WASHINGTON (AP) – Federal health regulators fined the American Red Cross $16 million for sloppy screening of donated blood, the latest in a series of violations that have cost the group millions of dollars.
The Food and Drug Administration said in a statement that the group failed to take precautions to assure the safety of blood donations. Despite those oversights, the FDA says the U.S. blood supply appears to be safe.
Regulators fined the group nearly $10 million for mismanagement of blood products – including red blood cells, plasma and platelets – and over $6 million for faulty manufacturing practices. The violations occurred in fiscal years 2008 and 2009.
The FDA has cited the Red Cross a dozen times already and fined the group over $21 million since 2003.
Under the terms of a 2003 consent decree, the Red Cross pledged to investigate and correct its chronic blood safety violations.
“FDA is encouraged by recent efforts made by the Red Cross leadership,” the federal agency said in a statement, adding “the FDA is hopeful these fines will encourage the Red Cross to act more quickly to take the actions necessary to address and correct the issues.”
Last month a group representing Red Cross nurses alleged that staffing cuts, excessive work scheduling and mismanagement are responsible for many of the mistakes cited by the FDA over the years.
The Red Cross said in a statement that 98 percent of the violations cited by the FDA occurred before 2008, and that the group has made significant improvements since then.
“We appreciate the fact that the FDA has recognized that the Red Cross is making progress in improving compliance, but are disappointed that the FDA believed it necessary to fine us for prior violations dating back several years,” the group said.
The American Red Cross is one of several organizations that collect and manage the nation’s blood supply. The group provides about 43 percent of the U.S. blood supply, selling blood products to health facilities.
Date: June 17, 2010
Source: Associated Press
Filed Under: Drug Discovery
