The Doctors Company’s Disclosure Program

Disclosure Policy

Patients have a right to be informed of the medical facts pertaining to their health status and medical treatment. Physicians have a responsibility to provide accurate, timely information to patients and, when appropriate, to the patient’s family members about events that impact the patient’s health status and future treatment needs—including the disclosure of adverse events and outcomes.

The Doctors Company encourages its insured physicians to cooperate with institutional adverse event disclosure programs by disclosing adverse events and outcomes that result in patient injury.  

Physicians are encouraged to seek guidance from individuals with patient safety and risk management expertise in both the communication and reporting of adverse events.

Physicians also have a responsibility to the patient, their colleagues, and their health care organization to avoid gratuitous blame and unsubstantiated speculation before a detailed review and analysis have disclosed the facts surrounding an adverse event or outcome.

Disclosing Adverse Outcomes in the Physician’s Office

An adverse outcome is a result that differs from the anticipated result of a treatment or procedure and results in harm to the patient. It is American Medical Association policy that following an unanticipated outcome, the physician is ethically required to inform the patient of all the facts necessary to ensure an understanding of what occurred. The ethical rationale is that the patient and his or her family have a right to know what happened—simply put, it’s “the right thing to do.”

When an adverse outcome occurs, most doctors want to disclose the factors that contributed to the event. However, there may be reluctance to do so because of fear of a malpractice claim or concern that insurance coverage may be compromised by the disclosure. The Doctors Company encourages its insured physicians to participate in adverse outcome disclosure programs (also known as “I’m Sorry” programs).
 
Patients usually know when they have been injured as a consequence of an adverse outcome. When no one explains what happened, they assume a mistake is being concealed—and they become angry. Anger drives many malpractice claims. Disclosure takes the “edge” off anger and is essential if the physician-patient relationship is to be maintained.

Adverse outcome disclosure requires an open, honest communication that includes full disclosure of the unanticipated event coupled with a genuine expression of concern that may include an apology—if appropriate. The basic components of disclosure include the following:

• Physician disclosure of the event to the patient and family, explaining what happened, and responding to questions
• Physician acceptance of overall responsibility for the patient’s care (not an admission of fault or negligence)
• Empathizing with the patient, genuinely expressing concern and regret
• A discussion of the future consequences of the injury (hospitalization, medications, surgery, disability, etc.)
• An explanation of what is being done to prevent this event from happening again to another patient

The Doctors Company has developed guidelines physicians can use in their office practices to enhance their effectiveness when disclosing errors, bad outcomes, and complications. The Doctors Company’s regional patient safety/risk manager will work with the physician to provide support, communication coaching, and assistance.

Events Covered by These Guidelines:

Since all Joint Commission–accredited facilities are required to have their own disclosure policy, this program is intended for a physician’s office practice or group practice (unless the office or group is owned and governed by a Joint Commission–accredited facility). Specifically, it is not for hospital inpatients and should not be used for office disclosure of adverse outcomes that occurred in a hospital. All outpatient adverse outcomes resulting in patient injury are included.

Situations Not Covered by These Guidelines:

• When there is a written demand for compensation
• When there is an attorney representing the patient
• When the state medical board has been notified
• When the event occurred in a hospital or Joint Commission–accredited setting (e.g., a surgicenter or a nursing home).

The Physician’s Immediate Response to an Adverse Outcome:

1. The first priority is to provide immediate clinical care for the patient to prevent further harm.
2. Preserve evidence: medications, equipment, and supplies, etc.
3. Document the basic medical facts associated with the adverse outcome.
4. Meet with the patient/family. Since the cause of the event may not be immediately apparent, review only the known medical facts. If a question cannot be answered, it’s OK to say “I don’t know.”
5. • Meet with the patient and family as soon as possible after the adverse outcome occurs.
   • It is appropriate to express regret. Examples of empathetic statements can be found in Appendix 2.
   • Focus on the patient’s current condition and the steps being taken on the patient’s behalf, and explain any changes in the patient’s treatment plan. Assure the family they will be kept informed as additional information becomes available.
   • Provide the patient and family with the names and contact information of individuals who will be available to address their concerns and answer questions.
   • A follow-up meeting should be arranged when additional information becomes available. Who will arrange this meeting? How—by letter or phone? Where—in the office or at home? When can the patient expect a follow-up call?

