Problems Persist With Red Cross Blood Services

For 15 years, the American Red Cross has been under a federal court order to improve the way it collects and processes blood. Yet, despite $21 million in fines since 2003 and repeated promises to follow procedures intended to ensure the safety of the nation’s blood supply, it continues to fall short.

The situation has proved so frustrating that in January the commissioner of food and drugs attended a Red Cross board meeting — a first for a commissioner — and warned members that they could face criminal charges for their continued failure to bring about compliance, according to three Red Cross officials who attended the meeting and requested anonymity because Red Cross policy prohibits public discussion of its meetings with regulators.

“If fear is a motivator, we’re happy to help out in that way,” said Eric M. Blumberg, deputy general counsel at the Food and Drug Administration, though he declined to confirm what the commissioner, Andrew C. von Eschenbach, said at the meeting.

Some critics, including former Red Cross executives, have even suggested breaking off the blood services operations from the rest of the organization, as the Canadian Red Cross did a decade ago.

The problems, described in more than a dozen publicly available F.D.A. reports — some of which cite hundreds of lapses — include shortcomings in screening donors for possible exposure to diseases; failures to spend enough time swabbing arms before inserting needles; failures to test for syphilis; and failures to discard deficient blood.

In some cases, the lapses have put the recipients of blood at risk for diseases like hepatitis, malaria and syphilis. But according to the food and drug agency, the Red Cross has repeatedly failed to investigate the results of its mistakes, meaning there is no reliable record of whether recipients were harmed by the blood it collected.

The Red Cross, which controls 43 percent of the nation’s blood supply, agrees that it has had quality-control problems and is working to fix them. Both its officials and the drug agency point out that none of the identified problems involve the most serious category of infractions. For instance, the Red Cross does a good job of testing for H.I.V. and hepatitis B, officials on all sides agree. And in general, Red Cross blood is regarded as some of the safest in the world.

Still, the drug agency says, the problems that remain in screening donors and following protocols for collection add unnecessary risk to blood transfusions, almost five million of which were done in 2007, according to the National Heart, Lung and Blood Institute.

“This is a critical piece of the public health infrastructure,” Mary A. Malarkey, director of the Office of Compliance and Biologics Quality at the drug agency, said in an interview. “I know it’s difficult to get so many people trained and properly supervised, but it has to be done.”

This week, the agency sent the Red Cross the results of yet another recent investigation that makes Ms. Malarkey’s point: From December 2006 to April 2008, the Red Cross distributed more than 200 blood products that it had already identified as problematic, according to the investigation report.

A Troubled History

While many Americans see the Red Cross as the ubiquitous organization that responds to disasters big and small, its disaster-relief operation, which spends $400 million to $500 million annually, is small compared with its blood business, which generated $2.1 billion in revenue in the fiscal year that ended in June 2007.

In fact, the Red Cross is the world’s largest single steward of blood, more than twice the size of the second-largest known blood collection operation. The rest of the world’s blood supply is controlled by dozens of smaller organizations, only three of which have ever been under F.D.A.-requested consent decree.

After years of quiet complaints about the Red Cross’s blood business, the F.D.A. reluctantly decided to go public with its concerns in 1993, obtaining a consent decree that required the Red Cross to strengthen quality control and training and improve its ability to identify, investigate and record problems.

“It was one of the hardest things I did as commissioner,” said Dr. David A. Kessler, the F.D.A. commissioner from 1990 to 1997. Dr. Kessler said he had agonized that the move would cause undue alarm.

The news media, however, barely made note of it.

Fifteen years later, that consent decree, toughened in 2003 to allow the F.D.A. to impose fines for failing to properly identify, handle and report quality control problems, has produced only modest improvements, food and drug officials said.

“Leaving aside who’s at fault here, it’s not working,” said Dr. Kessler, now a professor of pediatric medicine at the University of California, San Francisco. “Whether it’s that the American Red Cross just doesn’t get it, whether it’s that the relationship between the regulator and regulated is beyond the point of repair is immaterial. It’s just not working.”

