The U.S. Food and Drug Administration (FDA) has suspended a Miami blood bank's license to operate after the blood bank incurred several violations.
U.S. Blood Bank received a letter from the FDA earlier in the month saying the company did not make better attempts at notifying at least 120 donors from August 2013 to May 2015 that they had tested reactively to HIV and, as such, will have to get tested again to verify results.
Esther Hernandez, president of U.S. Blood Bank, countered that letters had been sent to affected donors regarding their test results but admitted that the notification was not aggressive because the company didn't want to scare them.
Aside from the HIV issue though, the company also failed to properly inform at least six donors from September 2014 to February 2015 that they tested reactively to hepatitis B and C. U.S. Blood Bank also didn't check donors for scars or skin punctures that may be indicative of drug use and did not properly document where it moved blood stores when malfunctions occurred in refrigeration units.
The company has acknowledged the FDA's notice and is working with the agency to address all violations levied against it to re-open at the soonest time possible. It maintains though that all of its transfusion units have been found to be pure and safe.
While the blood bank's violations have to do with notifying donors, both U.S. Blood Bank and the FDA clarified that the public is not at risk because possibly tainted blood that had been shipped out were headed for research facilities.
However, the extent of the company's violations prompted the agency to suspend U.S. Blood Bank's license to operate, a move that the FDA has not done in over 10 years.
Taking full note of the contents of the FDA's letter, the blood bank said that it will be changing the type of letters sent out to donors and amending its record-keeping arrangements.
"We're changing everything ... We're making all pertinent changes," said Hernandez.
Aside from this internal overhaul, U.S. Blood Bank was also required by the FDA to notify all distributors that received blood supplies from the company up to 60 days before the suspension took effect, telling them about the results of the inspection. The agency took it upon itself to alert state health authorities about the suspension.
