V.6.2.2 Substance Approval Query Information Model

V.6.2.2.1 E/R Model

The Substance Approval Query Information Model is represented by the Entity Relationship diagram shown in figure V.6-2.

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Figure V.6-2 Substance Approval E-R Diagram

The attributes of the Information Entities can be found in the following Modules in PS 3.3.

— Patient Identification Module

— Patient Demographics Module

— Visit Identification Module

— Substance Administration Module

— Substance Approval Module

— Product Characteristics Module

Only selected attributes of these Modules are used in the Substance Approval Query Information Model.

The Information Model is used in a bottom-up manner in the query; i.e., given a Product and a Patient, or alternatively a Product and a Visit, for a proposed Substance Administration act at the current time, find the Approval.

The Visit IE is included in the Information Model to support those institutions that identify patients (e.g., on a bar coded wristband) by Admission ID (i.e., the ID of the Visit), rather than Patient ID. This allows automation of query construction using a scan of the Admission ID. The Admission ID can be mapped to the Patient ID by the SCP for the purpose of the performing the query matching.

Notes: 1. The Visit is identified by the Admission ID (0038,0010) Attribute, but in the “Model of the Real World for the Purpose of Modality-IS Interface” (see PS 3.3), the Visit is subsidiary to the Patient; hence the Admission ID may only be unique within the context of the patient, not within the context of the institution. The use of the Admission ID Attribute to identify the Visit (and hence the Patient) is only effective if the Admission ID is unique within the context of the institution.

2. Certain institutions, e.g., ambulatory imaging centers that do not “admit” patients, may use the Imaging Service Request Identifier, or Accession Number, as an equivalent of the Admission ID. The SCU of this Query Service does not need to know the true origin or nature of the identifier, only that it is passed in the Query in the Admission ID (0038,0010) Attribute.

3. There is conceptually a datetime of administration attribute of the Substance Administration act, which is implicitly assumed to be approximately the time of the query in this SOP Class.

4. There is conceptually a dose attribute of the Product entity, which is the entire product identified by the bar code, and the request is for approval of administration of the entire product.

V.6.2.2.2 Substance Approval Query Attributes

Table V.6-2 defines the Attributes of the Substance Approval Query Information Model.

Table V.6-2ATTRIBUTES FOR THE SUBSTANCE APPROVAL QUERY INFORMATION MODEL

Description / Module Tag Match-ing Key Type Return Key Type Remark/Matching Type
Patient
Patient’s Name (0010,0010) O 2
Patient ID (0010,0020) R 1 Shall be retrieved with Single Value Matching only. One or both of Patient ID (0010,0020) and Admission ID (0038,0010) shall be present as a Matching Key in the Query
Issuer of Patient ID (0010,0021) O 2
Issuer of Patient ID Qualifiers Sequence (0010,0024) O 3
>All attributes of the Issuer of Patient ID Qualifiers Sequence O 3
Patient’s Birth Date (0010,0030) - 2
Patient's Sex (0010,0040) - 2
Visit
Admission ID (0038,0010) R 2 Shall be retrieved with Single Value Matching only. One or both of Patient ID (0010,0020) and Admission ID (0038,0010) shall be present as a Matching Key in the Query
Issuer of Admission ID Sequence (0038,0014) O 3
>Local Namespace Entity ID (0040,0031) O 1C Required if Universal Entity ID (0040,0032) is not present; may be present otherwise
>Universal Entity ID (0040,0032) O 1C Required if Local Namespace Entity ID (0040,0031) is not present; may be present otherwise.
>Universal Entity ID Type (0040,0033) O 1C Required if Universal Entity ID (0040,0032) is present.
Product
Product Package Identifier (0044,0001) R 1 Shall be retrieved with Single Value Matching only. Shall be present as a Matching Key in the Query.
Substance Administration
Administration Route Code Sequence (0054,0302) R 1 Shall be present as a Matching Key in the Query.
>Code Value (0008,0100) R 1
>Coding Scheme Designator (0008,0102) R 1
>Code Meaning (0008,0104) - 1
Approval
Substance Administration Approval (0044,0002) - 1
Approval Status Further Description (0044,0003) - 2
Approval Status DateTime (0044,0004) - 1

One or both of Patient ID (0010,0020) and Admission ID (0038,0010) shall be present as a Matching Key in the Query.

Product Package Identifier (0044,0001) shall be present as a Matching Key in the Query. The Product Package Identifier might not be globally unique and might conflict with other identifiers used within the scope of the institution.

Note: The package identifiers are typically unique within the scope of the substance administration management systems. This is a warning that they are not UIDs.

Administration Route Code Sequence (0054,0302) shall be present as a Matching Key in the Query, and a single Item shall be present in that Sequence with Code Value (0008,0100) and Coding Scheme Designator (0008,0102) as Matching Keys.

V.6.2.2.3 Substance Approval Query Responses

A Query response may have a status of Success or Failure (see V.4.1.1.4). A Failure Query response carries no semantics about the existence or status of approval of the Substance Administration.

A successful Query response will contain zero or one Pending response items. The case of zero Pending responses carries the semantics of no matching Approval Information Entity found, i.e., that the SCP cannot determine an approval, rather than that the substance administration is approved or disapproved. In this case a decision on substance administration needs to be made by the healthcare provider.

Note: Zero Pending responses may occur due do inability of the SCP to match the patient ID, product ID or route of administration.

In the case of one Pending response, the matching Approval Information Entity will explicitly convey the Substance Administration Approval (0044,0002) value of APPROVED, WARNING, or CONTRA_INDICATED.