Candor FAQs

What are communication and resolution programs?

Communication and resolution programs have been in place for nearly two decades and have evolved during that time. These have been promoted by the Agency for Healthcare Research and Quality (AHRQ) which developed a toolkit for a process for providers to respond in a timely, thorough, and just way when unexpected events cause patient harm.¹ Candor laws, such as the Colorado Candor Act, were developed to encourage the Seven Pillars Program, which was a precursor to what became CANDOR (Communication and Optimal Resolution) supported by the AHRQ CANDOR toolkit.²

The Seven Pillars Program included the following principles for a comprehensive process for responding to patient safety incidents:

1. Patient safety incident reporting — A culture of reporting any patient safety incident is encouraged to trigger the process.
2. Investigation — A preliminary review of the incident is conducted to determine if patient harm has occurred or if it was a “near miss” worthy of further analysis. If harm has occurred, a root- cause analysis (RCA) of the incident is performed to determine whether care was reasonable or not. A standardized approach is used to determine the underlying cause, whether there was personal culpability or systems failures, and to make process and quality improvement recommendations.
3. Communication and disclosure — Because communication is the centerpiece of Seven Pillars, ongoing communication with the patient and family must be maintained throughout the process. To avoid the risk of prematurely disclosing information and conclusions that may later turn out to be incorrect, only the findings surrounding the incident that are reasonably certain and unlikely to change as the investigation proceeds are communicated to the patient. If there is a consensus by the investigation team that the care was unreasonable, the team moves forward with a full disclosure of the unreasonable care and how harm was caused. A patient liaison is assigned to address any subsequent concerns. Communicating the details of a patient safety incident involves a series of meetings. Generally, the responsible provider is part of and often leads the disclosure and delivers the apology if indicated. Health care providers who are trained in complex communications after patient safety incidents are available to facilitate communication with a patient or family and are present during a full disclosure. These providers ensure that the disclosure includes an apology for any unreasonable care, what happened, and the link between the care and outcomes in a manner that is meaningful to the patient, and ensure the quality of the disclosure process.
4. Apology and remediation — When an investigation reveals that the patient harm resulted from unreasonable care, in addition to an apology, the process includes a mechanism to provide rapid remediation and an early offer of compensation, if warranted.
5. System improvement — Each investigation’s findings are used to identify and implement systems improvements to prevent a recurrence of system breakdowns. Patients and families are invited to actively participate in this process. The review team is responsible for evaluating proposed system improvements and overseeing quality metrics for effectiveness and reporting progress to oversight committees.
6. Data tracking and performance evaluation — Data is collected about the type of patient safety incident, investigations, disclosures, financial, legal, and public relations implications of the event, system improvements, and the number and quality of encounters with the trained communication team. These data are used for internal quality assurance, research, public outreach, and dissemination.
7. Education and training — There are initial and continuing training requirements for professional, administrative, and support staff ranging from didactic to experiential using standardized patients and role plays. In addition, the communication staff are trained to identify the need for providers to be referred for peer support. All care providers involved in an event associated with harm are encouraged to actively participate in the communication process and disclosure as part of their healing and learning process.

What is the role of state Candor laws?

Communication and resolution programs can be put in place without creating a statutory privilege and confidentiality around open communications and offers of compensation, where warranted, but health care providers may be reluctant to participate. They are often afraid that their statements will be used against them if a patient or family decides to bring a lawsuit. If a patient has sought advice from an attorney, health care practitioners are advised that they can no longer speak with the patient or family about the patient’s care. Providers may also be willing to “take a chance” that a patient’s case will be considered too small for them to bring a lawsuit, otherwise known as the “delay, deny, and defend” approach.

Health care providers are deterred from settling cases of negligence because such settlements, no matter the dollar amount, are reportable to the National Practitioner Data Bank. This is something that must be explained as part of the credentialing process with hospitals, group practices, and insurers for the rest of the provider’s career.

Candor laws, such as those passed in Iowa and Colorado, were drafted to remove some of the barriers to implementing a Seven Pillars process in a health care organization. While such laws are not required to implement a transparency program after a patient safety incident, they can provide a voluntary framework for doing so. These laws have five key features to encourage the Candor process:

1. The laws provide patient protections through their notice provisions. They require a notice to patients that the provider wants to enter into Candor discussions. This notice advises patients of their rights, which includes:
   • The right to receive a copy of their medical records related to the adverse health care incident;
   • a notice about the relevant statute of limitations (or time frame) to bring a claim and notice about requirements under the state governmental immunity law, if any,
   • and their right to have an attorney present throughout the Candor process.

   This ensures a fair process so that a health system or professional liability insurer doesn’t have an unfair advantage over an individual patient or “unfair bargaining power.”

2. They create a Candor privilege so that any discussions as part of the Candor process can’t be used in a subsequent legal proceeding. This can be considered a “safe space” where people can feel free to say what they want. This encourages providers who participated in the patient’s care to come to the table during open discussions with the patient and family where they may have been reluctant to do so otherwise. This allows each provider to speak about their own care and eliminates the need for other providers to try to “fill in the gaps” about what happened. It also gives patients the opportunity to ask questions of all of their providers.
3. The laws allow patients and their families to be part of the health care entity’s quality review process to determine the steps the provider or health facility will take to prevent future occurrences of the adverse health care incident. Patients and their families bring a different perspective, particularly around the communications they received during and after the patient’s care, that providers may not appreciate. They want to know that they will be safe coming back to that provider or health facility in the future.
4. The laws avoid automatic reporting to the National Practitioner Data Bank (NPDB) if the patient receives compensation. State Candor laws can’t change federal law around NPDB reporting. However, under the Candor law framework, the provider initiates the discussion with the patient and there is no written claim or demand for payment based on a health care provider’s furnishing (or failure to furnish) health care services. Because any compensation is the result of a provider-initiated process, any resulting compensation is not in response to a patient’s written claim or demand for payment, so it is not reportable to the NPDB.
5. To encourage improvements in patient safety, a provision was included in these laws that allows a health care provider or health facility that participates in Candor open discussions to provide de-identified information about an adverse health care incident to a nonprofit organization for use in patient safety research and education without waiving the Candor privilege. The Candor Institute was created as a 501(c)(3) public charity for that purpose.

---

Footnotes

1. AHRQ Communication and Optimal Resolution (CANDOR) Toolkit, available at https://www.ahrq.gov/patient-safety/capacity/candor/modules.html.
2. Responding to patient safety incidents: the “seven pillars,” available at https://pubmed.ncbi.nlm.nih.gov/20194217.