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Digital Imaging and Communications in Medicine (DICOM)

Supplement 159:

Radiopharmaceutical Radiation Dose Reporting (Dose SR)

DICOM Standards Committee

1300 N. 17th Street, Suite 1752

Rosslyn, Virginia 22209 USA

Version: Public CommentLetter Ballot

Send comments to: [email protected]

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Supplement 159: Radiopharmaceutical Administration Radiation Dose Reporting (Dose SR)

November 422, 2013

Developed pursuant to DICOM Work Item 2010-04-B

Table of Contents

Scope and Field ........................................................................................................................................... 3Changes to NEMA Standards Publication PS 3.2-2011 ...............................................................................4Changes to NEMA Standards Publication PS 3.3-2011 ...............................................................................5

A.35.X Radiopharmaceutical Radiation Dose SR Information Object Definition .............................9Changes to NEMA Standards Publication PS 3.4-2011 .............................................................................11

B.5 .......STANDARD SOP CLASSES ..................................................................................................11I.4 ........MEDIA STORAGE SOP CLASSES ........................................................................................12

Changes to NEMA Standards Publication PS 3.6-2011 .............................................................................13Annex A Registry of DICOM unique identifiers (UID) (Normative) ........................................................13Changes to NEMA Standards Publication PS 3.16-2011 ...........................................................................15

RADIOPHARMACEUTICAL RADIATION DOSE SR IOD TEMPLATES .............................................15TID XXXX1 Radiopharmaceutical Radiation Dose .................................................................15TID XXXX3 Radiopharmaceutical Administration Event Data ................................................16TID XXXX5 Radiopharmaceutical Administration Organ Data ...............................................20TID XXXX7 Radiopharmaceutical Administration Patient Characteristics ..............................21CID 9301 Modality PPS Discontinuation Reasons .....................................................................25CID CXXX2 Radiopharmaceutical Organ Dose Reference Authority ......................................25CID CXXX3 Source of Radioisotope Dose Information ...........................................................26CID CXXX7 Administration Completion Status .......................................................................27CID CXX10 Intravenous Extravasation Symptoms .................................................................27CID CXX11 Radiosensitive Organs ........................................................................................28CID CXX14 Radiopharmaceutical Patient States ...................................................................29CID CXX15 Glomerular Filtration Rate Methods .....................................................................30

Changes to NEMA Standards Publication PS 3.17-2011 ...........................................................................35XX.2 REAL-WORLD NUCLEAR MEDICINE AND PET RADIOPHARMACEUTICAL RADIATION DOSE (RRD) SR WORKFLOW ...................................................................................................................... 36XX.2 REAL-WORLD NUCLEAR MEDICINE AND PET RADIOPHARMACEUTICAL IDENTIFIER RELATIONSHIP .................................................................................................................................. 41

Scope and Field ........................................................................................................................................... 3Open Issues ................................................................................................................................................. 4Closed Issues .............................................................................................................................................. 5Changes to NEMA Standards Publication PS 3.2-2011 ...............................................................................9Changes to NEMA Standards Publication PS 3.3-2011 .............................................................................10

A.35.X Radiopharmaceutical Radiation Dose SR Information Object Definition ...........................15Changes to NEMA Standards Publication PS 3.4-2011 .............................................................................17

B.5 .......STANDARD SOP CLASSES ..................................................................................................17I.4 ........MEDIA STORAGE SOP CLASSES ........................................................................................18

Changes to NEMA Standards Publication PS 3.6-2011 .............................................................................19

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Supplement 159: Radiopharmaceutical Administration Radiation Dose Reporting (RARD SR)

6 ....Registry of DICOM data elements .......................................................................................................19Annex A Registry of DICOM unique identifiers (UID) (Normative) ........................................................19Changes to NEMA Standards Publication PS 3.16-2011 ...........................................................................20

RADIOPHARMACEUTICAL RADIATION DOSE SR IOD TEMPLATES .............................................22TID XXXX1 Radiopharmaceutical Radiation Dose .................................................................22TID XXXX3 Radiopharmaceutical Administration Event Data ................................................23TID XXXX5 Radiopharmaceutical Administration Organ Data ...............................................26TID XXXX7 Radiopharmaceutical Administration Patient Characteristics ..............................27CID 3108 NM/PET Procedures ..................................................................................................31CID 9301 Modality PPS Discontinuation Reasons .....................................................................32CID CXXX2 Radiopharmaceutical Organ Dose Reference Authority ......................................32CID CXXX3 Source of Radioisotope Dose Information ...........................................................34CID CXXX7 Administration Completion Status .......................................................................35CID CXX10 Intravenous Extravasation Symptoms .................................................................35CID CXX11 Radiosensitive Organs ........................................................................................37CID CXX14 Radiopharmaceutical Patient States ...................................................................38CID CXX15 Glomerular Filtration Rate Methods .....................................................................39

Changes to NEMA Standards Publication PS 3.17-2011 ...........................................................................44XX.2 REAL-WORLD NUCLEAR MEDICINE AND PET RADIOPHARMACEutical Radiation Dose (RRD) SR workflow ............................................................................................................................. 45XX.2 REAL-WORLD NUCLEAR MEDICINE AND PET RADIOPHARMACEUTICAL IDENTIFIER RELATIONSHIP .................................................................................................................................. 50

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Scope and Field

This supplement to the DICOM standard introduces a template for reporting of radiation dose due to administration of radiopharmaceuticals, as in NM or PET imaging, in DICOM. The concepts of Structured Reporting will be used in this context.

The supplement was developed by WG3 (Nuclear Medicine). In this supplement, radiation-related aspects of NM have been addressed with the advice of AAPM and SNMMI.

The Radiopharmaceutical Radiation Dose (RRD) report is based on the SOP class of “X-ray Radiation Dose SR”. Specific templates for the recording of the dose and the acquisition parameters in a NM environment have been developed.

The dose report records radiopharmaceutical activity amount, and administration time and other information. NM and PET modalities can read the reports to complete administration information essential for PET SUV calculations. Dose Registry and Dose Reporter systems will consume these reports.

Patient dose from background activity is not recorded in the report.

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Changes to NEMA Standards Publication PS 3.2-2011


Part 2: Conformance

Add new SOP Classes in Table A.1-2

Table A.1-2UID VALUES

UID Value UID NAME Category

…

1.2.840.10008.5.1.4.1.1.88.XX Radiopharmaceutical Radiation Dose SR

Transfer

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Part 3: Information Object Definitions

Change Table A.1-1 to add “C” to the Synchronization module and the NM IOD

Change PS3.3 Section A.5-4:A.5.4 NM Image IOD Module Table

Table A.5-1 NM IMAGE IOD MODULES

IE Module Reference Usage

Patient Patient C.7.1.1 M

Clinical Trial Subject C.7.1.3 U

Study General Study C.7.2.1 M

Patient Study C.7.2.2 U

Clinical Trial Study C.7.2.3 U

Series General Series C.7.3.1 M

Clinical Trial Series C.7.3.2 U

NM/PET Patient Orientation C.8.4.6 M

Frame of Reference

Frame of Reference C.7.4.1 M

Synchronization C.7.4.2 C- Required if time synchronization was applied.

