OSEHRA Medical Device Integration Adapter (MDIA) Project

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OSEHRA Medical Device
Integration Adapter
(MDIA) Project
Briefing
Medical Device Integration
Adapter (MDIA) Project
The Medical Device Integration Adapter (MDIA), Open-Source Project
group is undertaking the development of a Java-based component to
receive, process, and persist the exchange of standards-based device
measurements, using Integrating the Healthcare Enterprise (IHE) Patient
Care Devices (PCD) conformant, HL7 Version 2.7 and HL7 FHIR RESTful
services. The MDIA will provide conformance testing capability for
standards-based interoperability with OSEHRA VistA, leveraging existing
NIST test tools for IHE PCD. After initial development and testing, the
adapter will be used within a series of HI industry demonstrations and
connectathons, encompassing a variety of standards-based medical
devices. Upon completing this initial v1.0 functionality testing and
demonstration, the project scope may be expanded to address additional
functional aspects of medical device interoperability integration,
management, and tracking (e.g. FDA guidelines on Universal Device
Identifier, Medical Device Data System), identified throughout v1.0
development.
2
Overview
• Concept:
• In conjunction with VA membership in the Open Source Electronic Health Record
Alliance (OSEHRA), we will develop an Open Source VistA, Medical Device
Integration Adapter (MDIA) to enable interoperability between standards-based
Medical Devices and associated HIT system or components
• Background:
• OSEHRA (Open Source Electronic Health Records Alliance) is a community for the
development of open-source healthcare informatics
• Currently no organic VA capability to test commercial devices for interoperability
with VistA or explicit support for specific device interoperability
• Home Telehealth program experience multiple issues due to lack of rigorous testing
• Pulse Oximetry Integration was created as a new specification to support VA needs
• The VA has not participated to date in the annual IHE North American
Connectathon
• A virtual VA test platform for medical device integration would be desirable
3
MDIA Value Proposition
• 3-Point Value Proposition:
• Substantial improvement in patient safety through providing
automatic access to complete standards-based medical device
measurements (e.g. vitals, pulse oximetry), as well as device
identity from the point of care (i.e. patient-device association).
• Overall semantic interoperability improvements
• MDIA could be a first component of several intended to
enhance VistA interoperability
• Provision for 24/7 test capability of standards-based device
interoperability with OSEHRA VistA
4
Additional benefits
• Lower the cost of integration
• Fixed/low cost integration for standard-based devices
• Create a market of standard-based devices
• Promote standard-based devices by providing on-going testing and validation
• Require standard-based device interoperability
• Increase the usability of integrated device solutions
• Integrate workflow processes across from patient care  documentation  review
• Lower the cost of acquiring new devices to the VistA end-users
• New, innovative, standard-based device become more accessible to VA clinicians
• Remove vendor lock-in using customized solutions
• Develop new capabilities alongside the open-source
community
• Open Source EHR Alliance
5
MDIA Information Flow
direct or using a Device or Vendor Manager
sd Information Flow - systems only
Measured results,
abnormal flags, error
information
Vital
SignOximeter
Monitor
Pulse
Pulse Oximeter
PCD-01
Standard
Message (Device
results)
PCD-01
Pulse Oximetry
Content
Profile - Vol 3
«flow»
Device results
PulseOximetryResults
«flow»
PCD-01
PulseMessage
Oximetry
Content
Profile - Vol 3
PCD-01
Standard
(Device
results)
«flow»
Information System
VistA CPRS
Device Manager
Device Manager
Vital Signs6
Desired Future State (application enhancement)
sd Information Flows - continuous
Standards-based
Transactions
Patient
Probe
Alarm
Vendors may provide a solution
consisting of devices managed
by a single device
manager computer system.
«flow»
Pulse Oximeter
PulseOximetryResults
«flow»
PCD-01 Pulse Oximetry Content Profile - Vol 3
«flow»
Information System
Device Manager
Verification
«flow»
Verification
Verifier
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Standards-based Automatic Medical Device Results
Reporting
• Automatic Process including Clinician Validation: VistA Vitals
• Associate the device with the patient
• Start measurements
• Review measurements in VistA Vitals
or CPRS Chart
• Click the flowsheet to refresh
• Mark “in error”, if needed
Vitals Lite
Pulse
and
Device
O
reported
2Sat
Project Milestone Dates – MDIA V 1.0
• Phase I – Project Scope Definition/Charter approval
(completed)
• Phase II – Development/Testing
• Presentation at the 2015 OSEHRA Open Source Summit (29 July, 2015)
• IHE Connectathon Unit Testing (November 2015)
• IHE Connectathon, Cleveland (January 2016)
• HIMSS Interoperability Showcase, Las Vegas (February 2016)
• Optional: FHIR Connectathon, Atlanta (May, 2015)
• Deployment (starting March 2016)
• Code review and integration into OSEHRA code base and unit testing
dashboard
• March 2016 – revisit the charter and needs for v2 evolution development
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Proposed Vital Signs
Medical Device Integration Adapter Components
Medical
Device
Vital Signs
Device Manager
System
(Vendor-specific)
Transport
Support:
TCP/IP MLLP
HTTP POST
PCD-01
HL7 V 2.7
MLLP
Test id
Map
Enhanced
Adapter
VistA
Vitals
Cache DB
FileMan
dm Vital Signs
GMRV_VITAL_TYPE
FHIR (http POST)
«column»
*
RowId :VARCHAR
*PK IEN :VARCHAR = $$next^%apiSQL(...
