NYSDOH Releases Report On Tonsillectomy Death Investigation
New York, October 2 --- State Health Commissioner Barbara A. DeBuono, M.D., today released a report on the Health Department's extensive investigation into the death last March of a 4-year-old girl, Deziree Wade, from bleeding four days after a tonsillectomy.
While investigators and a panel of consulting physicians could not positively identify what caused the fatal hemorrhaging, they did raise several issues of concern about the care she received. As a result, the Commissioner issued two Statements of Deficiency which she made public today.
"The tragic death of this child has spotlighted critical issues which must be addressed by both the hospital where the tonsillectomy was performed and the managed care organization responsible for Deziree Wade's overall medical care," Dr. DeBuono said. "I will ensure that appropriate corrective actions are taken."
St. Luke's/Roosevelt Hospital, where the tonsillectomy was performed at the ambulatory surgery center on March 17, was cited for two deficiencies related to the surgeon's use of a harmonic scalpel, an ultrasonic device that simultaneously dissects and coagulates. The Department could identify no other surgeon or hospital in New York using the device for tonsillectomies. Deziree Wade's surgeon, Dr. Daniel Kuriloff, used a harmonic scalpel in her case and with seven other patients (five prior to Deziree) for removing one side of the tonsils. The other side was removed using a standard scalpel, and the results were compared to determine if the harmonic scalpel caused less post-operative pain.
The Department concluded that use of the harmonic scalpel for this tonsillectomy constituted research, not standard medical procedure. As a result, the hospital's governing board was cited for failure to review and approve appropriate research protocols for the use of the instrument for this purpose. In addition, the hospital was cited for failure to provide the child's mother with enough information to give truly informed consent to the use of a harmonic scalpel in the operation. Specifically, when Dr. Kuriloff told the child's mother there was no known risk from using the device, he did not indicate that this assurance was based on his own very limited experience with five previous cases out of 500 tonsillectomies he had performed.
The hospital also was cited for poor followup with the patient after her discharge from ambulatory surgery center. Although the nursing staff called the Wade home to check on Deziree's condition on Monday, March 20, three days after the surgery, the staff member accepted information from the child's uncle and made no attempt to verify it with her mother.
Health Insurance Plan of Greater New York (HIP), was cited for deficiencies in the followup care provided to the child when her mother brought her to a HIP center on Saturday, March 18, the day after the surgery, complaining of high fever. The HIP urgent care physician who examined the child, Dr. Giuseppi Ceraolo, failed to refer the case back to the surgeon or the hospital where the procedure was performed. The urgent care physician also failed to notify the child's HIP primary care physician on the next workday so that physician, who had treated Deziree from birth and had referred her for the tonsillectomy, could have followed up.
St. Luke's/Roosevelt Hospital and HIP will be required to submit plans of corrective action in response to the Statements of Deficiency within 10 days.
Background Of The Case
Because of Deziree Wade's history of recurrent tonsillitis, her HIP primary care physician referred her to Dr. Daniel Kuriloff, who saw her on February 15, 1995. Based on his examination, as well as the child's record of airway obstruction, difficulty with swallowing and eating, noisy breathing, recurrent tonsillitis and sleep apnea, Dr. Kuriloff found that surgery was warranted. After receiving approval from HIP for the operation, the child was admitted to the ambulatory surgery center on March 17.
The surgery began at 9:58 a.m. with Dr. Kuriloff as the primary surgeon. A resident removed the left tonsil using a steel scalpel and standard procedures, including electrocautery. Dr. Kuriloff then used the harmonic scalpel to remove the right tonsil. There was some bleeding and electrocautery was used to stop it. Deziree was brought to the recovery room at 11:30 a.m. No problems developed and she was discharged from the recovery room at 12:55 p.m. Along with discharge medications, Deziree's mother was instructed to call Dr. Kuriloff if problems arose with bleeding, fever, pain, redness, nausea or vomiting.
The following day, a Saturday, the child awoke and was "burning up," according to her mother. The mother called the HIP Center and was instructed to bring in Deziree, who was seen by an urgent care physician on duty, Dr. Giuseppi Ceraolo. He recommended continuation of the Amoxicillin that had been prescribed by Dr. Kuriloff and that Deziree be given fluids.
On Monday, March 20, a nurse from the hospital's ambulatory surgery center called the Wade House and spoke with Deziree's uncle, who indicated she was eating and drinking little, had a fever and was seen over the weekend by a physician at the HIP Center. There was no mention of blood or a problem with bleeding. The nurse did not speak with Deziree's mother.
The mother reports that early the next morning, March 21, Deziree woke up choking and then began to bleed profusely from her mouth. She was taken by EMS ambulance at 6:30 a.m. to Harlem Hospital, where she was pronounced dead an hour and a half later. An autopsy was performed by the New York City Chief Medical Examiner's Office, which described the cause of death as "post operative hemorrhage from right lingual artery following tonsillectomy due to chronic tonsillitis." The manner of death was listed as "therapeutic complication."
The Department'S Investigation
The Department's investigation of Deziree Wade's death included review of medical records at the HIP Center, St. Luke's/Roosevelt Ambulatory Surgery Center, Harlem Hospital and EMS. Investigators interviewed the child's mother and the physicians and nurses involved in the case. Information was obtained from the manufacturer of the harmonic scalpel, as well as the U.S. Food and Drug Administration (FDA), which had approved it for marketing, but did not specify or limit the procedures that could be performed with it. Other New York City hospitals and an otolaryngology professional association were contacted to determine if other surgeons were using harmonic scalpels for tonsillectomies.
Finally, the Department sought and obtained extensive expert physician consultation. A panel of eight physicians with pediatric, surgical and otolaryngology (ear, nose and throat or ENT) specialties was consulted after being provided with medical records, other consultant assessments, the autopsy report, interview summaries and information on the harmonic scalpel.
The investigators and the physician consultants addressed the following questions: Was the tonsillectomy necessary? Was the post-operative care the child received at the HIP center adequate? Was the use of the harmonic scalpel appropriate, did it cause her death and was the informed consent sufficient?
The consultant panel did not reach an absolute consensus on the need for the surgery. As a result, the Department reported there was not sufficient evidence to conclude the tonsillectomy was unnecessary.
Concerning the post-operative care at the HIP center, the panel examined the question of whether Dr. Ceralolo should have examined Deziree Wade's throat (he did not), and again the panel could not reach consensus. Pediatricians on the panel thought he should have, but ENT experts said such an examination would have revealed little, could not have predicted subsequent bleeding and might actually have precipitated a problem by causing gagging from the pressure of a tongue depressor. The Department, however, did find that Dr. Ceralolo erred in not referring Deziree back to the surgeon and alerting the surgeon about the post-operative problems.
The panel found that the harmonic scalpel should not have been used for a tonsillectomy without appropriate research protocols and that the girl's mother did not receive adequate information to provide informed consent. However, no evidence could be found to establish that the harmonic scalpel was the cause of the fatal bleeding.
10/2/95-107 OPAContact: Claudia Hutton, Director, Public Affairs (518) 474-7354
New York State Department of Health, Posted: October 23, 1995