It was a tragic mistake. A routine diagnostic test administered at a UF outpatient clinic went terribly wrong, and after a string of additional errors at UF and Shands HealthCare facilities over the next 48 hours, 3-year-old Sebastian Ferrero was dead.
“Our investigation to date has identified a series of errors that collectively caused this tragic outcome, and the family has been made aware of our findings,” said UF pediatrics Vice Chairman for Clinical Affairs Donald Novak, MD, during a somber press conference held just 15 days after the boy’s death. “Words cannot describe our profound regret for these events.”
Although, the university, the College of Medicine and Shands HealthCare took full responsibility for Sebastian’s death and a settlement was quickly reached with the boy’s parents, the story does not end there.
What happened next changed the College of Medicine forever.
A Bright Future
A family photo reveals the happy life Horst and Luisa Ferrero were building. Luisa holds her baby boy, Sergio, dressed in his christening dress, and Horst holds their oldest son, Sebastian. The baby and toddler meet at the noses with delightful grins. It’s just one of thousands of pictures of Sebastian that Horst Ferrero has saved on his laptop.
At only 3 years old, Sebastian spoke three languages, had visited three continents and cruised the Mediterranean, Baltic and Caribbean seas. He loved his baby brother and Thomas the Tank Engine. His big brown eyes and sweet smile revealed a kind and intelligent spirit, and his laugh was infectious. People who knew Sebastian will tell you he had a bright future.
Today his parents can’t hide the pain of losing a child. It is impossible to run from it, says Sebastian’s mother, Luisa.
“It is always in my mind,” she says. “There is a big hole in your life wherever you go.”
The couple moved to Gainesville in 2003 from their home country of Venezuela to oversee a real estate development in which they are partners. Horst Ferrero is a lawyer with a master’s degree in international law from American University and an MBA from the University of Florida. Luisa Ferrero speaks four languages and comes from a large Italian family living in South America. Sebastian was born at North Florida Regional Medical Center a year after the Ferreros arrived in Gainesville.
In October 2007 the couple brought Sebastian to the UF Physicians Pediatric Outpatient Clinic at the recommendation of his pediatrician because the preschooler’s growth rate was below average for his age. Janet Silverstein, MD, chief of pediatric endocrinology at the College of Medicine, ordered a growth hormone stimulation test. The 29-year veteran of pediatric medicine prescribed the proper dose — based on the boy’s age and weight — of the amino acid arginine, a naturally occurring substance used to test growth hormone deficiency.
Days before the test was to take place, the Ferreros attempted to fill the prescription at a few pharmacies in Gainesville until they were told the Shands Medical Plaza Outpatient Pharmacy would have to provide the substance. They returned to the clinic for the scheduled test on Monday, Oct. 8. Silverstein was not scheduled to be at the clinic that day.
The dose Silverstein prescribed for Sebastian’s test was 5.75 grams. Sebastian received 60 grams.
What went wrong?
The Medical Plaza pharmacy, which doesn’t stock arginine, ordered two bottles of the solution from a supplier for Sebastian’s test. Each 300-milliliter bottle contained 30 grams of arginine. The prescribed dose of 5.75 grams was correctly printed on the bottles, but the bottles were also marked “1 of 2” and “2 of 2,” which may have led clinic staff to think both bottles were needed. The 5.75-gram dose equals about one-sixth of one bottle.
“I questioned the nurse because it seemed like two bottles was a lot of medicine for a 3-year-old,” says Luisa. “The nurse checked and thought she was doing the right thing and started doing the test. As a mom, I questioned her but trusted what she told me.”
More than halfway through the procedure, when Sebastian showed signs of distress and complained of a severe headache, his father asked for the test to be halted and requested a physician. A doctor checked Sebastian’s chart and told his parents the side effects were normal. She did not examine Sebastian or check the bottles of arginine. Clinic staff restarted the procedure.
When the test was complete, the Ferreros took their son home and nurses told them his symptoms would subside. But by 11:30 that night, his condition had worsened. They rushed him to the emergency room at Shands AGH, where he was treated for dehydration. Doctors monitored his progress over the next day, and ultimately he was transported to the pediatric intensive care unit at Shands at UF early Wednesday, Oct. 10, after doctors determined he was suffering from cerebral edema, or swelling of the brain. The overdose of arginine was discovered that morning. He died the next day.
Parents pledge to honor their son
Between 44,000 and 98,000 patients die from medical errors in U.S. hospitals every year, according to a 1999 landmark report by the Institute of Medicine. A more recent study from the IOM reported that medication errors are among the most common medical errors, harming at least 1.5 million people every year.
Even the most elite hospitals are not immune. In February 2001, 18-month-old Josie King died from medical errors at Johns Hopkins Children’s Center. A 17-year-old girl died in 2003 at Duke University Hospital after receiving a heart and lungs from a donor with an incompatible blood type. A year earlier, at Children’s Hospital in Boston, a 5-year-old boy died after his doctors failed to treat him for a seizure because each thought someone else was in charge.
In the wake of Sebastian’s death, UF and Shands leaders took immediate measures to ensure such a tragedy does not occur again. And now they find themselves working side by side with the Ferreros to ensure his legacy includes cultivating a culture at the University of Florida that leads to improved care for all patients.
