1. ICE-PAC Rapid Device Configuration ICE-PAC Rapid Device Configuration Project Discussion 2010.07.22

2. ICE-PAC RDC Project Discussion ICE-PAC RDC Project Discussion Topics RDC Project Objectives ICE-PAC Process & Project Status Architectural Options Enabling / Limiting Considerations Tooling Support Project Phase I Proposal Optional/Subsequent Project Phases Next Steps

3. ICE-PAC RDC Project Discussion ICE-PAC RDC Project Discussion Topics RDC Project Objectives ICE-PAC Process & Project Status Architectural Options Enabling / Limiting Considerations Tooling Support Project Phase I Proposal Optional/Subsequent Project Phases Next Steps

4. 4 ICE-PAC RDC Project Discussion RDC Project ~ Objectives General project objectives: Take ICE-PAC process through to prototype demo @ HIMSS Focus on ICE clinical scenarios patient transport (clinical context change) w/ device transitions Advance PCD DPI Development (including discovery, “plug-and-play”, R-T monitoring, …) Identify Synergies & Gaps in Standards and IHE Profiles, incl.  Factor in DCM work which focuses initially on vents Advance use of open source tooling – esp. from NIST Provide open source reference implementations – especially for U.S. NHIN

5. 5 ICE-PAC RDC Project Discussion RDC Project ~ Objectives Project “learning” objectives: Use of a Web Services-based architecture for DPI connectivity, factoring in 11073 standards Understand better the business model …

6. ICE-PAC RDC Project Discussion ICE-PAC RDC Project Discussion Topics RDC Project Objectives ICE-PAC Process & Project Status Architectural Options Enabling / Limiting Considerations Tooling Support Project Phase I Proposal Optional/Subsequent Project Phases Next Steps

7. 7 ICE-PAC RDC Project Discussion RDC Project ~ Building on Clinical Requirements Risk Analysis System Modeling Technical Solution and Clinical Implementation Design Engineers Clinical Engineers Clinical Scenario Clinical Workflow Analysis Clinical Scenario Clinicians  Gathering Requirements from Clinical System  Providing Traceability of System Requirements  Provide Systems Level Risk Analysis  Provides Traceability to Mitigating Risk  Designing for the System, not modifying the system causing unintended consequences  General Building Blocks and Interactions between the blocks are key to Safety  If General Building Blocks make up Specific Systems then Systems are safe

8. 8 ICE-PAC RDC Project Discussion RDC Project ~ Process Phases Risk Analysis System Modeling Technical Solution and Clinical Implementation Design Engineers Clinical Engineers Clinical Scenario Clinical Workflow Analysis Clinical Scenario Clinicians These process blocks indicate project phases and though they generally initiate top-down, the activities will overlap and iterate.

9. 9 ICE-PAC RDC Project Discussion RDC Project ~ Process & Deliverables: Clinical Scenarios A brief description of a clinical situation or event, providing background and illustrating the need for a technical solution There are three sections to a scenario: 1.Current state & associated risks 2.Proposed state, resulting benefits and any new risks  Risk reduction is a major benefit 3.Clinical Concept of Operations - a more detailed story of the processes and events, for both current & proposed states (e.g., which clinicians, which devices, steps, etc.) Risk Analysis System Modeling Technical Solution and Clinical Implementation Design Engineers Clinical Engineers Clinical Scenario Clinical Workflow Analysis Clinical Scenario Clinicians

10. 10 ICE-PAC RDC Project Discussion Scenario I: PACU ICU w/ Vent & Pumps Scenario II: Device failure in ICU … “hotswap” Proposed: ED transfer to Surgery RDC Project ~ Process & Deliverables: Clinical Scenarios – STATUS Risk Analysis System Modeling Technical Solution and Clinical Implementation Design Engineers Clinical Engineers Clinical Scenario Clinical Workflow Analysis Clinical Scenario Clinicians

