Lead surgical nurse Sara King placed a small metal bowl into the icy slush that sat just a few feet from the operating table inside Operating Room 5 at the University of Toledo Medical Center.
Ed Hall promptly replaced the metal basin with a square plastic box marked “donor kidney,” explaining that this is the new container to be used for organs awaiting transplant.
“Simple is good,” said Mr. Hall, administrator of surgical services for UTMC, the former Medical College of Ohio.
The new container, which has both a lid and a label, is a small but significant change in the way UTMC surgical teams are to perform kidney transplants in the aftermath of an Aug. 10 surgery in which a viable kidney was removed from a young man, cleaned, placed in a metal basin, stored in the slush machine to await transplant, and then inadvertently thrown away by a nurse who apparently was unaware the organ was in the slush.
Although the mistake was quickly discovered, it took nearly two hours for the kidney to be retrieved from the hospital's medical waste system, and it could not be safely implanted into the waiting patient, the donor’s sister.
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The mistake — deemed “baffling” by a medical reviewer and “an inexplicable human error” by UT President Dr. Lloyd Jacobs — has prompted a complete review of policies and procedures in the surgery department at UTMC and at hospitals across the country where organ transplants are performed. UTMC’s living-donor kidney transplant program remains on voluntary suspension.
“We know what happened. Why it happened is baffling, and that’s the human error element of it, which we’ve been unable to explain,” Mr. Hall said during a tour of the operating room where the incident occurred. “Why does anyone make a mistake at any point in the day? Distraction? Having a bad day?
“What we try to do here, regardless of this incident, is to put processes in place to reduce the risk of human error, and unfortunately we had this terrible incident,” he said. “We’re taking it very seriously. We looked at everything we do with a fine-toothed comb. We changed some of the things we do.”
Among the new policies and the changes:
● Nothing may leave the operating room until the patient has been removed after surgery.
● Members of the surgical team must check with the surgeon before going on break.
● An infrared motion detector has been mounted near the slush machine that sounds an alarm when anyone gets close to it.
● A ring-shaped magnetic device has been designed to fit on top of the slush machine. It will have a visual and auditory alarm that will go off when it is lifted.
“Mistakes spur innovation and improvement, and I think they have begun to do that already,” Dr. Jacobs told The Blade last week. Mr. Hall, who was temporarily placed on paid leave after the incident and then was reinstated, said no one in the transplant community had heard of a viable organ being discarded before it happened at UTMC.
“This exact incident isn’t on anybody’s radar screen in the country — lots of other issues are — so nobody was walking around saying, ‘How can we prevent this exact type of incident?’ ” Mr. Hall said. “This showed us that it could happen.”
Checks and balances
Still, Dr. Robert Higgins, director of the comprehensive transplant center at Ohio State University Wexner Medical Center and a former president of the United Network for Organ Sharing, said there is a reason this kind of aberration has not occurred before.
“The fact that this hasn’t happened anywhere else is probably because there are already checks and balances in place,” he said, explaining that OSU requires that donor organs be packaged and labeled after removal and that they not leave the sight or control of the operating surgeon.
Still, Dr. Higgins said the entire transplant community is following what happened in Toledo, and his own medical center has taken a look at its policies in light of the incident.
“We’ve reinforced our senses to what we should be doing and how we should be conducting our affairs,” Dr. Higgins said.
UTMC said that is a constant process — mistake or no.
Marge McFadden, administrator of quality management at UTMC, said the hospital does not wait for an occurrence to look at quality and safety.
“We are always looking at quality and safety, and we’re always looking for opportunities to improve the care that we provide to the patients we serve,” she said. “So, while this event occurred, it gave us another opportunity, but we would be doing that anyway.”
Two employees involved in the incident no longer work at UTMC. Judith Moore, a part-time nurse who discarded the contents of the slush machine — including the kidney — before the surgery was finished, resigned Sept. 10. UTMC fired Melanie Lemay, a 30-year employee and full-time registered nurse, who was the circulating nurse during the surgery. Ms. Lemay, who relieved Ms. Moore while Ms. Moore went on a lunch break, failed to update her on the status of the surgery when she returned from her break, among other procedural infractions, according to disciplinary records. She has contested her termination.
UT President Dr. Jacobs reiterated last week his stance that the two women are no longer employed because they violated procedures, not because they made a mistake.
“People who do not follow policy are the people who can't work here any longer, and that goes for all 3,000 people who work in the clinical arena, as long as I am president of the institution,” he said.
Effect on staff
Ms. McFadden, speaking for the nursing staff, said everyone was affected by the incident.
“It just touches your heart,” she said. “It touches every piece of what we do and what we’re here to do.”
Dr. Andrew Casabianca, medical director of the operating room and an anesthesiologist at UTMC, found it hard to describe the impact the incident had on staff and morale. He was in and out of the operating room the day of the incident.
“You have no idea how devastating this was,” he said.
Dr. Jacobs, who was a vascular surgeon for 30 years, said he certainly has made mistakes during his career. He cited the speech he made when he was inaugurated as president of the medical college in 2004. In that talk, he recalled operating by himself as a resident on a young woman who’d been stabbed in the upper abdomen. The knife had penetrated her aorta in an area that he did not know how to get to. She bled to death.
Many years later, he was supervising a trainee who, during surgery, pulled too hard on the patient's liver. He saw the mistake but said nothing. The patient suffered a tearing of the veins of the liver and died later that evening.
“Personally how do you deal with it? You lay awake at night. You regret for decades,” he said. “This business takes a toll on you personally. People involved in these kinds of things carry a burden.”
It's much easier, he said, to deal with medical errors institutionally. “You build safeguards. You build policies, procedures, checklists, and you insistently continue on a journey to safety and quality,” Dr. Jacobs said.
Dr. Michael Rees, who was stripped of his director’s title but remains on staff at UTMC, has declined to make any public statements about the incident. He was scheduled that day to remove the donor’s kidney and to transplant it into the recipient afterward — something Mr. Hall said happens about half the time.
Dr. Rees is one of two surgeons who perform kidney transplants at the medical center. According to a UTMC corrective action form for one of the team members involved that day, Dr. Rees had completed the first surgery when he turned around to retrieve the donor kidney from the slush machine and discovered the grave error.
Dr. Rees had declared the first surgery a “good case,” said he would be taking the donor kidney to the operating room where the recipient patient was waiting, shook everyone’s hands, backed away from the operating table, walked around to the slush machine, and stopped, the report stated.
“Where is the kidney?” Dr. Rees asked.
While Ms. LeMay said she hadn’t seen anyone take it and questioned, “Who would take it?” nurse Judith Moore then re-entered the room, the report states.
“Dr. Rees then asked her, ‘Where’s the kidney?’ To which she replied, ‘Oh my God, I flushed the kidney.’ ”
Contact Jennifer Feehan at email@example.com or 419-724-6129.