American Red Cross Face Fines After Blood Safety Lapses

by Medindia Content Team on  November 29, 2006 at 6:29 PM Medico Legal News   - G J E 4
American Red Cross Face Fines After Blood Safety Lapses
The American Red Cross find themselves in a sticky situation having failed to meet the standards for blood safety procedures coined by FDA. Following lapses in sticking to rules pertaining to blood safety, The American Red Cross has been penalized again. This brings the total penalty toll against the American Red Cross up to $15 million.

The FDA divulged that the organization had been fined close to $5.7 million, recently, for failing to adhere to the safety rules promulgated in 2003. Since the American Red Cross failed to comply with requirements postulated by the FDA,the FDA has issued a deadline for the organization to explain how they intend to rectify their mistakes. If they fail to meet the deadlines, they will be penalized again, warned the FDA.

In a previous instance, the American Red Cross had to pay a huge sum, amounting to$10 million as fines for discrepancies seen in maintaining blood safety regulations. This was in violation of the decree promulgated in 2003.This settlement had appeased the charges that tainted the Red Cross. The allegations mentioned irregularities in blood safety measures by the organization, dating back to almost 17 years.

Later in the year 2004 the Red Cross, in an earnest attempt to be accountable, implemented a plan. This plan was given the green signal by the FDA.This involved a annual comprehensive evaluation of the Red Cross to detect, and monitor any loose chinks in its armor. This was initiated so that timely correction would be taken in the event of any lapses cropping up.

However an inspection conducted in 2005, ended up being their waterloo. More than 207 discrepancies were detected. The screening revealed unpardonable shortcomings related to quality control, donor screening, inventory management etc, during the inspection which spanned over 29 days.

The result of the inspection was that the Red Cross will have to cough up $5.7 million dollars as a penalty for breach in standards.

Officials representing the American Red Cross have disclosed that they hope to formulate a more functional plan that will not compromise the standards projected by the FDA.

The Red Cross will use the revenue generated from the sale of blood products to pay up the fine. More than 40 per cent of the U.S' demand for blood products for medical emergencies is met by the Red Cross

Source: Medindia

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