Equipment General Equipment C.7.5.1 M

Image General Image C.7.6.1 M

Image Pixel C.7.6.3 M

Acquisition Context C.7.6.14 U - See Section A.5.4.1

Device C.7.6.12 U

Specimen C.7.6.22 U

NM Image Pixel C.8.4.7 M

Multi-frame C.7.6.6 M

NM Multi-frame C.8.4.8 M

NM Image C.8.4.9 M

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NM Isotope C.8.4.10 M

NM Detector C.8.4.11 M

NM TOMO Acquisition C.8.4.12 C - Required if Image Type (0008,0008) Value 3 is TOMO, GATED TOMO, RECON TOMO or RECON GATED TOMO

NM Multi-gated Acquisition C.8.4.13 C - Required if Image Type (0008,0008) Value 3 is GATED, GATED TOMO, or RECON GATED TOMO

NM Phase C.8.4.14 C - Required if Image Type (0008,0008) Value 3 is DYNAMIC

NM Reconstruction C.8.4.15 C - Required if Image Type (0008,0008) Value 3 is RECON TOMO or RECON GATED TOMO

Overlay Plane C.9.2 U

Multi-frame Overlay C.9.3 U

VOI LUT C.11.2 U

ICC Profile C.11.15 U

SOP Common C.12.1 M

Frame Extraction C.12.3 C - Required if the SOP Instance was created in response to a Frame-Level retrieve request

Change Table A.1-1 to add “C” to the Synchronization module and the PET IMAGE IOD

Change PS3.3 Section A.21.3-1 - PET IMAGE IOD MODULES

Table A.21.3-1 PET IMAGE IOD MODULES

IE Module Reference Usage





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Series General Series C.7.3.1 M


PET Series C.8.9.1 M

PET Isotope C.8.9.2 M

PET Multi-gated Acquisition C.8.9.3 C - Required if Series Type (0054,1000) Value 1 is GATED.

NM/PET Patient Orientation C.8.4.6 M

Frame of Reference

Frame of Reference C.7.4.1 M

Synchronization C.7.4.2 C- Required if time synchronization was applied.


Image General Image C.7.6.1 M

Image Plane C.7.6.2 M

Image Pixel C.7.6.3 M

Device C.7.6.12 U

Specimen C.7.6.22 U

PET Image C.8.9.4 M

Overlay Plane C.9.2 U

VOI LUT C.11.2 U

Acquisition Context C.7.6.14 U

SOP Common C.12.1 M

Modify Part 3 Table C.8-10:

Table C.8-10NM ISOTOPE MODULE ATTRIBUTES

Table Tag Type Attribute Description

… … … …

Radiopharmaceutical Information Sequence

(0054,0016) 2 Sequence of items that describe isotope information.Zero or more items shall be included in this sequence.

… … … …

>Radiopharmaceutical Start Time (0018,1072) 3 Time of start of injection. See C.8.4.10.1.5 for further explanation.

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>Radiopharmaceutical Stop Time (0018,1073) 3 Time of end of injection. See C.8.4.10.1.6 for further explanation.

>Radionuclide Total Dose (0018,1074) 3 Total amount of radionuclide injected. See C.8.4.10.1.7 for further explanation.

>Radiopharmaceutical Administration Event UID

(0018,YYYY) 3 Unique identifier for the Radiopharmaceutical Administration Event associated with this image.

Note: The UID is the same Radiopharmaceutical Administration Event UID that is in the Radiopharmaceutical Radiation Dose Report.

… … … …

Add the following Coding Scheme to Part 3 Table C.8-61:

Table C.8-61 – PET ISOTOPE MODULE ATTRIBUTES

Attribute Name Tag Type Attribute Description

… … … …

>Radionuclide Total Dose (0018,1074) 3 The radiopharmaceutical dose administered to the patient measured in Becquerels (Bq) at the Radiopharmaceutical Start Time (0018,1072).

Note: In other IODs, such as the NM IOD, this same attribute is specified in MegaBecquerels (MBq).




… … … …

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Add the following Coding Scheme to Part 3 Table C.8.22.4:

Table C.8.22-9ENHANCED PET ISOTOPE MODULE ATTRIBUTES

Attribute Name Tag Type Attribute Description

… … … …

>Radionuclide Total Dose (0018,1074) 3 The radiopharmaceutical dose administered to the patient measured in MegaBecquerels (MBq) at the Radiopharmaceutical Start Datetime (0018,1078).




… … … …

Add PS3.3 Section A.35.X:

A.35.X Radiopharmaceutical Radiation Dose SR Information Object DefinitionA.35.X.1 Radiopharmaceutical Radiation Dose SR Information Object DescriptionThe Radiopharmaceutical Administration Radiation Dose SR IOD is used to convey the exposure characteristics and dose from the administration of radiopharmaceuticals.

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A.35.X.2 Radiopharmaceutical Radiation Dose SR IOD Entity-Relationship ModelThe E-R Model in Section A.1.2 of this Part applies to the Radiopharmaceutical Radiation Dose SR IOD. Table A.35.X-1 specifies the Modules of the Radiopharmaceutical Radiation Dose SR IOD.

A.35.X.3 Radiopharmaceutical Radiation Dose SR IOD Module TableTable A.35.X-1

RADIOPHARMACEUTICAL RADIATION DOSE SR IOD MODULESIE Module Reference Usage






Series SR Document Series C.17.1 M


Frame of Reference

Synchronization C.7.4.2 C - shall be present if system time is synchronized to an external reference. May be present otherwise.


Enhanced General Equipment

C.7.5.2 M

Document SR Document General C.17.2 M

SR Document Content C.17.3 M

SOP Common C.12.1 M

A.35.X.3.1.1 TemplateThe document may be constructed from Baseline TID XXX1 "Radiopharmaceutical Radiation Dose Report" (defined in PS3.16) invoked at the root node.

A.35.X.3.1.2 Value TypeValue 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.17-7 for Value Type definitions):

TEXTCODENUMDATETIMEUIDREFPNAMECONTAINER

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A.35.X.3.1.3 Relationship ConstraintsRelationships between content items in the content of this IOD may be conveyed by-value. Table A.35.X-2 specifies the relationship constraints of this IOD. See Table C.17.3-2 for Relationship Type definitions.

Table A.35.X-2RELATIONSHIP CONTENT CONSTRAINTS FOR RADIOPHARMACEUTICAL RADIATION DOSE SR

IODSource Value Type Relationship Type

(Enumerated Values)Target Value Type

CONTAINER CONTAINS TEXT, CODE, NUM, DATETIME, UIDREF, PNAME, CONTAINER

TEXT, CODE, NUM HAS OBS CONTEXT TEXT, CODE, NUM, DATETIME, UIDREF, PNAME, COMPOSITE

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

any type HAS CONCEPT MOD TEXT, CODE

TEXT, CODE, NUM HAS PROPERTIES TEXT, CODE, NUM, DATETIME, UIDREF, PNAME, CONTAINER.

