Device Observation Semantic Bridge (DSB/DOSB) Phase 1 IHE Proposal Draft Graphics September 04, 2014 Amended Based on NLM/IHTSDO Meeting – September 09, 2014 (last slide) 1
Jan 06, 2016
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Device Observation Semantic Bridge (DSB/DOSB)
Phase 1 IHE Proposal Draft GraphicsSeptember 04, 2014
Amended Based on NLM/IHTSDO Meeting – September 09, 2014 (last slide)
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Team
• VHA– Ioana Singureanu– Greg Staudenmaier– Loren Stevenson– Dan Morford – Catherine Hoang
• IHE – Alex Lippitt (HIMSS, IHE)– Paul Sherman – Technical
Project Manager – IHE Patient Care Device Domain(retired VHA)
– John Garguilo (NIST)– Paul Schluter (GE)
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The Device Observation Semantic Bridge (DSB/DOSB) Challenge
• Getting semantically correct data from patient care devices into clinical applications is difficult for a number of reasons:
– The applicable nomenclature from medical devices, IEEE 11073 10101, is not one of the Meaningful Use approved nomenclatures, reducing the incentive to use IEEE 11073 data in clinical applications
– There are no commonly accepted mappings of IEEE 11073 10101 to Meaningful Use approved nomenclatures (LOINC and SNOMED primarily) for clinical measures although there are vendors who have done so as proprietary interfaces
– There are still many circumstances where the specific numeric measures are not codified in a generally accepted standard, for example the current work with ventilators
– There are no good filtering standards to drive constraining device streams to be usable by clinical applications
The Patient Data is Here....
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But Not Here...............
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BENEFITS ofPatient Care Device Clinical and Operations Data Acquisition
• Improved workflow
• Improved data collection
• Improved safety
• Improved patient care
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Proposed Constraints
• Principles– Avoid semantic transformation where possible; work with both nomenclatures to align terminology and
value sets with each other (include whole chunks of 11073 101101 nomenclature where possible) – needs to merge into clinical realm - a lot of work done
– This is the start of an on-going process to ensure device / clinical harmonization over time• Scope Deferred
– Use cases beyond inpatient vital signs, events and alerts– Usage with consumer devices– Usage with portable lab devices
• Environmental Goals– Obtain approval to include this standard as a gap closer in the ONC Interoperability Roadmap– Obtain approval for IEEE 11073 10101 to be recognized as an MU approved nomenclature/vocabulary Prove
acceptance of a certain set of IEEE data; Obtain approval to add an MU 3 requirements requirement for hospitals and ambulatory clinics to use this standard to obtain vital signs from medical devices, with incremental (stretch goal)
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Proposed Inpatient Use Case – ICU, Step Down, Observation, General/Surgical
Device Clinical Data (Typical)
Smart Bed Weight with Alerts
Physiologic Monitoring Vital Signs with Alerts
Pulse OximeterO2 % BldC Oximetrywith Alerts
Patient is admitted – monitors are attached:
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Nomenclature / Terminologies Used
• Device (IHE PCD Technical Framework Volume 3 – Semantic Content)– IEEE 11073 10101 Nomenclature– MDC terms
• Clinical (HL7 Implementation Guide for CDA R2: IHE Health Story Consolidation, DSTU R1.1)– LOINC (observations)– SNOMED (constraints primarily)
• Device Information Model (DIM) – how a device maps to a hierarchical, containment tree model – GMDN. MDNS assumed in use but being phased out
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HIT Detail
• Messaging– HL7 V2.6 constrained by IHE DEC PCD-01 and RTM – Device Operations– Consolidated CDA, IHE Health Story Consolidation, DSTU R1.1* - Clinical Observations
• Message Transport
– Minimum Lower Layer Protocol (MLLP) over TCP/IP – Device Operations– Web Services(REST/SOAP) - Clinical Observations
• Systems Impacted
– EHRs primarily currently– Over time: Clinical Decision Support, Population Management, Clinical Research
* FHIR impact likely
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Content Type and Direction
Type of Interaction Nomenclature – Device Side Nomenclature – Clinical Side
Device Numerics Export IEEE 11073 10101 LOINC (observations)SNOMED (constraints)
Device Waveforms Export IEEE 11073 10101 IEEE 11073 10101Device Annotations Export IEEE 11073 10101 IEEE 11073 10101
Device Events Export IEEE 11073 10101 IEEE 11073 10101
Device Alerts Export IEEE 11073 10101 IEEE 11073 10101
Configuration/Subscription Import / Retro Query Order Import from DOC to DOF
N/A ?
