Electronic Oncology Systems the Management and the Safety Measures. Hansen Chen, Director, TDSI
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1 Electronic Oncology Systems the Management and the Safety Measures Hansen Chen, Director, TDSI
2 Radiation Oncology Department People Place Equipments Procedures Patients Hansen Chen 2
3 Radiation Oncology Staff People Oncologist Physicist Dosimetrist Engineer Sim Tech Administrator Therapist Nurse Clerical Billing Hansen Chen 3
4 Department Layout Place Linac Vault CT Vault Exam Room Brachy Suite Front Desk Tx Plan Offices Hansen Chen 4
5 Machines and Systems Equipment External Beam Machines CT Simulators Brachytherapy Machines Treatment Plan Systems Oncology Info Systems IT Infrastructure Calibration Devices Treatment Accessories Oncology PACS Hansen Chen 5
6 Clinical Procedures External Beam IMRT Image Guided Radiotherapy Procedure CT Simulation MammoSite APBI Stereotactic Radiosurgery HDR Brachytherapy Stereotactic Body Radiotherapy Prostate Seeds Implant Hansen Chen 6
7 Patient Visit Flow (ex. IMRT) Patient Consult CT Scan Virtual Sim Tx Plan Follow-up Tx Delivery Portal Film Physics QA Hansen Chen 7
8 Yes, It s s Quite Complicated Operation! People Place Equipment Procedure Hansen Chen 8
9 Mitigation of Potential Errors More Manpower More Checking Procedures More Equipments Use of Computer Technologies Buy More Liability Insurance Hansen Chen 9
10 What Computer Can Do Jaw Jaw Treatment Treatment Setup Setup Message Message Downloaded Downloaded (TSD (TSD- - JAW) JAW) Patient Patient ID: ID: A A Course: Course: 1, 1, Field: Field: '001A', '001A', Fraction Fraction 0, 0, Attempt: Attempt: 1 Oper. Oper. Mode: Mode: 1, 1, Seg. Seg. Total: Total: 20, 20, Seg. Seg. number: number: 1, 1, Seg. Seg. Attribute: Attribute: 0x x Mode: Mode: X-ray, X-ray, Energy Energy 6, 6, Technique: Technique: Fixed Fixed Dose: Dose: MU, MU, Dose Dose Rate: Rate: 0 MU/Min MU/Min # Used: Used: 1, 1, Accessory Accessory A: A: RETIC, RETIC, Accessory Accessory B: B:,Accessory,Accessory C: C: Collimator: Collimator: 90.0, 90.0, Gantry: Gantry: 0.0, 0.0, Arc: Arc: 0.0, 0.0, Direction: Direction: CCW CCW Field Field Type: Type: 0 Jaw Jaw X1: X1: 5.0, 5.0, Jaw Jaw X2: X2: Jaw Jaw Y1: Y1: 5.0, 5.0, Jaw Jaw Y2: Y2: MLC MLC X1: X1: 10.2, 10.2, 10.5, 10.5, 8.7, 8.7, 6.3, 6.3, 7.2, 7.2, 8.1, 8.1, 9.5, 9.5, 9.5, 9.5, 9.6, 9.6, 9.8, 9.8, 10.6, 10.6, MLC MLC X2: X2: 7.2, 7.2, 6.5, 6.5, 8.7, 8.7, 6.3, 6.3, 7.2, 7.2, 8.1, 8.1, 9.5, 9.5, 9.5, 9.5, 9.6, 9.6, 9.8, 9.8, 6.9, 6.9, Table Table Longitudinal: Longitudinal: 0.0, 0.0, Lateral: Lateral: 0.0, 0.0, Vertical: Vertical: Isocentric: Isocentric: 0.0, 0.0, Eccentric: Eccentric: Relative Relative Table Table Longitudinal: Longitudinal: 0.0, 0.0, Lateral: Lateral: 0.0, 0.0, Vertical: Vertical: Isocentric: Isocentric: 0.0, 0.0, Eccentric: Eccentric: Epid Epid Acquisition: Acquisition: 0 Epid Epid Table Table Longitudinal: Longitudinal: 0.0, 0.0, Lateral: Lateral: 0.0, 0.0, Vertical: Vertical: VW VW Original Original MU: MU: , , VW VW Dynamic Dynamic Jaw: Jaw: Data Data Valid Valid 32-Bit 32-Bit Mask: Mask: 0x0000f1ef 0x0000f1ef Hansen Chen 10
11 What Computer Can NOT Do Preparing the Data Jaw Jaw Treatment Treatment Setup Setup Message Message Downloaded Downloaded (TSD (TSD- - JAW) JAW) Patient Patient ID: ID: A A Course: Course: 1, 1, Field: Field: '001A', '001A', Fraction Fraction 0, 0, Attempt: Attempt: 1 Oper. Oper. Mode: Mode: 1, 1, Seg. Seg. Total: Total: 20, 20, Seg. Seg. number: number: 1, 1, Seg. Seg. Attribute: Attribute: Potential Error 0x x in Data Entry Mode: Mode: X-ray, X-ray, Energy Energy 6, 6, Technique: Technique: Fixed Fixed Dose: Dose: MU, MU, Dose Dose Rate: Rate: 0 MU/Min MU/Min # Used: Used: 1, 1, Accessory Accessory A: A: RETIC, RETIC, Accessory Accessory B: B:,Accessory,Accessory C: C: Collimator: Collimator: 90.0, 90.0, Gantry: Gantry: 0.0, 0.0, Arc: Arc: 0.0, 0.0, Direction: Direction: CCW CCW Field Field Type: Type: 0 Jaw Jaw X1: X1: 5.0, 5.0, Jaw Jaw X2: X2: Jaw Jaw Y1: Y1: 5.0, 5.0, Jaw Jaw Y2: Y2: MLC MLC X1: X1: 10.2, 10.2, 10.5, 10.5, 