81928396 Page 1 2 4 Digital Imaging and Communications in Medicine (DICOM) 6 Supplement 185: Object Evaluation Results IOD 8 10 12 14 16 DICOM Standards Committee, Working Group 7, Radiation Therapy 1300 N. 17th Street, Suite 1752 18 Rosslyn, Virginia 22209 USA 20 VERSION: 22 Developed pursuant to DICOM Workitem 2000-11-B Sup 185 - Revision 13 March 23, 2015 24 This is a draft document. Do not circulate, quote, or reproduce it except with the approval of NEMA. 26 81928396 Page 2 2 Table of Contents 4 Table of Contents ..................................................................................................................... 2 Foreword ................................................................................................................................... 3 6 Scope and Field of Application ................................................................................................. 3 Part 2 Addendum ...................................................................................................................... 3 8 10 12 14 Part 3 Addendum ...................................................................................................................... 4 A.X........ OBJECT EVALUATION RESULTS OBJECT DEFINITION ................................ 4 A.X.1 ........ Object Evaluation Results IOD Description ............................................... 4 A.X.2 ........ Object Evaluation Results IOD Entity-Relationship Model ......................... 4 A.X.3 ........ Object Evaluation Results IOD Module Table............................................ 5 C.8.8.x ..... Object Evaluation Results Module ............................................................. 5 Part 4 Addendum .................................................................................................................... 10 Part 6 Addendum .................................................................................................................... 11 16 ANNEX A REGISTRY OF DICOM UNIQUE IDENTIFIERS (UID) (NORMATIVE) . 12 Part 16 Addendum .................................................................................................................. 13 18 20 22 24 CID 7445 DEVICE PARTICIPATING ROLES ........................................................ 13 CID YYY1 OBJECT EVALUATION NUMERIC REPORTING TYPES .................... 14 CID YYY2 OBJECT EVALUATION TEXT REPORTING TYPES ........................... 14 CID YYY3 OBJECT EVALUATION NON-SPECIFIC REPORTING TYPES ........... 14 CID YYY4 OBJECT EVALUATION TYPE ............................................................... 15 81928396 Page 3 2 Foreword 4 This Supplement specifies a new IOD and supporting entries to describe the results of a clinical evaluation of the content of a DICOM Object. This document is an extension to the following parts of the published DICOM Standard: 6 8 10 PS 3.2 Conformance PS 3.3 Information Object Definitions PS 3.4 Service Class Specifications PS 3.6 Data Dictionary PS 3.16 Content Mapping Resource Scope and Field of Application 12 14 This Supplement specifies the IOD representing object evaluation findings against reference information. It stems from the development of the Quality Assurance with Plan Veto profile in IHE-RO. While the profile originated from use cases to evaluate RT Plan, the IOD is generalized to allow for reporting of evaluation results involving any DICOM object. 