FDA Suspends Local Blood Bank License After Inspection
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MIAMI (CBSMiami) -- Federal officials suspended the license of a local blood bank after an inspection revealed a series of violations that could "constitute a danger to health."
In a letter sent by the Food and Drug Administration (FDA), dated July 9th, they noted that inspections of the United States Blood Bank, Inc. turned up "significant deviations" that they said occurred routinely and "are of a serious nature" possibly posing a danger to public health.
Failing to notify donors that tested "reactive" for HIV, was among the violations listed in the suspension letter. The department said that at least 120 donors were notified they were "reactive" through "generic letters" that asked the donor to contact the blood bank but did not provide anymore information. Of those notified, only 16 returned to the blood bank to be notified of their reactive HIV test results, according to the letter.
The department said the blood bank also failed to notify at least six donors who tested reactive for Hepatitis B and/or Hepatitis C.
The letter also states the blood bank failed to "adequately determine the suitability of donors as a source of Whole Blood." This means they needed to determine donors were in good health to the extent that it does not create a risk of contamination of the blood. This includes checking donors arms and forearms for skin punctures or scars indicating an addiction to drugs which, according to the FDA, they did not do.
Among other violations listed in the letter, FDA officials said, there were 11 instances in which red blood cells were relocated due to a refrigerator malfunction or power outage. In those instances, the blood bank documentation did not specify how long the units were stored outside the approved temperature range.
Due to these violations and others listed in the letter, administration officials said they decided to suspend their license.
As part of the suspension, the company is not allowed to ship blood or blood components.
The company has 10 days from the date the letter was issued to appeal the suspension and comply. They will have to write out the specific actions taken to correct the violations.
Click here to read the full letter.
