SCANH17 Speaker Slides

Annual SCAN Health Global Networ king Event: Mapping the Global Journey to Supply Chain Excellence KEYNOTE SPEAKERS: Mr. Vance Moore, President of Business Integration, Mercy Mr. Kevin Capatch, Director Supply Chain Technology & Process Engineering, Geisinger Health System Dr. Joseph Drozda, Director of Outcomes Research, Mercy

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September 26, 2017

An Overview of Mercy

Services & Locations

June 2017

So how does Mercy compare…

By Number of Co-Workers: 39,000

By Revenue: $6.2 Billion

(would be #427 on Fortune 500)

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My Role: President, Business Integration Business Integration involves integration…

Within…

Integration of “best practices” within Mercy to help identify and drive out unproductive variation or accelerate the growth of profitable elements of our business leading to a better quality, service and cost position. (FIG & GIG – Financial and Growth Improvement Group).

Across…

Integration across all Mercy commercial service lines (Supply Chain, IT, Virtual Care, Revenue Management, Research, etc…) to deliver a more comprehensive and unified solution to our customers.

Between…

Integration between trading partners and Mercy to enhance the value of trading partner products and services, while at the same time increasing Mercy’s market differentiation for quality care at an affordable cost.

Among…

Integration among like-minded Providers to leverage assets, ideas, and care capabilities to better serve our care givers, patients, and collective communities.

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Jim Francis

Brent Johnson

Deborah Templeton

Laurel Junk

To help protect your privacy, PowerPoint has blocked automatic download of this picture.

Vance Moore Fall 2010

Common Beliefs…

• Lack of standards inhibit progress – clinically, operationally, financially • We could collectively influence for good – no single voice was good enough • We could work together - trust & respect • Too many collaborators might slow down the process 5

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REALITY: Life Expectancy vs. Health Expenditures Life Expectancy vs. health expenditures over time (1970-2014)

Health spending measures the consumption of healthcare good and services, including personal health care (curative care, rehabilitative care, longterm care, ancillary services and medical goods) and collective services (prevention and public health services as well as health administration), but excluding spending on investments. Shown is total health expenditures (financed by public and private sources).

Data Source: Health expenditures from the OECD; Life expectancy from the World Bank. Licensed under CC-BY-SA by the author Max Roser. The data visualization at OurWordinData.org and there you find more research and visualization on this topic.

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REALITY: Mercy Expense Breakout (Top 15) $1.2 BILLION spend in top 5 categories Representing 34.6% of Expense

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REALITY: Understanding Healthcare 5% of Patients consume 50% of medical resources

Source: Advisory Board

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REALITY: Health Attribution

Source: County Health Ranking Model

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REALITY: Respect the past but it will not define our future…

44% of the Fortune 500 have gone bankrupt, been acquired or cease to exist since 2000.

Big names that have fallen from the list…

• • • • • • •

Alltel America Online Bethlehem Steel Black & Decker Caremark Rx Circuit City Compaq

• • • • • • •

CompUSA Conoco Dell Eastman Kodak Enron Georgia Pacific Gateway

• • • • • • •

Gillette GTE Hasbro Kmart Maytag New York Times Quaker Oats

• • • • • • •

Radio Shack Ralston Purina Sun Microsystems Sears Texaco TWA USAir

How will we remain relevant?

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REALITY: Acceleration of Technology Adoption Curves

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OUR FUTURE: The Digital Hospital

82 companies reinventing the practice of medicine

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OUR FUTURE: Human vs. Machine There's a 50 percent chance artificial intelligence will exceed human performance in all tasks within 45 years.

Here's what respondents predict AI will outperform humans for five tasks.

1. Translating languages: 2024 2. Driving a truck: 2027 3. Working in retail: 2031 4. Writing a best-selling book: 2049 5. Working as a surgeon: 2053 The researchers — led by Katja Grace of the U.K.-based University of Oxford's Future of Humanity Institute — surveyed 1,634 machine learning researchers about how they think AI stacks up against human beings in a variety of tasks. Twenty-one percent, or 352 researchers.

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OUR FUTURE: Starts with the question “What is Important”?

