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. 17th 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 ........................................................................................................................................... 6 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 ............................... 12 A.35.X1.1 Planned Substance Administration SR Information Object Description ............... 12 A.35.X1.2 Planned Substance Administration SR IOD Entity-Relationship Model ............... 12 A.35.X1.3 Planned Substance Administration SR IOD Module Table .................................. 12 A.35.X1.3.1 Planned Substance Administration SR IOD Content Constraints12 A.35.X2 Performed Substance Administration SR Information Object Definition ........................... 14 A.35.X2.1 Performed Substance Administration SR Information Object Description ........... 14 A.35.X2.2 Performed Substance Administration SR IOD Entity-Relationship Model ............ 14 A.35.X2.3 Performed Substance Administration SR IOD Module Table ............................... 14 A.35.X2.3.1 Performed Substance Administration SR IOD Content Constraints 14 A.35.X3 Basic Performed Substance Administration Information Object Definition........................ 16 A.35.X3.1 Basic Performed Substance Administration Information Object Description ............................................................................................................................. 16 A.35.X3.2 Basic Performed Substance Administration IOD Entity-Relationship Model ........ 16 A.35.X3.3 Basic Performed Substance Administration IOD Module Table ........................... 16 A.35.X4 Defined Substance Administration SR Information Object Definition ................................ 11 A.35.X4.1 Defined Substance Administration SR Information Object Description ................ 11 A.35.X4.2 Defined Substance Administration IOD Entity-Relationship Model ...................... 11 A.35.X4.3 Defined Substance Administration IOD Module Table ......................................... 11 A.35.X4.3.1 Defined Substance Administration IOD Content Constraints .. 11 C.7.3.1.1 General Series Attribute Descriptions ...................................... 17 Annex C INFORMATION MODULE DEFINITIONS (NORMATIVE) .................................................... 17 C.xx.x Substance Administration Module ................................. Error! Bookmark not defined. 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 DEFINED SUBSTANCE ADMINISTRATION SR IOD TEMPLATES .................................................... 23 TID xxx16 Defined Substance Administration ..................................................................... 24 PLANNED SUBSTANCE ADMINISTRATION SR IOD TEMPLATES ................................................... 25 TID xxxx1 Planned Substance Administration .................................................................... 26 TID xxxx2 Pre-Medication Context for Substance Administration ...................................... 28 TID xxxx3 Patient Risk-Factor Context related to Imaging Agents ..................................... 29 TID xxxx5 Substance Information ....................................................................................... 30 TID xxxx6 Substance Administration Consumables ........................................................... 31 Page 3 80 85 90 95 100 105 TID xxxx7 Substance Administration Delivery Plan Template ............................................ 33 TID xxxx8 Substance Administration Delivery Step Template ............................................ 34 TID xxxx9 Substance Administration Delivery Phase Template ......................................... 34 PERFORMED SUBSTANCE ADMINISTRATION SR IOD TEMPLATES ............................................. 36 TID xxx10 Performed Substance Administration ................................................................. 38 TID xxx11 Substance Administration Adverse Events ........................................................ 39 TID xxx12 Substance Administration Device Information ................................................... 40 TID xxx14 Substance Administration Plan Template ............ Error! Bookmark not defined. TID XXX15 Radiopharmaceutical Substance Administration Data ....................................... 41 CID 9300 Procedure Discontinuation Reasons ............................................................................ 42 CID xxxx1 Substance Administration Adverse Event Reaction List .................................... 43 CID CXX10 Intravenous Extravasation Symptoms ................................................................ 43 CID xxxx2 Temporal Periods Relating To Contrast Procedure ........................................... 44 CID xxxx3 Contrast Agent Injection Substance Administration Syringe Type..................... 44 CID xxxx4 Contrast Agent Substance Administration Phase Type ..................................... 44 CID xxxx5 Substance Type ................................................................................................. 45 CID xxxx6 Substance Administration Consumable ............................................................. 45 CID xxxx7 Temporal Periods Relating To Procedure .......................................................... 45 CID xxxx8 Substance Administration Mode......................................................................... 45 CID xxxx9 Substance Administration Related Risk-Factor Indications ............................... 46 CID xxxx10 Substance Administration Injector Head Type ................................................... 47 CID xxxx11 Substance Administration Plan Type ................................................................. 47 CID xxxx12 Pre-Medication Agents for Substance Administration ........................................ 47 CID xxxx13 GFR Assessment Methods ................................................................................ 