The state of Florida has declined to investigate a complaint from a mother whose baby died after heart surgery at St. Mary’s Medical Center in West Palm Beach, which CNN found had a high mortality rate for pediatric open-heart surgeries from 2011 to 2013.
In a July 20 letter, a representative of the Agency for Health Care Administration expressed her condolences to Nneka Campbell, whose 10-month-old daughter, Amelia, passed away after open-heart surgery at the hospital.
“Loss of a loved one is difficult at any time, but particularly when the family has questions concerning that loved one’s care,” wrote Michelle Hart, a senior management analyst supervisor with the agency’s Complaint Administrative Unit.
Hart then went on to tell Campbell that “it has been determined the Agency will not conduct an investigation for your specific complaint.”
“I read it again and again and again, and I just couldn’t believe it,” said Campbell. “How can someone say, ‘We choose not to hear you?’ ”
Several experts reached by CNN expressed surprise and concern about the agency’s letter to Campbell, whose daughter died in 2012.
“Their response to that poor parent was terrible,” said Dr. Louis St. Petery, the executive vice president of the Florida chapter of the American Academy of Pediatricians for 30 years, until last month. “Either children’s lives matter or they don’t, and (the agency) is saying they just don’t care.”
The CNN stories in June showed that at least nine babies, including Amelia, died after heart surgery at St. Mary’s from 2011 through June 2015, and another was paralyzed. The surgeries and the deaths continued even after the chairman of an expert state panel recommended in June 2014 that St. Mary’s stop doing heart surgeries on babies under the age of 6 months, and stop doing complex heart surgeries on all children.
After CNN’s story was published, the hospital released a statement saying that CNN’s mortality calculations were “wrong,” “exaggerated,” and “completely erroneous” and that the program’s risk-adjusted mortality rate was within the average range for pediatric heart surgery programs nationwide.
The hospital also said it would launch a comprehensive review of its pediatric cardiac surgery program and wouldn’t schedule any elective pediatric congenital cardiac surgery cases until the review was completed.
‘The children of Florida deserve better’
Campbell said she’d never even heard of the Agency for Health Care Administration until she read CNN’s coverage in June.
“I read where they said they hold hospitals accountable, so I’m saying to myself, ‘OK, maybe they’re serious,’ ” she said.
Campbell filed a complaint with the agency in early July. “My daughter’s treatment at St. Mary’s hospital was far below the standard of care. It led to her death. I’d like to talk to someone in detail about what occurred at St. Mary’s hospital,” she wrote.
She says she expected someone from the agency to contact her.
Instead, Hart wrote that “(your) concerns have previously been reported to us and were investigated during our June 8-12, 2015 survey.”
Campbell wrote Hart back, asking how that was possible when no one from the agency had ever spoken to her or to Amelia’s father.
“How can you dismiss my complaint without being aware of the scope of my complaint?” she asked.
“You would expect at least a little investigation,” said Art Caplan, a bioethicist at New York University. “The death of a child is serious. I would expect more.”
The agency says it reviewed the care of the babies mentioned in CNN’s reports. Those stories did not include extensive details about Amelia’s care.
In a statement to CNN, Elizabeth Dudek, secretary of the Agency for Health Care Administration, said “a review of care (was) provided to each child referenced in CNN’s reporting on St. Mary’s. This 5-day review was conducted by a clinical team who examined patient care, nursing and surgical practices, and quality assurance and performance improvement. We will continue to hold every hospital in Florida accountable to the patients they serve.”
CNN asked why the agency hadn’t reached out to Campbell, and if Campbell was correct that her daughter’s treatment at St. Mary’s was far below the standard of care and led to her death, as Campbell’s complaint alleged.
“We will respond directly to Ms. Campbell,” answered a spokeswoman, Shelisha Coleman.
Coleman declined to answer whether or not the treatment of the other babies mentioned in CNN’s stories was below the standard of care.
The experts CNN consulted said the agency should have investigated Campbell’s complaint.
“They’re putting (Campbell) off and not responding to her complaint in a reasonable fashion,” said Dr. Ira Gessner, professor emeritus of pediatric cardiology at the University of Florida College of Medicine. “They were wrong.”
“Their response should have been to jump in and do an appropriate investigation and find out the validity of the parent’s complaint and what’s going on at that hospital,” added St. Petery, the former American Academy of Pediatricians chapter executive vice president.
Dudek, the Agency for Health Care Administration secretary, declined to respond directly to criticism of her agency’s response.
St. Petery said he holds not just the agency, but also Florida Gov. Rick Scott accountable.
“I think for political reasons, from the governor’s office on down, they’re taking a hands-off approach. That’s great for politics and for dollars, but not great for children,” said St. Petery, a pediatric cardiologist in Tallahassee who’s been practicing for 40 years. “The children of Florida deserve better than that, particularly this mom.”
The Agency for Health Care Administration “works to hold every hospital accountable to the patients they serve, and they have conducted seven site visits at St. Mary’s in the last 10 months,” John Tupps, a spokesman for the governor, wrote in an email.
Visits found deficiencies
In the letter to Campbell, the agency invited her to look at its inspection reports.
The agency reported four violations found during visits to the pediatric heart program at St. Mary’s on June 12 and June 26.
One pertained to electrical safety issues in the pediatric open-heart surgery operating room. Two others criticized the hospital for keeping incomplete patient care records and for lacking “coping interventions” to help the parents of a baby who was critically ill and then died after open-heart surgery. The fourth cited the hospital for failing to conduct policy and procedure reviews annually.
“Most of these deficiencies are not relevant to this mom,” added Caplan, the New York University bioethicist.
Gessner agreed.
“These don’t speak directly to the issues involved with the care of (Amelia Campbell) or the other patients,” he said. “I feel like (the agency) punted.”
While the agency emphasized in its statement to CNN that it had visited St. Mary’s seven times in the past 10 months, spokeswoman Coleman said that only three pertained to the program in question.
The experts consulted by CNN said they felt it was misleading for the agency to repeatedly emphasize seven visits instead of three.
“It’s not misleading,” Coleman wrote to CNN. “While our survey staff may visit a facility for a specific complaint they can still cite a facility for additional issues non-related to a specific complaint.”
CNN asked Coleman if the survey staff cited St. Mary’s for additional issues concerning the pediatric heart surgery program during the four unrelated inspections. She did not provide a response.
Inspection reports for three of the four unrelated visits are posted on the agency’s website. None of them describe problems with the pediatric heart surgery program, according to a review by CNN.
The fourth report is not posted. The agency says it does not post inspection reports to its website “where no deficiencies are cited.”
I. Glenn Cohen, a bioethicist at Harvard Law School, said inspections like these are not meant to directly assess whether patients received the appropriate care, or try to find the cause of bad outcomes. He said site visits evaluate the systems around the care, such as whether doctors and nurses are licensed and whether operating rooms are cleaned properly.
“The analogy would be to driving a car. Let’s say you get into a lot of accidents, they would come and certify that the signals work and you’ve taken your driver’s license test, but they don’t actually look at your driving record,” he said.
Caplan said he thinks when there’s a bad outcome at a hospital, a government agency should try to assess what went wrong and why, just as the National Transportation Safety Board does after a plane accident.
“I’ve been screaming for this for years,” he said. “I think it would improve patient safety.”