Annex V SUBSTANCE ADMINISTRATION QUERY SERVICE CLASS (Normative)

V.1 Overview

V.1.1 Scope

The Substance Administration Query Service Class defines an application-level class-of-service that facilitates obtaining detailed information about substances or devices used in imaging, image-guided treatment, and related procedures. It also facilitates obtaining approval for the administration of a specific contrast agent or drug to a specific patient.

This Service Class is intended as part of a larger workflow that addresses patient safety in the imaging environment. This Service addresses only the communication protocol that allows a point of care device (imaging modality) to interrogate an SCP Application for information about an administered substance, or for verification of appropriateness of the substance for the patient. The SCP Application uses patient safety related data, such as allergies, current medications, appropriate dosages, patient condition indicated by lab results, etc., to respond to the queries; however, the mechanism of such use is beyond the scope of this Standard. How the point of care device uses the responses to the queries, e.g., by display to a user, or by locking of certain device functions, is also beyond the scope of this Standard.

Notes: 1. The SCP of this Service Class is not necessarily a clinical decision support (CDS) system, but may be a gateway system between this DICOM Service and an HL7 or proprietary interface of a CDS system. Such implementation design is beyond the scope of the DICOM standard.

2. The Service will result in a Query response containing zero or one items. However, to facilitate implementation, the Service uses the general query mechanism supporting multiple item responses, as used in other DICOM query service classes.

V.1.2 Conventions

Key Attributes serve two purposes; they may be used as Matching Key Attributes and Return Key Attributes. Matching Key Attributes may be used for matching (criteria to be used in the C-FIND request to determine whether an entity matches the query). Return Key Attributes may be used to specify desired return Attributes (what elements in addition to the Matching Key Attributes have to be returned in the C-FIND response).

Matching Key Attributes may be of Type "required" (R) or "optional" (O). Return Key Attributes may be of Type 1, 1C, 2, 2C, 3 as defined in PS 3.5.

V.1.3 Substance Administration Query Information Model

In order to serve as a Service Class Provider (SCP) of the Substance Administration Query Service Class, a DICOM Application Entity (AE) must be able to return information about the Attributes of a substance, device, or a substance administration act. This information is organized into well defined Substance Administration Query Information Models.

A specific SOP Class of the Substance Administration Query Service Class consists of an informative Overview, an Information Model Definition and a DIMSE-C Service Group. In this Service Class, the Information Model plays a role similar to an Information Object Definition (IOD) of other DICOM Service Classes.

V.1.4 Service Definition

Two peer DICOM AEs implement a SOP Class of the Substance Administration Query Service Class with one serving in the SCU role and one serving in the SCP role. SOP Classes of the Substance Administration Query Service Class are implemented using the DIMSE-C C-FIND service as defined in PS 3.7.

Only a baseline behavior of the DIMSE-C C-FIND is used in the Service Class. Extended negotiation is not used.

The following description of the DIMSE-C C-FIND service provides a brief overview of the SCU/SCP semantics.

A C-FIND service conveys the following semantics:

— The SCU requests that the SCP perform a match for the Matching Keys and return values for the Return Keys that have been specified in the Identifier of the request, against the information that the SCP possesses relating to the Information Model specified in the SOP Class.

Note: In this Annex, the term "Identifier" refers to the Identifier service parameter of the C-FIND service as defined in PS 3.7.

— The SCP generates at most one C-FIND response for a match with an Identifier containing the values of all Matching Key Attributes and all known Return Key Attributes requested. This response shall contain a status of Pending.

— When the process of matching is complete, with zero or one match, a C-FIND response is sent with a status of Success and no Identifier.

— A Failure response to a C-FIND request indicates that the SCP is unable to process the request.

— The SCU may cancel the C-FIND service by issuing a C-CANCEL-FIND request at any time during the processing of the C-FIND service. The SCP will interrupt all matching and return a status of Canceled.

Note: The SCU needs to be prepared to receive C-FIND responses sent by the SCP until the SCP finally processed the C-CANCEL-FIND request.

V.2 Substance Administration Query Information Model Definition

The Substance Administration Query Information Model is identified by the SOP Class negotiated at Association establishment time. The SOP Class is composed of both an Information Model and a DIMSE-C Service Group.

Information Model Definitions for standard SOP Classes of the Substance Administration Query Service Class are defined in this Annex. A Substance Administration Query Information Model Definition contains:

— an Entity-Relationship Model Definition

— a Key Attributes Definition.

