|Published:||Aug 15, 2012 11:20 PM EDT|
|Updated:||Aug 16, 2012 12:16 PM EDT|
LEE COUNTY, Fla.- We're learning about a stern warning from the Federal Government for a south Florida blood bank.
The first thing we wanted to know is did any of that problem blood get here? It doesn't look like it. Even though the investigation is ongoing, the problems at the donation center happened last year.
The FDA found seven different violations against the "Community Blood Centers of Florida."
The problems happened at the non-profit's Lauderhill facility on the east coast.
They include mishandling blood samples, mixing up donor records by blood type, and even getting platelets out of the trash to complete a donation order. Blood from this donation center goes to blood mobiles and hospitals.
The FDA cites workers for failing to notify donors that their blood showed evidence of HIV infection. Inspectors also said workers did not use medical supplies according to manufacturers instructions. They also found that employees did not store red blood cells at the right temperature after processing.
WINK News just got a statement from a spokeswoman with "OneBlood." She tells WINK News they recalled all the problem blood, all regulations were followed and no medical problems were caused by it.
Blood Center Statement
More than a year ago Community Blood Centers of Florida implemented significant senior leadership changes. After these leadership changes were made, the regulatory, compliance and assurance departments were thoroughly evaluated. These internal evaluations showed deficiencies, and resulted in the blood center self-reporting its findings to the FDA. New leadership was put into place and key departments were reorganized and strengthened.
Ensuring safe blood is our top priority. Any unit in question was recalled and there were no patient safety issues identified as a result.
As these issues were identified all regulatory guidelines were followed. Most of these issues were discovered internally and self-reported to the FDA. Subsequent to the inspection the FDA has since acknowledged our efforts in resolving the issues. We take the FDA warning letter very seriously and have taken long term corrective actions to ensure we remain in compliance with all applicable current good manufacturing practices and reporting requirements.
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