TEXT, CODE, NUM INFERRED FROM TEXT, CODE, NUM, DATETIME, UIDREF, CONTAINER.

A.35.X.3.1.4 Time ConstraintsAll times are assumed to be in UTC unless otherwise specified in the Synchronization Module.

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Part 4: Service Class Specifications

Add SOP Class to Table B.3-3

Table B.3-3STANDARD AND RELATED GENERAL SOP CLASSES

SOP Class Name Related General SOP Class Name

…

Radiopharmaceutical Administration Dose Radiation Dose SR

Enhanced SR

Comprehensive SR

Add SOP Class to Table B.5-1

B.5 STANDARD SOP CLASSES

Table B.5-1STANDARD SOP CLASSES

SOP Class Name SOP Class UID IOD (See PS 3.3)

…

Radiopharmaceutical Radiation Dose SR

1.2.840.10008.5.1.4.1.1.88.XX Radiopharmaceutical Radiation Dose SR

Add Structured Reporting SOP Class to Section B.5.1.5

B.5.1.5 Structured Reporting Storage SOP ClassesThe requirements of Annex O apply to the following SOP Classes:

• …

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•

• Radiopharmaceutical Radiation Dose SR

Add SOP Class to Table I.4-1

I.4 MEDIA STORAGE SOP CLASSES

Table I.4-1Media Storage Standard SOP Classes

SOP Class Name SOP Class UID IOD (See PS 3.3)

…

Radiopharmaceutical Radiation Dose SR

1.2.840.10008.5.1.4.1.1.88.XX Radiopharmaceutical Administration Radiation Dose SR

Add SOP Class to Section I.4.1.2

I.4.1.2 Structured Reporting Storage SOP ClassesThe requirements of Annex O apply to the following SOP Classes:

• X-Ray Radiation Dose SR

• Radiopharmaceutical Radiation Dose SR

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Part 6: Data Dictionary

Add the following Data Elements to Part 6 Section 6:

Tag Name Keyword VR VM

(0018,YYYY) Radiopharmaceutical Administration Event UID

RadiopharmaceuticalAdministrationEventUID

UI 1

Add the following UID Value to Part 6 Annex A Table A-1:

Annex A Registry of DICOM unique identifiers (UID)(Normative)

Table A-1UID VALUES

UID Value UID NAME UID TYPE Part

... ... … …

1.2.840.10008.5.1.4.1.1.88.XX Radiopharmaceutical Radiation Dose SR Storage

SOP Class PS 3.4

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Add the following UID Value to Part 6 Annex A Table A-3:

Table A-3CONTEXT GROUP UID VALUES

Context UID Context Identifier

Context Group Name

... ... …

1.2.840.10008.6.1.XX CXXX2 Radiopharmaceutical Organ Dose Reference Authority

1.2.840.10008.6.1.XX CXXX3 Source of Radioisotope Dose Information

1.2.840.10008.6.1.XX CXXX7 Administration Completion Status

1.2.840.10008.6.1.XX CXXX10 Intravenous Extravasation Symptoms

1.2.840.10008.6.1.XX CXXX11 Radiosensitive Organs

1.2.840.10008.6.1.XX CXXX14 Radiopharmaceutical Patient States

1.2.840.10008.6.1.XX CXXX15 Glomerular Filtration Rate Methods

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Add update codes for the following radiopharmaceuticals



Part 16: Content Mapping Resource

CID 25 RadiopharmaceuticalsContext ID 25

RadiopharmaceuticalsType: Extensible Version: 20110224

Coding Scheme Designator(0008,0102)

Code Value(0008,0100)

Code Meaning (0008,0104)

Trade name (informative)

SRT C-163AB Technetium Tc^99m^ sestamibi

SRT C-B10A2 Technetium Tc^99m^ sestamibi

SRT C-163AC Technetium Tc^99m^Teboroxime

SRT C-B10A1 Technetium Tc^99m^Teboroxime

SRT C-163AD Technetium Tc^99m^Tetrofosmin

SRT C-B10A4 Technetium Tc^99m^Tetrofosmin

SRT C-B1130 Thallous chloride Tl^201^


SRT C-B1222 Technetium Tc^99m^ sulfur colloid

SRT C-B10F0 Technetium Tc^99m^ sulfur colloid

SRT C-B1214 Technetium Tc^99m^ pentetate

SRT C-B10B8 Technetium Tc^99m^ pentetate

SRT C-B1213 Technetium Tc^99m^ oxidronate

SRT C-B10D7 Technetium Tc^99m^ oxidronate

SRT C-B1212 Technetium Tc^99m^ medronate

SRT C-B10D8 Technetium Tc^99m^ medronate

SRT C-B1208 Technetium Tc^99m^ mebrofenin

SRT C-B109B Technetium Tc^99m^ mebrofenin

SRT C-B1223 Technetium Tc^99m^ exametazine

SRT C-B10C6 Technetium Tc^99m^ exametazine

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SRT C-B1207 Technetium Tc^99m^ disofenin

SRT C-B108F Technetium Tc^99m^ disofenin

SRT C-B1133 Technetium Tc^99m^ depreotide

SRT C-B10A8 Technetium Tc^99m^ depreotide

SRT C-B1204 Technetium Tc^99m^ albumin colloid


SRT C-B1206 Sodium pertechnetate Tc^99m^

SRT C-B10CD Sodium pertechnetate Tc^99m^

Notes: 1. In a prior version of this table, the code C-163AB was specified for the radiopharmaceutical Technetium Tc^99m^ sestamibi, C-163AC was specified for the radiopharmaceutical Technetium Tc^99m^Teboroxime, C-B10A1 was specified for the radiopharmaceutical Technetium Tc^99m^Tetrofosmin, C-B1214 was specified for the radiopharmaceutical Technetium Tc^99m^ pentetate, C-B1213 was specified for the radiopharmaceutical Technetium Tc^99m^ oxidronate C-B1212 was specified for the radiopharmaceutical Technetium Tc^99m^ medronate, C- B1208 was specified for the radiopharmaceutical Technetium Tc^99m^ mebrofenin, C-B1223 was specified for the radiopharmaceutical Technetium Tc^99m^ exametazine, C-B1207 was specified for the radiopharmaceutical Technetium Tc^99m^ disofenin, C-B1133 was specified for the radiopharmaceutical Technetium Tc^99m^ depreotide, C- B1204 was specified for the radiopharmaceutical Technetium Tc^99m^ albumin colloid, C-B1206 was specified for the radiopharmaceutical Sodium pertechnetate Tc^99m^ and C-B1130 was specified for the radiopharmaceutical Thallous chloride Tl^201^. Since these codes denote the substance and the replacement codes denote the injection of the product. SOP Instances may include the deprecated code for these radiopharmaceuticals, receiving applications should be aware of this change; see Annex J.

