The American Red Cross has been hit again with another fine. This one's $10 million over blood handling and management the FDA says may not be safe. The organization's been ordered to clean up its act--even threatened with criminal penalties--but nothing's been working. The ARC is "disappointed." Apparently it feels the fine concerning human safety is unfair.
That'd be the second fine: Red Cross did nothing to fix problems less than two years ago when it was hit for $16 mil. Not even money is making the Red Cross fix its problems. And that's serious. Usually money, or the loss of it, works.
Unbelievably it isn't the first time the entity so massively responsible for blood donations has been hit with a huge penalty-- seriously fined over accusations of unsafe practices and the blood it manages. It's more than reason for concern. This time the federal government's ordering the Red Cross to pay up $9.6 million. The FDA's last attempt to force the Red Cross to correct its issues wasn't cheap either.Yes, it's the second multi-million-dollar fine for ARC -- in just two short years.
This newest ten million dollar penalty's over the Food and Drug Administration (FDA) inspection of 16 American Red Cross (ARC) blood centers last year -- and the administration's not happy: In inspections taking place over six months, between April and October, the FDA argues that blood donors' health is at stake -- and could be endangered through unsafe practices that could feasibly allow potentially contaminated blood into the U.S. nation’s supply. While the FDA isn't claiming any actual evidence of any blood recipients being harmed, it's also not confirming no one has.
It's noted that the alleged violations could lead to conditions where health safety issues could happen. The penalty isn't good news for the organization in need of people donating blood for emergency supply, the Red Cross supplying more than one-third -- or 40-percent -- of blood to the entire nation.
And what the FDA's really unhappy about is that it claims uncorrected issues over safety aren't for lack of awareness but the American Red Cross' failure to fix known problems -- clearly outlined and sent in a 32-page document to the executive vice president of Biomedical Services for the Red Cross. That January letter contains some interesting content -- or what should be interesting to the organization: Accusations include the FDA claim that blood collection is riddled by poorly trained staff, record-keeping problems and even mishandled blood donations -- other blood donations misplaced. They're continued and known problems, says the FDA, that the Red Cross continues to refuse to fix. But there's far more -- more that could be the most dangerous of all, or a matter of life and death.
If it's all not absolutely frightening enough, the most alarming could be potential for transfer of disease and illness -- yes, instances of potentially infected blood being transfused into patients receiving blood donations.
American Red Cross seems to think it's unfair. A Red Cross spokeswoman claims problems centered around a Philadelphia location over a year ago and that the organization's addressed many of the issues since. Note that the ARC doesn't say they've all been addressed, despite that inspection occurring 15 months ago. And there's not a lot of word on the other 15 centers cited by the FDA.
The FDA says a Charlotte, North Carolina, has a backlog of around 15,000 records. It also claims Red Cross locations haven't been good with accuracy -- that donors who shouldn't be allowed to give blood because of infections or health-related problems have donated. And in that vein, the administration says “lookback” investigations haven't been performed -- to properly track received blood from donors who were infectious, a potential health hazard that's not included notification to blood recipients who could have received potentially contaminated blood.
Then there's the outright crazy that just sounds equally unbelievable and entirely avoidable: Bizarre instance that like that where FDA inspectors claim a phlebotomist at a Red Cross center stuck herself with a needle, then stuck a patient with the same needle for a blood draw. The American Red Cross is apparently disappointed with the whole scene and occurrence. Oddly, it doesn't like the fine. Apparently the Red Cross believes it wasn't necessary to impose a penalty for problems in an inspection from over a year go. But, oddly, the first $16 million dollar fine -- less than two years ago for similar, potentially hazardous health-related issues -- had no effect. The American Red Cross says the organization isn't aware of "any adverse donor reactions or patient issues due to the problems in the FDA report” -- and recipients of that blood may not be either, yet. Blood isn't used simply for emergencies.
Roughly 17 million units of blood get donated per year. Almost all of it, about 15 million units, are transfused per a 2009 survey. And that makes cited problems very scary.
American Red Cross speaking rep Patricia El-Hinnawy stresses that donating blood is safe -- and that risks associated with receiving a transfusion are far less than failing to receive blood when needed. Well, now, isn't that the obvious: One option has a person dead this year -- the other could have them dead within about ten. Neither is exactly the most ideal -- particularly when certain potential hazards can be avoided. The American Red Cross-issued 'kicker' is El-Hinnawy's statement being pumped to the press: “FDA strongly encourages people who are in good health to donate blood and become regular blood donors.” That's odd -- usually entities speak for themselves. And it's not the FDA issuing that statement.
In fact the FDA seems to be indicating something is seriously wrong -- hitting the American Red Cross with separte $10 million and $16 million dollar fines in less than two years. $25 million says El-Hinnawy's proposal is not exactly what the FDA is saying right now.