The World of Connectivity – Building a Strategy to Support Medical Device Integration and Alarm Management Presented by Izabella Gieras, MS, MBA, CCEJennifer.

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

Courtesy of Huntington Hospital

Huntington Hospital

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

Agenda

Background

Healthcare Environment

Healthcare Technology Management at Huntington Hospital &

Cedars-Sinai Health System

Medical Device Integration

Alarm Management

Background

Regulatory Requirements

Healthcare Environment

Patient Environment

Healthcare Technology Management in

Medical Device Integration

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.

www.diabetesmine.com

ECRI Institute Top 10 Health Technology Hazards

1.Alarm Hazards: Inadequate Alarm Configuration Policies and Practices

2.Data Integrity: Incorrect or Missing Data in EHRs and Other Health IT SystemsIT systems

www.ecri.org

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)

www.aami.org

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).

www.westhealth.org

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.

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.

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.

http://cerner.com/solutions/Medical_Devices/

Huntington Hospital Timeline

IMPLEMENTATION

EHR Implementation Scope

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

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

Device Integration Considerations

Clinical needs assessment

Device types Wireless vs Wired

Software version

Age of equipment

Physical location Type of mounts Position

EMR Device Setup

CE (Connectivity Engine) device

Datalux device(workstation)

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

Testing Station in CT

Device Integration Validation

READINESS & GO LIVE

Go Live Readiness

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

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

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

STABILIZATION

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

Service Workflow

OPTIMIZATION

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 12-18 months

BEYOND TODAY

Updated Timeline

Alarm Mgmt - Building the Foundation

Alarm Mgmt -Implementation

HEALTHCARE TECHNOLOGY MANAGEMENT IN ALARM

MANAGEMENT

Alarm Mgmt – Building the Foundation and Beyond

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

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)

Updated alarm default settings

Rhythm Default Recommended ChangeAsystole 4 seconds (adjustable) NoneVTach Rate >150 > 3 PVCS None

Rhythm Default Recommended ChangeNon Sustained VT On OffVentricular Rhythm On, >14 PVCS On >20 PVCSRun PVCs On, > 2 PVCs (not adjustable) OffPair PVCs On OffR on T PVCs On OffVentricular Bigeminy On OffVentricular Trigeminy On OffPVCs On, >10/minute OffMultiform PVCs On Off Pacer Not Capture On OffPacer Not Pace On OffMissed Beat On OffPause 2 seconds NoneSVT On, > 150/minute, > 5 SVBs NoneAFib On NoneIrregular HR On NoneCannot Analyze ECG On None

Courtesy of Huntington Hospital

Izabella Gieras, MS, MBA, CCE

Director, Clinical Technology

[email protected]

Jennifer Jackson: Introduction

Biomedical Engineer

Clinical Engineer

Hospital CE-IT Leader

Medical Device Interoperability AdvocateACCE 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

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

Overview of Cedars Sinai

Established in 1902 and located in Los Angeles, California

By the Numbers, from our 2014 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

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

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.

Clinical Engineering and nursing working together to plan out unit closures for the nurse call replacement.

We strive to be a center of excellence for innovative and robust solutions that promote leadership in delivering healthcare related services.

The Clinical Engineering & Device Integration Team

•Biomedical Equipment Technicians•Image Guided Systems Technicians•Clinical Systems Specialists•Clinical Systems Engineers•Project Specialists•Administrative Staff

What Makes Us Differentin the way we manage medical device systems

Unique organizational structureIndependent department within IT

Work side-by-side with applications and technical teams

Unique job rolesImage 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 SpecialistsStronger IT skill set than a

‘typical’ BMETMore of the technical lifecycle within one department

Building device records in the EHRTesting and maintaining orders/results interfaces Project managementTechnical supportSystem optimization

Reporting up into IT…and we are thriving…

48clinical and operational benefits of technology interoperability,

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

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

Additional Supporting Evidence on the Need for Device Integration

For Device Integration in OR/Procedure Areas

Anesthesia Information Management Systems: A Review Of Functionality And Installation ConsiderationsJM 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

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.”

page 53

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 page 54

IMPLEMENTATION ACROSS THE ENTERPRISE: TWO CASE STUDIES

Anesthesia Information System & IV Pump Integration

Device Integration in the OR/Procedure Areas

•91 anesthesia machines converted

•Devices integrated per machine:o Philips monitoro Anesthesia machineo BIS monitoro CCO monitoro INVOS monitoro Tangento Neuron (as the data concentrator)

•Total devices integrated/communication with EPIC – 490

o 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

Supporting complex technology integrations

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

Pump Integration Workgroup Structure

Workflows, workflows, workflows

Training and assessment

61clinical and operational benefits of technology interoperability,

Pump Integration Go-Live

June 7, 2014

Cedars-Sinai Pump Integration Utilizationshown as % of in-scope medication orders

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.

THANK YOU AND QUESTIONS

Jennifer Jackson

Director, Clinical Engineering & Device Integration [email protected]

@giengiakson

clinical and operational benefits of technology interoperability,

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