Radiopharmaceutical Administration Radiation Dose Reporting. RARD Reporting White Paper

Transcription

1 Radiopharmaceutical Administration Radiation Dose Reporting RARD Reporting White Paper A RARD report proposes a solution to connect the radiopharmaceutical management dominion with the image modalities and imaging dominion. Charles Smith, Lawrence Smith, George Gregg, Numa Inc. 2/13/2012 For latest version go to:

2 Contents Radiopharmaceutical Administration Radiation Dose Reporting... 3 Introduction... 3 Who is this for?... 5 Molecular Imaging Use Cases:... 5 Considerations:... 5 Review of IHE Radiation Exposure Monitoring (REM) technical framework IHE REM Use cases:... 6 Integrating Molecular Imaging workflow into REM workflow RARD Actor Transaction... 8 Workflow diagrams... 9 Real-World Molecular Imaging current workflow... 9 RARD Workflow with hot lab manager implemented RARD Actor RARD Workflow administrated dose without imaging RARD Workflow with an infusion system implementing the RARD Actor Radiopharmaceutical Dose Check Radiopharmaceutical Dose Check workflow Challenges Technoligist Push Back Assay of residual dose DICOM Standard Product labels Radiation Dosimetry estimation Radiopharmaceutical Quality Control, Isotope and Reagent Kit attributes Intervention drugs and Contrast Agent characteristics report Product Administration Approval Conculsion Appendix RARD PET\CT Sequence Example Review of Existing Standards DICOM SAS Substance Administration Services Radiopharmaceutical Administration Radiation Dose Structure Report Template Radiopharmaceutical Administration Dose Template RARD White Paper Page 1

3 Radiopharmaceutical Administration Accumulated Dose Radiopharmaceutical Administration Event Substance Administration Approval Code Reference Extension Radiopharmaceutical administration Dose Exposure per Organ Radioisotope Assay Data Template Patient Characteristics template Glomerular filtration rate Current published DICOM Codes Radiopharmaceuticals Context Id CID 25 Radiopharmaceuticals Isotopes in Radiopharmaceuticals CID PET Cardiology Radiopharmaceuticals CID Nuclear Cardiology Radiopharmaceuticals CID PET Radiopharmaceutical CID RARD White Paper Page 2

4 Radiopharmaceutical Administration Radiation Dose Reporting Introduction The following is a white paper comprised from a review of the DICOM, IHE, HL7 standards and current Molecular Imaging industry. The goal of this document is to raise awareness, stimulate discussion and help begin the process of finding solution to existing problems. We assume it is best to follow IHE and DICOM approach for X-Ray and CT exposure and develop DICOM structure report (SR) for radiopharmaceutical administration. There are other approaches to the problem but DICOM SR offers the best alignment with existing standards, profiles and systems. We will identify current parts of standards that refer to radiopharmaceuticals; define attributes of the report, define the role of the creator of the report and propose a Dose Check in the workflow. There are many opportunities for the molecular image industry with adoption of a standardization of dose report. A Radiopharmaceutical Administration Radiation Dose Structure Report (RARD) would create a means for communication between the radiopharmaceutical segment of the industry and the imaging segment. With communication established there are numerous uses for the report which could solve existing problems in the Molecular Imaging industry. The report would document radiopharmaceutical exposures and distribute them as defined in the IHE Radiation Exposure Monitoring (REM) Profile. The RARD contains radiopharmaceutical administration information required by PET systems for accurate and consistent SUV calculations. A standardized report and a time managed workflow is essential for the RSNA QIBA PET SUV Biomarker. A RARD report is a DICOM object so the information would flow with the images to reading stations and archives. The report could be de-identified and transferred from site to site or information could be gathered from sampling of RARD reports. (e.g. dose amount, uptake times and other patient characteristics) This information would be valuable for clinical research and setting exposure benchmarks in the imaging department. A National registry could be established to gather dose reports. Developing a radiation dose report for Molecular Imaging is a complex problem. The radiopharmaceutical product causes the radiation exposure to the patient, not the imaging system itself unlike other modalities. Doses are often created in specialized pharmacies outside of the imaging facilities. Doses are measured and recorded in systems (hot lab managers). The doses are often administered to patients several minutes before the patient is imaged. Hot lab managers currently have limited HL7 and DICOM Worklist capabilities. Currently, there is no defined standard to digital communicate radiopharmaceutical administration information in a time managed format to radiopharmaceutical imagers. For an accurate Radionuclide Total Dose it is essential that time is managed (consistent) for, when the dose is assayed, when the dose is administered and when the imager records the start of the acquisition. RARD White Paper Page 3

5 The RARD report needs to contain the information required to accurately compute exposure from a radiopharmaceutical. These components are: the radiopharmaceutical and radioisotope the measured activity and the time it was measured the time the product was administered the residual activity measured and the time it was measured the patient state (stress or rest) when the product was administered. Time is a reoccurring attribute in many of the exposure components. If the imaging modality is going to relate these components to acquired images (like in PET SUV) then it needs to be able too relate the exposure component times to the imagers acquisition start time. Another aspect of the radiopharmaceuticals that should be considered is that they are substances that are administered to patients. There are many parts of the DICOM standard that pertain to substances (e.g. Contrast Agent and Interventional drugs). The Interventional Drug Code Sequence is now part of the Nuclear Medicine and PET IOD. For hybrid PET/CT, SPECT/CT and PET/MR scanners, the contrast agent information is part of the CT and MR IOD. Though not as critical as radiopharmaceutical information, contrast agents and intervention drugs have the same problem; the technologist has to manually enter data about products administered several minutes earlier at the modality console. Hot lab management systems can track the administration substances other than radiopharmaceuticals. In this document we will review and incorporate appropriate information into the RARD report. Contrast Agents and interventional drugs should be handled in a different and separate Product Administration report. A product administration report would share many of the same attributes and workflow as the RARD report. What we are proposing is a four item solution. 1. Radiopharmaceutical Administration Radiation Dose SR IOD template (RARD SR). The report contains dose assay components and exposure components. 2. A RARD Creator Actor which defines the role and features of the RARD report creator. The profile can then be integrated in to IHE REM profile. 3. A Dose Alert component for the RARD Creator. It could act much like the CT Dose Check Initiative. 4. A Product Administration Report SR IOD template. It is used to communicate Intervention drugs and contrast products to the imaging modalities. Radiopharmaceutical Reports are differentiated from Product Administration reports so they can easily be identified by REM Dose information consumers. RARD should have a different SOP Class UID from Product Administration Reports. A product administration report and a RARD would share many of the same attributes, but a product administration report is beyond the scope of this document. RARD White Paper Page 4

