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  1. Project Scope Statements/Proposals
  2. PSS-1942

Extended RBC Phenotyping-genotyping FHIR IG

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    • Icon: Project Scope Statement Project Scope Statement
    • Resolution: Unresolved
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      Determination of RBC compatibility between patient and donor RBC unit is a core feature of transfusion medicine. With the advent of genotyping methods, phenotyping determination by genotyping has expanded to population levels of donors and increasing numbers of patients, especially those patients who require chronic transfusions. While a controlled vocabulary to describe RBC phenotypic findings is present (ISBT), the incorporation of a standard vocabulary for bidirectional exchange of this extended information has been lacking. Standardizing exchange of more extensive phenotyping information for both biologically derived products (ie, donor RBC units) and patients (eg, sickle cell patients) facilitates improved patient care through the ability to utilize RBC inventory more rational and reduce the generation of allo-antibodies or reduce the incidence of early and delayed transfusion reactions. Additionally, uniform phenotyping representation that this FHIR IG provides, can enable improved public health surveillance of transfused products and potential sequalae by exchanging more granular information if present.

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      Determination of RBC compatibility between patient and donor RBC unit is a core feature of transfusion medicine. With the advent of genotyping methods, phenotyping determination by genotyping has expanded to population levels of donors and increasing numbers of patients, especially those patients who require chronic transfusions. While a controlled vocabulary to describe RBC phenotypic findings is present (ISBT), the incorporation of a standard vocabulary for bidirectional exchange of this extended information has been lacking. Standardizing exchange of more extensive phenotyping information for both biologically derived products (ie, donor RBC units) and patients (eg, sickle cell patients) facilitates improved patient care through the ability to utilize RBC inventory more rational and reduce the generation of allo-antibodies or reduce the incidence of early and delayed transfusion reactions. Additionally, uniform phenotyping representation that this FHIR IG provides, can enable improved public health surveillance of transfused products and potential sequalae by exchanging more granular information if present.
    • Orders & Observations
    • CQI, Pharmacy, Public Health
    • TBD
    • None
    • Product Family Product Project Intent Lineage Ballot Type Target Cycle Actions
      1
      FHIR
      Implementation Guide
      Create New R1 Standard

      N/A

      STU
      May 2023
    • RBC FHIR IG
    • Biologically Derived Product IG for blood product entries and genotyping representation. FHIR R5.
    • TBD
    • Yes
    • TBD
    • N/A
    • Academic/Research, Association/Goverment Agency, Healthcare IT Vendors, Healthcare Provider/user, Patients, Payer/Third Party Administrator, Pharmaceutical/Biotech, Providers, Regulatory Agency, Standards Development Organizations (SDOs), Vendor/Manufacturer
    • US
    • US but may be extended to Universal pending stakeholder conversations

    Description

      The scope of the Extended RBC Phenotyping-genotyping FHIR IG is to expand red blood cell phenotype and antigen descriptions used to communicate blood component compatibility information in transfusion medicine. This IG will advance the bidirectional exchange of this information between healthcare facility blood bank laboratory information systems, donor center blood establishment computer systems, and electronic health record systems. Patient-specific and blood component-specific information will be included. The initial emphasis will be on red blood cell phenotypes and the underlying molecular descriptors of phenotype determination such as serologic methods, specific genotyping methods (e.g., array based, sequencing based, mass-array based), or gene sequencing methods.

      Because of significant clinical overlap with patient allo- and auto-antibody determinations in ascertaining suitability of donor units for testing in a specific patient, it may be desirable to include patient antibody descriptors. Determination of this activity is deferred until the FHIR development activity has begun. Platelet and plasma phenotyping may be included in future efforts. Although U.S. Realm and U.S. Core Profiles may be used for initial work, the goal is to apply this IG internationally.

      Determining RBC unit compatibility between patient and donor is a core function of transfusion medicine. With the advent of genotyping methods, phenotyping determination has expanded to population levels of donors and increasing numbers of patients, especially those who require chronic transfusions. Finding compatible blood for a patient with a low incidence antigen or one or more alloantibodies is becoming increasingly time consuming. While the International Society of Blood Transfusion (ISBT) maintains a controlled vocabulary to describe RBC phenotypic findings, a standard vocabulary for electronic bidirectional exchange of this extended information is needed.

      Standardizing the electronic exchange of extensive phenotyping information for both biologically derived products (e.g., donor RBC units) and patients (e.g., sickle cell disease patients) improves patient care by supporting judicious use of RBC inventory and reducing the incidence of allo-antibody generation or early and delayed transfusion reactions. The uniform phenotyping representation provided by this FHIR IG can improve public health surveillance and safety of transfused products and potential sequalae by exchanging more granular information.

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            kcooper21 Kit Cooper
            Kit Cooper Kit Cooper
            John Spinosa John Spinosa
            John Spinosa John Spinosa
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