V.2.1 Entity-Relationship Model Definition

Substance Administration Query Information Models consist of a single level that includes all Matching Key Attributes and all Return Key Attributes that may be sent from the SCU to the SCP in the request, and whose values are expected to be returned from the SCP to the SCU in the response (or Query items). The Matching Key Attribute values in the request specify the Query items that are to be returned in the response. All Key Attributes (the Matching Key Attributes and the Return Key Attributes) in the request determine which Attribute values are returned in the response for that Query.

V.2.2 Attributes Definition

Attributes are defined for each entity in the internal Entity-Relationship Model. An Identifier in a C-FIND request shall contain values to be matched against the Attributes of the Entities in a Substance Administration Query Information Model. For any Query request, the set of entities for which Attributes are returned shall be determined by the set of Matching and Return Key Attributes specified in the Identifier.

V.2.2.1 Attribute Types

All Attributes of entities in a Substance Administration Query Information Model shall be specified both as a Matching Key Attribute (either required or optional) and as a Return Key Attribute.

V.2.2.1.1 Matching Key Attributes

The Matching Key Attributes are Keys, which select Query items to be included in a requested Query.

V.2.2.1.1.1 Required Matching Key Attributes

A Substance Administration Query Service SCP shall support matching based on values of all Required Matching Key Attributes of the C-FIND request.

V.2.2.1.1.2 Optional Matching Key Attributes

In the Substance Administration Query Information Model, a set of Attributes may be defined as Optional Matching Key Attributes. Optional Matching Key Attributes contained in the Identifier of a C-FIND request may induce two different types of behavior depending on support for matching by the SCP. If the SCP

— does not support matching on the Optional Matching Key Attribute, then the Optional Matching Key Attribute shall be ignored for matching but shall be processed in the same manner as a Return Key Attribute.

— supports matching of the Optional Matching Key Attribute, then the Optional Matching Key Attribute shall be processed in the same manner as a Required Matching Key.

Notes: 1. The Conformance Statement of the SCP lists the Optional Matching Key Attributes that are supported for matching.

2. An SCU can not expect the SCP to support a match on an Optional Matching Key.

V.2.2.1.2 Return Key Attributes

The values of Return Key Attributes to be retrieved with the Query are specified with zero-length (universal matching) in the C-FIND request. SCPs shall support Return Key Attributes defined by a Substance Administration Query Information Model according to the Data Element Type (1, 1C, 2, 2C, 3) as defined in PS 3.5.

Every Matching Key Attribute shall also be considered as a Return Key Attribute. Therefore the C-FIND response shall contain, in addition to the values of the requested Return Key Attributes, the values of the requested Matching Key Attributes.

Notes: 1 The Conformance Statement of the SCP lists the Return Key Attributes of Type 3 that are supported.

2. An SCU may choose to supply any subset of Return Key Attributes.

3. An SCU can not expect to receive any Type 3 Return Key Attributes.

4. Return Key attributes with VR of SQ may be specified either with zero-length, or with a zero-length item in the sequence.

V.2.2.2 Attribute Matching

The following types of matching, which are defined by the Query/Retrieve Service Class in Annex C, may be performed on Matching Key Attributes in the Substance Administration Query Service Class. Different Matching Key Attributes may be subject for different matching types. The Substance Administration Query Information Model defines the type of matching for each Required Matching Key Attribute. The Conformance Statement of the SCP shall define the type of matching for each Optional Matching Key Attribute. The types of matching are:

— Single Value Matching

— Sequence Matching

The following type of matching, which is defined by the Query/Retrieve Service Class in Annex C of this Part, shall be performed on Return Key Attributes in the Substance Administration Query Service Class.

— Universal Matching

See Section C.2.2.2 and subsections for specific rules governing of Matching Key Attribute encoding for and performing of different types of matching.

The Specific Character Set (0008,0005) Attribute may be present in the Identifier but is never matched, i.e., it is not considered a Matching Key Attribute. See Section C.2.2.2 for details.

V.3 Query Information ModelS

Each Substance Administration Query Information Model is associated with one SOP Class. The following Substance Administration Query Information Models are defined:

V.4 DIMSE-C Service Group

One DIMSE-C Service is used in the construction of SOP Classes of the Substance Administration Query Service Class. The following DIMSE-C operation is used.

— C-FIND

V.4.1 C-FIND Operation

SCPs of SOP Classes of the Substance Administration Query Service Class are capable of processing queries using the C-FIND operation as described in PS 3.7. The C-FIND operation is the mechanism by which queries are performed. Matches against the keys present in the Identifier are returned in C-FIND responses.