6 Who is this for? There are many aspects to reporting exposure within the MI department. Therefore, there are many players who should be aware and involved in developing the report. The following is a list of potential players. Facilities exposing patient to radiation from radiopharmaceuticals. MI Physician and Technologist Modality Manufacturers of Nuclear Medicine, PET and Hybrid systems. Radiopharmaceutical manufacturers Radiopharmaceutical Pharmacies Dose Management System Developers Dose calibrator manufacturers Rubidium Generator manufacturers Infusion System manufacturers Non-Imaging Nuclear Medicine systems manufactures, Uptake Probe, Blood Volume. Molecular Imaging Use Cases: In the following list we will try to capture the use cases and other considerations we used for the design of the RARD report. The RARD Report will: 1.) Record radiopharmaceutical exposure in an IHE REM compatible format. 2.) Record product information not entered/available to the scanner at time of the acquisition or must be edited after the acquisition. 3.) Support multiple scans (and/or, multiple reconstructed images series) in a study, from 1 product administration. 4.) Support multiple product administration within a study (e.g. Cardiac Rest/Stress study) 5.) Create reports for non-imaging procedures. (e.g. Thyroid Uptakes probes, Blood volume systems) 6.) Create reports for administered products even if patient cancels imaging step. 7.) Create reports for therapeutic doses that are not imaged. 8.) Record the Patient State when the radiopharmaceutical was administered. Patient state affects radiopharmaceutical dose. Considerations: 1.) Exposure Reporting a. Effective Dose (as per product label) b. Organ Exposure (as per product label) 2.) Model Injection/Administration as event, and include some mechanism of uniquely identifying that administration event (analogous to CT irradiation event ). 3.) Accumulated Dose 4.) Dose Information is transferred and stored with images. 5.) Coded Radiopharmaceutical 6.) Coded Radioisotope 7.) Coded Route of Administration RARD White Paper Page 5

7 8.) PET SUV Components a. Total dose b. Administration date/time c. Patient Weight d. Patient Size (height) 9.) Radioisotope Assay Data a. Observer Context 10.) Time Management (Consistent Time when recording the dose, and product administration) 11.) Patient Uptake Location 12.) Patient Characteristics a. Patient State Stress\Rest b. Glucose level c. GFR/eGFR d. Allergies e. Patient Medications 13.) Product characteristics a. Product Package Identifier b. Manufacturer c. Product Type Code Sequence d. Product Lot identifier e. Product Expiration Date Time f. Product QC data g. Isotope characteristics h. Reagent Kit characteristics 14.) Volume Administered 15.) Interventional Drugs (Stress Agents) 16.) Prescription Id 17.) Unit Dose or local compounded 18.) Clinical Trials integration 19.) Image report 20.) Product administration integration (Medicine Administration Report) 21.) Product approval 22.) Meaningful Use (MU) component requirements Review of IHE Radiation Exposure Monitoring (REM) technical framework. The following is a list of the use cases identified for REM. The use cases were identified for CT, X-ray and fluoroscopy system but most of these points are applicable to molecular imaging. IHE REM Use cases: 1.) Department QA (Process Control) 2.) Patient Impact Evaluation 3.) Population Dose and Dose Indicators 4.) Dose Reference Levels 5.) Site Benchmarking RARD White Paper Page 6

8 6.) Population Epidemiology 7.) Clinical Trials 8.) Procedure Operational Awareness (Quasi-real time) 9.) Clinical Management 10.) Longitudinal Patient Dose Record RARD White Paper Page 7

9 Integrating Molecular Imaging workflow into REM workflow. The following is a drawing that is identical to the Actor diagram in the IHE REM profile except for the Acquisition modality actor has been replaced with a RARD Creator actor. Molecular Imaging modalities, which only image, do not appear in the diagram because they do not expose patients. For PET especially, the camera should perform the role of the Dose Information consumer. The RARD report contains information essential for SUV calculations. Figure 1 RARD Creator in IHE Actor diagram RARD Actor Transaction Actor Transactions Optionality Reference RARD Creator Maintain Time [ITI-1] Query Modality Worklist [RAD-5] Store Dose Information[RAD-62] Storage Commitment [RAD-10] Modality PS in Progress [RAD-6] Modality PS in Complete [RAD-7] O R R R O O IHE IT Infrastructure Vol. 1 Section 7 IHE Radiology Vol. II Section 4.5 IHE REM Vol. 4 Section 62 IHE REM Vol 4 Section 10 IHE Radiology Vol. II Section 4.6 IHE Radiology Vol. II Section 4.7 RARD White Paper Page 8

10 Workflow diagrams Real-World Molecular Imaging current workflow The following figure is a diagram of the typical current molecular imaging workflow. The blue represents RIS\HIS scheduling workflow. The orange represents radiopharmaceutical management workflow. The green represents the patient workflow. The red is imaging modality workflow. Some dose management systems are connected to the HIS/RIS for ordering. Note there is no connection between the radiopharmaceutical management and the imaging modality. Time is not managed between dose measurement and product administration and the imaging scanner. Figure 2 Current Molecular Imaging Workflow RARD White Paper Page 9

11 RARD Workflow with hot lab manager implemented RARD Actor. The following diagram demonstrates workflow where there is a RARD actor. It is recording the dose measurements and the product administration measurements. In this instance the RARD report is being sent directly to the imaging scanner. The scanner can read the report to populate the radiopharmaceutical administration information it requires. The scanner s images can now reference the RARD report. The scanner images and the RARD report can be stored and read from the image manager/archive (PACS). Figure 3 Dose Management system RARD Actor Workflow RARD White Paper Page 10

12 RARD Workflow administrated dose without imaging. The following figure shows the workflow for non-imaging dose or procedure where the patient is administered a radiopharmaceutical but is not imaged. A record of the administration is still produced and stored. This action may prompt the billing system that the procedure step was performed. Time is managed between the dose assay time and the product administration time. Figure 4 RARD Workflow with no imaging step RARD White Paper Page 11