48 CID xxxx14 Substance Administration Consumable Type .................................................... 48 CID xxxx15 Administration Completion Status ...................................................................... 49 Annex D DICOM Controlled Terminology Definitions (Normative) ....................................................... 49 Changes to NEMA Standards Publication PS 3.17-2011 ............................................................................. 51 Annex XX Substance Administration Report Template (Informative) .......................................................... 52 Page 4 DOCUMENT HISTORY Document Version 110 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) Page 5 Scope and Field of Application The supplement applies to all modalities in which radiographic, radiopharmaceutical or other imaging agents are introduced into a circulatory system in a controlled fashion (CT, MR, XA, NM, US). 115 Following are the new SOP Classes introduced to describe administration events, flows, pressure, timings, physio-chemical attributes and pharmacological attributes of the agent administration and also consumables related to the administration. These SOP classes do not describe radioactivity or dosimetry administered. 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. The Planned Substance Administration SR Storage SOP Class is intended for representing the plan or program to deliver imaging agent customized to a specific patient. Often, it is planned by the radiologists where the plan is tuned to the characteristics of a patient and needs of that procedure. 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. In addition, the Basic Performed Substance Administration provides a summarized version of the performed substance administration. This is 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 120 125 130 135 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. 140 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 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). Page 6 TO DO 150 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. OPEN ISSUES 6 Does the Basic Substance Administration need any additional attributes to make Q/R more effective? The design intent is that the pump will store the above SOP Instance directly to the modality. 7 Are the Enhanced Contrast/Bolus Module, Enhanced PET Isotope module and the Interventional modules sufficient for recording radio-pharmaceutical substance administration? (For PET/SPECT/Nucmed imaging) Is UPC Code is the correct code to identify a consumable related to substance administration? 8 CLOSED ISSUES 155 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 Page 7 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. 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-ObjectionSelection 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 Page 8 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 hangingprotocol objects. 12 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. 13 Work on Adverse Event Grade under adverse event template. Not a WG-06 question. 14 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. 15 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 Closed. Page 9 16 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? Closed. 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. 17 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? Closed. 18 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? – Wanted to clarify if this contradicts with the existing Substance Administration? 19 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)? Closed. Nothing could be done about it. Cannot be addressed in DICOM. 160 Changes to NEMA Standards Publication PS 3.2-2011 Digital Imaging and Communications in Medicine (DICOM) Part 2: Conformance Item #01: Add new SOP Classes in Table A.1-2 165 Table A.1-2 UID VALUES Page 10 UID Value UID NAME Category … 1.2.840.10008.5.1.4.1.1.88.X4 Defined Substance Administration SR Transfer 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 … 170 Changes to NEMA Standards Publication PS 3.3-2011 Part 3: Information Object Definitions Page 11 Item#2: Add new SR IOD of PS 3.3 A.35: 175 A.35.X0 Defined Substance Administration SR Information Object Definition A.35.X0.1 Defined Substance Administration SR Information Object Description 180 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 SR Admin IOD 185 A.35.X0.3 Defined Substance Administration IOD Module Table Table A.35.X0-1 DEFINED SUBSTANCE ADMINISTRATION IOD MODULES IE Module Equipment Document Reference Usage General Equipment C.7.5.1 M Enhanced General Equipment C.7.5.2 M SR Document General C.17.2 M SR Document Content C.17.3 M SOP Common C.12.1 M 190 A.35.X0.3.1 Defined Substance Administration IOD Content Constraints A.35.X0.3.1.2 Relationship Constraints A.35.X0.3.1.3 Content Constraints 195 Page 12 200 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 imaging agent material to patients during contrast-enhanced medical imaging studies. A.35.X1.2 Planned Substance Administration SR IOD Entity-Relationship Model 205 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 General Study C.7.2.1 M Patient Study C.7.2.2 U Clinical Trial Study C.7.2.3 U 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 Study Series 210 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): 215 220 225 TEXT CODE NUM DATETIME DATE TIME UIDREF PNAME COMPOSITE IMAGE WAVEFORM CONTAINER Page 13 A.35.X1.3.1.2 230 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 235 240 245 Note: 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. 