Children’s Hospital in Aurora is correcting problems at its blood bank after FDA inspectors cited safety concerns, a hospital administrator said Wednesday.
U.S. Food and Drug Administration officials said in a “warning letter” to the hospital that inspectors found “significant deviations” from regulations regarding blood.
For example, a would-be donor with hepatitis C was first placed on the inactive list for donation, but then — because of record-keeping flaws — returned to active donation status. Also, blood collected at mobile sites was left at room temperature longer than allowed, the FDA said.
Ed Orsini, medical director of the hospital’s transfusion medicine services, said Children’s has “implemented measures to address these concerns.”
“There was never blood released that was unsafe to the public,” Orsini said in a written statement.
Jennifer Brown, The Denver Post
