Important note: Information in this article was accurate in 1993. The state of the art may have changed since the publication date.
Food and Drug Administration, Health Care Financing Administration, U.S. Department of Health and Human Services - July 1, 1993
Monica Revelle (301) 443-4177 (FDA); Anne Verano (202) 690-6145 (HCFA)
"These proposals are designed to strengthen our efforts to protect the nation's blood supply and to minimize any risk to patients who need this life-saving gift," said HHS Secretary Donna E. Shalala.
FDA proposed a guideline for U.S. blood centers that places the emphasis on preventing problems rather than on detecting them after the fact. The guideline calls on manufacturers of blood and blood components to develop well-planned, written and managed quality assurance programs. These programs include employee training and competency evaluations, equipment validation and laboratory testing procedures as well as self-policing audits. These programs are designed to prevent accidents and errors that can result in the release of blood products that pose a risk for the transmission of infectious diseases.
"FDA is committed to holding all blood centers to the highest standards," said FDA Commissioner David A. Kessler, M.D. "When it comes to these vital products, our standards can never be too high."
Through its intensified oversight of blood centers in recent years, FDA has identified deficiencies related to blood centers' quality control procedures and practices. Based on these findings, FDA's proposed guideline would help blood centers develop effective quality assurance programs.
These quality assurance programs are intended to recognize and prevent recurrent problems in a blood center's performance by eliminating causes of errors, ensuring the integrity of test results, implementing effective controls for manufacturing processes and recordkeeping systems, and ensuring the adequacy of employee training.
In addition, FDA is proposing to make consistent and uniform the "look back" policy now being followed by blood centers. Blood centers are required to retrieve and quarantine units from prior collections whenever a repeat donor has a reactive screening test for HIV. Blood centers are then required to perform additional, more specific tests on the donor's blood. Based on the results of the additional tests, blood centers are required to eliminate those previously donated units of blood from use in transfusions.
Under FDA's proposed rule and a companion rule from the Health Care Financing Administration, blood centers would also provide donor test results to hospitals to ensure that a patient who had received units from prior donations could be notified if the same donor should later test positive for the antibody to HIV.
"The regulation we are proposing provides an extra measure of protection for the public and demonstrates our commitment to a safe blood supply," said HCFA Administrator Bruce C. Vladeck.
Written comments on FDA's proposals should be sent, within 60 days, to the Dockets Management Branch (HFA-205), Food and Drug Administration, Room 1-23, 12420 Parklawn Drive, Rockville, Md. 20857. Comments on HCFA's proposal may be submitted, also within 60 days, to the Health Care Financing Administration, Attn. BPD- 633-P, P.O. Box 26688, Baltimore, Md. 21207.
FDA is one of the eight Public Health Service agencies in HHS. HCFA, also an HHS agency, directs the Medicare and Medicaid programs which help pay the medical bills of 67 million Americans.
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SOURCE: Food and Drug Administration (FDA).
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