A Nashville hospital is in trouble with state regulators after a medication mix-up severely harmed four surgical patients and placed the facility in immediate jeopardy on three CMS (Centres for Medicare & Medicaid Services, a federal agency inside the Department of Health and Human Services) conditions of participation, a state survey found.
Becker’s Clinical Leadership reports that the mistake has also reignited debate over the criminalisation of medical mistakes, with national pharmacy groups warning against prosecution.
On 14 August, four patients at Ascension St Thomas Hospital Midtown, who were undergoing elective joint-replacement surgery, were injected in the spine with potassium phosphate – a high-alert medication – instead of the intended anaesthetic, Polocaine (mepivacaine), according to a survey report from the Tennessee Health Facilities Commission.
The syringes had been prepared the day before and mislabelled as mepivacaine.
All four patients required transfer to a higher level of care, and one briefly went into cardiac arrest during surgery, the report said. As of the survey team’s exit on 21 August, one patient remained on extracorporeal membrane oxygenation (ECMO), a form of life support, and three had significant lower-extremity neurologic impairment, including paralysis and loss of sensation from roughly the mid-abdomen down.
Surveyors traced the error to a sterile-compounding process with multiple failed safeguards. Surveillance video showed a pharmacy technician selecting vials of potassium phosphate while preparing what was ordered as a Polocaine batch: the two drugs come in look-alike vials, and both names begin with “P”.
A second technician drew the medication into five syringes and labelled them mepivacaine without visually checking the vials, telling surveyors it “had been normal practice for the vials to not be checked” in the compounding room.
The hospital’s compounding software allowed pharmacy technicians to override barcode scanning and manually enter vial information, bypassing the drug code and manufacturer data that would have flagged the wrong product, the report said.
A pharmacist’s final verification, which the report timed at about 29 seconds, did not catch the error, and a mismatch between the six syringes ordered and the five prepared went unreconciled.
The second pharmacy technician was in a probationary period that had been extended over documented competency concerns, including difficulty with sterile compounding workflow and medication calculations, according to the report.
The pharmacy tech received a “coaching feedback” form the morning of 13 August, the day the syringes were incorrectly filled.
Beyond the pharmacy, surveyors cited the hospital’s governing body. The anaesthesiologist who administered the injections was not placed on administrative leave and remained on call and available to provide anaesthesia at the hospital during the investigation, the report said.
A pharmacy technician involved also remained on duty. Surveyors found no documented peer review of the event and said hospital leaders could not produce documentation that the local board had been notified.
The report also faulted the hospital’s clinical response. No cerebrospinal fluid lavage – a procedure to flush the medication from around the spinal cord – was performed at Midtown: the affected patients were transferred to a second Ascension hospital hours later, where a neurosurgeon performed lavages using an ad hoc protocol he assembled from a literature search, as no established protocol existed.
The hospital submitted three immediate jeopardy removal plans during the survey, on 18, 19 and 21 August. All three were determined unacceptable, and the survey team exited on 21 August with all three jeopardies ongoing, according to the report.
Shubhada Jagasia, MD, president and CEO of Ascension Saint Thomas Hospital Midtown, said in an earlier statement that the system reported the event to state regulators the day it occurred.
“I am deeply sorry for the harm caused,” Jagasia said.
Ascension said it has since isolated high-alert medications in distinctly marked storage, added a mandatory hard stop requiring independent verification when a spinal-medication scan alert fires, required independent dual verification by trained pharmacists for spinal-medication workflows, and engaged independent third-party quality experts to review its mitigation plans.
The case has drawn wider scrutiny. The Tennessee Bureau of Investigation has opened an inquiry, though no charges have been filed, and the error has renewed debate over the criminalisation of medical mistakes.
One of the four patients was left paralysed from the sternum down and arrived at a Chicago rehabilitation hospital on 25 August: her family has publicly defended the clinicians involved.
In response to questions about the report, an Ascension spokesperson directed Becker’s to an earlier statement and did not address its specific findings, including the immediate jeopardy citations, the rejected removal plans or the status of the staff who remained on duty during the investigation.
The non-profit community hospital is the the largest such hospital in Middle Tennessee, licensed for 683 acute and rehab care beds.
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