Contacting The Doctors Company:

1. Call The Doctors Company’s Patient Safety Department at (800) 421-2368 extension 1243.
2. The patient safety/risk manager will provide you with the complete disclosure protocol (by e-mail, fax, or by directing you to our Web site) and review the protocol with you.
3. Experience has shown that most adverse outcomes fall into three categories:
4. 1. Medical and/or System Error
   2. Known Risk/Complication or Unforeseeable Event
   3. Unexplained Change in Patient Status or New Diagnosis of Late-Stage Disease 

Based on the information you provide to the patient safety/risk manager, and the event classification assigned, one of the following three protocols will be followed.

A. Medical and/or System Error:

Error is defined by the National Quality Forum Consensus report entitled Standardizing a Patient Safety Taxonomy as “the failure to perform a task satisfactorily against customary standards and the failure cannot be attributed to causes beyond the patient or provider.” When the investigation is completed (including a sentinel event root cause analysis) and the cause determined to be medical and/or system error, a disclosure meeting will take place.

Disclosure Meeting Protocol:

1. Determine where the meeting will take place:
   • It should be a quiet, private, and comfortable setting.
   • There should be no barrier (table or desk) between the physician and patient.
   • All beepers/pagers/phones should be turned off.
2. Decide on the agenda in advance.
3. Communications must be consistent—agree in advance on what is known, on what is not, and on what must await further investigation.
4. Be prepared to say “I don’t know” if some of the facts are unknown.
5. The regional patient safety/risk manager will coach the physician on disclosure communication (use of empathetic statements, silent listening skills, disclosure, and apology) immediately prior to the disclosure meeting.
6. Review the 25-minute training video Removing Insult from Injury: Disclosing Adverse Events.
7. The treating physician is usually responsible for the disclosure.
8. As a general rule, the physician should communicate his or her acceptance of overall responsibility but should not make admissions of personal negligence or fault.
9. Document the meeting in the patient’s medical record according to standard practice. An example of this documentation is shown in Appendix 1).
10. Avoid becoming angry, emotional, or defensive.
11. Stay away from blame and don’t finger point!
12. Avoid using names; focus on what happened, including system error(s) if present.
13. Follow these four steps in the disclosure:
    • Tell the patient/family what happened—limit the discussion to known facts; avoid speculation.
    • Assume overall responsibility as the patient’s caregiver—not only for what happened, but also for updating the patient and family, monitoring, and managing complications, etc.
    • Apologize if appropriate—when a personal apology is appropriate, the person responsible for the adverse event should make the apology.
    • Explain what will be done to prevent this from happening again—patients want to know that this won’t happen in the future to someone else.
14. Future consequences of the injury (such as hospitalization, medications, surgery, future medical treatments, or disability) should be disclosed.
15. Make time for the patient/family to ask questions and express their feelings. Communicate to the patient/family that they are being heard and their concerns taken seriously.
16. Be prepared to handle questions that might arise regarding compensation. (Is the bill being written-off? Is it being held pending further investigation?)

B. Known Risk/Complication or Unforeseeable Event:

The key factor in this category is preventability. Disclosure communications following unpreventable complications or unforeseeable events need to be forthright, open, and compassionate, though they differ qualitatively from apologies after preventable errors.

1. Review the known facts surrounding the adverse outcome.
2. Determine if the event was preventable.
3. Review your process of informed consent to determine if the known risk or complication was discussed.
4. Proceed to the disclosure meeting. Focus on discussing the cause(s) of the known risk or complication. Review the informed consent if appropriate. Explain how the unforeseeable event may have occurred. Explain any system failures and lessons learned that might prevent future similar occurrence.

C. Unexplained Change in Patient Status or New Diagnosis of Late-Stage Disease:

The main challenge in communicating after a Category C event is the avoidance of a premature conclusion that a severe and surprising outcome must be due to a negligent error. It is especially important in these circumstances to limit the information conveyed to the confirmed details and to provide ongoing updates as new information becomes available. These cases are particularly vulnerable to retraction and correction cycles that render all subsequent communications with the patient and family questionable.

1. Conduct an internal review of the medical records to determine exactly what happened and to determine if the status change was preventable or if the new diagnosis could have or should have been made earlier.
2. If appropriate, initiate an external expert review. Peer reviews of the medical care with the outcome blinded can lend unique insight into these events.
3. If a sentinel event occurred, a root cause analysis is appropriate.
4. Proceed to the disclosure meeting. Review the findings of your medical record review and investigation. Explain the implications of the change in the patient’s health status and how this will affect his or her subsequent disease management. Discuss the prognosis and management of the newly diagnosed late-stage disease.

• Appendix 1: Medical Record Disclosure Report
• Appendix 2: Examples of Empathetic and Non-Empathetic Statements
• Appendix 3: Disclosure Scenarios