View source for BiologicallyDerivedProduct FHIR Resource Proposal

 
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This page documents a [[:category:Pending FHIR Resource Proposal|Pending]] [[:category:FHIR Resource Proposal|FHIR Resource Proposal]]
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[[Category:FHIR Resource Proposal]]
[[Category:Pending FHIR Resource Proposal]]


<!-- For additional guidance on considerations for resource creation, refer to [[FHIR Resource Considerations]] -->


=BiologicallyDerivedProduct=

<!-- Resource names should meet the following characteristics:
* Lower camel case
* U.S. English
* Domain-friendly
* Short
* Clear
* Unique
* Avoid non-universal abbreviations (e.g. URL would be ok)
* Be expressed as a noun
* Be consistent with other similar resources
 -->

==Owning committee name==

<!-- The name of the committee that is proposed to have responsibility for developing and maintaining the resources. -->
[[Patient Care]]
==Committee Approval Date:==
<i>Please enter the date that the committee approved this Resource proposal</i>

==Contributing or Reviewing Work Groups==

<!-- Additional work groups that may have an interest in contributing to, or reviewing  the content of the resource (optional) -->
* Orders and Observations
* Pharmacy

==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 -->

==Scope of coverage==

<!-- Define the full scope of coverage for the resource.  The scope must be clearly delineated such that it does not overlap with any other existing or expected resource.  The scope will be used to govern "what is the set of potential applications to consider when evaluating what elements are 'core' – i.e. in the 80%"

Scope should consider numerous aspects of breadth of scope, including:
* Subject: Human vs. non-human vs. non-patient (e.g. lab bench medicine)
* Disciplines: Environmental Health, Palliative, Respiratory, Psychology, Maternity, Clinical Research
* Delivery environment (Community, Geriatric, Home care, Emergency, Inpatient, Intensive, Neonatal, Pediatric, Primary)
* Locale: Country, region

As a rule, resources should encompass all of these aspects.
 -->
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)

==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. -->

==Resource appropriateness==

<!-- Does the resource meet the following characteristics?

Must
* Represents a well understood, "important" concept in the business of healthcare
* Represents a concept expected to be tracked with distinct, reliable, unique ids
* Reasonable for the resource to be independently created, queried and maintained

Should
* Declared interest in need for standardization of data exchange</span>
* Resource is expected to contain an appropriate number of "core" (non-extension) data elements (in most cases, somewhere in the range of 20-50)
* 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"). Furthermore, there is established a relationship between two entities, the donor and the recipient.

==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. -->

==Content sources==

<!-- List all of the specifications (beyond those in the "standard" (FHIR_Design_Requirements_Sources) list of source specifications) that you’re planning to consult

Are there any source specifications that you wish to consult but are concerned about access to or expertise to consider? -->

* 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
* Patient receives blood (BiologicallyDerivedProduct) transfusion
* Patient receives HLA-matched platelets (BiologicallyDerivedProduct)
* Patient receives heart transplant
* Patient undergoes cardiac surgery receiving pig heart valve

==Resource Relationships==

<!-- What are the resources do you expect will reference this resource and in what context?

What resources do you expect this resource reference and in what context?

Note: These may be existing resources or "expected" resource

Reference to resources is really only relevant at the "same or higher level" (Bo – fix this wording)
 -->

==Timelines==

<!-- Indicate the target date for having the resource complete from a committee perspective and ready for vetting and voting -->

==gForge Users==

<!-- Identify the userids who will require commit access to gForge to maintain the resource.  (Ensure all users have registered for gForge.) -->

==When Resource Proposal Is Complete==
'''When you have completed your proposal, please send an email to [mailto:FMGcontact@HL7.org FMGcontact@HL7.org]'''

==FMG Notes==