Red Cross Agrees to Fines for Safety Violations
The American Red Cross (ARC) and U.S. Food and Drug Administration officials agreed to the new system of fines, even after the issue kept the two groups at odds in federal court for the last year and a half.
The agreement calls for the Red Cross to pay up to $10,000 for violations of established blood safety practices and up to $50,000 for the release of each unit of blood that could cause serious adverse health problems or death. The group collects and distributes nearly half of the donated blood supply in the U.S.
The announcement follows a report issued last December in which FDA inspectors accused the American Red Cross of widespread managerial lapses and safety violations, including collection of blood from ineligible donors and falsification of inventory records. FDA commissioner Dr. Mark McClellan said that ARC continues to participate in "a recurring pattern" of violations but that the new system "creates an important new incentive for ARC to improve the processes and controls necessary for making safer blood products."
The agency asked a federal court in December 2001 to hold ARC in contempt for repeated violations of managerial practices laid out in a 1993 consent decree. ARC had strongly objected to the fines and the case technically remains in mediation.
The organization got new management in August of this year when Marsha (Marty) Evans took over as president. McClellan said that ARC's willingness to agree to the new enforcement system represents "the biggest change we have seen" toward changing the organization's managerial culture.
A statement released by ARC said: "There is a recognized need to further strengthen our procedures and processes. This agreement is welcomed and marks a new era of cooperation between the Red Cross and the FDA.
ARC spokesman Phil Zepeda said that no management changes have been made in ARC biomedical services branch, which controls the organization's blood collection, testing, and distribution operations.
Friday's agreement caps possible fines at 1 percent of ARC's total revenue from blood operations in the first year and then increases the cap incrementally up to 4 percent of revenue in the fourth year. The organization currently takes in just under $2 billion each year from its blood operations, according to the FDA.
ARC said that public financial donations would not be used to pay any future fines that are assessed to it by FDA. Meanwhile, McClellan strove to reassure the public that ARC's alleged lapses have not compromised overall safety, saying that the U.S. has "about the safest blood supply in the world." "Patients that are recommended to get blood transfusions should get them," he said. (Reuters) -------------------------------------------------- -----------------------------
Lawmakers Break Smallpox Compensation Impasse
WASHINGTON -- U.S. Senate Democrats and the White House reached an agreement Thursday on a compensation package for healthcare workers who experience smallpox vaccine-related injuries, according to aids to a leading Democrat.
Aids to Senator Edward M. Kennedy, D-Mass., who led the fight against the administration's initial proposal in the Senate, told Reuters Health on Friday that the Senate Democrats had agreed to a tentative compromise, under which anyone disabled as a result of the inoculations would be eligible for up to $50,000 a year.
The compromise could potentially end the stalemate between the White House and Congress, allowing for passage of a compensation measure that Bush administration officials hope will spur enrollment in the government-sponsored initiative.
The Bush administration entered the negotiations with the Senate Democrats as part of a bipartisan effort to reach an agreement, after the Republican-led House soundly defeated the administration's first proposal earlier this month.
Health and Human Services Secretary Tommy G. Thompson began the push for the package last summer, saying the lack of compensation has been a primary reason U.S. healthcare workers are reluctant to participate in the program.
According to federal figures, about 31,000 U.S. healthcare workers have been vaccinated, while the administration had hoped to vaccinate 450,000 workers by now.
Under the compromise, Kennedy's staff said partially disabled workers would also be eligible for the $50,000 a year payment with a lifetime cap of $262,000. They said spouses of those killed would be eligible for a lump-sum payment.
The aids said a surviving spouse with children would be entitled to choose between the lump-sum payment or $50,000 a year until the children reach the age of 18. According to Kennedy's staff, initial funding for the vaccine campaign is expected to be included in an emergency appropriations bill for the Iraq war. (Reuters)