Digital Imaging and Communications in Medicine...

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Digital Imaging and Communications in Medicine (DICOM)

Supplement 164: Substance Administration Report

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DICOM Standards Committee, Working Group 6 (Base Standard) Ad Hoc Group

1300 N. 17th Street, Suite 1752

Rosslyn, Virginia 22209 USA

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Status: Draft

VERSION: Public Comment Draft

Nov 5, 2012

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Table of Contents

Table of Contents ......................................................................................................................................... 2 DOCUMENT HISTORY ............................................................................................................................... 3 Scope and Field of Application ..................................................................................................................... 5

LIMITATIONS OF CURRENT STANDARD ........................................................................................... 5 35

TO DO ......................................................................................................................................................... 6 OPEN ISSUES ............................................................................................................................................. 6 CLOSED ISSUES ........................................................................................................................................ 7 Changes to NEMA Standards Publication PS 3.2-2011 ............................................................................... 9 Changes to NEMA Standards Publication PS 3.3-2011 ............................................................................. 10 40

A.35.X1 Planned Substance Administration SR Information Object Definition .............................. 11 A.35.X1.1 Planned Substance Administration SR Information Object Description ............... 11 A.35.X1.2 Planned Substance Administration SR IOD Entity-Relationship Model ............... 11 A.35.X1.3 Planned Substance Administration SR IOD Module Table .................................. 11

A.35.X1.3.1 Planned Substance Administration SR IOD Content Constraints11 45

A.35.X2 Performed Substance Administration SR Information Object Definition ........................... 13 A.35.X2.1 Performed Substance Administration SR Information Object Description ........... 13 A.35.X2.2 Performed Substance Administration SR IOD Entity-Relationship Model ............ 13 A.35.X2.3 Performed Substance Administration SR IOD Module Table .............................. 13

A.35.X2.3.1 Performed Substance Administration SR IOD Content Constraints50

13 A.35.X3 Basic Performed Substance Administration Information Object Definition ....................... 15

A.35.X3.1 Basic Performed Substance Administration Information Object Description .......................................................................................................................... 15 A.35.X3.2 Basic Performed Substance Administration IOD Entity-Relationship Model ........ 15 55

A.35.X3.3 Basic Performed Substance Administration IOD Module Table........................... 15 A.35.X4 Defined Substance Administration Plan SR Information Object Definition ....................... 16

A.35.X4.1 Defined Substance Administration SR Information Object Description ................ 16 A.35.X4.2 Defined Substance Administration SR IOD Entity-Relationship Model ................ 16 A.35.X4.3 Defined Substance Administration SR IOD Module Table ................................... 16 60

A.35.X4.3.1 Defined Substance Administration SR IOD Content Constraints16 C.7.3.1.1 General Series Attribute Descriptions ..................................... 17

Changes to NEMA Standards Publication PS 3.3-2011 ............................................................................. 18 B.5 STANDARD SOP CLASSES ............................................................................................... 18 I.4 MEDIA STORAGE STANDARD SOP CLASSES ................................................................ 19 65

Changes to NEMA Standards Publication PS 3.6-2011 ............................................................................. 21 Changes to NEMA Standards Publication PS 3.16-2011 ........................................................................... 23

PLANNED SUBSTANCE ADMINISTRATION SR IOD TEMPLATES .................................................. 23 TID xxxx1 Planned Substance Administration ................................................................... 24 TID xxxx2 Pre-Medication Context .................................................................................... 26 70

TID xxxx3 Patient Risk-Factor Context related to Substance Administrations ................... 26 TID xxxx5 Substance Information ...................................................................................... 27 TID xxxx6 Substance Administration Consumables .......................................................... 28 TID xxxx7 Substance Administration Delivery Plan Template ........................................... 29 TID xxxx8 Substance Administration Delivery Step Template ........................................... 31 75

TID xxxx9 Substance Administration Delivery Phase Template ........................................ 31 PERFORMED SUBSTANCE ADMINISTRATION SR IOD TEMPLATES ............................................ 32

TID xxx10 Performed Substance Administration ............................................................... 34 TID xxx11 Substance Administration Adverse Events ....................................................... 35 TID xxx12 Contrast Injector Information ............................................................................ 36 80

TID xxx14 Substance Administration Plan Template ......................................................... 36 CID 9300 Procedure Discontinuation Reasons .......................................................................... 37 CID xxxx1 Substance Administration Adverse Event Reaction List ................................... 37 CID CXX10 Intravenous Extravasation Symptoms .............................................................. 38 CID xxxx2 Temporal Periods Relating To Contrast Procedure .......................................... 38 85

CID xxxx3 Contrast Agent Injection Substance Administration Syringe Type .................... 39 CID xxxx4 Contrast Agent Substance Administration Phase Type .................................... 39 CID xxxx5 Substance Type ............................................................................................... 39 CID xxxx6 Substance Administration Consumable ............................................................ 40 CID xxxx7 Temporal Periods Relating To Procedure ......................................................... 40 90

CID xxxx8 Substance Administration Mode ....................................................................... 40 CID xxxx9 Substance Administration Related Risk-Factor Indications ............................... 41 CID xxxx10 Substance Administration Injector Head Type .................................................. 41 CID xxxx11 Substance Administration Plan Type ................................................................ 42 CID xxxx12 Pre-Medication Agents for Substance Administration ....................................... 42 95

CID xxxx13 GFR Assessment Methods ............................................................................... 43 CID xxxx14 Substance Administration Consumable Type ................................................... 43 CID xxxx15 Administration Completion Status ..................................................................... 43

Annex D DICOM Controlled Terminology Definitions (Normative) ...................................................... 44 Changes to NEMA Standards Publication PS 3.17-2011 ........................................................................... 46 100

Annex XX Substance Administration Report Template (Informative) ......................................................... 47

DOCUMENT HISTORY

Document Version

Date Content

01 2012/10/25 Initial Version

02 2013/01/22 Implemented review comments clean up template structures.

03 2013/02/04 Implemented review comments

04 2013/06/12 1. Rename “Contrast Agent Administration” to “Substance Administration”

2. Added Contrast Agent Admin. Plan SR IOD

3. Added Extravasation detail table from supplement159

4. Added Fasting Period Concept in Pre-Medication Context

05 2013/08/12 1. Renamed all concepts from “Contrast Administration” to “Substance Administration”

2. Added new “Defined” SOP Class 3. Removed Substance admin. Plan

storage (no need to have template)

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Scope and Field of Application

The supplement applies to all modalities in which radiographic, radiopharmaceutical or other agents are introduced into a circulatory system in a controlled fashion (CT, MR, XA, NM, US).

The new IODs describe administration events, flows, pressure, timings, physio-chemical attributes and pharmacological attributes of the agent administration and also consumables related to the administration. 110

These IODs do not describe radioactivity or dosimetry administered.

The Planned Substance Administration object is intended for representing the plan or program to deliver imaging agent to the patient for a study. It could be programmed at the time of schedule of a study or beginning of the study. Often, it is programmed at the power-Injector device console by the modality technician or radiologists. The plan may be altered by the delivery system or a user based on a variety of 115

factors.

The Performed Substance Administration SR is for reporting the actual plan or program that was used to deliver the diagnostic imaging agent during a medical imaging study.

The Defined Substance Administration SR is for defining generic substance administration protocols for known generic study protocols. The idea is to enable build a generic or default substance administration 120

protocols for known imaging study protocols, so as to be able to, further customize them easily. These objects are not patient specific; rather serve as a look up source for planning substance administration protocols.

In addition, the Basic Performed Substance Administration provides a summarized version of the performed substance administration. 125

This supplement defines SOP Classes and IODs for persisting and communication of information relevant to the administration of imaging agents used in medical imaging examinations. Furthermore, the supplement is constructed so as to convey planned and delivered substance administration using manual methods or automated power-injector devices.

Following are the SOP Classes defined in this supplement: 130

1. Planned Substance Administration SR Storage – SR document representing the plan of delivery of diagnostic agent for imaging.

2. Performed Substance Administration SR Storage – SR document representing what was actually delivered. 135

3. Basic Performed Substance Administration Storage – This is an attribute based class instead of a

SR document. The primary use of this class is for communicating administration data to a modality system during an imaging study. 140

4. Defined Substance Administration SR Storage – SR document representing the administration protocol plan of substance administration that is defined.

LIMITATIONS OF CURRENT STANDARD

Limited provision to record Planned Substance administration steps and detailed information 145

pertaining to the injection of the prescribed imaging agents relative to the scheduled and planned

injections. The current standard enables the encoding of some injection parameters like total substance volume, adminstration flow rates and ingredient however there is insufficient specifity in the existing IODs to enable the automated preperation of an injection device or fuller analysis of the injection steps for quality assurance and improvement activities. For instance, the collection of 150

generated pressures, flow rate vectors, multi-phased infusions, and the persistance of events that may occur during the delivery of substance (eg: flow rate limiting due to high pressures).

