St. John's Regional Medical Center fined for needle left in patient after heart surgery

St. John's Regional Medical Center, Oxnard

A nearly 3-inch-long metal needle was left in a woman’s abdominal tissue during a 2014 open-heart surgery at St. John’s Regional Medical Center, triggering a $40,400 fine, state officials said this month.

The needle broke just underneath the skin during a difficult operation that lasted several hours and involved dozens of needles and wires, said surgeon Dr. Bruce Toporoff. He described the incident as minor.

But California Department of Public Health officials classified the error as carrying the potential to cause serious injury or death and said their first concern was to make sure such an incident doesn’t happen again. They said the needle was finally removed more than seven months after surgery when the patient came to St. John’s emergency room complaining of a burning pain.

“She noticed a sharp object protruding from her abdomen when she bent forward,” an investigator wrote in a report.

Officials said the doctor and the operating room staff didn’t follow policies that include accurate counts of surgical instruments and X-rays to make sure objects aren’t left in patients. St. John’s was one of seven hospitals penalized by the state for incidents regulators label as adverse events placing patients in immediate jeopardy.

St. John’s in Oxnard was earlier fined for a 2015 surgery in which a heart lung machine malfunctioned. That penalty was announced in August.

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Hospital officials responded to several questions about the foreign object incident with a written statement emphasizing that patient care and safety are the highest priorities.

“We have conducted a thorough investigation and are working closely with the medical staff, patient care staff and hospital leadership, as well as with the California Department of Public Health to ensure that an incident like this does not happen again,” officials said. “Consistent with patient privacy laws and hospital policy, we respect our patients’ privacy by not discussing the specifics of their care.”

State authorities said in their written report that a woman came to the hospital on Dec. 19, 2014, for surgery to replace her mitral and aortic valves. According to the state report, the surgeon used an external pacemaker in which wires are connected to the heart to deliver an electrical stimulus and ensure a healthy beat.

The wires often temporarily remain in the patient after surgery, protruding from the chest. But a breakaway needle that is part of what is called a pacer wire is removed from the body. During the 2014 surgery, part of a needle broke off and was lost in abdominal tissue, according to the state report.

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In a phone interview Friday, Toporoff said the surgery can last six hours and can involve as many as 150 needles. He said the broken needle incident happened midway during the procedure.

“The lady was very obese. ... It (the needle) wasn’t long enough to come out of the skin and it broke off under the skin,” he said, noting that the object was lost in the tissue outside of the body’s cavity.

In the report, an investigator wrote that Toporoff said he forgot the needle was still in the patient. The surgical instruments were counted in a safety procedure conducted after surgery and did not record the missing instrument.

“I don’t think I used those words,” Toporoff said of forgetting the needle, confirming he was told by nurses all the surgical instruments had been removed. That’s why the missing needle wasn’t documented.

But a nurse and a senior scrub technician told the investigator they knew a needle hadn’t been recovered.

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“Everyone knew one needle was still inside the patient,” the scrub tech told the investigator, according to the state report. “We started counting by saying, ‘one needle in the patient.’ That was needle number one.”

Toporoff said the manner of the count meant it appeared all of the items had retrieved when they had not. He said nurses are responsible for the count.

“If they tell me the count is correct, I’m moving on to other things,” he said.

St. John’s officials didn’t answer questions about details of the incident, including the apparent miscommunication.

The surgery was performed on Dec. 19, 2014. The patient came to the emergency room in pain on July 6, 2015. A CT scan revealed a 2.75 inch-long metallic wire, according to the report.

It was removed from under the skin without complication. Toporoff called the removal procedure non-surgical, noting that the object had moved toward the skin’s surface.

If the count during surgery had documented the missing needle, Toporoff said he probably would not have tried to retrieve it because that could have caused more damage. Instead, he would have told the patient and then followed up to make sure no problems developed.

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“It was a minor incident,” said Toporoff who left St. John’s in 2016 to move to New York. “It required no rehospitalization. The needle was not in the (body’s) cavity. It was an inert piece of metal.”

But the state fine came via an administrative penalty program focused at errors with the potential to cause serious injury or death.

“The hospital failed to ensure the health and safety of a patient,” state public health officials wrote in a news release.

State officials said the findings of their investigation triggered concerns from the federal agency that administers Medicare and Medicaid.

“The hospital had to immediately improve their internal processes to ensure improved safe health outcomes for patients, and the prevention of medical and surgical errors. The facility is back in compliance at this time,” state public health officials said.

Actions taken by the hospital included adopting a policy for dealing with broken or malfunctioning instruments, according to the state report. Training and education sessions were conducted.

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Monitoring was performed to make sure surgical staff members followed the protocols. 

State officials said the involvement of the federal Medicare agency is not unusual in adverse event and immediate jeopardy situations.

The other six hospitals fined earlier this month include Kaiser’s Anaheim Medical Center, Kaweah Delta Medical Center in Visalia, Mercy Hospital in Bakersfield, Mercy Medical Center in Redding, Saint Agnes Medical Center in Fresno and Vibra Hospital of Sacramento.