1. Medical Device Integration with an Ambulatory EMR
HIMSS 2010
Fred D. Rachman, MD

2. Conflict of Interest Disclosure
Fred D Rachman, MD
has no real or apparent
conflicts of interest to report.
I have no significant conflicts of interest to support.

3. Interconnecting Devices and the EMR
Medical Device Interoperability includes two distinct aspects:
1. Bi-directional data communication capability to support complete and accurate data acquisition between an EHR/EMR and devices Medical device control capability to permit the integration of distributed medical devices to produce “error-resistant” systems.
Our discussion will focus on the first of these aspects, although the functionalities and considerations are related and overlapping.

4. Why Connect Devices to an EMR?
Improved Data Access
Reduced Errors
Improved Workflow
Device Data Capture
Improved Workflow
Eliminate manual and paper recording of diagnostic testing
Streamline efficiency & workflow
Reduced Errors
Reduction in lost results
Reduction in transcription errors
Reduction in patient ID errors
Reduction in “missed opportunities”
Why connect devices to an EMR?
Connection of Medical Devices to an EMR have ability to impact care in three dimensions: Efficiency, Safety and Access to Data.
Integratin of the EMR can improve workflow efficiency, eliminate manual and paper recording, and eliminated data entry.
In some studies, % of all transcribed test results were found to be errant. Integration and seamles capture can reduce patient ID and other transcription errors, lost results, and through automation of workflow decrease the likelihood that tests will not be performed.
Improved data capture results in more immediate availabilty of results, and captures of data elements not previously available. Comprehensive data acquisition will also enable the development of advanced clinical decision support systems, intelligent alerts, collection of observations from remote patient locations and robust databases for Continuous Quality Improvement.
Improved Data Access
Immediate enterprise-wide access to results data
Capture of elements not previously available
Improve documentation filing and reporting for regulatory/malpractice

5. Current State Devices developed in isolation
Lack of adherence to cross-vendor standards
Custom interfaces needed
Scarcity of well-defined use cases
Primary experience in Hospital settings
Currently, medical devices operate largely independently of each other and from Electronic Health Records
Medical devices are developed around individual clinical needs, by different manufacturers, and in absence of uniform standards to which they conform.
Clinicians and Health Care organizations make choices of devices based upon their individual capabilities, and have not generally considered interoperability in the selection process.
This is even true of Health Centers and Health Centers purchasing equipment in the context of implementation of operation of an EMR.
A scan of the literature reveals a paucity of well defined use cases or evaluation, these are largely in the Hospital setting; this both reflects and contributes to the current state of medical device integration

6. Challenges Getting data into the proper data fields is laborious
Often many parameters exist for different types of data
Example: blood pressure data taken with different body positions
Disparate data sources with different clinical value
Example: heart rate from an ECG and heart rate from a pulse oximeter; often a clinician needs to make the decision
There are inherent challenges in trying to define uniform data capture strategies.
Mapping data from devices requires a laborious process of categorizing the data, and mapping the parts of the record and fields into which they should be imported.
Single observations may need to be expanded to include different data elements to place them in the correct clinical context. Furthermore, devices utilizing different capture methods for the same clinical observation may provide conflicting values requiring clinical interpretation and reconciliation.

7. Efforts to promote increasing interoperability of Medical Devices with each other and with EMRs
Consumer driven initiatives to promote medical device interoperability
Vendor efforts to promote ability of EMR to integrate with Medical Devices
Use cases to drive ROI
There are several efforts to mobilize key stakeholders to realize the potential of medical device integration.
Some examples of these efforts include a vendor initiated effort to promote interoperability with EMRs, and a consumer driven initiative to promote interoperability.
Use case demonstration/evaluations such as the one we will describe in this presentation are another strategy to understand barriers and benefits and promote further investment by both vendors and consumers.