TO DO

2 Add “CM” part of Modality type, under Part-3 Section C.7.3.1.1.1. This is a new modality attribute value proposed, indicating a contrast agent administration.

3 Add explanatory information part of Part-17 describing Basic Performed Substance Administration SOP class

4 Add ‘fasting period’ concept part of pre-medication as patients might have to fast in case of oral contrast delivery.

5 How to add “Contrast Agent IE” into parts. What are the parts affected..? See Open Issue#5

6 Ask WG-06 on putting plan into separate SR instance.. Closed. See Closed Item#11

7 Add templates from sup-159 – patient characteristics?

8 Fasting Period concept – Explain this concept clear in Pre-medication context. Additionally, add this concept part of Contrast Admin.

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OPEN ISSUES

1 As an Infusion Manager, one who creates the Contrast Agent Admin. objects, how do we link to the related radioactivity/dosimetry objects (sup159) ? Do we share a common event UID and have it referred under use General Series module? If the answer is yes for the above question, how does one obtain the Event UID string? Ans: They are permitted to be same and how they are coordinated is out of scope of the document. If they are different, it seems tractable to find pairing on based on patient and time.

2 In relation to closed issue#1 – if we have decided to support data from radiopharmaceuticals, then what items from radiopharmaceutical template should be included? Sup159 has exhaustive details What data from supplement 159 related to radio-pharma administration needs inclusion?

3 Consider renaming Contrast Agent Administration Reporting to Substance Administration Report? Yes. This would be a replacement for Substance Administration log. Need to include substance administration approval?

Comment [SRB1]: Change to ‘IA’ from CM Done

Comment [SRB2]: Take a look at SR IE series

Comment [SRB3]: Sections A.1.2.x: add ‘Imaging Agent IE’. Also, add editorial instruction to add imaging agent to figure A.1-1 in part-3. (Need to figure out imaging agent IE to series)

Comment [SRB4]: Just refer to sup159 and template number…

Comment [SRB5]: Comment relating to Closed Issue#1

4 In a scenario when an injector is physically moved to from modality A to modality B (but still configured to modality A), how do we prevent/handle the issue of injector device sending report to the wrong destination (i.e., modality A)?

5 Design of Defined SR IOD – Add Defined Subst. Admin. IE? How does it affect ‘Contrast Agent IE’ under Basic-Performed Object change then? Should we change it to ‘Subst. Admin. IE’? Use ‘Substance Admin. IE’ in both defined and Basic sop modules. Make ‘Defined’ object using the same document IE without Patient/Study/Series IE. Add ‘Subst. Admin IE’ and use it in Basic object – See Enhanced Contrast/Bolus module attributes C.7.64b and Substance Administration module attributes

6 Should we create performed object if the agent was never administered but only attempted? Yes, Utilization of suites, inventory perspective we generate one. Make up your own StudyUID in case not if there is’nt one available. It’s up to the PACS to re-concile.

7 Work on Adverse Event Grade under adverse event template. Not a WG-06 question. We will go ahead and propose.

8 Should 7.4.2 Synchronization module be optional under Planned/Performed Substance Admin. IODs? It is mandatory in performed object, not required to add in planned object.

9 Addition of Q/R model for substance administration. Not in this supplement? Not yet – Track CT protocol storage.

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CLOSED ISSUES

1 Q: Should this supplement address the planned and delivered infusion data for radiopharmaceuticals at NM studies? A conceivable use-case is that a contrast agent administration SR object is created by a contrast dose manager containing the administered radiopharmaceutical data. This object is accessed by a radiopharma manager actor and it extracts the relevant data for population into a radiopharma administration dose report SR object. A: Yes. Look up Supplement 159 for dosimtery. This issue is closed

2 Q. It was discussed that the summary object (Basic Performed Substance Admin) could reference the detailed objects (contrast agent admin SR Objects) - Under General Series, how do we refer to detailed objects, from the summary object? A: Contrast Agent Admin SR has been eliminated. In case of such a need to refer “performed” instance, use explicit UID reference. This issue is Closed.

3 Q: In Basic Contrast Administration SOP, the series is under General Series Module C.7.3.1 What is the value for modality attribute (0008,0060)? Do we assign a new modality value? A: Yes, there will be new value for all objects.

Comment [SRB6]: EventUID – consider for every phase

4 Q: Under module table of all new SOP definitions, “Synchronization” (C.7.4.2) module is included under “Frame Of Reference” IE. This module has Frame Of Reference UID as type 1 – which may not be available to the contrast infusion manager; Do we include a new module attribute table? A: Generate new UID for “Frame of Reference UID”. This issue is Closed.

5 Q: Similar to Issue 3, The Performed Substance Admin SOP could reference scheduled SOP instance? In this case, do we include this reference under series module? A: Either put an explicit UID reference in performed object or directly look up based on the Study UID. This issue is closed.

6 Q: What is the use of Contrast Agent Administration SR? Can we instead use Key-Objection-Selection SR document for this purpose? A: Originally, when proposed, the ‘Contrast Agent Administration SR’ is designed to hold various contexts like Patient risk-factor context, pre-medication contexts, other than the ‘Scheduled’ and ‘Performed’ Contrast Agent Admin. SR objects. This issue stands closed as ‘Contrast Agent Administration SR’ is eliminated.

7 Q: Design of Basic Performed Substance IOD: Treat it as SR (KOS Style) or treat it like standard tags, which require adding a new IE (Contrast/Bolus Agent IE). A: Adding a new Contrast/Bolus Agent IE. Closed.

8 To discuss: On a multiple injection per accession-number scenario, (where the injection is aborted for some reasons and redone again, or when a test injection is delivered before a main injection, etc.) there could be simply n “performed” objects – as we are not aggregating all of them under one “performed” object. What are the workflow implications? We want to ensure this point is clearly understood and handled before we finalize this design. A: Yes. Aggregated reporting is not considered. Closed

9 Could we add concept code values indicating if the contrast agent administration was completed or aborted. (this is for quick “Yes/No” indication to help consumer know if the injection was successful or not) Secondly, if we agree for the above, how does one add it under “Enhanced Contrast/Bolus Module” (C.7.6.4b of Part-3) “Basic Contrast Agent Admin. IOD”? - Should we go ahead and extend this module? A: Yes, we could flag Completed / Terminated / User Aborted, however cannot say successful.

10 Another workflow scenario question: As the “Basic Performed Substance Admin.” object is primarily meant for sending out to modality, the infusion manager that creates this object has to accurately obtain this Study UID? – how does one ensure this works especially when the modality is “site configured” to ignore sharing Study-UID coming from the worklist-server but generate one on its own? In other words, if the “Basic Performed Substance Admin.” object has a different Study-UID from that of the images cut by the modality, what is the impact? A: Question is Out of scope.

11 Substance Admin. Plan - Separate instance or just template? It was ideated to create another SOP for ‘Substance Administration Plan’, to be referenced under planned/performed objects – however it was then decided not to go in that direction (in Jun 2013 WG-06 meeting). Instead, will add “Defined” object, which is non-patient specific similar to hanging-protocol objects.

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Changes to NEMA Standards Publication PS 3.2-2011


Part 2: Conformance 165

Item #01: Add new SOP Classes in Table A.1-2

Table A.1-2 UID VALUES

UID Value UID NAME Category

…

1.2.840.10008.5.1.4.1.1.88.X1 Planned Substance Administration SR

Transfer

1.2.840.10008.5.1.4.1.1.88.X2 Performed Substance Administration SR

Transfer

1.2.840.10008.5.1.4.1.1.88.X3 Basic Performed Substance Administration Storage

Transfer

1.2.840.10008.5.1.4.1.1.88.X4 Defined Substance Administration Storage

Transfer

…

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Part 3: Information Object Definitions 175

Item#2: Add new SR IOD of PS 3.3 A.35:

A.35.X1 Planned Substance Administration SR Information Object Definition

A.35.X1.1 Planned Substance Administration SR Information Object Description 180

The Planned Substance Administration SR IOD is used in the process of managing, protocoling, and administering contrast material to patients during contrast-enhanced medical imaging studies.

