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Medical Forum / Diseases and Disorders / Arthritis / November 2006

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FDA Levies Another Fine On American Red Cross For Blood-Safety Violations

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Fire Chief - 28 Nov 2006 23:23 GMT
American Red Cross Faces Another Heavy Fine Over Blood-Safety
Violations
11-28-2006 12:28 AM
By ANDREW BRIDGES, Associated Press Writer

WASHINGTON --  The American Red Cross is facing another heavy fine over
blood-safety violations, bringing penalties against the organization to
more than $15 million despite a promise three years ago to fix the
problems.

The Food and Drug Administration disclosed that it had fined the
organization $5.7 million recently for continuing to violate
blood-safety rules and failure to comply with a 2003 agreement aimed at
correcting the unsafe practices.

The latest fine was noted in an FDA letter dated Nov. 21, to Red Cross
interim president and CEO Jack McGuire, and posted Monday on the FDA
Web site.

The Red Cross was given a mid-December deadline to produce a report on
how it intended to comply with FDA requirements, or possibly be subject
to additional penalties.

The latest fine is being added to a tally of nearly $10 million in
previous FDA penalties for violation of blood-safety laws, regulations
and the terms of the 2003 consent decree.

That settlement resolved charges that the Red Cross had committed
"persistent and serious violations" of federal blood safety rules
dating back 17 years.

In 2004, the Red Cross implemented a plan, with the FDA's blessing, to
detect, investigate, monitor and correct the sorts of problems
repeatedly cited by government investigators.

A 2005 inspection of a Red Cross facility in West Henrietta, N.Y. was
supposed to be the first comprehensive evaluation of how the plan was
working. But the federal inspectors, over 29 days, turned up 207
deviations from the plan, the FDA said.

The latest fine of $5.7 million stems from that inspection.

The inspectors found shortcomings in quality assurance, inventory
management, control of non-conforming blood products, donor screening
and blood component manufacturing issues as well as other problems,
according to the FDA.

The Red Cross said it would devise a new plan to comply with FDA
requirements. The Red Cross board of governors also has asked for an
independent and comprehensive assessment of how it complies with FDA
regulatory requirements.

The Red Cross does not use donated money to pay fines, but instead
relies on operating funds, according to the organization. Those include
revenue from the sales of blood products.

The Red Cross provides more than 40 percent of the nation's blood
supply, selling blood products to health facilities.


... Born free, but taxed to death.
Harvey R. Stone - 29 Nov 2006 01:06 GMT
To anyone,,,,   What do you make of this?

Harv

> American Red Cross Faces Another Heavy Fine Over Blood-Safety
> Violations
[quoted text clipped - 56 lines]
>
> ... Born free, but taxed to death.
ladylove77 - 29 Nov 2006 03:25 GMT
It means I definitely won't be giving my money to the Red Cross!
Gwen

> To anyone,,,,   What do you make of this?
>
[quoted text clipped - 60 lines]
>>
>> ... Born free, but taxed to death.
Fire Chief - 29 Nov 2006 04:46 GMT
> To anyone,,,,   What do you make of this?

My local blood bank, where I've been donating since 1966, charges only
a processing fee when blood is needed.  It does not sell blood like the
Red Cross does.

But this the same Red Cross that was selling cigarettes to G.I.s.
Cigarettes that were branded "Donated by .....name of tobacco company".

The same Red Cross that was rocked by scandel  3 years ago in SoCal.
It put dollars donated to/earmarked for fire victims into its general
budget to pay utility bills, etc.   Fire victims received less than 25%
of the donated monies.

The same Red Cross that's been investigated for padding the books
while running the ADA bus system under contract for the county.

... URA Redneck if you think Virginia Slims is a new brand of Condoms.
Smokie Darling (Annie) - 30 Nov 2006 17:26 GMT
On Nov 28, 9:46 pm, "Fire Chief" <CALIFORNIA_CH...@PEOPLEPC.COM>
wrote:
> > To anyone,,,,   What do you make of this? My local blood bank, where I've been donating since 1966, charges only
> a processing fee when blood is needed.  It does not sell blood like the
> Red Cross does.
>
>  But this the same Red Cross that was selling cigarettes to G.I.s.
> Cigarettes that were branded "Donated by .....name of tobacco company".

You know, according to Snopes this isn't true, but my Grandfather swore
he paid for ciggies from them, as did my husband's dad (they are
deceased now, so I can't "prove" what they said).  They say that the
Red Cross only made American GIs pay for coffee, doughnuts, and lodging
(a minimal fee).

The SAME Red Cross that took my husband's blood donations from 1972 -
2002, then said they couldn't anymore because of Mad Cow (he was in
Turkey in the early 80s and ate Highland Beef - from the UK).  Now,
they acknowledge that he would be dead by now if he HAD eaten infected
beef, but they won't accept his blood anymore.

When my husband's father passed (when hubby was a SGT), commander gave
him bereavement leave, he had no money.  The Red Cross told him that
because he had already received the LEAVE from his commander that they
couldn't help him (apparently THEY have to get the leave approved
themselves or you don't get a ticket to fly home).  I DESPISE them for
a number of reasons, and these are only a few.

>  The same Red Cross that's been investigated for padding the books
> while running the ADA bus system under contract for the county.