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Value SetsValue Sets(MU2 C-CDA) Code System – Device Side Code System – Clinical Side
Respiratory Rate ?? LOINC
Heart Rate ?? LOINC
O2 % BldC Oximetry ?? LOINC
BP Systolic ?? LOINC
BP Diastolic ?? LOINC
Body Temperature ?? LOINC
Height ?? LOINC
Height (Lying) ?? LOINC
Head Circumference ?? LOINC
Weight Measured ?? LOINC
BMI (Body Mass Index) ?? LOINC
BSA (Body Surface Area) ?? LOINC
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Vital Sign Observation Vocabulary ConstraintsConstraints (MU2 C-CDA) Device Side (MDC Term
Codes – IHE PCD Tech Framework Volume 3 Semantic Content)
Clinical Side Requirements (assume 1 instance unless otherwise noted)
Clinical Side Term Codes
classCode SHALL OBS
moodCode SHALL EVN
templateID SHALL
Id SHALL / 1 to Many
Code (vital sign result type) SHALL
Text (including link potential) SHOULD
statusCode (completed) SHALL (ActStatus) = completed
effectiveTime SHALL
value SHALL
InterpretationCode (qualifier) MAY
methodCode (qualifier) MAY
targetSiteCode (qualifier) MAY
author MAY
Encoded values come from SNOMED
UCUM used for Units of Measure yes
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Actor Definitions, Data Stores and Interactions (Key)
Existing IHE Actor
Event
NA
Document or Transaction
Data / Image / Document Repository
Trigger
Proposed IHE Actor
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IHE Actors Diagram (Current State)
Device Observation
Consumer (DOC)
Device Observation Filter
(DOF) Note – limited
implementation with infusion pumps (ex: 1 per
minute observations)
Device Observation
Reporter (DOR)
Device Observation Bridge (DOB)
PCD-02: Subscribe to PCD Data (inactive)
PCD-01: Communicate Device Data
PCD-01: Communicate Device Data
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Actor Definitions and Interactions (Initial Use Case)
Device Observation
Reporter (DOR)
Device Observation Consumer (DOC) A (EHR)
Device Observation Filter
(DOF)
Device Observation Consumer (DOC) B (CDS)
Device Observation Consumer (DOC) C
(Population Mgmt.)
Device Observation Consumer (DOC) D (Clinical Research)
Patient Records
CDS Audit Trail
Population Data
Warehouse
Clinical Research
Data Warehouse
1Configure/subscribe/query
Device Operations Repository
Device Observation
Clinical Repository
Device Observation
Bridge (DOB): mapping and
transform where necessary – (DOB)
Publish
Feed Availability / Publish Notification
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3
4
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6
7
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HL7 v2.6 messaging
C-CDA payload
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Inpatient Use Case Steps – ICU, Step Down, Observation, General/Surgical
1. Configuration for Device DOF/DOB – stream and timing scope, auto push / pull mode requirements
2. Device sends data to DOR3. DOR sends observation stream to DOF; 4. DOF filters stream to retain what is useful for retrospective work and stores filtered
stream in Device Operations Repository; minimally includes alerts in initial phase5. DOB maps clinical observations from filtered HL7 v2.6 messages to C-CDA and applies
data transformations required for LOINC and SNOMED nomenclatures6. DOB sends stream to Device Observation Clinical Repository, for storage7. Repositories a) trigger availability notification to applicable DOC or b) DOC auto pushes
depending on configuration8. DOCs query streams as appropriate
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Filtered Clinical and Device Operations Data: Avoiding Flooding
• Sample at specified intervals – EHR maintains sample data : all devices
• Intermittent example – PCA pump overdose, endangering patient: oxygen saturation: limited devices (may add or replace)
• Intermittent example – noninvasive blood pressure – clinician initiated
IHE Technical Solution
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Numerics
Waveforms
Annotations
Events
Alerts
Configuration
Commands
ISO/IEEE 11073 mapping to SNOMED and/or LOINCfor vital sign numerics
IHE PCD DEC
IHE PCD DECWCM, EC, ACM, …
Device Observation Reporters (DOR)
Network GatewaysDevice Integration Engines
Individual Devices
Device Observation Consumers (DOC)
Enterprise EMR, EHR, …1
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2
4
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IHE Technical Solution1. Enterprise gateways, device integration engines (e.g. Capsule, Iatric, iSirona, Nuvon) and
possibly individual devices send near real-time medical device data using the IHE PCD DEC Profiles (HL7 V2.6 messaging and ISO/IEEE 11073 nomenclatures. Filtering needs to be applied to meet data requirements without flooding.
2. For numeric vital signs observations, a normative mapping from ISO/IEEE 11073 to SNOMED and/or LOINC are developed (by organizations representing SNOMED and/or LOINC) and are made available on the NIST RTMMS and other nomenclature repositories. Enterprise “Device Observation Consumers” would use the normative mapping table to translate the ISO/IEEE 11073 nomenclature to SNOMED and/or LOINC.
3. Device-centric data (waveforms, events, alerts, configuration and commands) would use the ISO/IEEE 11073 nomenclature.
4. The IHE PCD DEC (Device Enterprise Communication) Technical Framework and ISO/IEEE 11073 nomenclature are recognized as “Meaningful Use” or equivalent profiles and standards for medical device data transfer to and from enterprise entities.
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HL7 / IEEE / IHE Asks from NLM/IHTSDO
• Clarification on the scope of IEEE 11073 10101 Nomenclature: US, Europe, International: where would there be interest/need regarding the work proposed?
• Clarification on the level of adoption of IEEE 11073 10101 Nomenclature: US, Europe, International?
• Any reference / contacts regarding anesthesia work harmonizing IEEE 11073 and SNOMED in the past
• List of the high-priority 100+ concepts from IEEE 11073 to be mapped to LOINC/SNOMED