1. The World of Connectivity – Building a Strategy to Support Medical Device Integration and Alarm Management
Presented by
Izabella Gieras, MS, MBA, CCE Jennifer Jackson, MBA, CCE
Huntington Memorial Hospital Cedars-Sinai Medical Center
October 23, 2015

2. Huntington Hospital
Courtesy of Huntington Hospital

3. Huntington Hospital 625 licensed beds Bariatric & Stroke Center
Magnet Recognition
3 Davinci Robotic Systems
18 Operating Rooms (4 MIS suites)
Skills Labs
5 Cath Labs & IR Suites
9000 medical devices
280 applications
450 servers with 200+ TB storage
1000+ wireless access points
4500+ end user computing devices
300+ hospital owned smart phones
60 Clinical & Information Technology employees
Courtesy of Huntington Hospital

4. Agenda Background Healthcare Environment
Healthcare Technology Management at Huntington Hospital & Cedars-Sinai Health System
Medical Device Integration
Alarm Management

5. Background

6. Healthcare Environment
Regulatory Requirements
Patient Environment

7. Healthcare Technology Management Medical Device Integration

8. Medical Device Integration
Connectivity – the physical interconnections between medical devices, the network, and the hardware and software required to capture data and make it available for use in the Electronic Health Record (EHR) or other clinical applications.

9. ECRI Institute Top 10 Health Technology Hazards
Alarm Hazards: Inadequate Alarm Configuration Policies and
Practices
Data Integrity: Incorrect or Missing Data in EHRs and Other
Health IT Systems
IT systems

10. AAMI Survey 2012
Survey of healthcare technology management professionals in 1,900 different U.S. hospitals placed interoperability issues top of the list
AAMI’s list of Top 10 Medical Device Challenges:
Medical devices and systems on the IT network (cited by 72 % of
respondents)
• Integrating device data into electronic health records (EHRs)
(cited by 65 % of respondents)

11. WHI (West Health Institute) Report
Improving interoperability between medical devices and EHRs in hospitals could save more than $30 billion a year while improving patient care and safety.
Increased capacity for treatment as a result of shorter lengths of stay ($18 billion)
Increased clinician productivity because of less time spent entering device data manually into EHRs ($12 billion)
Avoidance of redundant testing ($3 billion)
Reduction of adverse events ($2 billion).
Ken Terry | March 22, :15 PM , Medical Device, EHR Integration Could Save $30B: Study
Medical Device, EHR Integration Could Save $30B: Study, Information Week healthcare

12. WHI Report continued
More than 90% of hospitals use six or more types of devices that could be integrated with EHRs.
Examples: patient monitors, defibrillators, ECG machines, vital sign monitors, ventilators and infusion pumps.
Yet only a third of hospitals integrate any medical devices with EHRs, and those that do, on average, integrate only three types of devices.
The cost of medical device integration can range from $6,500 to $10,000 per bed in one-time costs, plus up to 15% of that in annual maintenance costs.
Ken Terry | March 22, :15 PM , Medical Device, EHR Integration Could Save $30B: Study
Medical Device, EHR Integration Could Save $30B: Study, Information Week healthcare

13. Business Case for Huntington Hospital
Huntington’s EHR Implementation Vision Statement
A clinical and operationally focused implementation that will integrate business and clinical information systems to support the goal of using technology to improve quality, patient safety, productivity and physician alignment.
Past and Present
What is being done with Meditech
Why did we move to Cerner?
Most hospital executives said improving clinical outcomes and efficiency improvements were the primary drivers for investing in an MDI solution.

14. Business Case for Huntington Hospital continued
Huntington’s EHR Partner Philosophy Create an environment where all devices are integrated and contextually aware to ensure the right data is present in the right format at the right time to improve health outcomes. Across the care continuum, medical devices contain life-critical information. It is essential for health care providers and patients to harness this information to make the best decisions regarding health.

