2.0 POLICY
2.1 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 United States (US) 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.
2.2 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.
2.3 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.