After the deaths of five infants, a team of doctors from across the state was asked in 2014 to review a Palm Beach County hospital's highly specialized program for doing heart surgeries on children.
The team's recommendation: St. Mary's Medical Center should not perform heart surgeries on babies under 6 months old because the program did not handle enough cases to maintain the expertise needed for quality care.
But surgeries continued at St. Mary's. And the issue has drawn national attention in recent weeks after CNN reported that eight infants died following heart surgery at the hospital over four years --- with another dying June 2, after the first CNN report aired.
St. Mary's and a state agency dispute CNN's findings. But some doctors are calling for the state to exert more control over the quality of hospitals that perform such life-and-death procedures.
The debate is tangled in discussions about the role of a long-running state program known as Children's Medical Services. The program oversees care for tens of thousands of children with special health-care needs. Behind the scenes, it also has standards of care that hospitals can choose to meet.
The team of pediatric cardiologists who went to St. Mary's in 2014 was told the hospital could decide whether to upgrade its infant cardiac program to Children's Medical Services standards voluntarily, based on the doctors' findings. The hospital says it has made a number of improvements as a result of the visit and could make more.
But in seeking more state control over such programs, some doctors want the standards put into state law, as was the case before 2001. Such standards would have required the St. Mary's program, in part, to reach a certain volume of infant cardiac surgeries.
In a June 4 email to a state Department of Health official, Children's Medical Services cardiac consultant Bill Blanchard urged the state to respond to the deaths at St. Mary's by "adopting the already existing CMS standards into law." Children's Medical Services is housed at the Department of Health.
Blanchard also advised the department to require any new program given what is known as a "certificate of need" to meet Children's Medical Services standards within three years. Certificates of need are part of a separate state regulatory process that helps determine whether hospitals can be built or expanded and whether they can offer certain types of programs.
"While this is the opposite direction we have been heading recently due to our lack of legislative authority, it seems to me to be the most prudent and conscientious way to proceed for the good of the children of Florida," wrote Blanchard, who was part of the team of cardiologists who conducted the site visit at St. Mary's in April 2014.
Shelly Weiss, a spokeswoman for Tenet Healthcare Corp., which owns St. Mary's, said the hospital has begun "exploring opportunities for formal partnerships" with other providers and conducting weekly presentations to a multi-disciplinary group of physicians.
The team of cardiologists that visited St. Mary's last year sat on a Children's Medical Services advisory panel for pediatric cardiology. The panel's chairman, Jeffrey Jacobs, confirmed to The News Service of Florida that the Department of Health told the panel in August 2014 that members could not conduct site visits or peer reviews of any infant cardiac surgery programs unless hospitals wanted such visits.
That has caused at least some pediatric cardiologists to raise questions about the oversight of the procedures.
"It suggests that we have moved from insisting on specific minimum standards to merely making suggestions with respect to cardiac care for the children of Florida," said David Nykanen, a pediatric cardiologist in Orlando and a member of the CMS Cardiac Technical Advisory Panel. "I believe this is a mistake for very highly specialized programs that offer care to kids with complex problems."
Department of Health spokeswoman Tiffany Cowie said in an email that neither the department nor the panel has "any independent legal authority to conduct site visits of pediatric cardiovascular programs. However, if a hospital voluntarily requests a site visit, Children's Medical Services may offer the expertise of highly qualified cardiac professionals from the CTAP (panel) to fulfill the hospital's request."
Phyllis Sloyer, who directed Children's Medical Services from 1998 to 2011, said hospitals that were cited in peer reviews during that time had complied to keep the designation of meeting the program's standards of care.
"During my tenure, I recall having at least one or two facilities issued warnings, and we saw the effectiveness of the actions they put into place with subsequent data and peer review," Sloyer said. "And that's what's so important in continuing to look at the quality of care for children who have significant chronic illnesses."
St. Mary's says it is has stopped performing elective infant heart surgeries until it has completed "a comprehensive review of our pediatric cardiovascular program to reinforce the community's confidence."
Although St. Mary's treats children enrolled in Children's Medical Services, its infant heart surgery program has not chosen to seek the designation of meeting CMS standards. "We are utilizing CMS standards as one basis for our internal review of our program," Weiss wrote in an email.
But Nykanen said the regulatory culture in Florida had changed.
"There is a sense that negative criticism of any group like this (St. Mary's) is not welcome … (that it) becomes an effort to remove any competition," he said. "When you come up with a negative report, the response from a bureaucratic standpoint has often been, 'Well, you guys are just trying to protect your own programs.' "
CNN calculated that from 2011 through 2013, the death rate for infant cardiac surgery at St. Mary's was 12.5 percent, more than three times the national average of 3.3 percent.
But in a June 7 statement, the hospital said CNN mischaracterized its performance and that "for the four-year period ending on June 30, 2014, the risk-adjusted mortality rate for our program was 5.3 percent."
"CNN's original presentation and ongoing coverage --- combining an inaccurate claim about our mortality rate with heartbreaking stories of individual patients arranged into a timeline that likely could be recreated for any program across the country --- are sensational, misleading, and lacking in journalistic integrity," the hospital said in a statement.
According to spokeswoman Weiss, St. Mary's is considering affiliating with another hospital that performs a greater number of infant heart surgeries.
"Our program is a new program, and all new programs start with low volume," she wrote in an email. "We are working carefully to build our case volume, while also remaining committed to gradually increase the complexity of the procedures performed as our program matures, as was advised by the external reviewers as part of the voluntary assessment we requested from the Florida Department of Health in early 2014."
The state Agency for Health Care Administration, which has regulatory oversight of St. Mary's, also disputed CNN's findings.
According to AHCA, the death rate following infant heart surgery at St. Mary's was 4.58 percent from October 2011 to September 2014, compared to the state average of 3.97 percent. The agency also said it had received one complaint concerning the pediatric cardiac program at St. Mary's, which was investigated in October 2012. The agency "cited the facility for issues related to its risk management program and … revisited the facility to confirm those problems had been corrected."
AHCA Secretary Liz Dudek said in recent statement that her agency had "conducted five site visits (at St. Mary's) over the last six months and will continue to work with our partner agencies to hold this hospital accountable to the patients they serve."
Aaron Albright, a spokesman for the federal Centers for Medicare & Medicaid Services, said his agency is taking the allegations "very seriously" and conducting an investigation. "Essentially, we look at whether the facility complies with federal law and meets our conditions of participation in the Medicare and Medicaid programs," he wrote in an email.