State Fines Beth Israel Medical Center $30,000 for Quality of Care Problems

Albany, N.Y., November 5, 1998 – The State Health Department has cited Beth Israel Medical Center for quality of care violations and fined the hospital $30,000 related to the death of a young woman undergoing an outpatient surgical procedure.

Following an extensive investigation of this case, the State Health Department has determined that the hospital violated accepted standards of medical practice, including: use of surgical equipment not approved by the hospital, and on which physicians and nurses had no formal training; permitting an unlicensed and unauthorized person to participate in a surgical procedure; communication problems among operating room staff; and failure to conduct a thorough investigation of the circumstances surrounding the death of this patient.

In a 12–page Investigative Report, the Department of Health details the unusual events that took place in the operating room when a 30–year old woman was undergoing surgery to remove a non–cancerous uterine fibroid tumor. Among the findings of the Department's investigation:

  1. For a month prior to the date of the surgery, an equipment salesman from Johnson & Johnson had been trying to convince the hospital to purchase a new device that he claimed was easier to use and safer than existing hysteroscopic equipment used in removing uterine tumors. The chairman of the hospital's Department of Ob/Gyn requested purchase of the equipment, subject to the approval of the hospital's Biomedical Engineering unit and the Budget Office.
  2. The day prior to the woman's surgery, the Johnson & Johnson salesman met with the woman's surgeon and his partner, claiming that he had obtained permission for using the new device from the Chairman of the Department of Ob/Gyn and the Administrative Director of Surgical Services at Beth Israel.
  3. The next day the salesman appeared in hospital scrubs with the device in the operating room where the woman was scheduled for surgery. When the operating room nurses pointed out that they had no training in use of the machine, they were told that the salesman would operate the controls.
  4. During the operation, the two surgeons in the room alternated use of the device, while the salesman operated the controls that regulated the amount of electrical current being used. The procedure involves distending the uterus by infusion of saline solution to make the fibroid tumor easier to see on a video monitor. A probe is then introduced into the uterine cavity and electrical current is generated from the probe to vaporize the fibroid.
  5. A nurse was responsible for monitoring the inflow and outflow of saline fluid during the procedure. Approximately midway through the procedure, the nurse alerted the surgeons that the fluid output had stopped. The nurse claims to have repeated this concern several times, but was informed by the lead surgeon that it was not a problem.
  6. When the lights were turned on at the end of the procedure, it was apparent that the patient was swollen from fluid retention and had pronounced abdominal distension. The lead surgeon reportedly said, "I had the outflow clamp closed because I wanted to get a good picture."
  7. Medication was administered to relieve the edema, however, the patient's condition began to deteriorate, and she ultimately suffered cardiac arrest and died. The autopsy report listed the cause of death as "Excessive infusion and absorption of normal saline during... (abdominal surgery)."
  8. The hospital subsequently developed rules concerning visitors in the operating room, guidelines for administration of intrauterine fluid during hysteroscopic procedures, and the approval process for having new surgical equipment authorized for use within the hospital. The hospital also suspended the privileges of both of the surgeons. One surgeon subsequently resigned and the lead surgeon is required to take a course before performing any further hysteroscopy procedures, and the first five procedures he performs must be observed.

Based on its investigation of the death, the Department of Health cited Beth Israel Hospital for:

  1. Care that did not meet acceptable standards of practice
  2. Failure to fulfill its quality assurance responsibilities
  3. Ineffective oversight and management systems
  4. Violation of patients' rights
  5. Inaccurate medical record documentation
  6. Providing incomplete information to the Department of Health.

The hospital is required to submit a Plan of Correction to the Health Department by November 9, 1998 identifying the steps that will be taken to prevent a recurrence of these problems.

11/5/98–105 OPA