P.3 Substance Administration Logging SOP Class Definition

The Substance Administration Logging SOP Class allows an SCU to report to an SCP the events that are to be recorded in a patient’s Medication Administration Record (MAR) or similar log, whose definition is outside the scope of the Standard. This allows devices with DICOM protocol interfaces to report administration of diagnostic agents (including contrast) and therapeutic drugs, and implantation of devices.

The Substance Administration reported through this SOP Class is related to the MAR by Patient ID or Admission ID. The mechanism by which the SCU obtains this identifier is not defined by this SOP Class.

The log entry to the MAR is authorized by at least one of the Operators identified in the Operator Identification Sequence. The mechanism by which the SCU obtains these identifiers is not defined by this SOP Class. The SCP may refuse the log entry if none of the identified Operators is authorized to add entries to the MAR. The mechanism by which the SCP validates such authorization is not defined by this SOP Class.

Notes: 1. The SCP of this Service Class is not necessarily the Medication Administration Record system, but may be a gateway system between this DICOM Service and an HL7 or proprietary interface of a MAR system. Such implementation design is beyond the scope of the DICOM standard.

2. This SOP Class is not limited to only specifying medications, although the conventional name of the destination log is the Medication Administration Record. The SOP Class may also be used to record the implantation of therapeutic devices, including both drug-eluting and bare stents, prosthetic and cardiovascular devices, implantable infusion pumps, etc.

3. The application level authorization of Operators for the purpose of logging a MAR entry is distinct from any access control mechanism at the transport layer (see User Identity Association profiles in PS3.15).

P.3.1 DIMSE Service Group

The DIMSE-N Services applicable to the Substance Administration Logging SOP Class are shown in Table P.3-1.

Table P.3-1 DIMSE SERVICE GROUP

DIMSE Service Element Usage SCU/SCP
N-ACTION M/M

The DIMSE-N Services and Protocol are specified in PS 3.7.

P.3.2 Operation

The DICOM AEs that claim conformance to this SOP Class as an SCU shall invoke the N-ACTION request. The DICOM AEs that claim conformance to this SOP Class as an SCP shall support the N-ACTION request.

P.3.2.1 Substance Administration Log Action Information

This operation allows an SCU to submit a Medication Administration Record log item or entry, providing information about a specific real-world act of Substance Administration that is the purview of the SCU. This operation shall be invoked through the DIMSE N-ACTION Service.

The Action Information attributes are defined by the Substance Administration Log Module specified in PS3.3. The DICOM AEs that claim conformance to this SOP Class as an SCU and/or an SCP shall support the Action Type and Action Information Attributes in the N-ACTION-RQ as specified in Table P.3-2.

Table P.3-2SUBSTANCE ADMINISTRATION LOGGING N-ACTION INFORMATION

Action Type Name Action Type ID Attribute Tag Requirement Type SCU/SCP
Record Substance Administration Event 1 Specific Character Set (0008,0005) 1C/1C (Required if an extended or replacement character set is used)
Patient ID (0010,0020) 1C/1C Either or both Patient ID and Admission ID shall be supplied by the SCU; the SCP shall support the attribute if supplied
Issuer of Patient ID (0010,0021) 3/2
Patient’s Name (0010,0010) 2/2
Admission ID (0038,0010) 1C/1C Either or both Patient ID and Admission ID shall be supplied by the SCU; the SCP shall support the attribute if supplied
Issuer of Admission ID (0038,0011) 3/2
Product Package Identifier (0044,0001) 1C/1C Either or both Product Package Identifier and Product Name shall be supplied by the SCU; the SCP shall support the attribute if supplied
Product Name (0044,0008) 1C/1C Either or both Product Package Identifier and Product Name shall be supplied by the SCU; the SCP shall support the attribute if supplied
Product Description (0044,0009) 3/3
Substance Administration DateTime (0044,0010) 1/1
Substance Administration Notes (0044,0011) 3/2
Substance Administration Device ID (0044,0012) 3/3
Administration Route Code Sequence (0054,0302) 2/2
>Code Value (0008,0100) 1/1
>Coding Scheme Designator (0008,0102) 1/1
>Code Meaning (0008,0104) 1/1
Substance Administration Parameter Sequence (0044,0019) 3/3
>All attributes of the Substance Administration Parameter Sequence 3/3
Operator Identification Sequence (0008,1072) 1/1
>Person Identification Code Sequence (0040,1101) 1/1
>>Code Value (0008,0100) 1/1
>>Coding Scheme Designator (0008,0102) 1/1
>>Code Meaning (0008,0104) 1/1

P.3.2.2 Service Class User Behavior

The SCU shall request logging of substance administration events for a specified Patient using the N-ACTION request primitive.

The SCU shall receive N-ACTION responses. The actions taken upon a response status of Failure, or upon non-response of the SCP, are implementation dependent.

P.3.2.3 Service Class Provider Behavior

The SCP shall receive, via the N-ACTION request primitive, requests for logging of substance administration events. The SCP shall incorporate those event records into a Medication Administration Record or similar log for the specified Patient.

Note: The patient’s identify may be conveyed explicitly by Patient ID (0010,0020), or implicitly by Admission (i.e., Visit) ID (0038,0010). An institution may typically chose one or the other to use as the primary patient identifier at the point of care, e.g., printed on a bar coded wristband, the use of which may facilitate data entry for the log entry. However, 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 (0038,0010) may only be unique within the context of the patient, not within the context of the institution. The use of the Admission ID (0038,0010) Attribute to identify the Patient is only effective if the Admission ID (0038,0010) is unique within the context of the institution.

The SCP shall support inclusion into the Medication Administration Record or similar log of values of all Type 1 and Type 2 Attributes for which the SCU has provided values. The SCP may convert these attributes into a form appropriate for the destination log.

Note: The SCP may convert coded data to free text in the log, with loss of the specific code values, if the log does not support such coded data.

The SCP shall return, via the N-ACTION response primitive, the N-ACTION Response Status Code applicable to the associated action request.

P.3.2.4 Status Codes

The Service Class specific status values defined for the N-ACTION Service are specified in Table P.3-3. See PS 3.7 for additional general response status codes.

Table P.3-3RESPONSE STATUS

Service Status Response Status Code Further Meaning
Success 0000
Failure C10E Operator not authorized to add entry to Medication Administration Record
C110 Patient cannot be identified from Patient ID (0010,0020)or Admission ID (0038,0010)
C111 Update of Medication Administration Record failed

P.3.3 Substance Administration Logging SOP Class UID

The Substance Administration Logging SOP Class shall be uniquely identified by the Substance Administration Logging SOP Class UID, which shall have the value "1.2.840.10008.1.42".

P.3.4 Substance Administration Logging Instance UID

The well-known UID of the Substance Administration Logging SOP Instance shall have the value "1.2.840.10008.1.42.1".

P.3.5 Conformance Requirements

The DICOM AE's Conformance Statement shall be formatted as defined in PS 3.2.

P.3.5.1 SCU Conformance

The SCU shall document in its Conformance Statement the behavior and actions that cause the SCU to generate an N-ACTION-RQ primitive.

The SCU shall document how it obtains the Patient ID (0010,0020) or Admission ID (0038,0010) attribute (e.g., through a Modality Worklist query, bar-code scan, manual entry, etc.).

The SCU shall document the behavior and actions performed when a success or failure status is received.

P.3.5.2 SCP Conformance

The SCP shall document in its Conformance Statement how it uses the information it receives for adding data to a Medication Administration Record.

The SCP shall document the behavior and actions that cause the SCP to generate a success or failure status for a received N-ACTION-RQ.