The federal government has opened an investigation of Johns Hopkins All Children’s Hospital, days after a state agency cited the hospital for not reporting two serious medical errors.
The federal review, by the Centers for Medicare and Medicaid Services, could be more wide-reaching than the state’s, which focused on the hospital’s procedures for minimizing risk and handling mistakes.
In an email to the Tampa Bay Times late Thursday, the hospital said it has been “transparent.”
“Patient safety and providing the highest quality care are foundational to our mission and the manner in which we care for children,” the statement said. “We work closely with local and federal regulatory agencies and will continue to collaborate in the interest of our patients and their families, who are always our number one priority.”
The CMS review will make sure the hospital is following federal rules and regulations, spokeswoman April Washington said. The federal agency contracts inspections related to its rules to the state Agency for Health Care Administration.
Inspectors typically perform what’s known as a Quality Assurance and Performance Improvement review to confirm hospitals are operating at acceptable standards and medical outcomes required to receive federal dollars. If they find problems, they give the hospital 10 days to devise a plan for correcting them.
Although the AHCA is the agency that licenses health care facilities in Florida, the federal CMS wields tremendous power. In the most extreme cases, the agency can shut hospitals out of the Medicaid program, which provides health insurance to low-income adults and kids.
That would be devastating for any hospital. All Children’s billed the program more than $550 million in 2016 — about 66 percent of its total charges, according to state data.
Problems within the hospital’s Heart Institute were first made public in a Times report in April. The newspaper highlighted a 2016 case in which a needle was left in 3-day-old Katelynn Whipple after surgery. Katelynn’s parents told the Times they did not learn about the needle until after their daughter was discharged. Later, they said, the surgeon who performed the procedure denied it existed.
In April, hospital leaders told the Times that surgical needles had been left behind in two patients since 2016. Dr. Jonathan Ellen, the CEO, also said the mortality rate among heart surgery patients had gone up in 2017, but declined to release the exact figure. The hospital’s latest four-year average is roughly the national average.
Ellen said the hospital was responding to those and other “challenges” by performing fewer heart surgeries and referring some complicated cases to other hospitals. In addition, he said, one of the Heart Institute’s three surgeons, Dr. Tom Karl, is not operating at this time.
Medical records indicate Karl was involved in Katelynn’s case. Karl did not return an email from the Times.
The state launched a review into the newspaper’s findings in late April.
An AHCA spokeswoman said All Children’s was due for a review into how it handles and prevents hazardous conditions, including medical errors. But the agency accelerated its investigation after learning about the two needle incidents.
In its report, released Tuesday, the state cited All Children’s for not reporting two so-called “adverse incidents” within 15 days, as required by law. The state also found that All Children’s violated Florida law by not disclosing one of the incidents to the patient or a patient representative.
The copy of the report provided to the Times did not include identifying information on the patient. But many of the details matched Katelynn’s medical records.
The AHCA shared the results with the federal government. The CMS then quickly asked for a wider review.