16 18 Part 2 Addendum Add new SOP Classes to PS3.2 Table A.1-2 UID Values: UID Value 1.2.840.10008.5.1.4.1.1.xx.y.z 20 UID Name Object Evaluation Results Storage Category Transfer 81928396 Page 4 2 4 Part 3 Addendum Add the following column in PS3.3 Section A.1.4, Table A.1-1 COMPOSITE INFORMATION OBJECT MODULES OVERVIEW – RADIOTHERAPY IODs Modules Object Evaluation Results Patient M Clinical Trial Subject U General Study M Patient Study U Clinical Trial Study U General Series M Clinical Trial Series U RT Series General Equipment M Approval U Common Instance Reference M SOP Common M Object Evaluation Results M 6 8 In PS3.3 add the following IOD to Annex A: 10 A.X OBJECT EVALUATION RESULTS OBJECT DEFINITION A.X.1 12 This IOD represents the results from an evaluation of the content of a SOP Instance . A.X.2 14 Object Evaluation Results IOD Description Object Evaluation Results IOD Entity-Relationship Model The E-R model for this IOD is illustrated in Figure A.X-1. 81928396 Page 5 Figure A.X-1. DICOM Object Evaluation Results IOD Information Model 2 A.X.3 Object Evaluation Results IOD Module Table Table A.X.3-1. Object Evaluation Results IOD Modules 4 IE Module Patient Study Series Equipment Reference Usage 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 GeneralSeries C.7.3.1 M Clinical Trial Series C.7.3.2 U General Equipment C.7.5.1 M C.8.8.x M C.8.8.16 U SOP Common C.12.1 M Common Instance Reference C.12.2 M Object Evaluation Object Evaluation Results Results Approval 6 The value of Modality (0008,0060) shall be ((TBD)). In PS3.3 add the following Module to Annex C: 8 C.8.8.x Object Evaluation Results Module This Module describes the results of the evaluation of an Object. 10 Table C.8.8.x-1 Object Evaluation Results Module Attributes Attribute Name MajorIssues Found Tag Type (gggg,ee01) 1 Attribute Description Issues were found that indicate the Evaluated Object has major quality or effecitveness concerns. If at least one Item in the Evaluation Findings Sequence (gggg,ee07) has Concern Level (gggg,ee08) equal to MAJOR, then this value shall be YES. Enumerated Values: YES NO 81928396 Page 6 Attribute Name Tag Type Attribute Description Evaluation DateTime (gggg,ee02) 1 Date and time that the evaluation was performed. Evaluation Description (gggg,ee03) 1 Description of the evaluation result. Evaluation Type (gggg,ee21) 1 Type of Evaluation that was performed. >Include Table 8.8-1 ‘Code Sequence Macro Attributes’ Baseline CID YYY4. Evaluator Result Key (gggg,ee16) 3 Result key issued by the evaluator to allow additional information to be reviewed. Evaluation Requester Sequence (gggg,ee17) 1 Identification of the device that made the evaluation request. Only a single item shall be included in this Sequence. >Operator’s Name (0008,1070) 1 Name(s) of the operator(s) of the contributing equipment. >Operator Identification Sequence (0008,1072) 2 Identification of the operator(s) of the equipment that made the request. One or more items are permitted in this sequence. The number and order of items shall correspond to the number and order of vlaues of the Operators’ Name (0008,1070) if present. >>Include Table 10-1 ‘Person Identification Macro Attributes Description Attributes’ >Requester Equipment Sequence (gggg,ee20) 2 Equipment that made the evaluation request. Required if information is supplied. Only a single Item shall be included in this Sequence. >>Requester AE Title (gggg,ee15) 2 The AE Title of the Evaluation Requester having requested the generation of this document. >>Manufacturer (0008,0070) 2 Manufacturer of the equipment that contributed to the composite instance. >>Institution Name (0008,0080) 2 Instituion where the equipment that requested the evaluation is located. >>Station Name (0008,1010) 3 User defined name identifying the machine that made the request. >>Institutional Department Name (0008,1040) 3 Department in the institution where the equipment is located. >>Manufacturer’s Model Name (0008,1090) 2 Manufacturer’s model name of the equipment. 