The U.S. Food and Drug Administration has suspended the license of a Doral-based blood bank after an inspection turned up a series of violations that includes improperly notifying dozens of blood donors who may have HIV.
A five-page letter from the FDA dated July 9 said that between August 2013 and May 2015, U.S. Blood Bank did not make “reasonable attempts” to notify at least 120 donors who tested reactive for HIV and would need a further test to verify the results. Instead, the company sent letters that told recipients to contact the U.S. Blood Bank but didn’t say why. Out of the number of donors who tested reactive, only 16 returned to the blood bank, according to the suspension letter.
The FDA said in the letter the “deviations are of a serious nature and constitute a danger to health.”
The company said in a statement Thursday it would address the issues outlined in the letter and that “not one of our units for transfusion was deemed to be anything but pure and safe.”
“The letters we sent out out weren’t aggressive,” said Esther Hernandez, the president of the company. “It was maybe our fault, but we didn’t want the donors to be scared.”
U.S. Blood Bank — which accepts blood donations and ships the blood to facilities that need it — also failed to adequately inform at least six donors who tested reactive for Hepatitis B and C between September 2014 and February 2015, according to the letter. Though the company was suspended for its notification procedures, both the FDA and the U.S. Blood Bank said that there is little risk to the public because no potentially tainted blood was shipped out except to research facilities.
“Due to the nature of the violations, FDA believes that there is little risk to blood and blood product recipients, and has found no evidence to suggest that these violations resulted in serious health consequences in recipients,” said Sarah Peddicord, an FDA spokeswoman.
The blood bank did not specify where it ships blood but said that it works with hospitals and other facilities both inside Florida and outside of the state. The FDA also cited U.S. Blood Bank for failing to obtain written approval to ship this blood, according to the suspension letter.
The list of violations was enough to trigger the unusual move by the FDA of suspending the company’s license to operate, something the government agency hasn’t done in more than a decade, Peddicord said.
The FDA declined to speculate on future actions it may take but said that under the suspension, U.S. Blood Bank has 10 days to respond to the violations outlined in the letter.
The company said Thursday it is not collecting or shipping any blood and most of its 43 employees are not working. Outside of the Doral offices, eight red-and-white painted donation vehicles with the slogan “donate blood, donate life” sat idle.
“We’re working very hard right now and by the end of next week we should have all of our paperwork submitted to the FDA,” said Hernandez. “We’re hoping to re-open.”
Among the other violations outlined in the suspension letter were failing to check donors for skin punctures or scars that may have indicated narcotics use and improperly documenting where blood was moved when there were refrigeration malfunctions.
U.S. Blood Bank is also required to notify any distributors that it supplied up to 60 days before the suspension about the inspection results and also furnish those records to the FDA. The government agency also notified state health authorities of the suspension.
According to the FDA, it is still the responsibility of U.S. Blood Bank to properly notify donors who may have HIV, Peddicord said. The company said that it would change the type of letters it sends to donors in the future and amend its record-keeping procedures.
“We’re changing everything,” said Hernandez. “The letter and everything. We’re making all pertinent changes.”