5 Digital Imaging and Communications in Medicine (DICOM) Supplement 164: Substance Administration Report 10 15 20 DICOM Standards Committee, Working Group 6 (Base Standard) Ad Hoc Group 1300 N. 17 th Street, Suite 1752 Rosslyn, Virginia 22209 USA 25 Status: VERSION: Draft Public Comment Draft Nov 5, 2012 30
Page 2 Table of Contents 35 40 45 50 55 60 65 70 75 Table of Contents... 2 DOCUMENT HISTORY... 3 Scope and Field of Application... 5 LIMITATIONS OF CURRENT STANDARD... 5 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 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 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 Constraints 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 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 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 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 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 TID xxxx9 Substance Administration Delivery Phase Template... 31 PERFORMED SUBSTANCE ADMINISTRATION SR IOD TEMPLATES... 32
Page 3 80 85 90 95 100 TID xxx10 Performed Substance Administration... 34 TID xxx11 Substance Administration Adverse Events... 35 TID xxx12 Contrast Injector Information... 36 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 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 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 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 Annex XX Substance Administration Report Template (Informative)... 47
Page 4 DOCUMENT HISTORY Document Date Version 01 2012/10/25 Initial Version Content 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) 105
Page 5 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). 110 115 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. 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 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. 120 125 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 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. 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. 130 Following are the SOP Classes defined in this supplement: 1. Planned Substance Administration SR Storage SR document representing the plan of delivery of diagnostic agent for imaging. 135 140 2. Performed Substance Administration SR Storage SR document representing what was actually delivered. 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. 4. Defined Substance Administration SR Storage SR document representing the administration protocol plan of substance administration that is defined. LIMITATIONS OF CURRENT STANDARD 145 Limited provision to record Planned Substance administration steps and detailed information pertaining to the injection of the prescribed imaging agents relative to the scheduled and planned
Page 6 150 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 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 155 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. 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 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 Comment [SRB5]: Comment relating to Closed Issue#1 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?
Page 7 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. 10 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? Comment [SRB6]: EventUID consider for every phase A: Yes, there will be new value for all objects.
Page 8 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.
Page 9 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 hangingprotocol objects. 160 Changes to NEMA Standards Publication PS 3.2-2011 Digital Imaging and Communications in Medicine (DICOM) 165 Part 2: Conformance 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 1.2.840.10008.5.1.4.1.1.88.X2 1.2.840.10008.5.1.4.1.1.88.X3 1.2.840.10008.5.1.4.1.1.88.X4 Planned Substance Administration SR Performed Substance Administration SR Basic Performed Substance Administration Storage Defined Substance Administration Storage Transfer Transfer Transfer Transfer 170
Page 10 Changes to NEMA Standards Publication PS 3.3-2011 175 Part 3: Information Object Definitions
Page 11 Item#2: Add new SR IOD of PS 3.3 A.35: 180 185 A.35.X1 Planned Substance Administration SR Information Object Definition A.35.X1.1 Planned Substance Administration SR Information Object Description 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. 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 190 195 200 205 A.35.X1.3.1 Planned Substance Administration SR IOD Content Constraints 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 NUM DATETIME DATE TIME UIDREF PNAME COMPOSITE IMAGE WAVEFORM CONTAINER
Page 12 210 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 byreference. Table A.35.X1-2 specifies the relationship constraints of this IOD. See Table C.17.3-8 for Relationship Type definitions. 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, COMPOSITE 1, IMAGE 1, WAVEFORM 1, CONTAINER (See below). TEXT, CODE, NUM, CONTAINER CONTAINER, IMAGE 1, WAVEFORM 1, COMPOSITE 1, NUM HAS OBS CONTEXT HAS ACQ CONTEXT TEXT, CODE, NUM, DATETIME, DATE, TIME, UIDREF, PNAME, COMPOSITE 1 TEXT, CODE, NUM, DATETIME, DATE, TIME, UIDREF, PNAME, CONTAINER. any type HAS CONCEPT MOD TEXT, CODE 2 TEXT, CODE, NUM HAS PROPERTIES TEXT, CODE, NUM, DATETIME, DATE, TIME, UIDREF, PNAME, IMAGE 1, WAVEFORM 1, COMPOSITE 1, CONTAINER. PNAME HAS PROPERTIES TEXT, CODE, DATETIME, DATE, TIME, UIDREF, PNAME TEXT, CODE, NUM INFERRED FROM TEXT, CODE, NUM, DATETIME, DATE, TIME, UIDREF, PNAME, IMAGE 1, WAVEFORM 1, COMPOSITE 1, CONTAINER. 215 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. 220
Page 13 225 230 235 A.35.X2 Performed Substance Administration SR Information Object Definition 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 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 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 Frame of Synchronization C.7.4.2 M Reference Equipment General Equipment C.7.5.1 M Enhanced General Equipment C.7.5.2 Document SR Document General C.17.2 M SR Document Content C.17.3 M SOP Common C.12.1 M M 240 245 250 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): TEXT CODE NUM DATETIME DATE TIME UIDREF PNAME COMPOSITE IMAGE
Page 14 WAVEFORM CONTAINER 255 260 A.35.X2.3.1.2 Relationship Constraints Relationships between content items in the content of this IOD may be conveyed either by-value or byreference. 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, COMPOSITE 1, IMAGE 1, WAVEFORM 1, CONTAINER (See below). TEXT, CODE, NUM, CONTAINER CONTAINER, IMAGE 1, WAVEFORM 1, COMPOSITE 1, NUM HAS OBS CONTEXT HAS ACQ CONTEXT TEXT, CODE, NUM, DATETIME, DATE, TIME, UIDREF, PNAME, COMPOSITE 1 TEXT, CODE, NUM, DATETIME, DATE, TIME, UIDREF, PNAME, CONTAINER. any type HAS CONCEPT MOD TEXT, CODE 2 TEXT, CODE, NUM HAS PROPERTIES TEXT, CODE, NUM, DATETIME, DATE, TIME, UIDREF, PNAME, IMAGE 1, WAVEFORM 1, COMPOSITE 1, CONTAINER. PNAME HAS PROPERTIES TEXT, CODE, DATETIME, DATE, TIME, UIDREF, PNAME TEXT, CODE, NUM INFERRED FROM TEXT, CODE, NUM, DATETIME, DATE, TIME, UIDREF, PNAME, IMAGE 1, WAVEFORM 1, COMPOSITE 1, CONTAINER. 265 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. 270 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 object, indicating the delivered plan.