11. 11 ICE-PAC RDC Project Discussion Graphical representation (e.g., flow chart) of the events, clinical processes, guidelines, templates / checklists that need to be followed. Tool for interaction with clinical staff in order to understand details. Risk Analysis System Modeling Technical Solution and Clinical Implementation Design Engineers Clinical Engineers Clinical Scenario Clinical Workflow Analysis Clinical Scenario Clinicians RDC Project ~ Process & Deliverables: Clinical Workflow

12. 12 ICE-PAC RDC Project Discussion Work in Progress! (Rausch / 2010.07.13) Risk Analysis System Modeling Technical Solution and Clinical Implementation Design Engineers Clinical Engineers Clinical Scenario Clinical Workflow Analysis Clinical Scenario Clinicians RDC Project ~ Process & Deliverables: Clinical Workflow – STATUS

13. 13 ICE-PAC RDC Project Discussion Risk Analysis System Modeling Technical Solution and Clinical Implementation Design Engineers Clinical Engineers Clinical Scenario Clinical Workflow Analysis Clinical Scenario Clinicians RDC Project ~ Process & Deliverables: Clinical Workflow – STATUS

14. 14 ICE-PAC RDC Project Discussion Includes but not limited to: UML Activity Diagram, in order to show relationships between parts of system with respect to structure (data) UML Interaction Diagram in order to show relationships between parts of a system with respect to behavior (time) May also include:  Defined terminology relating to the specific scenarios (key semantics that need to be tracked into the system design; semantic model; e.g., 60601-x-y type standardization)  Process state models / charts  Predicate requirements (orders, assessments, …)  Generalized templates, check lists, etc.  … Risk Analysis System Modeling Technical Solution and Clinical Implementation Design Engineers Clinical Engineers Clinical Scenario Clinical Workflow Analysis Clinical Scenario Clinicians RDC Project ~ Process & Deliverables: Workflow Analysis

15. 15 ICE-PAC RDC Project Discussion Systematic use of available information to identify hazards and to estimate risk Use IEC 80001-1 processes (e.g., see HDO guidance drafts) Produce a Systems Level Risk Analysis Chart (e.g., spreadsheet done on ICE-PAC PCA analysis) Risk Analysis System Modeling Technical Solution and Clinical Implementation Design Engineers Clinical Engineers Clinical Scenario Clinical Workflow Analysis Clinical Scenario Clinicians RDC Project ~ Process & Deliverables: Risk Analysis

16. 16 ICE-PAC RDC Project Discussion Not yet begun … predicated on above! RDC Project ~ Process & Deliverables: Workflow & Risk Analysis–STATUS Risk Analysis System Modeling Technical Solution and Clinical Implementation Design Engineers Clinical Engineers Clinical Scenario Clinical Workflow Analysis Clinical Scenario Clinicians

17. 17 ICE-PAC RDC Project Discussion Finalize technical requirement specifications (incl. actor interface specifications) Implementation independent / architecture agnostic …  Modeling methodology often implies a process & set of implementation architecture options … this will be minimized to the extent appropriate given …  The context for this modeling is device informatics as established within IHE PCD & related SDOs Device Specialization Specifications (e.g., ICS requirements) Models include: 1.Object / Information Models 2.State Models 3. … Risk Analysis System Modeling Technical Solution and Clinical Implementation Design Engineers Clinical Engineers Clinical Scenario Clinical Workflow Analysis Clinical Scenario Clinicians RDC Project ~ Process & Deliverables: System Modeling

18. 18 ICE-PAC RDC Project Discussion Patient Info Hx Dx Rx Orders Family Status Procedure Most Recent Vitals I/O Labs (pending/ most recent) Radiology (pending/ recent) Information Relevant During Device Transfer Begun … but not per formal process Risk Analysis System Modeling Technical Solution and Clinical Implementation Design Engineers Clinical Engineers Clinical Scenario Clinical Workflow Analysis Clinical Scenario Clinicians RDC Project ~ Process & Deliverables: System Modeling