13 RARD Workflow with an infusion system implementing the RARD Actor. The following is the workflow if the RARD Actor is an infusion system or generator. The consistent time triangle was removed from the drawing for simplifcation. Keeping consistent time is simpler because the infusion system is electronically preforming dose assays and dose administration. If time is managed between the infusion system and scanner then very accurate dose reports can be achieved. Also, since the patient characteristics can be entered in to the infusion system, patient specific dose reduction routines can be easily implemented. Dose assys are recorded electronically without technologist push back. Figure 5 Infusion System RARD Actor Workflow RARD White Paper Page 12

14 Radiopharmaceutical Dose Check If the MI industry implemented a dose check feature simular to CT industry, a logical place to put the check dose feature is in the RARD creator. RARD creator would ensure the radiopharmaceutical attributes. The following is a list of attributes for the RARD dose check. Radiopharmaceutical (Coded Value) Radiopharmaceutical Assay Measurement Assay Time (Time Managed) Electronic setting of dose calibrator for radiopharmaceutical Electronic reading of dose assay values. Schedule Administration Time or current time in same managed time as assay. Patient Age Procedure Configured Notification Value Reason for Proceding Person Participant Allergies Mediciations Other QC data RARD White Paper Page 13

15 Radiopharmaceutical Dose Check workflow The following is a proposed workflow for a radiopharmaceutical Dose Check. Patient age, weight, scheduled start time and requested procedure are gathered from DICOM Worklist. Products for the procedure are selected from inventory. The radiopharmaceutical is assayed in the dose calibrator. The electronic connection to the dose calibrator is important. First the RARD creator can ensure the dose calibrator is set to the correct isotope for the selected radiopharmaceutical. Secondly it eliminates transcription errors. Third it ensures the dose is assayed and the time. The patient is prepared for the administration of the radiopharmaceutical. Then just before administration there is a check of patient id to product id. It would be possible to check radiopharmaceutical dose using current time and last assay to ensure the dose is being administered at the proper time. Product approval by local pharmacy, drug interaction and patient interview results are not included in the workflow. Challenges Technologist Push Back Figure 6 Dose Check Workflow Electronic recording of Assay For several years, dose calibrators have had the ability to read assays electronically. Additionally, hot lab management systems have had the ability to read dose assays from the dose calibrators; however, today, few departments have their dose calibrators and hot lab RARD White Paper Page 14

16 managers connected. There may be several reasons for this including compatibility with the hot lab management system and dose calibrator, inexperience of the nuclear medicine technologist, and/or lack of recognition of the value of using integrated systems to reduce regulatory record keeping related to each administered dose. Education is the answer. The industry should educate physicians and technologists of the value of doses read electronically - and more specifically, work with individual departments to assure that the technology is well understood and super users are available within the institution for questions. An example of problems that can occur with manual dose measurements was cited from a study that was performed for QIBA PET SUV Biomarker that resulted in a rejection of 10% of the data because of dose calibrator isotope setting errors. The following summarizes the value of stressing electronic readings for dose assay: minimize transcription error minimize dose calibrator isotope setting errors improved accuracy of dose administration data based on time synchronization of the reading computer and imaging camera improved department efficiency and productivity (minimize time with manual data entry) improved dose reporting accuracy ensuring doses are validated and assayed before administration Assay of residual dose With the exception of PET, many departments do not record residual activity for most procedures following administration of the radiopharmaceutical. Multiple reasons are cited including residual dose information is not required for study interpretation; inadequate time in an already overbooked schedule; the actual time required to measure the residual dose, which for most dose calibrators takes longer based on the lower activity levels; the inability to enter the data in the hot lab management system and most importantly, the additional radiation exposure associated with handling a non-shielded radioactive syringe. The challenge is to note when the administration step is complete. Is the administration step complete when the dose is administered or when the residual dose has been assayed? DICOM Standard Duplicate codes for the same radiopharmaceutical exist between Nuclear Medicine Radiopharmaceutical and Nuclear Medicine Cardiology Radiopharmaceutical. The same for PET and PET Cardiology. Not all organs reported in the radiopharmaceutical product labels appear in the DICOM standard. (CP 1127 Add fields for Organ Dose to Dose SR) TID NM/PET Protocol Context. See Appendix Supplement 107 Substance Administration Information Services. See Appendix Product labels Radiation Dosimetry estimation The radiation dose on product labels provides an estimated dose to organs. Much like CT exposures these exposures are based on models. Patient s actual exposure may vary. Radiopharmaceuticals expose the whole body. This report estimates the total effective dose and RARD White Paper Page 15

17 the dose to each organ. If a better method of measuring dose is developed it would most likely report information in the same categories. Radiopharmaceutical Quality Control, Isotope and Reagent Kit attributes This document attempts to identify some of the attributes for quality control and component attributes but there may be other attributes that are needed. DICOM SRs are customizable so local department or applications can add attributes as needed. Intervention drugs and Contrast Agent characteristics report Intervention drug and contrast agent were not added to the RARD report for compatibility with REM. A SR report could be developed that would have the same workflow as RARD. It seems that if a camera is parsing a SR file for radiopharmaceutical information, it could parse an SR document for intervention drugs and contrast agent. The cross-enterprise document (XDS) would provide a good solution to product administration reporting. Product Administration Approval Product Administration reporting. (Joint Commission Medication Management (MM) standards). DICOM Substance Administration Services have a component to aid in integrating contrast agent and intervention drugs with pharmacy system. See appendix Drug-use controls in radiology present a difficult and challenging circumstance, one in which millions of patients per year are routinely exposed to dangerous drugs without the protections uniformly offered elsewhere in the hospital. Pharmacy must assume responsibility for the well-being of these patients and ensure best medication-related outcomes for patients referred for medical imaging. All patients should be protected by the safeguards pharmacy is uniquely positioned to provide. Conculsion It is possible to leverage existing standards and systems to provide a radiation dose report for radiopharmaceuticals. The report provides a Win-Win situation. Dose reporting systems can now gather more information to give a more complete picture of a patient s dose. Molecular Imaging wins by improved accuracy and efficiency in radiopharmaceutical administration. There are a number of challenges to completing the RARD report, but defining the report is the first step towards solving the problem. RARD White Paper Page 16

