclose without subjecting the facility to undue liability. Many training resources exist.

Train to explain without blame
There are barriers to disclosure when there has been an adverse medical outcome. However, providers are ethically and legally required to discuss medically relevant information to ensure patients are fully informed about their care, regardless of the impact on the provider. Legal protections for disclosure, such as apology statutes, are beneficial but are generally limited in scope.

Ultimately, the provider and health care facility should complete an ethical, legal and risk management disclosure analysis to promote communication that timely and sympathetically provides patients with medical information without assigning blame. They should then commit to a well thought-out and carefully crafted disclosure policy, didactic training and implementation process.

Assistant Professor Denise Hill teaches courses at DMU on health law and ethics, public health law and ethics, advocacy and conflict resolution. She practices law as an of counsel attorney with Whitfield & Eddy law firm. A trained mediator, Hill is president of the Iowa Society of Health Care Attorneys and serves on several health care and public policy boards.

Resources
www.thedoctors.com/KnowledgeCenter/PatientSafety/DisclosureResources/CON_ID_001054: includes a helpful adverse outcome flow chart, a series of disclosure scenarios and links to training videos.

www.ashrm.org/ashrm/education/resources/files/apology_statutes.pdf: listing of state apology statutes.

www.acpe.org/ACPEHome/Toolkit/apology.aspx: provides a listing of online resources on apology and disclosure.

www.oregon.gov/OPSC/docs/CUAO-Guidelines-KP.pdf: Kaiser Permanente offers effective guidelines for communicating unanticipated adverse outcomes.

Footnotes
1 American Society for Healthcare Risk Management (April 2001): Perspective on disclosure of unanticipated outcome information.

2 Fein S.P., Hilborne L.H., Spiritus E.M., et al. (2007): The many faces of error disclosure: a common set of elements and a definition. J Gen InternMed. 22(6), 755-761.

3 Leape, L. L.: Full disclosure and apology – an idea whose time has come.

4 Given that professional codes of ethics can be incorporated by reference into state licensing boards’ administrative rules, failure to disclose adverse events is a basis for professional discipline in some states. American Medical Association (2008): Code of Medical Ethics: Current Opinions with Annotations, 2008-2009.

5 The Joint Commission on Health Care Accreditation, Patient Safety Standard RI.1.2.2.

6 Patient Safety and Quality Improvement Act of 2005. Public Law 109-041. S 544, 109th U.S. Congress, 2005.

7 Centers for Medicare & Medicaid Services.

8 The Leapfrog Group.

9 Chicago Sun Times editorial (Feb. 25, 2005): Doc’s humble apology could be saving grace.

10 Clinton, H.R., & Obama, B., 2006: Making patient safety the centerpiece of medical liability reform. New England Journal of Medicine. 354 (21), 2205-2208.

11 Adams, D. (Sept. 22, 2009): Apologizing for medical errors may not stop you from being sued.

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