A blood bank that serves hospitals throughout South Florida has received a scathing warning letter from the Food and Drug Administration over unsafe practices in the handling of blood products.
Workers at Community Blood Centers of Florida, based in Lauderhill, failed to store red blood cells at the right temperature, retrieved a bag of platelets that had spent hours in a waste bin to complete an order, mixed up donor records by blood type and took 87 days to notify a donor who had tested HIV-positive, among other violations, according to the FDA.
The letter is dated April 27, but an FDA spokeswoman says the investigation is "open and ongoing."
The nonprofit blood center, which collects 250,000 pints a year, completed a merger this year with two other Florida blood suppliers to form a new company called OneBlood Inc., with offices in Orlando, Lauderhill and St. Petersburg.
Susan Forbes, chief marketing and communications officer for OneBlood, said the company does not dispute the FDA's findings. She said the company has moved quickly to clean up the situation in Lauderhill since these issues came to light, replacing the center's leadership, bringing in safety consultants and changing what she called center's "culture."
She said the company self-reported some of the problems to the FDA prior to receiving the letter, no members of the public were in danger and any questionable blood products were recalled.
"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 wrote in an email.
"We implemented corrective actions to address immediate concerns," she wrote. "Leadership changes were made as a result of the findings and we identified and implemented the need for additional resources surrounding training of personnel."
The FDA said in a July 5 letter to the company's chief executive officer, Donald Doddridge, "It appears you are taking steps to bring your company into compliance."
FDA spokeswoman Rita Chappelle said she could not comment on an open investigation.
Community Blood Centers of Florida operates 15 donor centers from Palm Beach County to the Florida Keys, deploys 50 bloodmobiles and delivers blood and blood products to hospital patients and kidney dialysis patients throughout South and Central Florida, according to its web site.
Florida's blood centers have been under scrutiny for the past few years, after news came to light of salaries for chief executives that exceeded $500,000 a year, sales of blood units out of state and other controversial practices.
One controversy involved former Broward School Board member Beverly Gallagher, who went to prison for accepting a bribe from an undercover agent. She had obtained a $53,000 a year job with the blood center while on the school board, through the efforts of a lobbyist who appeared before the school board.
The FDA warning letter resulted from an inspection conducted from Sept. 1 to Dec. 19, 2011, which examined records for the past several years. On one occasion, when workers realized they didn't have a sufficient volume of platelets, they retrieved a platelet bag that had not been drained from a biohazard waste bin and added to the order, even though it had been out of a temperature-controlled environment for more than 21 hours.
On at least six occasions, records for a donor of one blood type were entered over the existing donor of a different blood type, resulting in a discrepancy in the records. It was unclear from the letter whether this discrepancy existed only in the records or whether units were mislabeled.
On at least three occasions, red blood cells were not stored at the proper temperature of between 1 and 6 degrees Celsius, according to the letter.
The letter stated that employees in charge of making sure errors were caught, investigated and fixed "failed to conduct their duties" and that those in charge of internal audits did not conduct effective audits of the center's procedures "failed to identify deficiencies in the area of donor registration, blood products processing and testing, and investigation of deviations."
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