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U.S. Red Cross fined $4.2mby Jyotirmoy - September 10, 2006 - 0 comments
U.S. Administration on friday announced that it was fining the Red Cross $4.2 million for continued failures to adequately protect the safety of the nation's blood supply.
" title="U.S. Red Cross fined $4.2m"/> U.S. Administration on friday announced that it was fining the Red Cross $4.2 million for continued failures to adequately protect the safety of the nation's blood supply. The Food and Drug Administration’s fine is the largest-ever penalty for violating safety standards governing the collection and distribution of blood donations. The penalty is the culmination of a 20-year effort by federal regulators to force the U.S. Red Cross to improve its oversight of its giant blood business. It comes on top of $5.7 million in fines the agency has imposed since 2003 with a series of safety violations that forced the recall of approximately 12,000 units of blood and blood products between 2003 and the end of 2005. In a news conference, the American drug agency officials said that the blood supply remained safe and that they had no evidence that contaminated or recalled blood sickened anyone. Instead, the problems “indicated a decreased assurance of safety,” said Dr. Jay Epstein, director of the Office of Blood Research and Review at the American agency. They included incomplete donor checklists, failures to properly screen donors for travel to countries with a high malaria risk, and inadequate testing of units for the hepatitis B virus. Violation of Standards for screening potential donors for lifestyle-related risk factors including injectable drug use or high-risk sexual behavior are also included. In a case unsealed this year in Federal District Court in Washington, a former U.S. Red Cross quality-control manager accused the organization of releasing 607 pints of contaminated blood in New Jersey, even though U.S. Red Cross officials knew that the blood had been improperly collected and exposed to air. The FDA also ordered the U.S. Red Cross to review its procedures to prevent lapses from occurring again, with a prompt signal of not accepting things and situations at all from the other side. In a statement, the U.S. Red Cross said its senior management took the fine “seriously” and was “committed to full compliance” with the rules. It said it would officially respond in 20 days. Ryland Dodge, a spokesman for U.S. Red Cross Blood Services, stressed that no adverse health consequences are known to have resulted from any of the violations. Though he acknowledged that continuing reports of breaches and multimillion-dollar fines make harder for the organization to convince the public to donate blood and money. The U.S. Red Cross has struggled for years to put its multibillion-dollar blood business, by far its biggest money maker, into compliance with federal rules of U.S. It provides 45 percent of the U.S.'s blood supply. Lets hope, this fine serves as an incentive to address the remarkable issue faced by the United States Of America. |
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