by Cheryl Clark, Contributing Writer, MedPage Today June 2, 2022

Despite numerous advances in anesthesia safety over the years, former Tennessee nurse RaDonda Vaught's deadly medication error could have been prevented with a few system-wide fixes that aren't that difficult or costly. Certainly, criminalizing her mistake and charging her or any other nurse with negligent homicide and neglect was absolutely the wrong approach.

That's the view of the Anesthesia Patient Safety Foundation (APSF), an arm of the American Society of Anesthesiologists (ASA), whose task force has issued a call to action to hospitals nationwide after studying the circumstances in the Vaught case.

In a new advisory, the organization recommends that leaders make changes so mix-ups and missteps like those that killed 75-year-old Vanderbilt University Medical Center patient Charlene Murphey are nearly impossible.

One of those strategies is for hospitals and their pharmacies to create barriers to prevent or delay providers' access to certain high-risk medications in error, "such as wrapping plastic around vecuronium, or placing a hard, bright obtrusive label on it that says 'paralytic,' so there could be no confusion," said Daniel Cole, MD, former ASA president and current APSF president. "You wouldn't be able to gloss over the fine print."

Additionally, said Cole, hospitals could institute a policy requiring a "period of monitoring by a qualified practitioner" so that patients aren't just given a medication like the sedative midazolam (Versed) -- which Murphey was supposed to get to calm her anxiety ahead of a PET scan -- "and then sent to a corner somewhere."

A third strategy, he suggested, is for organizations to make sure their institutional culture does not "enable normalization of deviance," by which nurses and other practitioners normalize the process of finding workarounds, such as overriding safety blocks, to get things done.

Cole referenced an Institute for Safe Medication Practices report that said Vanderbilt nurses and other providers routinely overrode automated dispensing cabinet safety features. "Charlene Murphey had received almost two dozen medications via override from various nurses in the days prior to her death," the report stated. "It is highly unlikely that RaDonda (or any other nurse) perceived a significant or unjustifiable risk with obtaining medications via override."

Immediate Jeopardy in Four Ways

It's clear from federal documents addressing the 2017 incident that Vaught is hardly the only one who made mistakes that endangered Vanderbilt patients' lives.

As outlined in a 56-page report from CMS, which conducted an unannounced inspection of Vanderbilt after an anonymous tip apparently related to the Vaught case, the hospital failed or ignored accepted safety practices that placed its patients in "immediate jeopardy" in numerous ways.

The report said someone should have stayed with Murphey after she received the drug in case of adverse reactions, which were not detected for 30 minutes, constituting "neglect" of the patient and violating her rights. Instead, Murphey was left alone as Vaught was called away to the emergency room.

Even though the need for the drug for Murphey was not an emergency, no pharmacist reviewed the override and Vaught withdrew the wrong drug from the Pyxis machine. At Vanderbilt, "the override function allows the nurse to remove a medication from the machine before a pharmacist reviews the order," the CMS report stated.

Despite the requirement that the county medical examiner be notified in the case of unusual or unexpected deaths -- which many patient safety advocates say would detect fixable hospital errors and provide accountability -- hospital officials instead attributed her death to her brain bleed rather than a medication error.

The medical examiner told federal investigators that the office "released jurisdiction (did not investigate the death or perform an autopsy on patient Murphey) because there was an MRI that confirmed the bleed." The medical examiner told investigators that the Vanderbilt physician who reported her death said, "maybe there was a medication error, but that was hearsay, nothing has been documented. ... We [the medical examiner] didn't see any red flags."

The CMS report also said the name of the drug Murphey got, vecuronium, was not disclosed to the medical examiner.

The hospital's physicians also failed to notify state or federal officials of the error or the unexpected death, which they were obligated to do.

The incident and Vaught's involvement did not become public for almost a year, until an anonymous tip the following October prompted an unannounced federal inspection. The agency spent days questioning Vanderbilt personnel and found problems so serious, it threatened to revoke the system's Medicare reimbursement unless it took corrective action. That's when the incident became public.

Cole, a professor of clinical anesthesiology at the David Geffen School of Medicine at the University of California Los Angeles, said it's important to work on improving systems where 80% to 90% of the issues lie, rather than on "outlier individuals" like Vaught who made a mistake.

"I don't know too much about the culture at Vanderbilt, but it doesn't help to blame individuals. It creates a culture of fear and inhibits learning and improvement and prevention of errors," he said.

"We should celebrate error reporting rather than have retribution when someone discloses errors they make," he said. "That's the kind of culture that we're trying to improve. And this has just set us back."

Examples of other changes the foundation seeks at all acute care facilities include:

Cole noted that medication-related adverse events in anesthesia still occur at unacceptably high rates. He pointed to a 2019 paper in the British Journal of Anaesthesia that chronicled 7,072 provider-reported incidents in 104 hospitals in which a patient could have been or was harmed during a hospital procedure over a 10-year period in Chile and Spain. Of those incidents, 1,970 (28%) involved medication adverse events and of those, 31% harmed a patient, mostly during the medication administration phase.

Other reports document the frequency of anesthesia-related medication errors closer to home.

Massachusetts General Hospital researchers reviewed 277 operations over a 7-month period between 2013 and 2014. Of 3,671 medication administrations involved, 193 (5.3%) were medication errors or adverse drug events, and 153 of those 193 events were preventable. Three of the 153 events were life-threatening, 51 were significant, and 99 were serious.

Dangerous medication errors are also found in pediatric care settings. A quality improvement initiative from the Society for Pediatric Anesthesia called Wake Up Safe analyzed 6 years of medication error events at 32 institutions. Of 2,087 adverse events reported during more than 2.3 million anesthetic administrations, it found 276 medication errors -- the third highest category of events next to cardiac and respiratory events. The most common ones involved opioids or sedative/hypnotics.

While 30 of the errors took place during medication preparation and 67 occurred during prescribing, 79 errors occurred during medication administration, with the most common involving "accidental administration of the wrong drug." Some 15 events required life-sustaining intervention and 97% of the 276 were likely or certainly preventable.

The authors suggested that using prefilled medication syringes would avoid accidental ampule swap, bar-coding at the point of administration would prevent syringe swaps and confirm proper doses, and two-person checking of medication infusions would provide greater assurance of accuracy.

It is unlikely that these studies would have captured the kind of error that killed Murphey at Vanderbilt, however, because Murphey was getting sedation before an imaging study. It did not occur during an operating room procedure, Cole noted. That indicates to him that medication errors could be happening with greater frequency.

Cole feels the issue is critically important, but acknowledges that efforts toward improving patient safety and preventing errors within healthcare systems have died down or lost momentum in recent years, in part because of COVID.

"Yes, we have lost some mojo, the pandemic being one reason," he said. "But there is a big push right now to reignite this effort."

Cheryl Clark has been a medical & science journalist for more than three decades.

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