U.S. Department of Health & Human Services
Improving the health, safety, and well-being of America	Frequent Questions Search

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In March 1998, HHS adopted a Blood Action Plan designed to ensure greater coordination among the department's public health agencies and to increase the effectiveness of the FDA's scientific and regulatory activities to improve the safety of the blood supply. The plan focuses on key areas of concern, including monitoring and increasing the blood supply, responding to emerging diseases, and updating blood-safety regulations. The FDA, CDC, NIH, and Health Care Financing Administration (HCFA) all participate in implementing the plan. Details of the plan are available on the Internet at www.fda.gov/cber/blood/bap.htm.

Monitoring and improving the blood supply. In 1999, HHS established a working group to monitor the blood supply and to develop ways to increase blood availability. The group's efforts led to a 1999 report to the Assistant Secretary for Health, with specific recommendations for monitoring the blood supply, encouraging more donations by eligible donors, improving retention of donors, removing restrictions to safe donations, and addressing economic issues facing the blood industry. To meet these goals, the FDA, NIH, CDC and HCFA have conducted a wide range of activities, including reexamining donor suitability criteria; developing industry guidance on topics including donor incentives; monitoring the U.S. blood supply; sponsoring workshops on donor recruitment, increasing donations, and other issues; and clarifying reimbursement policies for blood services.

Combating emerging infectious diseases. As part of HHS' Emerging Infectious Disease Committee, the FDA, NIH and CDC are working together to identify potential new threats to the blood supply and to ensure appropriate steps are taken to protect blood safety. In 1998, the committee developed a strategy for evaluating and managing any emerging infection with potential to threaten the blood supply. The response includes four major phases: identifying the epidemiological characteristics of the agent and determining whether it can be transmitted by blood; conducting extensive laboratory investigations; issuing recommendations on donor screening and deferral; and establishing emergency communications to coordinate with state and local health departments and blood organizations.

Error and accident reporting. In November 2000, the FDA issued a final rule that strengthens and streamlines requirements to report errors and accidents in manufacturing that may affect the safety, purity, or potency of a blood product. Under the final rule, establishments involved in the manufacture of blood and blood components, including licensed manufacturers, unlicensed registered manufacturers, and transfusion services, must report certain product deviations to the FDA within 45 days. In the past, some reports were not made in a timely manner, and unlicensed blood establishments were not required to submit such reports.

Hepatitis C lookback. The CDC estimates there are about 3 million Americans chronically infected with the hepatitis C virus (HCV), including roughly 300,000 who were infected by blood transfusions prior to 1992. Many Americans with HCV are unaware they have the disease because it does not cause symptoms until it is far advanced. In 1998, a "lookback" was begun to notify people who received blood in the past from a potentially infected donor of the potential risk and the need to get tested. Based on guidance from the FDA, blood establishments have been identifying affected units and notifying hospital transfusion centers so that blood recipients can be traced. The CDC is evaluating this process and is working to educate health care providers and the public about hepatitis C. More information about HCV is available at the CDC hepatitis resource center at www.cdc.gov/hepatitis and in the HHS' hepatitis C fact sheet at http://www.hhs.gov/news/facts.

Nucleic acid testing. The FDA and NIH have encouraged the development of investigational nucleic acid testing by industry in order to increase the safety of the blood supply. Currently, both blood and plasma are tested for HCV using an FDA approved antibody test and for HIV using FDA approved antibody tests and a test for the viral p24 protein. The industry also is participating in investigational nucleic acid testing for HIV and HCV to further reduce the risk of an infectious unit being transfused.

Notifying users of withdrawals and recalls. In 1998, the blood industry implemented the Patient Notification System, a voluntary system to inform recipients when certain blood-derived products such as clotting factors are withdrawn or recalled. The system allows registered individuals to receive notifications by telephone, express mail, fax or electronic mail. To date, the voluntary program has registered fewer than 10 percent of eligible patients, health care providers and distributors. The FDA in 1999 announced its intent to issue regulations on tracking certain plasma derivatives and notifying users of withdrawals and recalls. The FDA solicited public comment and is now drafting proposed regulations.

New variant of Creutzfeldt-Jakob Disease. In April 2000, the blood industry implemented new policies to defer potential blood donors who had resided in the United Kingdom for at least six months between 1980 and 1996, the period of highest risk of exposure to bovine spongiform encephalopathy (BSE). The policy stemmed from HHS' Blood Safety Committee's recommendations and is a precautionary step until more is known about a new variant of Creutzfeldt-Jakob Disease and its potential transmissibility by blood products following reports associating it with BSE. Monitoring efforts have not found a decrease in blood product inventories since this deferral policy was implemented.

Addressing blood product shortages. In recent years, there have been occasional, acute shortages of clotting factor concentrates and other plasma derivatives, including Alpha-1 proteinase inhibitor and immune globulin intravenous (IGIV). These shortages have occurred primarily because of manufacturing problems that disrupted production or distribution. FDA has worked closely with the manufacturers to assist them in correcting deficiencies and to expedite the release of safe products, including reserves dedicated to use in medical emergencies. In the past year, FDA has approved several new recombinant Factor VIII products and has approved new manufacturing facilities. To ensure adequate access for Medicare beneficiaries, HCFA created new payment codes for blood-related services as part of Medicare's outpatient prospective payment system.

Updating blood regulations. Since 1994, the FDA has worked to update its regulations related to blood safety and supply in order to increase the effectiveness and efficiency of these efforts. As a result of these efforts, the FDA proposed updating the technical standards for blood and plasma products in direct final rules published in 1999. Also, the FDA in 1999 proposed revisions to the requirements for donor testing and for notification of deferred donors and is now preparing final regulations.

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Note: All HHS press releases, fact sheets and other press materials are available at http://www.hhs.gov/news.