81928396 Page 7 Attribute Name Tag Type Attribute Description >>Device Serial Number (0018,1000) 2 Manufacturer’s serial number of the equipment Evaluated Object Sequence (gggg,ee04) 1 Reference to the object that was supplied for evaluation Only a single Item shall be included in this Sequence. >Include Table 10-11 ‘SOP Instance Reference Macro Attributes’ >Reference Object Sequence (gggg,ee05) 1C Reference object used by the evaluator to compare to the Evaluated Object Required if the evaluator used persistent data to compare to the Evaluated Object. Only a single item shall be included in this sequence. >>Include Table 10-11 SOP Instance Reference Macro Attributes’ Number of Evaluation Findings (gggg,ee06) 1 Number of findings from the evaluation. If one or more items in the Evaluation Findings Sequence (gggg,ee07) have the value MAJOR in Level Of Concern (ggg,ee08), the value shall be greater than zero. Evaluation Findings Sequence (gggg,ee07) 1C Findings of the evaluation. Required if Number of Evaluation Findings (gggg,ee06)is non-zero. The number of Items included in the sequence shall equal the value of Number of Evaluation Findings (gggg,ee06). >Level Of Concern (gggg,ee08) 1 Indicates the level of concern regarding the quality or effectiveness of the Evaluated Object. of this finding. Enumerated Values: MAJOR indicates a high level of concern. MINOR indicates a moderate level of concern. NONE indicates the reporting of a finding that was consistent with the evaluation expectations. >Finding Description (gggg,ee0A) 1 Description of the evaluation. 81928396 Page 8 Attribute Name >Assessment Type Code Sequence Tag Type (gggg,ee0B) 1 Attribute Description Code for assessment issued by the Object Evaluator. Only a single Item shall be included in this Sequence. >>Include Table 8.8-1 ‘Code Sequence Macro Attributes’ Defined CIDs: CID YYY1 Object Evaluation Numeric Types or CID YYY2 Object Evaluation Text Reporting Types or CID YYY3 Object Evaluation NonSpecific Reporting Types >Numeric Assessment Sequence (gggg,ee0C) 1C Assessment of a numeric value. Required if Assessment Type Code Sequence (gggg,ee0B) contains a code from CID (YYY1) Assessment Numeric Reporting Types. Only a single Item shall be included in this sequence. >>Include Table 10-20 ‘Selector Attribute Macro Attributes’ >>Selector Attribute Name (gggg,ee18) 1 Name of the Selector Attribute (0072,0026). For standard data elements, this shall be the value of the Name column of PS3.6 Table 6-1. >>Selector Attribute Keyword (gggg,ee19) 1 Keyword of the Selector Attribute (0072,0026). For standard data elements, this shall be the value of the Keyword column of PS3.6 Table 6-1. >>Selector Attribute VR (0072,0050) 1 The Value Representation of Selector Attribute (0072,0026). See PS3.5 for Enumerated Values of Value Representation. >>Expected Upper Bound Value Sequence (gggg,ee0D) 1C Upper bound value of expected value of check. Required if Assessment Type Code Sequence (gggg,ee0B) contains a code of (XYZ002, DCM, ”Upper Bound”), (XYZ004, DCM, ”Range”), or (XYZ005, DCM, ”Numeric Equality”). Only a single item shall be included in this sequence. >>>Include Table C.23.4-2 ‘Hanging Protocol Selector Attribute Value Macro Attributes’ 81928396 Page 9 Attribute Name >>Expected Lower Bound Value Sequence Tag Type Attribute Description (gggg,ee0E) 1C Lower bound value of expected value of check. Required if Assessment Type Code Sequence (gggg,ee0B) contains a code of (XYZ003, DCM, “Lower Bound”) or (XYZ004, DCM, “Range”). Only a single item shall be included in this sequence. >>>Include Table C.23.4-2 ‘Hanging Protocol Selector Attribute Value Macro Attributes’ >>Supplied Attribute Value Sequence (gggg,ee10) 1 The value that was received. Only a single item shall be included in this sequence. >>>Include