18 Appendix RARD PET\CT Sequence Example The following shows a sequence diagram to moving a RARD from the creator to PET/CT modality. PET/CT system stores the CT radiation exposure report. Both reports are available to a DOSE information reporter. Reports are then submitted to a Dose Registry. Figure 7 RARD PET\CT REM Sequence RARD White Paper Page 17

19 Review of Existing Standards TID NM/PET Protocol Context This template defines the radiopharmaceutical information that can be added to the Protocol Context in a DICOM Schedule Worklist Step or a Performed Procedure Step. It provides a standard method to move information to the acquisition system via Modality Worklist or MPPS. Pros Figure 8. NM/PET Protocol Context Workflow Pros 1.) Coded Radiopharmaceutical 2.) Coded Radioisotope 3.) Total Dose measurement 4.) Radiopharmaceutical Start Time 5.) Route of Administration Cons 1.) No defined communication between worklist provider and dose measurement. 2.) No Consistent Time with measurements 3.) No Irradiation Event Id,Dose information could easily be confuse or duplicate duplicated between systems. 4.) No Exposure Information 5.) Difficult to relate stress dose or rest dose. RARD White Paper Page 18

20 DICOM SAS Substance Administration Services SAS introduces a new query SOP Class for imaging modalities to request verification of contrast agents and other drugs administered during an imaging or image-guided treatment procedure, based on the label bar code and the patient ID. Pros Cons Figure 9. Substance Administration Workflow 1.) Defined Product Character 2.) Defined Substance Approval 3.) Remote Administration 4.) Defined workflow for Contrast agent and Intervention Drugs 1.) Radiopharmaceuticals not defined. 2.) No consistent time 3.) Few if any implementations 4.) No defined communication to Medicine Administration Record (MAR or emar) 5.) No defined communication to Scheduled Workflow 6.) No defined communication to pharmacy 7.) No Interface with IHE REM, or IHE PRE. 3.) Nuclear Medicine and PET DICOM IOD defines fields for radiopharmaceuticals. The imaging modality requires that the operator manually fill in these fields. Often these fields are not completed and the manual process is prone to errors. 4.) Cardiac Stress Structure Reports have a define section for both PET and NM radiopharmaceuticals. It would require the information to be read from the images or manually input from the operator. RARD White Paper Page 19

21 5.) HL7 Structured Product Labels. HL7 and FDA worked together to develop a HL7 structure for product label. All radiopharmaceuticals have a structured product label but the SPL did not define a structure for the Radiation Dosimetry section. Radiopharmaceutical Administration Radiation Dose Structure Report Template The template provides details on proposed structure of the RARD SR document. It is laid out similar to the DICOM standard. It draws on many different defined attributes which exist in the DICOM standard. 1.) Radiopharmaceutical Administration Dose 2.) Radiopharmaceutical Administration Accumulated Dose 3.) Radiopharmaceutical Administration Dose Event Data 4.) Radiopharmaceutical administration Dose Exposure per Organ 5.) Radiopharmaceutical Administration Dose Measurement Data 6.) Radiopharmaceutical Administration Exposure 7.) Product Administration Patient Characteristics 8.) Product Characteristics 9.) Substance approval 10.) Substance Administration Radiopharmaceutical Administration Dose Template This 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 or person responsible for recording the log, generally the system). Accumulated values shall be kept for a whole Study or at least a part of a Study, if RARD White Paper Page 20

22 the Study is divided in the workflow of the examination, or a performed procedure step. Multiple Radiopharmaceutical Administration Dose objects may be created for one Study. NL Rel with Parent VT Concept Name VM Req Type Condition Value Set Constraint 1 CONTAINER Radiopharmaceutical Dose Report 2 > HAS CODE EV (121058, DCM, CONCEPT Procedure reported ) MOD 3 > HAS OBS CONTEXT CODE EV (113705, DCM, Scope of Accumulation ) 1 M 4 > HAS UIDREF DCID (10001) UID Types 1 M PROPERTIES 5 > CONTAINSs INCLUDE Radiopharmaceutical 1 Administration Accumulated Dose 6 > CONTAINS INCLUDE Radiopharmaceutical 1-n M Administration Event 7 > CONTAINS TEXT EV (121106, DCM, Comment ) 1 U Content Item Descriptions 1 M Radiophar maceutical Administra tion 1 M DCID (10000) Scope of Accumulati on Row 1 Radiopharmaceutical Dose Report. Code needs to be defined. In CT and XRAY this is EV (113701, DCM. X-Ray Radiation Dose Report ) Row 2 Notes this is a RARD report Row 3 Scope of Accumulation Study, Series, Performed Step, Irradiation Event, may need new Product Administration. Row 4 Study Instance UID, Series Instance UID, Performed Procedure Step SOP Instance UID, Irradiation Event UID Row 5 Holds accumulated does information in a sequence. Radiopharmaceutical Administration Accumulated Dose This general template provides detailed information on radiopharmaceutical dose value accumulations over multiple administration events over the scope of accumulation specified for the report (typically a Study or a Performed Procedure Step). NL Rel with Parent VT Concept Name VM Req Type Condition Value Set Constraint 1 CONTAINER Accumulated 1 M Radiopharmaceutical Administration Dose 2 > CONTAINS NUM Total Number of 1 M Units = EV RARD White Paper Page 21

