ice-pac rapid device configuration ice-pac rapid device configuration project discussion 2010.07.22

ICE-PACICE-PACRapid Device Rapid Device ConfigurationConfiguration

Project DiscussionProject Discussion

2010.07.222010.07.22

ICE-PAC RDC Project DiscussionICE-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

4ICE-PAC RDC Project DiscussionICE-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

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>

RDC Project ~ Building on Clinical Requirements

RiskAnalysis

SystemModeling

Technical Solution and

Clinical Implementation

ClinicalScenario

Clinical Workflow

Workflow Analysis

ClinicalScenario

ns 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

RDC Project ~ Process Phases

RiskAnalysis

SystemModeling

ClinicalScenario

Clinical Workflow

Workflow Analysis

ClinicalScenario

These process blocks indicate project phases and though they generally initiate top-down, the activities will overlap and iterate.

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.)

RiskAnalysis

SystemModeling

ClinicalScenario

Clinical Workflow

Workflow Analysis

ClinicalScenario

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

RiskAnalysis

SystemModeling

ClinicalScenario

Clinical Workflow

Workflow Analysis

ClinicalScenario

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.

RiskAnalysis

SystemModeling

ClinicalScenario

Clinical Workflow

Workflow Analysis

ClinicalScenario

nsRDC Project ~ Process & Deliverables: Clinical Workflow

Work in Progress!

(Rausch / 2010.07.13)

RiskAnalysis

SystemModeling

ClinicalScenario

Clinical Workflow

Workflow Analysis

ClinicalScenario

nsRDC Project ~ Process & Deliverables: Clinical Workflow – STATUS

RiskAnalysis

SystemModeling

ClinicalScenario

Clinical Workflow

Workflow Analysis

ClinicalScenario

nsRDC Project ~ Process & Deliverables: Clinical Workflow – STATUS

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. …

RiskAnalysis

SystemModeling

ClinicalScenario

Clinical Workflow

Workflow Analysis

ClinicalScenario

nsRDC Project ~ Process & Deliverables: Workflow 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)

RiskAnalysis

SystemModeling

ClinicalScenario

Clinical Workflow

Workflow Analysis

ClinicalScenario

nsRDC Project ~ Process & Deliverables: Risk Analysis

Not yet begun … predicated on above!

RDC Project ~ Process & Deliverables: Workflow & Risk Analysis–STATUS

RiskAnalysis

SystemModeling

ClinicalScenario

Clinical Workflow

Workflow Analysis

ClinicalScenario

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. …

RiskAnalysis

SystemModeling

ClinicalScenario

Clinical Workflow

Workflow Analysis

ClinicalScenario

nsRDC Project ~ Process & Deliverables: System Modeling

Patient Info

Orders

Family

Status

Procedure

Most Recent Vitals

Labs (pending/ most recent)

Radiology (pending/

recent)

Information Relevant During Device Transfer

Begun … but not per formal process

RiskAnalysis

SystemModeling

ClinicalScenario

Clinical Workflow

Workflow Analysis

ClinicalScenario

nsRDC Project ~ Process & Deliverables: System Modeling

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)

RiskAnalysis

SystemModeling

ClinicalScenario

Clinical Workflow

Workflow Analysis

ClinicalScenario

nsRDC Project ~ Process & Deliverables: Solution Implementation

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).

DTBRDTBR

DOR/agent

Rapid DeviceRapid DeviceConfiguratorConfigurator

DOC/manager

DOR/agent

Monitor Device Configuration / Status

Auto-Configure Device (external control)

Clinician Reviews / Manually Configures Device via User Interface

Legend

Devices Protocols

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

DTBRDTBR DRDR

DRIentDRIent

DRIpocDRIpoc

Pre-Coordinated Post-Coordinated

EnterprisePoint-of-Care

INDIRECT (Intermediated)

DIRECT (Non-Intermediated)

Standard Protocol (Enterprise)

Proprietary Protocol

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).

RDC Device Models – Leveraging NIST 11073 + IHE-PCD Tooling

NISTICSGenerator

Model Tool

ISO / IEEE 11073Information Model

ISO / IEEE 11073Terminology

IHE PCDIHE PCDhRosettahRosetta

ICE-PACRDConfigurator

IHE PCD Pump WG

PumpSystem

NISTConformance Test Tooling

NISTICS Compare

Service

CompatibilityAssessmentInfusion 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

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…

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

RDC Topology – ICE Framework Perspective – Standard Protocols

Device Models can leverage standard

profiles (a la ICS generator XML files)

Legend

Devices Protocols

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

DTBRDTBR DRDR

DRIentDRIent

Pre-Coordinated Post-Coordinated

EnterprisePoint-of-Care

INDIRECT (Intermediated)

DIRECT (Non-Intermediated)

Standard Protocol (Enterprise)

Proprietary Protocol

This approach focuses on an Enterprise-based Device Replacement Imtermediary or RDConfigurator.

ice-pac rapid device configuration ice-pac rapid device configuration project discussion 2010.07.22

process deliverables

clinical processes

clinical requirements

clinical situation

clinical staff

clinical workflow status

clinical scenarios status

current proposed states

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