Page 15 275 280 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 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. 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. 285 A.35.X3.3 Basic Performed Substance Administration IOD Module Table Table A.35.X3-1 BASIC PERFORMED SUBSTANCE ADMINISTRATION 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 General Series C.7.3.1 M Clinical Trial Series C.7.3.2 U Frame of Synchronization C.7.4.2 M Reference Equipment General Equipment C.7.5.1 M Substance Administration IE Enhanced General Equipment Enhanced Contrast Bolus Agent Module C.7.5.2 C.7-12b SOP Common C.12.1 M M M 290
Page 16 295 300 A.35.X4 Defined Substance Administration Information Object Definition 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. 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 realworld 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 IE Module Reference Usage Document SOP Common C.12.1 M Substance Administration C.X.X M Comment [SRB7]: Add Equipment IE 310 A.35.X4.3.1 A.35.X2.3.1.2 Defined Substance Administration IOD Content Constraints Relationship Constraints 315 A.35.X2.3.1.3 Content Constraints Add new Modality Type to PS 3.3: Defined Substance Administration IOD
Page 17 320 C.7.3.1.1 General Series Attribute Descriptions C.7.3.1.1.1 Modality Defined Terms for the Modality (0008,0060) are: IA = Imaging Agent Delivery System. 325 Add new IOD Definitions to PS 3.3: Annex C INFORMATION MODULE DEFINITIONS (NORMATIVE) 330 C.xx.x Substance Administration Module Table C.xx-x specifies the Attributes used to indicate administration of an imaging agent to a patient. 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 Injection Delay (xxxx,xxxx) 1 Scan Delay (xxxx,xxxx) 1 Delivery Phase (xxxx,xxxx) 1 (xxxx,xxxx) 1 (xxxx,xxxx) 1 Contrast Delivery Step Number 335
Page 18 Changes to NEMA Standards Publication PS 3.3-2011 340 Digital Imaging and Communications in Medicine (DICOM) 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 360 The SOP Classes in the Storage Service Class identify the Composite IODs to be stored. Table B.5-1 identifies Standard SOP Classes. Table B.5-1 STANDARD 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
Page 19 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 Performed Substance Administration SR Basic Performed Substance Administration Defined Substance Administration 1.2.840.10008.5.1.4.1.1.88.xx1 1.2.840.10008.5.1.4.1.1.88.xx2 1.2.840.10008.5.1.4.1.1.88.xx3 1.2.840.10008.5.1.4.1.1.88.xx4 Planned Substance Administration SR Performed Substance Administration SR Basic Performed Substance Administration Defined Substance Administration Encapsulated PDF Storage 1.2.840.10008.5.1.4.1.1.104.1 Encapsulated PDF IOD Comment [SRB8]: Move it up to top Comment [SRB9]: Change all defined object to SR 365 I.4 MEDIA STORAGE STANDARD SOP CLASSES 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
Page 20 370 Administration SR Performed Substance Administration SR Basic Performed Substance Administration Defined Substance Administration 1.2.840.10008.5.1.4.1.1.88.xx2 1.2.840.10008.5.1.4.1.1.88.xx3 1.2.840.10008.5.1.4.1.1.88.xx4 Administration SR Performed Substance Administration SR Basic Performed Substance Administration Defined Substance Administration 375 380 385 390
Page 21 Changes to NEMA Standards Publication PS 3.6-2011 395 Digital Imaging and Communications in Medicine (DICOM) Part 6: Data Dictionary 400 405 410 415
Page 22 420 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 1.2.840.10008.5.1.4.1.1.88.xx2 1.2.840.10008.5.1.4.1.1.88.xx3 1.2.840.10008.5.1.4.1.1.88.xx4 Planned Substance Administration SR Storage Performed Substance Administration SR Storage Basic Performed Substance Administration Storage Defined Substance Administration Storage SOP Class PS 3.4 SOP Class PS 3.4 SOP Class PS 3.4 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
Page 23 430 435 Changes to NEMA Standards Publication PS 3.16-2011 Digital Imaging and Communications in Medicine (DICOM) 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
Page 24 TID xxxx1 Planned Substance Agent Admin. TID 1002 Observer Context TID 3601 Procedure Context TID xxxx2 Pre-Medication Context TID xxxx3 Patient Risk-factors TID xxxx5 Substance Information TID xxxx6 Substance Administration Consumables TID xxxx7 Substance Administration Plan 450 Figure A.x-1: Planned Substance Administration SR IOD Template Structure TID xxxx1 Planned Substance Administration This template describes single scheduled administration plan.
