What is the Candor process?

The Candor process for addressing adverse health care incidents has developed over the last two decades as a response to data showing that there is an unacceptable level of preventable patient harm. This has led to “communication and resolution” programs which:

• promote transparency between health care providers and patients after an unexpected outcome,
• encourage patients and their families to be part of a health care facility’s or a practice’s quality improvement process to prevent a similar harm to other patients, and
• allow for remediation, which may include compensation where warranted.

Some states, such as Iowa and Colorado, have passed laws to encourage the Candor process. The Candor laws provide a framework for health care providers to follow after they become aware of an adverse health care incident. The Candor process under the law is voluntary for everyone involved and it doesn’t change a health care provider’s duty to notify a patient of an adverse health care incident or to answer the patient’s and families questions about what happened.

What is an “adverse health care incident?”

The Candor law defines an “adverse health care incident” as an objective and definable outcome arising from or related to patient care that results in the death or physical injury of a patient.

How does Candor start?

A health care provider initiates the Candor process by providing a patient or the patient’s legal representative with a notice that the provider wants to enter in Candor open discussions with the patient. Depending on the state law, the notice must be provided within 180 days to a year after the date on which the provider knew, or through the use of diligence should have known, of the adverse health care incident. The notice includes:

• The patient’s right to receive a copy of the medical records related to the adverse health care incident and the right to authorize their release to any third party.
• The patient’s right to seek legal counsel who may be present throughout the Candor process.
• A copy of the relevant statute(s) of limitation with notice that the time for a patient to bring a lawsuit is limited and will not be extended merely by engaging in the Candor process.
• A copy of relevant state law(s), for example governmental immunity laws, which require patients to file a notice within a certain time frame in order to bring a claim.
• Notice that, if the patient chooses to engage in an open discussion with the health care provider or facility, all communications made in the course of Candor discussions are privileged and confidential, and not admissible in a judicial, administrative, or arbitration proceeding.

Patients are not obligated to participate in the Candor process but if they choose to do so, they must agree in writing to engage in an open discussion.

What are open discussions under the Candor law?

“Open discussions” include all communications, documents, and other materials that are prepared for or submitted in the course of or in connection with the Candor process after an adverse health care incident.

In order to encourage participation in the Candor process, the law creates legal protections for these communications so that they can’t be used against a participant if there is a subsequent legal proceeding. This has been referred to as a “safe space,” that creates an environment to foster open discussions with patients after an unexpected outcome.

Open discussions allow health care providers to disclose to patients the results of any investigation into what happened as part of the quality review process. Patients should receive candid and thorough discussions of what happened as well as the steps a health care provider has taken to prevent a similar adverse outcome in the future, if possible.

These discussions allow patients and their families to ask questions about what happened and to provide their perspective and suggestions on the quality improvement process to address the incident.

The confidentiality and legal protections around the Candor open discussions do not apply to records and communications about the event that were not specifically created as part of the Candor process. This includes medical records or other communications that were created or occurred before or outside of the Candor process.

What happens at the Candor open discussion meeting?

When a patient agrees and signs the written consent to participate in the Candor open discussion, the health care provider will arrange to meet with the patient to discuss what happened and answer any questions. If there has been an investigation into the incident, the results will be disclosed to the patient as well as what the health care provider or health facility will do to prevent or reduce the chances of a similar outcome in the future.

Who else can participate in the Candor open discussions?

Once a patient signs the written agreement to participate in Candor open discussions, the patient, health care provider, or health facility may include additional parties in the open discussions. Patients can include family members, friends, and an attorney in this process. A health care facility or practice may include a patient safety representative, chief medical officer, or other person to facilitate the discussions.

A representative of the provider’s professional liability insurer or legal counsel may be present, although the focus of this meeting is to have a conversation between the patient and the health care providers regarding the clinical care. If the patient and family have additional questions that can’t be answered at this meeting, further discussions will be arranged to respond to these. There may be limitations if one of the treating providers involved in the patient’s care chooses not to participate in the Candor process. Health care providers who participate in Candor can only speak to the care they provided and can’t speculate about the care rendered by another provider. Ideally, all health care providers who participated in the patient’s care are encouraged to participate. The legal protections in the Candor law are meant to encourage all providers to participate but they can’t be forced to do so because Candor is a voluntary process.

Anyone who participates in the Candor open discussions is required to sign a participation agreement which includes their written agreement that all discussions and communications are privileged and confidential.

Can I talk about the Candor discussions afterwards?

The legal protections around the Candor discussions are to create a “safe space” where health care providers and other participants feel free to speak openly and candidly about what happened. Candor communications can only be discussed among participants who have agreed in writing to the confidential and privileged nature of the communications. For this reason, it is important for patients to include their loved ones and others who can support them as part of the Candor process. That way participants can hear directly from the health care providers who treated the patient and they can have their questions answered.

Nothing in the Candor law prevents a patient from disclosing their medical conditions or the health care they received related to the adverse health care incident, but they cannot disclose what other participants have said as part of the Candor discussions. While a patient may share their medical records and health information with family members and others, health care providers are subject to HIPAA and other privacy laws.

If I am unhappy with the Candor process, what can I do?

Because the Candor process is voluntary, a patient can withdraw from it at any time with a signed , dated, written notice to the health care provider who sent the initial notice to the patient of the desire to enter into a Candor open discussion. This should include the patient’s request to terminate the Candor process. If the patient received the initial notice from more than one health care provider participating in Candor (for example, both a hospital and a physician) the notice of termination should be sent to both.

Prior to terminating the Candor process, however, a patient should consider raising his or her concerns about the process with the person facilitating the Candor discussions for the health care providers. If a patient or family is represented by an attorney, they may be able to help identify some of the problem areas and suggest the best way to continue in Candor. Because Candor laws are relatively new, many health care providers may be engaged in the Candor process for the very first time. While some providers and hospital employees may have had extensive training in having empathetic discussions with patients after an unexpected outcome, others have not. Similarly, some health care providers may want to have legal counsel or representatives of the provider’s professional liability insurer present in the Candor open discussions. Their role in the Candor process is different than with a claim or litigation. In states where Candor laws are new, many claims adjustors and attorneys are still adjusting to addressing an adverse health care incident through the Candor process as opposed to managing a traditional claim.

If the issues with the Candor process cannot be resolved, a patient can terminate the process and may want to discuss with legal counsel the next steps to take. Participating in Candor does not prevent the patient from bringing a subsequent claim or initiating legal action. It also does not prevent a patient from bringing a complaint to the relevant licensing board about a health care provider or with the health department or other state regulatory body responsible for licensing a health care facility.

What if I receive an offer of compensation?

If a health care provider makes an offer of compensation, the Candor law requires notice to the patient of the patient’s right to seek legal counsel regarding the offer if the patient is not already represented by legal counsel. This is strongly encouraged so that patients understand whether the offer is reasonable and any legal obligations, such as the requirement to repay medical and other expenses that were paid by a third party, such as private health insurance, Medicare, or Medicaid.

If patients receive compensation, they will be asked to sign a release of liability which includes an agreement not to seek subsequent legal action arising from the medical care related to the adverse health care incident.