Problems at St. Mary's Hospital that led to a 16-year-old girl's death from a medication mix-up during childbirth are so serious they pose "an immediate threat" to patient safety, says a federal warning letter released Friday.
Jasmine Gant died after a nurse mistakenly gave her an epidural anesthetic intravenously, according to a state inspection report also released Friday.
If the hospital doesn't quickly correct the problems related to the Fitchburg teen's July 5 death, it will lose its contract with Medicare, the letter states.
Also, the state could ban the hospital from receiving new patients or revoke its license, officials said.
St. Mary's has started taking corrective action to avoid such penalties, hospital officials said.
Medicare, the government health plan for seniors and the disabled, generally accounts for a third of hospital revenues. A Medicare contract is considered vital to a hospital's livelihood.
"We have determined that the deficiencies are so serious they constitute an immediate threat to patient health and safety," says the letter from Robert Daly of the federal Centers for Medicare and Medicaid Services.
The Medicare contract will be terminated Aug. 5 if the hospital doesn't comply, the letter says.
The warning, which is rarely leveraged against hospitals, stems from an inspection last week by the state Department of Health and Family Services in response to Gant's death.
According to the inspection report, Gant was supposed to receive penicillin through an IV to prevent a bacterial infection from passing to the baby, who survived. The nurse infused the epidural instead.
An epidural is supposed to be injected into a fluid-filled sac around the spine, to numb the pelvic area during childbirth.
Shortly after Gant received the wrong drug intravenously, she had seizures. "Jaw clenched, gasping respirations," the inspection report says, citing a nurse's notes.
The notes said Gant died at 12:20 p.m., but she was not pronounced dead until 1:43 p.m. She received the drug about noon.
Gant would have been a junior at Verona High School this fall.
In an interview during the inspection, the nurse offered an explanation: Gant had been nervous, so the nurse brought out the epidural bag to show her how it worked. The bag got mixed up with the penicillin bag.
The inspection found three types of violations at the hospital involving poor nursing care and improperly stored medications:
Gant's nurse failed to scan bar codes on the drug and on the patient identification band. The nurse also didn't check the medication prior to giving it. Gant's identification band was in her medical chart, not on her body as it should have been, the nurse told investigators.
Drugs in several parts of the hospital weren't properly locked up on the day of the inspection, more than a week after Gant's death.
On the day of the inspection, at least four patients in the labor and delivery unit didn't have care plans detailing how nurses should treat them and respond to complications.
"Extremely serious" error
Each of the violations is considered "significant," said Stephanie Marquis, spokeswoman for the state health department.
"This medical error led to a death, which is extremely serious," Marquis said.
No other hospital patient deaths due to medication errors involving caregiver misconduct have been reported in Wisconsin in recent years, Marquis said.
The state Department of Regulation and Licensing, which oversees nurses' licenses, is reviewing whether to investigate the nurse involved in the case. The nurse is on paid administrative leave from St. Mary's, said hospital spokeswoman Sarah Carlson.
Dr. Frank Byrne, St. Mary's president, said in a prepared statement that Gant's family "was informed immediately upon St. Mary's discovery of the error."
He said the hospital promptly reviewed drug delivery policies with staff. It has also "strengthened" systems to keep medications secure and "improved the documentation" of care plans for the labor and delivery unit.
"St. Mary's takes quality of patient care extremely seriously," Byrne said.
Medicare action rare
The Centers for Medicare and Medicaid Services rarely views a hospital mishap as serious enough to threaten the termination of a Medicare contract, Daly said in an interview.
Such action is taken about 15 times a year among the 1,060 hospitals in the six-state region Daly oversees in Chicago. In nearly all of those cases, the hospitals correct the problems and avoid losing Medicare business, he said.
St. Mary's has to "show that they have revised policies and educated their staff on the proper administration of drugs," Daly said. "They have to put procedures in place to monitor this and assure it won't happen again."
The actions must be "more than just writing on paper," he said. "We want to see a real change in the practice of how they administer medications."
The state has given St. Mary's until Sept. 11 to take similar corrective action, Marquis said.
If the hospital doesn't, the state could ban patient admissions or revoke its license, she said, but such penalties aren't automatic.
AT A GLANCE
WHAT HAPPENED: Sixteen-year-old Jasmine Gant of Fitchburg died July 5 during childbirth at St. Mary's Hospital.
WHAT'S NEW: A state inspection report released Friday revealed that a nurse mistakenly gave Gant an epidural intravenously instead of penicillin.
WHAT'S NEXT: If St. Mary's doesn't promptly correct problems, the federal government will terminate the hospital's Medicare contract, and the state could revoke its license or ban hospital admissions. Hospital officials say they are complying.