23 Administration Events ({events} UCUM, events ) 3 > CONTAINS NUM Total Effective Dose 1 M Units = EV (msv, UCUM, msv ) 4 > HAS PROPERTIES CODE Dose Reference Authority 1 MC Product Label 5 > CONTAINS INCLUDE Radiopharmaceutical 1-n U administration Dose Exposure per Organ 6 > CONTAINS TEXT EV (121106, DCM, Comment ) 1 U Content Item Descriptions Row 1 Row 2 Row 3 Row 4 Row 5 Molecular Imaging Accumulated Dose Container. Total Number of Administration Events. Numa Molecular Imaging Total Effective Dose. Product Label or some other reference. Radiopharmaceutical administration Dose Exposure per Organ Radiopharmaceutical Administration Event The Radiopharmaceutical Administration Event conveys the dose and assay and time information of a single radiopharmaceutical event. NL Rel with Parent VT Concept Name VM Req Type Cond ition Value Set Constraint 1 CONTAINER EV (123001, DCM, Radiopharmaceutical ) 2 >> HAS CONCEPT MOD CODE EV (G-C0E8, SRT, Has Intent ) 3 > CONTAINS CODE EV (G-C032, SRT, Classification ) 4 > HAS PROPERTIES TEXT Product Package Identifier 1 M BCID (25) Radiopharmaceuticals or BCID (3107) PET Cardiology Radiopharmaceuticals or BCID (3111) Nuclear Cardiology Radiopharmaceutical BCID (4021) PET Radiopharmaceutical 1 M DCID (3629) Procedure Intent 1 U TID 9002 (0044,0007) Product Type Code Sequence 1 M (DCM Unit Serial Identifier) Identifier of the contrast agent, drug, or device RARD White Paper Page 22

24 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. 5 > HAS TEXT EV (111529, DCM, Brand 1 U PROPERTIES Name ) 6 > CONTAINS TEXT EV(???,???, Manufacturer) 1 U Administration Log IOD (0008,0070) 7 > HAS TEXT EV (121145, DCM, 1 U PROPERTIES "Description of Material") 8 > HAS CODE EV (G-C340, SRT, "Route of 1 M BCID (11) Route of PROPERTIES Administration administration") 9 > HAS DATETIME EV (123003, DCM, 1 M PROPERTIES Radiopharmaceutical Start Time ) 10 > HAS PROPERTIES DATETIME EV (123004, DCM, Radiopharmaceutical Stop Time ) 11 > CONTAINS NUMERIC EV (123006, DCM, Radionuclide Total Dose ) 12 > CONTAINS UIDREF EV (113769, DCM, Irradiation Event UID ) 13 > CONTAINS NUMERIC EV (123005, DCM, Radiopharmaceutical Volume ) 14 > HAS PROPERTIES PNAME EV (121152, DCM, Person administering drug/contrast ) 1 U 1 M Units = DT(Bq, UCUM, Bq ) 1 M TID U Units = DT(cm3, UCUM, cm3 ) 1 M 15 > CONTAINS CODE Dose Type 1 U Unit Dose, Multidose Vial 16 > CONTAINER CODE EV (C-B1000, SRT, Diagnostic Radioisotope) 1 U BCID 18 (NM) or 4020 (PET) 17 > CONTAINS NUMERIC Radionuclide Half Life 1 M Units = (min, UCUM, minute, h, UCUM, hour, d, UCUM, day) 18 > CONTAINS NUMERIC EV (123007, DCM, Radiopharmaceutical 1 U Units = DT(Bq/mol, UCUM, Bq/mol ) Specific Activity ) 19 > CONTAINS CONTAINER Radioisotope Assay Data 1-n 20 > CONTAINS CONTAINER Radioisotope Attributes 1 U 21 > CONTAINS CONTAINER Radiopharmaceutical Quality Control Attributes 1 U RARD White Paper Page 23

25 22 > CONTAINS CONTAINER Reagent Kit Attributes 1 23 > CONTAINS NUM Prescribed dosage 1 U Units = DT(Bq, UCUM, Bq ) 24 > CONTAINS TEXT RX Number 1 U 25 > CONTAINS CODE Substance Administration Approval 1 U Administration Log IOD(0044,0002) 26 > CONTAINS DATETIME Administration Approval Date Time 1 U Administration Log IOD (0044,0004) 27 > CONTAINS TEXT Approval Status Description 1 U Administration Log IOD (0044,0003) 28 > TEXT Comments Content Item Descriptions Row 1 Row 2 Row 3 Row 4 Row 6 Row 9 Row 11 Row 12 Row 13 Row 15 Row 18 Row 19 Row 20 Row 21 Row 22 Row 25 Row 26 Numa Molecular Imaging Dose Event Data Container. Intent of the radiopharmaceutical, Diagnostic Intent, Therapeutic Intent, Combined Diagnostic and Therapeutic Procedure No context group is provided for the value set, but it is recommended that values from a standard external coding scheme, such as SRT or NDC, be used. Also see (0044,0007) Product Type Code Sequence RxNorm based (many radiopharmaceuticals do not have RxNorm) Product Package Identifier. Code needs to be defined. 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. Manufacturer Code needs to be defined From DICOM Product Characteristics Module C.26.1 Manufacturer of product. Time of radiopharmaceutical administration to the patient for imaging purposes Total amount of radionuclide administered to the patient at Radiopharmaceutical Start Time Is a computed field from the assay times, isotope half-life, radiopharmaceutical Unique identification of a single irradiation event. This UID identifies unique and repeatable when referencing the radiopharmaceutical administration to this patient. Volume of radiopharmaceutical administered to the patient Identifies the dose type as a unit dose, multi-dose vial, capsule Codes will need to be developed for each type Activity per unit mass of the radiopharmaceutical at Radiopharmaceutical Start Time Radioisotope Assay Information Radioisotope Attributes (not defined) Radiopharmaceutical Quality Control Attributes (not defined) Reagent Kit Attributes (not defined) Substance Administration Approval Code needs to be defined. Status of request for substance administration. Administration Log IOD(0044,0002) Enumerated Values: APPROVED Use of the substance for the patient is approved, with related notes (e.g., appropriate dose for age/weight) in Approval Status Further Description (0044,0003) WARNING The substance may be used for the patient subject to warnings described in Approval Status Further Description (0044,0003) CONTRA_INDICATED The substance should not be used for the patient for the reasons described in Approval Status Further Description (0044,0003) Administration Approval Date Time Code needs to be defined. DICOM SUBSTANCE APPROVAL MODULE ATTRIBUTES C.26-2 Timestamp for the Substance Administration Approval response RARD White Paper Page 24

