Patient Dose Tracking for Imaging Studies. David E. Hintenlang, Ph.D., DABR University of Florida
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1 Patient Dose Tracking for Imaging Studies David E. Hintenlang, Ph.D., DABR University of Florida
2 Conflict of Interest Statement No affiliation or financial interests in any of the commercial products or enterprises discussed as part of this presentation.
3 Introduction to Patient Dose Tracking (PDT) Why Patient Dose Tracking (PDT)? What Dose Metrics are useful/attainable? How are dose metrics obtained? Where are dose metrics recorded? When is PDT required? What tools are available to assist with PDT?
4 Overview Motivation Dose Metrics PDT Requirements Regulatory Accreditation Strategies & Tools for PDT Examples of Commercial Products
5 Why track Patient Dose? Regulatory requirements Accreditation requirements Liability and Public Relations Research Quality Assurance Awareness & Patient Safety Individual Patient cumulative dose record PQI
6 Patient Dose Metrics Dose Organ Dose (Gy) /Equivalent Dose (Sv) Effective Dose (Sv) Dose Surrogates Cumulative Exposure Time (min) Entrance Air Kerma (Gy) Dose Area Product (Gy- cm 2 ) Cumulative Dose (Gy) Peak Skin Dose (Gy) CTDI (Gy) Dose Length Product (Gy-cm) Size Specific Dose Estimate (Gy)
7 Individual Patient Dose Measurement Measurement of Patient Dose Difficult Dosimeters Computational Predictions Dose Surrogates Easier to obtain Easier measurement Difficult interpretation for radiation detriment Not uniformly defined or applied Depend on biological endpoint
8 The dosimetry parameter that best represents the stochastic radiation detriment to a patient is 23% a. Cumulative Dose 17% 13% 30% 17% b. CTDI vol c. Dose Area Product d. Dose Length Product e. Effective Dose
9 Answer: e. Effective Dose Ref: Miller, et.al. Quality Improvement Guidelines for Recording Patient Radiation Dose in the Medical Record, J. Vasc. Interv. Radiology, 15: , 2004.
10 Requirements & Recommendations Federal 21CFR 803: Reporting of skin damage to fluoroscopic equipment manufacturers FDA Recommendations for Interventional Procedures States CA, TX, OH? Fluoro and CT Other Individual Health Care Systems Veterans Health Administration & NIH American College of Radiology, Dose Index Registry The Joint Commission
11 Sample Recommendations for Dose Metrics California: Effective Dose, Skin Dose Texas: Reference Levels Fluoro: Air kerma, or other estimates of skin dose CT: CTDI vol, DLP VHA: Cumulative fluoro time Cumulative air kerma or skin dose Dose-area-product
12 Recorded PDT Metrics likely dictated by regulatory and accreditation bodies
13 Requirements : California Senate Bill 1237 Report to DHS scans that are repeated or wrong body part resulting in: Effective Dose > 0.05 Sv Dose > 0.5 Sv to any organ or tissue Shallow dose to skin > 0.5 Sv Some exceptions Implementation: Reference levels for CTDIvol and DLP Exam and patient specific i.e. Cumulative CTDIvol of 650 mgy for any expected to exceed skin reporting threshold of 500 msv
14 Requirements : Texas 25 TAC Effective May 1, 2013 Radiation Protocol Committee for Fluoroscopically-Guided Interventional Procedures CT Systems Methods to monitor radiation output Establish Reference Levels for radiation output Actions for when reference level is exceeded Do not need to determine patient dose for each procedure
15 Requirements: Texas Fluoroscopy Make and maintain a record of radiation output information so the radiation dose to the skin may be estimated. To include: Cumulative air kerma or dose area product (if available on system) or Fluoro mode, Cumulative exposure time & number of recorded exposures. CT Make and maintain a record of radiation output information so the radiation dose to the skin may be estimated. CTDIvol and DLP (if system capable of calculating and displaying) or AAPM TG 111 Recommendations
16 Proposed: Ohio 3701: (3/3/2014) Fluoro: Interventional, cardiac cath pediatric, pregnant patients Record cumulative air kerma or DAP for each exam or Mode of operation, Cumulative fluoro exposure time, and number of radiographs
17 The State of Texas requires monitoring of patient doses for 17% a. Radiography and Fluoroscopy 30% 30% 17% 7% b. Fluoroscopy and CT c. Radiography and CT d. Fluoroscopy only e. CT only
18 Answer: b. Fluoroscopy and CT Ref: 25 Texas Adminstrative Code Use of Radiation Machines in the Healing Arts May 2013.