Page 25 455 NL Rel with Parent VT 1 CONTAINER EV (xx8, 99SUP164, Planned Substance Administration Procedure Report ) 2 > CONTAINS INCLUDE DTID (1200) Language Designation 3 > HAS PROPERTIES TEXT TID xxxx1 Planned Substance Administration Type: Extensible Order: Significant Concept Name VM Req Condition Type EV (121144, DCM, Document Title") 4 > CONTAINS INCLUDE DTID (xxxx2) Pre-Medication Context 5 > CONTAINS INCLUDE DTID (xxxx3) Patient Risk-Factor Context related to Imaging Agents 7 > CONTAINS INCLUDE DTID (1001) Observation Context 8 > CONTAINS INCLUDE DTID (xxxx5) Contrast-Agent Information 9 > CONTAINS CODE EV(xx9, 99SUP164, Injection Mode ) 10 > CONTAINS TEXT EV(xx10, 99SUP164, Rationale for Administering Contrast Agent) 11 > CONTAINS INCLUDE DTID (xxxx6) Substance Administration Consumables 12 > CONTAINS INCLUDE DTID(xxxx7) Contrast Delivery Plan 1 M 1 M Value Set Constraint DCID (xxxx8) Substance Administration Mode 1-n U 1-n U Content Item Descriptions Row 4 Row 5 Row 7 Row 8 Row 10 Row 11 Information about premedication administration available at the time of scheduling the Substance Administration protocol. Information about patient risk-factors available at the time of scheduling the Substance Administration protocol. Person responsible for authoring the content of this object. Information about the contrast-agent scheduled to be used for the plan. Each item should contain a single rationale however multiple such items could be included Only contrast agent consumable details that are known at the time of scheduling (e.g., Needle length)
Page 26 460 465 TID xxxx2 Pre-Medication Context Detailed information on medications administered to the patient, prior to the Substance Administration. NL Rel with Parent TID xxxx2 Pre-Medication Context Type: Extensible Order: Significant VT Concept Name VM Req Condition Type 1 CODE EV(xx1, 99SUP164, Drug Product Identifier) 2 > HAS CODE PROPERTIES 3 > HAS TEXT PROPERTIES 4 > HAS NUM PROPERTIES 5 > HAS CODE PROPERTIES 6 > HAS NUM PROPERTIES EV(xx2, 99SUP164, Equivalent Drug Code) EV(xxx, 99SUP164, Drug Name) DCID (3410) Numeric Parameters of Drugs/Contrast EV (G-C340, SRT, Route of Administration ) EV(x222, 99SUP164, Fasting Period) Value Set Constraint 1-n U DCID (xxxx12) Pre- Medication Agents for Substance Administration 1-n U 1-n U 1-n U DCID (11) Route of Administration UNITS = DT (h, UCUM, "h") Content Item Descriptions 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 Comment [SRB10]: Tweak it TID xxxx3 Patient Risk-Factor Context related to Imaging Agents 470 NL Rel with Parent TID xxxx3 Patient Risk-Factor Context related to Imaging Agents Type: Extensible Order: Significant VT Concept Name VM Req Condition Type 1 CONTAINER EV (xxxx, 99SUP164, Imaging- Agent Related Risk Factors ) 2 > CONTAINS CODE EV (F-01500, SRT, Risk factor ) 3 > CONTAINS NUM EV (xx4, 99SUP164, Serum Creatinine ) 4 >> HAS OBS CONTEXT DATETIME EV (121135, DCM, Observation Date time ) Value Set Constraint 1-n U DCID (xxxx9) Imaging Agent Related Riskfactor Indications 1-n U UNITS = DT( mg/dl,ucum, mg/dl ) 1 M 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.