15. Huntington Hospital Timeline
6/2012 – 2/2014
Implementation
2/2014 – 3/2014
Readiness & Go Live
3/2014 – 6/2014
Stabilization
6/ Today
Optimization
Beyond Today

16. Implementation

17. EHR Implementation Scope
6/2012–2/2014
Full EHR Implementation
40+ solutions
Financial ERP
Revenue Cycle
Clinical
Physician
Complete workflow re-design with new functionality
House-wide CPOE & Physician Documentation
Bar-coded Medication Administration
Device Integration expansion (from ~30 to 200 beds)
Imaging Voice Recognition
Patient Portal

18. Device Integration Scope
Wired and Wireless Physiological Monitors
PICU: 8
CCU: 30
Surgery:19
PACU:17
ED:56
Telemetry: 43
Endo:3
Anesthesia Gas Machines
Main Surgery: 16
L&D: 3
Endo:1
Angio: 1
Cath Lab: 1
Fetal Monitors: 30
Implementation
6/2012–2/2014

19. Device Integration Considerations
Clinical needs assessment
Device types
Wireless vs Wired
Software version
Age of equipment
Physical location
Type of mounts
Position
Implementation
6/2012–2/2014

20. EMR Device Setup Datalux device (workstation) CE (Connectivity
6/2012–2/2014
Implementation
Datalux device
(workstation)
CE (Connectivity
Engine) device

21. Device Integration Validation
Liaison with the Anesthesiologists and clinicians
Device Validation Tool
Spreadsheet with collected data to enable repeatability
Test every device and every data element
Schedule for testing
Overnight or early hours in Surgery
CE device and adapter tweaking
Testing workstation
Cheat sheet binder
Close collaboration between CT (Clinical Technology), IT and end users
Implementation
6/2012–2/2014

22. Testing Station in CT
Implementation
6/2012–2/2014

23. Device Integration Validation
Implementation
6/2012–2/2014

24. Readiness & GO Live

25. Go Live Readiness End user training Completion of Final Testing
2/2014 – 3/2014
Readiness & Go Live
End user training
Completion of Final Testing
Mock Go Lives and Detailed Walk through of Cutover
Multiple layers of Readiness Assessments
Departmental Leader Readiness Assessment
Go No Go Decision
Steering Committee
Board

26. Downtime the Night of Go Live
Downtime was scheduled for 2 ½ hours
Downtime was actually 6 ½ hours due to issues encountered
EHR Login issue
PACS & Pyxis Conversion
2/2014 – 3/2014
Readiness & Go Live

27. Communication Plan
Posters, Memo, and Tray liners (Patients & Visitors)
Team Shirts – Teal (staff) and Grey (physician)
Shift Change Meetings (Super users & Technical Staff)
Leadership Touch base
Regular Project Newsletter
Daily Reminders to Staff
SharePoint Communication site
Hot Sheets – Color Coded by Discipline
2/2014 – 3/2014
Readiness & Go Live

28. Stabilization

29. Stabilization Clinical Technology support
Proper training to all CT staff
Sign off before go live
Service work flow
Response time
Logging calls
Collaboration between IT, Nursing Informatics and end users
Spare par level
Configured datalux device
Downtime procedures
3/2014 – 6/2014
Stabilization

30. Service Workflow
3/2014 – 6/2014
Stabilization

31. Optimization

32. Optimization
Evaluating capability for integration for all new Clinical Technology purchases
Questions added for the procurement of equipment
Assessment of available applications from EMR vendor for overall consolidation
Upgrades every months
6/ Today
Optimization

33. BEYOND TODAY

34. Updated Timeline Beyond Today Alarm Mgmt -Implementation
Early Pilot
Wired CCU Monitors
Strategy & Phase I
Wired & Wireless Monitors (Critical Care Areas)
Anesthesia Gas Machines
Fetal Monitors
Blood Gas Analyzers
Lab Instruments
Point of Care
Phase I optimization
2015
Expand Wired &Wireless Monitors
Vents
Planning for Future
2015 
Pumps
Balloon Pumps
EKG Machines
Vital Sign Monitors
Other Devices?
Alarm Mgmt -Implementation
Alarm Mgmt - Building the Foundation