8. Medical Device Plug and Play Program (MDPnP)
Promotes standards based interoperability of Medical Devices to
create error-resistant medical systems,
support the widespread use of data obtained from medical devices,
improve clinical workflow to enhance patient safety and reduce healthcare costs, and
produce complete and accurate electronic health records for clinical care and research
enable the development of a medical grade network for high-acuity health care
Founding HCOs: Massachusetts General Hospital Partners HealthCare System, Inc. Kaiser Permanente  Johns Hopkins Medicine 
The Medical Device Plug and Play Programs (MDPnP) is a joint effort by Massachusetts General Hospital, Partners HealthCare System, Inc, Kaiser Permanente and Johns Hopkins.
MDPnP promotes medical device interoperability and connection with EMRs in order to:
create error-resistant medical systems,
support the widespread use of data obtained from medical devices,
improve clinical workflow to enhance patient safety and reduce healthcare costs, and
produce complete and accurate electronic health records for clinical care and research
enable the development of a medical grade network for high-acuity health care
The emphasis of the program in both on interoperability of the medical devices themselves to promote ability to integrate information among the devices for care delivery as well as two way capture of information between the devices and an EMR.
The effort includes a white paper, “ Medical Device "Free Interoperability Requirements for the Enterprise" on use cases and standards considerations, and sample RFP/ contracting language to be used vendor negotiations. The focus is primarily on hospital based devices, and largely for the acute care setting.

9. Vendor Certification
Vendors that are certified have had their EHRs successfully tested for connectivity to a set of commonly used devices in the Ambulatory setting.
Objectives:
1) To establish superior functionality and service standards for device connectivity 2) To improve the customer experience when installing and operating a connected device with software from a certified EHR partner
A vendor based initiative undertaken by a medical device manufacturer established an EMR certification program to simplify the process for EMR purchasers to evaluate options for medical device integration in their decision making, to motivate EMR vendors to improve software functionality to promote integration, and to drive standards in the field.

10. Minimum requirements to receive Certification
2006 and/or 2007 CCHIT certification
At least 300 installed customer sites
Independently verified completion of connectivity testing
Commitment to implementation and technical support coordination with device manufacturer to improve implementation and service for connected devices 
Certification requirements include CCHIT certification, sufficient customer experience, completion of connectivity testing and evidence of commitment to continued improvement.

11. Certified Devices Spot Vital signs equipment Vital Signs monitor
PC Based resting and stress ECG
PC Based Spirometer
The scope of certification currently covers devices are commonly used ambulatory care devices producing quantitative values.
These include spot vital signs equipments, resting and stress ECG, and PC Based Spirometer.

12. Future devices Digital Otoscope Digital Stethoscope
Rapid vision screening device
Intent is for certification to expand to devices capturing other types of observatiosn including auditory and visual.

13. Use cases Drive ROI on both Vendor and Consumer sides
Largely focused in Hospital Settings
Have focused largely on patient safety on cost
Need for use cases in the ambulatory setting
Further investment by device manufacturers, consumers and EMR vendors will likely be driven by more concrete demonstrations of value and return on investment.
As noted above to date these demonstrations have resided largely in the hospital and acute care settings. Certainly there are dramatic gains in safety, quality and efficiency to be realized in these settings. There are equally significant gains to be demonstrated in the Ambulatory sector.
We will briefly describe a use case demonstration being undertaken in a primary care ambulatory setting.

14. Advantages of HIT data
Ability to aggregate and correlate data for evaluation of impact of medical devices and services in terms of other process and outcome measures
Efficiencies
Reductions in errors
Reductions in needed referrals and tests
Outcomes and quality measures
Integration of Medical Devices has advantages not only in the areas described above, but in terms of evaluating the impact of the devices themselves. This allows practices to assess the return on investment in particular devices in terms of cost, quality and outcomes

15. Medical Device Integration Project
Collaboration between a Medical Device manufacturer and an ambulatory Health Care organization to:
Establish measures for quality and efficiency gains
Collect baseline data
Integrate selected devices with Electronic Health Record
Demonstrate gains.
Promote new uses for integrated devices in the ambulatory care setting.
The Medical Devce Integration is undertaken in partnership between a Medical Device manufacturer (Welch Allyn) and a well organized national collaboration of Safety Net health care organizations sharing a common electronic health record and related infrastructure (the Alliance of Chicago Community Health Services).
The goals of the project are to:
Establish measures for quality and efficiency gains
Collect baseline data
Integrate selected devices with Electronic Health Record
Demonstrate gains.
Promote new uses for integrated devices in the ambulatory care setting.

