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$10 Million Fine on Red Cross Highlights Its Troubled History of Blood Services

The nation’s largest supplier of blood has been hit with yet another big fine for longstanding problems with its blood services.

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A California man donates blood at Providence Holy Cross Medical Center for victims of the Sept. 12 head-on collision between a Metrolink commuter train and a freight train in Chatsworth, Calif., on Sept. 14, 2008. (David McNew/Getty Images)

A few weeks ago, the Food and Drug Administration hit the American Red Cross with a nearly $10 million fine for safety violations, lax oversight and faulty testing of its blood services. The fine is just the latest of more than a dozen the Red Cross has racked up in the last decade.

In 2003, a federal court, frustrated by repeated blood safety violations by the Red Cross, gave the FDA the power to fine the organization. Forty-six million dollars in penalties later, many of the same violations -- understaffing, ineffective screening of donors, failure to recall infected blood -- are outlined in the recent letter the FDA sent to the executive vice president of Biomedical Services for the Red Cross.

The 32-page letter describes hundreds of violations over several months in 2010 at 16 Red Cross facilities across the country, and details how the Red Cross repeatedly failed to properly track and record information about donors and blood units. (To see the actual document and others like it, go to our timeline of Red Cross fines.)

For example, the agency failed to notify health departments when donors had infectious diseases such as HIV and syphilis, failed to add new donors with infected blood to a national list of people who aren't allowed to donate, and failed to review records of donors who had bad reactions, such as a 16-year-old who lost consciousness and fell to the floor after giving a unit of blood. It also failed to follow written procedures, such as the case of a phlebotomist in Arizona who stuck herself with a needle before sticking a donor with the same needle to draw blood. The case went unreported for a month, because a staff member "was not aware of the need to immediately notify a Medical Director," according to the inspection letter.

In a recent statement, the Red Cross said it was disappointed that the FDA issued the fine for "an inspection conducted so long ago" and noted that it has "already taken corrective steps to address those matters and that improvements in operations have been made."

In an email to ProPublica, a Red Cross spokeswoman also said there is no evidence that these violations endangered any patients, adding that the blood supply is safer than it has ever been. The spokeswoman said the agency has made significant improvements, including reducing the number of problems system-wide by at least 65 percent, and is investing in technology upgrades. For example, the agency recently upgraded software and computer equipment at blood drives to better collect and track donor information.

The FDA's letter laying out the fines says the Red Cross "has known of these continuing problems and has failed to take adequate steps to correct them." The FDA also noted that "many of the violations recounted in this letter are virtually identical to violations charged in previous [letters]." In June 2010 the FDA imposed a $16 million penalty on the Red Cross for the same type of violations.

The chronic problems raise the question of whether penalties are working at all.

The Red Cross has been making promises and failing to keep them for over a decade, according to Sidney Wolfe, who heads the health research group at the consumer watchdog organization Public Citizen. Wolfe said he wrote to head of the FDA in 2000, urging it to hold the Red Cross in contempt of court. A federal court first put the Red Cross under government supervision in 1993 after finding blood safety lapses. A decade later, in 2003, the court empowered the FDA to impose fines.

"But fast-forward nine years ahead, and we have the same violations," Wolfe said.

If the Red Cross disagrees with an assessment, it can ask the FDA to reevaluate the penalty, but in most cases the fine only changes by a few thousand dollars.

Most of the recent problems inspectors cited have to do with managing records and tracking blood donors. The Red Cross says it is unaware of any infections or deaths that stemmed from problems noted in the report, and that "serious problems" account for only three percent of the total problems found.

The FDA doesn't think that's good enough.

"FDA cannot definitively say there was never any danger to the blood supply since the violations can create conditions that could lead to potential safety consequences," said FDA spokeswoman Patricia El-Hinnawy.

The government requires that the Red Cross (like any blood services operation) have multiple safeguards for its blood services. That includes asking a donor questions to identify any risks, checking his or her name against a national list of people who aren't allowed to give blood, testing for infectious diseases, keeping track of blood units so infected blood isn't released, and investigating any deviations from standards.

Because blood transfusions always carry a degree of risk, the FDA considers every step in that process critical to minimizing problems. "Failure of an individual safeguard does not automatically translate into the release of unsafe products," an FDA spokeswoman told ProPublica in an email, "however, it may increase the potential for risk."