*
NAME :VARCHAR
*
ABBREVIATION :VARCHAR
RATE :VARCHAR
NODE_1 :VARCHAR
RATE_INPUT_TRANSFORM :VARCHAR
RATE_HELP :VARCHAR
PCE_ABBREVIATION :VARCHAR
*
MASTER_ENTRY_FOR_VUID :VARCHAR
*
VUID :VARCHAR
«PK»
+
IDKeyIndex(VARCHAR)
Syntax
Support:
HL7 V2 ER7
FHIR XSD
+IDKeyIndex
(VITAL_TYPE = IEN)
«FK»
+FKey_VITAL_TYPE
GMRV_VITAL_MEASUREMENT
«column»
*
RowId :VARCHAR
*PK IEN :VARCHAR = $$next^%apiSQL(...
*
DATETIME_VITALS_TAKEN :TIMESTAMP
*FK PATIENT :VARCHAR
*FK VITAL_TYPE :VARCHAR
*
DATETIME_VITALS_ENTERED :TIMESTAMP
*FK HOSPITAL_LOCATION :VARCHAR
*FK ENTERED_BY :VARCHAR
RATE :VARCHAR
SUPPLEMENTAL_O2 :VARCHAR
ENTERED_IN_ERROR :VARCHAR
FK ERROR_ENTERED_BY :VARCHAR
«PK»
+
IDKeyIndex(VARCHAR)
«FK»
+
FKey_VITAL_TYPE(VARCHAR)
+
FKey_HOSPITAL_LOCATION(VARCHAR)
+
FKey_ENTERED_BY(VARCHAR)
+
FKey_ERROR_ENTERED_BY(VARCHAR)
+
FKey_PATIENT(VARCHAR)
GMRV_VITALS_PARAMETERS
«column»
*
RowId :VARCHAR
*PK IEN :VARCHAR = $$next^%apiSQL(...
*
NAME :VARCHAR
QUICK_ORDER_PROTOCOL_COUNTER :NUMERIC
GMRV_INITIALIZATION_SWITCH :NUMERIC
STOP_DATE_DEFAULT :NUMERIC
CANCEL_ON_WARD_TRANSFER :VARCHAR
CANCEL_ON_SERVICE_TRANSFER :VARCHAR
*
ABNORMAL_TEMPERATURE__HIGH :NUMERIC
*
ABNORMAL_TEMPERATURE__LOW :NUMERIC
*
ABNORMAL_PULSE__HIGH :NUMERIC
ABNORMAL_PULSE__LOW :NUMERIC
ABNORMAL_RESPIRATION__HIGH :NUMERIC
ABNORMAL_RESPIRATION__LOW :NUMERIC
ABNORMAL_SYSTOLIC__HIGH :NUMERIC
ABNORMAL_DIASTOLIC__HIGH :NUMERIC
ABNORMAL_SYSTOLIC__LOW :NUMERIC
ABNORMAL_DIASTOLIC__LOW :NUMERIC
*
ABNORMAL_CVP__HIGH :NUMERIC
*
ABNORMAL_CVP__LOW :NUMERIC
*
ABNORMAL_O2_SATURATION__LOW :NUMERIC
PHASE_I_COMPLETED :VARCHAR
PHASE_II_COMPLETED :VARCHAR
PHASE_II_LAST_RECORD :NUMERIC
«PK»
+
IDKeyIndex(VARCHAR)
Medical Device Integration Adapter Requirements
• Enhancements to the input data stream
• Add FHIR resource creation support
• Support for HTTP listener in addition to TCP/IP listener
• Optional, if available – reuse FHIR Patient resource for patient identity lookup
(generic capability, reusable by other adapters)
• Mapping test identifiers for vitals, not only Pulse Oximetry
• Enhanced data persistence
• Add support for FileMan RPC for persistence
• Define algorithm for data sampling (new Open-source VistA application
update)
• Based on relevant data changes (significant vitals changes)
• Based on relevant sampling intervals (e.g. every minute, every 5 minutes)
• Validation for medical record keeping
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Medical Device Integration Adapter Requirements
• Allows standards-based devices to interoperate with VistA/Open-Source VistA
• Lowers the cost for VA to acquire standard-based based devices
• Provides a 24/7 testing solution for third-party medical device vendors
• Allowsclinicians improved use of medical device measurements
• Eliminates the human burden and error of manually entered results
• Support validation/verification of measurements acquired from
devices and elimination of “artifacts”
• Improves patient safety
• Supports patient-to-device association
• Future enhancements are possible to bring patient identity validation
to the point-of-care
• Eliminates erroneous assignment of medical device measurement to a
patient record (i.e. currently one patient’s chart could be corrupted
with results intended for another patient)
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Follow up
• Weekly call on Wed @ 11 am EST – updates the MDIA project blog:
• http://www.osehra.org/groups/medical-device-integration-adapter
• Issues
• http://issues.osehra.org/browse/MDIA/
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