35. HEALTHCARE TECHNOLOGY MANAGEMENT
IN ALARM MANAGEMENT

36. Alarm Mgmt – Building the Foundation and Beyond

37. What Huntington Has Done
2003
- Committee was formed in response to the initial TJC SEA on Clinical Alarms
2013
- Formation of Clinical Alarms Management Committee
2014
- Alarms survey
- Preliminary data collection (labor intensive process)
Invited “middleware” vendors for presentations to evaluate strengths and shortcomings of each system
Evaluated medical equipment inventory with clinical alarms
Invited to the AAMI National Alarms Coalition

38. What Huntington Has Done cont.
2015 (completed and in progress)
- Changed alarm settings on two nursing units (case study)
- Defined critical equipment with critical alarms
- Completed a Risk Assessment tool on critical equipment
- Reviewed alarm settings for each critical equipment
Performed a short alarm management model survey
Update the hospital policy (addressed many 2016 deliverables)
- Upgrade of all central stations/servers to PicIx
Evaluate a middleware vendor for alarm management solutions
Create and deploy educational initiatives
Prioritized technologies (monitors, vents, infusion pups, etc)

39. Updated alarm default settings
Rhythm
Default
Recommended Change
Asystole
4 seconds (adjustable)
None
VTach
Rate >150 > 3 PVCS
Rhythm
Default
Recommended Change
Non Sustained VT On
Off
Ventricular Rhythm
On, >14 PVCS
On >20 PVCS
Run PVCs
On, > 2 PVCs (not adjustable)
Pair PVCs
R on T PVCs
Ventricular Bigeminy
Ventricular Trigeminy
PVCs
On, >10/minute
Multiform PVCs
Pacer Not Capture
Pacer Not Pace
Missed Beat
Pause
2 seconds
None
SVT
On, > 150/minute, > 5 SVBs
AFib
Irregular HR
Cannot Analyze ECG
Courtesy of Huntington Hospital

40. Thank you! Izabella Gieras, MS, MBA, CCE Director, Clinical Technology

41. Jennifer Jackson: Introduction
Biomedical Engineer
Clinical Engineer
Hospital CE-IT Leader
Medical Device Interoperability Advocate
ACCE 2015 Professional Achievement in Technology Award/Professional Development Award
CIMIT Edward M. Kennedy Award for Health Care Innovation in 2007 as member of the Medical Device “PnP” Interoperability Team

42. Cedars Sinai: Leading the Quest
Established in 1902, Cedars-Sinai Medical Center is renowned for:
Providing the highest quality patient care
Expanding scientific and medical knowledge through research that benefits patients
Educating healthcare professionals for the future
Improving the health status of the community

43. Overview of Cedars Sinai
Established in 1902 and located in Los Angeles, California
By the Numbers, from our Community Report:
886 licensed beds, Level I Trauma Center
251,803 Patient days
Approximately 690 per day
630,269 Outpatient visits
Approximately 1730 per day
85,305 Emergency Department visits
Approximately 235 per day
$43.4 million in research funding from NIH and other federal sources
$652.6 million in total quantifiable community benefits, including the unreimbursed cost of caring for Medicare patients
Primary service area includes 3.3 million people

44. Cedars Sinai: Not All Our Heroes Practice Medicine
From the HIMSS Analytics Press Release:
"Cedars-Sinai is one of the most fully deployed and automated facilities we have encountered in the HIMSS Analytics Stage 7 program. With all of their progress on device integration, including fully integrated smart pumps, Cedars-Sinai has approached a new level of patient safety, even among stage 7 facilities.”
-John Hoyt, executive vice president of HIMSS Analytics

45. CEDI Mission Statement
In close collaboration with clinicians, administrators, and other technology groups, Clinical Engineering and Device Integration (CEDI) promotes quality patient care through the appropriate and safe use of medical device technology.
Clinical Engineering and Anesthesiologists meeting to discuss the hardware mounting related to CS-Link Anesthesia Record implementation.
We strive to be a center of excellence for innovative and robust solutions that promote leadership in delivering healthcare related services.
Clinical Engineering and nursing working together to plan out unit closures for the nurse call replacement.