Great Patient Outcomes

Positive Bottom Line

Needs, Wants, Desires: Great Experience

What’s Important:

Understand and provide the best health/care… …do so with the least amount of resources Clinical Pathways + Operational Pathways (Effective) (Efficient) 14

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KEY ENABLER: Data is the Foundation of Progress

Action

• •

Real value only when acted upon Prescriptive analytics lives here

Insight

• •

Directional guidance Predictive analytics lives here

Knowledge

• •

Interesting yet dangerous Descriptive analytics lives here

Information

• •

Distillation process to relevancy May create confusion

Data

• •

Supervised & Unsupervised Very little value in this state

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WHAT: Designed from the five dimension of excellence

Designed to a Service Expectation

Designed to a Quality Standard

Designed with Community Involvement

Designed by the best Mercy talent

Designed to a Price Point

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REALITY: Waste Dominates Our Industry

Value 60%

Source: Sg2

Waste 40%

Medicare Waste

Examples

Unnecessary Care

• Preference based care without evidence of value • Defensive care • Excess or use of unproven technology

Inefficiency

• • • •

Provider Error

• Extended LOS due to error • Readmission due to error • Added cost to treat error

Lack of Care Coordination

• Duplicate testing • Inappropriate treatment because relevant history or previous treatment is not accessed • Use of ED for non-emergent conditions because primary care services are not available • Adverse drug reactions that occur when a record of a patient’s current medications is unavailable

Avoidable Conditions

• Timely access to quality outpatient care thereby avoiding hospitalizations • Care Management

Other

• Fraud and abuse

Over utilization of testing Over utilization of ICU Staff mix mis-match Lack of equipment leveraging

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HOW: a High-Level Vision The “Who” and “Where” of care delivery.

• Care Paths • Operating Paths

• • • •

Source: Sg2, 2013

Necessary Appropriate Redundant Waste

• Prevention Focus • Leverage system capabilities • Utilization • Outcomes

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HOW: Evolutionary & Revolutionary Change Evolutionary Approach: (how we operate)

Results

Alignment

• Create value for the patient / customer

• Create consistency of purpose • Think systemically

Process

People

• Focus on Process

• Lead with humility

• Embrace scientific thinking

• Respect every individual

• Flow & pull value • Assure quality at the source • Seek perfection

Revolutionary Approach: (what we do)

Eliminate

unnecessary work Step 1

Step 2

Rationalize

Minimize

Consolidate

Automate

Optimize

Leverage

Mechanize

necessary work

redundant work

appropriate work

Step 3

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CLINICAL ACCELERATION: Periop Performance Perioperative Results - Total Knee Arthroplasty

Total Knee Arthroplasty

CPI Adjusted Intraoperative Supply Cost Per Case

May 2012-Jan 2016 (n=11,834)

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RESULTS:

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OUR FUTURE: Respects Market Dynamics Continuum:

PreAdmission

Admission

Diagnostic

Procedure

Recovery

Discharge

Postdischarge

Home

Venue:

Local

Regional

Virtual

Mode:

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SUPPLY CHAIN’S UNIQUE ROLE: Supply Chain touches everyone… everyday…

Hospital/Clinic – Leaders (C-Level, VP’s)

• Accountability • Provider focused and based solutions • Leadership Collaboration

Health System Senior Leadership (Corporate Staff)

• “Systemness” • Relationship Management • Leadership (corporate)

Patients

Facility - Mid-Managers

(Chronic, Occasional, Peds) • Quality care • Convenient Locations • Personal Service

(Supervisors, Dir., Mgrs., VP’s)

• Harmonious with environment • Communication, be heard, access to information • Respect

Vendors

• Partnership Relationships • Access to Decision Makers • Profitable Sales

Clinicians

(Nurses, Pharmacists, Resp. – Lab tech) • Efficient work environment • Involvement in product decisions • Quality of patient care delivery / patient safety

Industry Leaders

(Influencers, Publishers, Regulators)

Physicians

• Autonomy • Quality of life and compensation • Quality of care / Patient Safety

• Compelling Story – new ideas • Advanced knowledge • Quality based business model

Supply Chain Team • Respect for individual input • Compensation/benefits • Tools to do the job

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The FLOW of FLOWS: In the healthcare supply chain Raw Materials

Plan

Harvest

Transport

Store

Pick

Convert / Make

Distribute (Raw)

Plan

Order

Receive

Store

Pick

Transport

Manufacture

Distribute (Finished)

Provider

Disposal

Plan

Plan

Plan

Pick up

Order

Order

Order

Transport

Receive

Store

Receive

Receive

Process

Pick

Store

Store

Pick

Pick

Transport

Transport (to unit)

Convert / Make

Package

Package

Transport

Store

Pick

Transport

Transport

Store

Pick

Transport

Transport

Store

Pick

Transport

Use

Dispose

Transport

Dispose

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Store

THE FLOW MULTIPLIER: Med/Surg Mfg.

