Digital Imaging and Communications in Medicine (DICOM) Supplement 164: Substance Administration Report

Transcription

1 5 Digital Imaging and Communications in Medicine (DICOM) Supplement 164: Substance Administration Report DICOM Standards Committee, Working Group 6 (Base Standard) Ad Hoc Group 1300 N. 17 th Street, Suite 1752 Rosslyn, Virginia USA 25 Status: VERSION: Draft Public Comment Draft Nov 5,

2 Page 2 Table of Contents 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 Changes to NEMA Standards Publication PS A.35.X1 Planned Substance Administration SR Information Object Definition A.35.X1.1 Planned Substance Administration SR Information Object Description A.35.X1.2 Planned Substance Administration SR IOD Entity-Relationship Model A.35.X1.3 Planned Substance Administration SR IOD Module Table A.35.X1.3.1 Planned Substance Administration SR IOD Content Constraints11 A.35.X2 Performed Substance Administration SR Information Object Definition A.35.X2.1 Performed Substance Administration SR Information Object Description A.35.X2.2 Performed Substance Administration SR IOD Entity-Relationship Model A.35.X2.3 Performed Substance Administration SR IOD Module Table A.35.X2.3.1 Performed Substance Administration SR IOD Content Constraints 13 A.35.X3 Basic Performed Substance Administration Information Object Definition A.35.X3.1 Basic Performed Substance Administration Information Object Description A.35.X3.2 Basic Performed Substance Administration IOD Entity-Relationship Model A.35.X3.3 Basic Performed Substance Administration IOD Module Table A.35.X4 Defined Substance Administration Plan SR Information Object Definition A.35.X4.1 Defined Substance Administration SR Information Object Description A.35.X4.2 Defined Substance Administration SR IOD Entity-Relationship Model A.35.X4.3 Defined Substance Administration SR IOD Module Table A.35.X4.3.1 Defined Substance Administration SR IOD Content Constraints16 C General Series Attribute Descriptions Changes to NEMA Standards Publication PS B.5 STANDARD SOP CLASSES I.4 MEDIA STORAGE STANDARD SOP CLASSES Changes to NEMA Standards Publication PS Changes to NEMA Standards Publication PS PLANNED SUBSTANCE ADMINISTRATION SR IOD TEMPLATES TID xxxx1 Planned Substance Administration TID xxxx2 Pre-Medication Context TID xxxx3 Patient Risk-Factor Context related to Substance Administrations TID xxxx5 Substance Information TID xxxx6 Substance Administration Consumables TID xxxx7 Substance Administration Delivery Plan Template TID xxxx8 Substance Administration Delivery Step Template TID xxxx9 Substance Administration Delivery Phase Template PERFORMED SUBSTANCE ADMINISTRATION SR IOD TEMPLATES... 32

3 Page TID xxx10 Performed Substance Administration TID xxx11 Substance Administration Adverse Events TID xxx12 Contrast Injector Information TID xxx14 Substance Administration Plan Template CID 9300 Procedure Discontinuation Reasons CID xxxx1 Substance Administration Adverse Event Reaction List CID CXX10 Intravenous Extravasation Symptoms CID xxxx2 Temporal Periods Relating To Contrast Procedure CID xxxx3 Contrast Agent Injection Substance Administration Syringe Type CID xxxx4 Contrast Agent Substance Administration Phase Type CID xxxx5 Substance Type CID xxxx6 Substance Administration Consumable CID xxxx7 Temporal Periods Relating To Procedure CID xxxx8 Substance Administration Mode CID xxxx9 Substance Administration Related Risk-Factor Indications CID xxxx10 Substance Administration Injector Head Type CID xxxx11 Substance Administration Plan Type CID xxxx12 Pre-Medication Agents for Substance Administration CID xxxx13 GFR Assessment Methods CID xxxx14 Substance Administration Consumable Type CID xxxx15 Administration Completion Status Annex D DICOM Controlled Terminology Definitions (Normative) Changes to NEMA Standards Publication PS Annex XX Substance Administration Report Template (Informative)... 47

4 Page 4 DOCUMENT HISTORY Document Date Version /10/25 Initial Version Content /01/22 Implemented review comments clean up template structures /02/04 Implemented review comments /06/12 1. Rename Contrast Agent Administration to Substance Administration 2. Added Contrast Agent Admin. Plan SR IOD 3. Added Extravasation detail table from supplement Added Fasting Period Concept in Pre-Medication Context /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

5 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) 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 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 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

6 Page 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 Add CM part of Modality type, under Part-3 Section C 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?

7 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 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 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.

8 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.