Add the following rows Annex J Microglossary Retired Codes

SNOMED DICOM Microglossary Retired Codes




Notes

SRT C-163AB Technetium Tc^99m^ sestamibi

SRT C-163AC Technetium Tc^99m^Teboroxime

SRT C-163AD Technetium Tc^99m^Tetrofosmin


SRT C-B1222 Technetium Tc^99m^ sulfur colloid

SRT C-B1214 Technetium Tc^99m^ pentetate

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SRT C-B1213 Technetium Tc^99m^ oxidronate

SRT C-B1212 Technetium Tc^99m^ medronate

SRT C-B1208 Technetium Tc^99m^ mebrofenin

SRT C-B1223 Technetium Tc^99m^ exametazine

SRT C-B1207 Technetium Tc^99m^ disofenin

SRT C-B1133 Technetium Tc^99m^ depreotide


SRT C-B1206 Sodium pertechnetate Tc^99m^

Add new Section to Annex A

RADIOPHARMACEUTICAL RADIATION DOSE SR IOD TEMPLATES

The templates that comprise the Radiopharmaceutical Radiation Dose SR are interconnected as in Figure A-x.1

Figure A.x-1.

Radiopharmaceutical Radiation Dose SR IOD Template Structure

TID XXXX1 Radiopharmaceutical Radiation DoseThis template defines a container (the root) with subsidiary content items, each of which corresponds to a single Radiopharmaceutical Administration Dose event entry. There is a defined recording observer (the system and/or person responsible for recording the assay of the radiopharmaceutical, and the person

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administered the radiopharmaceutical). Multiple Radiopharmaceutical Administration Dose objects may be created for one study.

TID XXXX1 RADIOPHARMACEUTICAL RADIATION DOSE

Type: Extensible Order: SignificantNL Rel with

ParentVT Concept Name VM Req

TypeCondition Value Set Constraint

1 CONTAINER

EV (CDXX01, $99SUP159, “Radiopharmaceutical Radiation Report”)

1 M

2 > HAS CONCEPT MOD

CODE EV (G-C2D0, SRT, ”Associated Procedure”)

1 M DCID (3108) NM/PET Procedures

3 >> HASCONCEPTMOD

CODE EV (G-C0E8, SRT, “Has Intent”)

1 M DCID (3629) Procedure Intent

4 > CONTAINS INCLUDE DTID (XXXX3) Radiopharmaceutical Administration Event Data

1 M

5 > CONTAINS INCLUDE DTID (XXXX7) Radiopharmaceutical Administration Patient Characteristics

1 M

6 > CONTAINS TEXT EV (121106, DCM, “Comment”)

1 U

Content Item Descriptions

Row 2 The associated procedure is the procedure performed, or if no procedure was performed the procedure that was ordered.

Row 5 The physician responsible for determining that the irradiating procedure was appropriate for the indications.The value may come from Requesting Physician (0032,1032), Requesting Physician Identification Sequence (0032,1031) or somewhere else based on hospital policies.

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TID XXXX3 Radiopharmaceutical Administration Event DataThe Radiopharmaceutical Administration Event conveys the dose and assay and time information of a single radiopharmaceutical event. A Radiopharmaceutical Administration event is one radioactive pharmaceutical administered to a patient.

TID XXXX3RADIOPHARMACEUTICAL ADMINISTRATION EVENT DATA



TypeCondition Value Set

Constraint

1 CONTAINER

EV (CDXX05, $99SUP159, ”Radiopharmaceutical Administration”)

1 M

2 > CONTAINS CODE EV (123001, DCM, “Radiopharmaceutical”)

1 M DCID (25) Radiopharmaceuticals or DCID (4021) PET Radiopharmaceutical

3 > CONTAINS UIDREF EV (CDXX12, $99SUP159, “Radiopharmaceutical Administration Event UID”)

1 M

4 > CONTAINS CODE EV (CDXX15, $99SUP159, “Intravenous Extravasation Symptoms”)

1-n U DCID (CXX10) Intravenous Extravasation Symptoms

5 > CONTAINS NUM EV (CDXX16, $99SUP159, “Estimated Extravasation Activity”)

1 U UNITS=EV (%,UCUM, “percent”)

6 > CONTAINS DATETIME EV (123003, DCM, “Radiopharmaceutical Start DateTime”)

1 M

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7 > CONTAINS DATETIME EV (123004, DCM, “Radiopharmaceutical Stop DateTime”)

1 U

8 > CONTAINS NUM EV (CDXX17, $99SUP159, “Administered activity”)

1 M Units = EV (MBq, UCUM, “MBq”)

9 > CONTAINS NUM EV (123005, DCM, “Radiopharmaceutical Volume”)

1 U Units = EV (cm3, UCUM, “cm3”)

10 > CONTAINS NUM EV (123007, DCM, “Radiopharmaceutical Specific Activity”)

1 U Units = EV (Bq/mol, UCUM, “Bq/mol”)

11 > CONTAINS TEXT EV (CDXX19, $99SUP159, “Radiopharmaceutical Vial Unit Serial Identifier”)

1 U

12 > CONTAINS TEXT EV (CDXX24, $99SUP159, “Reagent Identifier”)

1 U

113 > CONTAINS CODE EV (C-B1000, SRT, “Diagnostic Radioisotope”)

1 M DCID 18 (NM) or 4020 (PET)

124 > CONTAINS NUM EV (CDXX25, $99SUP159, “Radionuclide Half Life”)

1 M Units = EV (s, UCUM, “seconds”)

15 > CONTAINS TEXT EV (CDXX26, $99SUP159, “Radionuclide Identifier”)

1 U

136 > CONTAINS NUM EV (CDXX34, $99SUP159, ”Pre-Administration Measured Activity”)

1 U Units = EV (MBq, UCUM, “MBq”)

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147 >> HAS OBSCONTEXT

CODE EV (CDXX36, $99SUP159, “Source of Activity Measurement”)

1 U DCID CXXX3


INCLUDE DTID (1002) Observer Context

1-n U


DATETME EV (CDXX35, $99SUP159, “Measured Activity Date Time”)

1 U

1720 > CONTAINS NUM EV (CDXX143, $99SUP159, ”Post-Administration Measured Activity”)

1 U Units = EV (MBq, UCUM, “MBq”)


CODE EV (CDXX36, $99SUP159, “Source of Activity Measurement”)

1 U DCID CXXX3


INCLUDE DTID (1002) Observer Context

1-n U


DATETME EV (CDXX35, $99SUP159, “Measured Activity Date Time”)

1 U

214 > CONTAINS INCLUDE DTID (XXXX7) Radiopharmaceutical Administration Patient Characteristics

1 M

225 > CONTAINS INCLUDE DTID (XXXX5) Radiopharmaceutical Administration Organ Data

1 U

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236 > CONTAINS CODE EV (121147, DCM, “Billing Code”)

1-n U local billing codes

247 > CONTAINS INCLUDE DTID (XXX11) Product Administration Data

1 M

258 > CONTAINS TEXT EV (121106, DCM, “Comment”)

1 U


Row 3 Unique identification of a single radiopharmaceutical administration event.