46. The Clinical Engineering & Device Integration Team
Biomedical Equipment Technicians
Image Guided Systems Technicians
Clinical Systems Specialists
Clinical Systems Engineers
Project Specialists
Administrative Staff

47. What Makes Us Different in the way we manage medical device systems
Unique organizational structure Independent department within IT Work side-by-side with applications and technical teams Unique job roles Image Guided Systems Technicians Much more clinical than a ‘typical’ BMET, working side by side with surgeon during procedures to ensure the technology is properly aligned and functioning Clinical Systems Specialists Stronger IT skill set than a ‘typical’ BMET More of the technical lifecycle within one department Building device records in the EHR Testing and maintaining orders/results interfaces Project management Technical support System optimization

48. Reporting up into IT…and we are thriving…
CIO
Manager EIS Finance
Chief Technology Officer
Servers, SAN
Security
Network
Mobile device team
Director, Clinical Engineering
Device Integration
Clinical Communication
Nurse Call/RTLS
Clinical Engineering
OR Clinical Engineering
Chief Application Officer
EPIC Application support
PACS/VNA
Director, R&D
Wearables integration
Systems Integration
New technology evaluation
Director, Research Computing
IRB collaboration
Director, Business Systems
CMMS
Peoplesoft
clinical and operational benefits of technology interoperability,

49. Snapshot of CSMC Medical Device Connectivity
Infusion Pumps
1523 Infusion pump brains wirelessly communicate
Within infusion pump system: used to push datasets and download logs
With EHR: bidirectional interface; order goes to pump, flow rate and volume goes to patient chart
Patient Monitoring
~255 telemetry patients’ data imported to EHR (288 max – will increase in 2016)
690 multi-parameter monitoring devices imported to EHR
120 terminal servers in critical care areas for connection to ventilators, urimeters, CCO monitors, BIS monitors, etc..
85 anesthesia machine ‘systems’
Mobile vital signs collection – data validated instantly
Currently trialing wireless pulse oximetry devices with integration to alarm management and EHR

50. Snapshot of CSMC Medical Device Connectivity
Cardiology
35 EKG carts are wireless
Orders/results for cath lab hemodynamic systems
Ambulatory blood pressure system integrated (PDF report uploaded)
Pacemaker reporting system integrated (PDF report uploaded)
Fetal monitoring
24 Fetal monitors (LDR + Prenatal Clinic) interfaced with fetal monitoring system, then to EHR
Additional integration with smartphone application for near-real time remote monitoring
Alarms/Alerts
Nurse Call alarms/patient requests– sent to smartphones
Pulse Oximetry and some cardiac monitoring – sent to smartphones
Medical Device (“aux”) jack in each room for technologies not ready for network connectivity (i.e. chair exit alarm devices)
Tele monitor based alarms managed through central monitoring, filtered

51. Additional Supporting Evidence on the Need for Device Integration

52. For Device Integration in OR/Procedure Areas
Anesthesia Information Management Systems: A Review Of Functionality And Installation Considerations
JM Ehrenfeld et all (2011)
Called out benefits with device integration with anesthesia information management systems
Specific to Positive Impact on Patient Safety
Provision of real-time intraoperative decision support
Allows the anesthesia care team to focus on the patient, rather than recording vital signs
Better legibility and availability of historical records
More precise recording of intraoperative data & patient responses to anesthesia
Specific to positive impact on Anesthesia Practice
Provides precise, high-resolution records which can be used for educational purposes
Enables researchers to rapidly find rare events or specific occurrences across a large number of cases
Facilitates individual provider performance tracking
Allows better quality assurance functionality through the creation of more complete and precise records
Integration with other hospital databases can allow assessment of short and long term patient outcomes
Provision of additional legal protection via the availability of unbiased, precise information