16. History and Mission of Community Health Centers
first funded by the Federal Government as part of the War on Poverty in the mid-1960s.
designed to provide accessible, affordable personal health care services for people living in medically underserved communities
Mission encompasses quality, access, and responsiveness to particular needs of the community served.
Typical services include primary care (Including Pediatrics, Internal Medicine, OB/GYN, and Family Practice), dental, behavioral health, nutrition, case management and health education.
Community Health Centers form an important part of the Nation’s safety net, providing services to individuals who otherwise might not receive care due to economic, geographic, cultural, linguistic and other barriers.
By legislation, Community Health Centers are private not for profit entities serving a designated community, governed by members of the community and users of services. The Community Health Centers provide a comprehensive set of primary care and related services designed to meet the needs of patients and responsive to particular needs of the community they serve. Typically these services include Pediatrics, Internal Medicine, OB/GYN and Family practice, dental, behavioral health, case management and social services, health education, Services include preventive care, management of chronic diseases and acute conditions, coordination of subspecialty services and coordination of inpatient care.

17. Facts about Community Health Centers
Nearly 1,100 health center grant recipients operate more than 7,000 community-based clinics
One of every 19 people living in the U.S. now relies on a HRSA-funded clinic for primary care.
HRSA-supported health centers treated more than 16 million people in 2008.
Nearly forty percent of patients treated have no health insurance and one-third are children
Community Health Centers represent a signficant, highly organized network of ambulatory care. In the most recent reported statistics, there are nearly 1100 federally funded Community Health Centers nationally, operating more than 7000 service delivery sites. Together these sites provide comprehensive primary care to more than 5% of the population of the U.S., over forty percent of whom have not insurance.
Despite the fact that many Community Health Center patients cannot afford the cost of care, Community Health Centers have managed to provide high quality health care as demonstrated through performance on national measures. Working with limited resources Health Centers have been focuses on efficiency and concentration on effective interventions.

18. Alliance of Community Health Services Overview
HRSA funded Health Center Controlled Network founded by 4 Federally funded Health Centers located on the Near North Side of Chicago
Aim is to provide infrastructure through which Centers can share services at higher quality and lower cost.
Emphasis on shared Health information technology platform
Implementation and support of a common, centrally hosted EHR with integrated decision support and performance measures
The Alliance supports a centrally hosted EHRS shared by 24 Health Centers in 8 States.
Recognizing that the model of promoting relatively small, community responsive Health Centers is at odds with Health System forces driving consolidation into large health care systems, the Health Resources Services Administration who funds the Health Centers created the Health Center Controlled Networks (HCCN) Initiative. HCCNs represent an infrastructure in which groups of Health Centers can share infrastructure while maintaining autonomy. The Alliance of Chicago Community Health Services represents a successful HCCN.
In support of improving quality and access, the Alliance operates a common, centrally hosted EHR shared by a 24 Safety Net Health Center in 8 States. Emphasis is on incorporating all elements of Community Health Center services, and implementation of advanced functionality including clinical decision support and performance reporting on national performance measures. The Alliance is a vehicle not only to support the centrally hosted EMR, but to promote adoption of emerging health information technologies in ways to enhance care delivery and services for the Safety Net populations served.

