American Red Cross Is Facing Blood-Safety Violations. The American Red Cross is facing another heavy fine over blood-safety violations, bringing penalties against the organization to more than $15 million despite a promise three years ago to fix the problems.
The Food and Drug Administration disclosed that it had fined the organization $5.7 million recently for continuing to violate blood-safety rules and failure to comply with a 2003 agreement aimed at correcting the unsafe practices.
The latest fine was noted in an FDA letter dated Nov. 21, to Red Cross interim president and CEO Jack McGuire, and posted Monday on the FDA Web site.
The Red Cross was given a mid-December deadline to produce a report on how it intended to comply with FDA requirements, or possibly be subject to additional penalties.
The latest fine is being added to a tally of nearly $10 million in previous FDA penalties for violation of blood-safety laws, regulations and the terms of the 2003 consent decree.
That settlement resolved charges that the Red Cross had committed “persistent and serious violations” of federal blood safety rules dating back 17 years.
In 2004, the Red Cross implemented a plan, with the FDA’s blessing, to detect, investigate, monitor and correct the sorts of problems repeatedly cited by government investigators.
A 2005 inspection of a Red Cross facility in West Henrietta, N.Y. was supposed to be the first comprehensive evaluation of how the plan was working. But the federal inspectors, over 29 days, turned up 207 deviations from the plan, the FDA said.
The latest fine of $5.7 million stems from that inspection.
Shortcomings In Quality Assurance
The inspectors found shortcomings in quality assurance, inventory management, control of non-conforming blood products, donor screening and blood component manufacturing issues as well as other problems, according to the FDA.
The Red Cross said it would devise a new plan to comply with FDA requirements. The Red Cross board of governors also has asked for an independent and comprehensive assessment of how it complies with FDA regulatory requirements.
The Red Cross does not use donated money to pay fines, but instead relies on operating funds, according to the organization. Those include revenue from the sales of blood products.
The Red Cross provides more than 40 percent of the nation’s blood supply, selling blood products to health facilities.