Should medical errors be criminalized? This Fort Worth medical school offers another way
The Texas College of Osteopathic Medicine requires its medical students to take a patient safety certification exam.
Vanderbilt nurse RaDonda Vaught was chatting with a mentee the day after Christmas in 2017 when she typed the first two letters of her patient’s prescription into the drug cabinet monitor: V-E.
She wanted Versed, a sedative to help the 75-year-old patient — a woman hospitalized for a brain bleed — relax before her final scan. Instead, she selected vecuronium, a drug that causes paralysis. Vecuronium was Vaught’s top search result, and she didn’t check the label before administering it.
Within the hour, her patient had no pulse. In fewer than 12, she had died. Later, the patient’s medical examiner report would identify her cause of death: acute vecuronium intoxication, an error for which Vaught would, just last month, be criminalized.
In the decades since patient safety surfaced as a research priority, no official count of accidental patient deaths exists, but some experts estimate the number in the U.S. could be in the hundreds of thousands each year. “The system is not improving,” said Lillee Gelinas, a nurse and course director for patient safety at the Texas College of Osteopathic Medicine. “And you have to back up and say, ‘Why?’’”
Since 2019, before Vaught’s conviction swept national headlines, Gelinas and her colleagues at the medical school have worked to answer that question. One solution, she said, is academic — which is why, in 2020, the Texas College of Osteopathic Medicine became the only medical school in the world to require its students to take the internationally recognized Certified Professional in Patient Safety exam.
“At the end of the day, we are committed to developing safe providers of the future,” she said. “It’s our responsibility and accountability to our community.”
‘An epidemic’ of preventable harm
The second chapter of the seminal report, “To Err is Human: Building a Safer Health System” begins somberly: “Health care is not as safe as it should be.”
The 1999 report, published by the organization now known as the National Academy of Medicine, estimated that as many as 98,000 hospitalized Americans die each year from medical errors. The insights galvanized “the patient safety movement as we know it today,” Gelinas said.
More recent studies expand those estimates. In 2016, an analysis from Johns Hopkins University School of Medicine suggested that number could be more than 250,000 people each year, making medical error the third leading cause of death in the U.S. before the pandemic.
The uncertainty comes, in part, from the continued lack of a nationwide reporting system, which the To Err is Human report recommended. By 2015, just over half of the states, including Texas, required hospitals — but not necessarily clinics or outpatient providers — to report preventable harm.
“The bottom line: The amount of preventable harm and death is too many,” Gelinas said. Her boss and the dean of the Texas College of Osteopathic Medicine, Dr. Frank Filipetto, calls it “an epidemic.”
‘We’re carrying germs from patient to patient’
Dr. Conner Reynolds was scribing for an emergency room physician in Waco when he noticed the physician’s smartphone.
He would remove it from his pocket for every patient, calculating risk scores and checking treatment options — first for the diarrhea patient, then the stroke patient, then the heart attack patient. Following protocol, the physician would wash his hands in between, but he didn’t clean his phone.
“We’re carrying germs from patient to patient,” Reynolds pointed out. He and the physician looked at each other. “Is this OK? Is this something we need to consider?”
The question led Reynolds, who was in college at the time, to pursue a research study on health care student cell phone use when he enrolled at the Texas College of Osteopathic Medicine. The results reflected his physician’s behavior: Overall, health care students were likely to use their phones in the restroom and wash their hands afterward; however, they cleaned their phones less than once a week.
Reynolds, along with Gelinas, presented the research at the Institute for Healthcare Improvement’s national conference in late 2018. There, he learned about the Certified Professional in Patient Safety credential, an accolade that could only be earned by health professionals with three to five years of direct clinical experience under their belts.
The criteria excluded medical students, who typically start clinical rotations in year three and therefore wouldn’t be eligible to sit for the exam until at least their second year in residency.
“And we all sort of sat down and asked ourselves, ‘Why in the world would we want to send providers out into health care, let them learn bad habits … and then, five years later, teach them the right way to do things?’” Reynolds remembers.
He calls it a “Eureka moment,” and it aligned with the hiring of Filipetto, a staunch patient safety advocate, as dean of the medical school.
‘Tools to identify when there’s problems in the system’
The day after Filipetto had his tonsils removed as a 6-year-old, he felt something strange in the back of his throat. It was a piece of gauze, unintentionally left behind, and he started choking on it.
“That was terrifying,” he remembers. “My parents didn’t know what to do. Luckily, I was able to cough it up after a minute or two, but that was what we would call a ‘near-miss.’”
Years later, when he was applying to become dean, patient safety was part of his platform. “We know that people make mistakes. They’re not intentional,” he said. “It’s impossible to prevent human error, but how do we create a system whereby the system either catches that or … where bad outcomes don’t occur?”