26 Row 27 Approval Status Description. DICOM SUBSTANCE APPROVAL MODULE ATTRIBUTES C.26-2 Description of warning or contra-indication, or notes on approval. Substance Administration Approval Code Reference Extension Coding Scheme Designator Code Value (0008,0100) Code Meaning (0008,0104) (0008,0102) 99RARDSAS 99RARDSASAPPROVED APPROVED 99RARDSAS 99RARDSASWARNING WARNING 99RARDSAS 99RARDSAS CONTRA CONTRA_INDICATED Radiopharmaceutical administration Dose Exposure per Organ This general template provides detailed information on radiopharmaceutical dose value accumulations per Organ over multiple administration events over the scope of accumulation specified for the report (typically a Study or a Performed Procedure Step). NL Rel with Parent VT Concept Name VM Req Typ e 1 M Organ 1 CONTAINER "Dose Exposure Per Condition Value Set Constraint 2 > CONTAINS CODE Exposure Anatomic Region 1 M DICOM Annex I 3 > CONTAINS NUMERIC Region Exposure 1 M Units =EV(mGy, UCUM, mgy ) 4 > CONTAINS NUMERIC Region Exposure Conversion Factor 1 U Not used for accumulat ed dose Units =EV(mGy/B q, UCUM, mgy/bq ) 5 > CONTAINS CODE Dose Reference Authority 1 U Product Label Content Item Descriptions Row 1 Row 2 Row 3 Dose Exposure Per Region Exposure Anatomic Region. Codes needs to be defined. DICOM Annex I MIRD Tables organ or regions typically reported in Radio Product label have DICOM codes SRT T-B3000 Adrenal gland, SRT T-A0100 Brain, SRT T Breast,T Gall bladder, SRT T Small intestine, SRT T Stomach, SRT T Heart, SRT T Kidney, SRT T Liver, SRT T Lung, SRT T Muscle, SRT T Ovary, SRT T Pancreas, SRT T- C3000 Spleen, SRT T Testis, SRT T-B6000 Thyroid, SRT T-C8000 Thymus Gland Thymus, SRT T Bladder, SRT T Uterus The follow organ or region without DICOM defined codes. LLI Wall (lower large intestine), ULI (upper large intestine) Wall, Red Marrow, Bone Surfaces, Skin. Region Exposure Codes needs to be defined. RARD White Paper Page 25

27 Row 4 Row 5 Region Exposure Conversion Factor Codes needs to be defined. Radiopharmaceutical label, Oak Ridge Documentation, MIRD Radioisotope Assay Data Template NL Rel with Parent VT Concept Name VM Req Type Condition Value Set Constraint 1 CODE "Radioisotope Assay Data" 1 M 2 > CONTAINS Numeric Dose Assay 1 M Units = DT(Bq, UCUM, Bq ) 3 > CONTAINS DATETIME Dose Assay Date Time 1 M 4 > CONTAINS CODE EV (113854, DCM, Source of Dose Information ) 1 M EV (6862NM2 00, LNUMA, Dose Calibrator ) 5 > CONTAINS CODE Assay Reason 1 U 6 > HAS OBS CONTEXT INCLUDE Observer Context 1-n M DTID(1002) Content Item Descriptions Row 1 Radioisotope Assay Data. Code needs to be defined. Row 2 Dose Measurement Code needs to be defined. Dose Amount Measured Row 3 Dose Measurement Date Time Code needs to be defined. Dose Measured Row 4 Source of Dose Information Code needs to be defined for Dose Calibrator to DCID (10021) Row 5 Assay Reason Codes needs to be defined. Measure residual, Normal Dose Assessment, Dose Correction, Dose Receipt Activity Patient Characteristics template NL Rel with Parent VT Concept Name VM Req Type Condition Value Set Constraint 1 CONTAINER EV (121118, DCM, Patient 1 M Characteristics ) 2 > CONTAINS CODE EV (109054, DCM, Patient 1 MC Cardiac CID 3102 State ) Procedure 3 > CONTAINS INCLUDE DTID (3602) 1 M Cardiovascular Patient Characteristics 4 > CONTAINS NUMERIC Glucose Level 1 MC Units = DT(mg/dL, UCUM, mg/dl ) 5 > CONTAINS CODE Glomerular filtration rate 1 U Sequence 6 > CONTAINS DATETIME Patient Weighed Date 1 U RARD White Paper Page 26

28 Time 7 > CONTAINS TEXT Uptake Location 1 U 8 > CONTAINS NUM Uptake Duration 1 U Units = DT(min, UCUM, mi n ) 9 > CONTAINS TEXT SRT R Allergy and 1-n U Immunology 10 > CONTAINS INCLUDE DTID (9002) Medication, Substance 1-n U Content Item Descriptions Row 2 Row 3 Row 4 Row 5 Row 6 Row 7 Row 8 Row 9 Row 11 Stress or Rest Include Patient characteristics even if study is not cardiac Glucose Level is important for PET studies. Provides a mean for the technologist to record the glucose level and move the information to the camera. Provides a mean to record the GFR of the patient and communicate the information to the camera. Date time of patient note if patient is from a previous study or is stale. Weight based dosing should have current weight. Uptake Location room number or description Number of minute to patient should wait before scanning Allergies List A classification of a medicinal substance. Glomerular filtration rate NL Rel with Parent VT Concept Name VM Req Type Condition Value Set Constraint 1 CONTAINER "Glomerular filtration rate" 1 M 2 > CONTAINS NUMERIC Serum Creatinine Units 1 M mg/dl 3 > CONTAINS CODE Traceable to IDMS 1 U YES NO 4 > CONTAINS NUMERIC Glomerular filtration rate 1 M Units = DT(mL/min/ 1.73m2, UCUM, ml/min/1. 73m2 ) 5 > CONTAINS CODE GFR Formula 1 U eccr, MDRD, CKD-EPI, Mayo Quadratic, Schwartz > CONTAINS NUM EV (121033, DCM, "Subject Age ) 1 MC If not recorded else where > CONTAINS TEXT Ethnic Group 1 MC If not recorded else where CODE EV (121032, DCM, "Subject Sex ) If not DCID (7455) Sex RARD White Paper Page 27