19 Proposed: The Joint Commission Prepublication Standards: Diagnostic Imaging Services Requirements ; Provision of Care, Treatment, and Services (PC) Effective July 1, 2014 PC ; C5 For diagnostic CT.documents in the patient s medical record the radiation dose (CTDIvol or DLP) on every study produced during a CT examination. PC ; C6 For diagnostic CT.. The interpretive report of a diagnostic CT study includes the CTDIvol or DLP radation dose. The Dose is either recorded in the patient s interpretive report or included on the protocol page.
20 Only applicable for systems calculating and displaying radiation doses. Not applicable to systems for rad therapy treatment planning or dental cone beam CT
21 Proposed: The Joint Commission Prepublication Standards: Diagnostic Imaging Services Requirements ; Performance Improvement (PI) Effective July 1, 2014 PI ; A6 The hospital compiles and analyzes data on patient CT radiation doses and compares it with external benchmarks, when such benchmarks are available. i.e. collection of data where pre-identified radiation dose limits are exceeded.
22 Observations on proposed TJC standards Draft requirement for electronic transmission of protocol identifying radiation dose to PACS was removed from the standard. Expect a parallel set of Fluoroscopy standards in Phase Implementation.
23 Effective July 1, 2014,The Joint Commission accreditation will require documentation of each patient s radiation dose (CTDI vol or DLP) 10% 33% 20% 20% 17% a. in the patient medical record. b. by electronic transmission to the EMR. c. by electronic transmission to the hospital s electronic PACS. d. for diagnostic CT and dental cone beam CT systems. e. by a diagnostic medical physicist
24 Answer: a. in the patient medical record. Ref: TJC Prepublication Standard PC
25 Generation& Recording of Dose Metrics Measured vs Predicted DAP: measured Cumulative Air Kerma/Skin Dose: Measured CTDI : Predicted DLP: Predicted Recording Methods Manual DICOM Radiation Dose Structure Report RDSR Or other electronic transfer formats Optical Character Recognition (OCR) from images
26 Formats & Imaging Modalities DICOM Radiation Dose Structured Report RDSR DICOM Modality Performed Procedure Step MPPS IHE profile Radiation Exposure Monitoring Digital Modalities these are typically provided for: CT Fluoro: Interventional Radiography Cardio-Vascular Mobile C-Arms Radiography Mammography
27 Options for Legacy Equipment Manual entry / Logs Image Headers OCR from Images
28 Dose Tracking Applications Cumulative dose tracking throughout a health system (multiple modalities and procedures). Analysis to optimize image quality and minimize patient risk Compliance and Reporting: Internal Patients Governing & regulatory authorities
29 Patient Dose Tracking Threshold dose notifications Cumulative dose history prior to exams
30 Trend Analysis Dose comparisons as a function of Modality Protocol Sites Patient populations Time Etc.
31 Compliance Reporting Periodic Summary Reports Customized Diagnostic Reference Levels
32 Communication with other systems PACS RIS HIS EMR ACR DIR
33 Dose tracking software systems can integrate dose information from each of the following methods except 40% a. DICOM MPPS 17% b. DICOM RDSR 10% c. IHE Profile REM 20% d. NEMA OS % e. OCR
34 Answer: d. NEMA OS Ref: Manufacturer Websites listed at end of presentation
35 Commercial Solutions for Dose Tracking Broad range of capabilities Basic information recording Advanced analysis and interactive notification Multi-modality Transmission of dose information from imaging device or PACS Integration with PACS, RIS, & EMR Analysis and Reporting
36 Commercial PDT Tools Basic Custom Dedicated System
37 Basic Dose Tracking Integrated with an existing system Example: Meditech Integrated information system Many aspects of health care Includes a RIS and interfaces with PACS RDSR s flow into Meditech Subsequently recorded in patient record
38 Custom Applications Designed to meet specific needs Example: Primordial Customized applications in radiology Provide wide variety of Radiology services Departmental workflow, communications, QC,... Integration of PACS, RIS, and EMR Radiation Dose Monitoring Customizable Application
39 Dedicated Dose Tracking Software Integrate dose metrics from imaging systems or PACS typical formats: DICOM RDSR preferred Integrate with PACS, RIS, EMR Analysis capabilities Selection of Reference Doses Automated notification
40 Examples of Dedicated Dose Tracking Systems DoseMonitor (PACS Health) DoseTrack (Sectra) DoseWatch (GE) RADAR360 (MedPhys360) Radimetrics/eXposure(Bayer)
