Blood & Blood Products
The Center for Biologics Evaluation and Research (CBER) regulates the collection of blood and blood components used for transfusion or for the manufacture of pharmaceuticals derived from blood and blood components, such as clotting factors, and establishes standards for the products themselves. CBER also regulates related products such as cell separation devices, blood collection containers and HIV screening tests that are used to prepare blood products or to ensure the safety of the blood supply.
Most Recent Blood & Blood Products Assessments
Title
Date
COVID-19 Convalescent Plasma Surveillance Protocol
C19 Plasma Protocol 2021 (pdf)
06/15/2021
COVID-19 Convalescent Plasma Surveillance Protocol
Blood Components Exposure within the BEST Initiative EHR Network, 2012-2018
Blood Component Exposure Report 2020 (pdf)
- Apheresis Platelets DataPartner1 Report 2020 (pdf)
- Apheresis Platelets DataPartner2 Report 2020 (pdf)
- Apheresis Platelets DataPartner3 Report 2020 (pdf)
- Cryoprecipitate DataPartner1 Report 2020 (pdf)
- Cryoprecipitate DataPartner2 Report 2020 (pdf)
- Cryoprecipitate DataPartner3 Report 2020 (pdf)
- Plasma DataPartner1 Report 2020 (pdf)
- Plasma DataPartner2 Report 2020 (pdf)
- Plasma DataPartner3 Report 2020 (pdf)
- RBC DataPartner1 Report 2020 (pdf)
- RBC DataPartner2 Report 2020 (pdf)
- RBC DataPartner3 Report 2020 (pdf)
- Whole Blood DataPartner1 Report 2020 (pdf)
- Whole Blood DataPartner2 Report 2020 (pdf)
- Whole Blood DataPartner3 Report 2020 (pdf)
- Blood Component Exposure Report 2020 All Files (zip)
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08/2020
ISBT 128, Information Standard for Blood and Transplant 128 Coding System, Transfusion, Blood, Whole Blood, Blood Components, hemovigilance system, Observational Medical Outcomes Partnership, OMOP, CDM, common data model, EHR, Electronic Health Records, Red Blood Cells, Apheresis Platelets, Plasma, Cryoprecipitate, Infrastructure
Trends in Red Blood Cells Transfusions within the Biologics Effectiveness and Safety (BEST) Initiative Network, 2012-2018
10/19/2019
ISBT 128, Information Standard for Blood and Transplant 128 Coding System, Transfusion, Blood, Blood Components, Apheresis, Leukocyte-reduction, LR, Irradiation (IR), transfusion, EHR, Electronic Health Records, Red Blood Cells, RBC, transfusion episode, unit levels, NBCUS, National Blood Collections & Utilization Survey
Advancing the Use of the ISBT-128 Coding System in Electronic Health Records to Monitor Blood Transfusion Prevalence in the United States
ISBT codes characterize transfusion rates Abstract 2018 (pdf)
10/13/2018
ISBT 128, Information Standard for Blood and Transplant 128 Coding System, Transfusion, Blood, Whole Blood, Blood Components, transfusion related adverse events, AE, EHR, Electronic Health Records, Red Blood Cells, Platelets, Plasma, Cryoprecipitate
Biologics Effectiveness and Safety (BEST) Initiative: Building the Infrastructure for a National Hemovigilance System to Monitor Transfusion-Related Adverse Events
10/13/2018
ISBT 128, Information Standard for Blood and Transplant 128 Coding System, Transfusion, Blood, Whole Blood, Blood Components, transfusion related adverse events, AE, hemovigilance system, Observational Medical Outcomes Partnership, OMOP, CDM, common data model, EHR, Electronic Health Records, Red Blood Cells, Platelets, Plasma, Infrastructure
Biologics Effectiveness and Safety (BEST) Initiative: Incorporating ISBT-128 Codes into OHDSI’s OMOP Common Data Model to Build A National Hemovigilance System to Monitor Transfusion-Related Adverse Events
06/02/2018
ISBT 128, Information Standard for Blood and Transplant 128 Coding System, Transfusion, Blood, Whole Blood, Blood Components, transfusion related adverse events, AE, hemovigilance system, Observational Medical Outcomes Partnership, OMOP, CDM, common data model, EHR, Electronic Health Records, Red Blood Cells, Platelets, Plasma, Infrastructure
