The FDA has fined the American Red Cross (ARC) to the tune of $5.7 million over three years for failure to comply with a 2003 agreement meant to make sure the organization would amend its unsafe practices. The Adverse Determination Letter (ADL) (pdf with redacted non-public information) sent by the administration on November 21 states that inspections of the ARC's New York Penn Region's Blood Services facility done between August and December 2005 revealed many violations of the law, regulations, and the amended consent decree of permanent injunction entered in April 2003. In a statement the ARC answers it will review the ADL and prepare a plan of action to address the FDA's concerns within 20 days. The Red Cross, which supplies about 45 percent of the blood used in the U.S., pays all imposed fines from Biomedical Services operating funds rather than from monetary donations.
more... November 30, 2006 Related topics: Legal & legislative, Ethics & Scandals
On November 21st, Premier, Inc. was one of the three recipients of the 2006 Malcolm Baldrige National Quality Award. The award was established by Congress in 1987 "to promote quality awareness, to recognize quality and business achievements of U.S. organizations, and to publicize these organizations' successful performance strategies" and named after the Secretary of Commerce between 1981 and 1987. It's managed for the Commerce Department by the National Institute of Standards and Technology (NIST), a non-regulatory agency.
USA Today reports some medical manufacturers see this as an obvious conflict of interest, given the fact Richard Norling, Premier's President and CEO, is also a director of the Award Foundation. According to USA Today, a Premier spokesman said Norling offered to resign from his board seat at the foundation when he learnt his company was nominated, but he was told that wasn't necessary since as a board director he had no say in who would get the award. The panel of judges for 2006 included people from several healthcare organizations including Kaiser Permanente and Mayo Clinic.
more... November 29, 2006 Related topics: Ethics & Scandals, Group purchasing & GPOs
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