Medicare and Medicaid programs; hospital conditions of participation: laboratory services. Interim final rule with comment period.
This interim final rule with comment period requires hospitals that transfuse blood and blood components to: Prepare and follow written procedures for appropriate action when it is determined that blood and blood components the hospitals received and transfused are at increased risk for transmitting hepatitis C virus (HCV); quarantine prior collections from a donor who is at increased risk for transmitting HCV infection; notify transfusion recipients, as appropriate, of the need for HCV testing and counseling; and extend the records retention period for transfusion-related data to 10 years. These changes are based on recommendations by the Secretary's Advisory Committee on Blood Safety and Availability and are being published in conjunction with the Food and Drug Administration's (FDA) Final Rule, "Current Good Manufacturing Practice for Blood and Blood Components; Notification of Consignees and Transfusion Recipients Receiving Blood and Blood Components at Increased Risk of Transmitting HCV Infection" ("lookback") found elsewhere in this issue of the Federal Register. The intent is to aid in the prevention of HCV infection and to create opportunities for disease prevention that, in most cases, can occur many years after recipient exposure to a donor.
D001688:Biological Products; D001769:Blood / Q000382:microbiology; D001771:Blood Banks / Q000331:legislation & jurisprudence*; D001782:Blood Donors / Q000331:legislation & jurisprudence*; D001803:Blood Transfusion / Q000331:legislation & jurisprudence*; D018563:Disease Notification / Q000331:legislation & jurisprudence*; D018562:Disease Transmission, Infectious / Q000331:legislation & jurisprudence*; D006526:Hepatitis C / Q000097:blood*; D006801:Humans; D007882:Legislation, Hospital; D019221:Mandatory Reporting; D006278:Medicare / Q000331:legislation & jurisprudence; D014481:United States; D014486:United States Food and Drug Administration
D001688:Biological Products