The FDA conducted a nearly month-long inspection beginning on Jan. 13 and found five violations. One involved a donor who tested positive for hepatitis C, and was moved from a "deferred" list of donors not eligible to donate, to "active" or eligible status, when there was no record of that donor being retested and re-qualified to warrant the change.
Another violation was for blood at a mobile site that was not properly refrigerated. Three other violations related to record keeping, and not having appropriate controls in place so that only authorized personnel could change a donor's eligibility status.
The FDA says no potentially tainted blood was ever collected or distributed in connection with these violations.
The FDA sent a warning letter to The Children's Hospital Association Transfusion Medicine Services on April, outlining the violations. In that letter, the FDA acknowledged receiving a written response from the blood center after the inspection, in which the center said it took action to correct the problems. The FDA says while it found the actions generally adequate, The Children's Hospital Association Transfusion Medicine Services did not address a plan to prevent these issues from happening again.
9NEWS Medical Reporter Dr. John Torres says the warning letter is a serious matter.
"They are serious violations in the fact that there's a procedure that they go through and that procedure's been sidestepped a little bit here," Torres said. "You know my guess is that they'll get back to it, get back to the basics and really find out what went wrong and make sure it doesn't happen again because these are very serious things that could have happened."
9NEWS contacted The Children's Hospital on Wednesday, and received a statement from Dr. Ed Orsini, Medical Director at The Children's Hospital Clinical Laboratory and Transfusion Medicine Services:
"We do a thorough process of screening all potential donors and if donors do not meet the guidelines we mark them in the system as deferred. We have received a letter from the FDA concerning processes in record keeping. We have implemented measures to address these concerns and have responded to the FDA within the prescribed timeframe with an action plan. There was never blood released that was unsafe to the public."
The deadline to respond to the April 8th letter from the FDA was 15 business days.
On Wednesday, FDA spokesperson Devin Koontz could not confirm whether the agency received a letter from the blood center by the deadline. He did say the FDA conducts random inspections of blood centers at least once every two years, but because of the warning letter there will be a random inspection of The Children's Hospital Association Transfusion Medicine Services in the next six months. Koontz says he does not recall any warning letters ever being sent to blood center before the one in early April.
9NEWS asked the largest blood bank in Colorado, Bonfils Blood Center, how it works to meet FDA safety requirements. Dr. Kevin Land, chief medical and scientific officer and vice president of medical Affairs for Bonfils, says there are five layers of safety measures that are required by the FDA. They include donor screening, testing of donor blood, having a donor deferral list, having the ability to quarantine any suspect blood, and routine internal investigation of safety procedures.
Land says there are several systems in place at Bonfils Blood Center to maintain quality assurance and meet FDA regulations.
"In addition to the one to two audits that they have every month from the FDA and other regulatory bodies, we do about 30 internal audits, where we look to make sure in our most critical processes, or most manual processes, whether or not we're doing what we think that we're doing. I would say all donors have that to some capacity as well," Land said.
Land says it is easy to understand how errors can be made with manual processes, but he believes The Children's Hospital Association Transfusion Medicine Services shares his goal of making no mistakes.
"It's a constant concern for all of us that we might have missed something, and all good donor centers and I'm sure Children's one of them, worries about that every day," Land said.
Click here to read the full letter from the FDA.
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