41 Common Features DICOM or IHE standards for interfaces Single server web-based applications Interface with multiple modalities CT, Mammo, DR, Interventional vascular, Cardiac angiography, mobile C-arms HL7 Interface with PACS Customization for Ref. dose alerts Provide Near-time dose feedback Upload to ACR Dose Index Registry SSDE Prediction Based on patient EMR data
42 by PHS Technologies Group 2012 Single server, browser based design Direct integration with RIS, EMR, ACR DIR Supports CT, Mammo, DR, IV, CA
43 Features and Capabilities: Patient historical dose repository Customizable alerts and notifications Dose data exportable to dictation Reporting sort by Technologist Procedure Physician
44 8000 studies over 6 months
45 RADAR360 by MedPhys360 Radiation Dose Analyzing & Reporting Queries PACS for CT data CTDI & DLP Analyis Protocol Management Pediatric Techniques Evaluation Customizable designed to be affordable
46
47 DoseTrack by Sectra Cloud based dose monitoring Supports CT, Mammo, DR, IV, CA Alerts when thresholds exceeded i.e. User defined Dose Reference Levels Fluoro cumulative dose maps Analysis: Patient specific Dose profiles for imaging systems Comparison of individual performance
48
49 DoseTrack
50 Radimetrics Radimetrics (exposure) by Bayer Stand alone system- in house server Integrates with PACS & RIS Patient Score Card Cumulative dose tracking CT Dosimetry Prediction Monte Carlo simulation engine Organ doses Effective dose Protocol evaluation
51
52
53 Radimetrics Protocol Management Supports multiple scanners Tracks & authorizes revisions Set uniform dose reference levels (CTDI, DLP, E, Organ Dose) Reporting Customizable dashboard Select items of items of interest Pateint Scorecard integrates with most EMR systems Productivity Monitoring & Analysis of equipment utilization Integrates with Contrast dose management tools
54 DoseWatch GE HealthCare Multi-modality Not vendor specific Centralized system- web-based interface Integrates with RIS and EMR Tracking and statistical analysis Identifies dose outliers notification
55 DoseWatch Reporting By device, operator or protocol User defined thresholds notifications Trend analysis Baselines for procedures Benchmark for improvements/optimization
56 DoseWatch Legacy systems Extracts dose info from OCR on dose report images CT : Size Specific Dose Estimate (SSDE) Per AAPM TG 204 Based on scout images Fluoroscopy: Incidence Map
57 SSDE
58
59
60 Effectiveness & Advances Demonstrated reduction in patient doses Even without extensive analysis Seamlessly satisfy recording requirements Management of doses, equipment, training Endless PQI possibilities Development of Real-Time Dose Monitoring Fluoroscopy Real-time integration & body mapping of fields using RDSR
61 Real-Time Skin Dose Mappng RDSR Radiation Dose Structured Report Collaboration with UF, UF Health Jacksonville and Columbia University Medical Center in NYC PI : Wesley Bolch, Ph.D.
62 The cumulative dose incidence map provides 13% 20% 23% 13% 30% a. A planar represention of the surface air kerma distribution b. A summary of the DAP per study c. A visualization of cumulative organ doses through the body d. The variation of a facilities cumulative delivered dose over time e. A correlation of the number of studies performed with cumulative dose
63 Answer: a. a planar representation of the surface air kerma distribution. Ref: Manufacturer Websites listed at end of presentation
64 Summary Evolving Industry Expect increasing numbers & advanced capabilities Products are readily customized to users needs Patient population or individual based applications Valuable QA tools Support regulatory focus & compliance Dose metrics not uniform across modality Unavailable for legacy equipment Integration of patient dose? Integrate with other systems (PACS, EMR, RIS, HIS ) Difficult to track across health care systems
65 References 25 Texas Adminstrative Code Use of Radiation Machines in the Healing Arts May VHA Handbook , Fluoroscopic Safety, Department of Veterans Affairs, Veterans Health Administration, Washington, DC 20420, July Miller, et.al. Quality Improvement Guidelines for Recording Patient Radiation Dose in the Medical Record, J. Vasc. Interv. Radiology, 15: , Amis, et. al. American College of Radiology White Paper on Radiation Dose in Medicine, J. Am. Coll. Radiol. 4: , Hospitals & Health Networks, Radiation dose management: A Patient Safety priority, Gatefold, The Joint Commission: Prepublication Standards: Diagnostic Imaging Services Requirements ; Provision of Care, Treatment, and Services, Dec Ambulatory Care, Critical Access Hospital, and Hospital Comprehensive Accreditation Manual March 2014.
66 Commercial Product Web-Sites and Descriptions Dose_Management/DoseWatch
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