V.4.1.1 C-FIND Service Parameters

V.4.1.1.1 SOP Class UID

The SOP Class UID identifies the Substance Administration Query Information Model against which the C-FIND is to be performed. Support for the SOP Class UID is implied by the Abstract Syntax UID of the Presentation Context used by this C-FIND operation.

V.4.1.1.2 Priority

The Priority Attribute defines the requested priority of the C-FIND operation with respect to other DIMSE operations being performed by the same SCP.

Processing of priority requests is not required of SCPs. Whether or not an SCP supports priority processing and the meaning of the different priority levels shall be stated in the Conformance Statement of the SCP.

V.4.1.1.3 Identifier

Both the C-FIND request and response contain an Identifier encoded as a Data Set (see PS 3.5).

V.4.1.1.3.1 Request Identifier Structure

An Identifier in a C-FIND request shall contain

— Key Attributes values to be matched against the values of Attributes specified in that SOP Class.

— Conditionally, the Attribute Specific Character Set (0008,0005). This Attribute shall be included if expanded or replacement character sets may be used in any of the Attributes in the Request Identifier. It shall not be included otherwise.

Note: This means that Specific Character Set (0008,0005) is included if the SCU supports expanded or replacement character sets in the context of this service. It will not be included if expanded or replacement character sets are not supported by the SCU.

The Key Attributes and values allowable for the query shall be defined in the SOP Class definition for the corresponding Substance Administration Query Information Model.

V.4.1.1.3.2 Response Identifier Structure

The C-FIND response shall not contain Attributes that were not in the request or specified in this section.

An Identifier in a C-FIND response shall contain:

— Key Attributes with values corresponding to Key Attributes contained in the Identifier of the request (Key Attributes as defined in V.2.2.1.)

— Conditionally, the Attribute Specific Character Set (0008,0005). This Attribute shall be included if expanded or replacement character sets may be used in any of the Attributes in the Response Identifier. It shall not be included otherwise. The C-FIND SCP is not required to return responses in the Specific Character Set requested by the SCU if that character set is not supported by the SCP. The SCP may return responses with a different Specific Character Set.

Note: This means that Specific Character Set (0008,0005) is included if the SCP supports expanded or replacement character sets in the context of this service. It will not be included if expanded or replacement character sets are not supported by the SCP.

— Conditionally, the Attribute HL7 Structured Document Reference Sequence (0040,A390) and its subsidiary Sequence Items as specified in the SOP Common Module (see PS3.3). This Attribute shall be included if HL7 Structured Documents are referenced within the Identifier, e.g., in the Pertinent Documents Sequence (0038,0100).

V.4.1.1.4 Status

Table V.4.-1 defines the status code values that might be returned in a C-FIND response. Fields related to status code values are defined in PS 3.7.

Table V.4-1C-FIND RESPONSE STATUS VALUES

Service Status Further Meaning Status Codes Related Fields
Failure Refused: Out of Resources A700 (0000,0902)
Identifier Does Not Match SOP Class A900 (0000,0901) (0000,0902)
Unable to process Cxxx (values C000 through CFFF as assigned by the implementation) (0000,0901) (0000,0902)
Cancel Matching terminated due to Cancel request FE00 None
Success Matching is complete - No final Identifier is supplied. 0000 None
Pending Matches are continuing - Current Match is supplied and any Optional Keys were supported in the same manner as Required Keys. FF00 Identifier
Matches are continuing - Warning that one or more Optional Keys were not supported for existence for this Identifier. FF01 Identifier

Note: Status Codes are returned in DIMSE response messages (See PS 3.7). The code values stated in column "Status Codes" are returned in Status Command Element (0000,0900).

V.4.1.2 C-FIND SCU Behavior

All C-FIND SCUs shall be capable of generating query requests that meet the requirements of the Query Search Method (see V.4.1.3.1).

Required Keys and Optional Keys associated with the Query may be contained in the Identifier.

An SCU conveys the following semantics using the C-FIND requests and responses:

— The SCU requests that the SCP perform a match of all keys specified in the Identifier of the request against the information it possesses of the Query specified in the request.

— The SCU shall interpret Pending responses to convey the Attributes of a match of an item.

— The SCU shall interpret a response with a status equal to Success, Failure, or Cancel to convey the end of Pending responses.

— The SCU shall interpret a Failure response to a C-FIND request as an indication that the SCP is unable to process the request.

— The SCU may cancel the C-FIND service by issuing a C-FIND-CANCEL request at any time during the processing of the C-FIND. The SCU shall recognize a status of Cancel to indicate that the C-FIND-CANCEL was successful.

