Child's death leads to new medication error policies
Epinephrine/lidocaine mix-up triggered fatal sequence
Seven-year-old Ben Kolb died in December 1995 in Stuart, FL, following routine elective surgery to remove scar tissue and a benign tumor from his left ear. Despite the use of widely accepted procedures by an experienced, highly qualified surgical team, something went wrong. Dick Harman, president and CEO of Stuart-based Martin Memorial Health Systems, expressed sorrow and concern to Ben's family shortly after that day and made two promises: to conduct a thorough investigation, and to respect the family's privacy. Subsequently, representatives of the organization have assumed full responsibility for the medical error and all of its consequences.
"Although an isolated error like this is extremely rare, no failure is acceptable," Harman says. "We can't bring Ben back, but we're determined to do all in our power so that an incident like this never happens again here or anywhere."
"Our goal is to make Ben's death make a difference for others," says Doni Haas, director of corporate risk management at Martin Memorial, "and his parents are very much a part of that effort." Haas kept in close touch with the family throughout that difficult time. "We were open and honest throughout the entire investigation. When we discovered what had happened, I called and set up a meeting for the anesthesiologist, myself, Mr. and Mrs. Kolb, and their attorney. There wasn't a dry eye in the room." Later, their attorney told Haas and the others he was surprised they had been so honest about the course of events. Martin Memorial later reached a confidential financial settlement with the family. The case never went to court.
"One of the strongest opinions I have as a risk manager is about the manner in which a hospital responds when something goes wrong," says James R. Jensen, PhD, of Risk Management Consulting in Portland, OR. "What Memorial did is exactly what hospitals should do. The fact that they were not sued when they were forthright and made an admission of guilt is exactly what happens in the vast majority of cases where people admit that something went wrong."
When Ben was injected with the anesthetic lidocaine and epinephrine in preparation for his surgery, his blood pressure and pulse shot up alarmingly. The surgical team stabilized him, and the boy's vital signs returned to normal; the surgeons proceeded with the case. Nine minutes later the child went into cardiac arrest. Following resuscitative efforts, the surgery was aborted, and the wound closed. He remained in a coma in the ICU till evening, then was transferred to a tertiary care center that specializes in pediatrics. The next day he died.
"I was summoned to the operating room at the time of the cardiac arrest," says Haas. "The medical director and I immediately secured all medications and syringes." The anesthesiologist and surgeon met with Haas prior to talking to Ben's mother and explained they felt the problem was related to the infiltration of the local anesthetic. They zeroed in on that initially and activated the medication recall system, thinking there had to have been a product problem, but later expanded the investigation to the total medical management and history.
Within days of the incident, a team headed by Haas took samples from the syringes used in the procedure and vials of the same lot numbers and sent them to a researcher at the University of Georgia in Athens to have their contents analyzed. At the same time, they began interviewing everyone who had been present in the operating room. "We took statements from everyone individually," says Haas. "If we got conflicting information, we'd call people back to clarify the facts. As the investigator, I found I was stepping into someone else's world, and I had to see the road they saw."
Facility pledges to make the best better
Even before they knew what had in fact occurred, the nurse administrator activated a task force in the operating room to look at the process. "Common practice had become - incorrectly - not to label syringes when only one medication is used," says Haas. was wrong." Since then, even if only one medication is in use, every syringe is labeled.
A peer review meeting was held, and in attendance were Haas, the surgeon, the anesthesiologist, the chief of surgery, the chief of anesthesia, the chairman of the medical quality review committee, the chief of staff, and the vice president of medical affairs. They looked at all aspects of the medical management of the case. "At that meeting, the chief of anesthesia said she had seen a similar reaction in a Miami hospital years ago," says Haas. "There they thought the topical adrenaline had been used instead of the lidocaine. We didn't focus on that at the meeting, however, because our syringes were in the process of being tested." The conclusion of the meeting was that the medical management seemed to be appropriate. Haas gave the Miami information to the task force, after which it began to concentrate its efforts on the process for transferring medications into a sterile field.
On Dec. 21, a representative of the lab at the University of Georgia called to say the solution that was in the syringe did not match what was in the vial. He said he couldn't say more than that, but he requested that the task force send him another sample. At that point the task force located another lab to be doubly sure. "Our pharmacist hand-carried the syringe used on Ben to National Medical Services in Willowgrove, PA, and stayed with it throughout their testing process," says Haas. "That lab employed a different analytic technique from that of the university. They are more of a criminal lab."
By January, both labs had confirmed that the syringe contained only epinephrine, with no lidocaine at all. That pointed to an overdose of epinephrine. "That was the cause of Ben's death," says Haas.
Ben's case now figures in JCAHO's training
Haas contacted the Joint Commission on Accreditation of Healthcare Organizations in Oakbrook Terrace, IL, as soon as this sentinel event occurred. "After we found the cause of the accident, we advised them of our procedure changes," she explains. "We told them we'd had an independent consultant come in to review our changes and make sure everyone was well trained." Ben's death occurred two years before the Joint Commission revised its sentinel event policy, but the Joint Commission shows a video on Martin Memorial's excellent handling of the case at the beginning of its nationwide "Sentinel Events in the Age of Performance Improvement" training sessions.
Based on findings, the team immediately set about reviewing all procedures to determine whether the facility could have provided even more safety checks than prevailing standards require. They pledged to institute measures providing additional safeguards. By day 28 of the Ben Kolb incident, Martin Memorial had put in place revised procedures that eliminate confusion and avoid errors.
In evaluating the process for the transfer of medications from nonsterile to sterile fields, the task force found that the use of intermediate containers on the fields provided an opportunity for an error of that type to occur. They now have eliminated that step in the process by the use of a filter straw or a spike for direct transfer. (See Martin Memorial's new OR process standard for transfer of medications to a sterile field, pp. 144-145.) Meds now are withdrawn directly by the scrub tech into the labeled end-use syringe. "That was the critical remedy," says Haas.
Other systems were changed as well. "It had been over 10 years since a pediatric code had occurred at our facility," she says. "We now have drills frequently as part of skills training. The awareness of staff was heightened after this incident. There's a reason for steps and processes, and if you start taking shortcuts, it doesn't work."
Martin Memorial's risk management team contacted colleagues across the country following Ben's death, and found that virtually everyone was using the same OR techniques they were. "It was standard practice, but flawed nevertheless," says Haas. "I've learned of five cases over these couple of years where the same thing occurred - the wrong medication in the syringe." Many people have asked to see Martin Memorial's new process standard for transfer of medications to sterile field, and Haas' office has sent it out to them.
Ben Kolb was not the first and will not be the last victim of an error of that type, says Michael Cohen, president of the Institute for Safe Medication Practices in Warminster, PA. "Facilities continue to report similar errors to us - incidents where materials were not properly labeled. It's unfortunate that other hospitals haven't learned from the Kolb incident."
His advice: "Walk down to your OR or ambulatory surgical unit today, and chances are you'll find that the nurses and doctors there frequently draw medications and place them in aluminum basins just as the staff at Martin Memorial did. Chances are they donhave a protocol for proper labeling and don't label syringes. We have to address the issue at every hospital and every ambulatory care site before more patients are hurt."