A.35.X1.2 Planned Substance Administration SR IOD Entity-Relationship Model

The E-R Model in Section A.1.2 of this Part applies to the Planned Substance Administration SR IOD. Table A.35.X1-1 specifies the Modules of the Planned Substance Administration SR IOD. 185

A.35.X1.3 Planned Substance Administration SR IOD Module Table

Table A.35.X1-1 PLANNED SUBSTANCE ADMINISTRATION SR IOD MODULES

IE Module Reference Usage

Patient Patient C.7.1.1 M

Clinical Trial Subject C.7.1.3 U

Study General Study C.7.2.1 M

Patient Study C.7.2.2 U

Clinical Trial Study C.7.2.3 U

Series SR Document Series C.17.1 M

Clinical Trial Series C.7.3.2 U

Equipment General Equipment C.7.5.1 M

Document SR Document General C.17.2 M

SR Document Content C.17.3 M

SOP Common C.12.1 M

A.35.X1.3.1 Planned Substance Administration SR IOD Content Constraints 190

A.35.X1.3.1.1 Value Type

Value Type (0040,A040) in the Content Sequence (0040,A730) of the SR Document Content Module is constrained to the following Enumerated Values (see Table C.17.3-7 for Value Type definitions):

TEXT CODE 195

NUM DATETIME DATE TIME UIDREF 200

PNAME COMPOSITE IMAGE WAVEFORM CONTAINER 205

A.35.X1.3.1.2 Relationship Constraints

Relationships between content items in the content of this IOD may be conveyed either by-value or by-reference. Table A.35.X1-2 specifies the relationship constraints of this IOD. See Table C.17.3-8 for Relationship Type definitions. 210

Table A.35.X1-2 RELATIONSHIP CONTENT CONSTRAINTS FOR EXTENSIBLE SR IOD

Source Value Type Relationship Type (Enumerated Values)

Target Value Type

CONTAINER CONTAINS TEXT, CODE, NUM, DATETIME, DATE, TIME, UIDREF, PNAME, COMPOSITE1, IMAGE1, WAVEFORM1, CONTAINER (See below).

TEXT, CODE, NUM, CONTAINER

HAS OBS CONTEXT TEXT, CODE, NUM, DATETIME, DATE, TIME, UIDREF, PNAME, COMPOSITE1

CONTAINER, IMAGE1, WAVEFORM1, COMPOSITE1, NUM

HAS ACQ CONTEXT TEXT, CODE, NUM, DATETIME, DATE, TIME, UIDREF, PNAME, CONTAINER.

any type HAS CONCEPT MOD TEXT, CODE2

TEXT, CODE, NUM HAS PROPERTIES TEXT, CODE, NUM, DATETIME, DATE, TIME, UIDREF, PNAME, IMAGE1, WAVEFORM1, COMPOSITE1, CONTAINER.

PNAME HAS PROPERTIES TEXT, CODE, DATETIME, DATE, TIME, UIDREF, PNAME

TEXT, CODE, NUM INFERRED FROM TEXT, CODE, NUM, DATETIME, DATE, TIME, UIDREF, PNAME, IMAGE1, WAVEFORM1, COMPOSITE1, CONTAINER.

Note: 1. The SOP Classes to which an IMAGE, WAVEFORM or COMPOSITE Value Type may refer, is documented in the Conformance Statement for an application (see PS 3.2 and PS 3.4). 215

2. The HAS CONCEPT MOD relationship is used to modify the meaning of the concept name of a parent node (or Source Content Item), with a modifier or qualifier in a child (target node) to provide a more descriptive explanation, a different coded language translation, or to define a post-coordinated concept.

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A.35.X2 Performed Substance Administration SR Information Object Definition 225

A.35.X2.1 Performed Substance Administration SR Information Object Description

The Performed Substance Administration SR IOD is used to convey the contrast medication that was delivered using manual methods or using automated power-injector devices, to a patient during a contrast study. It includes references to the Planned Substance Administration Procedure SR SOP instance.

A.35.X2.2 Performed Substance Administration SR IOD Entity-Relationship Model 230

The E-R Model in Section A.1.2 of this Part applies to the Performed Substance Administration SR IOD. Table A.35.X2-1 specifies the Modules of the Performed Substance Administration SR IOD.

A.35.X2.3 Performed Substance Administration SR IOD Module Table

Table A.35.X2-1 PERFORMED SUBSTANCE ADMINISTRATION SR IOD MODULES 235







Series SR Document Series C.17.1 M


Frame of Reference

Synchronization C.7.4.2 M


Enhanced General Equipment

C.7.5.2 M

Document SR Document General C.17.2 M

SR Document Content C.17.3 M

SOP Common C.12.1 M

A.35.X2.3.1 Performed Substance Administration SR IOD Content Constraints

A.35.X2.3.1.1 Value Type

Value Type (0040,A040) in the Content Sequence (0040,A730) of the SR Document Content Module is constrained to the following Enumerated Values (see Table C.17.3-7 for Value Type definitions): 240

TEXT CODE NUM DATETIME DATE 245

TIME UIDREF PNAME COMPOSITE IMAGE 250

WAVEFORM CONTAINER


Relationships between content items in the content of this IOD may be conveyed either by-value or by-255

reference. Table A.35.X-2 specifies the relationship constraints of this IOD. See Table C.17.3-8 for Relationship Type definitions.

Table A.35.X-2 RELATIONSHIP CONTENT CONSTRAINTS FOR EXTENSIBLE SR IOD

Source Value Type Relationship Type (Enumerated Values)

Target Value Type

CONTAINER CONTAINS TEXT, CODE, NUM, DATETIME, DATE, TIME, UIDREF, PNAME, COMPOSITE1, IMAGE1, WAVEFORM1, CONTAINER (See below).

TEXT, CODE, NUM, CONTAINER

HAS OBS CONTEXT TEXT, CODE, NUM, DATETIME, DATE, TIME, UIDREF, PNAME, COMPOSITE1

CONTAINER, IMAGE1, WAVEFORM1, COMPOSITE1, NUM

HAS ACQ CONTEXT TEXT, CODE, NUM, DATETIME, DATE, TIME, UIDREF, PNAME, CONTAINER.

any type HAS CONCEPT MOD TEXT, CODE2

TEXT, CODE, NUM HAS PROPERTIES TEXT, CODE, NUM, DATETIME, DATE, TIME, UIDREF, PNAME, IMAGE1, WAVEFORM1, COMPOSITE1, CONTAINER.

PNAME HAS PROPERTIES TEXT, CODE, DATETIME, DATE, TIME, UIDREF, PNAME

TEXT, CODE, NUM INFERRED FROM TEXT, CODE, NUM, DATETIME, DATE, TIME, UIDREF, PNAME, IMAGE1, WAVEFORM1, COMPOSITE1, CONTAINER.

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Note: 1. The SOP Classes to which an IMAGE, WAVEFORM or COMPOSITE Value Type may refer, is documented in the Conformance Statement for an application (see PS 3.2 and PS 3.4).

2. The HAS CONCEPT MOD relationship is used to modify the meaning of the concept name of a parent node (or Source Content Item), with a modifier or qualifier in a child (target node) to provide a more descriptive explanation, a different coded language translation, or to define a post-coordinated concept. 265

A.35.X2.3.1.3 Content Constraints

The Performed Substance Administration SR IOD may refer to maximum of two different Substance administration Plan SR SOP instances, one indicating programmed plan and another delivered plan. In the case of manual administration of contrast agent, there shall be only one Substance administration Plan 270

object, indicating the delivered plan.

A.35.X3 Basic Performed Substance Administration Information Object Definition

A.35.X3.1 Basic Performed Substance Administration Information Object Description

The Basic Performed Substance Administration IOD is used to convey the contrast medication that was 275

delivered using manual methods or using automated power-injector devices, to a patient during a contrast study.

The Basic Performed Substance Administration IOD enables contrast infusion managers to encode and transfer only relevant summary information data in a standard attribute based structure for interested consumers like Acquisition modalities. 280

A.35.X3.2 Basic Performed Substance Administration IOD Entity-Relationship Model

The E-R Model in Section A.1.2 of this Part applies to the Basic Performed Substance Administration IOD. Table A.35.X3-1 specifies the Modules of the Basic Performed Substance Administration IOD.

A.35.X3.3 Basic Performed Substance Administration IOD Module Table

Table A.35.X3-1 285

BASIC PERFORMED SUBSTANCE ADMINISTRATION IOD MODULES IE Module Reference Usage






Series General Series C.7.3.1 M


Frame of Reference

Synchronization C.7.4.2 M


Enhanced General Equipment

C.7.5.2 M

Substance Administration IE

Enhanced Contrast Bolus Agent Module

C.7-12b M

SOP Common C.12.1 M

290

A.35.X4 Defined Substance Administration Information Object Definition 295

A.35.X4.1 Defined Substance Administration Information Object Description

The Defined Substance Administration SR is for defining generic substance administration protocols for known generic study protocols. The idea is to enable build a generic or pre-defined set of default substance administration protocols for known imaging study protocols, so as to further customize them into planned or performed substance administration protocols easily. These objects are not patient specific. 300

A.35.X4.2 Defined Substance Administration IOD Entity-Relationship Model

A Defined Substance Administration IOD is not related to other Information Entities of the DICOM real-world model, as it is not associated with a specific patient.

Defined Substance Admin IOD

305

A.35.X4.3 Defined Substance Administration IOD Module Table

Table A.35.X4-1 DEFINED SUBSTANCE ADMINISTRATION IOD MODULES


Document SOP Common C.12.1 M

Substance Administration C.X.X M

A.35.X4.3.1 Defined Substance Administration IOD Content Constraints 310


A.35.X2.3.1.3 Content Constraints 315

Add new Modality Type to PS 3.3:

Defined Substance

Administration IOD

Comment [SRB7]: Add Equipment IE

C.7.3.1.1 General Series Attribute Descriptions

C.7.3.1.1.1 Modality 320

Defined Terms for the Modality (0008,0060) are:

IA = Imaging Agent Delivery System

.

