Medical Device Daily Washington Editor

The FDA and the American Red Cross (ARC; Washington) have a long common history pockmarked by a series of fines over the past few years. Among those fines was one imposed this past September to the tune of $4.2 million, but the agency’s Sept. 8 press release included the statement that the agency had “no evidence that these violations resulted in serious health consequences.”

The agency and ARC are at it again with the release of a new adverse determination letter (ADL) and a fresh round of fines totaling $5.7 million, with the grand total of fines running toward $15 million. The letter, dated Nov. 21, states that last year’s inspection of the ARC facility in West Henrietta, New York, produced a list of 207 deviations from problem-management procedures and regulations. Signed by Baltimore district director Evelyn Bonnin, the ADL states further that “the high number of deviations” at West Henrietta indicates that problem management procedures have not been followed and that “significant deficiencies exist in the regional QA [quality assurance] department.”

ARC personnel were said to have failed to follow procedures for investigating the incorrect storage of blood or blood components. Such lapses are said to be reportable to senior management and, in some cases, to the FDA. The ADL, which was redacted prior to publication, indicated that ARC had responded to the findings in June, insisting that no negative impact was observed. However, the agency retorted that “ARC may not violate its own SOPs [standard operating procedures] and dismiss the violation as inconsequential.”

Also among the findings that led to that action were failure to ask required screening questions of blood donors and failure to conduct appropriate tests on donated blood (Medical Device Daily, Sept. 11, 2006).

The FDA letter also noted that an April 2005 report indicated that five blood components “had been placed into an electronic location” for components that tested negative for cytomegalovirus without any indication that the units had been tested. The problem report for this incident is said to have lacked documentation that described how this was discovered and where the units were located at the time. A similar incident involving three apheresis components occurred two months later, with the problem report lacking the same set of information as the April incident.

ARC’s senior vice president for quality and regulatory affairs, Bill Cherry, told Medical Device Daily that part of the problem with compliance is that “we are so large and geographically dispersed.” The organization employs more than 18,000 and is engaged in hundreds of blood collection activities per day, including blood drives.

Cherry said that despite the fact that the organization’s West Henrietta, New York, facility was the subject of some ire at FDA, that site “had a pretty spotless record” up until recently. Many of the problems cited at West Henrietta were for the problem management system that FDA recently reviewed for the first time. Still, “we don’t believe that the West Henrietta problems are representative” of the entire ARC system, he said.

The long-time industry executive, who has overseen compliance work at IDEC Pharmaceuticals (San Diego) among other places, said that the organization hopes that its woes with FDA are now a thing of the past, but that “I can’t say we won’t get any more fines.” However, he promised that ARC is working diligently to beef up its compliance systems, and said that since 2004, the organization has cut its regulatory problems by 40%.

As any manager might deduce, personnel issues are part of the problem. Cherry said that ARC’s turnover “system wide is about 30% per year,” and that this is an area that management “has identified for improvement.” However, he said that the greatest turnover is in blood collection, a job that is difficult to fill because the work is unpleasant. In order to reduce the loss of staff, ARC is working out a way to ensure that applicants are “a good match for the job.”

At present, “we have a huge computer project getting into implementation,” Cherry said, that is part of “a continuous improvement initiative.” ARC wants to “get away from manual steps” for any functions that lend themselves to automation. He said that the system for corrective and preventive action, the problem management system, is also the subject of an IT upgrade provided by Pilgrim Software (Tampa, Florida). Cherry declined to discuss the dollar value of the investment that ARC will make in IT during the fiscal year.

Ann Saunders, vice president of the ARC division that oversees the region in which West Henrietta is located, said that no adverse health reactions have been reported in connection with the citations from the ADL, and that the organization’s system of multiple checks ensures that questionable blood and blood components will not slip into distribution.

“Both the FDA and Red Cross think blood supply is safer today than it’s ever been,” Saunders said, adding that she is concerned that “people will read [about] this and not donate, and that’s something the FDA would not want to have happen, either.”

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