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Difference between revisions of "201609 Device Integration"

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<TBD>
 
<TBD>
  
=== Scenario 4:  Patient-Device-Operator Association. Management using EHR Encounter and FDA UDI ===  
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=== Scenario 4:  Patient-Device and Device-Operator Associations and Management using FHIR Procedure, FHIR Device, and UDI ===  
  
This scenario will show how could use FHIR services to associate a patient to device(s) and t operator/nurse who configured/set up the device. The device will be identified using the UDI scanned at the point of care along the patient id wristband, and the operator's employee badge.  
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This scenario uses FHIR Procedure and Device to associate a patient to one or more device(s) and operator/nurse/physician who configured or implanted the device. The device will be identified using the UDI scanned at the point of care along the patient id wristband, and the provider's badge.  
  
The FHIR Encounter resource does not support a Device as a  participant to the encounter so we will need a profile with an extension to specify "device-involved" encounters.
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* Create a FHIR Procedure specifying the patient, the device or devices involved, and the operator (i.e. nurse, respiratory therapist, etc) or provider who configured the device, validated its configuration and initiated the procedure.
* '''Pending''': FHIR Encounter Profile that specifies one or more participating devices - identified by their UDI.
 
* Create a FHIR Encounter specifying the patient, the devices, and the operator.
 
This encounter allows the FHIR server to associate any results specified with the  
 
  
* Update the FHIR Encounter to end the association between the patient, the device, and its operator.
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* If the device is implanted, a FHIR Device resource will associate the patient with the implanted device. The Patient Device List will be created by querying the EHR using a Device.search (by patient) operation.
  
'''Note''': the FHIR Encounter does not support "Devices" as participants to encounters. A profile will be drafted to include the Device reference as an extension.
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* If the device is used monitor the patient or administer medication the procedure indicates duratiom, the associated medication order.
  
==== Vital Sign Monitoring ====
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==== Implantable Devices ====
 +
[[File:File:Patient-to-device association.png|600px|thumb|center|Patient-to-implementable Association using FHIR Device resource and FHIR Procedure]]
 +
 
 +
==== Vital Sign Monitoring Procedure ====
 
[[File:Patient-to-device -to-operator association for Vital Sign Monitoring.png|600px|thumb|center|Patient-to-device-to-operator Association using FHIR Encounter]]
 
[[File:Patient-to-device -to-operator association for Vital Sign Monitoring.png|600px|thumb|center|Patient-to-device-to-operator Association using FHIR Encounter]]
  
====  5+3 Rights of Medication Administration ====
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====  Medication Administration BCMA Procedure ====
  
 +
The 5+3 rights of of bedside computerized medication adminsitra
 
Reference: [http://www.sickkids.ca/Nursing/Education-and-learning/Nursing-Student-Orientation/module-two-clinical-care/medadmin/index.html See discussion @ www.SickKids.ca Nursing - Medication Administration]
 
Reference: [http://www.sickkids.ca/Nursing/Education-and-learning/Nursing-Student-Orientation/module-two-clinical-care/medadmin/index.html See discussion @ www.SickKids.ca Nursing - Medication Administration]
 +
  
 
[[File:Encounter and DevieMetricsObservation.png|600px|thumb|center|5+3 Rights of Medication Administration]]
 
[[File:Encounter and DevieMetricsObservation.png|600px|thumb|center|5+3 Rights of Medication Administration]]

Revision as of 23:24, 28 June 2016

Device Data Integration

The focus for this track is the exchange of information from a simple pulse oximeter to a physiological monitor to an infusion pump. Scenarios and test scripts will ensure that at least 80% of the core data elements for these device-related resources are leveraged. Data exchanged will be consistent (per resource mappings) with the ISO/IEEE 11073 standards for device semantic content. This will include integration of data that is sourced from an IEEE 11073-based Personal Health Device (PHD), as well as, communicated using the HL7 v2-based profiles supported by the IHE Patient Care Device (PCD) group.