Row 5 The estimated percentage of administered activity lost at the injection site. The estimation includes extravasation, paravenous administration and leakage at the injection site.

Row 6 The time the radiopharmaceutical was administered to the patient for imaging purposes.

Row 8 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 10 Activity per unit mass of the radiopharmaceutical at Radiopharmaceutical Start Time

Row 11 See PS3.17 Section XX.2 for the relationship between Rows 11,12 and 15


Row 124

The value of Half-life that was used for computing the decay of the administered radiopharmaceutical. It is not intended for use by the receiver for any further computation.


Row 236

The billing code for the administration of the radiopharmaceutical.

TID XXXX5 Radiopharmaceutical Administration Organ DataThe Radiopharmaceutical Administration Organ Data conveys the organ information of a single radiopharmaceutical administration event.

46

300

302

304


TID XXXX5 RADIOPHARMACEUTICAL ADMINISTRATION ORGAN DATA


ParentVT Concept

NameVM Req


Constraint

1 CONTAINER

EV (CDXX06, $99SUP159, ”Radiopharmaceutical Administration Dose”)

1 M

2 > CONTAINS

CODE EV (CDXX30, $99SUP159, “Organ”)

1 M DCID (CXX11) Radiosensitive Organs

3 > CONTAINS

NUM EV (CDXX31, $99SUP159, “Reference Dose”)

1 M Units = EV (mGy, UCUM, “mGy”)

4 >> HAS PROPERTIES

CODE EV (121406, DCM, “Reference Authority”)

1 MC XOR Row 5 BCID (CXXX2) Radiopharmaceutical Organ Dose Reference Authority

5 >> HAS PROPERTIES

TEXT EV (121406, DCM, “Reference Authority”)

1 MC XOR Row 4

6 > CONTAINS

NUM EV (CDXX32, $99SUP159, “Estimated Mass of Organ”)

1 U Units= EV (g, UCUM, “grams”)

7 >> HAS CONCEPT MOD

TEXT EV (G-C036, SRT, “Measurement Method”)

1 M


Row 3 Organ dose ( in units of mGy). Organ is specified by row 2.

Row 6 The estimated mass of organ in grams used when calculating the organ dose.

Row 7 Method used to obtain the estimate. This could include a method that does not involve performing a measurement. (E.g., Standard Organ Mass Tables)

48

306

308

310


TID XXXX7 Radiopharmaceutical Administration Patient CharacteristicsThis template describes the characteristics of the patient that are specific to the current clinicalpresentation (visit). The characteristics noted may affect the activity received, and how dose is calculated for the patient. Patient Characteristic concepts in this template, which may replicate attributes in the Patient Study Module, are included here as possible targets of by-reference relationships from other content items in the SR tree.

TID XXXX7 RADIOPHARMACEUTICAL ADMINISTRATION PATIENT CHARACTERISTICS



TypeCondition Value Set Constraint

1 CONTAINS

CODE EV (109054, DCM, ”Pathological states”)

1-n U DCID (CXX14) Radiopharmaceutical Patient States

2 CONTAINS

NUM EV (121033, DCM, “Subject Age”)

1 M DCID (7456) Units of Measure for Age

3 CONTAINS

CODE EV (121032, DCM, “Subject Sex”)

1 M DCID (7455) Sex

4 CONTAINS

NUM EV (8302-2, LN, “Patient Height”)

1 U UNITS = EV (cm, UCUM, “cm”)

5 CONTAINS

NUM EV (29463-7, LN, “Patient Weight”)

1 M UNITS = EV (kg, UCUM, “kg”).

6 CONTAINS

NUM EV (8277-6, LN, “Body Surface Area”)

1 U UNITS = EV (m2, UCUM, “m^2”)

7 > INFERRED FROM

CODE EV (8278-4, LN, “Body Surface Area Formula”)

1 U BCID (3663) Body Surface Area Equations

8 CONTAINS

NUM EV (F-01860, SRT, “Body Mass Index”)

1 U UNITS = EV (kg/m2, UCUM, “kg/m^2”)

9 > INFERRED FROM

CODE EV (121420, DCM, “Equation”)

1 U DT (122265, DCM, “BMI = Wt/Ht^2”)

10 CONTAINS

NUM EV (14749-6, LN, “Glucose”)

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

50

312

314

316

318

320


11 CONTAINS

NUM EV(CDX144, $99SUP159, ”Fasting Duration”)

1 U Units = DT(h, UCUM, “hours”)

12 CONTAINS

NUM EV(CDX145, $99SUP159, ”Hydration”)

1 U Units = DT(mL, UCUM, “mL”)

13 CONTAINS

TEXT EV(CDX146, $99SUP159, ”Recent Physical Activity”)

1 U

14 CONTAINS

NUM EV (2160-0, LN, ”Serum Creatinine”)

1 U Units = DT(mg/dL, UCUM, “mg/dL”)

15 CONTAINS

NUM EV (CDX166, $99SUP159, ” Glomerular Filtration Rate”)

1 U Units = DT(mL/min/1.73m2, UCUM, “mL/min/1.73m2”)

16 > HAS PROPERTY

INCLUDE EV (CDX167, $99SUP159, ”GFR Method”)

1 MC IFF Glomerular Filtration Rate is reported

DCID (CXX15) Glomerular Filtration Rate Methods


Row 2 Defaults to value of Patient’s Age (0010,1010) in Patient Study Module

Row 4 Patient height may differ from Patient Size (0010, 1020). Row 7 because difference in patient height between the procedure been scheduled and height at the time of radiopharmaceutical administration. Row 7 is the weight valued used for any weight based protocols.Observation DateTime (0040,A032) may be used to record when the measurement was taken.

Row 5 Patient weight may differ from Patient Weight (0010, 1030). Row 7 because difference in patient weight between the procedures been scheduled and weight at the time of radiopharmaceutical administration. Row 7 is the weight valued used for any weight based protocols.Observation DateTime (0040,A032) shall be used to record when the measurement was taken.

Row 10 Patient’s Blood Glucose level.Observation DateTime (0040,A032) shall be used to record when the measurement was taken.

Row 14 Serum Creatinine Observation DateTime (0040,A032) shall be used to record when the measurement was taken.

Row 15 Glomerular Filtration Rate Observation DateTime (0040,A032) shall be used to record when the measurement was taken.

