ICE-PAC Rapid Device Configuration

ICE-PACRapid Device Configuration Project Discussion2010.07.22

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

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

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 • … <pull in from e-mail thread>

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

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

Clinicians Clinical Scenario Clinical Scenario Clinical Workflow Clinical Engineers Workflow Analysis Risk Analysis Design Engineers System Modeling Technical Solution and Clinical Implementation 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: • Currentstate & associated risks • Proposedstate, resulting benefits and any new risks • Risk reduction is a major benefit • ClinicalConceptofOperations - a more detailed story of the processes and events, for both current & proposed states (e.g., which clinicians, which devices, steps, etc.)

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

Clinicians Clinical Scenario Clinical Scenario Clinical Workflow Clinical Engineers Workflow Analysis Risk Analysis Design Engineers System Modeling Technical Solution and Clinical Implementation RDC Project~ Process & Deliverables: Clinical Workflow • 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.

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

Clinicians Clinical Scenario Clinical Scenario Clinical Workflow Clinical Engineers Workflow Analysis Risk Analysis Design Engineers System Modeling Technical Solution and Clinical Implementation RDC Project~ Process & Deliverables: Clinical Workflow – STATUS

Clinicians Clinical Scenario Clinical Scenario Clinical Workflow Clinical Engineers Workflow Analysis Risk Analysis Design Engineers System Modeling Technical Solution and Clinical Implementation RDC Project~ Process & Deliverables: Workflow Analysis 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. • …

Clinicians Clinical Scenario Clinical Scenario Clinical Workflow Clinical Engineers Workflow Analysis Risk Analysis Design Engineers System Modeling Technical Solution and Clinical Implementation RDC Project~ Process & Deliverables: Risk Analysis • 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)

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

Clinicians Clinical Scenario Clinical Scenario Clinical Workflow Clinical Engineers Workflow Analysis Risk Analysis Design Engineers System Modeling Technical Solution and Clinical Implementation RDC Project~ Process & Deliverables: System Modeling • 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: • Object / Information Models • State Models • …

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

Clinicians Clinical Scenario Clinical Scenario Clinical Workflow Clinical Engineers Workflow Analysis Risk Analysis Design Engineers System Modeling Technical Solution and Clinical Implementation RDC Project~ Process & Deliverables: Solution Implementation • 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 standardizationgaps • Establish tooling needed to support the project (esp. NIST) • Prototyped & demonstrated “real-world” systems, incl. clinical evaluation (could be simulated or real-world)

<In this section …> • …

Rapid Device Configurator DOC/manager DTBR DOR/agent DOR/agent DR RDC Logical Actors / Intermediary Architecture Monitor Device Configuration / Status Auto-Configure Device (external control) Clinician Reviews / Manually Configures Device via User Interface 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).

Pre-Coordinated Post-Coordinated Enterprise Point-of-Care INDIRECT (Intermediated) DIRECT (Non-Intermediated) • Legend • DevicesProtocols • DTBR Device To Be Replaced / Reconfigured Standard; Enterprise Context • DR Device Replacement Standard; Point-of-Care Context • DRI Device Replacement Intermediary Proprietary; Point-of-Care Context • DRIpoc DRI Point-of-Care Context • DRIent DRI Enterprise Context RDC Topology - Generalized DRIent Standard Protocol (Enterprise) DRIpoc Proprietary Protocol (PoC) Standard Protocol (PoC) DTBR DR T 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).

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

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 • …

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 … !

Additional Background Slides

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.

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).

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…

Supervisor External Interface Controller Data Logger DTBR Model DR Model Primary Data Stream Non Functional Data Stream DR DTBR 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

RDC Topology – ICE Framework Perspective – Standard Protocols Device Models can leverage standard profiles (a la ICS generator XML files)

Pre-Coordinated Post-Coordinated Enterprise Point-of-Care INDIRECT (Intermediated) DIRECT (Non-Intermediated) • Legend • DevicesProtocols • DTBR Device To Be Replaced / Reconfigured Standard; Enterprise Context • DR Device Replacement Standard; Point-of-Care Context • DRI Device Replacement Intermediary Proprietary; Point-of-Care Context • DRIpoc DRI Point-of-Care Context • DRIent DRI Enterprise Context RDC Topology – Enterprise-based DRI DRIent Standard Protocol (Enterprise) Proprietary Protocol (PoC) DTBR DR T This approach focuses on an Enterprise-based Device Replacement Imtermediary or RDConfigurator.

ICE-PAC Rapid Device Configuration