“There were so many things that went wrong,” Luisa says. “It wasn’t just the overdose. From there we started analyzing the situation and understood the only way we could honor Sebastian’s memory is to not let this go under the table.
“It’s so painful, and it’s so ugly to lose a child like this,” she continues. “It’s unnecessary and I wouldn’t want another mom to go through something so horrible.”
In the midst of their grief, the Ferreros pledged to partner with the very institutions responsible for their boy’s death and to work together to develop a nationally recognized, comprehensive patient safety program. His death accelerated efforts the college had begun to cultivate a “culture of quality” across the spectrum of patient care.
“Sebastian Ferrero has changed the College of Medicine forever,” says interim dean Michael Good, MD, who was the college’s senior associate dean for clinical affairs at the time of Sebastian’s overdose. “It’s unfortunate that it takes an event like this to raise the level of attention to the point where cultural change is achieved.”
The driving force in making lasting changes at UF is the courage of Sebastian’s parents, explains Good.
“Through this tragedy they want to make the world a better place,” says Good, who is working with the couple to establish a Sebastian Ferrero Office of Clinical Quality and Safety at the College of Medicine.
During a May press conference on the UF campus, Horst and Luisa Ferrero announced they were creating the Sebastian Ferrero Foundation.
“We want to honor our son and turn our tragedy into a positive,” said Horst Ferrero. “The foundation will serve as a catalyst for profound change in patient safety and pediatric care.”
The Ferreros’ plan, however, includes more than patient safety. The foundation’s mission also is to advocate and fundraise for a state-of-the-art children’s hospital in Gainesville. The couple announced they would match up to $1 million in donations made to the foundation.
“Our family didn’t need money, we needed Sebastian,” Horst Ferrero says. “So it was clear to us what to do after this tragedy.”
Cultivating a culture of quality
In the weeks after Sebastian’s death, new models were put into action quickly, including a Medication Committee that includes a multidisciplinary group of physicians, nurses, pharmacists and hospital administrators who established new processes for approving, administering and tracking intravenous infusions and other medications. Now physician directors of quality and safety are in place to coordinate departmental and institutional quality improvement activities.
UF’s ambulatory care clinics are on schedule for installation of an electronic medical record system, which will help to prevent medical errors. At Shands at UF, “Rapid Cycle Teams” and the patient/family-initiated Condition “H” Partners in Care program were implemented to quickly resolve clinical quality and safety issues in real-time.
On the research front, the College of Medicine began funding intramural Clinical Quality Education Grants, promoting faculty research in approaches to improved care. A new session on quality and safety was added to the college’s annual Research Day program.
In August the College of Medicine implemented what many believe is the country’s only comprehensive Quality and Patient Safety curriculum throughout the four-year medical student educational program. When students from the medical school class of 2012 graduate, they will leave UF with four years of exposure to the issues of quality and patient safety that began with their first day of orientation.
“I don’t believe such an integrated, longitudinal program that spans all four years exists at another medical school; this should be looked at as a model for others,” says Marvin Dewar, MD, associate dean for continuing medical education. “We cannot change the tragedy, but we can make something good come out of it. Sebastian’s case has galvanized people in our institution to do the right thing in terms of patient safety initiatives.”
The accidental overdose has had a profound impact on physicians and the way they practice – not the least of whom is Silverstein. As the doctor who ordered Sebastian’s growth hormone test, she has struggled with the sad reality of the error, and she has cried with his mother.
“That day was the hardest of my life,” says Silverstein, speaking of two days after the test when doctors confirmed the arginine overdose. “He was an amazing child.”
The lesson begins
Flash forward to Oct. 29, 2008, a little more than one year after Sebastian died. Horst and Luisa Ferrero are back at UF. They have with them Sergio, 2, and their 3-month-old son, Santiago. The Ferreros have an appointment with 135 first-year medical students. This day is an important part of the plan to bring patient safety into the medical classroom from the first day to graduation day.
The Ferreros address a crowded auditorium in the Medical Science Building and once again tell their story of medical errors, miscommunication and unbearable grief. It is the first annual Patient Safety Grand Rounds, a major component of the medical school’s newly created patient safety curriculum.
“Many people within the college recognized the Ferrero case as a sentinel event for our institution,” says Eric Rosenberg, MD, the patient safety course director and a member of the task force charged with designing the curriculum. “Obviously we want to learn to prevent this type of error from happening again, but we also will use it to teach our students to reflect on what’s going on around them and inspire them to improve systems to eliminate such errors.”
Horst Ferrero begins his talk by describing the disastrous chain of events in detail for the students, and later he asks them to remember five points:
- Treat every patient with compassion, courtesy and dignity.
- Give every patient the time and attention they deserve.
- Listen to parents. They know their children better than anyone.
- Work as a team with your colleagues and staff. Patient safety is everybody’s responsibility
- Don’t assume that others have checked; double-checking can save lives.
Luisa Ferrero takes the microphone and begins by answering the question on most people’s minds: Where do they find the strength to help others?
“From the love we have for Sebastian and Sergio and Santiago,” she says. “It is not easy. Every morning I look up into the sky and I tell Sebastian ‘Today, I will do this for you.’ But I can’t stop wishing to hug him one more time.”