State and federal inspectors visit All Children’s after reports on heart surgery deaths

State and federal inspectors descended on Johns Hopkins All Children’s Hospital this week, following sharp calls for an investigation into problems in the hospital’s heart surgery unit, the Tampa Bay Times has learned.

The scope of the inspection is unclear. But hospital regulators had been criticized in recent weeks for their lax response to early signs of an increase in mortality at the hospital’s Heart Institute.

A Florida Agency for Health Care Administration spokeswoman said her agency had been at the facility.

A spokeswoman for the hospital confirmed federal inspectors had been there, too.

“We appreciate the oversight role that our regulators play and we will, as always, be fully cooperative and collaborative as they conduct any reviews necessary,” a statement from the hospital said.

A spokeswoman for the federal Centers for Medicare and Medicaid Services declined to comment beyond saying the matter remained “an ongoing review.”

In November, the Times reported that the mortality rate for heart surgery patients at All Children’s tripled from 2015 to 2017 to become the highest rate in Florida. The increase occurred after staff members warned the hospital’s leaders about problems with two heart surgeons, the Times found.

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

State and federal regulators knew the institute was having problems months earlier. In April, the hospital’s CEO told the Times that the institute had “challenges” that led to an uptick in mortality, and acknowledged the hospital had left surgical needles inside two children.

In May, state regulators cited the hospital for not properly reporting two medical mistakes, which is required by state law. Days later, a spokeswoman for the federal agency told the Times that it would perform its own investigation.

But state regulators didn’t fine the hospital, and overlooked several subsequent warnings that its surgical results had been poor.

And federal inspectors later changed course and decided not to undertake a comprehensive review of the heart surgery program, the Times reported last month. One reason was that state inspectors hadn’t found any violations of federal rules, a spokeswoman said. Another was that a nonprofit hospital accreditor was due to perform a scheduled review.

[ More coverage: State, federal officials missed warnings at All Children’s heart unit ]

When the program’s mortality rate was revealed, the agency faced criticism from local lawmakers. Democratic U.S. Reps. Kathy Castor and Charlie Crist called for a federal investigation to “provide the answers and accountability demanded by the seriousness of this situation.”

In a joint statement Friday, Castor and Crist called this week’s inspection “long overdue.”

“But it shouldn’t require outside pressure for regulators to do their job protecting patients,” they added. “Inadequate oversight prolonged the pain and suffering for patients and their loved ones. This inaction demands greater accountability from CMS, AHCA and All Children’s.”

Although much of the federal government is shut down, the Centers for Medicare and Medicaid Services remains open and federal investigators are being paid.

State and federal regulators wield tremendous power over hospitals. The state can revoke a hospital’s license to operate. Federal officials can shut hospitals out of the Medicaid program, which provides health insurance to low-income adults and kids. All Children’s billed the program more than $550 million in 2016 — about 66 percent of its total charges, state data shows.

For All Children’s, the inspection is only the latest fallout since the depth of the Heart Institute problems were revealed. The CEO, three vice presidents and two surgeons have since left the hospital.

The institute is not currently performing surgeries.

Johns Hopkins Medicine, which owns the hospital, has hired a former federal prosecutor to lead an investigation into what happened at the institute and a panel of outside experts to help it develop a plan to reopen the heart surgery program.

Contact Kathleen McGrory at kmcgrory@tampabay.com. Follow @kmcgrory. Contact Neil Bedi at nbedi@tampabay.com. Follow @_neilbedi.

[ Click here to read all of the Times' coverage of All Children‘s Heart Institute ]