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Biologically Derived Product

Data Element

Information from the submission form

Biologically Derived Product information
This set of data elements describes information related to the biologically derived product:
a. Product Code (productCode): this is the data element which can store 1 to many codable concepts describing the product. We propose the ability to use the following product codes to identify biologically derived products:
a.i. ISBT-128 Product Code: identifies the biologically derived product type, such as blood components, fluids, tissues, organs, or cells.
a.ii. ISBT-128 Donation Identification Number: uniquely identifies a biologic product donation, such as blood components, fluids, tissues, organs, or cells.
a.iii. NDC or RxNorm codes can be used for biologically derived products that are manufactured and labeled with an NDC, such as blood derived products (e.g. IVIG’s, clotting factors). Vaccines shall use the Immunization Data Class resource.
b. Product Type/Category (FHIR R4: productCategory): this element identifies the product type (e.g. organ | tissue | fluid | cells | biologicalAgent).
c. Collector (FHIR R4: collector): identifies the collection entity practitioner resource instance, if appropriate.
d. Source (FHIR R4: source): linkage to Patient or Organization resource identifying the biologically derived product donation source.
e. Collected date/time (FHIR R4: collected): date and time of biologic product collection.
f. Quantity (FHIR R4: quantity): quantity of biologic product identified in the resource instance.

Comment

ICCBBA support for Biologically Derived Product Information Data

The use cases identified by FDA/CBER demonstrate the importance of this data element to support safety and effectiveness surveillance, and to facilitate portability of treatment information.  Additional use cases include: assisting hospital transfusion committees in the analysis of MPHO usage leading to improved efficiency; assisting researchers in the analysis of treatment regimens and clinical outcomes (e.g. convalescent plasma or massive transfusion protocols) to determine best practice; providing detailed MPHO usage information to support financial analysis and billing; and, enhancing the ability to perform an efficient lookback for either a single product or multiple products from the same donation.  The inclusion of MPHO information in a standardized manner and location within the EHR will significantly improve traceability by making this important transfusion and transplantation information more readily accessible. ICCBAA strongly supports the creation of the Biologically Derived Product Information Data Element within the USCDI and recommends that the MPHO Unique Identifier, as separately submitted (see https://www.healthit.gov/isa/uscdi-data/unique-identifier-a-medical-product-human-origin) be incorporated within this Biologically Derived Product Information Data Element.  The MPHO Unique Identifier combines existing ISBT 128 data elements (donation identification number, product description code, and division number) that are widely used in transfusion and transplantation practice and provides critical, globally unique, traceability to the donor and processing facility.  The MPHO Unique Identifier contains elements a.i and a.ii as detailed in this submission.  

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