Med/Surg Dist.

Mercy Hospitals

Pharma Mfg.

Pharma Dist.

Mercy Clinics

Lab Mfg.

Lab Dist.

Other Hospitals

Office Sup. Mfg.

Office Sup. Dist.

Other Clinics

Dietary Mfg.

Dietary Dist.

Retail Pharmacy

Linen Mfg.

Linen Service

Home Health Lab Extended Care Other???

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COMPLEXITY AMPLIFIER: Supplier Complexity:

F/A-18 Super Hornet

20,000 SKU

40,000 SKU

50,000 SKU

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SUPPLY CHAIN: evolution to integration Manufacturer

Traditional Supply Chain

Disintermediated Supply Chain

Many

Manufacturer

Compressed

Integrated Supply Chain

Manufacturer

Integrated Processes

GPO

Distributor

Limited Accountability

GPO

GPO

Integrated Contracting

Silos

Generic

Distributor

Direct Contracting

Provider

Provider

Internal Logistics

Silos

Distributor

Provider

Integrated Logistics

Integrated Processes 27

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TRANSFORMATION: A Changing Landscape for Success PAST EFFORTS

FUTURE EFFORTS

CARE

FOCUS

HEALTH

Come to Me

SERVICE

Go to You

Provider Centric Central Responsive Assessment Treatment Tactical - Specific Area Computerization

CENTRICITY CARE LOCATIONS PRACTICE

Distributed Predictive Analysis

GOAL APPROACH

Prevention Strategic - Entire Enterprise

SYSTEMS

Respectable / Incremental

IMPROVEMENT

Administration / Physician

LEADERSHIP

Fee-for-Service

Patient Centric

PAYMENT

Automation Transformative / Phase Shift Physician / Administration Fee-for-Value

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RESULTS: Benefits of our Integrated Supply Chain • Proven method to reduce cost.

• Proven method to improve patient safety.

• Proven service enhancement model that is a key satisfier for co-workers and patients.

• Proven method to unite culture within the system and increase collaboration.

• Proven element of differentiation.

• Proven mechanism for collaboration.

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Thank You Vance Moore

President, Business Integration -

vance.moore@mercy.net @VanceMoore

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HTG Summit 2017 A Look back September 26-28, 2017 Mercy – St. Louis, MO

©HTG - Confidential

Agenda • HTG (About) • HTG Summit History • HTG Vision Adjustments • HTG Achievements • Roadmap • HTG News – Position Papers • Welcome to St. Louis!

©HTG - Confidential

HTG About (website)

©HTG - Confidential

HTG About (2017 Current Language) Original Language HTG members share this common foundation: • Accelerate change across the supply chain • Enhance patient safety • Improve supply chain efficiencies • Drive the adoption of GS1 Standards with suppliers • Communicate in the marketplace through one voice

Current Language Revised @ HTG F2F – May 3rd, 2017

Common Foundation – To leverage Supply Chain as a strategic asset focused on improving the patient/member/community experience across the continuum of care; home, to hospital, to home.

• • • •

Accelerate change across the healthcare supply chain Communicate in the marketplace through one voice Drive outcomes-based decision making with application of supply chain information and analytics Enhance patient safety

Note: Drive the adoption of GS1 Standards with suppliers , is now foundational. ©HTG - Confidential

HTG Summit History Location Mercy Mercy Mercy

Year 2011 2012 2012

Intermountain

2013 May

29&30

Kaiser Permanente Geisinger Mayo Mercy

2014 2015 2016 2017

17&18 18&19 28&29 27&28

ŠHTG - Confidential

Month May May Dec

Sep Aug Sep Sep

Days 3&4 1&2 13&14

Comment Tornado April 22, 2011 Mercy Conference Center IT Summit Intermountain Supply Chain Center Kaiser Permanente Innovation Center Pine Barn Inn & Knoebels Come on - It's Mayo!

Mercy Conference Center SCANH – September 2017

HTG Summit History Location

Year Key Topic Forming and how we selected the top 20 (Why you were invited!)