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. Page 14 A.35.X2 Performed Substance Administration SR Information Object Definition A.35.X2.1 Performed Substance Administration SR Information Object Description 250 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 255 IE Module Reference Usage Patient Patient C.7.1.1 M Clinical Trial Subject C.7.1.3 U General Study C.7.2.1 M Patient Study C.7.2.2 U Clinical Trial Study C.7.2.3 U SR Document Series C.17.1 M Clinical Trial Series C.7.3.2 U Frame of Reference Synchronization C.7.4.2 M Equipment General Equipment C.7.5.1 M Enhanced General Equipment C.7.5.2 M SR Document General C.17.2 M SR Document Content C.17.3 M SOP Common C.12.1 M Study Series Document 260 265 270 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 15 WAVEFORM CONTAINER 275 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 280 Source Value Type Note: 285 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. 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. A.35.X2.3.1.3 290 Relationship Type (Enumerated Values) 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 16 A.35.X3 Basic Performed Substance Administration Information Object Definition 295 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. 300 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. 305 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 General Study C.7.2.1 M Patient Study C.7.2.2 U Clinical Trial Study C.7.2.3 U General Series C.7.3.1 M Clinical Trial Series C.7.3.2 U Frame of Reference Synchronization C.7.4.2 M Equipment General Equipment C.7.5.1 M Enhanced General Equipment C.7.5.2 M Enhanced Contrast/Bolus C.7.6.4b C – Required if non-radiopharmaceutical substance was administered Enhanced PET Isotope C.8.22.4 C – Required if radiopharmaceutical substance was administered Intervention C.7.6.13 C – Required if interventional substance was administered C.12.1 M Study Series Substance Administration SOP Common 310 Page 17 315 A.35.X3.X Basic Substance Administration IOD Content Constraints A.35.X3.3.1 Modality The value of Modality (0008,0060) shall be IA. A.35.X3.3.2 Radionuclide Code Sequence The Baseline Context Group for Radionuclide Code Sequence (0054,0300) are CID 18 and CID 4020. 320 A.35.X3.3.3 Radiopharmaceutical Code Sequence The Baseline Context Group for Radiopharmaceutical Code Sequence (0054,0304) are CID 25 and CID 4021. 325 Add new Modality Type to PS 3.3: 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 330 . Add new IOD Definitions to PS 3.3: 335 340 Annex C INFORMATION MODULE DEFINITIONS (NORMATIVE) Page 18 Changes to NEMA Standards Publication PS 3.3-2011 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: 360 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. SOP Class Name Table B.5-1 STANDARD SOP CLASSES 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 Defined Substance Administration 1.2.840.10008.5.1.4.1.1.88.xx4 Defined Substance Administration 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 Encapsulated PDF Storage 1.2.840.10008.5.1.4.1.1.104.1 Encapsulated PDF IOD … … … 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.4-1 370 SOP Class Name … Table I.4-1 Media Storage Standard SOP Classes 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 Defined Substance 1.2.840.10008.5.1.4.1.1.88.xx4 Defined Substance Page 20 Administration SR 375 380 385 390 Administration 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 … … … Page 21 395 Changes to NEMA Standards Publication PS 3.6-2011 Digital Imaging and Communications in Medicine (DICOM) Part 6: Data Dictionary 400 405 410 415 420 Page 22 Add new SOP Class to PS 3.6 Table A-1: 425 … … … ... 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.xx4 Defined Substance Administration 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 1.2.840.10008.5.1.4.1.1.104.1 Encapsulated PDF Storage SOP Class PS 3.4 … … … … 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 440 445 Add new Section to Annex A of PS 3.16: DEFINED SUBSTANCE ADMINISTRATION SR IOD TEMPLATES The templates that comprise the Defined Substance Administration are interconnected as in Figure A-x.0 450 Page 24 TID 1003 Person Observer Identifying Attributes TID xxx16 Defined Substance Administration TID 1005 Procedure Context TID xxxx5 Substance Information TID xxxx7 Substance Administration Plan Figure A.x-0: Defined Substance Administration SR IOD Template Structure TID xxx16 Defined Substance Administration This template describes single defined administration plan. 455 TID xxx16 Defined Substance Administration Type: Extensible Order: Significant NL Rel with Parent 1 2 > CONTAINS 3 > HAS PROPERTIES 4 > HAS OBS CONTEXT VT Concept Name VM Req Condition Type CONTAINER EV (xx??, 99SUP164, “Defined Substance Administration”) INCLUDE DTID (1200) Language Designation EV (121144, DCM, TEXT “Document Title") 1 M 1 U 1 U INCLUDE 1 M DTID (1003) Person Observer Identifying Attribtues Value Set Constraint Page 25 460 5 > HAS OBS CONTEXT INCLUDE DTID (1005) Procedure Context 6 > CONTAINS CODE EV(xx9, 99SUP164, “Injection Mode”) 7 > CONTAINS INCLUDE 8 > CONTAINS 9 > 10 1 U DTID (xxxx5) Substance Information 1-n U NUM EV(xx??, 99SUP164, “Maximum Administered Activity”) 1 UC IFF TID xxxx5 Row 5 Units = EV (MBq, UCUM, =EV(xx??, DCM, “MBq”) “Radiopharmaceutical” ) CONTAINS NUM EV(xx??, 99SUP164, “Minimum Administered Activity”) 1 UC IFF TID xxxx5 Row 5 Units = EV (MBq, UCUM, =EV(xx??, DCM, “MBq”) “Radiopharmaceutical” ) > CONTAINS NUM EV(xx??, 99SUP164, “Maximum Administered Volume”) 1 UC IFF TID xxxx5 Row 5 Units = EV (cm3, UCUM, =EV(xx??, DCM, “cm3”) “Radiopharmaceutical” ) 11 > CONTAINS DATETIME EV(xx??, 99SUP164, “Scheduled Administration Time”) 1 UC IFF TID xxxx5 Row 5 =EV(xx??, DCM, “Radiopharmaceutical” ) 12 > CONTAINS NUM EV(xx??, 99SUP164, “Uptake Time”) 1 UC IFF TID xxxx5 Row 5 UNITS = DT (min, UCUM, =EV(xx??, DCM, "min") “Radiopharmaceutical” ) Content Item Descriptions Row 3 Describes a human readable text description of this defined substance administration Row 4 Person responsible for authoring the content of this object Row 5 This is to provide context information so as to understand – what type of study is this plan intended for. Row 7 Information about the substance or imaging-agent that is defined to