Providers
Chapter 11
Section 5.1
Provider Standards For Potentially
Human Immunodeficiency Virus (HIV) Infectious Blood And Blood Products
Issue Date: July 8, 1998
Authority: 21 CFR 606.100; 21 CFR 610.45, 46, and 47;
42 CFR 482.27
Revision:
1.0 ISSUE
Provider standards for potentially Human Immunodeficiency
Virus (HIV) infectious blood and blood products.
2.0 POLICY
Authorized providers are subject to the requirements
published in the Federal Register on September 9, 1996,
by the Centers for Medicare and Medicaid Services (CMS) and the
U.S. Food and Drug Administration (FDA) that will ensure proper
health and safety steps are taken to minimize further spread of
HIV infection. The CMS Final Rule provides standards for Medicare
and Medicaid participating hospitals and the FDA Final Rule provides
standards for blood establishments.
The
CMS Final Rule requires hospitals participating in the Medicare
and Medicaid programs to take appropriate action when the hospitals
learn they have received blood or blood products that are at increased
risk of transmitting HIV infection. If the hospital learns it has
received blood or blood products collected from a donor recently
exposed to HIV, before the donor has a sufficient level of antibody
to be detected by the screening test for antibody to HIV, the hospital
must quarantine any blood or blood products remaining in inventory
pending confirmatory testing. If the presence of HIV is confirmed
by more specific testing, the hospital must notify patients who
received the blood or blood product.
The
FDA Final Rule applies the same requirements to entities furnishing
transfusion services that do not participate in Medicare and Medicaid
programs and clarifies the responsibilities of blood establishments
to identify and notify the transfusion service that received affected
blood and blood products.
3.0 EFFECTIVE
DATE
The effective date of these regulations
is November 8, 1996.
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