Page 27 5 > CONTAINS NUM EV (xx5, 99SUP164, Glomerular Filtration Rate ) 6 >> HAS OBS CONTEXT 7 >> HAS OBS CONTEXT CODE EV(xx6, 99SUP164, Assessment Method ) DATETIME EV (121135, 99SUP164, Observation Date time ) 1-n U UNITS = DT(mL/min/1.73m2, UCUM, ml/min/1.73m2 ) 1 M DCID (xxxx13) GFR Assessment Method 1 M Comment [SRB14]: Changed from U to M for row 6,7 475 Content Item Descriptions Row 3 Row 6 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. The Assessment method indicates if a GFR is estimated or measured. Comment [SRB15]: Drop this row desc. 480 TID xxxx5 NL Rel with Parent Substance Information TID xxxx5 Substance Information Type: Extensible Order: Significant VT Concept Name V M 1 CONTAINER EV(123011, DCM, Contrast/Bolus Agent ) EV(xxxxx, 99SUP164, Substance Admin.) 2 > CONTAINS TEXT EV(C-B0300, SRT, Contrast Agent ) 3 > CONTAINS CODE EV(xx12, 99SUP164, Contrast Agent ) 4 > HAS CODE PROPERTIES EV(xx2, 99SUP164, Equivalent Drug Code) Req Condition Type 1 M 1 M 1- n U Value Set Constraint DCID (12) Radiographic Contrast Agent 4b Is Radiopharmaceutical DCID (230) Yes - No 5 > CONTAINS CODE EV(G-C52F, SRT, Active Ingredient ) 6 > CONTAINS NUM EV(xx13, 99SUP164, Contrast Concentration ) 7 > CONTAINS NUM EV(xx14, 99SUP164, Molarity ) 8 > CONTAINS NUM EV(xx15, 99SUP164, Relaxivity ) 9 > CONTAINS NUM EV(xx16, 99SUP164, Osmolality at 37C ) 10 > CONTAINS NUM EV(xx17, 99SUP164, Osmolarity at 37C ) DCID (13) Radiographic Contrast Agent Ingredient UNITS = EV (mm^-1*sec^-1, UCUM, mm^-1*sec^-1 ) UNITS = EV (mosm/kg, UCUM, mosmol/kg ) UNITS = EV(mmol/L, UCUM, mmol/l ) 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.
Page 28 11 > CONTAINS NUM EV(xx18, 99SUP164, Viscosity at 37C ) 12 CONTAINS NUM EV(xx19, 99SUP164, > Flush Concentration ) 13 > CONTAINS DATETIME EV(xx20, 99SUP164, Contrast-Agent Order Date ) 14 > CONTAINS CODE EV (G-C340, SRT, "Route of administration") 15 > CONTAINS NUM EV(xx??, 99SUP164, Scheduled Administered Activity ) 16 > CONTAINS NUM EV(xx??, 99SUP164, Maximum Administered Activity ) 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 ) UNITS = EV(mOsm/kg H20, UCUM, mosm/kg H20 ) UNITS = EV(Mg/L, UCUM, Mg/L ) DCID (11) Route of Administration 1 MC IFF Row 4b Equals Yes C IFF Row 4b Equals Yes C IFF Row 4b Equals Yes C IFF Row 4b Equals Yes C IFF Row 4b Equals Yes Units = EV (MBq, UCUM, MBq ) Units = EV (MBq, UCUM, MBq ) Units = EV (MBq, UCUM, MBq ) Comment [SRB19]: Add units Content Item Descriptions 485 TID xxxx6 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 Row 15 Row 16 Row 17 Row 18 NL Rel with Parent Date-time the Contrast-Agent was ordered by the physician. The desired activity to be administered. The not to exceed amount of activity The amount of activity is not available do not adminisiter the radiopharmaceutical Some radiopharmaceuticals can be deadly if too much is given to the patient Substance Administration Consumables TID xxxx6 Substance Administration Consumables Type: Extensible Order: Significant VT Concept Name VM Req Condition Type 1 CONTAINER EV(xx21, 99SUP164, Contrast-Agent Consumable Information ) Value Set Constraint 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.
Page 29 2 > CONTAINS CODE EV(xx45, 99SUP164, Substance Consumable Type ) 3 > CONTAINS TEXT EV (121148, SRT, Unit Serial Identifier ) 4 > CONTAINS TEXT EV (121149, DCM, Lot identifier ) 1-n U DCID (xxxx14) Substance Administration Consumable Type 5 > CONTAINS TEXT EV(xx46, 99SUP164, UPC Code ) 6 > CONTAINS TEXT EV (121145, SRT, Description of Material ) 7 > CONTAINS DATE EV(xx22,99SUP164, "Expiry Date") 8 > CONTAINS NUM EV (111467, DCM, Needle Length ) 9 > CONTAINS CODE EV (122319, DCM, Catheter Size ) 10 > CONTAINS TEXT EV(xx23, 99SUP164, Manufacturer Name ) 11 > CONTAINS CODE EV(xx24, 99SUP164, Syringe Type ) 12 > HAS PROPERTIES NUM EV (121146, DCM, Quantity of material ) 10 > CONTAINS TEXT EV(xx25, 99SUP164, Cartridge Description ) 13 > CONTAINS TEXT EV (121147, DCM, "Billing Code") 1 C IFF Row Equals UNITS = EV (cm, (xxxx, DCM, Syringe ) UCUM, centimeter ) UNITS = DCID (3510) Catheter Size Units 1 C IFF Row Equals DCID (xxxx3) Contrast Agent (xxxx, DCM, Syringe ) Injection Syringe Type 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 490 Content Item Descriptions Row 3 Row 4 Row 6 Row 7 Row 8 Row 10 Row 11 Row 12 Row 10 Row 11 Serial ID of the contrast agent consumable LOT identifier of the contrast agent Description about the contrast agent material if any Expiry date of Substance Needle Length of the catheter used Syringe manufacturer name See new CID for syringe type (Pre-filled or Empty) Syringe quantity number Description about Cartridge 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.
