The FDA sent a stern warning to a large South Florida blood bank after finding multiple cases of unsafe practices -- including the use of platelets stored in a biohazardous waste bin for more than 21 hours.
Community Blood Centers of Florida locations were inspected from September to December 2011, during which time staff found dangerous “deviations” from health protocol, according to letter sent in April and first reported by the South Florida Sun-Sentinel.
In one case cited by the FDA, CBCF staff did not have a sufficient amount of platelets in a bag and filled the remainder with platelets that had been sitting in a biohazardous waste bin for more than 21 hours -- and had not been stored at proper temperature. The blood was then used in a December 2007 transfusion.
Another case involved a donor who was not told that his or her blood tested positive for HIV for 87 days, despite protocol that dictates notification within 45 days. Other unsafe practices cited by the FDA include misused supplies, overwritten and improperly maintained records, and errors left undiscovered by poor quality control checks.
Community Blood Centers of Florida collects more than 250,000 pints of blood and blood products for hospital and kidney dialysis patients, according to its website. The non-profit operates 15 donor centers in Palm Beach, Broward, Miami-Dade and Monroe Counties, and 50 blood mobiles also travel throughout South Florida and Central Florida.
According to the letter, which noted issues found in May 2004 and July 2007, the blood bank has not been following protocol for quite some time.
“You promised corrective actions in your responses to deviations noted from those inspections; however, we are concerned that your corrective actions were inadequate to prevent recurrence of these deviations,” the letter reads.
Susan Forbes, the chief marketing and communications officer for OneBlood, which merged with CBCF earlier this year, told the Sun Sentinel that the organization has taken action to correct the problems.
"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," she told the Sentinel. "Leadership changes were made as a result of the findings and we identified and implemented the need for additional resources surrounding training of personnel."