Add new IOD Definitions to PS 3.3: 325

Annex C INFORMATION MODULE DEFINITIONS (NORMATIVE)

C.xx.x Substance Administration Module

Table C.xx-x specifies the Attributes used to indicate administration of an imaging agent to a patient. 330

Table C.xx-1 SUBSTANCE ADMINISTRATION MODULE ATTRIBUTES

Attribute Name Tag Type Attribute Description

Modality (0008,0060) 1 The modality appropriate for the Substance Administration.

Plan Type (xxxx,xxxx) 1 Plan Type

Contrast Delivery Step Number

(xxxx,xxxx) 1 Contrast Delivery Step Number

Injection Delay (xxxx,xxxx) 1

Scan Delay (xxxx,xxxx) 1

Delivery Phase (xxxx,xxxx) 1

… (xxxx,xxxx) 1

335


Digital Imaging and Communications in Medicine (DICOM) 340

Part 4: Service Class Specifications

345

350

355

Add new SOP Class to PS 3.4 Annex B and I tables:

B.5 STANDARD SOP CLASSES

The SOP Classes in the Storage Service Class identify the Composite IODs to be stored. Table B.5-1 identifies Standard SOP Classes. 360

Table B.5-1STANDARD SOP CLASSES

SOP Class Name SOP Class UID IOD Specification(defined in PS 3.3)

… … …

Basic Text SR 1.2.840.10008.5.1.4.1.1.88.11 Basic Text SR

Enhanced SR 1.2.840.10008.5.1.4.1.1.88.22 Enhanced SR

Comprehensive SR 1.2.840.10008.5.1.4.1.1.88.33 Comprehensive SR

Procedure Log 1.2.840.10008.5.1.4.1.1.88.40 Procedure Log

Mammography CAD SR 1.2.840.10008.5.1.4.1.1.88.50 Mammography CAD SR IOD

Key Object Selection 1.2.840.10008.5.1.4.1.1.88.59 Key Object Selection Document

Chest CAD SR 1.2.840.10008.5.1.4.1.1.88.65 Chest CAD SR IOD

X-Ray Radiation Dose SR 1.2.840.10008.5.1.4.1.1.88.67 X-Ray Radiation Dose SR

Planned Substance Administration SR

1.2.840.10008.5.1.4.1.1.88.xx1 Planned Substance Administration SR

Performed Substance Administration SR

1.2.840.10008.5.1.4.1.1.88.xx2 Performed Substance Administration SR

Basic Performed Substance Administration

1.2.840.10008.5.1.4.1.1.88.xx3 Basic Performed Substance Administration

Defined Substance Administration

1.2.840.10008.5.1.4.1.1.88.xx4 Defined Substance Administration

Encapsulated PDF Storage 1.2.840.10008.5.1.4.1.1.104.1 Encapsulated PDF IOD

… … …

…

I.4 MEDIA STORAGE STANDARD SOP CLASSES 365

The SOP Classes in the Media Storage Service Class identify the Composite and Normalized IODs to be stored. The following Standard SOP Classes are identified in Table I.4-1

Table I.4-1 Media Storage Standard SOP Classes

SOP Class Name SOP Class UID IOD Specification

… … …

Basic Text SR 1.2.840.10008.5.1.4.1.1.88.11 Basic Text SR

Enhanced SR 1.2.840.10008.5.1.4.1.1.88.22 Enhanced SR

Comprehensive SR 1.2.840.10008.5.1.4.1.1.88.33 Comprehensive SR

Procedure Log 1.2.840.10008.5.1.4.1.1.88.40 Procedure Log

Mammography CAD SR 1.2.840.10008.5.1.4.1.1.88.50 Mammography CAD SR IOD

Key Object Selection Document 1.2.840.10008.5.1.4.1.1.88.59 Key Object Selection Document

Chest CAD SR 1.2.840.10008.5.1.4.1.1.88.65 Chest CAD SR IOD

X-Ray Radiation Dose SR 1.2.840.10008.5.1.4.1.1.88.67 X-Ray Radiation Dose SR

Encapsulated PDF Storage 1.2.840.10008.5.1.4.1.1.104.1 Encapsulated PDF IOD

Planned Substance 1.2.840.10008.5.1.4.1.1.88.xx1 Planned Substance

Comment [SRB9]: Change all defined object to SR

Comment [SRB8]: Move it up to top

Administration SR Administration SR

Performed Substance Administration SR

1.2.840.10008.5.1.4.1.1.88.xx2 Performed Substance Administration SR

Basic Performed Substance Administration

1.2.840.10008.5.1.4.1.1.88.xx3 Basic Performed Substance Administration

Defined Substance Administration

1.2.840.10008.5.1.4.1.1.88.xx4 Defined Substance Administration

… … …

370

375

380

385

390


Digital Imaging and Communications in Medicine (DICOM) 395

Part 6: Data Dictionary

400

405

410

415

420

Add new SOP Class to PS 3.6 Table A-1:

… … … ...

1.2.840.10008.5.1.4.1.1.88.1 Text SR Storage – Trial (Retired) SOP Class PS 3.4

1.2.840.10008.5.1.4.1.1.88.2 Audio SR Storage – Trial (Retired) SOP Class PS 3.4

1.2.840.10008.5.1.4.1.1.88.3 Detail SR Storage – Trial (Retired) SOP Class PS 3.4

1.2.840.10008.5.1.4.1.1.88.4 Comprehensive SR Storage – Trial (Retired)

SOP Class PS 3.4

1.2.840.10008.5.1.4.1.1.88.11 Basic Text SR Storage SOP Class PS 3.4

1.2.840.10008.5.1.4.1.1.88.22 Enhanced SR Storage SOP Class PS 3.4

1.2.840.10008.5.1.4.1.1.88.33 Comprehensive SR Storage SOP Class PS 3.4

1.2.840.10008.5.1.4.1.1.88.40 Procedure Log Storage SOP Class PS 3.4

1.2.840.10008.5.1.4.1.1.88.50 Mammography CAD SR Storage SOP Class PS 3.4

1.2.840.10008.5.1.4.1.1.88.59 Key Object Selection Document Storage

SOP Class PS 3.4

1.2.840.10008.5.1.4.1.1.88.65 Chest CAD SR Storage SOP Class PS 3.4

1.2.840.10008.5.1.4.1.1.88.67 X-Ray Radiation Dose SR Storage SOP Class PS 3.4

1.2.840.10008.5.1.4.1.1.88.xx1 Planned Substance Administration SR Storage

SOP Class PS 3.4

1.2.840.10008.5.1.4.1.1.88.xx2 Performed Substance Administration SR Storage

SOP Class PS 3.4

1.2.840.10008.5.1.4.1.1.88.xx3 Basic Performed Substance Administration Storage

SOP Class PS 3.4

1.2.840.10008.5.1.4.1.1.88.xx4 Defined Substance Administration Storage

SOP Class PS 3.4

1.2.840.10008.5.1.4.1.1.104.1 Encapsulated PDF Storage SOP Class PS 3.4

… … … …

425

430

Changes to NEMA Standards Publication PS 3.16-2011 435


Part 16: Content Mapping Resource

440

Add new Section to Annex A of PS 3.16:

445

PLANNED SUBSTANCE ADMINISTRATION SR IOD TEMPLATES

The templates that comprise the Planned Substance Administration are interconnected as in Figure A-x.1

Figure A.x-1: Planned Substance Administration SR IOD Template Structure 450

TID xxxx1 Planned Substance Administration

This template describes single scheduled administration plan.

TID xxxx1 Planned Substance Agent Admin.

TID 1002 Observer Context

TID xxxx5 Substance Information

TID xxxx6 Substance Administration Consumables

TID xxxx7 Substance Administration Plan

TID xxxx2 Pre-Medication Context

TID xxxx3 Patient Risk-factors

TID 3601 Procedure Context

TID xxxx1 Planned Substance Administration 455

Type: Extensible Order: Significant

NL Rel with Parent

VT Concept Name VM Req Type

Condition Value Set Constraint

1 CONTAINER EV (xx8, 99SUP164, “Planned Substance Administration Procedure Report”)

1 M

2 > CONTAINS INCLUDE DTID (1200) Language Designation

1 U

3 > HAS PROPERTIES

TEXT EV (121144, DCM,

“Document Title") 1 U

4 > CONTAINS INCLUDE DTID (xxxx2)

Pre-Medication Context

1 U

5 > CONTAINS INCLUDE DTID (xxxx3)

Patient Risk-Factor Context related to Imaging Agents

1 U

7 > CONTAINS INCLUDE DTID (1001) Observation Context

1 M

8 > CONTAINS INCLUDE DTID (xxxx5) Contrast-Agent Information

1 U

9 > CONTAINS CODE EV(xx9, 99SUP164, “Injection Mode”)

1 U DCID (xxxx8) Substance Administration Mode

10 > CONTAINS TEXT EV(xx10, 99SUP164, Rationale for Administering Contrast Agent)

1-n U

11 > CONTAINS INCLUDE DTID (xxxx6) Substance Administration Consumables

1-n U

12 > CONTAINS INCLUDE DTID(xxxx7) Contrast Delivery Plan

1 U

Content Item Descriptions

Row 4 Information about premedication administration available at the time of scheduling the Substance Administration protocol.

