SubPart 58-2 - Blood Banks and Laboratories Performing Immunohematology Testing

Effective Date

10/22/2025

SubPart 58-2 - Blood Banks and Laboratories Performing Immunohematology Testing
Section 58-2.1 - Definitions

Section 58-2.2 - Qualifications of donors

Section 58-2.3 - Required laboratory tests for donated blood

Section 58-2.4 - Collection of blood

Section 58-2.5 - Sterilization of instruments

Section 58-2.6 - Collection and handling of blood for subsequent allogeneic or autogeneic transfusion

Section 58-2.7 - Immunohematology testing

Section 58-2.8 - Standard operating procedures

Section 58-2.9 - Issuance of blood, blood components and derivatives

Section 58-2.10 - Required records and confidentiality

Section 58-2.11 - Records to be kept when blood is collected for autogeneic or allogeneic transfusion

Section 58-2.12 - Records to be kept when blood, blood components or derivatives are issued for allogeneic or autogeneic transfusion

Section 58-2.13 - Distribution facilities

Section 58-2.14 - RESERVED

Section 58-2.15 - Collection of blood components by apheresis

Section 58-2.16 - Required standards for transfusion

Section 58-2.17 - Laboratory tests to be performed prior to allogeneic or autogeneic transfusion

Section 58-2.18 - Records to be kept when blood or blood component transfusions are performed

Section 58-2.19 - Records to be kept when derivatives are infused

Section 58-2.20 - REPEALED

Section 58-2.21 - Limited transfusion services

Section 58-2.22 Reserved

Section 58-2.23 - HIV-1 and HIV-2 antibody testing results

Section 58-2.24 - Disposal of untransfused and expired blood units

Section 58-2.25 - Intraoperative and postoperative blood recovery and normovolemic hemodilution

Section 58-2.26 - Exceptions

Section 58-2.27 - Reinfusion procedures

Section 58-2.28 - Incorporation by reference