be used. Maximum allowed amount of activity to be administered Row 10 465 DCID (xxxx8) Substance Administration Mode PLANNED SUBSTANCE ADMINISTRATION SR IOD TEMPLATES The templates that comprise the Planned Substance Administration are interconnected as in Figure A-x.1 Page 26 TID xxxx1 Planned Substance Agent Admin. TID 1003 Person Observer Identifying Attributes TID 1005 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 Figure A.x-1: Planned Substance Administration SR IOD Template Structure 470 TID xxxx1 Planned Substance Administration This template describes single scheduled administration plan. Page 27 TID xxxx1 Planned Substance Administration Type: Extensible Order: Significant 475 NL Rel with Parent VT Concept Name VM Req Condition Type Value Set Constraint 2 > CONTAINS 3 > HAS PROPERTIES CONTAINER EV (xx8, 99SUP164, “Planned Substance Administration Procedure Report”) INCLUDE DTID (1200) Language Designation EV (121144, DCM, TEXT “Document Title") 4 > CONTAINS INCLUDE DTID (xxxx2) Pre-Medication Context For Substance Administration 1 U 5 > CONTAINS INCLUDE DTID (xxxx3) Patient Risk-Factor Context related to Imaging Agents 1 U 7 > HAS OBS CONTEXT INCLUDE DTID (1003) Person Observer Identifying Attribtues 1 M 8 > HAS OBS CONTEXT INCLUDE DTID (1005) Procedure Context 9 > CONTAINS INCLUDE DTID (xxxx5) Substance Information 1-n U 10 > CONTAINS CODE EV(xx9, 99SUP164, “Injection Mode”) 1 U 11 > CONTAINS TEXT EV(xx10, 99SUP164, Rationale for Administering Substance) 1-n U 12 > CONTAINS INCLUDE DTID (xxxx6) Substance Administration Consumables 1-n U 13 > CONTAINS NUM EV(xx??, 99SUP164, “Scheduled Administered Activity”) 1 MC IFF TID xxxx5 Row 5 Units = EV (MBq, UCUM, =EV(xx??, DCM, “MBq”) “Radiopharmaceutical” ) 14 > CONTAINS NUM EV(xx??, 99SUP164, “Maximum Administered Activity”) 1 UC IFF TID xxxx5 Row 5 Units = EV (MBq, UCUM, =EV(xx??, DCM, “MBq”) “Radiopharmaceutical” ) 1 1 M 1 U 1 U DCID (xxxx8) Substance Administration Mode Page 28 15 > CONTAINS NUM EV(xx??, 99SUP164, “Minimum Administered Activity”) 1 UC IFF TID xxxx5 Row 5 Units = EV (MBq, UCUM, =EV(xx??, DCM, “MBq”) “Radiopharmaceutical” ) 16 > CONTAINS NUM EV(xx??, 99SUP164, “Maximum Administered Volume”) 1 UC IFF TID xxxx5 Row 5 Units = EV (cm3, UCUM, =EV(xx??, DCM, “cm3”) “Radiopharmaceutical” ) 17 > CONTAINS DATETIME EV(xx??, 99SUP164, “Scheduled Administration Time”) 1 UC IFF TID xxxx5 Row 5 Units = EV (s, UCUM, =EV(xx??, DCM, “seconds”) “Radiopharmaceutical” ) 18 > CONTAINS NUM EV(xx??, 99SUP164, “Uptake Time”) 1 UC IFF TID xxxx5 Row 5 UNITS = DT (min, UCUM, =EV(xx??, DCM, "min") “Radiopharmaceutical” ) 19 > CONTAINS INCLUDE DTID(xxxx7) Substance Administration Plan 1 UC IFF TID xxxx5 Row 5 =EV(xx??, DCM, “Contrast Agent”) $PlanType = EV(xx??, DCM, “Planned”) Content Item Descriptions Row 3 Describes a human readable text description of this planned substance administration 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 This is to provide context information so as to understand – what type of study is this plan intended for. Row 9 Information about the substance or imaging-agent scheduled to be used for the plan. Row 11 Each item should contain a single rationale however multiple such items could be included Row 12 Only imaging agent consumable details that are known at the time of scheduling (e.g., Needle length) Row 13 The desired activity to be administered. Row 14 Maximum allowed amount of activity to be administered Row 16 Some radiopharmaceuticals can be deadly if too much is given to the patient TID xxxx2 480 Pre-Medication Context for Substance Administration Detailed information on medications administered to the patient, prior to the Substance Administration. Page 29 TID xxxx2 Pre-Medication Context For Substance Administration Type: Extensible Order: Significant NL Rel with Parent 1 VT Concept Name CODE EV(xx1, 99SUP164, Drug Product Identifier) VM Req Condition Type 1-n U Value Set Constraint DCID (xxxx12) PreMedication Agents for Substance Administration 2 > CODE HAS PROPERTIES 1-n EV(xx2, 99SUP164, Equivalent Drug Code) U 3 > TEXT HAS PROPERTIES EV(xxx, 99SUP164, Drug Name) 1-n U 4 > NUM HAS PROPERTIES DCID (3410) Numeric Parameters of Drugs/Contrast 1-n U 5 > CODE HAS PROPERTIES EV (G-C340, SRT, “Route of Administration”) 1 U DCID (11) Route of Administration 6 > NUM HAS PROPERTIES EV(x222, 99SUP164, Fasting Period) 1 U UNITS = DT (h, UCUM, "h") Content Item Descriptions 485 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 substance administration TID xxxx3 Patient Risk-Factor Context related to Imaging Agents TID xxxx3 Patient Risk-Factor Context related to Imaging Agents Type: Extensible 490 NL Rel with Parent 1 VT Concept Name CONTAINER EV (xxxx, 99SUP164, ”ImagingAgent Related Risk Factors”) VM Req Condition Type 1 U Order: Significant Value Set Constraint 2 > CONTAINS CODE EV (F-01500, SRT, ”Risk factor”) 1-n U DCID (xxxx9) Imaging Agent Related Riskfactor 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 5 > CONTAINS NUM EV (xx5, 99SUP164, “Glomerular Filtration Rate“) 1-n U UNITS = DT(mL/min/1.73m2, UCUM, “mL/min/1.73m2”) 6 >> HAS OBS CONTEXT CODE EV(xx6, 99SUP164, “Assessment Method”) 1 M DCID (xxxx13) GFR Assessment Method Page 30 7 >> HAS OBS CONTEXT DATETIME EV (121135, 99SUP164, “Observation Date time”) 1 M Content Item Descriptions 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. 495 TID xxxx5 Substance Information This template describes the nature of the substance in the scope of Substance administration for the purpose of imaging. TID xxxx5 Substance Information Type: Extensible Order: Significant 500 NL Rel with Parent VT Concept Name CONTAINER EV(xxxxx, “99SUP164”, Substance Admin.) 