Submitted by cscohn@umn.edu on
Physician support for Biologically Derived Product data element
I strongly support the inclusion of biologically derived product data (BPD) in USCDA v4. The inclusion of BPD in the USCDI will further enhance the ability of electronic medical records to support both traceability and biovigilance across the full spectrum of Medical Products of Human Origin (MPHO) by providing the ability to link key MPHO information in a standard manner to the recipient’s record. We need this enhanced traceability to quickly track patients affected by infectious disease transmission, such as recently occurred with tuberculosis in bone grafts. This will also allow for an enhanced hemovigilance system that tracks blood components and adverse effects from transfusion reactions. Since transfusions are the most frequently performed medical procedure in the United States it is critical that we have secure means for tracking transfusions and the associated adverse events.
Submitted by rbaker@cdisc.org on
Promote Biological Derived Product Data Class in USCDI v5
Promote the Biologically Derived Product Data Class for patient safety reasons for the USCDI v5.
Product Code and Unique Identifier are the priority data elements in the Biologically Derived Product Data Class.
Product Code and Unique Identifier data elements are recorded in the documentation, having discrete elements will help with tracking reactions and improve patient safety.
Adding these data elements will inform clinical research and serious adverse event evaluations during clinical trials. The serious adverse event adjudication committee will have more information to understand the factors surrounding biological products which may provide insight into study drug adverse events and the relationship to a study drug.