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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

5

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