Table C.23.4-2 ‘Hanging Protocol Selector Attribute Value Macro Attributes’ >>Measurement Units Code Sequence (0040,08EA) 1 Units of measurement for a numeric value in this name-value Item. Only a single Item shall be included in this Sequence. >>>Include Table 8.8-1 ‘Code Sequence Macro Attributes’ Baseline CID 82 . >Text Assessment Sequence (gggg,ee11) 1C Assessment of a non-numeric value. Required if Assessment Type Code Sequence (gggg,ee0B) contains a code of CID YYY2 Only a single Item shall be included in this sequence. >>Include Table 10-20 ‘Selector Attribute Macro Attributes’ >>Selector Attribute Name (gggg,ee18) 1 Name of the Selector Attribute (0072,0026). For standard data elements, this shall be the value of the Name column of PS3.6 Table 6-1. >>Selector Attribute Keyword (gggg,ee19) 1 Keyword of the Selector Attribute (0072,0026). For standard data elements, this shall be the value of the Keyword column of PS3.6 Table 6-1. >>Selector Attribute VR (0072,0050) 1 The Value Representation of Selector Attribute (0072,0026). See PS3.5 for Enumerated Values of Value Representation. >>Expected Value Sequence (gggg,ee12) 1 Expected value of assessment Only a single item shall be included in this sequence. 81928396 Page 10 Attribute Name Tag Type Attribute Description >>>Include Table C.23.4-2 ‘Hanging Protocol Selector Attribute Value Macro Attributes’ >>Supplied Attribute Value Sequence (gggg,ee10) 1 The value that was assessed in the Evaluated Object.. Only a single item shall be included in this sequence. >>>Include Table C.23.4-2 ‘Hanging Protocol Selector Attribute Value Macro Attributes’ >Non-Specific Assessment Sequence (gggg,ee13) 1C Anssessment whose result cannot be expressed as a numeric or textual comparison.. Required if Assessment Type Code Sequence (gggg,ee0B) contains a code of CID YYY3 Only a single Item shall be included in this Sequence. >>Non-Specific AssessmentDescription (gggg,ee14) 2 1 Description detailing the nature of the assessment. Part 4 Addendum Add the following to PS3.4, Appendix B.5, Table B.5-1 4 Table B.5-1. Standard SOP Classes SOP Class Name Object Evaluation Results Storage SOP Class UID 1.2.840.10008.5.1.4.1.1.xx.y.z IOD Specification (defined in PS3.3) Object Evaluation Results IOD 6 Add the following to PS3.4, Table I.4-18 Table I.4-1. Media Storage Standard SOP Classes SOP Class Name SOP Class UID IOD Specification (defined in PS3.3) 81928396 Page 11 SOP Class Name Object Evaluation Results Storage SOP Class UID IOD Specification (defined in PS3.3) 1.2.840.10008.5.1.4.1.1.xx.y.z 2 Object Evaluation Results IOD Part 6 Addendum To PS3.6, add the following Data Elements: 4 Table 6-1. Registry of DICOM Data Elements Tag Name Keyword VR VM (gggg,ee01) Critical Issues Found CriticalIssuesFound CS 1 (gggg,ee02) Evaluation DateTime EvaluationDateTime DT 1 (gggg,ee03) Evaluation Description EvaluationDescription UT 1 (gggg,ee04) Evaluated RT Object Sequence EvaluatedRTObjectSequence SQ 1 (gggg,ee05) Reference Object Sequence ReferenceObjectSequence SQ 1 (gggg,ee06) Number of Evaluation Findings NumberOfEvaluationFindings UL 1 (gggg,ee07) Evaluation Findings Sequence EvaluationFindingsSequence SQ 1 (gggg,ee08) Level Of Concern LevelOfConcern CS 1 (gggg,ee0A) Finding Description FindingDescription LO 1 (gggg,ee0B) Assessment Type Code Sequence AssessmentTypeCodeSequen ce SQ 1 (gggg,ee0C) Numeric Assessment Sequence NumericAssessmentSequence SQ 1 (gggg,ee0D) Expected Upper Bound Value Sequence ExpectedUpperBoundValueSe quence SQ 1 (gggg,ee0E) Expected Lower Bound Value Sequence ExpectedLowerBoundValueSe quence SQ 1 (gggg,ee10) Supplied Attribute Value Sequence SuppliedAttributeValueSequen ce SQ 1 (gggg,ee11) Text Assessment Sequence TextAssessmentSequence