Red Cross tightens blood supervision

WASHINGTON — The American Red Cross brought its local blood services programs under national control Friday, announcing dozens of new positions and tighter supervision that it said would help ensure a safe blood supply.

Red Cross Chairman George F. Moody called the changes a milestone and said they were prompted by “searing self-examination” as well as months of scrutiny by the press and the Food and Drug Administration.

They symbolize a “recommitment to our goal of ensuring that the American people can count on a blood supply that is safe and adequate to meet their needs,” he said.

FDA inspectors have found several problems in the Red Cross system of reporting, investigating and following up on accidents and errors that occur in the course of collecting and distributing blood.

One of the inspectors, Mary Carden, said at a congressional hearing last month that the national headquarters sometimes took months to review reports of AIDS cases associated with transfusions of blood collected by Red Cross centers.

Stephen Richards, newly named executive vice president of the Red Cross, on Friday acknowledged procedural and record-keeping problems. But he added that “we have not seen any evidence of contaminated blood … being transfused into a patient” as a result of those problems.

Moody attributed some of the problems cited by the FDA to a tremendous backlog of reports, which he said is almost resolved. He said the steps announced Friday are meant to address both the FDA criticisms and the shortcomings that came to light in an internal Red Cross study.

Under the group’s restructuring plan, each region will get a new “principal officer,” appointed and paid for by the national headquarters. The officers will report directly to a new senior vice president for blood services, Dr. Jeffrey McCullough of St. Paul.

Previously, regional blood services directors had reported to their local chapters. But Moody said the increasingly complex business of blood services, including relatively new tests for AIDS and hepatitis, made it necessary to centralize supervision.

“We have had to clarify the reporting relationship and the line of authority,” Moody said.

The Red Cross also said it is doubling, from eight to 16, the number of people responsible for evaluating the blood services offered by local chapters and following up on their accident and error reports.

And Moody said the organization is nearly tripling its regulatory affairs unit in Washington, from five to 14 people, to better comply with FDA regulations.

The 54 Red Cross blood regions supply blood to more than half the hospitals in the country. The organization’s $500 million blood bank network is the largest in the nation.

Brad Stone, an FDA spokesman, said the agency believes the new Red Cross moves will help standardize procedures and eliminate communications problems among the central and regional offices.