FDA has bad blood with Red Cross
By Rachana Dixit, news editor
Posted on September 18, 2006

In the past when JMU Athletics Lifestyles Director Tiffany Hall donated blood through the American Red Cross, she didn’t think there was a reason to be skeptical about the procedure.

“At that time, I did not feel any need to be concerned,” Hall said.

However, recently, that has not stopped the FDA from slapping a $4.2 million fine on the Red Cross for violating blood-safety regulations.

According to a Sept. 8 Associated Press article, FDA officials said the violations include failing to ask appropriate questions of potential donors and not following test procedures.

The article cites that the fine was the largest single penalty assessed so far under terms of a 2003 court settlement that allows the large fines when the Red Cross violates FDA rules. The 2003 agreement settled charges that the Red Cross had committed “persistent and serious violations” of federal blood safety rules dating back 17 years. Previously, the FDA had fined the Red Cross a total of $5.7 million.

Tammy Berfield, a Red Cross donor recruiter for Central Virginia’s Blood Services, said the fines were given because a number of blood units were disposed of between April 2004 and April 2005. The blood, Berfield said, could have been disposed for any number of reasons, such as if forms were filled out improperly or the blood supply itself were contaminated. In the AP story, the FDA said the blood recalls could have been prevented.

The Red Cross supplies approximately 50 percent of the nation’s blood supply, while the other 50 percent comes from independent blood donation services across the country.

Berfield said, “We have one of the safest blood supplies that we have ever had,” adding that she has not seen a contaminated blood supply in the five years she has been a donor recruiter.

“We’re continually adding new tests in the lab,” she said. Currently, the Red Cross tests for at least nine infectious diseases, including HIV, hepatitis and West Nile virus, which was added to the list in the past few years.

The process of donating blood, Berfield said, can take anywhere from 45 minutes to one hour between the time the donor enters and exits the area.

During the first part of the process, the potential donor is given a booklet to read as a preview for what questions they will be asked later. Next, the donor has a physical to measure blood pressure, temperature and iron levels. Once that is completed, a Red Cross Health Historian will ask the donor a variety of questions about medications, lifestyle choices and former places of residency. Any of these can play a role in whether the potential donor will be able to give blood.

Hall, who has volunteered at the Red Cross in her hometown of Ann Arbor, Mich., said, “When people do come in to give blood, they have to read a full binder of information, even if they have donated blood.”
These procedures are followed as well when blood drives are held at JMU. Holly Wade, wellness coordinator for UREC, said blood drives held at the university in recent years have been fairly successful.

Last semester, she said, the UREC-sponsored blood drive had about 40 to 50 participants over the whole day. UREC has been holding blood drives since 1997 and is coordinating this semester’s blood drive with the Red Cross.

“To my understanding, all of the time slots fill up,” Wade said. She added that she thinks blood donation has been successful recently because of the Sept. 11 terrorist attacks and Hurricane Katrina last year.

“I think 9/11 helped us understand the need for us to donate,” Wade said. “People started right away because that was the one thing that people across the nation felt that they could do. Katrina helped to keep that awareness.”

Berfield hopes that the issue between the Red Cross and the FDA will not have negative consequences on future blood donation, since restrictions are already very stringent.

“Five percent of the population is who will give,” she said, “and we rely on them to supply the hospitals and patients.”

She added, “Right now there is no artificial substitute for human blood. We just need to ask people to roll up their sleeves.”