SQ 1 (gggg,ee12) Expected Value Sequence ExpectedValueSequence SQ 1 (gggg,ee13) Non-Specific Assessment Sequence NonSpecificAssessmentSeque SQ 1 81928396 Page 12 Tag Name Keyword VR VM nce (gggg,ee14) Non-Specific Check Description NonSpecificCheckDescription UT 1 (gggg,ee15) Requester AE Title RequesterAETitle AE 1 (ggg,ee16) Evaluator Result Key EvaluatorResultKey LO 1 (gggg,ee17) Evaluation Requester Sequence EvaluationRequesterSequence SQ 1 (gggg,ee18) Selector Attribute Name SelectorAttributeName LO 1 (gggg,ee19) Selector Attribute Keyword SelectorAttributeKeyword LO 1 (gggg,ee20) Requester Equipment Sequence ReguesterEquipmentSequenc e SQ 1 (gggg,ee21) Evaluation Type EvaluationType CS 1 2 Add the following to PS3.6 Annex A: 4 ANNEX A REGISTRY OF DICOM UNIQUE IDENTIFIERS (UID) (NORMATIVE) 1.2.840.10008.5.1.4.1.1.xx.y.z 6 Object Evaluation Results Storage SOP Class PS 3.4 81928396 Page 13 2 Part 16 Addendum In PS3.16, Annex D, table DICOM Code Definitions, add the following rows: 4 Code Value 6 Definition XYZ002 Upper Bound Assessment An assessment that a value does not exceed an expected maximum value. XYZ003 Lower Bound Assessment An assessment that a value is not less than an expected minimum value XYZ004 Range Assessment An assessment a value falls within an expected range. XYZ005 Numeric Equality Assessment An assessment that a value equals an expected numeric value. XYZ006 Equality Assessment An assessment that a value equals an expected value. XYZ007 Non-Specific Assessment An assessment that is not categorizable under either a numeric range, lower or upper comparison, or a value comparison. For example, this would apply to an assessment that requires a value be in a certain set of values XYZ008 Attribute Consistency Assessment An assessment that a value is consistent with other attribute values. XYZ009 RT Pre-Treatment Dose Check An evaluation performed before treatment to check for safe dose delivery. XYZ010 RT Pre-Treatment Consistency Check A pre-treatment comparison with a previously quality-assured treatment plan. In PS3.16, add the following row to Context ID 7445: CID 7445 8 Code Meaning DEVICE PARTICIPATING ROLES Context ID 7445 Notes 81928396 Page 14 Device Participating Roles 2 Type: Extensible Coding Scheme Designator Version: 20110110 Code Value Code Meaning (0008,0100) (0008,0104) (0008,0102) DCM XYZ001 Object Evaluator 4 In PS3.16 add the following CID tables to Annex B: 6 CID YYY1 OBJECT EVALUATION NUMERIC REPORTING TYPES 8 Context ID YYY1 Object Evaluation Numeric Reporting Types 10 Type: Extensible Version: yyyymmdd Coding Scheme Designator (0008,0102) Code Value Code Meaning (0008,0100) (0008,0104) DCM XYZ002 Upper Bound Assessment DCM XYZ003 Lower Bound Assessment DCM XYZ004 Range Assessment DCM XYZ005 Numeric Equality Assessment 12 CID YYY2 OBJECT EVALUATION TEXT REPORTING TYPES 14 Context ID YYY2 Object Evaluation Text Reporting Types 16 Type: Extensible Version: yyyymmdd Coding Scheme Designator (0008,0102) Code Value Code Meaning (0008,0100) (0008,0104) DCM XYZ006 Equality Assessment DCM XYZ008 Attribute Consistency Assessment 18 CID YYY3 20 OBJECT EVALUATION NON-SPECIFIC REPORTING TYPES Context ID YYY3 Object Evaluation Non-Specific Reporting Types 81928396 Page 15 Type: Extensible Version: yyyymmdd 2 Coding Scheme Designator (0008,0102) Code Value Code Meaning (0008,0100) (0008,0104) DCM XYZ007 Non-Specific Assessment 4 CID YYY4 OBJECT EVALUATION TYPE 6 Context ID YYY4 Object Evaluation Type 8 10 Type: Extensible Version: yyyymmdd Coding Scheme Designator (0008,0102) Code Value Code Meaning (0008,0100) (0008,0104) DCM XYZ009 RT Pre-Treatment Dose Check DCM XYZ010 RT Pre-Treatment Consistency Check
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