1 EV(xxxx, “99SUP164”, “Substance”) EV(xx12,”99SUP164”, “Substance Code”) 2 > CONTAINS TEXT 3 > CONTAINS CODE 4 > CODE HAS PROPERTIES EV(xx2, 99SUP164, Equivalent Drug Code) 5 > CODE HAS PROPERTIES 6 > CONTAINS CODE 7 > CONTAINS TEXT VM Req Condition Typ e 1 M 1 U Value Set Constraint 1 M 1-n U EV(xxx, 99SUP164, Substance Type) EV(G-C52F, SRT, “Active Ingredient”) 1 M DCID (xxxx16) Administrable Substance Type 1 U DCID (13) Radiographic Contrast Agent Ingredient EV (xx??, $99SUP164, “Substance Manufacturer”) 1 U BCID (12) Radiographic Contrast Agent or BCID (25) Radiopharmaceuticals or BCID (3107) PET Cardiology Radiopharmaceuticals or BCID (3111) Nuclear Cardiology Radiopharmaceutical or BCID (4021) PET Radiopharmaceutical Page 31 8 > CONTAINS DATETIME EV(xx20, 99SUP164, “Substance Order Date”) 1 U 9 > CONTAINS NUM 1 U UNITS = EV(Mg/L, UCUM, “Mg/L”) 10 > CONTAINS NUM 1 U 11 > CONTAINS NUM EV(xx13,”99SUP164”, “Contrast Concentration”) EV(xx14, 99SUP164, “Molarity”) EV(xx15, 99SUP164, “Relaxivity”) 1 U UNITS = EV(mmol/L, UCUM,“ mmol/L” ) UNITS = EV (mM^-1*sec^-1, UCUM, “mM^-1*sec^-1”) 12 > CONTAINS NUM EV(xx16, 99SUP164, “Osmolality at 37C”) 1 U 13 > CONTAINS NUM EV(xx17, 99SUP164, “Osmolarity at 37C”) 1 U 14 > CONTAINS NUM EV(xx18, 99SUP164, “Viscosity at 37C”) 1 U CONTAINS NUM EV(xx19, 99SUP164, “Flush Concentration”) 1 U 15 > UNITS = EV (mOsm/kg, UCUM, “mOsmol/kg”) UNITS = EV(mmol/L, UCUM,“ mmol/L” ) UNITS = EV(mOsm/kg H20, “UCUM”, “mOsm/kg H20”) UNITS = EV(Mg/L, UCUM, “Mg/L”) > CONTAINS CODE EV (G-C340, SRT, "Route of administration") 1 U 17 > CONTAINS TEXT EV (CDXX24, $99SUP159, “Reagent Identifier”) 1 U 18 > CONTAINS CODE EV (C-B1000, SRT, “Diagnostic Radioisotope”) 1 UC IFF Row 5 Equals Yes BCID 18 (NM) or 4020 (PET) 19 > CONTAINS NUM EV (CDXX25, $99SUP159, “Radionuclide Half Life”) 1 UC IFF Row 5 Equals Yes Units = EV (s, UCUM, “seconds”) 20 > CONTAINS TEXT EV (CDXX26, $99SUP159, “Radionuclide Identifier”) 1 16 U DCID (11) Route of Administration IFF Row 5 Equals Yes IFF Row 5 Equals Yes Content Item Descriptions 505 Row 4 Local equivalent drug code for Row 3 Row 5 Indicates whether the substance is radiopharmaceutical or contrast agent Row 6 Row 7 Mg/ml of active ingredient Substance or Imaging-Agent Manufacturer. Could be department for locally compounded items. Reagent manufacturer is noted in reagent parameters. Row 8 Date-time the Contrast-Agent was ordered by the physician. Row 9 Row 10 Contrast Concentration, referring to the concentration of contrast type given in row 4 One of: “Iodine”, “Gadolinium”, etc Row 11 Relaxivity at 37C at B0 field strength Row 20 Identification for the radionuclide component of the radiopharmaceutical TID xxxx6 Substance Administration Consumables These are consumable used in the course of a substance administration procedure. Page 32 TID xxxx6 Substance Administration Consumables Type: Extensible Order: Significant NL Rel with Parent 1 VT Concept Name VM Req Condition Type CONTAINER EV(xx21, 99SUP164, “Substance Administration Consumable Information”) 1 U 1-n U Value Set Constraint 2 > CONTAINS CODE EV(xx45, 99SUP164, “Substance Consumable Type”) 3 > CONTAINS TEXT 1 EV (121148, SRT, “Unit Serial Identifier”) 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 9 > CONTAINS NUM EV (122319, DCM, “Catheter Size”) 1 U 10 > CONTAINS TEXT EV(xx23, 99SUP164, 1 “Manufacturer Name”) U 11 > CONTAINS CODE EV(xx24, 99SUP164, “Syringe Type”) 1 C IFF Row 2 Equals DCID (xxxx3) Substance (xxxx, DCM, “Syringe”) Administration Injection Syringe Type 12 > HAS NUM PROPERTIES 1 EV (121146, DCM, “Quantity of material”) U Units = EV (1,UCUM,”no units”) 13 > CONTAINS EV (121147, DCM, "Billing Code") U TEXT 1 510 Content Item Descriptions Row 3 Serial ID of the substance consumable Row 4 LOT identifier of the substance Row 6 Description about the substance 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 DCID (xxxx14) Substance Administration Consumable Type IFF Row 2 Equals UNITS = EV (cm, (xxxx, DCM, “Syringe”) UCUM, ”centimeter”) UNITS = DCID (3510) Catheter Size Units Page 33 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. 515 TID xxxx7 Parameters Parameter Name $PlanType Parameter Usage Coded term for Concept Name of a plan type TID xxxx7 Substance Administration Delivery Plan Template Type: Extensible Order: Significant 520 NL Rel with Parent 1 VT Concept Name VM Req Condition Type CONTAINER EV(xx26, 99SUP164, “Substance Delivery Procedure Plan”) 1 M 1 M 2 > CONTAINS CODE EV(xx27, 99SUP164, “Plan Type”) 3 > CONTAINS INCLUDE 1-n DTID(xxx8) “Substance Administration Delivery Step” 4 > CONTAINS NUM EV(xx27, 99SUP164, “Pressure Limit”) 5 > CONTAINS NUM EV(122094, DCM, “Rate of administration”) 6 > CONTAINS WAVEFORM EV(xx??, DCM, 1-n MC “Measurement Graph”) 1 $PlanType M UC 1 Value Set Constraint IF TID xxxx1 Row 4 = UNITS = EV(kPa,UCUM, EV(xx??, DCM, “kPa“) “Automated Injection”) or TID xxx10 Row 8 = EV(xx??, DCM, “Automated Injection”) U UNITS = EV(ml/S,UCUM, “ml/S“) IF TID xxx10 Row 8 = EV(xx??, DCM, “Automated Injection”) and Row 2 = EV(xx??, DCM, “Delivered”) Content Item Descriptions 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 6 This item shall only be added for performed when the value for row 2 is “Delivered” with Injection Page 34 mode as Power Injector Generally, 3 waveform objects referenced: a. Flow-Rate vs Time, b. Pressure vs Time c. Volume vs Time 525 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. TID xxxx8 Substance Administration Delivery Step Template Type: Extensible Order: Significant 530 NL Rel with Parent 1 VT Concept Name VM Req Condition Type CONTAINER EV(xx28, 99SUP164, “Substance Delivery Procedure Step”) 1 M Value Set Constraint 2 > CONTAINS NUM EV(xx, 99SUP164, “Substance Delivery Step Number”) 1 M Units = EV (1,UCUM,”no units”) 3 > CONTAINS NUM EV(xx29, 99SUP164, “Injection Delay”) 1 M 4 > CONTAINS NUM EV(xx30, 99SUP164, "Scan Delay ") 1 M UNITS = EV (s, UCUM, “s”) UNITS = EV (s, UCUM, “s”) 5 > CONTAINS CODE EV(xx31, 99SUP164, “Substance Delivery Phase”) 1-n M Content Item Descriptions Row 2 Substance Delivery Step Number indicates a delivery step, it starts with 1 and increases monotonically by 1. 