CMS cited Houston-based Baylor St. Luke's Medical Center for not keeping working defibrillator paddles in its operating room during a heart transplant for a patient who died two months after the surgery, according to the Houston Chronicle and ProPublica.
Here are five things to know.
1. The transplant for the patient, James Lewis, took place in January. Masahiro Ono, MD, a surgeon at Baylor St. Luke's Medical Center, tried using a defibrillator to jump-start Mr. Lewis' heart into rhythm during a crucial stage of the transplant, but the device did not active. Dr. Ono told House Chronicle and ProPublica reporters he pumped the transplanted heart by hand while hospital staff looked for another defibrillator. About 10 minutes passed before a backup defibrillator was brought to the operating room.
"I was so frustrated," Dr. Ono told the publications in an April interview. "I tried my best to preserve the function of the heart but it couldn't make it. That did happen, and I'm very sorry about that."
2. Mr. Lewis' heart transplant failed and was replaced with an artificial heart. He underwent at least 20 follow-up surgeries and procedures before dying in March. During Mr. Lewis' last procedure, a thin wire stuck to his artificial heart, causing it to malfunction.
3. During an October review, CMS determined "there were not sufficient quantities of emergency equipment immediately available during cardiac surgery," according to a federal report cited by ProPublica and the Houston Chronicle.
4. Marilyn Gerry, a spokesperson for St. Luke's, shared the following statement with ProPublica and Houston Chronicle Oct. 31:
"In our subsequent review of the case it was determined that the defibrillator paddles — not the machine itself — were the source of the inoperation. We since increased inventories of backup paddles in the sterile surgical core [near the operating room] and enhanced our testing procedures of paddles. This includes not only daily checks of defibrillators and paddles, but additional checks in advance of each relevant surgical procedure."
5. Two other heart patients died after undergoing heart transplants at the hospital in the first five months of 2018, which prompted St. Luke's to suspend its heart transplant program for two weeks in June. CMS cut Medicare funding for heart transplants at St. Luke's in August after it found the hospital did not take actions to improve care and patient safety. St. Luke's is appealing this decision. In October, St. Luke's hired two surgeons to replace the surgical director of the transplant program. Dr. Ono left St. Luke's in May to head up a heart transplant program in San Antonio.
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