19. Health Centers at the Forefront of Quality and Health Information Technology
Comprehensive model of comprehensive primary care predating Medical Home concept
Long history of formal chronic disease management, evidence based practice and reporting on national measures.
Federal investment Health Center Controlled Network model to support adoption of HIT has resulted in examples of advanced use and resembles REC strategy of ONC
Focus on quality while respecting limitations in resources have led Health Centers to explore strategies to promote efficiciency
Several factors have allowed Community Health Centrs to be at the forefront of Heatlh Information Technology adoption.
First, the Centers operate from a comprehensive primary care model. Reflecting key aspects of the medical home concept, the model had focused Health Centers on goals of comprehensive HIT use. Through a national chronic disease management intitiative, the Health Disparities Collaboratives, the Health Centers have experience in utilizing patient registries, implementing evidence based practice recommendations and tracking and reporting on a common set of performance measures.
The Federal investment in helping Community Health Centers implement HIT has been through collaborative efforts of the HCCNs. This has allowed rapid advancement through sharing of experience, resources and best practices. The Regional Extension Center program shares many features of this approach.
Finally, the focus of Heatlh Centers on delivering high quality services with limited resources has led Health Centers to focus on quality and efficiency in HIT implementations.
Long history of formal chronic disease management, evidence based practice and reporting on national measures.
Federal investment Health Center Controlled Network model to support adoption of HIT has resulted in examples of advanced use and resembles REC strategy of ONC
Focus on quality while respecting limitations in resources have led Health Centers to explore strategies to promote efficiciency

20. Common Medical Equipment Used in Health Centers
Eye, Ear, Nose & Throat
Stethoscopes
Blood Pressure Management
Cardiopulmonary
Thermometry
Monitoring
Women’s Health
Radiology
Endoscopy
The list of commonly used medical equipment in Community Health Centers reflects the primary care services delivered.
Equipment includes ophthalmoscopes, otoscopes, audiometers, tympanometers, vision testing equipment, ultrasound equpment, culposcopy and endocsopy equipment

21. Drivers for Medical Device Integration in the Ambulatory Setting.
Improve efficiency of patient flow
Reduce errors
Capture information to facilitate new opportunities for care delivery
Capture observations to enable clinical decision support
Facilitate aspects of Meaningful Use
The drivers for medical device integration in the ambulatory setting are the same as those decribed above, with particular emphasis on aspects relevant to primary care. Furthermore, integration of medical device equipment can expand options for care delivery models, facilitate clinical decision support, and relate to apsects of meaningful use of HIT.

22. Categories of Benefits from Device Integration.
More efficient capture of information, with reduction in error
eg, integrated Vital Sign Device
Capture of data elements not easily captured previously for decision support
eg, EKG, QT intervals used for decision support around medications
Ability to share data for new patterns of service delivery
eg, digital stethoscope, used for remote consultation, comparison of observations over time
The Medical Device integration project focuses on devices to illustrate use cases in three categoriesL
More efficient capture of information, with reduction in error
eg, integrated Vital Sign Device
Capture of data elements not easily captured previously for decision support
eg, EKG, QT intervals used for decision support around medications
Ability to share data for new patterns of service delivery
eg, digital stethoscope, used for remote consultation, comparison of observations over time

23. Electronic Vitals Connectivity
Electronic vital signs data is integrated directly into the EHR vitals template with one-click data collection and transfer
Parameters
NIBP, Thermometry, SpO2, Heart Rate
Connected (integrated)
Data transfer via IR RS-232, USB, and/or RS-232 cables
Our Electronic Vitals Portfolio
Through the project, vital signs equipment is integrated with the EMR to import blood pressure, heart rate, temperature and pO2 directly into the record.

24. Connecting Cardiopulmonary Devices
Provide bi-directional exchange of information between the EHR system and cardiopulmonary device software
EKG data integration is bidiredtional. Utilizing a streamlined, bi-directional interface, patient demographic data is pulled instantly from the EMR prior to running the EKGdiagnostic test. The test results are then automatically transferred directly into the patient record.

