The Red Cross: A Question of Competence
In 1988 the American Red Cross had signed a voluntary agreement with the F.D.A. to fix its error-plagued blood program. But the charity continued to have problems, and it became the subject of a Congressional hearing in 1990 and 1991. As Gilbert Gaul reported in The Philadelphia Inquirer, by April 1991 the Red Cross had begun to plan an overhaul of its blood program that executives hoped would meet the F.D.A. standards.
Mrs. Dole's special team strongly urged her to announce the program formally in a major press conference only three months after her arrival to give the impression of action, to buy time with the F.D.A. and to score a significant public relations victory. Not bothering to consult field personnel in advance, Mrs. Dole called a news conference on May 20, 1991.
Asserting that "because of the AIDS epidemic nothing short of a transformation is needed," she announced "beginning today a five-part transformation program to be implemented over the course of the next two and a half years." Its centerpiece: "We will temporarily shut down every Red Cross blood center throughout the nation. We will do so in stages, region by region, for eight weeks at a time." During the shutdown, Dole promised, staff would be retrained and new computer systems would be installed to track donors and double-check blood samples.
Dole also talked about permanently shutting down many of the more than fifty blood-testing laboratories and consolidating them into a few select labs, increasing quality control and replacing the twenty-eight separate computer systems with one national computer system that would maintain records of the medical history and test results of donors. She declared that the Red Cross would spend some $120 million on the sweeping reorganization, and she described the plan as "the most dramatic and far-reaching public safety step the Red Cross has taken in its history."
The announcement had the intended short-term effect. Representatives John Dingell, who had been one of the most vocal critics of the Red Cross, told The New York Times, "This is evidence that the new leadership of the Red Cross takes the issue of blood safety very seriously and has the courage to face up to the problems they have had in the past." And Dole's speech generated glowing editorials in newspapers around the country. But executives in the blood industry had a different opinion of the transformation program. "Shutting down all of our blood banks for eight weeks would have caused total chaos in the medical community--it simply couldn't be done," says Tony Dombroski, principal officer of the Northeastern Pennsylvania Region of American Red Cross Blood Services.
Don Thomson, then the director of the Red Cross Greater Ozarks Blood Region, first heard about the transformation program on National Public Radio while sitting in his room at a San Diego hotel, where he was attending a national conference of the Red Cross. "No one had bothered to tell us about the transformation program before Mrs. Dole announced it to the world, even though it would involve massive layoffs," says Thomson, whose former Red Cross region spanned thirty-nine counties, including parts of Arkansas, Kansas and Missouri. "This was the first in a series of major decisions which Mrs. Dole announced first and planned later."
In other words, the transformation program (the brainchild of Dr. Jeffrey McCullough, Kyle's predecessor as senior vice president of biomedical services; McCullough was already working on it when Dole arrived) was prematurely launched for political rather than public health considerations. When asked, McCullough, now professor of laboratory medicine at the University of Minnesota Hospital and Clinic, denies feeling rushed by Dole's decision to announce the transformation while planning was still in process, and even says that members of the special team, particularly Will and Goldfarb, "brought a valuable perspective to our discussions about the blood supply." But he left shortly after the announcement, and Dole hired Kyle to replace him.
"Kyle found out that the transformation program was more show than substance, and that this grand scheme to shut down the blood banks simply wasn't very practical," recalls Jim MacPherson, executive director of the Council of Community Blood Centers (C.C.B.C.). "The Red Cross wound up not shutting them down, because they couldn't have collected enough blood to make up for the shortfall."
Meanwhile, the Red Cross corporate headquarters began to generate scores of press releases crowing about the transformation program. But instead of buying time from the F.D.A., the bold statements promised more than the organization could deliver in two years, and that began to have disastrous consequences. "Elizabeth's announcement may have set the clock running at the F.D.A., and when we couldn't meet the two-year deadline for transformation, they came after us," says Buzz Braley.
Indeed, in 1993, two years after Dole's announcement of the transformation program, the F.D.A. cited the Portland, Oregon, Blood Collection Center for improper procedures. Most of the criticism was for minor clerical errors and failure to follow strict federal guidelines, according to Braley. "To allay the fears of the people of Oregon, a blue-ribbon panel of experts from the local area, including doctors and hospital executives, analyzed the procedures at the center and declared it safe," he says. "No tainted blood was ever released in Oregon, and no one at the Red Cross was seriously worried about the blood supply." But the local press was running stories about the F.D.A. finding, and John Heubusch of the special team, pointing out that the Doles didn't need the negative publicity, recommended firing the director.
Kyle, who declined to comment for the record, was asked to fire the Portland center head but refused on the ground that the director (who was ultimately forced to take early retirement) was being made a scapegoat. Braley and others in the industry say that Kyle became increasingly disillusioned. "Fred Kyle had had a distinguished career in the pharmaceutical industry, and he came to the Red Cross at a tremendous cut in pay because he thought it was a noble cause," says MacPherson of the C.C.B.C. "We began to hear that Kyle was disgusted with the way things were going at the Red Cross and especially the micro-management by Mrs. Dole's personal advisers and consultants."
Kyle couldn't get Dole to make decisions without her team's input, adds Braley. "She tended to use her personal advisers as her sounding board for issues involving the blood banks, when she should have used Kyle and his medical experts."
With lack of clear guidance from corporate headquarters, the transformation program began to lag further and further behind schedule, and to run millions over budget.