Mercy

2011

Mercy Mercy

2012 2012

The famous Brent Johnson , “No bar code, no business!”

Intermountain

2013

Kaiser Permanente Geisinger Mayo Mercy

2014 2015 2016 2017

“The Grocery Video” http://youtu.be/g7D6pm_bLyU We expanded vendors, invited solution providers, “ We scanned a stent!” even used Google Glass

©HTG - Confidential

Need our Solution Providers engaged Introduced the Clinical Bias – Dr. Muhlestein, “ I can scan my crackers, can’t scan a stent!”

Less presentation more collaboration Review of 5 core position statements.

Active participation and pain point discussion SCANH Pre- Summit

2013 Award - Cook Medical

©HTG - Confidential

2014 Award – Abbot & J& J

©HTG - Confidential

2015 Award – Aclon & Boston Scientific

©HTG - Confidential

HTG 2015 – And a little fun!

©HTG - Confidential

2016 Award - W. L. Gore

©HTG - Confidential

HTG History – 2012 Score Card

©HTG - Confidential

HTG History – 2012 Score Card

©HTG - Confidential

HTG History – 2012 Score Card

©HTG - Confidential

HTG History – 2016 Score Card

©HTG - Confidential

HTG History – 2016 Score Card

©HTG - Confidential

HTG History – 2016 Score Card

©HTG - Confidential

HTG History – 2016 Score Card

©HTG - Confidential

HTG History – 2016 Score Card

©HTG - Confidential

HTG History – 2016 Score Card

©HTG - Confidential

HTG History – 2016 Score Card

©HTG - Confidential

HTG History – 2016 Score Card

©HTG - Confidential

HTG History – 2016 Score Card

©HTG - Confidential

HTG Vision - Adjustemnts 2011

2016

Subtle adjustments, Same Foundation

©HTG - Confidential

HTG Achievements • HTG Website • HTG Continuity • HTG Minor Vision Adjustments • HTG Achievements • Roadmap • HTG News – Position Papers • Welcome to St. Louis!

©HTG - Confidential

HTG Roadmap – Data Standards

©HTG - Confidential

HTG Roadmap – Beyond Standards

©HTG - Confidential

HTG 2016 – News Position Papers

©HTG - Confidential

Welcome to St. Louis!

©HTG - Confidential

Integration of Clinical and Device Data for Improving Care Quality, Safety and Efficiency: The HTG Experience Joseph P. Drozda, Jr., M.D. Director of Outcomes Research, Mercy

UDI: The Key to Knowledge

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HTG Research and Development Team • Physician led.

• Staffed with experts including SCM, IT, Revenue Cycle, EHR, etc • Develop and test solutions.

• Clearly document recommendations and short comings in the overall environment.

• Seek funding for research efforts through grants and awards.

HTG Structure Leadership Committee

Overall mission, objectives and oversight.

Research and Development Team

Implementation Team

Solution development and testing.

Lead Adopters and Implementation of industry standards.

HTG R&D Team Members • • • • •

Jove Graham, Ph.D., Geisinger (Lead) J. Brent Muhlestein, M.D., Intermountain Liz Paxton, Ph.D., Kaiser Permanente Robert Rea, M.D., Mayo Joseph Drozda, M.D., Mercy

How do we leverage device and clinical data for device evaluation?

1. Link the device with the patient.

2. Link clinically meaningful attributes to the device.

3. Combine device/attribute data with clinical (EHR) data in a database for effectiveness and safety analyses

The HTG UDI Strategy • Integration of UDI into multiple electronic systems • Creation of data sets containing clinical & UDIassociated device information • Linkage among 3 health systems (Geisinger, IHC, Mercy) & to national registries (Distributed Data Network)

An Overview of Mercy

Services & Locations

May 2017

Why

?