Dr. Kessler said Congress should intervene at this point.

Dr. Bernadine Healy, the former chief executive of the Red Cross who made repairing the organization’s blood operations a paramount goal, said the best solution might be to spin off the Red Cross’s blood services.

“Two-thirds of the revenue base of the Red Cross is blood, yet the Red Cross is run by people who think of it as primarily a disaster-relief organization, relegating blood to stepchild status,” Dr. Healy said. “When is the last time you saw a Red Cross fund-raising appeal for money to make the blood supply safer or support its blood research?”

Dr. Healy said she tried to start such a fund-raising program when she ran the Red Cross, but met internal resistance to it.

The Red Cross has toyed with selling off its blood operations, or otherwise decoupling them from its disaster work, but has never done so, in part because of a belief that the billions in revenue from blood has subsidized its disaster operations. But its financial systems are so antiquated that no one really knows.

“I can’t tell you that for sure because I can’t find it out,” said Kevin M. Brown, the Red Cross’s chief operating officer. “I wish I could.”

Mr. Brown noted, however, that the blood business was an integral part of the Red Cross. “It is consistent with our overall mission, which is saving lives,” he said. “Having an ample and safe blood supply is critical to that mission.”

Failing to Act

The frustrations of dealing with the Red Cross are illustrated by the story of Michelle Hoyte, a whistle-blower who was first ignored, then dismissed.

Ms. Hoyte led a team of auditors who conducted a routine visit to the Red Cross blood services operation in Philadelphia in 2004. The team discovered that the facility, with the approval of a senior executive at the national headquarters in Washington, had decided not to recall some 600 units of blood collected using improper methods.

Such mistakes must be reported in writing to the F.D.A. within 15 days of detection, and the blood must be recalled. But Ms. Hoyte spent six months pleading with various supervisors to report the problem, first identified on Dec 18, 2003. Then she was fired.

“It wasn’t just that I thought it was the right thing for them to do; they are required to tell the F.D.A. under the terms of the consent decree,” Ms. Hoyte, who worked for the F.D.A. before joining the Red Cross, said in an interview. “They didn’t want to hear it.”

Ms. Hoyte, who unsuccessfully sued the Red Cross for wrongful termination, had received “excellent performance appraisals,” according to the lawsuit, and received a bonus and merit raise in the two years before her firing.

The Red Cross contends that her dismissal had nothing to do with her insistence on abiding by the court order. It said in court papers that she had been warned of shortcomings in her performance.

The Red Cross also defended its handling of the episode. “They followed the process and did what they should have done,” said Eva Quinley, the senior vice president for quality and regulatory affairs at the Red Cross.

But the Red Cross did not recall the components produced from that blood until Feb. 23, 2005, 14 months after the problem was discovered, according to an F.D.A. report. By then, those components would have been used or discarded, and whether they caused any problems for patients is unknown.

Determining how often, if ever, blood supplied by the Red Cross has been responsible for serious health problems is difficult. F.D.A. documents rarely spell out the consequences of the failures they catalogue, a reflection, to some degree, of the agency’s concern about alarming the public. But often they simply do not know. “Patients who get blood transfusions tend to be pretty sick,” Dr. Healy said. “If they spike a fever post-transfusion, no one is likely to suspect that the blood caused it.”

Various records of F.D.A. inspections and correspondence with the Red Cross highlight poor follow-up, including falsified records.

On Nov. 19, 2001, for example, a patient receiving blood bought from the Red Cross’s greater Chesapeake and Potomac region, which serves the Washington area, died of hepatitis, according to an F.D.A. report. The agency concluded that the Red Cross had failed to perform a thorough investigation.

Furthermore, the drug agency found that the Red Cross had failed to investigate 134 cases of suspected post-transfusion hepatitis that occurred across all its regions from January 2000 to June 2002.

Ms. Quinley said procedures had been changed since then in an effort to ensure that such cases would be investigated.

