C.26 Substance Administration Modules
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## C.26 Substance Administration Modules

### C.26.1 Product Characteristics Module

Table C.26-1 specifies the Attributes used to convey the characteristics or parameters of a contrast agent, drug, or device.

Table C.26-1. Product Characteristics Module Attributes

Attribute Name | Tag | Attribute Description
--- | --- | ---
Product Package Identifier | (0044,0001) | Identifier of the contrast agent, drug, or device being characterized, typically from a package bar code, RFID, or other materials management ID. This ID might not be globally unique and might conflict with other IDs used within the scope of the institution.
Manufacturer | (0008,0070) | Manufacturer of product.
Product Type Code Sequence | (0044,0007) | Coded type of product. Only a single Item shall be included in this sequence.
>Include Table 8.8-1 “Code Sequence Macro Attributes” | For drugs, a coded terminology in the US is RxNorm For devices, a coded terminology in the US is the FDA CDRH Product Code Classification
Product Name | (0044,0008) | Trade or generic name of product. ### Note May be multi-valued.
Product Description | (0044,0009) | Further description in free form text describing the drug or device. ### Note This attribute is limited by the LT Value Representation to 10240 characters. Larger text descriptions, or graphical descriptions, may be referenced in the Pertinent Documents Sequence (0038,0100).
Product Lot Identifier | (0044,000A) | Identifier of the manufacturing batch of which this product is part.
Product Expiration DateTime | (0044,000B) | The date and time after which the manufacturer no longer ensures the safety, quality, and/or proper functioning of the material.
Product Parameter Sequence | (0044,0013) | Parameters of the product. Zero or more Items shall be included in this sequence.
>Include Table 10-2 “Content Item Macro Attributes Description” | For drugs or contrast agents, for Concept Name Code Sequence, Baseline CID 4050 “Drug Or Contrast Agent Characteristics” For devices, for Concept Name Code Sequence, Baseline CID 3423 “Numeric Device Characteristics”
Pertinent Documents Sequence | (0038,0100) | Reference to a Product Label document for the product. Zero or more Items shall be included in this sequence.
>Referenced SOP Class UID | (0008,1150) | Unique identifier for the class of an HL7 Structured Product Label document.
>Referenced SOP Instance UID | (0008,1155) | Unique identifier for the HL7 Structured Product Label Document as used in DICOM instance references (see Section C.12.1.1.6)
>HL7 Instance Identifier | (0040,E001) | Instance Identifier of the referenced HL7 Structured Document, encoded as a UID (OID or UUID), concatenated with a caret ("^") and Extension value (if Extension is present in Instance Identifier).
>Retrieve URI | (0040,E010) | Retrieval access path to Product Label Document. Includes fully specified scheme, authority, path, and query in accordance with [RFC 3986] ### Note The VR of this attribute has changed from UT to UR.

### C.26.2 Substance Approval Module

Table C.26-2 specifies the Attributes used to approve the administration of a contrast agent, drug, or device to a patient.

Table C.26-2. Substance Approval Module Attributes

Attribute Name | Tag | Attribute Description
--- | --- | ---
Substance Administration Approval | (0044,0002) | Status of request for substance administration. Enumerated Values: APPROVED Use of the substance for the patient is approved, with related notes (e.g., appropriate dose for age/weight) in Approval Status Further Description (0044,0003) WARNING The substance may be used for the patient subject to warnings described in Approval Status Further Description (0044,0003) CONTRA_INDICATED The substance should not be used for the patient for the reasons described in Approval Status Further Description (0044,0003)
Approval Status Further Description | (0044,0003) | Description of warning or contra-indication, or notes on approval.
Approval Status DateTime | (0044,0004) | Timestamp for the Substance Administration Approval response

### C.26.3 Substance Administration Module

Table C.26-3 specifies the Attributes used to describe the act of administration of a contrast agent, drug, or device to a patient.

Table C.26-3. Substance Administration Module Attributes

Attribute Name | Tag | Attribute Description
--- | --- | ---
Administration Route Code Sequence | (0054,0302) | Route of administration for drug or contrast. Only a single Item shall be included in this Sequence.
>Include Table 8.8-1 “Code Sequence Macro Attributes” | Baseline CID 11 “Route of Administration”.

### C.26.4 Substance Administration Log Module

Table C.26-4 specifies the Attributes used to record the act of administration of a contrast agent, drug, or device to a patient.

Table C.26-4. Substance Administration Log Module Attributes

Attribute Name | Tag | Attribute Description
--- | --- | ---
Patient's Name | (0010,0010) | Patient's full name
Patient ID | (0010,0020) | Primary identification number or code for the patient.
Include Table 10-18 “Issuer of Patient ID Macro Attributes” |
Admission ID | (0038,0010) | Identification number of the visit as assigned by the healthcare provider
Issuer of Admission ID Sequence | (0038,0014) | Identifier of the Assigning Authority that issued the Admission ID. Only a single Item shall be included in this sequence.
>Include Table 10-17 “HL7v2 Hierarchic Designator Macro Attributes” |
Product Package Identifier | (0044,0001) | Identifier of the contrast agent, drug, or device administered, typically from a package bar code, RFID, or other materials management ID. This ID might not be globally unique and might conflict with other IDs used within the scope of the institution.
Product Name | (0044,0008) | Trade or generic name of product. ### Note May be multi-valued.
Product Description | (0044,0009) | Text description of the contrast agent, drug, or device administered.
Substance Administration DateTime | (0044,0010) | Date and Time of Substance Administration
Substance Administration Notes | (0044,0011) | Comments provided by the operator responsible for the substance administration.
Substance Administration Device ID | (0044,0012) | Identifier for a device that controls substance administration, e.g., injector, infusion pump, etc.
Administration Route Code Sequence | (0054,0302) | Route of administration for drug or contrast. Only a single Item shall be included in this Sequence.
>Include Table 8.8-1 “Code Sequence Macro Attributes” | Baseline CID 11 “Route of Administration”.
Substance Administration Parameter Sequence | (0044,0019) | Parameters of the substance as administered to the patient, e.g., volume, quantity. Zero or more Items shall be included in this sequence.
>Include Table 10-2 “Content Item Macro Attributes Description” | For administration of drugs or contrast agents, Baseline Context Group for Concept Name Code Sequence is CID 3410 “Numeric Parameters of Drugs/Contrast”.
Operator Identification Sequence | (0008,1072) | Person administering the substance to the patient, or legally responsible for the administration, and authorized to add an entry to the Medication Administration Record. One or more Items shall be included in this Sequence.
>Person Identification Code Sequence | (0040,1101) | Coded identifier of the person administering the contrast agent, drug, or device. Only a single Item shall be included in this Sequence.
>>Include Table 8.8-1 “Code Sequence Macro Attributes” | No Baseline CID is defined. The Coding Scheme Designator attribute may indicate a local coding scheme (e.g., with value "L") when it is implicitly that of the institution's employee identifier system. The Code Meaning attribute, though it is encoded with a VR of LO, may be encoded according to the rules of the PN VR (see Section 10.1).

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