FIRST BLOOD: HOW THE RED CROSS WOUNDED A RESUME

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Despite glowing reports from the Red Cross press office, however, the problems cited by the FDA persisted. In fact the agency's concerns intensified, peaking when an inspection of the Red Cross's national headquarters found that officials still had little control over their nationwide operation. Says James Simmons, director of the FDA's biologics compliance office: "There simply was not a lot of evidence of changes or improvements." Two years into Mrs. Dole's presidency, the FDA, still frustrated, went to court to force the Red Cross to act. The result was a May 1993 consent decree setting out a stringent five-year plan for reform.

Resolutely positive, Mrs. Dole says the FDA sought the consent decree merely as a yardstick to measure improvement. She was so prepared for this conversation with TIME that she read aloud remarks by Health and Human Services Secretary Donna Shalala and FDA commissioner David Kessler praising her management. The consent decree, she says, "literally was a ratification, it was a ratification of what we were doing."

Well, not exactly. In 1994, in its first annual progress assessment, the FDA noted that a Red Cross quality-assurance plan submitted to meet the decree was "unacceptable," and that "several of your submissions on computer systems and databases are inadequate." According to the assessment, obtained by TIME under the Freedom of Information Act, at some blood centers the FDA's inspectors had found continued failures to keep accurate records and follow required testing procedures.

To be sure, the Red Cross is finally showing some real progress. It opened a new training center, built nine central testing laboratories and began a costly centralization of its computer systems; the FDA's Simmons estimates it has achieved "75% to 80%" of what the consent decree requires. But the Red Cross still has much to prove. A second progress assessment--delivered in June 1995--applauded improved communication between the Red Cross and the FDA, but also included a long list of violations, some of them troubling. Its Birmingham unit, for instance, drew blood from donors with histories of malaria and Hodgkin's disease. "One of the continuing problems," the FDA warned, "is the failure of employees to follow prescribed procedures."

The Red Cross blood network simmers now with discontentment arising primarily from the perception among its outlying blood banks that the new plan, with its emphasis on headquarters control, has devalued the contributions of local volunteers. Last year a group of employees and directors of the Red Cross's Ozarks unit quit and established an independent blood bank. At a time of such stress and dislocation, officials of some blood regions express unhappiness with Mrs. Dole's decision to take leave. "Frankly I was shocked that they would allow her to take a one-year leave of absence and then come back," says Bob Bordogna, chairman of the Red Cross blood unit in Louisville, Kentucky. "That's pretty hard for an organization to deal with, while [its] president goes on hiatus to campaign for her husband."