8.7, 8.7, 6.3, 6.3, 7.2, 7.2, 8.1, 8.1, 9.5, 9.5, 9.5, 9.5, 9.6, 9.6, 9.8, 9.8, 10.6, 10.6, MLC MLC X2: X2: 7.2, 7.2, 6.5, 6.5, 8.7, 8.7, 6.3, 6.3, 7.2, 7.2, 8.1, 8.1, 9.5, 9.5, 9.5, 9.5, 9.6, 9.6, 9.8, 9.8, 6.9, 6.9, Table Table Longitudinal: Longitudinal: 0.0, 0.0, Lateral: Lateral: 0.0, 0.0, Vertical: Vertical: Isocentric: Isocentric: 0.0, 0.0, Eccentric: Eccentric: Relative Relative Table Table Longitudinal: Longitudinal: 0.0, 0.0, Lateral: Lateral: 0.0, 0.0, Vertical: Vertical: Isocentric: Isocentric: 0.0, 0.0, Eccentric: Eccentric: Epid Epid Acquisition: Acquisition: 0 Epid Epid Table Table Longitudinal: Longitudinal: 0.0, 0.0, Lateral: Lateral: 0.0, 0.0, Vertical: Vertical: VW VW Original Original MU: MU: , , VW VW Dynamic Dynamic Jaw: Jaw: Data Data Valid Valid 32-Bit 32-Bit Mask: Mask: 0x0000f1ef 0x0000f1ef Hansen Chen 11
12 Electronic Oncology Systems (EOS) Treatment Plan System Oncology Information System Treatment Delivery System Treatment Verification System Hansen Chen 12
13 EOS System Design Guidelines Patient Safety Electronic Oncology Quality of Care Operation & Care Cost Time & Efforts Hansen Chen 13
14 Electronic Oncology Systems Management IT Infrastructure Servers and Clients Data Safety in Storage Backup and Archive Data Safety in Communication Data Integrity in Transmission & Execution Systems Monitoring Responsibilities Policy & Procedures Policy & Procedures System Malfunction etc Hansen Chen 14
15 EOS IT Infrastructure Centralized Computing System Redundancy Hansen Chen 15
16 Systems Infrastructure Before Columbia Campus Cornell Campus License + Service Hansen Chen 16
17 Centralized System Infrastructure Columbia Campus Cornell Campus Hansen Chen 17
18 Systems Redundancy Clustered Data Servers SAN (Storage Area Network) Hansen Chen 18
19 Application Deployment Servers Citrix Server Farms SunRay Server Array Hansen Chen 19
20 Citrix ITA Thin Client Access Hansen Chen 20
21 Oncology Information System Topology Hansen Chen 21
22 Pinnacle SunRay Thin Client Hansen Chen 22
23 Pinnacle SmartEnterprise Topology Philips Philips Pinnacle Pinnacle Server Server Cluster Cluster x Server Server Client 810 Client 810 Client Client Philips Philips Pinnacle Pinnacle Compute Compute Modules Modules x 2 Server End Cornell Campus Teaching Units Fiber Optics Network Network Switch Switch Client Sites SunGuard SunGuard SAN SAN Storage Storage System System NYP NYP P3PC P3PC Gateway Gateway x 2 Cornell + Columbia Campuses Hansen Chen 23
24 Centralized Tx Plan Topology Centralized Tx Plan Office Server Vault Physician & Physics Offices Hospital Hansen Chen 24
25 One Workstation for 10 People Hansen Chen 25
26 Bring Technology to People Not People to Technology Hansen Chen 26
27 Contouring Hansen Chen 27
28 Tx Plan Hansen Chen 28
29 Plan Review Hansen Chen 29
30 Multi-User Environment CT-Sim Image Fusion Contour Plan Define Isocenter Import Diagnostic Images Target Delineation Dose Shaping ROI Define Beams Import Planning CT Images Run DIR Beams Registration Contour Modification Dose Objective Hansen Chen 30
31 Workflow Streamline a Straight Line Hansen Chen 31
32 PACS-RT System Candelis ImageGrid Redundant Server Auto Replication PACS-RT DICOM & Data DICOM RT/WFM Data Data TCP/IP Network (4D) CT Simulator Tx Plan Systems Contouring W/S RTT IGRT W/S PET/CT/MR HDR Brachy TPS Plan Review W/S Oncologist W/S Enterprise PACS PSI Brachy TPS Physics W/S Reporting W/S Hansen Chen 32
33 Workflow Management PACS-RT Web Based Workflow Manager System Functions Dicom/RT Store/Receive Dicom/RT Query/Retrieve Unattended TPS Backup TPS Patient Restore R&V, HIS Patient Archive Off-Line / Off-Site Backup Patient Workflow Patient Simulation Fusion & Contouring Treatment Plan Tx Plan Review Physics Check/QA IGRT / VGRT Image/Report Review Weekly & EOT Chk User Configurable Workflow Required Staff Views Physician Dosimetrist Physicist Therapist Hansen Chen 33
34 Oncology PACS Storage Hansen Chen 34