9 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 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 X X X X4 Planned Substance Administration SR Performed Substance Administration SR Basic Performed Substance Administration Storage Defined Substance Administration Storage Transfer Transfer Transfer Transfer 170

10 Page 10 Changes to NEMA Standards Publication PS Part 3: Information Object Definitions

11 Page 11 Item#2: Add new SR IOD of PS 3.3 A.35: A.35.X1 Planned Substance Administration SR Information Object Definition A.35.X1.1 Planned Substance Administration SR Information Object Description 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 M Clinical Trial Subject C U Study General Study C M Patient Study C U Clinical Trial Study C U Series SR Document Series C.17.1 M Clinical Trial Series C U Equipment General Equipment C M Document SR Document General C.17.2 M SR Document Content C.17.3 M SOP Common C.12.1 M A.35.X1.3.1 Planned Substance Administration SR IOD Content Constraints A.35.X 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 for Value Type definitions): TEXT CODE NUM DATETIME DATE TIME UIDREF PNAME COMPOSITE IMAGE WAVEFORM CONTAINER

12 Page A.35.X 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 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

13 Page 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 M Clinical Trial Subject C U Study General Study C M Patient Study C U Clinical Trial Study C U Series SR Document Series C.17.1 M Clinical Trial Series C U Frame of Synchronization C M Reference Equipment General Equipment C M Enhanced General Equipment C Document SR Document General C.17.2 M SR Document Content C.17.3 M SOP Common C.12.1 M M A.35.X2.3.1 Performed Substance Administration SR IOD Content Constraints A.35.X 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 for Value Type definitions): TEXT CODE NUM DATETIME DATE TIME UIDREF PNAME COMPOSITE IMAGE

14 Page 14 WAVEFORM CONTAINER A.35.X 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 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.X 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.

15 Page 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 M Clinical Trial Subject C U Study General Study C M Patient Study C U Clinical Trial Study C U Series General Series C M Clinical Trial Series C U Frame of Synchronization C M Reference Equipment General Equipment C M Substance Administration IE Enhanced General Equipment Enhanced Contrast Bolus Agent Module C C.7-12b SOP Common C.12.1 M M M 290

16 Page 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.X Defined Substance Administration IOD Content Constraints Relationship Constraints 315 A.35.X Content Constraints Add new Modality Type to PS 3.3: Defined Substance Administration IOD

17 Page C General Series Attribute Descriptions C 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

18 Page 18 Changes to NEMA Standards Publication PS Digital Imaging and Communications in Medicine (DICOM) Part 4: Service Class Specifications 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 Basic Text SR Enhanced SR Enhanced SR Comprehensive SR Comprehensive SR Procedure Log Procedure Log

19 Page 19 Mammography CAD SR Mammography CAD SR IOD Key Object Selection Key Object Selection Document Chest CAD SR Chest CAD SR IOD X-Ray Radiation Dose SR X-Ray Radiation Dose SR Planned Substance Administration SR Performed Substance Administration SR Basic Performed Substance Administration Defined Substance Administration xx xx xx xx4 Planned Substance Administration SR Performed Substance Administration SR Basic Performed Substance Administration Defined Substance Administration Encapsulated PDF Storage 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 Basic Text SR Enhanced SR Enhanced SR Comprehensive SR Comprehensive SR Procedure Log Procedure Log Mammography CAD SR Mammography CAD SR IOD Key Object Selection Document Key Object Selection Document Chest CAD SR Chest CAD SR IOD X-Ray Radiation Dose SR X-Ray Radiation Dose SR Encapsulated PDF Storage Encapsulated PDF IOD Planned Substance xx1 Planned Substance

20 Page Administration SR Performed Substance Administration SR Basic Performed Substance Administration Defined Substance Administration xx xx xx4 Administration SR Performed Substance Administration SR Basic Performed Substance Administration Defined Substance Administration

21 Page 21 Changes to NEMA Standards Publication PS Digital Imaging and Communications in Medicine (DICOM) Part 6: Data Dictionary

22 Page Add new SOP Class to PS 3.6 Table A-1: Text SR Storage Trial (Retired) SOP Class PS Audio SR Storage Trial (Retired) SOP Class PS Detail SR Storage Trial (Retired) SOP Class PS Comprehensive SR Storage Trial (Retired) SOP Class PS Basic Text SR Storage SOP Class PS Enhanced SR Storage SOP Class PS Comprehensive SR Storage SOP Class PS Procedure Log Storage SOP Class PS Mammography CAD SR Storage SOP Class PS Key Object Selection Document Storage SOP Class PS Chest CAD SR Storage SOP Class PS X-Ray Radiation Dose SR Storage SOP Class PS xx xx xx 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 Encapsulated PDF Storage SOP Class PS

23 Page Changes to NEMA Standards Publication PS 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

24 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.

25 Page 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)

26 Page 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.

27 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.

28 Page > 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.

29 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.

30 Page 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

31 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 ) 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

32 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

33 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

34 Page 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

35 Page 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.)