Smokie Darling (Annie)
Rosemarie Shiver - 29 Nov 2006 06:50 GMT
I think the quality of their for-profit blood collection and delivery is
about the same as the speed and quality of their non-profit disaster relief
: if not poor than really bad.

   The problem is the same as the United Way...all chiefs (no offense
meant, Joe) and few Indians; retention of the Indians sux and having to
start from scratch each time is dragging the effectiveness WAY down.

    If you're gonna be a professional outfit for profit and your major goal
beyond that is fundraising, then do it. Or allow other real and truly
professionally run not for profit NGO's to do the staffing and deliver the
charitable and emergency services.

    The way it is now is the reputation ( both RC and UW) doesn't match
what actually happens when the rubber meets the road....and it's what
happens when there is lax oversight and mere appointees rather than seasoned
professionals at the top...the heads are not really working or even knowing
exactly what it is they should be leading and getting done.

    Ummm....does that answer the ??, Harv?

Hugs from Rosie

Signature

"If you wanna get it done, you gotta fight for yourself." -- Meat Loaf, Bat
Outta Hell II

> To anyone,,,,   What do you make of this?
>
[quoted text clipped - 60 lines]
> >
> > ... Born free, but taxed to death.
Harvey R. Stone - 29 Nov 2006 13:59 GMT
>   I think the quality of their for-profit blood collection and delivery is
> about the same as the speed and quality of their non-profit disaster
[quoted text clipped - 22 lines]
>
> Hugs from Rosie

Pretty well and thanks,,,,  in other words kind of like the fed. gov.  even
though the state gov. was worse when that hurricane hit New Orleans.   They
did not even have water in the Super dome and that was the place people were
told to go.   All those school buses lined up and under water with thousands
of stranded people in N.O.
So it goes.
Harv
Rosemarie Shiver - 29 Nov 2006 14:37 GMT
It doesn't have to be that way, tho'. And some states and definitely the
military have professional emergency response teams that are the best in the
world. The Miami-Dade Fire/Rescue Team flies out world wide to do search and
recovery of earthquake victims and they train, train, train when not busy
saving lives. They're state employees.

  Andrew was a more destructive hurricane than Katrina. It was the loss of
the levee walls in NOLA that caused the flooding...Katrina just set the
stage. Remember all the thank yous and back patting immediately after? Then
the levees were breached and that was that. The levees were an Army Corps of
Engineers problem that was left unattended to...and the same thing is
happening with the levees around Lake Okeechobee here in FL.  It took the
Army to help the people that the Army Corps of Engineers left stranded. And
they died. More people than died from the Twin Towers disaster died in NOLA.
They kept dying way after the 72 hours the government tells ya you have to
be responsible for yourself and your family. NOLA ripped open the curtain
where there were literally thousands of Wizard of Oz disaster responders not
responding.

   It took the 82nd Airborne to be peacekeepers and do the job of feeding
and then moving all us Andrew refugees. It's just the way it is....the
military actually does the work and afterwards it's the Red Cross getting
credit but in reality telling ya sorry, but they can't really help ya. They
refused to help me obtain any meds. at all after there had been 3 in a row
hurricanes here in 2004. If the Red Cross won't help with medicine (there
weren't any pharmacies open for 2 months straight) then who will?

   Ya really gotta demand better....we as Americans can do better and
deserve better. Our generous fellow Americans pay top dollar in donations to
have disaster survivors helped...way before you get washed into the bayou
and right down into the Gulf yerself there, Harv.

Disaster Preparedness Hugs from Rosie

Signature

"If you wanna get it done, you gotta fight for yourself." -- Meat Loaf, Bat
Outta Hell II

>
> >   I think the quality of their for-profit blood collection and delivery is
[quoted text clipped - 31 lines]
> So it goes.
> Harv
Harvey R. Stone - 29 Nov 2006 15:00 GMT
>  It doesn't have to be that way, tho'. And some states and definitely the
> military have professional emergency response teams that are the best in
[quoted text clipped - 38 lines]
>
> Disaster Preparedness Hugs from Rosie

A really good look at the world around us.  Thanks Rosie....
harv
Rosemarie Shiver - 29 Nov 2006 15:29 GMT
Yer very welcome, Harv. And should you and yours need a place...me and
Norm will be here 4 ya.

ReHugs from Rosie

Signature

"If you wanna get it done, you gotta fight for yourself." -- Meat Loaf, Bat
Outta Hell II

>
> >  It doesn't have to be that way, tho'. And some states and definitely the
[quoted text clipped - 42 lines]
> A really good look at the world around us.  Thanks Rosie....
> harv
Harvey R. Stone - 30 Nov 2006 02:01 GMT
>   Yer very welcome, Harv. And should you and yours need a place...me and
> Norm will be here 4 ya.
>
> ReHugs from Rosie

That is so nice,,,   Aaah, the winter cold is going to reach us tomorrow and
I was thinking of farther south would be good.  :-)
Harv
Fire Chief - 30 Nov 2006 04:57 GMT
Harv wrote:

> Aaah, the winter cold is going to reach us tomorrow and
> I was thinking of farther south would be good.  :-)
> Harv

It's arrived here.  30 degrees in the valleys and 40 coastal areas.

... URA Redneck if truckers tell your wife to watch her language.

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