Page 30 495 NL Rel with Parent TID xxxx7 Substance Administration Delivery Plan Template Type: Extensible Order: Significant VT Concept Name VM Req Condition Type 1 CONTAINER EV(xx26, 99SUP164, Substance Delivery Procedure Plan ) 1 M Value Set Constraint 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 ) 5 >> HAS CONCEPT MODIFIER CODE 6 > CONTAINS NUM EV(121401,DCM,"Deri vation") EV(122094, DCM, Rate of administration ) IFF Shall be included only for Power injection method 1 C This modifier shall be included only for the above encoded Pressure concept. UNITS = EV(kPa,UCUM, kpa ) UNITS = EV(ml/S,UCUM, ml/s ) Comment [SB26]: How does one use IFF construct for these conditions below? 7 > CONTAINS WAVEFORM $MeasurementGraph 1-n MC Required if the value of Row 2 is Delivered with Injection mode as Power Injector. Content Item Descriptions Row 1 Row 2 Plan Name /Title or simply a Plan number as text 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 500 Generally, 3 waveform objects referenced: a. Flow-Rate vs Time, b. Pressure vs Time c. Volume vs Time
Page 31 TID xxxx8 Substance Administration Delivery Step 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. 505 NL Rel with Parent TID xxxx8 Substance Administration Delivery Step Template Type: Extensible Order: Significant VT Concept Name VM Req Condition Type 1 CONTAINER EV(xx28, 99SUP164, Contrast Delivery Procedure Step ) 1 M Value Set Constraint 2 > CONTAINS NUM EV(xx, 99SUP164, Contrast Delivery Step Number ) 3 > CONTAINS NUM EV(xx29, 99SUP164, Injection Delay ) 4 > CONTAINS NUM EV(xx30, 99SUP164, "Scan Delay ") 5 > CONTAINS CODE EV(xx31, 99SUP164, Delivery Phase ) 1 M Units = EV (1,UCUM, no units ) 1 M UNITS = EV (s, UCUM, s ) 1 M UNITS = EV (s, UCUM, s ) 1 M Content Item Descriptions 510 Row 2 Contrast Delivery Step Number indicates a delivery step, it increases monotonously. 515 TID xxxx9 Substance Administration Delivery Phase 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. NL Rel with Parent TID xxxx9 Substance Delivery Phase Template Type: Extensible Order: Significant VT Concept Name VM Req Condition Type 1 CONTAINER EV(xx32, 99SUP164, Substance Delivery Phase ) > CONTAINS CODE EV(xx62, 99SUP164, Substance Delivery Phase Type ) 2 > CONTAINS CODE EV(xx33, 99SUP164, Substance Type ) 3 > CONTAINS NUM EV(xx33, 99SUP164, "Substance Flush Ratio") 4 > CONTAINS NUM EV(122095, DCM, Duration of administration ) 1 M Value Set Constraint 1 M DCID (xxx4) Substance Phase Type 1 MC IFF Row 1a equals (xxxx, DCM, Fluid ) 1 MC IFF Row 1a equals (xxxx, DCM, Fluid ) CID xxxx5 Substance Type UNITS = EV({0:100}, UCUM, range 0-100 ) 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
Page 32 5 > CONTAINS NUM EV(122091, DCM, 1 MC IFF Row 1a equals Volume Administered (xxxx, DCM, Fluid ) 6 > CONTAINS NUM EV(122094, DCM, Rate of administration ) 7 > CONTAINS DATETIME EV(111526, DCM, DateTime Started 8 > CONTAINS DATETIME EV(111527, DCM, DateTime Ended 9 > CONTAINS NUM EV(xx34, 99SUP164, Starting Substance Volume ) 10 > CONTAINS NUM EV(xx35, 99SUP164, Rise Time") C IFF Row 1a equals (xxxx, DCM, Fluid ) C IFF Row 1a equals (xxxx, DCM, Fluid ) UNITS = EV(ml/sec, UCUM ml/sec ) 1 M UNITS = EV (s, UCUM, s ) Content Item Descriptions 520 Row 3 Row 5 Row 7 Row 8 Row 9 Row 10 Ratio contains the ratio number of the fluid in context. (i.e., Referred in the previous Fluid Type item) Shall be included only if the type of Contrast Delivery Phase is Fluid Date time of when the Substance delivery started for the current phase This Item is only required for Performed Substance Administration SOP Instance. Date time of when the Substance delivery ended for the current phase This Item is only required for Performed Substance Administration SOP Instance. Starting Contrast Volume Number Rise time of the phase 525 PERFORMED SUBSTANCE ADMINISTRATION SR IOD TEMPLATES The templates that comprise the Performed Substance Administration are interconnected as in Figure A- x.2
Page 33 TID xxxx10 Performed Contrast Agent Admin. TID 1002 Observer Context TID 3601 Procedure Context TID xxx2 Pre-Medication Context TID xxx3 Patient Risk-Factors 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