For the 2016-09 track, device data will include physiological data ("observations"),both periodic and aperiodic, and device settings. Waveform data may be considered as a stretch goal; however, device alert information will be deferred to a subsequent FHIR connectathon.

NOTE: Subsequent FHIR connectathon tracks will include more advanced scenarios and applications, such as medication administration or CDS utilization of real-time high granularity device acquired information.

Submitting WG/Project/Implementer Group

"'Health Care Devices (DEV) WG"'

Justification

This track is intended to advance the maturity of device-related FHIR resources (i.e., Device, DeviceComponent and DeviceMetric) to FMM2 (see FHIR Maturity Model). It will test mappings for the ISO/IEEE 11073 information model, as well as the IHE Patient Care Device (PCD) profiles based on HL7 v2. This work will inform the potential development of an implementation guide for device information integration, as well as the possible definition of profiles for specific device modalities (e.g., an LVP Infusion Pump).

Proposed Track Lead

Todd Cooper
E-mail: Todd@TrustedSolutionsFoundry.com
Skype: ToddCooperAFC

Expected participants

The following organizations have indicated an interest in participating in this track:

Devices ...
Draeger (Stefan Schlicting)
Lampry Networks (Brian Reinhold)
Philips (John Rhoads)
CDS / EHR / Infrastructure ...
Bernoulli / Nuvon (John Zaleski)
Cognitive Medical & CDS Collaborators
Epic (Chris Courville)

NOTE: Other organizations are actively considering participation:

  • Pump Vendor(s)

Roles

Device Observation Reporter (DOR)

Send device acquired information to a FHIR server using the device-related resources (i.e., [Device], DeviceComponentDeviceMetric, Observation).

NOTE: This is analogous to the IHE PCD Device Enterprise Communication (DEC) profile DOR actor. Typically a device or a device "gateway" system.

Device Information Server (DIS)

Process updates from a DOR and respond to queries from a DOC.

Device Observation Consumer (DOC)

Retrieve and use device-acquired information from the DIS, e.g. for flow-charting or clinical decision support applications.

NOTE: This is analogous to the IHE PCD Device Enterprise Communication (DEC) profile DOC actor. Typically an EHR or similar information system.

Scenarios

Scenarios will leverage previous work, but will replace standardized FHIR interfaces where appropriate and feasible:

  • IHE PCD TF vol 1 / Connectathon Use Cases for DEC:
  • Case DEC-1: Communicate patient identified DEC data to EMR/EHR
  • Case DEC-2: Communicate validated periodic DEC data to EMR/EHR
  • NOTE: Additional use cases address person-device association
  • IHE PCD Showcase Examples
  • 2016 HIMSS Interop Showcase Use Case examples are (here)
  • IHE PCD Profiles demonstrated included DEC, PIV, IPEC, ACM, MEMDMC, MEMLS
  • Device modalities demonstrated included physiologic monitors, spot check monitors, infusion pumps (LVP, syringe, and PCA), surgical anesthesia system, Central Nervous System (CNS) surgical anesthesia monitor, a NICU infant warmer, and EMR systems (EHR for DEC and IPEC and orders for PIV).
  • CDS Collaborative HIMSS'16 Demo
  • See demonstration overview
  • Intent in this track would be to replace the front end with a FHIR-compliant data source (including waveforms)
  • Integrate at HL7 EPS (Event Pub/Sub) Level
  • Can include security "wrappers" at this point too if needed


Devices (anticipated) include:

  1. Physiological Monitor (including waveform capability) - Acute Care
  2. Pulse oximeter (either from a physio monitor or a Personal Health Device (PHD))
  3. Personal Health Device (PHD) - specifically non-acute care settings; mobile / tele-care
  4. Infusion Pump - LVP or PCA for acute care
  5. Gateway - as an IHE PCD DOR or integrating a FHIR server
  6. Application Hosting Device (AHD) - Personal Health Device (PHD) gateway
  7. TBD DOR from the device interface

Specific areas of capability to be targeted include:

  • Periodic reporting (a la PCD DEC) - for example, 5 minute "snapshot" updates
  • Tuned (filtered) periodic reporting - for example, only vital signs parameters
  • Async reporting - for example, spot-check monitor used by a clinician hourly
  • IHE mACM ver 2.0 for device alert reporting
  • Sync'd with the IHE PCD ACM, IEC 60601-1-8 & IEC 80001-2-5
  • From an Alert Manager (AM) to an Alert Communicator (AC) that interacts with the individual
  • Not supported will be FHIR for reporting alerts directly from a healthcare device
  • Snapshot Pull - Retrieve last reported values
  • Trended Pull - Retrieve specified set of parameters over the last 24 hours
  • Waveform - Snippet + Streaming
  • Pub/Sub Reporting (may be addressed by one of the above)
  • Person-device association [There are a number scenarios related to this topic ... see below]
  • NOTE: Patient-to-device-to-operator association could be supported by a FHIR Encounter instance - needs extensions to support a device as a participant to an encounter.
  • FDA UDI device identification [Need to synchronize with other connectathon tracks?]
  • Location tracking
  • Real-Time Location Services (RTLS) & RFID based [see IHE PCD MEM-LS profile for this]
  • Document exchange with device-sourced content
  • Time Normalization -
  • IHE CT is the foundation for all IHE Connectathon testing
  • Address how to ensure time normalization / synchronization within a device informatics use context

Desired journey from "device specializations" (e.g., infusion pump) to FHIR resource profiles:

  1. Nomenclature / terminology in NIST RTMMS =>
  2. Information model / "containment tree") in NIST DIM Editor =>
  3. XML representation (exported from DIM Editor) =>
  4. ADL representation (transformed from XML; harmonized @ CIMI) =>
  5. FHIR Resource profiles & StructureDefinition [Alternatives?] (translated from ADL)

Additional areas of alignment / harmonization (stretch goals!):

  • ISO/IEEE 11073 Semantic Representation harmonized
  • MDIDS aligned (MDPnP / OpenICE / etc.)
  • CIMI aligned (ensure device-sourced data is aligned)
  • NIST tooling leveraged (esp. if target includes an IHE connectathon)

Devices on FHIR Roadmap (near term):

  • 2016-09 FHIR Connectathon - move toward FMM2 on device-related resources + validate approach
  • 2017-01 FHIR Connectathon - add more detailed use scenarios such as medication administration "closed loop" (from Physician to Pharmacy to Clinician to Patient ... and back)
  • This will include IHE PIV and IPEC profile usage
  • Future consideration:
  • Device control (from alarm limit setting to therapeutic control parameters)
  • ...


Scenario 1: <Acute Care Reporting Scenario>

<TBD>

Scenario 2: <PHD Reporting Scenario>

<TBD>

Scenario 3: <CDS Scenario>

<TBD>

Scenario 4: Patient-Device and Device-Operator Associations and Management using FHIR Procedure, FHIR Device, and UDI

This scenario uses FHIR Procedure and Device to associate a patient to one or more device(s) and operator/nurse/physician who configured or implanted the device. The device will be identified using the UDI scanned at the point of care along the patient id wristband, and the provider's badge.

  • Create a FHIR Procedure specifying the patient, the device or devices involved, and the operator (i.e. nurse, respiratory therapist, etc) or provider who configured the device, validated its configuration and initiated the procedure.
  • If the device is implanted, a FHIR Device resource will associate the patient with the implanted device. The Patient Device List will be created by querying the EHR using a Device.search (by patient) operation.
  • If the device is used monitor the patient or administer medication the procedure indicates duratiom, the associated medication order.

Implantable Devices

File:File:Patient-to-device association.png
Patient-to-implementable Association using FHIR Device resource and FHIR Procedure

Vital Sign Monitoring Procedure

Patient-to-device-to-operator Association using FHIR Encounter

Medication Administration BCMA Procedure

The 5+3 rights of of bedside computerized medication adminsitra Reference: See discussion @ www.SickKids.ca Nursing - Medication Administration


5+3 Rights of Medication Administration

TestScript(s)

TBD - Based on evaluation of what needs to be performed to ensure the requisite 80% + coverage.