Row 5 Information about patient risk-factors available at the time of scheduling the Substance Administration protocol.

Row 7 Person responsible for authoring the content of this object.

Row 8 Information about the contrast-agent scheduled to be used for the plan.

Row 10 Each item should contain a single rationale however multiple such items could be included

Row 11 Only contrast agent consumable details that are known at the time of scheduling (e.g., Needle length)

TID xxxx2 Pre-Medication Context 460

Detailed information on medications administered to the patient, prior to the Substance Administration.

TID xxxx2 Pre-Medication Context


NL Rel with Parent



1 CODE EV(xx1, 99SUP164, Drug Product Identifier)

1-n U DCID (xxxx12) Pre-Medication Agents for Substance Administration

2 > HAS PROPERTIES

CODE EV(xx2, 99SUP164, Equivalent Drug Code)

1-n U

3 > HAS PROPERTIES

TEXT EV(xxx, 99SUP164, Drug Name)

1-n U

4 > HAS PROPERTIES

NUM DCID (3410) Numeric Parameters of Drugs/Contrast

1-n U

5 > HAS PROPERTIES

CODE EV (G-C340, SRT, “Route of Administration”)

1 U DCID (11) Route of Administration

6 > HAS PROPERTIES

NUM EV(x222, 99SUP164, Fasting Period)

1 U UNITS = DT (h, UCUM, "h")

465


Row 2 Local national code equivalent for the drug in Row 1

Row 3 Describes drug name in text indicated in Row 1

Row 6 Fasting period in hours prior to

TID xxxx3 Patient Risk-Factor Context related to Imaging Agents

TID xxxx3 470

Patient Risk-Factor Context related to Imaging Agents Type: Extensible Order: Significant

NL Rel with Parent



1 CONTAINER EV (xxxx, 99SUP164, ”Imaging-Agent Related Risk Factors”)

1 U

2 > CONTAINS CODE EV (F-01500, SRT, ”Risk factor”)

1-n U DCID (xxxx9)

Imaging Agent Related Risk-factor Indications

3 > CONTAINS NUM EV (xx4, 99SUP164, “Serum Creatinine”)

1-n U UNITS = DT( mg/dL,UCUM,”mg/dL”)

4 >> HAS OBS CONTEXT

DATETIME EV (121135, DCM, “Observation Date time”)

1 M

Comment [SRB10]: Tweak it

Comment [JK11]: I think we should enable the storage of relevant lab values in the SR somewhere ( at least, initially, sCR, eGFR or GFR). This may be a logical place to store them.

Comment [JK12]: There may be multiple sCRs on record for the patient.. there are some clinical algorithms that assess the slope of the sCR (and/or eGFR) to ascertain whether a patient should receive contrast (Iodinated or Gadolinum) or if a reduced volume etc should be used

Comment [SRB13]: Changed from U We require a date/time while recording SCR screening.

5 > CONTAINS NUM EV (xx5, 99SUP164, “Glomerular Filtration Rate“)

1-n U UNITS = DT(mL/min/1.73m2, UCUM, “mL/min/1.73m2”)


CODE EV(xx6, 99SUP164, “Assessment Method”)

1 M DCID (xxxx13) GFR Assessment Method


DATETIME EV (121135, 99SUP164, “Observation Date time”)

1 M

Content Item Descriptions 475

Row 3 There may be multiple sCRs on record for the patient.. there are some clinical algorithms that assess the slope of the sCR (and/or eGFR) to ascertain whether a patient should receive contrast (Iodinated or Gadolinum) or if a reduced volume etc should be used.

Row 6 The Assessment method indicates if a GFR is estimated or measured.

TID xxxx5 Substance Information

TID xxxx5 Substance Information 480


NL Rel with Parent

VT Concept Name VM

Req Type


1 CONTAINER EV(123011, DCM, “Contrast/Bolus Agent”)

EV(xxxxx, “99SUP164”,

Substance Admin.)

1 M

2 > CONTAINS TEXT EV(C-B0300, SRT, “Contrast Agent”)

1 U

3 > CONTAINS CODE EV(xx12,”99SUP164”, “Contrast Agent”)

1 M

DCID (12) Radiographic Contrast Agent

4 > HAS PROPERTIES

CODE EV(xx2, 99SUP164, Equivalent Drug Code)

1-n

U

4b Is Radiopharmaceutical DCID (230) Yes - No

5 > CONTAINS CODE EV(G-C52F, SRT, “Active Ingredient”)

1 U DCID (13) Radiographic Contrast Agent Ingredient

6 > CONTAINS NUM EV(xx13,”99SUP164”, “Contrast Concentration”)

1 U

7 > CONTAINS NUM EV(xx14, 99SUP164, “Molarity”)

1 U

8 > CONTAINS NUM EV(xx15, 99SUP164, “Relaxivity”)

1 U UNITS = EV (mM^-1*sec^-1, UCUM, “mM^-1*sec^-1”)

9 > CONTAINS NUM EV(xx16, 99SUP164, “Osmolality at 37C”)

1 U UNITS = EV (mOsm/kg, UCUM, “mOsmol/kg”)

10 > CONTAINS NUM EV(xx17, 99SUP164, “Osmolarity at 37C”)

1 U UNITS = EV(mmol/L, UCUM,“ mmol/L” )

Comment [SRB14]: Changed from U to M for row 6,7

Comment [SRB15]: Drop this row desc.

Comment [SRB16]: Change concept name to Subst. admin. all over.

Comment [SRB17]: Add units for row 6,7

Comment [SRB18]: Check for valid UCUM encoding throughout the document.

11 > CONTAINS NUM EV(xx18, 99SUP164, “Viscosity at 37C”)

1 U UNITS = EV(mOsm/kg H20, “UCUM”, “mOsm/kg H20”)

12

>

CONTAINS NUM EV(xx19, 99SUP164, “Flush Concentration”)

1

U

UNITS = EV(Mg/L, UCUM, “Mg/L”)

13 > CONTAINS DATETIME EV(xx20, 99SUP164, “Contrast-Agent Order Date”)

1 U

14 > CONTAINS CODE EV (G-C340, SRT, "Route of administration")

1 U DCID (11) Route of Administration

15 > CONTAINS NUM EV(xx??, 99SUP164, “Scheduled Administered Activity”)

1 MC IFF Row 4b Equals Yes

Units = EV (MBq, UCUM, “MBq”)

16 > CONTAINS NUM EV(xx??, 99SUP164, “Maximum Administered Activity”)

1 UC IFF Row 4b Equals Yes


17 > CONTAINS NUM EV(xx??, 99SUP164, “Minimum Administered Activity”)



18 > CONTAINS NUM EV(xx??, 99SUP164, “Maximum Administered Volume”)


19 > CONTAINS DATETIME EV(xx??, 99SUP164, “Scheduled Administration Time”)



Row 4 Local equivalent drug code for Row 3

Row 5 Mg/ml of active ingredient

Row 6 Contrast Concentration, referring to the concentration of contrast type given in row 4

Row 7 One of: “Iodine”, “Gadolinium”, etc

Row 8 Relaxivity at 37C at B0 field strength

Row 13 Date-time the Contrast-Agent was ordered by the physician.

Row 15 The desired activity to be administered.

Row 16 The not to exceed amount of activity

Row 17 The amount of activity is not available do not adminisiter the radiopharmaceutical

Row 18 Some radiopharmaceuticals can be deadly if too much is given to the patient

TID xxxx6 Substance Administration Consumables 485

TID xxxx6 Substance Administration Consumables Type: Extensible Order: Significant

NL Rel with Parent



1 CONTAINER EV(xx21, 99SUP164, “Contrast-Agent Consumable Information”)

1 U

Comment [SRB19]: Add units

Comment [SRB20]: Re-phrase row 16, 17, 18 – should not sound as an instruction, rather as a description.

Comment [SRB21]: Change all over to subst. admin.