19. 19 ICE-PAC RDC Project Discussion IHE PCD-based system solution specifications with traceability back to all levels of requirements & risk analysis Fill “gaps” in IHE profiles Engage SDOs to address standardization gaps Establish tooling needed to support the project (esp. NIST) Prototyped & demonstrated “real-world” systems, incl. clinical evaluation (could be simulated or real-world) Risk Analysis System Modeling Technical Solution and Clinical Implementation Design Engineers Clinical Engineers Clinical Scenario Clinical Workflow Analysis Clinical Scenario Clinicians RDC Project ~ Process & Deliverables: Solution Implementation

20. ICE-PAC RDC Project Discussion ICE-PAC RDC Project Discussion Topics RDC Project Objectives ICE-PAC Process & Project Status Architectural Options Enabling / Limiting Considerations Tooling Support Project Phase I Proposal Optional/Subsequent Project Phases Next Steps

21. 21 ICE-PAC RDC Project Discussion …

22. 22 ICE-PAC RDC Project Discussion RDC Logical Actors / Intermediary Architecture Logically, the actors are relatively simple. DTBR must supply configuration & status info to the RDC. The RDC also retrieves configuration (static & operational) from the DR + interacts with the clinician, especially to resolve non-compatibility DTBR-to-DR issues; RDC may also automatically program the DR if supported; otherwise, it may monitor DR configuration status as the clinician interacts both with it and the DR (manually configuring / confirming). DTBR DOR/agent Rapid Device Configurator DOC/manager DR DOR/agent Monitor Device Configuration / Status Auto-Configure Device (external control) Clinician Reviews / Manually Configures Device via User Interface

23. 23 ICE-PAC RDC Project Discussion Legend DevicesProtocols DTBRDevice To Be Replaced / ReconfiguredStandard; Enterprise Context DRDevice ReplacementStandard; Point-of-Care Context DRIDevice Replacement IntermediaryProprietary; Point-of-Care Context DRIpocDRI Point-of-Care Context DRIentDRI Enterprise Context RDC Topology - Generalized DTBR DR DRIent DRIpoc Pre-CoordinatedPost-Coordinated Enterprise Point-of-Care INDIRECT (Intermediated) DIRECT (Non-Intermediated) T Standard Protocol (Enterprise) Proprietary Protocol (PoC) Standard Protocol (PoC) This is a generalized topological diagram (incomplete!) that shows some of the key dimensions to be addressed (e.g., PoC vs. Ent., Direct/Indirect, pre- vs. post- coordination, standard & non- standard protocols).

24. ICE-PAC RDC Project Discussion ICE-PAC RDC Project Discussion Topics RDC Project Objectives ICE-PAC Process & Project Status Architectural Options Enabling / Limiting Considerations Tooling Support Project Phase I Proposal Optional/Subsequent Project Phases Next Steps

25. 25 ICE-PAC RDC Project Discussion …

26. ICE-PAC RDC Project Discussion ICE-PAC RDC Project Discussion Topics RDC Project Objectives ICE-PAC Process & Project Status Architectural Options Enabling / Limiting Considerations Tooling Support Project Phase I Proposal Optional/Subsequent Project Phases Next Steps

27. 27 ICE-PAC RDC Project Discussion …

28. 28 ICE-PAC RDC Project Discussion RDC Device Models – Leveraging NIST 11073 + IHE-PCD Tooling NIST ICSGenerator Model Tool ISO / IEEE 11073 Information Model ISO / IEEE 11073 Terminology IHE PCD hRosetta ICE-PAC RDConfigurator IHE PCD Pump WG Pump System NIST Conformance Test Tooling NIST ICS Compare Service Compatibility Assessment Infusion Pump ICS Model ICE-PAC Rapid Device Configurator (see prev. slide) can use the NIST ICS model “compare device” service to support creation of a Compatibility Assessment. WGs manage device specific Rosetta terms + device specialization content profiles (captured in model) Device Info / Services Reference Models NIST Tooling built on semantic standards & content profiles