535 TID xxxx9 Substance Administration Delivery Phase Template This template provides detailed information on Substance Administration delivery plan. A plan may consist of multiple steps of delivery; a step in turn may consist of multiple phases. TID xxxx9 Substance Delivery Phase Template Type: Extensible Order: Significant 540 NL Rel with Parent 1 VT Concept Name CONTAINER EV(xx32, 99SUP164, “Substance Delivery Phase”) VM Req Condition Type 1 M Value Set Constraint Page 35 2 > CONTAINS NUM EV(xx, 99SUP164, “Substance Delivery Phase Number”) 1 M Units = EV (1,UCUM,”no units”) 3 > CONTAINS CODE EV(xx62, 99SUP164, “Substance Delivery Phase Type”) 1 M DCID (xxx4) Substance Phase Type 4 > CONTAINS CODE EV(xx33, 99SUP164, “Substance Type”) 1 MC IFF Row 3 equals (xxxx9, DCM, “Administration”) DCID (xxxx5) Substance Type 5 > CONTAINS NUM EV(xx33, 99SUP164, "Substance Flush Ratio") 1 MC IFF Row 3 equals (xxxx9, DCM, “Administration”) UNITS = EV(%, UCUM, “%”) 6 > CONTAINS NUM 1 EV(122091, DCM, “Volume Administered” MC IFF Row 3 equals (xxxx9, DCM, “Administration”) UNITS = EV (ml, UCUM, “ml”) 7 > CONTAINS NUM EV(122094, DCM, “Rate of administration”) 1 UC IFF Row 3 equals (xxxx9, DCM, “Administration”) UNITS = EV(ml/s, UCUM “ml/s”) 8 > CONTAINS NUM EV(122095, DCM, “Duration of administration”) 1 U 9 > CONTAINS DATETIME EV(111526, DCM, “DateTime Started” 1 MC IFF SOP class is Performed Substance Administration SR 10 > CONTAINS DATETIME EV(111527, DCM, “DateTime Ended” 1 MC IFF SOP class is Performed Substance Administration SR 11 > CONTAINS NUM EV(xx34, 99SUP164, “Initial Volume of Substance in Container”) 1 UC IFF Row 3 equals (xx??, DCM, “Administration”) UNITS = EV (ml, UCUM, “ml”) 12 > CONTAINS NUM EV(xx3x, 99SUP164, “Residual Volume of Substance in Container”) 1 UC IFF Row 3 equals (xx??, DCM, “Administration”) UNITS = EV (ml, UCUM, “ml”) 13 > CONTAINS NUM EV(xx35, 99SUP164, “Rise Time") 1 MC IF Row 3 equals (xx??, DCM, “Administration”) And IF TID xxxx7 Row 2 equals (xx??,DCM, “Delivered”) UNITS = EV (s, UCUM, “s”) UNITS = EV (s, UCUM, “s”) Content Item Descriptions 545 Row 2 Substance Delivery Phase Number indicates a delivery phase, it starts with 1 and increases monotonically by 1. Row 5 The ratio of volume of substance to volume of flush Row 9 Date time of when the Substance delivery started for the current phase Row 10 Date time of when the Substance delivery ended for the current phase Page 36 PERFORMED SUBSTANCE ADMINISTRATION SR IOD TEMPLATES 550 The templates that comprise the Performed Substance Administration are interconnected as in Figure Ax.2 Page 37 TID xxxx10 Performed Substance Admin. TID 1003 Person Observer Identifying Attributes TID 1005 Procedure Context TID xxx2 Pre-Medication Context TID xxx3 Patient Risk-Factors TID xxx11 Substance Information TID xxxx5 Substance Administration Device Information TID xxxx6 Substance Administration Consumables TID xxxx7 Substance Administration Plan TID xxx15 Radiopharmaceutical Substance Administration Data TID xxx11 Adverse Event Reactions Page 38 Figure A.x-2: Performed Substance Administration SR IOD Template Structure 555 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). TID xxx10 Performed Substance Administration Type: Extensible 560 NL Rel with Parent 1 VT Concept Name VM Req Condition Type CONTAINER EV (xx??, DCM, “Performed Substance Administration Procedure Report”) INCLUDE DTID (1204) Language Designation EV (xx??, DCM, TEXT “Summary Text") 1 M 1 U 1 U 2 > CONTAINS 3 > CONTAINS 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 (1003) Person Observer Identfying Attributes 1-n U 7 > CONTAINS INCLUDE DTID (1005) Procedure Context 1 U 8 > CONTAINS CODE EV(xx36, 99SUP164, “Injection Mode”) 1 M 9 > CONTAINS INCLUDE DTID (xxxx12) Substance Administration Device Information 1 MC 10 > CONTAINS INCLUDE DTID (xxxx5) Substance Information 1 M 11 > CONTAINS INCLUDE DTID (xxxxx6) Substance Administration Consumables 1-n M 12 > CONTAINS INCLUDE DTID (xxxx7) Substance Administration Plan 1 MC IFF TID xxxx5 Row 5 =EV(xx??, DCM, “Contrast Agent”) 13 > CONTAINS INCLUDE DTID (xxxx7) Substance Administration Plan 1 MC IFF TID xxxx5 Row 5 =EV(xx??, DCM, “Contrast Agent”) 14 > CONTAINS INCLUDE DTID(xxx15) Radiopharmaceutical Substance Administration Data 1 Value Set Constraint DCID (xxxx8) Substance Administration Mode IFF Row 8 = EV(xx??, DCM, “Automated Injection”) UC IFF TID xxxx5 Row 5 =EV(xx??, DCM, “Radiopharmaceutical”) $PlanType = EV(xx??, DCM, “Performed”) Page 39 15 > CONTAINS INCLUDE DTID (xxx11) Substance Administration Adverse Events 1 M 16 > CONTAINS CODE EV(xx60,99SUP164, “Substance Administration Completion Status”) 1 M DCID (xxxx15) Substance Administration Completion Status Content Item Descriptions Row 3 Describes a human readable text description of substance administration 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 565 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 Substance Administration Adverse Event Reactions Type: Extensible 570 NL Rel with Parent 1 VT Concept Name VM Req Condition Type CONTAINER EV (xx??, 99SUP164, 1 "Substance Administration Adverse Event”) EV (xx??, 99SUP164, 1 NUM "Number Of Adverse Events”) CODE 1-n EV(xx??, DCM, “Substance Administration Adverse Reaction”) 2 > CONTAINS 3 > CONTAINS 4 >> CODE HAS PROPERTIES 5 >> CODE HAS PROPERTIES 6 >> DATETIME HAS PROPERTIES EV(xxxx, 99SUP164, 1 “Adverse Event Severity”) EV (xxxxx, 99SUP164, “Relative Time of Occurrence of Adverse Event”) EV(xx37, 99SUP164, 1 “Adverse Event Observation Date Time”) Value Set Constraint M Units = EV (1,UCUM,”no units”) M MC IFF Row 2 > 0 BDCID(9300) Procedure Discontinuation Reasons U BCID (3716) Severity U DCID (xxxx2) Temporal Periods Relating To Contrast Procedure M Page 40 x > NUM HAS PROPERTIES EV (CDXX16, $99SUP159, “Estimated Extravasation Activity”) 1 U x > NUM HAS PROPERTIES EV (CDXX16, $99SUP164, “Estimated Extravasation Volume”) 1 U 7 >> NUM HAS PROPERTIES EV(xx38, 99SUP164, “Adverse Reaction Step”) 1 U Units = EV (1,UCUM,”no units”) 8 >> NUM HAS PROPERTIES 1 U Units = EV (1,UCUM,”no