V.4.1.3 C-FIND SCP Behavior

All C-FIND SCPs shall be capable of processing queries that meet the requirements of the Query Search (see V.4.1.3.1).

An SCP conveys the following semantics using the C-FIND requests and responses:

— The SCP is requested to perform a match of all the keys specified in the Identifier of the request, against the information it possesses. Attribute matching is performed using the key values specified in the Identifier of the C-FIND request as defined in Section V.2.

— The SCP generates at most one C-FIND response for a match using the "Query" Search method. Such a response shall contain an Identifier whose Attributes contain values from the match. The response shall contain a status of Pending.

— When matching is complete and any match has been sent, the SCP generates a C-FIND response that contains a status of Success. A status of Success shall indicate that a response has been sent for any match known to the SCP.

Notes: 1. No Identifier is contained in a response with a status of Success. For a complete definition, see PS 3.7.

2. When there are no matches, then no responses with a status of Pending are sent, only a single response with a status of Success.

— The SCP shall generate a response with a status of Failure if it is unable to process the request. A Failure response shall contain no Identifier.

— If the SCP receives a C-FIND-CANCEL indication before it has completed the processing of the matches it shall interrupt the matching process and return a status of Cancel.

V.4.1.3.1 Query Search Method

The following procedure is used to generate matches.

The key match attributes contained in the Identifier of the C-FIND request are matched against the values of the Key Attributes for each Query entity. For each entity for which the Attributes match all of the specified match attributes, construct an Identifier. This Identifier shall contain all of the values of the Attributes for this entity that match those in the C-FIND request. Return a response for each such Identifier. If there are no matching keys, then there are no matches; return a response with a status equal to Success and with no Identifier.

V.5 Association Negotiation

Association establishment is the first phase of any instance of communication between peer DICOM AEs. The Association negotiation procedure specified in PS 3.7 shall be used to negotiate the supported SOP Classes.

Support for the SCP/SCU role selection negotiation is optional. The SOP Class Extended Negotiation is not used by this Service Class.

V.6 SOP Class Definitions

V.6.1 Product Characteristics Query SOP Class

V.6.1.1 Product Characteristics Query SOP Class Overview

The Product Characteristics Query SOP class defines an application-level class of service that facilitates the communication of detailed information about drugs, contrast agents, or devices identified by a bar code or similar identifier. The detailed information is intended to be used both for automated processing and for presentation to a system operator.

The Product Characteristics Query SOP class supports the following example use cases:

— Obtain the active ingredient, concentration, or other parameters of a contrast agent for inclusion in the image SOP Instances created during use of the agent, or for setting up image acquisition parameters (e.g., ultrasound transducer frequency)

— Obtain the size parameters of a device (e.g., a catheter) for use in calibrating images that show that device

— Obtain a network reference for an online copy of the “product label” (regulated prescribing and use data) for a drug, contrast agent, or device.

V.6.1.2 Product Characteristics Query Information Model

V.6.1.2.1 E/R Model

The Product Characteristics Query Information Model is represented by the Entity Relationship diagram shown in figure V.6 -1.

[pic]

Figure V.6-1 Product Characteristics E-R Diagram

There is only one Information Entity in the model, which is the Product. The attributes of a Product can be found in the following Module in PS 3.3.

— Product Characteristics Module

V.6.1.2.2 Product Characteristics Query Attributes

Table V.6-1 defines the Attributes of the Product Characteristics Query Information Model:

Table V.6-1ATTRIBUTES FOR THE PRODUCT CHARACTERISTICS QUERY INFORMATION MODEL

Description / Module Tag Match-ing Key Type Return Key Type Remark/Matching Type
Product Package Identifier (0044,0001) R 1 Shall be retrieved with Single Value Matching only.
Product Type Code Sequence (0044,0007) - 1
>Code Value (0008,0100) - 1
>Coding Scheme Designator (0008,0102) - 1
>Code Meaning (0008,0104) - 1
Product Name (0044,0008) - 1
Product Expiration DateTime (0044,000B) - 2
Product Parameter Sequence (0044,0013) - 2
>Value Type (0040,A040) - 1
>Concept Name Code Sequence (0040,A043) - 1
>>Code Value (0008,0100) - 1
>>Coding Scheme Designator (0008,0102) - 1
>>Code Meaning (0008,0104) - 1
>All other Attributes of Product Parameter Sequence - 1C Conditional on value of Value Type (0040,A040); See PS 3.3 Content Item Macro.
All other Attributes of Product Characteristics Module - 3

The Product Package Identifier (0044,0001) 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.

