Amara Le thought her newborn daughter’s surgery had gone well.
So it came as a shock when, at a followup appointment, a doctor alerted her to a serious complication: The baby had been released from Johns Hopkins All Children’s Hospital in St. Petersburg with a needle in her heart.
Le and her fiance, Joshua Whipple, rushed their daughter back to All Children’s and demanded the needle be removed. But the surgeon who had operated on Katelynn told them it didn’t exist.
They went home, Le recalled. “We had no choice.”
Ten days later, Katelynn needed emergency surgery, unrelated to the needle. Her parents took her to a different hospital. Within a half-hour, that surgeon had found the needle stuck in Katelynn’s aorta.
Asked Tuesday by the Tampa Bay Times about Katelynn’s case and broader issues with the hospital’s Heart Institute, All Children’s leaders acknowledged a series of problems that had not previously been made public.
The mortality rate among heart surgery patients has increased, they said. At least one top surgeon has stopped operating. And surgeons from another hospital, brought in to evaluate the program, found what All Children’s leaders would describe only as “challenges.”
All Children’s also acknowledged that since 2016, needles have been left in not one but two children.
“If I said to you we didn’t have challenges, I’d be lying,” said Dr. Jonathan Ellen, the hospital’s CEO.
In response, the institute has cut its number of operations significantly and stopped performing some complicated surgeries, Ellen said.
A Times examination of Katelynn’s treatment, based on medical records and interviews, illustrates how those problems affected patients’ lives, and just how easily one of Florida’s most prestigious children’s hospitals was able to keep a serious medical mistake out of the public eye.
All Children’s later settled out of court with Katelynn’s family for a total of about $50,000, most of which will be paid to Katelynn when she is an adult, records show.
Le and Whipple, who are now married, were only 16 and 18 when they had Katelynn; they didn’t know anything about the workings of a baby’s heart. But Le trusted her daughter was safe at All Children’s.
“Everyone was telling me it’s the best hospital — it’s the best place you can be,” she said.
• • •
Katelynn Whipple was born with an interrupted aortic arch, a condition that affects fewer than three in a million babies.
It wasn’t detected before her birth. When Katelynn failed two blood oxygen tests, the Pinellas County hospital that delivered her on July 4, 2016, sent her by ambulance to All Children’s.
A team there quickly diagnosed the problem: A gap in the blood vessel carrying oxygen-rich blood from Katelynn’s heart to her body was cutting off circulation to her lower extremities.
She needed emergency surgery.
On July 7, physicians opened Katelynn’s chest, lengthened her aorta with tissue from a donor, and relocated her pulmonary artery. The lead surgeon, Dr. Tom Karl, couldn’t sew up her chest after the procedure; her organs were too swollen. He left Katelynn’s chest open, covered with a patch, for two days — a sometimes acceptable practice.
Katelynn’s parents knew one of her vocal cords might have been nicked during the procedure, and that she might develop problems speaking and eating. They also knew the surgeons chose to leave a small pacing wire behind.
Nobody told them about a needle.
The hospital staff knew it was there. Katelynn’s medical records describe another doctor raising concerns about a missing suture needle shortly after the surgery, when the number of needles retrieved from Katelynn’s body fell short of the original count. The tiny needles are used to help stitch tissue together.
On July 9, a scan showed a “needlelike foreign body” in her chest.
“It likely does represent a surgical needle,” a radiologist wrote in a report.
Karl searched for the missing needle when he sewed up Katelynn’s chest on July 9, the records show. But he couldn’t find it. The radiologists noted it again July 14.
It would be more than two weeks until anyone told her parents.
• • •
In the interview with the Times, Ellen said the Heart Institute was taking steps to improve patient care and keep children from being harmed.
“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,” he said.
But when pressed by a reporter, he would not say exactly what went wrong or provide updated statistics on the institute’s performance.
Like many other pediatric heart surgery programs, All Children’s publishes its mortality rates on the Society of Thoracic Surgeons website. The hospital provides an overall death rate for surgical patients over a four-year period. The rate is then adjusted based on the complexity of the procedure.
Its latest 3.4 percent mortality rate, calculated from January 2013 to December 2016, is near the national average. The adjusted rates are also consistent with the national averages, though the Heart Institute did a little worse on the most challenging cases.
Heart Institute deputy director Dr. Jeffrey Jacobs, a surgeon who led a national campaign for hospitals to publish heart surgery statistics, said the institute has already prepared its 2017 figures and submitted them to the Society of Thoracic Surgeons. When asked to provide those numbers to the Times, however, All Children’s declined.
“Any one year is the wrong indicator of the program,” Ellen said.
Ellen said he expects a “slight increase” in the four-year mortality rate when the 2014 to 2017 numbers are released this summer because of the recent troubles.
It is also difficult to know the number of preventable mistakes that happened at the hospital. Hospitals are required to document such mistakes in state “adverse incident reports,” but those records are kept secret.
Experts consider leaving a surgical instrument inside a patient’s body a “never event” — a mistake so serious and preventable that it should never happen. Nurses carefully count each needle and instrument before a procedure. They count again before the patient is sewn up.
Across Florida, so-called “foreign objects” are rarely left behind in patients. Statewide figures — which are available — show hospitals removed only 100 foreign objects in 2016, and 83 in 2017, according to state records.
The Joint Commission, a major hospital accreditation agency, says that mistake can cause patients immense physical and emotional harm and even lead to death.
Ellen said he could “appreciate the fact that [a surgical needle] causes a lot of anxiety” for a family.
“That being said, these are really complex surgeries and the needles are really small and it’s not unusual for some organizations not to even count the needles,” he said.
