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Following a three-week inspection of the blood bank at Brookdale Hospital Medical Center, FDA officials last May cited the facility for six violations of federal health guidelines. Along with failing to maintain equipment and proper testing records, a federal investigator discovered that Brookdale was guilty of an even more serious safety breach.
According to FDA records obtained by the Voice through a Freedom of Information Act request, Brookdale's blood bank failed to "restrict the use of blood and blood components" that tested positive for the hepatitis B virus. A May 1998 FDA warning letter to Brookdale states that although some blood tested positive for hepatitis B, it was released for transfusion, and that "two of the blood components" red blood cells and plasma were subsequently transfused.
FDA records show that two Brookdale patients received transfusions from the same unit of tainted blood. Both patients, who are not identified in the FDA records, later died, though hospital officials said the patients "expired of their primary disease during that admission." In a June 1988 response to the FDA inspection, Dr. William Steier, director of the blood bank, noted that "the error has been reported to the New York State Department of Health."
Brookdale spokesman Eric Matza said that the hospital had "no comment" on the FDA findings. Steier said that he was not authorized to speak about the government investigation, though he did say that "no litigation" had resulted from the transfusion errors. However, it remains unclear what steps, if any, Brookdale has taken to notify the dead patients' families of the blood snafu.
In a June 1998 letter to the FDA acknowledging the various violations, Steier stated that the "donor room nurse and/or blood bank supervisory personnel" failed to follow hospital procedures, a lapse that resulted in the release of tainted blood components. Brookdale later reported that staff members had been retrained since the error occurred, and that written procedures for interpreting viral testing results had been established.
FDA investigator Valerie Grecek-Trinh also reported that a second unit of blood tainted with hepatitis B had been improperly placed in Brookdale's blood bank inventory. But before the blood could be transfused, the unit was discarded on its "expiration date."
Brookdale was also cited for its failure to properly maintain "a record from which unsuitable donors may be identified so that products from such individuals will not be distributed." The FDA warning letter specifically notes that the blood bank failed to place the names of two donors one who tested positive for hepatitis B and another whose blood carried the hepatitis C virus on a list of ineligible donors, a compendium known as the "deferral system."
According to the Centers for Disease Control, hepatitis B can lead to chronic liver disease and sometimes death. In many carriers, though, symptoms primarily include jaundice, fatigue, abdominal pain, loss of appetite, and nausea. CDC officials estimate that the hepatitis B virus has left over 1 million Americans "chronically infected."
Each year, more than 200,000 people in the U.S. are infected with hepatitis B and close to 5000 die of sickness caused by the virus, according to the CDC. There is no cure for the disease.
Brookdale, which describes itself as one of Brooklyn's largest "nonprofit voluntary teaching hospitals," was founded in 1921 and now occupies a 14-acre campus in Brownsville that includes more than 30 buildings. At the same time FDA inspectors were probing Brookdale's blood bank, the hospital announced that it was launching an innovative "blood conservation program" designed to reduce or eliminate the use of donor blood during surgical procedures.
Employing state-of-the-art technology, the procedure allows blood to be collected from a patient in the operating suite, minimizing the need to rely on a blood transfusion from another party. An April 1998 Brookdale press release quoted one of their doctors saying, "Obviously, the lowest-risk blood patients can receive is their own, instead of receiving donor blood when a transfusion is needed."