Page 34 530 Figure A.x-2: Performed Substance Administration SR IOD Template Structure 535 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). NL Rel with Parent TID xxx10 Performed Substance Administration Type: Extensible VT Concept Name VM Req Condition Type 1 CONTAINER EV (XXXXXX, DCM, Performed Substance Administration Procedure Report ) 2 > CONTAINS INCLUDE DTID 1200 Language Designation 3 > CONTAINS TEXT EV (121144, DCM, Document Title") 4 > CONTAINS INCLUDE DTID(xxxx1) Pre-Medication 5 > CONTAINS INCLUDE DTID (xxx3) Patient Risk-Factor Context related to Imaging Agents 6 > CONTAINS INCLUDE DTID (1002) Observer Context 8 > CONTAINS CODE EV(xx36, 99SUP164, Injection Mode ) 9 > CONTAINS INCLUDE DTID (xxx5) Substance Information 10 > CONTAINS INCLUDE DTID (xx12) Contrast- Injector Information 11 > CONTAINS INCLUDE DTID (xxxx6) Substance Consumables 12 > CONTAINS INCLUDE DTID(xxxx7) Substance Administration Plan 13 > CONTAINS INCLUDE DTID(xxx14) Contrast Administration Plan 14 > CONTAINS INCLUDE DTID (xxx11) Substance Administration Adverse Events 15 > CONTAINS CODE EV(xx60,99SUP164, Substance Administration Completion Status ) 1 M 1-n U Value Set Constraint 1 M DCID (xxxx8) Substance Administration Mode 1 M 1 MC Required IFF a programmable injection device is used 1-2 U 1-n MC IFF Performed and patient had adverse reactions 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
Page 35 540 Content Item Descriptions 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 Comment [SRB32]: Tech Vs Device Vs Supervising radiologist for Manual / Automated administration. 545 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. NL Rel with Parent TID xxx11 Substance Administration Adverse Event Reactions Type: Extensible VT Concept Name VM Req Condition Type 1 CONTAINER EV (xxxxx, 99SUP164, "Substance Administration Adverse Event ) Complications") 2 > CONTAINS CODE EV(DF-10781, DCM, Substance Administration Adverse Reaction ) 3 >> HAS TEXT PROPERTIES 4 >> HAS CODE PROPERTIES 5 >> HAS DATETIME PROPERTIES 6 >> HAS NUM PROPERTIES 7 >> HAS NUM PROPERTIES 8 >> HAS NUM PROPERTIES EV (DD-60002, SRT, Complication of Procedure ) EV (xxxxx, 99SUP164, Relative Time ) EV (G-D709, SRT, "Relative Time ) EV(xx37, 99SUP164, Adverse Event Observation Date Time ) EV(xx38, 99SUP164, Adverse Reaction Step ) EV(xx39, 99SUP164, Adverse Reaction Phase ) EV(xxxx, 99SUP164, Adverse Event Reaction Grade ) 1 M Value Set Constraint 1 M DCID(930) Procedure Discontinuation Reasons U 1 M DCID (xxxx2) Temporal Periods Relating To Contrast Procedure Comment [SRB33]: Work on Grade number. NCI( National Cancer Institute), SNOMED, WHO (World Health Org.)
Page 36 Content Item Descriptions 550 Row 3 Row 5 Row 6 Row 7 Description about the nature of the complication Date and time when the adverse event was observed Indicates the performed step number in this plan where an adverse reaction found to occur. Indicates the performed phase number in the step of this plan where an adverse reaction found to occur. 555 TID xxx12 Contrast Injector Information This template provides detailed information about the contrast injector system used for delivery. NL Rel with Parent TID xxx12 Contrast Injector Information Template Type: Extensible VT Concept Name VM Req Condition Type 1 > CONTAINS CONTAINER EV(xx40, 99SUP164, Contrast Injector Information ) 2 >> HAS TEXT PROPERTIES 3 >> HAS TEXT PROPERTIES 4 >> HAS TEXT PROPERTIES 5 >> HAS TEXT PROPERTIES EV(xx41, 99SUP164, Injector Manufacturer ) EV(xx42, 99SUP164, Injector Model ) EV(xx43, 99SUP164, Injector Software Version ) EV(xx44, 99SUP164, Injector Type ) 1 M Value Set Constraint DCID (xxxx10) Contrast Agent Substance Administration Injector Head Type Comment [SRB34]: Look for Device Module in part-16 Content Item Descriptions Row 5 Type of injector Dual Head, Single Head, etc. 560 TID xxx14 Substance Administration Plan Template This template provides detailed information on substance adminstration delivery plan. A plan consists of multiple steps of delivery; a step in turn consists of multiple phases. NL Rel with Parent TID xxx14 Substance Administration Plan Template Type: Extensible Order: Significant VT Concept Name VM Req Condition Type 1 CONTAINER EV(200, 99SUP164, Substance Administration Plan ) Value Set Constraint
Page 37 2 > CONTAINS CODE EV(xx27, 99SUP164, Plan Type ) 1 M DCID (xxxx11) Substance Administration Plan Type 565 3 > CONTAINS COMPOSITE EV(xx201, 99SUP164, Substance Administration Plan Report ) Content Item Descriptions 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: 570 575 CID 9300 CID xxxx1 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 Substance Administration Adverse Event Reaction List 580 Coding Scheme Designator (0008,0102) Context ID xxxx1 Substance Administration Adverse Event Agent Reaction List Type: Extensible Version: 2012xxxx Code Value (0008,0100) Code Meaning (0008,0104) DCM xxx1 Pressure limiting event occurred during injection,
