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.