Days after state regulators complete their on-site investigation of the UNC pediatric heart surgery program, UNC Health Care announces changes.

By Anne Blythe

The UNC Health Care system announced Monday it would temporarily halt its “most complex pediatric heart surgeries” at the North Carolina Children’s Hospital to give an advisory board of medical experts from outside UNC time to review the pediatric heart surgery program.

The announcement comes a little more than two weeks after The New York Times published an article on May 30, raising questions about the program. Not only did the investigative report spotlight higher death rates for children who received surgery there in 2016 and 2017, it also exposed the health care system’s refusal to release risk-adjusted mortality data.

Mandy Cohen, secretary of the state Department of Health and Human Services, quickly assembled a team to investigate the program.

The team’s onsite work was completed Friday, according to Kelly Haight Connor, a spokeswoman for the state DHHS, giving them 10 business days to complete a report that then is to be submitted to the Centers for Medicare and Medicaid Services for review.

“While UNC Health Care and its Board of Directors have strong confidence in our extraordinary current pediatric heart surgery team, we believe it is vitally important that both current and future patients, our medical colleagues, key regulators, and the public share this confidence,” Charlie Owen, the UNC Health Care board of directors chairman, said in a statement released Monday.

Wesley Burks, CEO of UNC Health Care, shared an email with staff the day the Times report was published describing the problems as limited to a time in 2016 and 2017, when the “program faced cultural challenges.”

During that time, according to the Times’ report, pediatric cardiologists at UNC were so disturbed by the high death rates in the pediatric heart surgery program that they questioned whether they would send their own patients or children there.

The program, Burks assured staff in his May 30 email, had improved since then, in large part, because of personnel changes.

He also noted a quality improvement effort that called for a Department of Pediatrics review after every death in the Pediatric Intensive Care Unit.

“Our pediatric heart program cares for very sick children with incredibly complex medical problems, and our clinical team works tirelessly to help those patients return to normal, healthy and productive lives,” Burks said in a statement released Monday.

“We grieve with families anytime there is a negative outcome, and we constantly push to learn from those tragic instances,” Burks continued. “I want to acknowledge in the sincerest way possible, that for our team and me personally, the death of any child is one too many.”

The steps announced Monday, Burks said, “are part of a comprehensive effort to ensure UNC Health Care’s mission to serve all North Carolinians with the highest quality care.”

They include:

Developing the external advisory board. The members will report to the UNC Health Care Board of Directors and are expected to come from the University of Southern California, the University of Michigan, Nationwide Children’s Hospital in Columbus, Ohio and the University of Pittsburgh Medical Center, according to the UNC Health Care news release.

Creating a Family Advisory Council designed to give patients, family members and staff a voice with hospital leadership.

Recruiting more physicians and care providers for the pediatric surgery team. Three new pediatric cardiologists and two new pediatric cardiac critical care physicians have been hired for the program. They are set to begin work this summer.

Bringing the investment in new technology and other program “enhancements” that have been made incrementally over the past two years up to $10 million by the end of next year.

Creating a better avenue through which senior leadership and the health care system’s board of directors can be informed of Quality and Safety reporting efforts.

Recruiting more physicians and care providers for the pediatric surgery team.

Showing their surgery results

The health-care system also posted to a North Carolina Children’s Hospital web page the data the Times sought in a public records request and a lawsuit filed in state court.

UNC also has agreed to share the information with the Society of Thoracic Surgeons to post on a website where three-quarters of all hospitals performing surgeries on young children with congenital heart defects share their outcomes.

The data show that in the past there were periods in which survival rates for the most complex cases were below the national average, according to the news release. Survival rates for less complex cases were higher than the national average in some periods, too.

“The UNCHC Board of Directors and our leadership believe it is important to acknowledge the past time period when our survival rate was below the national average and share data previously used for our internal peer review,” Owen said.

According to the news release, UNC worried about sharing the data publicly, fearing that risk adjustments made by the Society of Thoracic Surgeons would confuse people more than providing the number of surgeries performed, as the hospital did, along with the deaths that occurred.

From July 2018 through May, the news release states, the program performed 100 surgeries with a 97 percent survival rate.

Should Duke and UNC merge?

The Times’ report has highlighted the push and pull between operating low-volume pediatric surgery programs, such as UNC does, in the shadow of a larger program just miles away at Duke.

When pediatric cardiologists pressed UNC administrators in 2016 and 2017 for answers about the high death rates in the pediatric cardiac surgery program, in conversations that were taped and obtained by the Times, the physician who was in the top administrative post at the North Carolina Children’s Hospital cautioned them about the revenue that would be lost if fewer surgeries were performed.

Milton Packer, a cardiologist at the Baylor University Medical Center who writes the Revolution and Revelation blog at Medpage Today, suggested in a column posted on June 5 that hospital administrators should have considered merging with the program at Duke.

“Because the pediatric cardiac surgical program at UNC was a low-volume enterprise, UNC could have combined its program with a similar program at nearby Duke University, and together, that would have created a strong combined program,” Packer wrote in “Does Medicine Have a Wall of Silence?” “But that did not happen. Instead, investment in the program at UNC stalled. The hospital lost its best pediatric cardiac intensivists and its most experienced nurses. When that happens, it is often best to close the program. Closure and consolidation of low-volume centers saves lives.”

Pipeline to administrators and overseers

In 2018, UNC opened a new pediatric catheterization laboratory, provided more education for the program team and upgraded echocardiography equipment, according to the news release.

A cardiac intensive care unit is slated to open this summer in the N.C. Children’s Hospital.

It’s unclear how quickly the external advisory board will review the program and develop recommendations for whether it is equipped to do the complex surgeries that have been temporarily suspended.

“We will resume performance of these surgeries only after both regulators and the esteemed physicians on the Advisory Board agree it is appropriate,” Burks added.

Owen posted a letter to families who have children in the pediatric heart surgery program to an N.C. Children’s Hospital website inviting them to bring any questions or concerns to the committee overseeing the program.

“As the governing body for UNC Health Care, our commitment to you is that we will regularly evaluate the quality of the pediatric heart surgery program by reviewing all data, listening to our caregivers and to the external expert advisory board, in addition to the family advisory council, and ensuring we approve the resources necessary to offer the highest quality care and service to your child and your family,” Owen said in the letter dated June 2019.