V.6.1.3 Conformance Requirements

An implementation may conform to the Product Characteristics Query SOP Class as an SCU or an SCP. The Conformance Statement shall be in the format defined in PS 3.2.

V.6.1.3.1 SCU Conformance

An implementation that conforms to the Product Characteristics Query SOP Class shall support queries against the Information Model described in Section V.6.1.2 using the baseline C-FIND SCU Behavior described in Section V.4.1.2.

An implementation that conforms to the Product Characteristics Query SOP Class as an SCU shall state in its Conformance Statement the Return Key Attributes it requests, and how those Attributes are used in the application.

An implementation that conforms to the Product Characteristics Query SOP Class as an SCU shall state in its Conformance Statement how it makes use of Specific Character Set (0008,0005) when encoding queries and interpreting responses.

V.6.1.3.2 SCP Conformance

An implementation that conforms to the Product Characteristics Query SOP Class shall support queries against the Product Characteristics Query Information Model described in Section V.6.1.2 using the C-FIND SCP Behavior described in Section V.4.1.3.

An implementation that conforms to the Product Characteristics Query SOP Class as an SCP shall state in its Conformance Statement the Return Key Attributes that it supports.

An implementation that conforms to the Product Characteristics Query SOP Class as an SCP shall state in its Conformance Statement how it makes use of Specific Character Set (0008,0005) when encoding responses.

V.6.1.4 SOP Class

The Product Characteristics Query SOP Class in the Substance Administration Service Class identifies the Product Characteristics Query Information Model, and the DIMSE-C operations supported. The following Standard SOP Class is identified:

SOP Class Name SOP Class UID
Product Characteristics Query Information Model – FIND 1.2.840.10008.5.1.4.41

V.6.2 Substance Approval Query SOP Class

V.6.2.1 Substance Approval Query SOP Class Overview

The Substance Approval Query SOP Class defines an application-level class of service that allows a device at the point of care to obtain verification of the appropriateness of contrast agents and other drugs administered during a procedure, based on the substance label barcode and the patient ID. The response is an authorization to proceed, or a warning, or a contra-indication for presentation to the system operator.

The Substance Approval Query SOP class supports the following example use cases:

— Obtain verification that administration of a specific drug or contrast agent for an image acquisition is appropriate for the patient

— Obtain verification that the implantation of a specific device under imaging guidance is appropriate for the patient

The Substance Approval Query SOP Class does not specify the mechanism used by the SCP to verify such appropriateness of administration (e.g., by comparison to allergy information in the patient’s electronic health record). The duration of validity of an approval beyond the time of the response is not defined by the Standard.

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.

[pic]

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.

V.6.2.3 Conformance Requirements

An implementation may conform to the Substance Approval Query SOP Class as an SCU or an SCP. The Conformance Statement shall be in the format defined in PS 3.2.

V.6.2.3.1 SCU Conformance

An implementation that conforms to the Substance Approval Query SOP Class shall support queries against the Information Model described in Section V.6.2.2 using the baseline C-FIND SCU Behavior described in Section V.4.1.2.

An implementation that conforms to the Substance Approval Query SOP Class as an SCU shall state in its Conformance Statement how the Query Attributes are used in the application, and how the application displays the returned attributes, in particular the values of Substance Administration Approval (0044,0002) and Approval Status Further Description (0044,0003). It shall state how it indicates a Query response with zero Pending items, or a Failure status.

An implementation that conforms to the Substance Approval Query SOP Class as an SCU shall state in its Conformance Statement how it makes use of Specific Character Set (0008,0005) when encoding queries and interpreting responses.

V.6.2.3.2 SCP Conformance

An implementation that conforms to the Substance Approval Query SOP Class shall support queries against the Substance Approval Query Information Model described in Section V.6.2.2 using the C-FIND SCP Behavior described in Section V.4.1.3. It shall support all of the Attributes specified in the Information Model.

An implementation that conforms to the Substance Approval Query SOP Class as an SCP shall state in its Conformance Statement how it processes Required and Optional Matching Key Attributes. It shall state how it obtains the values for the Return Key Attributes.

An implementation that conforms to the Substance Approval Query SOP Class as an SCP shall state in its Conformance Statement how it makes use of Specific Character Set (0008,0005) when interpreting queries, performing matching and encoding responses.

V.6.2.4 SOP Class

The Substance Approval Query SOP Class in the Substance Administration Service Class identifies the Substance Approval Query Information Model, and the DIMSE-C operations supported. The following Standard SOP Class is identified:

SOP Class Name SOP Class UID
Substance Approval Query Information Model - FIND 1.2.840.10008.5.1.4.42