units”) 9 >> TEXT HAS PROPERTIES EV(xx39, 99SUP164, “Adverse Reaction Phase”) EV (121106, DCM, “Comment”) 1 U IFF TID xxxx5 Row 5 Units = EV (MBq, UCUM, =EV(xx??, DCM, “megabecquerel”) “Radiopharmaceutical” ) Units = EV (ml, UCUM, “ml”) Content Item Descriptions Row 6 Date and time when the adverse event was noted by the observer. Row 7 Indicates the performed step number in this plan (as recorded in row 2 of TID xxx8) where an adverse reaction found to occur. Row 8 Indicates the performed phase number (as recorded in row x of TID xxx7) in the step of this plan where an adverse reaction found to occur. Row 9 For end user comments. Not to be used programmatically. TID xxx12 575 Substance Administration Device Information This template provides detailed information about the device that was used to administer the substance. TID xxx12 Substance Administration Device Information Template Type: Extensible NL Rel with Parent 1 VT Concept Name VM Req Condition Type CONTAINS CONTAINER EV(xx40, 99SUP164, 1 “Substance Administration Device Information”) M INCLUDE 2 > HAS OBS CONTEXT DTID (1004) Device Observer Identifying Attributes 1 M 3 > CODE HAS PROPERTIES EV(xx??, 99SUP164, “Programmable Device”) 1 U 4 > TEXT HAS PROPERTIES EV(xx??, 99SUP164, “Device Observer Software Version”) 1 U 5 > TEXT HAS PROPERTIES EV(xx44, 99SUP164, “Injector HeadType”) 1 U 580 Content Item Descriptions Value Set Constraint DCID (230) Yes - No DCID (xxxx10) Substance Administration Injector Head Type Page 41 585 Row 3 Indicates whether the injector device is capable of programming a delivery plan for automated administration of substance to the patient. Row 5 Type of injector – Dual Head, Single Head, etc. TID XXX15 Radiopharmaceutical Substance Administration Data The Radiopharmaceutical Substance Administration Data conveys the dose and assay and time information of a single radiopharmaceutical event. A Radiopharmaceutical Administration event is one radioactive pharmaceutical dispensed to a patient. TID XXXX3 RADIOPHARMACEUTICAL SUBSTANCE ADMINISTRATION DATA Type: Extensible Order: Significant 590 NL Rel with Parent 1 VT Concept Name VM Req Condition Type CONTAINER EV (CDXX05, $99SUP159, ”Radiopharmaceutical Administration”) 1 M Value Set Constraint 2 > CONTAINS CODE EV (123001, DCM, “Radiopharmaceutical ”) 1 M 3 > CONTAINS UIDREF EV (CDXX12, $99SUP159, “Radiopharmaceutical Administration Event UID”) 1 MC 4 > CONTAINS TEXT EV (CDX111, $99SUP159, “Purpose of Administration ”) 1 M 7 > DATETIME HAS PROPERTIES EV (123003, DCM, “Radiopharmaceutical Start Time”) 1 M 8 > DATETIME HAS PROPERTIES EV (123004, DCM, “Radiopharmaceutical Stop Time”) 1 U 9 > CONTAINS NUM EV (CDXX17, $99SUP159, “Administered activity”) 1 M Units = EV (MBq, UCUM, “megabecquerel”) 10 > CONTAINS NUM EV (123005, DCM, “Radiopharmaceutical Volume”) 1 U Units = EV (cm3, UCUM, “cm3”) BCID (25) Radiopharmaceuticals or BCID (3107) PET Cardiology Radiopharmaceuticals or BCID (3111) Nuclear Cardiology Radiopharmaceutical BCID (4021) PET Radiopharmaceutical Page 42 11 > CONTAINS NUM EV (123007, DCM, “Radiopharmaceutical Specific Activity”) 1 U Units = EV (Bq/mol, UCUM, “Bq/mol”) 12 > CONTAINS NUM EV(xxxx, 99SUP164, “Flush Delivered”) 1 U Units = EV (ml, UCUM, “ml”) Content Item Descriptions Row 3 Unique identification of a single radiopharmaceutical administration event. Row 4 Local description of the purpose of the administration of the radiopharmaceutical in the procedure (i.e. “Cardiac Stress Injection”, “Cardiac Rest Injection”) In order to facilitate the selection of the proper dose when querying the image archive, Series Description (0008,103E) should contain the same information as the Purpose of Administration. Row 6 The estimated activity of extravasated radiopharmaceutical. This estimated value can be subtracted from administered activity for PET SUV calculations. Observation DateTime (0040,A032) shall be used to record the time of the estimate. Row 7 The time the radiopharmaceutical was administered to the patient for imaging purposes. Row 9 Total amount of radioactivity administered to the patient at Radiopharmaceutical Start Time. It is a computed field from the TID XXX6 Measured Activity Row 2, TID XXX6 Measured Activity Date Time Row 3, Radionuclide Half Life Row 15 and Radiopharmaceutical Start Time Row 7. Does not include estimated extravasation activity. Row 11 Activity per unit mass of the radiopharmaceutical at Radiopharmaceutical Start Time 595 Add the following CID’s to Part 16 Annex B: CID 9300 Procedure Discontinuation Reasons Context ID 9300 Procedure Discontinuation Reasons Type: Extensible Version: 20110128 600 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 Page 43 CID xxxx1 Substance Administration Adverse Event Reaction List Context ID xxxx1 Substance Administration Adverse Event Agent Reaction List Type: Extensible Version: 2012xxxx 605 Coding Scheme Designator (0008,0102) Code Meaning (0008,0104) DCM xxx1 Pressure limiting event occurred during injection, DCM xxx2 DCM xxx3 DCM xxx4 Flow-rate limiting event occurred during injection. Indicates occurrence of both pressure and flowrate limit event detections. Injection aborted by clinician operator DCM xxx5 DCM Include CID CXX10 xxx6 Intravenous Extravasation Symptoms (From Supplement 159) CID CXX10 610 Code Value (0008,0100) Anaphylactic Reaction observed during administration Dyspnea wheezing 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 Intravenous Extravasation Symptoms Type: Extensible Version: yyyymmdd Coding Scheme Designator (0008,0102) 615 Code Value (0008,0100) Code Meaning (0008,0104) $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: Page 44 CID xxxx2 Temporal Periods Relating To Contrast Procedure Context ID xxxx2 Temporal Periods Relating To Contrast Procedure Type: Extensible Version: 2012xxxx 620 Coding Scheme Designator (0008,0102) Code Value (0008,0100) Code Meaning (0008,0104) SRT R-422A4 After Procedure SRT R-40FBA During Procedure SRT