Row 16 The formula used to in the reported Glomerular Filtration Rate

52

322

324

326

328


TID XXX11PRODUCT ADMINISTRATION EVENT DATA




Constraint

1 CONTAINER

EV (CDX110, $99SUP159, ”Drug Product Identifier”)

1-n UC

2 > CONTAINS TEXT EV (111529, DCM, ”Brand Name”)

1 UC

3 > CONTAINS TEXT EV (121148, DCM, Unit Serial Identifier)

1-n MC IF identifier is available

4 >> CONTAINS TEXT EV (CDXX19, $99SUP159, “Radiopharmaceutical Vial Unit Serial Identifier”)

1 U

5 >> CONTAINS TEXT EV (CDXX24, $99SUP159, “Reagent Identifier”)

1 U

6 >> CONTAINS TEXT EV (CDXX26, $99SUP159, “Radionuclide Identifier”)

1 U

74 > CONTAINS CODE EV (G-C340, SRT, “Route of administration”)

1 M BCID (11) Route of Administration

85 > CONTAINS CODE EV (CDXX14, $99SUP159, “Substance Administration Approach Anatomic Site”)

1 MC IF Row 4 equals (G-D101,SRT, “Intravenous Route”) or (G-D103,SRT,”Intramuscular Route”)

DCID (3746)Percutaneous Entry Site

96 >> HAS CONCEPT MOD

CODE EV (G-C171, SRT, “Laterality”)

1 U DCID (244) Laterality

107 > CONTAINS TEXT EV (CDXX23, $99SUP159, “Prescription Number”)

1 U

54

330

332


118 > CONTAINS NUM EV (CDXX92, $99SUP159, “Administration Sub-ID Counter”)

1 U EV ({1:10}, UCUM, “range: 1:10”)

129 > CONTAINS CODE EV (CDXX93, $99SUP159, “Prescription Order Status”)

1 U BCID (CXXX7) Administration Completion Status

130 > HAS OBS CONTEXT

INCLUDE DTID (1020) PersonParticipant

1-n M $PersonProcedureRole =EV (113851, DCM,

“Irradiation Administering”)


Row 1 Registered drug establishment code for the product. A coding scheme example is NDC, WHO-DDE or RxNorm. Multiple entries can be used for equivalent drug product codes.

Row 3 Unit Serial Identifier or Product Package Identifier. From DICOM Product Characteristics Module C.26.1 Identifier of the contrast agent, drug, or device being characterized, typically from a package bar code, RFID, or other materials management ID. This ID might not be globally unique and might conflict with other IDs used within the scope of the institution. See PS3.17 Section XX.2 for an explanation.

Row 8 This field starts with 1 the first time that medication/treatment is administered for this order. Increments by one with each additional administration the medication/treatment.

Row 10 Identifies the person administering the product. If an infusion system is used, the system can also be noted.

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

CID 3108 NM/PET ProceduresContext ID 3108

NM/PET ProceduresType: Extensible Version: 20080927 yyyymmdd



Code Meaning(0008,0104)

SRT P5-D30F8 Nuclear medicine cardiovascular study

56

334

336

338

340


SRT P5-0A006 PET heart study

SRT P5-D6000 Radioisotope study of endocrine system

SRT P5-D6500 Radioisotope study of hematopoietic system

SRT P5-D5000 Radioisotope study of gastrointestinal system

SRT P5-D0063 Radionuclide study for localization of inflammatory disease

SRT P5-D10F8 Nuclear medicine diagnostic procedure on musculoskeletal system

SRT P5-D90F8 Nuclear medicine diagnostic procedure on nervous system

SRT P5-D0040 Radionuclide localization of tumor

SRT P5-D2000 Radioisotope study of respiratory system

SRT P5-D7000 Radioisotope study of genitourinary system

SRT P5-0A001 PET brain study

SRT P5-0A00D PET breast study

SRT P5-0A00A PET study for localization of tumor

CID 9301 Modality PPS Discontinuation ReasonsContext ID 9301

Modality PPS Discontinuation ReasonsType: Extensible Version: 20090616 yyyymmdd




… … ..

SRT D0-B0330 Injection Site Extravasation

SRT DF-10780 Radiopharmaceutical Adverse Reaction

CID CXXX2 Radiopharmaceutical Organ Dose Reference AuthorityContext ID CXXX2

Radiopharmaceutical Organ Dose Reference AuthorityType: Extensible Version: yyyymmdd

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342

344

346

348

350

352

354





$99SUP159 CDXX58 MIRD Pamphlet 1

$99SUP159 CDXX59 ICRP Publication 53

$99SUP159 CDXX60 MIRDOSE

$99SUP159 CDXX61 OLINDA-EXM

$99SUP159 CDX120 Package Insert

$99SUP159 CDX121 Institutionally Approved Estimates

$99SUP159 CDX122 Investigational New Drug

$99SUP159 CDX123 ICRP Publication 80

$99SUP159 CDX142 ICRP Publication 106

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356


CID CXXX3 Source of Radioisotope Dose InformationContext ID CXXX3

Source of Radioisotope Dose InformationType: Extensible Version: yyyymmdd




$99SUP159 CDXX62 Dose Calibrator

$99SUP159 CDXX63 Infusion System

$99SUP159 CDXX64 Generator

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358

360

362


CID CXXX7 Administration Completion Status

Context ID CXXX7 Administration Completion Status

Type: Extensible Version: yyyymmddCoding Scheme

Designator(0008,0102)



$99SUP159 CDXX95 Administration was canceled

$99SUP159 CDXX96 Administration is completed

$99SUP159 CDXX97 Administration was discontinued

$99SUP159 CDXX98 In process, unspecified

CID CXX10 Intravenous Extravasation Symptoms This list of Extravasation Symptoms are taken from ACR NRDR-ICE Registry, IV Contrast Extravasation Reporting Form version 1.3 from NRDR.ACR.ORG

Context ID CXX10 Intravenous Extravasation Symptoms

Type: Extensible Version: yyyymmddCoding Scheme

Designator(0008,0102)



$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 Extravasation visible in image

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364

366

368

370

372

374

376

Supplement 159: Radiopharmaceutical Administration Radiation Dose Reporting (Dose SR)66


CID CXX11 Radiosensitive OrgansContext ID CXX11

Radiosensitive OrgansType: Extensible Version: yyyymmdd


Code Value(0008,0100


SRT T-B3000 Adrenal gland

SRT T-74000 Bladder

SRT T-A0100 Brain

SRT T-04000 Breast

SRT T-59300 Colon

SRT T-56000 Esophagus

SRT T-63000 Gall bladder

SRT T-32000 Heart

SRT T-71000 Kidney

SRT T-62002 Liver

SRT T-28000 Lung

SRT T-C4000 Lymph node

SRT T-13001 Muscle

SRT T-65000 Pancreas

SRT T-9200B Prostate

SRT T-58000 Small intestine

SRT T-C3000 Spleen

SRT T-57000 Stomach

SRT T-94000 Testis

SRT T-C8000 Thymus

SRT T-B6000 Thyroid

SRT T-83000 Uterus

SRT T-87000 Ovary

SRT T-C1000 Bone Marrow

SRT T-00009 Skin

SRT T-D0859 Bone Surface

SRT T-61007 Salivary Glands

68

378

380

382


SRT T-83009 Uterus

SRT T-9200B Prostate

SRT T-51300 Oral mucosa

SRT T-AA700 Eye lenses

CID CXX14 Radiopharmaceutical Patient StatesContext ID CXX14

Radiopharmaceutical Patient States Type: Extensible Version: yyyymmdd




INCLUDE CID 3102 Rest-Stress

$99SUP159 CDX161 Abnormal Renal Function$99SUP159 CDX162 Acute unilateral renal blockage

