Chciago Tribune - March 2, 2001
Michael Higgins, Tribune Staff Writer

The U.S. Food and Drug Administration said LifeSource lacked documentation to explain why some people appeared to move between lists of eligible and ineligible blood donors.

The warning letter, dated Feb. 8, does not allege that the agency provided tainted blood to any area hospitals or other clients.

The FDA said the company failed to follow its own operating procedures regarding, for example, when test results must be reviewed by a second staff person to prevent errors.

"You should take prompt action to correct these violations," Raymond Mlecko, director of the FDA's Chicago district office, told LifeSource in a five-page letter.

FDA officials began inspecting LifeSource in September. In October, they gave the blood bank a list of their findings. The warning letter gives LifeSource 30 days to show it is taking specific steps to correct the problems.

Bookkeeping is a serious matter for blood banks, said Dr. Paul Holland of Sacramento, a past chairman of the standards committee of the American Association of Blood Banks.

"I can't tell from this that anybody was put at risk," said Holland, medical director of the Sacramento Blood Center. "But the potential was there."

LifeSource officials said Thursday that the problems stem largely from the company's 1998 takeover of United Blood Services, a competing blood bank. LifeSource, based in Glenview, has been working to merge the two companies' records and computer systems.

"This is strictly an issue of documentation," said LifeSource spokesman Gerry Oher.

"We've talked to [FDA officials] several times between Feb. 8 and now and the FDA is very satisfied with the action we have been taking."

LifeSource has 17 donor centers. Ninety percent of the hospitals in Cook County get at least some blood from LifeSource, Oher said.

FDA officials in Chicago could not be reached. Lenore Gelb, an FDA spokeswoman in Washington, could not comment on the specific allegations in the warning letter, but she said the FDA has the power to suspend or revoke the licenses of blood banks that don't comply with federal regulations.

"We expect establishments to take warning letters seriously," Gelb said.

The FDA has a history of tangling with blood banks. Some, including the American Red Cross, have faced federal litigation and been forced to operate under consent decrees.

LifeSource has not been subject to a consent decree, but the company did receive a warning letter in 1993, Oher said.

"The FDA inspects all blood centers every two years," he said. "They always have recommendations on how blood centers can improve their operations. ... Every once in while you get [a warning letter]."

Officials at Northwestern Memorial Hospital, which receives about one-quarter of its blood from LifeSource, won't take any specific action in response to the FDA letter, said Dr. Glenn Ramsey, co-director of the hospital's blood bank.

"I think [the issues] are mostly in the general category of record keeping," Ramsey said. "There doesn't seem to be any specific information about patient harm."

The merger with United Blood Services could explain some of the confusion, because UBS had had its own tangles with the FDA, Holland said.

"This may not be as bad as looks; on the other hand it's not great," Holland said. "They did not follow their own procedures. They didn't document the things they said they would. And it makes you wonder."

The fact that an ineligible person, known as a "deferred" donor, might have given blood doesn't mean that tainted blood entered the system, Holland said.

Those donations are still screened--four times for HIV, twice each for hepatitis B and C--before being sent to hospitals.

"The chances of getting HIV from a blood transfusion today is less than one in a million," he said.

010302
CT010301

Always watch for outdated information. This article first appeared in 2001. This material is designed to support, not replace, the relationship that exists between you and your doctor.

AEGiS presents published material, reprinted with permission and neither endorses nor opposes any material. All information contained on this website, including information relating to health conditions, products, and treatments, is for informational purposes only. It is often presented in summary or aggregate form. It is not meant to be a substitute for the advice provided by your own physician or other medical professionals. Always discuss treatment options with a doctor who specializes in treating HIV.

Copyright ©1980, 2001. AEGiS. All materials appearing on AEGiS are protected by copyright as a collective work or compilation under U.S. copyright and other laws and are the property of AEGiS, or the party credited as the provider of the content. .