State investigating problems at All Children’s Heart Institute

State regulators are investigating problems at the Johns Hopkins All Children’s Hospital Heart Institute that were made public in a Tampa Bay Times report last week.

In the report, hospital leaders said the mortality rate among pediatric heart surgery patients had increased and that a top surgeon had stopped operating. They also said their surgeons had left needles in two children since 2016.

The Agency for Health Care Administration, which licenses and regulates health care facilities across the state, is reviewing each of those issues, agency spokeswoman Shelisha Coleman said Friday.

Separately, the Joint Commission, a hospital accreditation group that sets standards for safe, high-quality patient care, is requesting a written response from All Children’s regarding at least one of the needle incidents.

In a statement Friday, All Children’s said that AHCA had arrived at the hospital Thursday morning for a “routine, unannounced review” that the hospital “had been anticipating.”

AHCA characterized the visit as part of an investigation. The inspectors will issue a report and could recommend sanctions, including fines, if they find violations.

Medical experts consider accidentally leaving a surgical instrument inside a patient a “never event” — an error so egregious, it should never happen.

“If it happened once, you can say the process didn’t work,” said Alan Levine, AHCA’s top administrator from 2004 to 2006 and now CEO of Ballad Health in Tennessee. “But if it happened twice, somebody would need to say stop and figure out what was wrong with the process.”

All Children’s said it could not discuss individual cases, citing federal privacy laws. But the hospital also said leaving a needle smaller than 10 millimeters in a patient is allowed under its policies when it is intentional by the surgeon and “in the best interest of the patient.”

“The time that the surgeon spends looking for a small needle may cause harm because seconds count during such operations,” the hospital wrote in its statement.

All Children’s cited a study by the NoThing Left Behind Surgical Patient Safety Project that found no evidence of needles smaller than 15 millimeters ever hurting a patient when left in large cavities like the chest. The author of the report, Dr. Verna Gibbs, told the Times that it is up to a surgeon to decide whether “to remove the surgical item or if it is safer to leave it where it is.”

The Times report highlighted the case of a then-3-day-old girl, Katelynn Whipple, who was at All Children’s for open-heart surgery. Medical records show fewer surgical needles were retrieved from Katelynn than were used in the procedure. Doctors later repeatedly spotted what appeared to be a needle on scans of her chest.

The girl’s parents told the Times they weren’t aware of the issue until Katelynn was discharged and another physician noticed it in Katelynn’s records during a follow-up visit. Amara Le and Joshua Whipple returned to All Children’s to have the needle removed. But when they spoke to the lead surgeon, Dr. Tom Karl, he insisted there was no needle in their daughter’s chest, they said.

Surgeons at a different hospital later found a 7 millimeter needle in the girl’s aorta during a second heart surgery, unrelated to the needle. All Children’s settled with the family out of court for about $50,000, most of which will be paid to the girl after she turns 18, records show.

Karl is not currently practicing at the hospital, though he remains on the medical staff and could resume operating if he were needed, the hospital said. He did not respond to an email and declined to comment through a hospital spokeswoman.

In an interview for last week’s story, the hospital’s CEO acknowledged “challenges” at the Heart Institute, and told the Times that the hospital had appropriately reported any mistakes.

“If we found something that went wrong, we would notify our board, we would notify the right regulatory agencies, we would look at our processes,” Dr. Jonathan Ellen said.

Friday, however, the hospital’s statement said that it “does not report” cases to AHCA where surgeons leave a needle in a patient intentionally.

Levine said as the CEO of a hospital system, he would have reported it.

“If the evidence showed the doctor knew the needle was there and did something safe, I would report it and explain that to the state,” he said. “I would stand by the doctor but not reporting it undermines the regulatory system.”