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Difference between revisions of "BiologicallyDerivedProduct FHIR Resource Proposal"

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<div style="float: left;">[[Image:OpenHotTopic.GIF|35px| ]]</div>Current version: https://confluence.hl7.org/display/FHIR/BiologicallyDerivedProduct+FHIR+Resource+Proposal
<div style="background:#F0F0F0">
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<br /><div style="background:#F0F0F0">
 
This page documents a [[:category:Pending FHIR Resource Proposal|Pending]] [[:category:FHIR Resource Proposal|FHIR Resource Proposal]]
 
This page documents a [[:category:Pending FHIR Resource Proposal|Pending]] [[:category:FHIR Resource Proposal|FHIR Resource Proposal]]
 
</div>
 
</div>
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=PutProposedResourceNameHere=
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=BiologicallyDerivedProduct=
  
 
<!-- Resource names should meet the following characteristics:
 
<!-- Resource names should meet the following characteristics:
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<!-- The name of the committee that is proposed to have responsibility for developing and maintaining the resources. -->
 
<!-- The name of the committee that is proposed to have responsibility for developing and maintaining the resources. -->
[[YourCommitteeName]]
+
[[Orders & Observations]]
 +
 
 
==Committee Approval Date:==
 
==Committee Approval Date:==
 
<i>Please enter the date that the committee approved this Resource proposal</i>
 
<i>Please enter the date that the committee approved this Resource proposal</i>
 +
October 5, 2017
  
 
==Contributing or Reviewing Work Groups==
 
==Contributing or Reviewing Work Groups==
  
 
<!-- Additional work groups that may have an interest in contributing to, or reviewing  the content of the resource (optional) -->
 
<!-- Additional work groups that may have an interest in contributing to, or reviewing  the content of the resource (optional) -->
* Work Group Name
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*[[Patient Care]]
* or link
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*[[Pharmacy]]
* or "None"
 
  
 
==FHIR Resource Development Project Insight ID==
 
==FHIR Resource Development Project Insight ID==
  
 
<!-- Please specify the id of your work group’s PSS for doing FHIR work.  (If submitted but not yet approved, just write “pending”.) The link to the PSS template can be found here: http://gforge.hl7.org/gf/download/docmanfileversion/6832/9398/HL7FHIR_DSTUballotPSS-20120529.doc -->
 
<!-- Please specify the id of your work group’s PSS for doing FHIR work.  (If submitted but not yet approved, just write “pending”.) The link to the PSS template can be found here: http://gforge.hl7.org/gf/download/docmanfileversion/6832/9398/HL7FHIR_DSTUballotPSS-20120529.doc -->
 +
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1128 Patient Care FHIR resource review
  
 
==Scope of coverage==
 
==Scope of coverage==
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As a rule, resources should encompass all of these aspects.
 
As a rule, resources should encompass all of these aspects.
 
  -->
 
  -->
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A material substance originating from a biological entity intended to be transplanted or infused
 +
into another (possibly the same) biological entity.
 +
 +
Examples include:
 +
 +
*hematopoietic stem cells (bone marrow, peripheral blood, or cord blood extraction)
 +
*blood (whole, extracted cells, plasma, etc)
 +
*organs
 +
*tissues (porcine valves, skin, bovine cardiac tissue, etc.)
 +
*manipulated cells (e.g. CAR T-cells)
 +
 +
The workflow using this resource (e.g., request, administration) should be discussed and implemented in a consistent way as other similar resources are handled (e.g., device, medication)
  
 
==RIM scope==
 
==RIM scope==
  
 
<!-- Identify the formal RIM mapping for the root concept of the resource.  The expectation is that the RIM mapping will be sufficiently precise so as to not overlap with any other resource definition. -->
 
<!-- Identify the formal RIM mapping for the root concept of the resource.  The expectation is that the RIM mapping will be sufficiently precise so as to not overlap with any other resource definition. -->
 +
No identified mappings to RIM 2.46 objects.
  
 
==Resource appropriateness==
 
==Resource appropriateness==
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* Have the characteristics of high cohesion & low coupling – need to explore whether coupling is good some places, not elsewhere – layers from Bo’s document  
 
* Have the characteristics of high cohesion & low coupling – need to explore whether coupling is good some places, not elsewhere – layers from Bo’s document  
 
  -->
 
  -->
 +
Organs, tissues, and fluids obtained from one biological entity (person or animal) for the purpose of infusion, transplantation or grafting to another biological entity are neither Specimens ("used for diagnostic and environmental testing") nor Devices ("an instance or a type of a manufactured item") nor Medications (drug, ingredients, and packaging) nor Substances ("homogeneous material with a definite composition"). Furthermore, there is established a relationship between two entities, the donor and the recipient.
  
 
==Expected implementations==
 
==Expected implementations==
  
 
<!--Key resources are justified by CCDA, for resources not deemed "key", what interest is there by implementers in using this particular resource. Provide named implementations if possible - ideally provide multiple independent implementations. -->
 
<!--Key resources are justified by CCDA, for resources not deemed "key", what interest is there by implementers in using this particular resource. Provide named implementations if possible - ideally provide multiple independent implementations. -->
 +
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This will be used in reporting clinical outcomes to the Center for International Blood and Marrow Transplant Research (CIBMTR) after hematopoietic cell transplant (bone marrow, peripheral blood stem cells, cord blood).
 +
 +
This resource is not used in CCDA.
  
