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 family’s 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. This definition may vary somewhat depending on the state’s Candor law.

How does Candor start?

If a health care provider becomes aware of an unexpected patient outcome, including a known complication, he or she should notify their employer, their facility’s or practice’s patient safety representative, and their professional liability insurer, as applicable, to consider whether the Candor approach would be appropriate.

An employer, such as a health care facility or group practice, or the provider’s professional liability insurer or both will assist the provider through the Candor process. The Candor process is completely voluntary for an individual provider as well as the patient. Before participating in Candor, a provider should fully understand the goals of Candor, what the provider’s role is in the Candor meeting, and the potential benefits or challenges of going through the Candor process.

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, that 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 Candor 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. The legal protections also apply to the documents used to initiate the Candor process. 

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 after the patient/family agrees to the Candor process?

A patient safety team member or patient safety representative should be identified as the point of contact for the patient/family to keep them apprised of any ongoing investigation into the unexpected outcome and next steps.

The provider, facility, or practice should investigate what happened and how it could have been prevented, if possible. Once a patient agrees in writing to engage in an open discussion, the patient, health care provider, or health facility engaged in the discussions may include other persons in the open discussion, who must be advised in writing that the communications are privileged and confidential.

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 other providers were involved in the incident, they will be asked whether they would be willing to participate in the Candor open discussion meeting. That way each provider will speak about their own care rather than having to speculate about another provider’s care. This benefits the patient and family by allowing them to understand the entire course of care. 

What happens at the Candor open discussion meeting?

When a patient signs the written consent to participate in Candor open discussions, a patient safety team member or facilitator will arrange a meeting with the patient and/or family 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. 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.

A patient safety team member may reach out to the patient and family or their legal counsel in preparation for the meeting. The patient should be receptive to having the meeting and understand who will be attending and what to expect. The meeting will be more effective if the providers understand what questions they will be asked and the patient’s areas of concern they should address. While legal counsel for the patient or the provider may be present, the discussion of the clinical care should be between the health care provider(s) and the patient.

This is an opportunity for the health care provider(s) to explain their thought process that went into their medical decision-making at the time. Family members who were not present during the informed consent process may not have understood that there were certain risks to a surgical procedure or medical treatment. The meeting allows family members to have their questions answered as well. If more than one provider will be at the meeting, everyone should decide ahead of time about who will be speaking on what topic.

Patients want providers to understand the impact that the adverse outcome has had on them. The meeting is an opportunity for the provider to listen empathetically rather than defensively. Whether an adverse outcome was the result of a known complication or care provided below the acceptable standard, patients want providers to express how sorry they are about what happened.

Patients also want assurances that preventable adverse outcomes won’t happen to someone else. The Candor meeting allows them to participate in a practice’s or facility’s quality improvement process. Patients bring a different perspective, particularly around communication. In a hospital, for example, the physicians and other providers see the patient episodically, but the patient is the only one who is there for the whole process.

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.

What happens after the Candor meeting?

After the Candor meeting, a decision is made about whether an offer of compensation is warranted. This may involve getting expert reviews to determine if the care met an acceptable standard or if it involved a known complication where an appropriate informed consent process occurred. For the provider’s or facility’s liability insurer and legal counsel, this analysis is similar to what would be done for a medical malpractice claim based on the same set of facts. If the event involved more than one provider or facility with different insurers, the amount of compensation may be apportioned among them.

Even where no compensation is warranted, a provider or facility may want to consider other gestures of goodwill that would be meaningful to the patient or family to promote healing.

What reporting requirements are there under the Candor law?

Because no payments are made as a result of a written complaint or claim demanding payment based on a practitioner’s provision of health care services, incidents handled through the Candor process are not required to be reported to the National Practitioner Data Bank. They are also not reportable as medical malpractice judgments or settlements under state law.

Nothing in state Candor laws limit a patient from filing a complaint with the relevant licensing board. Candor laws do not change a health care entity’s obligation to report an adverse professional review action as required by federal law.