29 recorded else where GFR CODES Coding Code Value Code Meaning Scheme Designator 99RARDGFR 99RARDGFR-1 Cockcroft-Gault formula (eccr) 99RARDGFR 99RARDGFR-2 Modification of Diet in Renal Disease (MDRD) formula (egfr) 99RARDGFR 99RARDGFR-3 CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration) formula (egfr) 99RARDGFR 99RARDGFR-4 Mayo Quadratic formula (egfr) 99RARDGFR 99RARDGFR-5 Schwartz formula (egfr) for children Current published DICOM Codes Radiopharmaceuticals Context Id 25 CID 25 Radiopharmaceuticals Coding Scheme Designator (0008,0102) Code Value (0008,0100) Context ID 25 Radiopharmaceuticals Type: Extensible Version: Code Meaning (0008,0104) SRT C-B1302 Carbon^14^ D-xylose SRT C-B1300 Carbon^14^ triolein SRT C-B1304 Cholyl-carbon^14^ glycine SRT C-B1140 Chromic phosphate P^32^ SRT C-B1012 Chromium^51^ albumin SRT C-B1013 Chromium^51^ chloride SRT C-B1051 Colloidal gold Au^198^ SRT C-B1063 Colloidal Indium^111^ SRT C-B1017 Copper^64^ acetate SRT C-B1016 Copper^64^ versenate SRT C-B1018 Copper^67^ ceruloplasmin SRT C-B1021 Cyanocobalamin Co^57^ SRT C-B1022 Cyanocobalamin Co^58^ SRT C-B1023 Cyanocobalamin Co^60^ SRT C-B1000 Diagnostic radioisotope SRT C-B1092 Diiodofluorecein I^131^ SRT C-B1062 Disodium indium^111^ SRT C-B1122 Ferrous chloride Fe^59^ SRT C-B1121 Ferrous citrate Fe^59^ Trade name (informative) RARD White Paper Page 28

30 SRT C-B1123 Ferrous sulfate Fe^59^ SRT C-B1082 Fibrinogen I^123^ SRT C-B1031 Fluorodeoxyglucose F^18^ SRT C-B1041 Gallium^67^ citrate SRT C-145AB Indium^111 Capromab Pendetide Prostascint SRT C Indium^111 Chloride Zevalin SRT C-145AA Indium^111 Pentetreotide Octreoscan SRT C-B1061 Indium^111^ pentetate SRT C-B1066 Indium^111^ red cell label SRT C-B1067 Indium^111^ transferrin SRT C-B1065 Indium^111^-Fe(OH)>3< SRT C-B1135 Indium^111^oxyquinoline SRT C-B1068 Indium^113m^ bleomycin SRT C-B1069 Indium^113m^ chloride SRT C-B1072 Indium^113m^ oxoquinoline platelet label SRT C-B1073 Indium^113m^ oxoquinoline RBC label SRT C-B1071 Indium^113m^ oxoquinoline WBC label SRT C-B1070 Indium^113m^ pentetate SRT C-B1084 Iodinated I^125^ albumin SRT C-B1100 Iodinated I^125^ human serum albumin SRT C-B1094 Iodinated I^125^ levothyroxine SRT C-B1093 Iodinated I^125^ oleic acid and triolein SRT C-B1096 Iodinated I^125^ povidone SRT C-B1097 Iodinated I^125^ Rose Bengal SRT C-B1098 Iodinated I^125^ sealed source SRT C-B1099 Iodinated I^125^ sodium iodine SRT C-B1090 Iodinated I^131^ aggregated albumin SRT C-B1089 Iodinated I^131^ albumin SRT C-B1111 Iodinated I^131^ gamma globulin SRT C-114AB Iodine^ (4-Iodophenyl)- 3(R,S)-Methylpentadecanoic Acid BMIPP SRT C-B110E Iodine^123 3-Iodobenzylguanidine MIBG SRT C-B112D Iodine^131 3-Iodobenzylguanidine MIBG Cardiodine SRT C-114B6 Iodine^131 Methylnorcholestenol Adosterol RARD White Paper Page 29

31 SRT C-B1109 Iodine^131^ polyvinylpyrrolidone SRT C-B1087 Iodocholesterol I^131^ SRT C-B1095 Iodohippurate I^123^ sodium SRT C-B1105 Iodohippurate I^125^ sodium SRT C-B1091 Iodohippurate I^131^ sodium SRT C-B1108 Iofetamine I^123^ hydrochloride SRT C-B1088 Iothalamate sodium I^125^ SRT C-B1124 Iron Fe^59^ labeled dextran SRT C-173A5 Krypton^81m SRT C-B1083 Oleic acid I^125^ SRT C-B1251 Pentetate calcium trisodium Yb^169^ SRT C-B1151 Potassium carbonate K^42^ SRT C-B1152 Potassium chloride K^42^ SRT C-B1150 Potassium chloride K^43^ SRT C-B1085 Rose Bengal sodium I^131^ SRT C-B1172 Selenium^75^ HCAT SRT C-B1171 Selenomethionione Se^75^ SRT C-B1176 Sodium chloride Na^22^ SRT C-B1175 Sodium chloride Na^24^ SRT C-B1011 Sodium chromate Cr^51^ SRT C-B1032 Sodium fluoride F^18^ SRT C-B1081 Sodium iodide I^123^ SRT C-B1086 Sodium iodide I^131^ SRT C-B1206 Sodium pertechnetate Tc^99m^ SRT C-B1142 Sodium phosphate P^32^ SRT C-B1180 Strontium chloride Sr^85^ SRT C-B1181 Strontium chloride Sr^87^ SRT C-B1182 Strontium nitrate Sr^85^ SRT C-B1183 Strontium nitrate Sr^87^ SRT C-B1205 Technetium Tc^99c^ albumin microspheres SRT C-B1200 Technetium Tc^99m^ aggregated albumin SRT C-B1204 Technetium Tc^99m^ albumin colloid SRT C-B1133 Technetium Tc^99m^ depreotide SRT C-B1207 Technetium Tc^99m^ disofenin SRT C-B1223 Technetium Tc^99m^ exametazine SRT C-B1210 Technetium Tc^99m^ iron ascorbate SRT C-B1209 Technetium Tc^99m^ lidofenin RARD White Paper Page 30