$99SUP159 CDX163 Low Thyroid Uptake

$99SUP159 CDX164 High Thyroid Uptake

$99SUP159 CDX165 Severely Jaundiced

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384

386

388

390


CID CXX15 Glomerular Filtration Rate MethodsContext ID CXX15

Glomerular Filtration Rate MethodsType: Extensible Version: yyyymmdd




LN 33914‐3 Glomerular Filtration Rate (MDRD)

LN 48642-3 Glomerular filtration Rate non-black (MDRD)

LN 48643-1 Glomerular Filtration Rate black (MDRD)

LN 50044-7 Glomerular Filtration Rate female (MDRD)

LN 50210-4 Glomerular Filtration Rate Cystatin-based formula

LN 50384-7 Glomerular Filtration Rate Creatinine-based formula (Schwartz)

Item #19: Add the following Definitions to Annex D

DICOM Code Definitions (Coding Scheme Designator “$99SUP159” Coding Scheme Version “01”)Code Value Code Meaning Definition

…

CDXX01 Radiopharmaceutical Radiation Dose Report

The procedure report is a Radiopharmaceutical Radiation Dose report

CDXX05 Radiopharmaceutical Administration Event Data

Structure to record information pertaining to the administration of a radiopharmaceutical

CDXX06 Radiopharmaceutical Administration Organ Dose

Structure to record information of the estimated dose to organs from the administration of a radiopharmaceutical

CDXX08 Radioisotope Activity Data Structure to record the measured activity of a radioisotope.

CDXX10 Glomerular Filtration Rate Measurement Data

The Glomerular Filtration Rate (GFR) of a patient.

CDXX12 Radiopharmaceutical Administration Event UID

Unique identification of a single radiopharmaceutical administration event.

72

392

394

396

398

400


CDXX14 Substance Administration Approach Anatomic Site

Description of the anatomic site where the substance was administered.

CDXX15 Intravenous Extravasation Symptoms

Initial signs or symptoms of extravasation

CDXX16 Estimated Extravasation Activity The estimated percentage of administered activity lost at the injection site. The estimation includes extravasation, paravenous administration and leakage at the injection site.

CDXX17 Administered activity The calculated activity at the Radiopharmaceutical Start Time when the radiopharmaceutical is administered to the patient. The residual activity (i.e. radiopharmaceutical not administered), if measured, is reflected in the calculated value. The estimated extravasation is not reflected in the calculated value.

CDXX19 Radiopharmaceutical Vial Unit Serial Identifier

Identifies the Radiopharmaceutical Vial for multi-dose types. The Unit Serial Number record the identification for each individual dose. See PS3.17 Figure XX7

CDXX23 Prescription Number Administered Product Prescription Number

CDXX24 Reagent Identifier Lot or Unit Serial number for the reagent component for the radiopharmaceutical. See PS3.17 Figure XX7

CDXX25 Radionuclide Half Life Half-life used in decay calculations. Expressed in seconds.

CDXX26 Radionuclide Identifier Lot or Unit Serial number for the radionuclide component for the radiopharmaceutical. See PS3.17 Figure XX7.

CDXX27 Procedure Discontinuation Reason The reason the procedure was discontinued after a product was administered.

CDXX29 Dose Reference Authority Description

Description of how the dose reference authority use criteria (Sex, Weight)

CDXX30 Organ Absorbed Dose Organ reported

CDXX31 Reference Dose The absorbed radiation dose to organ in Grays

CDXX32 Estimated Mass of Organ Estimated mass of the organ used to compute organ absorbed dose

CDXX34 Pre-Administration Measured Activity Radioactivity measurement of radiopharmaceutical before or during the administration.

CDXX35 Measured Activity Date Time Date and Time of Measured Activity

74


CDXX36 Source of Activity Measurement The type of device that performed the activity measurement.

CDXX37 Reason for Activity Measurement Record the reason the product’s activity was measured. Verification, Residual, Correction

CDXX41 Serum Creatinine The measured Serum Creatinine

CDXX42 Traceable to IDMS Is measurement of Glomerular Filtration Rate is traceable to isotope dilution mass spectrometry

CDXX43 Glomerular filtration rate Glomerular Filtration Rate (GFR) describes the flow rate of filtered fluid through the kidney.

CDXX52 Fetus Effective Dose The effective dose to the fetus.

CDXX55 Radiopharmaceutical Administration Event

The scope of accumulation is for a single radiopharmaceutical event

CDXX58 MIRD Pamphlet 1 Radiopharmaceutical Dose reference. MIRD Pamphlet No.1 (rev),Society of Nuclear Medicine, 1976

CDXX59 ICRP Publication 53 International Commission on Radiological Protection (ICRP) Publication 53 Radiopharmaceutical Dose reference

CDXX60 MIRDOSE MIRDOSE Radiopharmaceutical Dose reference

CDXX61 OLINDA-EXM OLINDA/EXM Radiopharmaceutical Dose reference

CDXX62 Dose Calibrator The device that measures the radiation activity of the radiopharmaceutical

CDXX63 Infusion System Radiopharmaceutical Infusion System

CDXX64 Generator Radioisotope Generator

CDXX65 Pre-Administration Radioisotope Activity measurement reason to verify activity before administration to patient.

CDXX66 Residual Measured residual activity in syringe after administration

CDXX92 Administration Sub-ID Counter This field starts with 1 the first time that medication/treatment is administered for this order. Increments by one with each additional administration the medication/treatment.

CDXX93 Prescription Order Status Status should be ‘in progress”, ”completed” or “canceled”

CDXX95 Administration was canceled Prescription Administration canceled. Product was not administered.

CDXX96 Administration is completed Prescription Administration was completed.

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CDXX97 Administration was discontinued Prescription Administration started but not finished.

CDXX98 In process, unspecified Prescription order in-progress

CDX110 Drug Product Identifier Registered drug establishment code for product, coding scheme example is NDC or RxNorm

CDX111 Purpose of Administration Local description of the intended use for an example “Cardiac Stress Dose”.

CDX115 PET Procedure PET procedure is reported in the Radiopharmaceutical Administration Report

CDX116 Nuclear Medicine Procedure Nuclear Medicine procedure is reported in the Radiopharmaceutical Administration Report

CDX117 Non-imaging procedure Non-imaging procedure is reported in the Radiopharmaceutical Administration Report

CDX118 Activity Measurement Device Participant role for radiopharmaceutical Activity Measurement.

CDX120 Package Insert The reported organ dose is based on radiopharmaceutical’s package insert.

CDX121 Institutionally Approved Estimates The reported organ dose is based on Institutionally approved estimates from the Radioactive Drug Research Committee (RDRC) of the institution itself.

CDX122 Investigational New Drug The reported organ dose is based on an Investigation new drug.