2 > CONTAINS CODE EV(xx45, 99SUP164, “Substance Consumable Type”)

1-n U DCID (xxxx14) Substance Administration Consumable Type

3 > CONTAINS TEXT EV (121148, SRT, “Unit Serial Identifier”)

1 U

4 > CONTAINS TEXT EV (121149, DCM, “Lot identifier”)

1 U

5 > CONTAINS TEXT EV(xx46, 99SUP164, “UPC Code”)

1 U

6 > CONTAINS TEXT EV (121145, SRT, ”Description of Material”)

1 U

7 > CONTAINS DATE EV(xx22,99SUP164, "Expiry Date")

1 U

8 > CONTAINS NUM EV (111467, DCM, “Needle Length”)

1 C IFF Row Equals

(xxxx, DCM, “Syringe”)

UNITS = EV (cm, UCUM, ”centimeter”)

9 > CONTAINS CODE EV (122319, DCM,

“Catheter Size”) 1 U UNITS = DCID (3510)

Catheter Size Units

10 > CONTAINS TEXT EV(xx23, 99SUP164, “Manufacturer Name”)

1 U

11 > CONTAINS CODE EV(xx24, 99SUP164, “Syringe Type”)

1 C IFF Row Equals

(xxxx, DCM, “Syringe”)

DCID (xxxx3) Contrast Agent Injection Syringe Type

12 > HAS PROPERTIES

NUM EV (121146, DCM, “Quantity of material”)

1 U

10 > CONTAINS TEXT EV(xx25, 99SUP164, “Cartridge Description“)

1 U

13 > CONTAINS TEXT EV (121147, DCM, "Billing

Code")

1 U


Row 3 Serial ID of the contrast agent consumable

Row 4 LOT identifier of the contrast agent

Row 6 Description about the contrast agent material if any

Row 7 Expiry date of Substance

Row 8 Needle Length of the catheter used

Row 10 Syringe manufacturer name

Row 11 See new CID for syringe type (Pre-filled or Empty)

Row 12 Syringe quantity number

Row 10 Description about Cartridge

Row 11 Cartridge Quantity Number

TID xxxx7 Substance Administration Delivery Plan Template

This template provides detailed information on Substance Administration delivery plan. A plan consists of multiple steps of delivery; a step in turn consists of multiple phases.

Comment [SRB22]: Check for concept code – may have one in SNOMED,LOINC or check part-16. FDA’s coming up with UDI

Comment [SRB23]: Discrete integers – 14,16,18,20,22,24

Comment [SRB24]: Look up for codes if available already

Comment [SRB25]: Missing units –add UCUM – check for UCUM descriptions…

TID xxxx7 495

Substance Administration Delivery Plan Template Type: Extensible Order: Significant

NL Rel with Parent



1 CONTAINER EV(xx26, 99SUP164, “Substance Delivery Procedure Plan”)

1 M

2 > CONTAINS CODE EV(xx27, 99SUP164, “Plan Type”)

1 M DCID (xxxx11) Substance Administration Plan Type

3 > CONTAINS INCLUDE DTID(xxx8) “Substance Administration Delivery Step”

1-n M

4 > CONTAINS NUM EV(xx27, 99SUP164, “Pressure Limit”)

1 U IFF Shall be included only for Power injection method

UNITS = EV(kPa,UCUM,

“kPa“)

5 >> HAS CONCEPT MODIFIER

CODE EV(121401,DCM,"Derivation")

1 C This modifier shall be included only for the above encoded Pressure concept.

6 > CONTAINS NUM

EV(122094, DCM, “Rate of administration”)

1 U UNITS = EV(ml/S,UCUM,

“ml/S“)

7 > CONTAINS WAVEFORM $MeasurementGraph 1-n MC Required if the value of Row 2 is “Delivered”” with Injection mode as Power Injector.


Row 1 Plan Name /Title or simply a Plan number as text

Row 2 Scheduled –To be encoded while this plan is scheduled under “Planned Substance Administration Procedure SR IOD”

Programmed – To be encoded if this plan is programed at the injector under “Performed Substance Administration Procedure SR IOD”.

Delivered – To be encoded if this plan was used in actual delivery of drug to the patient, under “Performed Substance Administration Procedure SR IOD”.

Row 7 This item shall only be added for performed when the value for row 2 is “Delivered” with Injection mode as Power Injector Generally, 3 waveform objects referenced: a. Flow-Rate vs Time, b. Pressure vs Time

c. Volume vs Time

500

Comment [SB26]: How does one use IFF construct for these conditions below?

TID xxxx8 Substance Administration Delivery Step Template


TID xxxx8 505

Substance Administration Delivery Step Template Type: Extensible Order: Significant

NL Rel with Parent



1 CONTAINER EV(xx28, 99SUP164, “Contrast Delivery Procedure Step”)

1 M

2 > CONTAINS NUM EV(xx, 99SUP164, “Contrast Delivery Step Number”)

1 M Units = EV (1,UCUM,”no units”)

3 > CONTAINS NUM EV(xx29, 99SUP164, “Injection Delay”)

1 M UNITS = EV (s, UCUM, “s”)

4 > CONTAINS NUM EV(xx30, 99SUP164, "Scan Delay ")

1 M UNITS = EV (s, UCUM,

“s”)

5 > CONTAINS CODE EV(xx31, 99SUP164, “Delivery Phase”)

1 M


Row 2 Contrast Delivery Step Number indicates a delivery step, it increases monotonously.

510

TID xxxx9 Substance Administration Delivery Phase Template


TID xxxx9 515

Substance Delivery Phase Template Type: Extensible Order: Significant

NL Rel with Parent



1 CONTAINER EV(xx32, 99SUP164, “Substance Delivery Phase”)

1 M

> CONTAINS CODE EV(xx62, 99SUP164, “Substance Delivery Phase Type”)

1 M DCID (xxx4) Substance Phase Type

2 > CONTAINS CODE EV(xx33, 99SUP164, “Substance Type”)

1 MC IFF Row 1a equals

(xxxx, DCM, “Fluid”)

CID xxxx5 Substance Type

3 > CONTAINS NUM EV(xx33, 99SUP164, "Substance Flush Ratio")



UNITS = EV({0:100}, UCUM, “range 0-100”)

4 > CONTAINS NUM EV(122095, DCM, “Duration of administration”)

1 U UNITS = EV (s, UCUM,

“s”)

Comment [JK27]: Should we have radiopharma stuff in here?? Based on larger discussion

Comment [SRB28]: From Part-16, section 7.2.2

5 > CONTAINS NUM EV(122091, DCM, “Volume Administered”



6 > CONTAINS NUM EV(122094, DCM, “Rate of administration”)

1 UC IFF Row 1a equals


UNITS = EV(ml/sec, UCUM “ml/sec”)

7 > CONTAINS DATETIME EV(111526, DCM, “DateTime Started”

1 U

8 > CONTAINS DATETIME EV(111527, DCM, “DateTime Ended”

1 U

9 > CONTAINS NUM EV(xx34, 99SUP164, “Starting Substance Volume”)

1 UC IFF Row 1a equals


10 > CONTAINS NUM EV(xx35, 99SUP164, “Rise Time")

1 M UNITS = EV (s, UCUM, “s”)


Row 3 Ratio contains the ratio number of the fluid in context. (i.e., Referred in the previous “Fluid Type” item)

Row 5 Shall be included only if the type of ‘Contrast Delivery Phase’ is ‘Fluid’

Row 7 Date time of when the Substance delivery started for the current phase

This Item is only required for Performed Substance Administration SOP Instance.

Row 8 Date time of when the Substance delivery ended for the current phase

This Item is only required for Performed Substance Administration SOP Instance.

Row 9 Starting Contrast Volume Number

Row 10 Rise time of the phase

520

PERFORMED SUBSTANCE ADMINISTRATION SR IOD TEMPLATES 525

The templates that comprise the Performed Substance Administration are interconnected as in Figure A-x.2

TID xxxx10 Performed Contrast Agent Admin.

TID 3601 Procedure Context

TID 1002 Observer Context

TID xxx11 Contrast Agent Information

TID xxxx5 Contrast Injector Information

TID xxxx6 Substance Administration

C

TID xxxx7 Substance Administration Plan

TID xxx11 Adverse Event Reactions

TID xxx2 Pre-Medication Context

TID xxx3 Patient Risk-Factors

Figure A.x-2: Performed Substance Administration SR IOD Template Structure 530

TID xxx10 Performed Substance Administration

This template defines a container (the root) with subsidiary content items, each of which corresponds to a single Substance Administration delivered. There is a defined recording observer (the system or person responsible for planning the schedule). 535

TID xxx10 Performed Substance Administration

Type: Extensible

NL Rel with Parent



1 CONTAINER EV (XXXXXX, DCM, “Performed Substance Administration Procedure Report”)

1 M

2 > CONTAINS INCLUDE DTID 1200 Language Designation

1 U

3 > CONTAINS TEXT EV (121144, DCM, “Document Title")

1 U

4 > CONTAINS INCLUDE DTID(xxxx1)

Pre-Medication

1 U

5 > CONTAINS INCLUDE DTID (xxx3)

Patient Risk-Factor Context related to Imaging Agents

1 U

6 > CONTAINS INCLUDE DTID (1002) Observer Context

1-n U

8 > CONTAINS CODE EV(xx36, 99SUP164, “Injection Mode”)

1 M DCID (xxxx8) Substance Administration Mode

9 > CONTAINS INCLUDE DTID (xxx5) Substance Information

1 M

10 > CONTAINS INCLUDE DTID (xx12) Contrast-Injector Information

1 MC Required IFF a programmable injection device is used

11 > CONTAINS INCLUDE DTID (xxxx6) Substance Consumables

1 U

12 > CONTAINS INCLUDE DTID(xxxx7) Substance Administration Plan

1-2 U

13 > CONTAINS INCLUDE DTID(xxx14) Contrast Administration Plan

1 U

14 > CONTAINS INCLUDE DTID (xxx11) Substance Administration Adverse Events

1-n MC IFF Performed and patient had adverse reactions

15 > CONTAINS CODE EV(xx60,99SUP164, “Substance Administration Completion Status”)

1 MC IFF Performed only. DCID (xxxx15) Substance Administration Completion Status

Comment [SRB29]: Changed from U to M

Comment [SRB30]: Added HandHeld concept

Comment [SRB31]: Changed from U to MC


Row 3 Values could be like “Abdomen”, “Chest Abdomen Pelvis”, etc.