In 2008, the Red Cross consolidated its blood work to two facilities: one in Charlotte, N.C., and the other in Philadelphia. The offices are in charge of managing, tracking and, if need be, recalling blood. But according to the inspection letter, both offices have been chronically understaffed, and simply haven't been able to carry out their required functions in a timely or effective manner. As of 2010, the offices had a backlog of about 18,000 donor management cases.

The Red Cross has a long history of negligence, incompetence, predatory pricing and self enrichment.  In 1989 Gilbert Gaul won a pulitzer for his series in the Philadelphia Inquirer “Blood Brokers”.
http://www.bloodbook.com/part-1.html

This story is in-depth and there is no denying what it exposes.

It’s good to know that the FDA is finally going after the villainout Red Cross instead of wasting time preventing E. coli contamination in the food supply, tainted drugs, or fraudulent medical treatments…

Look, I get that blood is important, and some of these infractions could have led to big problems, but seeing a charity fined for not snitching to the government that a donor has HIV (does the government have a right to know that?) seems inconsequential in comparison to sexual potency pills advertised on TV with FDA approval despite a shopping list of side-effects longer than, well, the result of the pill.  That’s great humanitarian science, apparently, but they draw the line at private institutions not filing paperwork and want their cut of the donation money…

Interesting that the FDA was not allowed to levy those fines prior to going to court over repeat violations. Is it possible they have no enforcement power? Thanks for the excellent investigative reporting! I’ve linked to it on my ad-free blog for baby boomers who are always interested in health-related issues.  http://babyboomerswriting.blogspot.com

To John: Perhaps not the FDA but government i.e. the Dept of Health and Human Services definitely has a right to keep track of contaminated blood. As a Nurse, I must stress the importance of making sure patients who required a blood transfusion do not end up with an unexpected disease.

This issue should not be taken lightly.

KC, I meant the patient, not the blood.  The article says, “the agency failed to notify health departments when donors had infectious diseases such as HIV and syphilis, failed to add new donors with infected blood to a national list of people who aren’t allowed to donate,” and so forth.

I absolutely agree with you on care with the blood “in the bag,” and screening (and action on it) is critical, but I’m talking about the HHS or whoever recording that “you” (not an abstract Sample #437,105,385) have HIV.

Keeping in mind that a lot of authoritarians want a DNA database, what are the limits to data collection as technology improves?  Given the obvious bias against people with STDs and especially AIDS, what privacy rights are there and who can/will the information be shared with?  When are the blood donors made aware that their information might be collected?

So no, it shouldn’t be taken lightly, but neither should data collection on citizens.  I can’t help but envision a world where people are mysteriously denied health coverage after donating blood, they suddenly get piles of advertising for therapy for a genetic defect they’ve never told anybody about, or in the panic of a new disease, people look at the listing and wonder if it’s best to execute the carriers to prevent the sprerad, which I remember was suggested more than once when AIDS was new and terrifying.

Mike Seifried

Feb. 2, 2012, 4:32 p.m.

Maybe the Red Cross should just get out of the blood business. Oh wait. Where will hospitals get blood?

Richard Schmidt

Feb. 2, 2012, 4:47 p.m.

This article is why I decided several years ago to donate my blood through the Community Blood Center of the Carolinas. I obtain all the advantages of donating my blood to babies and other immune compromised without the baggage the Red Cross brings to every venture.

Bet there is Gadolinium metal from MRI scans and technetium nuclear waste from CT scans inthe blood supply as well as organ donors..
I will refuse blood, blood products, carrimune, IVIG and all scans, xrays, now that I have gadolinium blood levels and in my skin. Radiation burns if I were to get any xrays, scans. UCH denver did this as did the VA.

Jorge Watanabe

Feb. 2, 2012, 7:09 p.m.

I was doing consulting work for ARC (not in the blood biz, tho) when the first fine was expected.  Top mgt was in complete denial.,  Only a fig leaf of internal investigation took place—by accountants, not blood mgt experts or mgt experts.  Top mgt did not seem to get the importance of the problems and what a grave threat they posed.  As in other areas, like using donations as intended by the donors, the ARC needs more and more surveillance, investigation and self-provided transparency.

