SpecimenDefinition FHIR Resource Proposal

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SpecimenDefinition

Owning committee name

Orders_&_Observations_WG

Committee Approval Date:

2017-01-19 - in principal

2017-03-30 - content

Contributing or Reviewing Work Groups

None

FHIR Resource Development Project Insight ID

Ordering Service Interface Specification Project (1010)

Scope of coverage

SpecimenDefinition will define a kind of specimen, which can be associated with in vitro diagnostic procedures described in a catalog of orderable services. SpecimenDefinition describes the kind of specimen to be collected from the subject of these procedures as well as the requirements applying to the collection activity, the preparation of the subject for this collection. This resource also describes the associated type(s) of specimen conditioned for testing, which are the output of the specimen collection activity. A specimen conditioned for testing is described with the type(s) of container and possible additive to be used, the minimal and normal volumes of collection, the conditions of storage, transportation and handling for the specimen once collected and conditioned. This resource is a necessary building block of a sharable catalog of orderable in vitro diagnostic services. The subjects of these orderable services may be human patients, non-human living subjects or non-living materials such as water, surfaces, medical devices ... All sub-specialties of clinical and anatomic pathology latoratories are concerned, as well as all care services prone to order in vitro diagnostic services to those laboratories. A catalog of orderable services generally belongs to a specific laboratory or facility. Nonetheless, the data items used to build this catalog are of universal meaning and interest.

RIM scope

The correspondence of the new resource SpecimenDefinition with V3 can be established with the R_Specimen lite CMET (COCT_RM080200UV). The parts of this CMET, which are relevant for the proposed resource are:
- Entry point Specimen (role)
- Natural (entity playing this role)
- SpecimenContainer (role of specimen natural in a container)
- Container (entity scoping this role)
- SpecimenCollectionProcess (act whose specimen is a productOf),
- ActDefinition (the definition of the specimen collection procedure)

Resource appropriateness

The SpecimenDefinition resource represents a kind of specimen with the associated set of requirements applying to the provision of specimen instances of this kind. This is a supporting resource in a catalog of orderable in vitro diagnostic services. In such a catalog, all diagnostic services that require the same kind of specimen and associated set of requirements, reference the same instance of SpecimenDefinition, which is, thus, defined and identified once in the catalog. This resource helps with the creation and maintenance of the catalog: When defining or updating the definition of an in vitro diagnostic service in the catalog, one does not need to express again all the detailed properties and associated requirements of the kind of specimen needed by this service. Instead, one searches for the appropriate kind of specimen defined in the catalog, and references it.

The goal of catalogs of orderable diagnostic services is to provide guidance to clinicians for ordering these services, and to specimen collectors for obtaining and delivering the specimens needed for the execution of these services.

The exchange of catalogs is standardized in V2 by a set of Master Files messages (chapter 8), further refined by implementation guides such as the eDOS implementation guide for the US realm, and the IHE LCSD profile for the UV realm. The #1010 project of O&O, among other things, transposes these specifications into the FHIR standard.

Expected implementations

  • Cognitive Medical Systems, Inc
  • Intermountain Healthcare
  • Phast

Content sources

The main source of specifications is represented by:

  • HL7 v2.8.2 and >, chapter 8 "Master files", segment OM4, message structures MFN^M08 & MFN^M10 ;
  • The electronic Directory of Services (eDOS) implementation guide constraining these message structures for the US realm ;
  • The IHE Laboratory Code Set Distribution (LCSD) profile doing the same for the UV realm, however based on HL7 2.5 and 12 years old.

Example Scenarios

  • CPOE of a healthcare institution deriving the specimen collection plan from a set of test orders placed to a laboratory.
  • Ambulatory phlebotomists checking which specimens are expected for the test orders related to their patients.

Resource Relationships

The SpecimenDefinition resource is referenced by the resource CatalogEntry, when it carries the definition of an in vitro diagnostic testing activity.

The SpecimenDefinition resource is referenced by the Catalog resource, which represents a whole catalog, to enable the creation and maintenance of kinds of specimens within a catalog of orderable diagnostic services.

The SpecimenDefinition resource references the Substance resource, in order to describe the type of substance (body fluid, other material) concerned by a kind of specimen. It also references the Substance resource to describe additives to be used in the production of specimens of some kind.

Timelines

The Ordering Service Interface Specification Project (#1010) is aiming at the September 2017 ballot.

gForge Users

N/A: Identified contributors already have a gForge account.

When Resource Proposal Is Complete

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

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