Row 6 Persons responsible for administering the Substance .

Row 7 This is to provide context information so as to understand – what type of study is this plan intended for.

Row 11 Substance consumable information

Row 12 Programmed plan, contains detailed steps of a delivery plan.

Typically, there is only one delivery plan for a Planned Substance Administration SOP class, two for Performed Substance Administration SOP class, indicating both programmed and delivered delivery steps.

Row 13 Performed delivery plan, containing detailed steps for actual delivery of Substance

TID xxx11 Substance Administration Adverse Events

This general template provides detailed information on adverse events occurring to a patient as a reaction to administration of Substance.

TID xxx11 545

Substance Administration Adverse Event Reactions Type: Extensible

NL Rel with Parent



1 CONTAINER EV (xxxxx, 99SUP164,

"Substance Administration Adverse Event”) Complications")

1 M

2 > CONTAINS CODE EV(DF-10781, DCM, “Substance Administration Adverse Reaction”)

1 M DCID(930) Procedure Discontinuation Reasons

3 >> HAS PROPERTIES

TEXT EV (DD-60002, SRT, “Complication of Procedure”)

1 U

4 >> HAS PROPERTIES

CODE EV (xxxxx, 99SUP164, “Relative Time”) EV (G-D709, SRT, "Relative Time”)

U DCID (xxxx2) Temporal Periods Relating To Contrast Procedure

5 >> HAS PROPERTIES

DATETIME EV(xx37, 99SUP164, “Adverse Event Observation Date Time”)

1 M

6 >> HAS PROPERTIES

NUM EV(xx38, 99SUP164, “Adverse Reaction Step”)

1 U

7 >> HAS PROPERTIES

NUM EV(xx39, 99SUP164, “Adverse Reaction Phase”)

1 U

8 >> HAS PROPERTIES

NUM EV(xxxx, 99SUP164, “Adverse Event Reaction Grade”)

1 U

Comment [SRB32]: Tech Vs Device Vs Supervising radiologist for Manual / Automated administration.

Comment [SRB33]: Work on Grade number. NCI( National Cancer Institute), SNOMED, WHO (World Health Org.)


Row 3 Description about the nature of the complication

Row 5 Date and time when the adverse event was observed

Row 6 Indicates the performed step number in this plan where an adverse reaction found to occur.

Row 7 Indicates the performed phase number in the step of this plan where an adverse reaction found to occur.

550

TID xxx12 Contrast Injector Information

This template provides detailed information about the contrast injector system used for delivery.

TID xxx12 Contrast Injector Information Template

Type: Extensible 555

NL Rel with Parent



1 > CONTAINS CONTAINER EV(xx40, 99SUP164, “Contrast Injector Information”)

1 M

2 >> HAS PROPERTIES

TEXT EV(xx41, 99SUP164, “Injector Manufacturer”)

1 U

3 >> HAS PROPERTIES

TEXT EV(xx42, 99SUP164, “Injector Model”)

1 U

4 >> HAS PROPERTIES

TEXT EV(xx43, 99SUP164, “Injector Software Version”)

1 U

5 >> HAS PROPERTIES

TEXT EV(xx44, 99SUP164, “Injector Type”)

1 U DCID (xxxx10) Contrast Agent Substance Administration Injector Head Type


Row 5 Type of injector – Dual Head, Single Head, etc.

TID xxx14 Substance Administration Plan Template

This template provides detailed information on substance adminstration delivery plan. A plan consists of 560

multiple steps of delivery; a step in turn consists of multiple phases.

TID xxx14 Substance Administration Plan Template Type: Extensible Order: Significant

NL Rel with Parent



1 CONTAINER EV(200, 99SUP164, “Substance Administration Plan”)

1 U

Comment [SRB34]: Look for Device Module in part-16

2 > CONTAINS CODE EV(xx27, 99SUP164, “Plan Type”)

1 M DCID (xxxx11) Substance Administration Plan Type

3 > CONTAINS COMPOSITE EV(xx201, 99SUP164, “Substance Administration Plan Report”)

1 U

565


Row 3 Shall refer to a SOP instance of type Substance Administration Plan SOP Class.

Add the following CID’s to Part 16 Annex B:

570

CID 9300 Procedure Discontinuation Reasons

Context ID 9300 Procedure Discontinuation Reasons Type: Extensible Version: 20110128

Coding Scheme Designator (0008,0102)

Code Value (0008,0100)

Code Meaning (0008,0104)

DCM 110526 Resource pre-empted

DCM 110527 Resource inadequate

DCM 110528 Discontinued Procedure Step rescheduled

DCM 110529 Discontinued Procedure Step rescheduling recommended

Include CID 9301 Modality PPS Discontinuation Reasons

Include CID 9302 Media Import PPS Discontinuation Reasons

Include CID xxxx1 Substance Administration Adverse Event Reaction List

575

CID xxxx1 Substance Administration Adverse Event Reaction List

Context ID xxxx1 Substance Administration Adverse Event Agent Reaction List

Type: Extensible Version: 2012xxxx 580




DCM xxx1 Pressure limiting event occurred during injection,

DCM xxx2 Flow-rate limiting event occurred during injection.

DCM xxx3 Indicates occurrence of both pressure and flow-rate limit event detections.

DCM xxx4 Injection aborted by clinician operator

DCM xxx5 Anaphylactic Reaction observed during administration

DCM xxx6 Dyspnea wheezing

Include CID CXX10 Intravenous Extravasation Symptoms (From Supplement 159)

CID CXX10 Intravenous Extravasation Symptoms

This list of Extravasation Symptoms are taken from ACR NRDR-ICE Registry, IV Contrast Extravasation Reporting Form version 1.3 from NRDR.ACR.ORG

Context ID CXX10 585

Intravenous Extravasation Symptoms Type: Extensible Version: yyyymmdd




$99SUP159 CDX127 Decreased Perfusion

$99SUP159 CDX128 Skin Induration

$99SUP159 CDX129 Erythema

$99SUP159 CDX130 Altered sensation

$99SUP159 CDX131 No Signs or Symptoms

$99SUP159 CDX135 Swelling Mild

$99SUP159 CDX136 Swelling Moderate

$99SUP159 CDX137 Swelling Severe

$99SUP159 CDX138 Pain

$99SUP159 CDX139 Skin Blistering or Ulceration

$99SUP159 CDX140 Compartment Syndrome

$99SUP159 CDX141 Other Extravasation Symptom

Add new CID for Radiosensitive Organs in Part 16:

CID xxxx2 Temporal Periods Relating To Contrast Procedure 590

Context ID xxxx2 Temporal Periods Relating To Contrast Procedure

Type: Extensible Version: 2012xxxx




SRT R-422A4 After Procedure

SRT R-40FBA During Procedure

SRT R-40FB9 Before Procedure

DCM 110514 Procedure discontinued due to incorrect patient or procedure step selected from modality work-list

CID xxxx3 Contrast Agent Injection Substance Administration Syringe Type 595

Context ID xxxx3 Contrast Agent Injection

Substance Administration Syringe Type Type: Extensible Version: 2012xxxx




DCM xxxx7 Pre-filled

DCM xxxx8 Empty (or Not Pre-filled)

600

CID xxxx4 Contrast Agent Substance Administration Phase Type

Context ID xxxx4 Contrast Agent

Substance Administration Phase Type Type: Extensible Version: 2012xxxx 605




DCM xxxx9 Injection Fluid Administration Fluid

DCM xxx10 Administration Hold

DCM xxx11 Administration Pause

CID xxxx5 Substance Type

Context ID xxxx5 Substance Type





DCM xxx12 Flush or Saline

DCM xxx13 Contrast-Agent

Comment [SRB35]: Injection or Administration?

