A blood center at the Children’s Hospital has been singled out for some pretty serious problems, according to a 9News report that’s troubling, considering Children’s reputation and its own promises. The hospital’s website touts values that include high-quality patient care and “safe medical care for children.”
But an inspection by federal officials found five violations at the center, including one involving a donor who tested positive for hepatitis C but was moved from a list of donors not eligible to donate to “active” or eligible status without records to show why.
Another violation was found at a mobile site, where blood was not being properly refrigerated. Three more violations were related to record keeping and inappropriate safety controls, according to a U.S. Food and Drug Administration warning letter sent to the Children’s Hospital Association Transfusion Medicine Services.
No patients are known to have been harmed as a result, and Dr. Ed Orsini, medical director at the Children’s Hospital Clinical Laboratory and Transfusion Medicine Services, tells 9News in a statement: “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.”