The needles are usually a quarter-inch long. A newborn’s heart is the size of a walnut’s shell.
• • •
Le was terrified when she learned about the needle, she recalled. She and Whipple wanted Katelynn readmitted to All Children’s that day.
The family drove to the hospital and asked a hospital employee to get Karl on the phone. Whipple spoke to Karl. He told the Times that the surgeon acknowledged having looked for a needle after the procedure, but insisted it wasn’t in Katelynn’s chest.
Whipple asked Karl for a written statement, he said. None was provided.
Karl, 69, did not return calls from the Times.
The family went home to Tarpon Springs, where they were living at the time. Whipple and Le said they were afraid to pick up their daughter; a physician had warned the sharp needle might puncture an organ.
At Katelynn’s next followup appointment, the doctor noticed her legs were cold to the touch. Her parents rushed her to St. Joseph’s Children’s in Tampa, where surgeons said she needed another heart procedure.
Then they found the needle.
The family hired a lawyer. All Children’s ultimately agreed to give Katelynn $5,000 annually for four years, beginning on her 18th birthday, and $25,384 on her 25th birthday, records show.
The hospital gave Le and Whipple an additional $2,500 each, they said.
Le said she wished she had pushed for more money. But “we wanted to move on,” she said.
Ellen told the Times that Karl would have been taught to bring the issue to the parents’ attention. “Our policy is as soon as we find a problem, we tell the parents about it,” he said.
He could not comment on an individual case, he said.
All Children’s hired Karl in 2014 from Mater Children’s Hospital in Queensland, Australia, despite malpractice settlements and problems in prior roles, state records show.
In 2008, the University of California San Francisco suspended his clinical privileges following allegations that his conduct “disrupted patient care and educational activities,” according to the medical license application he filed in Florida in 2014.
Karl wrote that the suspension was for political reasons unrelated to his clinical performance and that he and the university later reached a confidential settlement agreement.
In the same paperwork, Karl indicated that he had settled two malpractice cases for more than $100,000 in the last 10 years. One was settled by the Children’s Hospital of Pennsylvania for $3.5 million. Karl told the Department of Health he was deemed responsible for $800,000 of the settlement.
“This was a tragic outcome which involved multiple rare complications of a rare disease,” he wrote.
The second case involved a patient who had renal failure after surgery. The patient claimed Karl did not get consent for a procedure and had allowed an unqualified doctor to participate. Karl denied both allegations and wrote that he had saved the patient’s life. The case settled in mediation for $1 million in 2006.
Ellen said Karl had been thoroughly vetted before his hiring.
“My assumption is that he passed all of the muster that he needed to pass,” he said.
But Katelynn’s parents were disturbed to learn about those incidents from the Times.
“I feel like that’s something we should have known,” Le said. “Before we did the surgery, I asked what his history was like. He didn’t acknowledge that he had any issues.”
• • •
The All Children’s Heart Institute is one of 10 pediatric heart surgery programs in Florida.
Five are within roughly 100 miles of St. Petersburg. Two are in the Tampa Bay area.
Heart surgery programs add to a hospital’s prestige. They can also bring in millions of dollars annually.
But experts say pediatric heart surgeons need high patient volumes to keep their skills sharp. And that can be a challenge in an oversaturated market.
Ellen believes there are five too many in the state.
“None of them have stood out as nationally recognized, top 20 heart programs,” he said.
Last November, amid compounding problems, All Children’s had surgeons from the top-rated Texas Children’s Hospital Heart Center come and evaluate its heart program. The delegation reported concerns about the team at All Children’s, Ellen said, and urged employees to communicate better.
On Nov. 6, Jacobs and another doctor sent an email to the Heart Institute’s medical staff saying Karl would no longer be “actively working or providing patient care” at the hospital effective that day.
The announcement also said that same thing about the chief of the cardiovascular intensive care unit, Dr. Mel Almodovar.
“These decisions are never easy, but (we) believe they are in the best interests of our programs, our patients we serve and our staff,” they wrote.
Tuesday, Ellen told the Times that although Karl is not currently practicing at the hospital, he remains on its medical staff “and could be called on upon if there was an emergency.” After a “hard conversation,” Karl is now focusing on mission work and academics, Ellen said. He is still listed on the institute’s website as a surgeon.
Ellen said Almodovar resigned “in the end.” He called Almodovar an “exceptional physician” who “just did not fit for our culture.”
Almodovar did not return calls from the Times.
Since the departures, a surgeon has been flying to St. Petersburg twice a month from another Johns Hopkins hospital to help with the caseload, Ellen said.
Over the last two years, the number of cardiac surgeries performed at the Heart Institute has dropped from 258 to 164, Jacobs said.
Ellen said the hospital is referring some complex cases to other heart programs.
“We don’t think we necessarily at this point are the best for some of the highly complex cases,” he said.
On its website, however, All Children’s continues to describe its heart surgery program as “world class” and bill itself as “a leading center for neonatal (newborn) and pediatric heart transplant.”
Ellen said he remains optimistic about the future of the Heart Institute. He is conducting a nationwide search for a surgeon to lead the department. Eventually, he said, he hopes to build it into an elite program.
• • •
Katelynn is a now a bubbly toddler who loves coloring books and chasing the family’s two dogs from room to room in their Ocala home. She is learning simple words and speaks them in a quiet, raspy voice. The nicked vocal cord, her mom says.
The needle that was left behind in Katelynn’s chest didn’t do any damage, and, overall, her prognosis is good. But because of her condition, she will almost certainly need additional heart surgeries as she gets older.
Her parents say she won’t be returning to All Children’s.
Times data reporter Connie Humburg contributed to this report.
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