Page 38 DCM xxx2 Flow-rate limiting event occurred during injection. DCM xxx3 Indicates occurrence of both pressure and flowrate 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 585 Coding Scheme Designator (0008,0102) Context ID CXX10 Intravenous Extravasation Symptoms Type: Extensible Version: yyyymmdd Code Value (0008,0100) $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 Code Meaning (0008,0104) $99SUP159 CDX139 Skin Blistering or Ulceration $99SUP159 CDX140 Compartment Syndrome $99SUP159 CDX141 Other Extravasation Symptom Add new CID for Radiosensitive Organs in Part 16: 590 CID xxxx2 Temporal Periods Relating To Contrast Procedure Coding Scheme Designator (0008,0102) Context ID xxxx2 Temporal Periods Relating To Contrast Procedure Type: Extensible Version: 2012xxxx Code Value (0008,0100) Code Meaning (0008,0104)
Page 39 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 595 600 605 CID xxxx3 CID xxxx4 Contrast Agent Injection Substance Administration Syringe Type Coding Scheme Designator (0008,0102) Context ID xxxx3 Contrast Agent Injection Substance Administration Syringe Type Type: Extensible Version: 2012xxxx Code Value (0008,0100) DCM xxxx7 Pre-filled DCM xxxx8 Empty (or Not Pre-filled) Contrast Agent Substance Administration Phase Type Coding Scheme Designator (0008,0102) Code Meaning (0008,0104) Context ID xxxx4 Contrast Agent Substance Administration Phase Type Type: Extensible Version: 2012xxxx Code Value (0008,0100) DCM xxxx9 Injection Fluid Administration Fluid DCM xxx10 Administration Hold DCM xxx11 Administration Pause Code Meaning (0008,0104) Comment [SRB35]: Injection or Administration? 610 CID xxxx5 Substance Type Context ID xxxx5 Substance Type Type: Extensible Version: 2012xxxx Coding Scheme Designator (0008,0102) Code Value (0008,0100) DCM xxx12 Flush or Saline DCM xxx13 Contrast-Agent Code Meaning (0008,0104)
Page 40 DCM xxxxx Radio-Pharmaceutical 615 CID xxxx6 Substance Administration Consumable Context ID xxxx6 Substance Administration Consumables Type: Extensible Version: 2012xxxx Coding Scheme Designator (0008,0102) Code Value (0008,0100) DCM 121145 Description of Material DCM 121148 Unit Serial Identifier DCM 121149 Lot Identifier Code Meaning (0008,0104) 620 CID xxxx7 Temporal Periods Relating To Procedure Context ID xxxx7 Temporal Periods Relating To Procedure Type: Extensible Version: 2012xxxx Coding Scheme Designator (0008,0102) Code Value (0008,0100) SRT R-422A4 After Procedure SRT R-40FBA During Procedure SRT R-40FB9 Before Procedure Code Meaning (0008,0104) 625 CID xxxx8 Substance Administration Mode Context ID xxxx8 Substance Administration Mode Type: Extensible Version: 2012xxxx Coding Scheme Designator (0008,0102) Code Value (0008,0100) DCM xxx14 Power Injector Automated Injection DCM xxx15 Manual Injection Code Meaning (0008,0104) Comment [SRB36]: Automated Injection
Page 41 630 635 CID xxxx9 Substance Administration Related Risk-Factor Indications Context ID xxxx9 Substance Administration Related Risk-factor Indications Type: Extensible Version: 2012xxxx Coding Scheme Designator (0008,0102) Code Value (0008,0100) DCM xxx16 Renal Insufficiency DCM xxx17 Diabetes DCM xxx18 Asthma DCM xxx19 Other Cardiac Disease DCM xxx20 Aortic Stenosis DCM xxx21 Angina Code Meaning (0008,0104) 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 Comment [SRB37]: Check for SNOMED and LINC codes See Part-16 and obtain them. 640 CID xxxx10 Substance Administration Injector Head Type Context ID xxxx10 Substance Administration Injector Head Type Type: Extensible Version: 2012xxxx Coding Scheme Designator (0008,0102) Code Value (0008,0100) DCM xxx34 Dual Head Code Meaning (0008,0104)
Page 42 DCM xxx35 Single Ahead 645 CID xxxx11 Substance Administration Plan Type Context ID xxxx11 Substance Administration Plan Type Type: Extensible Version: 2012xxxx Coding Scheme Designator (0008,0102) Code Value (0008,0100) DCM xxx36 Scheduled Planned DCM xxx37 Programmed DCM xxx38 Delivered DCM xxxxx Defined Code Meaning (0008,0104) Comment [SRB38]: Chang to Planned 650 655 CID xxxx12 Coding Scheme Designator (0008,0102) Pre-Medication Agents for Substance Administration Context ID xxxx12 Pre-Medication Agents for Substance Administration Type: Extensible Version: 2012xxxx Code Value (0008,0100) Code Meaning (0008,0104) 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 Trade Name (Informative) (From url) Comment [SRB39]: Check SNOMED Comment [SRB40]: Is this Dexamethasone sodium sulfate or phosphate? Pls. check.