53. For More Automated Medication Administration
Executive Summary: the State of the Science on Safe Medication Administration symposium.
KG Burke (2005)
Provides great summary of the problem
It’s estimated that five medication errors occur per 100 medication administrations.
Adverse drug events (ADEs) occur at an estimated rate of 6.5 per 100 hospital admissions.
One of every three ADEs related to medication errors occurs during administration.
It has been estimated that 56% of medication errors are related to prescriptions.
IV medications and infusion pumps are also being increasingly viewed as safety concerns.
Quite simply put:
“Currently available smart pumps will fail to generate meaningful improvements in patient safety until they can be interfaced with other systems such as the electronic medical record, computerized prescriber order entry, bar coded medication administration systems, and pharmacy information systems.”

54. For More Automated Medication Administration
The impact of traditional and smart pump infusion technology on nurse medication administration performance in a simulated inpatient unit.
P Trbovich (2010)
Discusses benefits of smart pumps
Pre-defined drug library uploaded to each pump
Each drug has a set of limits
Provides feedback to nurse
Dose or infusion rate is too high or too low for that medication
Intended to catch majority of potential programming errors
Can catch estimated 58% of potential medication errors
Also discusses the opportunities for error
Current state can catch only estimated 58% of potential medication errors
Nurse can still bypass using the library (time-saving)
Still allows for programming errors within the set limits

55. Implementation across the enterprise: two case studies
Anesthesia Information System & IV Pump Integration
Implementation across the enterprise: two case studies

56. Device Integration in the OR/Procedure Areas
91 anesthesia machines converted
Devices integrated per machine:
Philips monitor
Anesthesia machine
BIS monitor
CCO monitor
INVOS monitor
Tangent
Neuron (as the data concentrator)
Total devices integrated/communication with EPIC – 490
4 different configurations were created for the different areas
All stakeholders involved with configuration and developing technical support model
Clinical and Technical support during Go-Live
Total calls since go-live – 132
Tangent issues – 65
Neuron reset – 24
Server – 12
Neuron failure – 12
Damaged cables – 11
Operator Error – 8
A specific phone number was deployed to the end users for first call support and a quick reference card was installed on all anesthesia machines providing instructions on how to access device on/off/reset buttons.
Installation of mounting hardware and new devices was completed in 2 1/2 months without interrupting operating rooms schedule.

57. Supporting complex technology integrations

58. Pump Integration
IV Pump Integration went into production at Cedars-Sinai on June 7, 2014.
All adult inpatient locations using barcoded medication administration protocols as of January 2014
Considered an improvement to patient safety:
Improved our compliance with drug library use
Reduced the frequency of reprogramming or editing the pump program before starting an infusion
From CS-Link to IV Pump:
Drug Name, Dose, Flow Rate
From IV Pump to CS-Link:
Flow Rate, Volume Infused

59. Pump Integration Workgroup Structure
Steering Committee
EPIC 2012 integration
Drug Dataset alignment
Interfaces
New pump deployment
Workflow analysis
Testing
Training

60. Workflows, workflows, workflows

61. Training and assessment
clinical and operational benefits of technology interoperability,

62. Cedars-Sinai Pump Integration Utilization shown as % of in-scope medication orders
Go-Live
June 7, 2014

63. My “one-liner” about medical device integration
Medical Device Integration standardizes clinical and technical workflows. If done right, you’ve spent more time defining the nontechnical processes than talking about the technology itself.

64. Thank you and Questions
Jennifer Jackson
Director, Clinical Engineering & Device Integration
@giengiakson
Thank you and Questions
clinical and operational benefits of technology interoperability,