32 SRT C-B1208 Technetium Tc^99m^ mebrofenin SRT C-B1212 Technetium Tc^99m^ medronate SRT C-B1203 Technetium Tc^99m^ microaggregated albumin SRT C-B1225 Technetium Tc^99m^ N-substituted iminodiacetate SRT C-B1213 Technetium Tc^99m^ oxidronate SRT C-B1214 Technetium Tc^99m^ pentetate SRT C-B1215 Technetium Tc^99m^ pyro and polyphosphates SRT C-B1216 Technetium Tc^99m^ serum albumin SRT C-163AB Technetium Tc^99m^ sestamibi SRT C-B1220 Technetium Tc^99m^ sodium glucoheptonate SRT C-B1211 Technetium Tc^99m^ stannous etidronate SRT C-B1221 Technetium Tc^99m^ succimer SRT C-B1222 Technetium Tc^99m^ sulfur colloid SRT C-B1224 Technetium Tc^99m^ tagged red cells SRT C-163AC Technetium Tc^99m^Teboroxime SRT C-163AD Technetium Tc^99m^Tetrofosmin SRT C-163BD Technetium^99m Dimercaptosuccinic Acid DMSA SRT C-163B6 Technetium^99m Galactosyl Human Serum Albumin Diethylenetriamine GSA SRT C-163B7 Technetium^99m Hydroxymethylene diphosphonate HMDP Kidneyscinti Asialoscinti SRT C-163B9 Technetium^99m labeled carbon Technegas SRT C-163B8 Technetium^99m Mercaptoacetyl triglycine MAG3 SRT C-163BA Technetium^99m N-pyridoxyl-5- methyltryptophan SRT C-163BB Technetium^99m Phytate SRT C-163BC Technetium^99m Stannous Colloid SRT C-B1231 Thallous chloride Tl^201^ SRT C-B1010 Therapeutic radioisotope SRT C-B1251 Yb^169^-DTPA - pentetate MAGscinti Hepatimage RARD White Paper Page 31

33 Isotopes in Radiopharmaceuticals CID 18 Coding Scheme Designator (0008,0102) Context ID 18 Isotopes in Radiopharmaceuticals Type: Extensible Version: Code Value (0008,0100) SRT C-105A2 ^14^Carbon SRT C-111A1 ^18^Fluorine SRT C-155A1 ^22^Sodium SRT C-155A2 ^24^Sodium SRT C-106A1 ^32^Phosphorus SRT C-135A2 ^42^Potassium SRT C-135A3 ^43^Potassium SRT C-129A2 ^51^Chromium SRT C-144A3 ^57^Cobalt SRT C-144A4 ^58^Cobalt SRT C-130A3 ^59^Iron SRT C-144A6 ^60^Cobalt SRT C-127A2 ^64^Copper SRT C-127A3 ^67^Copper SRT C-131A2 ^67^Gallium SRT C-116A3 ^75^Selenium SRT C-173A5 ^81m^Krypton SRT C-173A7 ^85^Krypton SRT C-158A3 ^85^Strontium SRT C-158A5 ^87m^Strontium SRT C-158A6 ^89^Strontium SRT C-162A7 ^90^Yttrium SRT C-163A8 ^99m^Technetium SRT C-145A4 ^111^Indium SRT C-145A5 ^113m^Indium SRT C-114A4 ^123^Iodine SRT C-114A6 ^125^Iodine SRT C-114B1 ^131^Iodine SRT C-122A5 ^133^Barium SRT C-172A8 ^133^Xenon SRT C-178A8 ^153^Gadolinium SRT C-B1134 ^153^Samarium SRT C-181A3 ^169^Ytterbium SRT C-101ED ^177^Lutetium Code Meaning (0008,0104) RARD White Paper Page 32

34 SRT C ^186^Rhenium SRT C-1018D ^188^Rhenium SRT C-146A9 ^198^Gold SRT C-138A9 ^201^Thallium PET Cardiology Radiopharmaceuticals CID 3107 Coding Scheme Designator Code Value Context ID 3107 PET Cardiology Radiopharmaceuticals Type: Extensible Version: Code Meaning SRT C-B1031 Fluorodeoxyglucose F^18^ SRT C-107A1 ^13^Nitrogen SRT C-159A2 ^82^Rubidium Nuclear Cardiology Radiopharmaceuticals CID 3111 Coding Scheme Designator Context ID 3111 Nuclear Cardiology Radiopharmaceuticals Type: Extensible Version: Code Value Code Meaning SRT C-B1130 Thallium-201 SRT C-B10A2 Tc-99m sestamibi SRT C-B10A4 Tc-99m tetrofosmin PET Radiopharmaceutical CID 4021 Coding Scheme Designator (0008,0102) Context ID 4021 PET Radiopharmaceutical Type: Extensible Version: Code Value (0008,0100) SRT C-B1043 Acetate C^11^ SRT C-B103C Ammonia N^13^ SRT C-B07DB ATSM Cu^64^ SRT C-B07DC Butanol O^15^ SRT C-B103B Carbon dioxide O^15^ Code Meaning (0008,0104) SRT C-B1045 Carbon monoxide C^11^ SRT C-B103A Carbon monoxide O^15^ RARD White Paper Page 33

35 SRT C-B103F Carfentanil C^11^ SRT C-B07DD EDTA Ga^68^ SRT C-B07DE Flumazenil C^11^ SRT C-B07DF Flumazenil F^18^ SRT C-B07E0 Fluorethyltyrosin F^18^ SRT C-B1031 Fluorodeoxyglucose F^18^ SRT C-B07E1 Fluoromisonidazole F^18^ SRT C-B07E2 Fluoromethane F^18^ SRT C-B07E3 Fluorouracil F^18^ SRT C-B07E4 Fluorobenzothiazole F^18^ SRT C-B1034 Fluoro-L-dopa F^18^ SRT C-B1046 Germanium Ge^68^ SRT C-B103D Glutamate N^13^ SRT C-B07E5 Mespiperone C^11^ SRT C-B103E Methionine C^11^ SRT C-B07E6 Monoclonal antibody I^124^ SRT C-B1038 Oxygen O^15^ SRT C-B1039 Oxygen-water O^15^ SRT C-B1044 Palmitate C^11^ SRT C-B07E7 PTSM Cu^62^ SRT C-B1042 Raclopride C^11^ SRT C-B1037 Rubidium chloride Rb^82^ SRT C-B1032 Sodium fluoride F^18^ SRT C-B07E8 Sodium iodide I^124^ SRT C-B1047 Sodium Na^22^ SRT C-B1033 Spiperone F^18^ SRT C-B1036 Thymidine (FLT)F^18^ RARD White Paper Page 34