Page 43 660 CID xxxx13 GFR Assessment Methods Context ID xxxx13 GFR Assessment Methods Type: Extensible Version: 2012xxxx Coding Scheme Designator (0008,0102) Code Value (0008,0100) Code Meaning (0008,0104) 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 665 CID xxxx14 Substance Administration Consumable Type Context ID xxxx14 Substance Administration Consumable Type Type: Extensible Version: 2012xxxx Coding Scheme Designator (0008,0102) Code Value (0008,0100) DCM xxx53 Contrast DCM xxx54 Flush DCM xxx55 Syringe DCM xxx56 Cartridge DCM Xxx? Code Meaning (0008,0104) Comment [SRB41]: Include Radio-pharma see sup 159 670 675 CID xxxx15 Administration Completion Status Context ID xxxx15 Substance Administration Completion Status Type: Extensible Version: 2012xxxx Coding Scheme Designator (0008,0102) Code Value (0008,0100) Code Meaning (0008,0104) DCM xxx57 Administration Completed DCM xxx58 Administration Aborted DCM xxx59 User Aborted Injection DCM xxx59 Administration In Progress Comment [SRB42]: Administration Completed Done Comment [SRB43]: Follow MPPS status COMPLETED / DISCONTINUED Look up for reason for discontinuation See CID 9300
Page 44 Comment [SRB44]: Add Code definitions for all new DCM codes : See Annex D of Part-16 Done. See below. 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. 685 Code Value xxx1 xxx2 xxx3 xxx4 xxx5 xxx6 xxxx7 xxxx8 xxxx9 xxx10 xxx11 xxx12 xxx13 xxxxx xxx14 xxx15 xxx16 DICOM Code Definitions (Coding Scheme Designator DCM Coding Scheme Version 01 ) Code Meaning Definition Notes Pressure limiting event occurred during injection. Flow-rate limiting event occurred during injection. Indicates occurrence of both pressure and flow-rate limit event detections. Injection aborted by clinician operator Anaphylactic Reaction observed during administration Dyspnea wheezing Pre-filled Empty (or Not Pre-filled) Administration Fluid Administration Hold Administration Pause Flush or Saline Contrast-Agent Radio-Pharmaceutical Automated Injection Manual Injection Renal Insufficiency Generally, this does not abort the injection however conveys if there was occurrence of any pressure limiting event. Generally, this does not abort the injection however conveys if there was occurrence of any flow-rate limiting event.
Page 45 xxx17 xxx18 xxx19 xxx20 xxx21 xxx22 xxx23 xxx24 xxx25 xxx26 xxx27 xxx28 xxx29 xxx30 xxx31 xxx32 xxx33 xxx34 xxx35 xxx36 xxx37 xxx38 Xxxxx xxx49 xxx50 xxx51 xxx52 xxx53 xxx54 xxx55 xxx56 xxx57 Diabetes Asthma Other Cardiac Disease Aortic Stenosis Angina Congestive Heart Failure Symptoms Primary Pulmonary Hypertension Cardiomyopathy Anxiety Paraproteinemias Multiple myeloma Use of Beta-adrenergic blocking agents Carcinoma of the thyroid Use of intra-arterial injection papaverine Dehydration Contrast Agent Allergy Infant or Neonate Patient Dual Head Single Ahead Planned Programmed Delivered Defined MDRD estimation of GFR Cockroft-Gault Formula estimation of GFR CKD-EPI Formula estimation of GFR Direct Measurement Method of GFR Contrast Flush Syringe Cartridge Administration Completed
Page 46 xxx58 xxx59 Administration Aborted Administration In Progress 690 Changes to NEMA Standards Publication PS 3.17-2011 Digital Imaging and Communications in Medicine (DICOM) Part 17: Explanatory Information 695 700 705 710
Page 47 715 720 Add new Section to Annex XX of PS 3.17: 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. 725 730 The Planned Substance Administration object is intended for representing the plan or program to deliver 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 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. 735 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) XX.2 Real-World Substance Administration Reporting Workflow Figure xx-1 demonstrates the workflow of administration of contrast agent during an imaging study.
Page 48 Figure xx-1 740 Figure xx-2 shows Data flows with Contrast Agent Administration SR
Page 49 Figure xx-2 745 750 755
Page 50 Figure xx-3 shows the Case 1 Manual Bolus Injection System 760 Figure xx-3 Case 2 Manul Bolus Injection with input from DSS/Order Filler/Modality
Page 51 Figure xx-4 765 Case 3 Automatic Infusion Pump Contrast Reporting
Page 52 Figure xx-5 770 Case 4 Automatic infusion pump contrast reporting : Dispense and Administration
Page 53 Figure xx-6 775
Page 54 Case 5 Automatic infusion pump contrast reporting : Dispense, administration and realtime check of dispensed product. 780 Figure xx-7 785
Page 55 Use case 6 Integration with CT / MR Figure xx-8 790 795
Page 56 Use case Integration with CV 800 Figure xx-9 805 810
Page 57 Use case 8 Reporting 815 Figure xx-10
Page 58 Use case 9 Protocoling 820 825
Page 59 Template of Contrast Agent Administration SR structure 830
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