Date post: | 17-Jan-2016 |
Category: |
Documents |
Upload: | katrina-boyd |
View: | 221 times |
Download: | 0 times |
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
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
5ICE-PAC RDC Project DiscussionICE-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
… <pull in from e-mail thread>
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
7ICE-PAC RDC Project DiscussionICE-PAC RDC Project Discussion
RDC Project ~ Building on Clinical Requirements
RiskAnalysis
SystemModeling
Technical Solution and
Clinical Implementation
Des
ign
Eng
inee
rsC
linic
al E
ngin
eers
ClinicalScenario
Clinical Workflow
Workflow Analysis
ClinicalScenario
Clin
icia
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
8ICE-PAC RDC Project DiscussionICE-PAC RDC Project Discussion
RDC Project ~ Process Phases
RiskAnalysis
SystemModeling
Technical Solution and
Clinical Implementation
Des
ign
Eng
inee
rsC
linic
al E
ngin
eers
ClinicalScenario
Clinical Workflow
Workflow Analysis
ClinicalScenario
Clin
icia
ns
These process blocks indicate project phases and though they generally initiate top-down, the activities will overlap and iterate.
9ICE-PAC RDC Project DiscussionICE-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.)
RiskAnalysis
SystemModeling
Technical Solution and
Clinical Implementation
Des
ign
Eng
inee
rsC
linic
al E
ngin
eers
ClinicalScenario
Clinical Workflow
Workflow Analysis
ClinicalScenario
Clin
icia
ns
10ICE-PAC RDC Project DiscussionICE-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
RiskAnalysis
SystemModeling
Technical Solution and
Clinical Implementation
Des
ign
Eng
inee
rsC
linic
al E
ngin
eers
ClinicalScenario
Clinical Workflow
Workflow Analysis
ClinicalScenario
Clin
icia
ns
11ICE-PAC RDC Project DiscussionICE-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.
RiskAnalysis
SystemModeling
Technical Solution and
Clinical Implementation
Des
ign
Eng
inee
rsC
linic
al E
ngin
eers
ClinicalScenario
Clinical Workflow
Workflow Analysis
ClinicalScenario
Clin
icia
nsRDC Project ~ Process & Deliverables: Clinical Workflow
12ICE-PAC RDC Project DiscussionICE-PAC RDC Project Discussion
Work in Progress!
(Rausch / 2010.07.13)
RiskAnalysis
SystemModeling
Technical Solution and
Clinical Implementation
Des
ign
Eng
inee
rsC
linic
al E
ngin
eers
ClinicalScenario
Clinical Workflow
Workflow Analysis
ClinicalScenario
Clin
icia
nsRDC Project ~ Process & Deliverables: Clinical Workflow – STATUS
13ICE-PAC RDC Project DiscussionICE-PAC RDC Project Discussion
RiskAnalysis
SystemModeling
Technical Solution and
Clinical Implementation
Des
ign
Eng
inee
rsC
linic
al E
ngin
eers
ClinicalScenario
Clinical Workflow
Workflow Analysis
ClinicalScenario
Clin
icia
nsRDC Project ~ Process & Deliverables: Clinical Workflow – STATUS
14ICE-PAC RDC Project DiscussionICE-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. …
RiskAnalysis
SystemModeling
Technical Solution and
Clinical Implementation
Des
ign
Eng
inee
rsC
linic
al E
ngin
eers
ClinicalScenario
Clinical Workflow
Workflow Analysis
ClinicalScenario
Clin
icia
nsRDC Project ~ Process & Deliverables: Workflow Analysis
15ICE-PAC RDC Project DiscussionICE-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)
RiskAnalysis
SystemModeling
Technical Solution and
Clinical Implementation
Des
ign
Eng
inee
rsC
linic
al E
ngin
eers
ClinicalScenario
Clinical Workflow
Workflow Analysis
ClinicalScenario
Clin
icia
nsRDC Project ~ Process & Deliverables: Risk Analysis
16ICE-PAC RDC Project DiscussionICE-PAC RDC Project Discussion
Not yet begun … predicated on above!
RDC Project ~ Process & Deliverables: Workflow & Risk Analysis–STATUS
RiskAnalysis
SystemModeling
Technical Solution and
Clinical Implementation
Des
ign
Eng
inee
rsC
linic
al E
ngin
eers
ClinicalScenario
Clinical Workflow
Workflow Analysis
ClinicalScenario
Clin
icia
ns
17ICE-PAC RDC Project DiscussionICE-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. …
RiskAnalysis
SystemModeling
Technical Solution and
Clinical Implementation
Des
ign
Eng
inee
rsC
linic
al E
ngin
eers
ClinicalScenario
Clinical Workflow
Workflow Analysis
ClinicalScenario
Clin
icia
nsRDC Project ~ Process & Deliverables: System Modeling
18ICE-PAC RDC Project DiscussionICE-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
RiskAnalysis
SystemModeling
Technical Solution and
Clinical Implementation
Des
ign
Eng
inee
rsC
linic
al E
ngin
eers
ClinicalScenario
Clinical Workflow
Workflow Analysis
ClinicalScenario
Clin
icia
nsRDC Project ~ Process & Deliverables: System Modeling
19ICE-PAC RDC Project DiscussionICE-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)
RiskAnalysis
SystemModeling
Technical Solution and
Clinical Implementation
Des
ign
Eng
inee
rsC
linic
al E
ngin
eers
ClinicalScenario
Clinical Workflow
Workflow Analysis
ClinicalScenario
Clin
icia
nsRDC Project ~ Process & Deliverables: Solution Implementation
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
21ICE-PAC RDC Project DiscussionICE-PAC RDC Project Discussion
<In this section …>
…
22ICE-PAC RDC Project DiscussionICE-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).
DTBRDTBR
DOR/agent
Rapid DeviceRapid DeviceConfiguratorConfigurator
DOC/manager
DRDR
DOR/agent
Monitor Device Configuration / Status
Auto-Configure Device (external control)
Clinician Reviews / Manually Configures Device via User Interface
23ICE-PAC RDC Project DiscussionICE-PAC RDC Project Discussion
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)
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).
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
25ICE-PAC RDC Project DiscussionICE-PAC RDC Project Discussion
<In this section …>
…
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
27ICE-PAC RDC Project DiscussionICE-PAC RDC Project Discussion
<In this section …>
…
28ICE-PAC RDC Project DiscussionICE-PAC RDC Project Discussion
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
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
30ICE-PAC RDC Project DiscussionICE-PAC RDC Project Discussion
<In this section …>
…
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
32ICE-PAC RDC Project DiscussionICE-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
…
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
34ICE-PAC RDC Project DiscussionICE-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 … !
35ICE-PAC RDC Project DiscussionICE-PAC RDC Project Discussion
Additional Background Slides
36ICE-PAC RDC Project DiscussionICE-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.
37ICE-PAC RDC Project DiscussionICE-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).
38ICE-PAC RDC Project DiscussionICE-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…
39ICE-PAC RDC Project DiscussionICE-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
40ICE-PAC RDC Project DiscussionICE-PAC RDC Project Discussion
RDC Topology – ICE Framework Perspective – Standard Protocols
Device Models can leverage standard
profiles (a la ICS generator XML files)
41ICE-PAC RDC Project DiscussionICE-PAC RDC Project Discussion
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)
T
Standard Protocol (Enterprise)
Proprietary Protocol
(PoC)
This approach focuses on an Enterprise-based Device Replacement Imtermediary or RDConfigurator.
42ICE-PAC RDC Project DiscussionICE-PAC RDC Project Discussion