IMPROVE TRACEABILITY OF MPHO WITHIN ELECTRONIC HEALTH RECORDS IN THE U.S.


ICCBBA invites you to comment on multiple submissions to the USCDI and improve traceability of MPHO within electronic health records.


The United States Core Data for Interoperability (USCDI) is a standardized set of health data classes and constituent data elements for nationwide, interoperable health information exchange. There is currently not a standardized method to capture critical traceability information regarding the receipt of medical products of human origin, such as blood transfusions and cell or tissue transplantation, in the electronic health record (EHR).


There are three submissions from FDA/CBER currently at Level 1 and one submission from ICCBBA at the Comment level for the Biological Derived Product Class. We need your help to ensure that these submissions move forward. Your comments can help support inclusion of the Biologically Derived Product and specifically, the MPHO Unique Identifier in the USCDI.

We request that you review and add supporting comments to the FDA submissions for the Class ‘Biologically Derived Product’ and the Data Element ‘Biologically Derived Product information’, as well as to the ICCBBA Data Element ‘Unique Identifier for Medical Product of Human Origin’.


USCDI General Information:

USCDI Fact Sheet: https://www.healthit.gov/cures/sites/default/files/cures/2020-03/USCDI.pdf

  • A USCDI “Data Class” is an aggregation of various Data Elements by a common theme or use case.

  • A USCDI “Data Element” is the most granular level at which a piece of data is exchanges.

How to comment:

Timeline and Comment Process: https://www.healthit.gov/isa/isa-timeline-and-comment-process


Please note that a free Interoperability Standards Advisory (ISA) site account is required to add a comment.

Direct link to the Biologically Derived Product Submissions: https://www.healthit.gov/isa/uscdi-data/biologically-derived-product-0

Select the Level 1 tab to access the FDA/CBER submissions. Select the Comment tab to access the ICCBBA submission regarding the MPHO Unique Identifier.

ICCBBA has already added supporting comments to the FDA/CBER submissions. Our comments are provided below for your information.

Comments may be entered by individuals or by individuals acting on behalf of organizations. Feel free to share this request with others. If you are not the correct person in your organization, please forward this email. We would appreciate knowing if you are able to add comments. Thank you for taking the time to enhance the traceability of MPHO within electronic health records.

Biologically Derived Product:

ICCBBA support for Biologically Derived Product Class


As identified by FDA/CBER, medical products of human origin are a group of therapeutic products that have unique characteristics due to their human origin. In particular, the fact that each product is derived from a human donor, and that many different product types can be derived from a single donation event, creates special traceability requirements to support tracking between donor and recipient, and cross-referencing of all products derived from a donor. Existing traceability systems for synthetic medicines and medical devices do not provide optimal identifiers to support these requirements. Currently traceability information for these products is captured in hospital blood bank systems, other clinical systems, or product manufacturer systems but is not held in a structured manner in the EHR. For this reason, ICCBBA strongly supports the creation of a new Class for Biologically Derived product in the USCDI.


ICCBBA support for Biologically Derived Product Information Data Element

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.