FDA looking into possible tainted blood from Phx. co.

By The Associated Press
Arizona Daily Wildcat
April 24, 1996

WASHINGTON - The government is probing whether ''a handful'' of patients received tainted blood from a Phoenix company. Still, officials said the U.S. blood supply is safe and getting safer every year.

''If anybody needs a blood transfusion they should get it because the risk of not getting the blood far exceeds any risk of getting it,'' said Food and Drug Administration Deputy Commissioner Mary Pendergast.

The FDA on Monday announced a consent decree calling for United Blood Services, which supplies blood to hospitals in 18 states, to spend $16 million to strengthen the safety of its blood products.

FDA inspections had found problems at United Blood since 1994, when the company voluntarily surrendered the licenses for three of its Texas blood centers.

But the FDA discovered some company-wide problems too, mostly in how United Blood screened donors to ensure they had no infectious diseases. Some donors weren't properly questioned or, when they revealed possible risks, the company didn't take the proper next step - deciding to investigate further or that the risk was serious enough to immediately reject the donor, Pendergast explained.

Also, United Blood sometimes didn't follow exactly instructions for testing blood against certain viruses, which can throw off a test result, Pendergast said.

The FDA has not found any cases where an improperly screened donor's blood also was not properly tested, so it cannot say that any tainted blood was used.

''It's a possibility; we're not certain,'' Pendergast said. If ''the blood bank isn't perfect, up to the standards we expect of it, it does not mean necessarily the unit of blood is a contaminated unit.''

But the government is investigating ''a handful'' of reports from patients who fear they were exposed to the AIDS virus or hepatitis, she said.

One told CBS News he had no other risks for the HIV virus - and had tested negative for it - when he had his leg amputated 11/2 years ago. James George told CBS he blamed a United Blood transfusion for his HIV.

But when George's Phoenix hospital gave United Blood a list of the blood he received, the company traced all 10 donors and none had the AIDS virus, said United Blood spokeswoman Barbara Kain.

United Blood insists no tainted blood escaped. ''The blood supply we have is very, very safe,'' Kain said.

The consent decree is not unusual - even the American Red Cross, which provides half the blood in the country, has operated under one since 1993 after the FDA discovered similar problems at a Red Cross center in Florida.

Blood banks are required to report to the FDA any errors in their safeguard system, even if those errors are caught in time to prevent improperly scrutinized blood from being shipped. That's because a lapse might not cause a problem one time, but if not corrected, it could hurt someone later.

But many blood banks didn't report errors unless they required blood to be recalled. So in 1993, the FDA began cracking down - and reports of errors have risen 44 percent.

Does that mean more blood banks are committing more errors? No, Pendergast said, it's mostly tighter scrutiny. In fact, 5 percent of blood banks in 1994 committed violations so severe they needed regulatory action, but that number dropped to 3 percent last year, FDA figures show.

''The FDA wants us to . operate with the tight controls and extensive documentation the pharmaceutical companies use,'' said Kain, who blamed much of United Blood's problems on ''catching up to the new expectations.''

United Blood provides blood to hospitals in Chicago and parts of 17 other states: Alabama, Arizona, Arkansas, California, Colorado, Louisiana, Minnesota, Mississippi, Montana, Nebraska, Nevada, New Mexico, North Dakota, Oklahoma, South Dakota, Texas and Wyoming.

(OPINIONS) (SPORTS) (NEXT_STORY) (DAILY_WILDCAT) (NEXT_STORY) (POLICEBEAT) (COMICS)