25. Cardiology Workstation Solution
The EKG/ spirometer equipment selected makes it possible to retrieve and edit cardiopulmonary diagnostic tests on the computer screen. Electronic reporting and analytic features simplify the diagnostic test capture and clinical interpretation process. Since the test data is electronic, test reports can be ed or e-faxed directly to partner MD groups for consultation, and are imported directly into the EMR as discrete data.
Retrieve records with keystroke and on the screen edit
Access information remotely
Fax or reports directly
Connect to EHR to streamline diagnostic testing workflow

26. Digital Otoscope and Stethoscope
Digital otoscope and stethoscopes make it possible to capture visual and sound images as files for incorporation into the EMR.
These files can be reviewed by different clinical providers, or can be reviewed by the same provider to compare observations over time.
Visual files can also be shared with patients.
Digital otoscope can capture a still photographic image which can be incorporated into a patient chart in the EMR. Similarly, the a sound recording from the digital stethoscope can be stored for playback through the EMR.
These files can be reviewed by different clinical providers, making new patterns of consultation possible even between care delivery sites. This is of key significance for Health Centers sites in remote locations, or where consultation among disciplines is desirable. Furthermore, since observations are stored, they can be reviewed by the same provider to compare observations over time, and/or promote continuity where patients must be seen by different providers for follow up visits.
Finally, the ability to store visual files in the EMR makes it possible to share images with patients, promoting patient engagement and education.

27. Measures Vital Signs EKG Digital Otoscope Spirometer
Improved Accuracy completeness of data capture
Improved workflow efficiency
Opportunity for improved quality patient service
Improved data Capture for clinical decision support
New Data Capture for clinical decision support/ patient service
Following from the functionalities of the equipment selected, the integration project eavluation focuses on measures appropriate to expected impact.

28. Challenges Encountered
Technical challenges in establishing interface
Design of appropriate data collection forms in EMR.
Changes in workflow required
Signficant challenges encountered included:
Technical challenges in establishing the interface. These were complicated by the fact that the application is centrally hosted and delivered through Citrix, and that the deployment model is thin client.
Design of appropriate data collection forms in the EMR. Collection of the observations through the equipment changed the pattern and workflow of collection, often in a site specific way. This together with need to designate descriptions for some observations such as serial or positional blood pressures, created need for revisions in the end user screens. Proprietary technology meant involvement of a particular vendor in design and modification of these forms. The net effect was a loss of control over the design of he end user screen, with attendant cost and time implications.
Most significant were workflow implications. In particular, the requirement that some equipment be tethered to particular workstations limited flexibility on where certain care processes could be performed.

29. Preliminary Findings High level of staff and patient satisfaction
Improved efficiency of recording data
Overall improvement in accuracy and reduction of errors, however potential for new types of errors may be introduced.
Data was collected before and after introduction of the integrated devices. Data included both objective and subjective data. Preliminary results from initial pilot sites indicated:
High level of staff and patient satisfaction
Improved efficiency of recording data
Overall improvement in accuracy and reduction of errors, however potential for new types of errors may be introduced.

30. How Medical Device Integration Fits with Meaningful Use
Promotes quality and safety
Provides structured data for performance measurement and clinical decision support
Health information exchange capacity
Telemedicine
Can support patient engagement
Integration of medical devices has significance in light of current and emerging concepts of meaningful use of technology.
These include improved quality and safety, improved accuracy, availability and scope of information for clinical decision support, performance measurement and health information exchange, telemedicine applications, and new opportunities for patient engagement.

31. Promises and Challenges of the Future
Wireless Connectivity and Mobility
Expanded devices
Telemedicine and home based services capabilities.
Increased automation of clinical decision support
New challenges with wireless mobile devices and remote data collection:
associating devices to a verified patient identifier
theft
Our discussion ends with contemplation of future opportunities through medical device integration.
This includes improvement in mobility of connected devices, expanded types of devices, and deployment in remote sites.
As in the acute care setting, potential linkage of set parameters to active decision support may improve safety and quality of care and prompt more timely and appropriate interpretation of values and clinical response.

32. Questions and Discussion