How on earth can anyone be referred to as a phlebotomist (a title that indicates they have received specific medical training on how to extract blood), and not know that sticking one needle into two people without applying approved cleaning processes between-times is a no-no?  Maybe they should be referred to as “alleged phlebotomist” or “inadequately trained phlebotomist”?

From Snopes: 

  ” American Red Cross: The information presented above is outdated (as of October 2010), as Marsha J. Evans resigned her position as CEO of the American Red Cross in 2005. The current President and CEO of the American Red Cross (since 2008) is Gail J. McGovern, whose last reported total yearly compensation was $1,032,022, considerably higher than the $651,957 figure mentioned above. Charity Navigator and Forbes both rate this organization’s efficiency at 92%, much higher than the 39% figure claimed in the e-mail.”“

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You’d think that for this level of salary and benefits, these ladies could have cured the chronic blood supply problem.  A clue might be found in the last sentences of ProPublica’s article:

“But according to the inspection letter, both offices have been chronically understaffed, and simply haven’t been able to carry out their required functions in a timely or effective manner. As of 2010, the offices had a backlog of about 18,000 donor management cases. “

So the head cheese gets the magna-bucks, but the foot soldiers don’t have enough staff and equipment to do the job.

Caveat emptor—or in this case, helpless recipient of problem blood.

This is of no surprise..My brother was charged for a pair of socks during WW2 after just getting off the front line. (fought the Japenese)  He had no socks in his shoes and went to the Red Cross for a pair of socks.  He was sent back to the battle ground shortly after.  We had not seen him in uniform ever, except for a picture in his dress uiniform.  USMC..He came home over 3 later…

I had to go home on emergency leave while AD USAF,  of course, had lower pay than my civilian nursing job, had to “borrow” money under a grant from the RED CROSS and had to pay it back in 1987. Screw them. The blood supply is contaminated with old blood, hiv blood, babesias, undetected until you get the disease post transfusion and gadolinium toxic metal and technetium nuclear tracers from MRI scans and CT scans. I’ll never get blood , not even the 3 pints free under Medicare.

Rosanne Angel

Feb. 6, 2012, 1:29 p.m.

It is sad and irresponsible when people try to jump on a bandwagon to disgrace the American Red Cross.  Sensationalism sells to the media.  As a Red Cross Volunteer, I see first hand how the volunteers are on call 24/7 to attend to victims of a disaster.  I personally have stayed up all night to help put victims of a fire in a hotel, provide food and clothing vouchers, and turned them over to casework help for follow-up.  This occurs everyday with the Red Cross. This is not newsworthy?  If you become a victim of a disaster, who is going to be there to help you?  Why do people take advantage of the good and condemn the mistakes of an organization? We are all improving, including what happened a long time ago with the blood situation. We are very fortunate to have an organization like the Red Cross.

Good work. And next time you have to buy a pint of blood at your local hospital check your bill. I’ve seen the price upwards of $3500/pt. You’d think some one could afford to finally do it right…

Roseanne, I agree that the organization is mostly good, but disagree on two serious points.  First, no, doing what you’re supposed to do isn’t newsworthy, and I hope nobody is motivated to save lives by the chance to get their name in the news.  Second, the good they do should in no way give them a pass on any problems in the organization; as a volunteer who feels the need to defend the Red Cross, you hopefully see the value in shining a light on the indefensible parts so they can be eliminated.

My objection to the investigation stands, though.  There are bigger fish to fry than some volunteer didn’t help track “undesirable” people on behalf of the government.

Medicare pays for the first 3 pints. I wouldn’t take it if it were free. Oh , the FDA can do any experimental treatment they want on you if no one around to speak for you , with or without advanced directives. if you are terminal. See their rule on experimental treatments at end of life.
no ethics or morals allowed.

Kathy Pennington

Feb. 7, 2012, 12:33 p.m.

Does the government have the right to know if a doner has HIV? You bet it does. And the recipient of the blood has the right to know that the doner DOES NOT have HIV.

This article is part of an ongoing investigation:
Red Cross

Red Cross

We’re investigating issues around the organization and how it has spent donated money after Hurricane Sandy and other disasters.

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