Black Marks for the Red Cross

[Woodmonkey]

One thing Americans do not want to hear when they are injured or facing surgery is that blood from the American Red Cross may actually harm them. So it was unnerving, to put it mildly, to learn that the Red Cross, which collects and distributes some 43 percent of blood given to patients in this country, has failed to follow quality-control measures ordered by a federal court 15 years ago.

The organization’s sloppy procedures and its lethargy in investigating possible harm have put untold numbers of Americans at risk. These failures have been identified in reports and investigations by the Food and Drug Administration, which regulates the safety of the American blood supply, and summarized in The Times on Thursday by Stephanie Strom.

The F.D.A. found shortcomings in the way the Red Cross screens donors for possible exposure to infectious diseases, failures to swab arms properly before inserting needles, failures to test for syphilis and failures to discard potentially risky blood, among other deficiencies.

There is little or no evidence that recipients of the blood have been harmed; the skimpy record doesn’t allow an assessment. Regulators say the Red Cross no longer routinely releases unsuitable blood, as it did in the late-1980s and early-1990s. Blood supplied by the Red Cross is generally considered among the safest in the world, and the organization is praised for doing a good job of testing for the AIDS virus and hepatitis B, two of the most feared infections.

What should shame the Red Cross is its repeated failure to investigate potential harm. In 2001, when a patient died of hepatitis that may have been contracted from a Red Cross blood product, the F.D.A. concluded that the organization had failed to perform a thorough investigation. All told, the Red Cross failed to investigate more than 130 cases of suspected post-transfusion hepatitis between 2000 and mid-2002.

Often the problem is bureaucratic. Just this week, the F.D.A. chided the Red Cross for distributing more than 200 blood products that the organization itself had identified as problematic but failed to intercept before distribution. Other times the failure is deliberate. A blood facility in Philadelphia, with approval from a senior national executive, decided not to recall some 600 units of blood that had been collected using improper methods.

What can be done to turn things around is not clear. The Red Cross has already reorganized its blood operations, deployed electronic monitors to improve arm swabbing and invested heavily in a centralized database that should, if it ever gets up and running, make it easier to track down flawed blood products. The organization says that under new leadership it has put in place an aggressive plan to comply fully with F.D.A. regulations.

Some critics believe the Red Cross should sell off its blood banking services and stick to disaster relief, but that might present financial difficulties. The disaster relief activities are said to be heavily subsidized by blood banking revenues, although the organization’s financial systems are so antiquated that even its own top executives do not know for sure.

At a minimum, Congress should explore ways to strengthen regulatory oversight and force the Red Cross to meet the highest safety standards.

In January, a frustrated commissioner of food and drugs warned Red Cross board members that they could face criminal charges for continued failure to bring their organization into compliance with safety mandates.

They need to get cracking.

The Source