The patient safety component was part of a larger curriculum shift Filipetto had advocated: the inclusion of health systems science to a traditional spate of courses like anatomy and clinical skills. Health systems science takes a bird’s-eye view of health care delivery, requiring a critical look at how health professionals work together.
“You want a (medical) student that’s a systems thinker, that doesn’t just think siloed … You also want somebody that has an open mindset,” said Dr. Janet Lieto, who directs the health systems science curriculum at the medical school.
After the Eureka moment, Lieto and Gelinas set to work creating a patient safety course for the school’s medical students. Their first priority: collaborating with the Institute for Healthcare Improvement, an organization that provides educational resources for the Certified Professional in Patient Safety exam.
To prove that medical students could, indeed, pass the exam before three years of clinical experience, they received permission from the Certification Board to pilot a patient safety course with 10 students — nine of whom passed the exam on the first try. The national average is 70%.
Once the Institute for Healthcare Improvement and the Certification Board gave the go-ahead, the college received the necessary approvals to incorporate patient safety into the school’s curriculum. Less than two years after the Eureka moment, in July 2020, the Texas College of Osteopathic Medicine became the only medical school in the world that requires its students to take the patient safety certification exam before graduating.
The Institute for Healthcare Improvement tracks data on every person who has passed the exam, a spokesperson told the Fort Worth Report. She confirmed the Texas College of Osteopathic Medicine’s globally unique status.
On the institute’s website, Texas’ list of certified professionals vastly overshadows that of other states. After nearly 500 medical students have taken the patient safety course, the school’s pass rate is 98%.
The course itself spans just two weeks, about eight hours a day, during a medical student’s third year, Gelinas said. The cost to each student, which covers the training materials and the exam, is about $900. When they pass the exam, students can add “C.P.P.S.” to their white coats.
When Reynolds, who passed the exam in 2021, applied for residency programs, the initials came up again and again in his interviews. Now, as a resident at JPS Health Network, he’s helping his colleagues develop safer systems to protect their patients.
“The initials after the name isn’t the most important thing,” Lieto said. “The most important thing is giving them those tools to identify when there’s problems in the system.”
‘We can eliminate preventable death’
Charlene Murphey’s head ached when she checked into the emergency room at Vanderbilt University Medical Center in Nashville, Tennessee. It was Christmas Eve 2017, and Murphey had been shopping earlier that day, according to a Centers for Medicare & Medicaid Services report.
The 75-year-old lived about 30 miles away, in a suburb called Gallatin, and had had her share of health troubles: Guillain-Barre syndrome, lupus and breast cancer, but her prognosis looked hopeful. A CT image revealed bleeding in her brain, but her condition improved, and by Dec. 26, she was almost ready to leave. Before her final scan, Murphey mentioned she was claustrophobic, and her physician prescribed Versed to calm her nerves.
Months after Murphey died from vecuronium intoxication, the Centers for Medicare & Medicaid paid Vanderbilt University Medical Center a surprise visit.
Inspectors found the hospital’s policies lacked guidance about when and how to monitor patients after administering “high-alert” drugs like vecuronium. The report also determined the hospital lacked adequate safety measures to prevent providers from accidentally acquiring such medicines from the drug cabinet. Finally, the hospital had not reported the error to the Tennessee Department of Health, a requirement by state law.
“So when people talk about safety, I worry that they just see that (Vaught) made this mistake,” Lieto said. “You have to ask why … and when you come down to it, it’s usually a system error or a process error in addition to a human error. And that’s the piece that people forget about.”
Vaught’s criminal conviction in late March undercuts a key component of patient safety, Gelinas said: Just culture, or an environment where people feel safe to discuss mistakes without fear of punishment. “This one case, the criminalization of medical error, has really put a chilling effect on a lot of the progress that we’ve made,” she said.
A patient safety course like the one at the Texas College of Osteopathic Medicine acknowledges that, while people make mistakes, good systems can prevent bad outcomes. Gelinas hopes more and more medical schools come to adopt a similar strategy; she and Lieto are scheduled to present their success at the Institute for Healthcare Improvement’s Patient Safety Congress in May.
“So long as it involves humans, health care will never be free of errors,” she said. “But it can be free of preventable death.”
What’s the problem?
Although no official count of accidental patient deaths exists, some experts estimate the number in the U.S. could be in the hundreds of thousands each year.
What’s a possible solution?
Since 2020, the Texas College of Osteopathic Medicine has required its medical students to take a patient safety course and the Certified Professional in Patient Safety exam before graduating. The requirement involves a collaboration between the school and the Institute for Healthcare Improvement.