R-40FB9 DCM 110514 Before Procedure Procedure discontinued due to incorrect patient or procedure step selected from modality work-list CID xxxx3 Contrast Agent Injection Substance Administration Syringe Type Context ID xxxx3 Contrast Agent Injection Substance Administration Syringe Type Type: Extensible Version: 2012xxxx 625 Coding Scheme Designator (0008,0102) Code Value (0008,0100) DCM xxxx7 Pre-filled DCM xxxx8 Empty (or Not Pre-filled) CID xxxx4 Code Meaning (0008,0104) Contrast Agent Substance Administration Phase Type Context ID xxxx4 Contrast Agent Substance Administration Phase Type Type: Extensible Version: 2012xxxx 630 Coding Scheme Designator (0008,0102) Code Value (0008,0100) Code Meaning (0008,0104) DCM xxxx9 Administration DCM xxx10 Programmed Hold DCM xxx11 Manual Pause Page 45 CID xxxx5 Substance Type Context ID xxxx5 Substance Type Type: Extensible Version: 2012xxxx 635 Coding Scheme Designator (0008,0102) Code Value (0008,0100) DCM xxx12 Flush or Saline DCM xxx13 Contrast-Agent DCM xxxxx Radio-Pharmaceutical CID xxxx6 Code Meaning (0008,0104) Substance Administration Consumable Context ID xxxx6 Substance Administration Consumables Type: Extensible Version: 2012xxxx 640 Coding Scheme Designator (0008,0102) Code Value (0008,0100) Code Meaning (0008,0104) 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 645 Coding Scheme Designator (0008,0102) Code Value (0008,0100) Code Meaning (0008,0104) 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 Type: Extensible Version: 2012xxxx 650 Coding Scheme Designator (0008,0102) Code Value (0008,0100) Code Meaning (0008,0104) Page 46 DCM xxx14 Automated Injection DCM xxx15 Manual Injection 655 660 CID xxxx9 Substance Administration Related Risk-Factor Indications Context ID xxxx9 Substance Administration Related Risk-factor Indications Type: Extensible Version: 2012xxxx 665 Coding Scheme Designator (0008,0102) Code Value (0008,0100) Code Meaning (0008,0104) 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 Page 47 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) Code Meaning (0008,0104) DCM xxx34 Dual Head DCM xxx35 Single Head 670 CID xxxx11 Substance Administration Plan Type Context ID xxxx11 Substance Administration Plan Type Type: Extensible Version: 2012xxxx 675 Coding Scheme Designator (0008,0102) Code Value (0008,0100) DCM xxx36 Planned DCM xxx37 Programmed DCM xxx38 Delivered DCM xxx?? Defined CID xxxx12 Code Meaning (0008,0104) Pre-Medication Agents for Substance Administration Context ID xxxx12 Pre-Medication Agents for Substance Administration Type: Extensible Version: 2012xxxx 680 Coding Scheme Designator (0008,0102) Code Value (0008,0100) Code Meaning (0008,0104) Trade Name (Informative) (From url) SRT C-37138 Prednisone SRT C-51450 Diphenhydramine 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 Benadryl Page 48 SRT 685 C-68050 CID xxxx13 Ephedrine 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 690 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) Code Meaning (0008,0104) DCM xxx53 Imaging agent DCM xxx54 Flush DCM xxx55 Syringe DCM xxx56 Cartridge DCM Xxx? 695 CID xxxx16 Administrable Substance Type Context ID xxxx16 Administrable Substance Type Type: Extensible Version: 2012xxxx Coding Scheme Designator (0008,0102) Code Value (0008,0100) Code Meaning (0008,0104) DCM xx?? Radiopharmaceutical DCM xx?? Flush DCM xx?? Contrast-Agent Page 49 DCM xx?? Flush DCM xx?? Interventional 700 CID xxxx15 Administration Completion Status Context ID xxxx15 Substance Administration Completion Status Type: Extensible Version: 2012xxxx 705 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 710 Annex D 715 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”) Code Value Code Meaning xxx1 Pressure limiting event occurred during injection. xxx2 Flow-rate limiting event occurred during injection. Definition Notes 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 50 xxx3 Indicates occurrence of both pressure and flow-rate limit event detections. xxx4 xxx6 Injection aborted by clinician operator Anaphylactic Reaction observed during administration 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 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 xxx5 Page 51 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 720 Changes to NEMA Standards Publication PS 3.17-2011 725 Digital Imaging and Communications in Medicine (DICOM) Part 17: Explanatory Information Page 52 730 735 740 745 750 Add new Section to Annex XX of PS 3.17: Annex XX Substance Administration Report Template (Informative) XX.1 PURPOSE OF THIS ANNEX 755 This Annex describes the use of the Substance Administration Reporting. The Substance Administration Report objects records the scheduled and performed delivery of contrasting agents. Page 53 760 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. 765 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) XX.2 Real-World Substance Administration Reporting Workflow Figure xx-1 demonstrates the workflow of administration of contrast agent during an imaging study. 770 Figure xx-1 Figure xx-2 shows Data flows with Contrast Agent Administration SR Page 54 775 780 785 Figure xx-2 Page 55 Figure xx-3 shows the Case 1 – Manual Bolus Injection System 790 Figure xx-3 Case 2 – Manul Bolus Injection with input from DSS/Order Filler/Modality Page 56 795 Figure xx-4 Case 3 – Automatic Infusion Pump – Contrast Reporting Page 57 800 Figure xx-5 Case 4 – Automatic infusion pump contrast reporting : Dispense and Administration Page 58 Figure xx-6 805 Page 59 810 Case 5 – Automatic infusion pump contrast reporting : Dispense, administration and realtime check of dispensed product. Figure xx-7 815 Page 60 Use case 6 – Integration with CT / MR 820 825 830 Figure xx-8 Page 61 Use case – Integration with CV Figure xx-9 835 840 Page 62 Use case 8 – Reporting 845 Figure xx-10 850 Page 63 Use case 9 – Protocoling 855 860 Page 64 Template of Contrast Agent Administration SR structure Page 65 Page 66 1 865