1. Investigations

State may publish more data on heart surgery deaths

The change could alert families to problems like the ones at the All Children’s Heart Institute much more quickly.
Johns Hopkins All Children's Hospital [Times file]
Johns Hopkins All Children's Hospital [Times file]
Published Dec. 17, 2018
Updated Dec. 17, 2018

A state panel is considering a proposal to publish statistics online that would detail the number of deaths at Florida children’s heart surgery programs each year and be updated as often as every six months.

The move would make the centers subject to an unprecedented level of transparency, letting prospective patients and their families know whether programs are struggling far more quickly than is currently possible.

The proposal could be finalized as soon as January and is coming under consideration as the oversight surrounding Florida’s heart programs faces increased scrutiny.

Two weeks ago, a Tampa Bay Times investigation found the Johns Hopkins All Children’s Heart Institute last year had the worst death rate of any Florida pediatric heart program at any point in the past decade.

[ Read the full investigation: Johns Hopkins promised to elevate All Children’s Heart Institute. Then patients started to die at an alarming rate. ]

The Times also reported that state regulators missed multiple signs the institute was having problems.

Earlier this year, the hospital’s then-CEO Dr. Jonathan Ellen repeatedly declined to provide the program’s 2017 mortality rate to the Times. Reporters ultimately performed their own analysis of state data. Ellen resigned as the hospital’s CEO last week.

[ Read: How we calculated All Children’s surgical mortality rates ]

If data had been published every six months, the problems might have become public sooner. The Times analysis found that the Heart Institute’s mortality rate in the second half of 2016 was the program’s worst six-month period in eight years.

The rate kept rising. At least eight children died in 2017.

Most of the families that spoke with the Times did not know there were serious problems at the institute when they brought their children to the hospital for surgery. The data available to the public did not reflect the program’s struggles.

A spokeswoman for All Children’s parent company, Johns Hopkins Medicine, said Friday the hospital would now support the panel’s proposal to publish more data.

Dr. Jeffrey Jacobs, a former heart surgeon at All Children’s whose surgeries were a focus of the Times investigation, had led the state panel since April 2018. He left the hospital’s staff on Tuesday and resigned as the panel’s chairman Thursday night.

Jacobs’ attorney said he supports the panel’s work and the proposal for the state to publish data more often.

Nine heart-surgery programs, including All Children’s, currently send annual data to the Society of Thoracic Surgeons, which publishes an average surgical mortality rate for each hospital based on the past four years of data. One Florida hospital, Nicklaus Children’s Hospital in Miami, also posts the results of surgeries almost immediately on its website. Another, Wolfson Children’s Hospital in Jacksonville, lists some data on its own website but has no information on the society’s website.

The Society of Thoracic Surgeons updates the averages with new data every year. It has declined to release older data to the Times, and earlier this year rejected a request from reporters to buy data for individual years. It said reports can be given only to hospitals and government health agencies, and only if the heart surgery programs consent.

Four-year averages can mask major problems. In All Children’s case, the figures released this year on the society’s site show mortality increasing by only a tenth of a percentage point, to 3.5 percent. Looking one year at a time, however, the Times’ analysis found the program’s mortality rate had tripled between 2015 and 2017. Nearly 10 percent of patients died last year.

The All Children’s Heart Institute is the second Florida children’s heart surgery program to face media scrutiny for its death rates in recent years. In June 2015, CNN reported that a new program at St. Mary’s Hospital had a high mortality rate. St. Mary’s heart surgery unit shut down two months later.

In response, the Florida Legislature created the Pediatric Cardiology Technical Advisory Panel in 2017 to help the state Agency for Health Care Administration better regulate children’s heart surgery programs.

Florida hospitals already needed to comply with a list of standards before opening heart surgery programs, including having at least one surgeon who met requirements set by the American Board of Thoracic Surgery.

The panel of pediatric heart surgeons, cardiologists and other medical professionals was tasked with creating specific rules for programs once they were operating.

The committee has been considering how programs should report their results for months.

When the Times reported in April that a heart surgery patient had left All Children’s with a needle in her chest, Ellen said the program had faced “challenges” and the mortality rate had increased. But he would not release surgical results from 2017, saying four-year rates were the “industry standard.”

Dr. Jorge McCormack, a pediatric cardiologist who practices in the Tampa Bay region, expressed concern during a May meeting of the panel that Ellen was not forthcoming with the annual results.

“I don’t think we should wait — or the people of Florida or the cardiologists of Florida should wait — for four years to realize that something is wrong,” McCormack said.

McCormack declined to comment to the Times.

Since then, the panel has met more than 20 times. It has developed a 60-page document of recommended rules that include forcing programs to report data to the state on a yearly basis, requiring additional board certifications for heart program staffers and setting minimum standards for laboratory equipment.

The panel is waiting on cost estimates from the Society of Thoracic Surgeons to see if it is feasible to publish one-year and four-year data. It is also looking into asking the society to more regularly audit the data Florida programs submit.

In its most recent meeting Thursday, the group also considered instituting regular site reviews of every program in the state conducted by teams of pediatric heart surgeons and cardiologists.

Thursday, McCormack said regular check-ins could “help prevent” the type of issues that occurred at All Children’s.

Dr. David Nykanen, the group’s interim chairman, said he is hoping the panel is able to finalize the recommended standards by the next meeting, which would be after the new year. They would go next to the Agency for Health Care Administration for approval.

State Sen. Aaron Bean, a Fernandina Beach Republican who chairs the Health and Human Services Appropriations Subcommittee and played a key role in establishing the advisory panel, said his office would be “carefully monitoring” the panel’s recommendations.

What happened at All Children’s, he added, “should not happen.”

[ Click here to read all the Times' reporting on the All Children’s Heart Institute ]


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