DCM xxxxx Radio-Pharmaceutical

CID xxxx6 Substance Administration Consumable

Context ID xxxx6 Substance Administration Consumables Type: Extensible Version: 2012xxxx 615




DCM 121145 Description of Material

DCM 121148 Unit Serial Identifier

DCM 121149 Lot Identifier

CID xxxx7 Temporal Periods Relating To Procedure

Context ID xxxx7 Temporal Periods Relating To Procedure Type: Extensible Version: 2012xxxx 620




SRT R-422A4 After Procedure

SRT R-40FBA During Procedure

SRT R-40FB9 Before Procedure

CID xxxx8 Substance Administration Mode

Context ID xxxx8 Substance Administration Mode





DCM xxx14 Power Injector Automated Injection

DCM xxx15 Manual Injection

Comment [SRB36]: Automated Injection

630

CID xxxx9 Substance Administration Related Risk-Factor Indications

Context ID xxxx9 Substance Administration Related Risk-factor Indications 635





DCM xxx16 Renal Insufficiency

DCM xxx17 Diabetes

DCM xxx18 Asthma

DCM xxx19 Other Cardiac Disease

DCM xxx20 Aortic Stenosis

DCM xxx21 Angina

DCM xxx22 Congestive Heart Failure Symptoms

DCM xxx23 Primary Pulmonary Hypertension

DCM xxx24 Cardiomyopathy

DCM xxx25 Anxiety

DCM xxx26 Paraproteinemias

DCM xxx27 Multiple myeloma

DCM xxx28 Use of Beta-adrenergic blocking agents

DCM xxx29 Carcinoma of the thyroid

DCM xxx30 Use of intra-arterial injection papaverine

DCM xxx31 Dehydration

DCM xxx32 Contrast Agent Allergy

DCM xxx33 Infant or Neonate Patient

CID xxxx10 Substance Administration Injector Head Type

Context ID xxxx10 640

Substance Administration Injector Head Type Type: Extensible Version: 2012xxxx




DCM xxx34 Dual Head

Comment [SRB37]: Check for SNOMED and LINC codes See Part-16 and obtain them.

DCM xxx35 Single Ahead

CID xxxx11 Substance Administration Plan Type 645

Context ID xxxx11 Substance Administration Plan Type





DCM xxx36 Scheduled Planned

DCM xxx37 Programmed

DCM xxx38 Delivered

DCM xxxxx Defined

650

CID xxxx12 Pre-Medication Agents for Substance Administration

Context ID xxxx12 Pre-Medication Agents for Substance Administration





Trade Name (Informative)

(From url)

SRT C-37138 Prednisone

SRT C-51450 Diphenhydramine Benadryl

SRT C-37128 Methylprednisolone

SRT C-A01D1 Methylprednisolone sodium succinate (Solu-Medrol)

SRT C-A0173 Hydrocortisone sodium succinate (Solu-Cortef)

SRT C-913A4 Dexamethasone sodium sulfate (Decadron)

SRT C-51071 H-1 Antihistamine

SRT C-68050 Ephedrine

Comment [SRB38]: Chang to Planned

Comment [SRB39]: Check SNOMED

Comment [SRB40]: Is this Dexamethasone sodium “sulfate” or “phosphate”? Pls. check.

CID xxxx13 GFR Assessment Methods

Context ID xxxx13 GFR Assessment Methods 660





DCM xxx49 MDRD estimation of GFR

DCM xxx50 Cockroft-Gault Formula estimation of GFR

DCM xxx51 CKD-EPI Formula estimation of GFR

DCM xxx52 Direct Measurement of GFR

CID xxxx14 Substance Administration Consumable Type

Context ID xxxx14 665

Substance Administration Consumable Type Type: Extensible Version: 2012xxxx




DCM xxx53 Contrast

DCM xxx54 Flush

DCM xxx55 Syringe

DCM xxx56 Cartridge

DCM Xxx?

CID xxxx15 Administration Completion Status 670

Context ID xxxx15 Substance Administration Completion Status





DCM xxx57 Administration Completed

DCM xxx58 Administration Aborted

DCM xxx59 User Aborted Injection

DCM xxx59 Administration In Progress

675

Comment [SRB41]: Include Radio-pharma – see sup 159

Comment [SRB42]: Administration Completed Done

Comment [SRB43]: Follow MPPS status COMPLETED / DISCONTINUED Look up for reason for discontinuation See CID 9300

680

Annex D DICOM Controlled Terminology Definitions (Normative)

This Annex specifies the meanings of codes defined in DICOM, either explicitly or by reference to another part of DICOM or an external reference document or standard.

DICOM Code Definitions (Coding Scheme Designator “DCM” Coding Scheme Version “01”) 685

Code Value

Code Meaning Definition Notes

xxx1 Pressure limiting event occurred during injection.

Generally, this does not abort the injection however conveys if there was occurrence of any pressure limiting event.

xxx2 Flow-rate limiting event occurred during injection.

Generally, this does not abort the injection however conveys if there was occurrence of any flow-rate limiting event.

xxx3 Indicates occurrence of both pressure and flow-rate limit event detections.

xxx4 Injection aborted by clinician operator

xxx5 Anaphylactic Reaction observed during administration

xxx6 Dyspnea wheezing

xxxx7 Pre-filled

xxxx8 Empty (or Not Pre-filled)

xxxx9 Administration Fluid

xxx10 Administration Hold

xxx11 Administration Pause

xxx12 Flush or Saline

xxx13 Contrast-Agent

xxxxx Radio-Pharmaceutical

xxx14 Automated Injection

xxx15 Manual Injection

xxx16 Renal Insufficiency

Comment [SRB44]: Add Code definitions for all new DCM codes : See Annex D of Part-16 Done. See below.

xxx17 Diabetes

xxx18 Asthma

xxx19 Other Cardiac Disease

xxx20 Aortic Stenosis

xxx21 Angina

xxx22 Congestive Heart Failure Symptoms

xxx23 Primary Pulmonary Hypertension

xxx24 Cardiomyopathy

xxx25 Anxiety

xxx26 Paraproteinemias

xxx27 Multiple myeloma

xxx28 Use of Beta-adrenergic blocking agents

xxx29 Carcinoma of the thyroid

xxx30 Use of intra-arterial injection papaverine

xxx31 Dehydration

xxx32 Contrast Agent Allergy

xxx33 Infant or Neonate Patient

xxx34 Dual Head

xxx35 Single Ahead

xxx36 Planned

xxx37 Programmed

xxx38 Delivered

Xxxxx Defined

xxx49 MDRD estimation of GFR

xxx50 Cockroft-Gault Formula estimation of GFR

xxx51 CKD-EPI Formula estimation of GFR

xxx52 Direct Measurement Method of GFR

xxx53 Contrast

xxx54 Flush

xxx55 Syringe

xxx56 Cartridge

xxx57 Administration Completed

xxx58 Administration Aborted

xxx59 Administration In Progress

690



Part 17: Explanatory Information

695

700

705

710

715

Add new Section to Annex XX of PS 3.17: 720

Annex XX Substance Administration Report Template (Informative)

XX.1 PURPOSE OF THIS ANNEX

This Annex describes the use of the Substance Administration Reporting. The Substance Administration Report objects records the scheduled and performed delivery of contrasting agents.

The Planned Substance Administration object is intended for representing the plan or program to deliver 725

contrast agent to the patient for a contrast study. It could be programmed at the time of schedule of a study or beginning of the study. Often, it is programmed at the power-Injector device console by the modality technician or radiologists. The plan may be altered by the delivery system or a user based on a variety of factors.

The Performed Substance Administration SR IOD is for reporting the actual plan or program that was used 730

to deliver the contrast agent during a medical imaging study.

In addition to the above objects, the Basic Performed Substance Administration SOP class provides a summarized version of the performed Substance Administration.

The scope is intended to cover all modalities in which radiographic, radiopharmaceutical or other agents are introduced into a circulatory system in a controlled fashion (CT, MR, XA, NM, US) 735

XX.2 Real-World Substance Administration Reporting Workflow

Figure xx-1 demonstrates the workflow of administration of contrast agent during an imaging study.

Figure xx-1

740

Figure xx-2 shows Data flows with Contrast Agent Administration SR

Figure xx-2

745

750

755

Figure xx-3 shows the Case 1 – Manual Bolus Injection System

Figure xx-3 760

Case 2 – Manul Bolus Injection with input from DSS/Order Filler/Modality

Figure xx-4

765

Case 3 – Automatic Infusion Pump – Contrast Reporting

Figure xx-5

Case 4 – Automatic infusion pump contrast reporting : Dispense and Administration 770

Figure xx-6

775

Case 5 – Automatic infusion pump contrast reporting : Dispense, administration and realtime check of dispensed product.

780

Figure xx-7

785

Use case 6 – Integration with CT / MR

Figure xx-8

790

795

Use case – Integration with CV

800

Figure xx-9

805

810

Use case 8 – Reporting

Figure xx-10 815

Use case 9 – Protocoling

820

825

Template of Contrast Agent Administration SR structure

830

Digital Imaging and Communications in Medicine...

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