 
==Content sources==
 
==Content sources==
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For reporting of clinical outcomes to CIBMTR, source data would come from federated systems at the transplant center, e.g., from the EHR, transplant databases, labs
  
 
<!-- List all of the specifications (beyond those in the "standard" (FHIR_Design_Requirements_Sources) list of source specifications) that you’re planning to consult
 
<!-- List all of the specifications (beyond those in the "standard" (FHIR_Design_Requirements_Sources) list of source specifications) that you’re planning to consult
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Are there any source specifications that you wish to consult but are concerned about access to or expertise to consider? -->
 
Are there any source specifications that you wish to consult but are concerned about access to or expertise to consider? -->
  
==Example Scenarios==
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*Patient undergoes hematopoetic cell transplantation (HCT) using autologous BiologicallyDerivedProduct
 
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*Patient undergoes HCT using HLA-matched BiologicallyDerivedProduct from another person
<!-- Provide a listing of the types of scenarios to be represented in the examples produced for this resource.  They should demonstrate the full scope of the resource and allow exercising of the resources capabilities (full element coverage, inclusion & omission of optional elements, repeating and singleton repeating elements, etc.) -->
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*Patient receives post-HCT infusion of donor t-cells (BiologicallyDerivedProduct)
 +
*Patient receives blood (BiologicallyDerivedProduct) transfusion
 +
*Patient receives HLA-matched platelets (BiologicallyDerivedProduct)
 +
*Patient receives heart (BiologicallyDerivedProduct) transplant from deceased donor Patient
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*Patient donates kidney (BiologicallyDerivedProduct) for transplantation in another Patient
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*Patient received pig heart valve (BiologicallyDerivedProduct)
  
 
==Resource Relationships==
 
==Resource Relationships==
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Reference to resources is really only relevant at the "same or higher level" (Bo – fix this wording)
 
Reference to resources is really only relevant at the "same or higher level" (Bo – fix this wording)
 
  -->
 
  -->
 +
ProcedureRequest (for collection)
 +
 +
Patient ("receiver" and "source")
 +
 +
Practitioner (who collected product)
 +
 +
Substance (product processing)
 +
 +
DiagnosticReport (containing HLA-typing)
 +
 +
BiologicallyDerivedProduct ("parent" product for multi-day collections)
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 +
Procedure (one for collection and one for transplantation, will need to add BiologicallyDerivedProduct to the "usedReference")
  
 
==Timelines==
 
==Timelines==
  
 
<!-- Indicate the target date for having the resource complete from a committee perspective and ready for vetting and voting -->
 
<!-- Indicate the target date for having the resource complete from a committee perspective and ready for vetting and voting -->
 +
 +
ready by Jan 2018 connectathon
 +
 +
??? voting
  
 
==gForge Users==
 
==gForge Users==

Latest revision as of 14:59, 31 October 2019



BiologicallyDerivedProduct

Owning committee name

Orders & Observations

Committee Approval Date:

Please enter the date that the committee approved this Resource proposal October 5, 2017

Contributing or Reviewing Work Groups

FHIR Resource Development Project Insight ID

1128 Patient Care FHIR resource review

Scope of coverage

A material substance originating from a biological entity intended to be transplanted or infused into another (possibly the same) biological entity.

Examples include:

  • hematopoietic stem cells (bone marrow, peripheral blood, or cord blood extraction)
  • blood (whole, extracted cells, plasma, etc)
  • organs
  • tissues (porcine valves, skin, bovine cardiac tissue, etc.)
  • manipulated cells (e.g. CAR T-cells)

The workflow using this resource (e.g., request, administration) should be discussed and implemented in a consistent way as other similar resources are handled (e.g., device, medication)

RIM scope

No identified mappings to RIM 2.46 objects.

Resource appropriateness

Organs, tissues, and fluids obtained from one biological entity (person or animal) for the purpose of infusion, transplantation or grafting to another biological entity are neither Specimens ("used for diagnostic and environmental testing") nor Devices ("an instance or a type of a manufactured item") nor Medications (drug, ingredients, and packaging) nor Substances ("homogeneous material with a definite composition"). Furthermore, there is established a relationship between two entities, the donor and the recipient.

Expected implementations

This will be used in reporting clinical outcomes to the Center for International Blood and Marrow Transplant Research (CIBMTR) after hematopoietic cell transplant (bone marrow, peripheral blood stem cells, cord blood).

This resource is not used in CCDA.

Content sources

For reporting of clinical outcomes to CIBMTR, source data would come from federated systems at the transplant center, e.g., from the EHR, transplant databases, labs


  • Patient undergoes hematopoetic cell transplantation (HCT) using autologous BiologicallyDerivedProduct
  • Patient undergoes HCT using HLA-matched BiologicallyDerivedProduct from another person
  • Patient receives post-HCT infusion of donor t-cells (BiologicallyDerivedProduct)
  • Patient receives blood (BiologicallyDerivedProduct) transfusion
  • Patient receives HLA-matched platelets (BiologicallyDerivedProduct)
  • Patient receives heart (BiologicallyDerivedProduct) transplant from deceased donor Patient
  • Patient donates kidney (BiologicallyDerivedProduct) for transplantation in another Patient
  • Patient received pig heart valve (BiologicallyDerivedProduct)

Resource Relationships

ProcedureRequest (for collection)

Patient ("receiver" and "source")

Practitioner (who collected product)

Substance (product processing)

DiagnosticReport (containing HLA-typing)

BiologicallyDerivedProduct ("parent" product for multi-day collections)

Procedure (one for collection and one for transplantation, will need to add BiologicallyDerivedProduct to the "usedReference")

Timelines

ready by Jan 2018 connectathon

??? voting

gForge Users

When Resource Proposal Is Complete

When you have completed your proposal, please send an email to FMGcontact@HL7.org

FMG Notes