Red Cross Negligence Threatens Blood Safety, Panel Says

The nation’s blood supply is not as safe as it should be because of inadequate screening and reporting by the American Red Cross and other blood suppliers, a congressional panel charged Friday.

“Various Red Cross collection centers have released infected blood, mixed up records, violated AIDS testing procedures and failed to deter infected or undesirable donors,” said Rep. John D. Dingell (D-Mich.), chairman of the House Energy and Commerce subcommittee on oversight and investigations.

Dingell said the problems were documented by Food and Drug Administration inspection reports and “the Red Cross’ own internal reports.”

Dingell’s subcommittee heard testimony on a preliminary FDA report, released earlier this week, that cited cases in which patients were infected by the virus that causes AIDS or received serious bacterial infections as a result of apparent Red Cross negligence.

Red Cross executives, who were not invited to testify before the panel, disputed some of the charges outside the hearing room.

“We resent the manner in which this was made public,” said Stephen H. Richards, senior vice president of the American Red Cross. “This raises a lot of serious and very complicated questions to which we wish we had a chance to respond.”

The Red Cross is preparing a full written reply to the FDA investigation. The response will be released next week, Richards said.

In testimony before the panel, Mary T. Carden, the FDA’s chief biological investigator, charged that Red Cross regional blood centers either delayed or failed to file reports about cases of contaminated blood.

Even when regional centers filed the required reports, she said, the national headquarters failed in many cases to report them to the FDA, as required under government regulations.

For instance, she cited three cases in the Washington, D.C., area in the last year in which patients died from serious bacterial infections after receiving blood products distributed by the Red Cross. The cases were not reported to the FDA, she said.

Richards, however, said that, because of their seriousness, the Red Cross had reported the incidents to the FDA by telephone immediately after learning of them and saw no need to file subsequent written reports.

Carden said some of the problems could be traced to the computer system used by the Red Cross.

Carden charged also that the organization, which supplies more than half of the nation’s blood supply, was unhelpful and “nonchalant” during her investigation. “There were no promises of corrective action,” she said.

Richards contested Carden’s characterization and said the report “is something which we take very seriously.”

The subcommittee heard testimony from a panel of experts concerning AIDS contamination of the nation’s blood supply that occurred before the test to determine the presence of the human immunodeficiency virus was developed in 1985.

Panel members, including Rep. Ron Wyden (D-Ore.), said the Red Cross and other blood suppliers “dragged their feet” in implementing blood-screening procedures that would test for hepatitis and other diseases that sometimes are found in connection with the AIDS virus.

Before the advent of the HIV test, witnesses said, screening for the other diseases could have reduced significantly the extent of contamination. They cited studies indicating that such “surrogate” tests could detect 94% to 98% of blood donors infected with the virus.

But Red Cross executives said the evidence at the time was equivocal and other studies indicated a significantly lower detection rate.

Richards said that 48 hours after the HIV test was licensed in March, 1985, the Red Cross began distributing test kits to its regional blood centers.

Subcommittee members also criticized the Red Cross for understating the number of AIDS cases that have resulted from contaminated blood transfusions.

Richards acknowledged that in a statement issued earlier this week the organization erroneously said there have been only six such cases since 1985, when in fact there have been 11 or 12.

Subcommittee members said they lacked sufficient time to include the Red Cross in the hearing but that the organization will have an opportunity to testify before the panel this fall.