35 Centralized PACS-RT Server OIS Server PACS-RT Server Patient Data Patient Schedule CT Simulation Oncologist W/S Tx Plan RTT W/S Input: CT-Sim Worklist Output: Patient CT Images RT Plan & RTSS Acknowledge Completed Input: CT-Sim Worklist Patient CT Images RT Plan & RTSS Input: CT-Sim Worklist Patient CT Images RT Plan & RTSS Input: CT-Sim Worklist Patient CT Images RT Plan & RTSS Output: All RT Objects Output: All RT Objects Output: All RT Objects Hansen Chen 35
36 Integration with PACS-RT Use of Back-bone PACS-RT Server Supporting DICOM Query & DICOM Work List PACS-RT Oncologist Review Physicist Monitoring Contour Evaluation DVH Analysis IMRT/IGRT QA Evaluation Hansen Chen 36
37 Data Tsunami Active Data Patients Under Care Static Data Patient Follow-Ups Data Types Data Types Medical Records, DICOM Images, DICOM RT Objects Hansen Chen 37
38 EOS Safety in Storage Online Data Redundancy Clustered Servers and SAN Patients Under Treatment Near-Line Data Redundancy Oncology PACS 6 Months to a Year Off-Line Data Redundancy Enterprise Archive in Different Geometric Locations Beyond a Year Hansen Chen 38
39 EOS Safety in Communication Adapting from FDA 510K Guidelines High Level System Description Architecture Design Chart Hazard Analysis & Risk Management System Requirement Specification (SRS) System Design Specification (SDS) Hazard Trace Matrix & Traceability Analysis Operation Environment Verification and Validation Unresolved Anomalies Hansen Chen 39
40 High Level Systems Description Approved Tx Plan Daily Tx Delivery Hansen Chen 40
41 Architecture Design Chart Approved Tx Plan Daily Tx Delivery R&V System Hansen Chen 41
42 Hazard Analysis & Risk Management Approved Tx Plan R&V System Daily Tx Delivery Hansen Chen 42
43 SRS & SDS to Mitigate the Risks Extensive Bit-to to-bit Data Check by Human is Too Much Work Designing a Computer Software Tool to Mitigate the Risks A Computer-Aided Tx Data Auditing Software to Improve the Efficiency A Software which can Automatically Monitor Tx Data being Delivered Hansen Chen 43
44 SRS & SDS to Mitigate the Risks Module A: New Plan Checks Approved Tx Plan R&V System New Software for Tx Data Checking Hansen Chen 44
45 SRS & SDS to Mitigate the Risks Module B: Daily Tx Log Checks Approved Tx Plan Daily Tx Delivery New Software for Tx Data Checking Hansen Chen 45
46 Hazard Traceability Analysis Approved Tx Plan R&V System Daily Tx Delivery Hansen Chen 46
47 Electronic Oncology System Monitoring Whose Responsibility? Hansen Chen 47
48 Whose Fault? RAID 5 Array Failing Hansen Chen 48
49 Whose Fault? Restarting a Database Service Hansen Chen 49
50 Balance with True Colors Server Operating System Network Database Application Desktop Research Development Reporting Troubleshooting Configuration Installation User Rights Clinical Data Hansen Chen 50
51 Policy & Procedures When Server is Down Should off-line treatment be carried out? Off-line data roll back integrity checks Overwrite Staff role and their rights for overwriting Quality auditing for overwritten data User Rights For each staff group, plus senior staff Who can define user rights Generic user account? Hansen Chen 51
52 Policy & Procedures Paperless Chart / Electronic Medical Record Patient medical record accessibility by other medical staff Paper signing off vs. electronic signature Login & Logout Login & logout enforcement User activity logging System Continuity Configuration change policy System update policy Hansen Chen 52
53 Summary Electronic Oncology System (EOS) is playing an essential role in today s s Radiation Oncology service EOS Management Considerations EOS Management Considerations IT Infrastructure Data Safety in Storage Data Safety in Communication Systems Monitoring Policy & Procedures Hansen Chen 53
54 Conclusion The emerging radiation therapy technology has became more and more complicated with increased clinical procedures and equipments Electronic Oncology System provides one solution to such complicated environment Well designed EOS management from its infrastructure to the implementation is important Safety measures for EOS is by no means critical to the Radiation Oncology practice Hansen Chen 54
55 Thank You
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