NoBlood

Jan B. Wade · #1 (**permalink**) 05-18-2003, 08:10 AM

Red Cross Blood Practices a Health Danger

Red Cross Blood Practices a Health Danger
Bob Dart
c.2002 Cox News Service

The Food and Drug Administration has told a federal court that the
American Red Cross is ``jeopardizing the public health'' through its
``chronic inattention and callous indifference'' in collecting and
processing blood.

In the latest legal filing in a decade-long court case, the FDA asked
the court to hold the Red Cross in contempt and to force speedy compliance
with a 1993 consent decree intended to remedy the ongoing problems.

In light of newly discovered violations, the FDA said, the Red Cross
should not be allowed ``another decade - or even another year - to stroll
towards compliance.''

However, in a statement accompanying its original request for a
contempt citation last December, the FDA stressed that patients needing
transfusions should not hesitate to receive blood, and donors should
continue to replenish the nation's blood supply.

``The risk of not receiving a needed transfusion far outweighs the
risk of receiving blood,'' said Bernard A. Schwetz, FDA's acting principal
deputy commissioner. ``I also want to encourage Americans to continue to
donate blood. Giving blood is a safe and unselfish act. The health of
millions depends on it.''

In addition asking that the Red Cross be held in civil contempt, the
FDA has asked the court for authority to levy prospective fines for future
violations. A hearing on the motion is set for Sept. 24 in U.S. District
Court here.

The Red Cross collects and distributes nearly half of the nation's
blood supply.

The FDA maintains that its inspections of Red Cross facilities have
found infractions over the past 16 years. The agency said ``persistent and
serious violations of blood safety rules'' have continued despite a 1993
consent decree in which the Red Cross promised to make substantial
improvements.

The latest FDA brief, filed last week, cites violations found during
an inspection of Red Cross Chesapeake Region facilities that ended June 21.
The region covers parts of Maryland, Virginia and Pennsylvania and the
entire District of Columbia.

Among the FDA charges are that the Red Cross:

- ``Continues to accept donors who have not completed the health
history questionnaire, including those who leave unanswered the question
designed to detect those at high risk for HIV/AIDS.''

- Accepts blood from donors with very low blood pressure and those who
have given within the past eight weeks, putting them at risk of adverse
reactions including anemia.

- Has ``lax inventory control,'' including ``losing blood products''
and ``distributing unsuitable blood products.''

Both FDA and Red Cross officials refrained from commenting directly on
the pending litigation.

``The American Red Cross and the FDA agree on two issues. The nation's
blood supply is safe and should be made even safer,'' said Trudy Sullivan,
the Red Cross Bio-Medical Services' vice president for communications and
strategy.

``We share that common goal,'' she said. ``The American Red Cross's
top priority is to work in partnership with the FDA to continue to improve
the safety of the blood supply.''

In its 36 blood regions across the country, the Red Cross needs to
collect 25,000 units of blood per day to meet normal demands of more than
3,000 hospitals, said Sullivan. Currently, there is less than a three-day
supply.

``Our comfort level is five to seven days, not one to three days,''
she said.

In its most recent filing, the FDA cited potential dangers to both
donors and recipients.

Nancy L. Rose, the FDA compliance officer, headed the inspections of
the Red Cross facilities. Among her filings, she reported that the Red Cross
accepted blood last January from three donors who failed to answer all the
required questions. One did not respond to: ``In the past 12 months, have
you given money or drugs to anyone to have sex with you?''

After the blood components had been distributed, the donors were
contacted by phone and asked the required questions, Rose said. The Red
Cross then reported the distributed blood products were ``not in jeopardy,''
she said.

Rose also reported instances in which donors gave blood despite being
ineligible under the Red Cross's own rules governing how often donors can
give and what their physical condition should be.

``In my opinion as a regulator and physician,'' the reported
deficiencies ``pose serious, and potentially fatal, medical threats to blood
donors and recipients,'' wrote Leslie Holness, an FDA medical officer.