29. ICE-PAC RDC Project Discussion ICE-PAC RDC Project Discussion Topics RDC Project Objectives ICE-PAC Process & Project Status Architectural Options Enabling / Limiting Considerations Tooling Support Project Phase I Proposal Optional/Subsequent Project Phases Next Steps

30. 30 ICE-PAC RDC Project Discussion …

31. ICE-PAC RDC Project Discussion ICE-PAC RDC Project Discussion Topics RDC Project Objectives ICE-PAC Process & Project Status Architectural Options Enabling / Limiting Considerations Tooling Support Project Phase I Proposal Optional/Subsequent Project Phases Next Steps

32. 32 ICE-PAC RDC Project Discussion RDC Project ~ Optional / Subsequent Project Phases Topics deferred to subsequent project phases: Device-to-Device Direct Configuration (no intermediary) Full device external configuration control Combined PoC & Enterprise coordination Multi-device transfer coordination Enhanced / comprehensive clinical context awareness in RDC algorithms …

33. ICE-PAC RDC Project Discussion ICE-PAC RDC Project Discussion Topics RDC Project Objectives ICE-PAC Process & Project Status Architectural Options Enabling / Limiting Considerations Tooling Support Project Phase I Proposal Optional/Subsequent Project Phases Next Steps

34. 34 ICE-PAC RDC Project Discussion RDC Project ~ Next Steps Review & approve project direction & Phase I Proposal Identify project participants & roles Establish web-based project support (wiki, ftp, etc.) Develop more comprehensive Project Plan Get on with it … !

35. 35 ICE-PAC RDC Project Discussion Additional Background Slides

36. 36 ICE-PAC RDC Project Discussion Clinical Scenario I The a patient is post operative and is currently on an ICU ventilator and is being transported from the PACU to the ICU and is receiving IV fluids, antibiotics, pain medication and a sedative. The patient is placed on a transport ventilator, moved to the ICU and handoff exchange occurs. The patient is moved from a transport ventilator back to an ICU ventilator. Ventilation is then optimized and infusions are verified and checked at the time of handoff.

37. 37 ICE-PAC RDC Project Discussion At the time of handoff the ventilator is switched from the transport ventilator to the real ventilator. The infusion pumps were disconnected in the PACU with the lines left in place with the intent of new infusion pumps and drugs to be connected in the ICU. (NEED TO VERIFY).

38. 38 ICE-PAC RDC Project Discussion Scenario II Patient is stable in ICU and an device fails. The device needs to be swapped quickly for a new device. The new device I brought into the room and the device is setup. – Infusion Pump switch Site of medication Order Amt given since order was administered If PCA time since last press, amt given since order – Ventilator transfer Mode Rate FIO2 Etc…

39. 39 ICE-PAC RDC Project Discussion DTBR DR DTBR Model DR Model Controller Data Logger Supervisor External Interface Primary Data Stream Non Functional Data Stream RDC Topology – ICE Framework Perspective – General Model Device Models can leverage standard PCD profiles (a la ICS generator XML files) NOTE: ICS-based profiles include semantics, services & event notifications

40. 40 ICE-PAC RDC Project Discussion RDC Topology – ICE Framework Perspective – Standard Protocols Device Models can leverage standard profiles (a la ICS generator XML files)

41. 41 ICE-PAC RDC Project Discussion Legend DevicesProtocols DTBRDevice To Be Replaced / ReconfiguredStandard; Enterprise Context DRDevice ReplacementStandard; Point-of-Care Context DRIDevice Replacement IntermediaryProprietary; Point-of-Care Context DRIpocDRI Point-of-Care Context DRIentDRI Enterprise Context RDC Topology – Enterprise-based DRI DTBR DR DRIent Pre-CoordinatedPost-Coordinated Enterprise Point-of-Care INDIRECT (Intermediated) DIRECT (Non-Intermediated) T Standard Protocol (Enterprise) Proprietary Protocol (PoC) This approach focuses on an Enterprise-based Device Replacement Imtermediary or RDConfigurator.

42. 42 ICE-PAC RDC Project Discussion