Until 1991, Red Cross blood operations were largely controlled by its regional chapters, which operated 53 blood centers in vastly different and often idiosyncratic ways. That year, Elizabeth Dole, then chief executive of the Red Cross, announced a sweeping overhaul that wrested control of the blood operations from the chapters and reorganized them into 10 regions, which were expected to adhere to a uniform set of standards and procedures.

That event is still referred to among many at the Red Cross as “the Divorce,” a measure of the organization’s entrenched culture.

While Mrs. Dole won praise for taking a bold step to address a long history of sloppy testing and record keeping that raised concerns among regulators and the public about blood being potentially contaminated with H.I.V., chapters and their staff and volunteers saw it as an effort by the national headquarters to control the vast amount of money the blood services generate.

That legacy persists.

“We have never truly moved away from independence to national, central standards,” said J. Chris Hrouda, executive vice president and a 20-year veteran of the Red Cross’s biomedical services, as the blood operations are known.

Nor did anyone anticipate the cost and difficulty of the reorganization, current and former executives said. At first the project was budgeted at $120 million, but the cost of developing a centralized database has run to at least $1 billion so far, according to estimates by former executives. The database would make it easier to track down flawed blood components and to flag donors who have been previously screened out because of diseases or travel to places where malaria is common.

“There is no system to meet our needs,” Mr. Hrouda said. “We are six times the size of the next-largest blood operations, and clearly that’s a hindrance.”

A small company in Paris, Mak-System International Group, is working to create such a system, but Mr. Hrouda had no estimate of when it would be up and running.

Thus, the Red Cross’s current blood operations, 36 regions grouped into seven divisions served by five testing laboratories, are still controlled by different systems that cannot easily “talk” to one another.

In the meantime, the Red Cross has incorporated technology intended to help it prevent mistakes when blood is collected.

The most frequent errors cited by F.D.A. investigators involve failing to ask donors questions that would reveal their ineligibility to give blood. For instance, an interviewer forgets to ask a donor whether he has traveled in an area where malaria is a problem. So increasingly, donors fill out online questionnaires, which helps ensure that all required questions are answered.

Blood collection is also error prone, governed as it is by strictly prescribed procedures. After phlebotomists locate a vein, they must scrub a 3-inch-by-3-inch area with antiseptic soap for 30 seconds, then use an antiseptic swab and, starting at the point where they will insert the needle, work outwards in concentric circles. They must then allow the area to dry for precisely 30 seconds before inserting the needle.

To improve that process, Red Cross phlebotomists recently began wearing electronic devices that time each of those steps.

The organization is also improving oversight on the mobile units used to collect roughly 80 percent of the blood it processes by assigning full-time supervisors.

Such measures, however, are undercut by high turnover among employees, who are paid little better than minimum wage, former executives say.

Mr. Hrouda said there was no plan to address high turnover. “We think we’re able to recruit people at the wages we pay and are good at training them,” he said.

The F.D.A., however, sees the main problem differently. “Size is no longer an excuse,” said Mr. Blumberg, the agency’s deputy general counsel.

Ms. Malarkey, of the F.D.A.’s Office of Compliance and Biologics Quality, said: “Right now, the biggest issue confronting the Red Cross is what we refer to as their problem management. They have standard operating procedures by which they should be able to investigate, evaluate, correct and control to prevent recurrence of the issues we have identified again and again, but they have a lot of difficulty implementing those procedures and, frankly, in having people follow them.”

Ms. Malarkey said a recent “adverse determination letter,” the process through which the F.D.A. informs the Red Cross of violations it has identified and demands payment of fines, illustrated her point.

In that letter, dated Feb. 8, the drug agency listed 113 “events” involving 4,094 flawed blood components that were recalled by 15 of the Red Cross’s 36 regions. The recalls occurred largely from April 15, 2003, to April 15, 2006. (It is not uncommon for letters to list hundreds of infractions — one 2005 letter identified more than 22,000 flawed blood components that were recalled — and recalls do not mean every blood product is returned.)

“We are not seeing what we were seeing in the late 1980s and early 1990s, where unsuitable blood was routinely being released,” Ms. Malarkey said, “but they still need to make more progress, and we would like to see that progress made quickly.”

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