CMS investigating Florida hospital where surgeons left needle in baby's heart

CMS has opened an investigation into St. Petersburg, Fla.-based Johns Hopkins All Children's Hospital days after the state's healthcare agency cited the hospital for not reporting two medical errors in which needles were left in patients' hearts after surgery, according to the Tampa Bay Times.

Here are five things to know about CMS' investigation into the St. Petersburg hospital.

1. A CMS spokesperson told the Tampa Bay Times the review aims to ensure the hospital is following all federal health regulations. The agency contracts with the Florida Agency for Health Care Administration to conduct inspections. The publication reports state officials typically perform a quality assurance and performance improvement review, which aims to confirm hospitals are operating at acceptable standards to receive federal reimbursement.

2. In an email to the Tampa Bay Times, Johns Hopkins All Children's said the institution has been "transparent" with regulators.

"Patient safety and providing the highest quality care are foundational to our mission and the manner in which we care for children. 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 hospital said.

3. Federal and state regulators began investigating the hospital after a Tampa Bay Times investigation in April revealed a needle was found in 3-day-old Katelynn Whipple's heart during a follow-up visit to the hospital after she underwent heart surgery in 2016. However, the surgeon who operated on the child told her parents the needle did not exist. Ten days later, Katelynn's parents took her to a different hospital for emergency surgery unrelated to the needle. The surgeon operating on the child reportedly discovered the needle 30 minutes into the operation.

4. In April, hospital leaders told the publication surgical needles had been left behind in two patients since 2016. Jonathan Ellen, MD, president, CEO and physician-in-chief of Johns Hopkins All Children's, said at the time the hospital has since performed fewer heart surgeries and is referring complicated cases to other hospitals, according to the report. Dr. Ellen also confirmed one of the hospital's three heart surgeons, Tom Karl, MD, is not operating at this time. Medical records obtained by the Tampa Bay Times indicate Dr. Karl was involved in Katelynn's surgery.

5. The AHCA told the Tampa Bay Times Johns Hopkins All Children's was due for a review, but the agency decided to accelerate its investigation into the hospital after learning of the two needle incidents, according to the report. The results of the April investigation, released May 15 and obtained by the Tampa Bay Times, cited the hospital for not reporting the two "adverse incidents" within 15 days as required by law. The hospital also violated state law by not disclosing the incident to the patient or a patient representative.

AHCA shared the results of its investigation with CMS, who proceeded to ask for a wider review of the hospital's operations, the report states.

To access the Tampa Bay Times report, click here.

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