CDX123 ICRP Publication 80 The reported organ dose is based on ICRP publication 80.

CDX127 Decreased Perfusion Intravenous Extravasation exhibits decreased perfusion.

CDX128 Skin Induration Intravenous Extravasation exhibits skin induration

CDX129 Erythema Intravenous Extravasation exhibits erthema

CDX130 Altered sensation Intravenous Extravasation exhibits altered sensation.

CDX131 No Signs or Symptoms Intravenous Extravasation exhibits no signs or symptoms

CDX132 Multiple Procedure Type Procedure report value for reports that contain more than administration events for different procedure types. ( PET and a NM administration event)

CDX133 Prescribing Physician Physician that prescribed the radiopharmaceutical.

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CDX134 Radiopharmaceutical Administrating Person that administered the radiopharmaceutical.

CDX 135 Swelling Mild Intravenous Extravasation exhibits mild swelling

CDX136 Swelling Moderate Intravenous Extravasation exhibits moderate swelling

CDX137 Swelling Severe Intravenous Extravasation exhibits severe swelling

CDX138 Pain Intravenous Extravasation causes pain or the patient reports pain from suspected extravasation.Intravenous Extravasation exhibits mild swelling

CDX139 Skin Blistering or Ulceration Intravenous Extravasation exhibits skin blistering or ulceration

CDX140 Compartment Syndrome Intravenous Extravasation exhibits compartment syndrome

CDX141 Extravasation visible in image Extravasation, paravenous administration and leakage at the injection site, is visible in the images.

CDX142 ICRP Publication 106 The reported organ dose is based on ICRP publication 106

CDX143 Post-Administration Measured Activity

Radioactivity measurement of radiopharmaceutical after the administration.

CDX144 Fasting Duration The number hours the patient has gone without food.

CDX145 Hydration The amount of fluids the patient has consumed before the procedure.

CDX161 Abnormal Renal Function The patient exhibits symptoms of impaired renal function. For example, enlarged kidneys, Pyelonephritis, Hydroureteronephrosis…

CDX162 Acute unilateral renal blockage Blockage in one of the tubes (ureters) that drain urine from the kidneys

CDX163 Low Thyroid Uptake 5% or less Thyroid Uptake of Iodine

CDX164 High Thyroid Uptake 25% or higher of Iodine

CDX165 Severely Jaundiced The patient exhibits symptoms severe jaundice and/or has a Bilirubin >10 mg/dL.

CDX166 Glomerular filtration rate Numeric value reported for Glomerular filtration rate

CDX167 Glomerular Filtration Rate Method The method used to calculate the Glomerular filtration rate

80

Supplement 159: Radiopharmaceutical Administration Radiation Dose Reporting (Dose SR)82

402




Part 17: Explanatory Information

Add a new Annex section:

Annex XX Radiopharmaceutical Radiation Dose Structured Report (Informative)

XX.1 PURPOSE OF THIS ANNEX

This Annex describes the use of the Radiopharmaceutical Radiation Dose (RRD) object. PET, Nuclear Medicine and other non- imaging procedures necessitate that radiopharmaceuticals are administered to patients. The RRD records the amount of activity and estimates patient dose. Radiopharmaceuticals are often administered to patients several minutes before the imaging step begins. A dose management system records the amount of activity administered to the patients. Currently these systems can be configured to receive patient information from HIS/RIS systems via HL7 or DICOM messaging. Figure XX-1 demonstrates a workflow for a “typical” Nuclear Medicine or PET department.

Hot Lab Management

System

Procedure Orders

Modality

Radiopharmaceutical Administered

HL7

DICOM Worklist

DICOM Worklist

Radiopharmaceutical

Patient Scanned

Image Archive

DICOM

84

404

406

408

410

412

414

416

418

420

422

424

426

428


Figure XX - 1 Workflow for a “typical” Nuclear Medicine or PET department

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430

432


XX.2 REAL-WORLD NUCLEAR MEDICINE AND PET RADIOPHARMACEUTICAL RADIATION DOSE (RRD) SR WORKFLOW

The Figure XX – 2 demonstrates a Hot Lab management system as the RRD user. It records the activity amount and the administration time. It creates the RRD report and sends it to the modality. Consistent time is required to accurately communicate activity amount. The consistent time region highlights systems and steps where accurate time reporting is essential. A DICOM Store moves the report to the modality.

Figure XX - 2 Hot Lab management system as the RRD user

Consistent Time

Hot Lab Management

System

Procedure Orders

Modality


DICOM Worklist

DICOM Worklist

Radiopharmaceutical

Patient Scanned

Archive

DICOM

RARD SR

RARD SR

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434

436

438

440

442

444

446

448

450

452


The Figure XX – 3 demonstrates RRD workflow where a radiopharmaceutical is administered to a patient for a non-imaging procedure. The report is sent to the image manager/ image archive for storage and reporting.

Figure XX - 3 Workflow for a non-imaging procedure

Hot Lab Management

System

Procedure Orders


DICOM Worklist

Radiopharmaceutical

Archive

RARD SR

Consistent Time

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454

456

458

460

462

464

466

468

470


Figure XX-4 demonstrates when an infusion system or a generator is the RRD user.

Figure XX - 4 Workflow for an infusion system or a generator

Hot Lab Management

System

Procedure Orders

Modality

Radiopharmaceutical Infusion Device

DICOM Worklist

DICOM Worklist

Radiopharmaceutical

Patient Scanned

Archive

DICOM

RARD SR

RARD SR

Consistent Time

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476

478

480

482

484

486


Figure XX – 5 is an UML sequence drawing to illustrate steps for creation and downstream use case for Radiopharmaceutical Administration Radiation Dose report and CT dose report for the PET\CT system. The RRD is stored to the an image archive and retrieved by the PET\CT scanner.

Figure XX - 5 UML sequence drawing for typical workflow

•

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490

492

494


Figure XX-6 is an UML sequence drawing to illustrate steps for creation and downstream use for radiopharmaceutical that is administered when the modality starts acquisition. The drawing illustrates that the dose report is reconciled with the image at later time by an image processing step.

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498


Figure XX - 6 UML sequence drawing for when radiopharmaceutical and the modality are started at the same time

XX.2 REAL-WORLD NUCLEAR MEDICINE AND PET RADIOPHARMACEUTICAL IDENTIFIER RELATIONSHIP

• The hierarchical relationship between the Unit Serial Identifier, Radiopharmaceutical Vial Unit Serial Identifier, Reagent Identifier and Radionuclide Identifier is shown in Figure XX-6. A radiopharmaceutical is created by a radio-pharmacist combining reagent and a radionuclide. The Reagent Identifier is for the reagent and the Radionuclide Identifier for the nuclide. The combined mixture is now a Radiopharmaceutical Vial. The vial may be used for a single patient or multiple patients. The Unit Serial Identifier is the serial for the product prepared for administration to the patient. For single patient vials, the Radiopharmaceutical Vial Unit Serial Identifier and Unit Serial Identifier may be the same.

Figure XX - 7

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