New rule taking effect Oct. 1 requires hospital transparency on patient safety and medical errors, encourages use of CANDOR

Efforts to protect U.S. hospital patients’ safety, require transparent disclosure of medical errors, and empower hospital staff to confidentially report safety concerns are taking a giant step forward this fall.

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Communication and Optimal Resolution (CANDOR) programs for U.S. hospitals designed to protect patient safety, require transparent disclosure of medical errors, and empower hospital staff to report safety concerns have won a major endorsement from the U.S. Centers for Medicare & Medicaid Services. A new rule taking effect Oct. 1 will require hospitals to attest to whether they are taking several steps to promote and report patient safety, including implementation of CANDOR. PHOTO CREDIT: COD Newsroom

A new U.S. Centers for Medicare & Medicaid Services (CMS) regulation being published on August 28 and taking effect on October 1 will require hospital leaders to attest to whether they are taking several steps to promote accountability and transparency around medical errors, which are the third leading cause of death for Americans after heart disease and cancer.

The regulation specifically endorses the Communication and Optimal Resolution (CANDOR) program as a way for hospitals to commit to being honest and open with patients and their families about medical errors, why they happened, and what steps the hospital will take to prevent them from recurring.

An alternative to the once-common response to medical errors known as “deny and defend,” CANDOR has been shown by several studies to reduce malpractice claims and the duration and expense of litigation.

“Early evidence shows the value of CANDOR programs to increase confidence in hospital leadership and improve healthcare worker job satisfaction,” said Thomas A. Mroz, Professor Emeritus of Economics at Georgia State University. “These benefits may reduce turnover of hospital workers, including nurses, physicians, and hospital leaders.’’

Colorado, Iowa, Minnesota, and Utah have all adopted laws to make it easier for hospitals to use CANDOR. Georgia’s Legislature came within one procedural vote of enacting a Georgia CANDOR law before the 2024 session expired. CANDOR-type policies are also sometimes referred to as communication-and-resolution programs (CRP).

The new CMS regulation, available online at https://federalregister.gov/d/2024-17021 , states that “accountability for outcomes, as well as transparency around safety events and performance, represent the cornerstones of a culture of safety. For hospital leaders, clinical and non-clinical staff, patients, and families to learn from safety events and prevent harm, there must exist a culture that promotes event reporting without fear or hesitation, and safety data collection and analysis with the free flow of information.’’

As a condition of participating in Medicare, Medicaid, and the Children’s Health Insurance Program (CHIP), starting Oct. 1 U.S. hospitals must attest whether they:

  • have a “confidential safety reporting system that allows staff to report patient safety events, near misses, precursor events, unsafe conditions, and other concerns”
  • report “serious safety events, near misses and precursor events” to a Patient Safety Organization (PSO) listed by the Agency for Healthcare Research and Quality (AHRQ)
  • track and report patient safety metrics to all staff and make them available for public review by patients, families, and visitors
  • have implemented “a defined, evidence-based communication and resolution program reliably implemented after harm events,” with CANDOR listed by name as the model program, that identifies harm events that have occurred, promotes open and ongoing communication with patients and families and proactive offers by the hospital of both financial and non-financial reconciliation, and fosters investigation into and learning about how to prevent similar harm events from occurring again.

Failing to implement these programs can lead to lower quality ratings of hospitals and other healthcare providers.

Media contacts: Dr. Florence R. LeCraw, CANDOR Coalition: frlwatts@gmail.com Peter J. Howe, Denterlein strategic communications/PR, phowe@denterlein.com 617.482.0042