The groundwork was laid by Mercy IT: The Epic EHR – 5 years in the making – All of our hospitals – All of our integrated physician practices 10

UDI Demonstration Project Aims (FDA CDRH contract: DHHS/FDA-22320172C)

1. Implement a coronary artery stent UDI-based surveillance system in the EHR in a multi-hospital system (Mercy) 2. Identify obstacles to implementation of UDI in clinical information & to characterize the effectiveness of interventions to overcome them; 3. Assess the validity and utility of data obtained from the EHR and incorporated UDIs for purposes of post-market surveillance 11

Healthcare Transformation Group

Key Components of Mercy’s UDI Demonstration  Create prototype UDIs & associate with attributes in the FDA Global UDI Database (GUDID)  Create clinically meaningful supplemental attributes to be stored in a reference database  Create UDI data flow through ERP to cath lab to EHR to UDI data set  Create UDI fields in the CathPCI Registry  Perform studies to demonstrate validity and reliability of data  Identify obstacles to incorporating UDIs into EHR and explore solutions

Healthcare Transformation Group Mercy’s UDI Demonstration Partnership  Health Systems (Healthcare Transformation Group)  Professional Societies (American College of Cardiology and the Society for Cardiovascular Angiography & Interventions)  National Registry (CathPCI/National Cardiovascular Data Registry)  Industry (Abbott, Boston Scientific, Medtronic)  FDA

The Expert Workgroup • The Expert Panel: Five interventional cardiologists appointed in conjunction with ACC and SCA&I • “Ex officio” members – FDA representatives – Coronary Stent manufacturer representatives – HTG system representatives – NCDR representatives

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Tasks for Expert Work Group • Develop a constrained list of coronary stent clinical attributes to supplement the GUDID attributes (Expert Panel) • Propose a permanent home for UDI clinical (supplemental) attribute database (SUDID) • Recommend a governance structure for the SUDID • Develop a proposal for an organization and processes for ongoing maintenance of the SUDID

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3rd Step – GUDID Data Device Attributes (Examples) For each DI: • Manufacturer, Make/model, Brand/Trade Name • Clinically relevant size • Contact information • Sterility information • Natural Rubber Information • FDA premarket authorization (510k, PMA) • FDA product code (procode) • Marketing Status/date • For single-use • Higher levels of packaging • Rx – OTC • GMDN/SNOMED 16

Expert Work Group Outputs • Constrained list (9) of supplemental coronary stent attributes • Use cases for UDI associated data in clinical data sets • Recommendations re governance and operations of Supplemental UDI Database (SUDID) • Recommendations re broader registry-centered data sharing network for device surveillance

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SUDID Clinical Attributes Attribute

Definition

Parameter

Length

Nominal length per manufacture specification

Fractional dimension in mm

Diameter

Nominal (inner) diameter per manufacturer specification

Fractional dimension in mm

Non-conventional Property

Stent having nonconventional design, variable or multiple length/diameter parameters

Covered stent Bifurcation Stent Tapered Stent

Alphanumeric

Structural Material

Composition of principal structural element

Constrained list e.g. L605 cobalt chromium -- Constrained list to be developed

Alphanumeric

Coating(s)

Non-Structural material covering surface of structural element

Constrained list -- Constrained list to be developed --Need to handle multiples --Name that would be mostly referenced --Start with what is in the IFU --Accommodate multiple coatings

Alphanumeric

Drug(s)

Active agent released from stent

NDC directory (default) --Use name if no applicable NDC code—do it uniformly

Alphanumeric

Strut Thickness

Maximum nominal thickness of stent struts on a radius from the center of the stent

Dimension in microns

4 integer digits

Surface to Artery Ratio*

Percentage of the surface area of the artery covered by the stent at nominal expansion of the stent

Expansion Method

Method used to achieve nominal stent deployment

Balloon Self

Alphanumeric

MRI compatibility category per testing

4 categories per existing standard: --Safe --Conditional --Unsafe --Not tested

4 Categories

MRI Compatibility

Data Type 4 significant digits, w/1 precision 4 significant digits, w/2 precision

3 significant digits, w/1 precision

*This attribute was originally selected by the Expert Panel but subsequently withdrawn SUDID = Supplemental Unique Device Identifier Database; IFU = Instructions for Use; NDC = National Drug Code; MRI = Magnetic Resonance Imaging

Barcode Scanning in the Cath Labs Mercy Performance Solutions - What we did‌ The Mercy UDI demonstration required us to make changes to Cath Lab processes The changes we made improved many aspects of the workflow in the Cath Lab

- What we did…

Patient Level Product Inventory Mgmt. Automated Charging Scanning Major Process

Major Process

• Scanning product barcode to patient • Capture of UDI including lot / serial / exp date of product • Capture cost per case

• Tracking of shelf level inventory • Shelf level tracking of lot / serial / exp date of product • Automated inventory replenishment

Major Process • Automated charge capture • Lost charge reporting

Goal: Enable capture of the UDI to the patient… Apply automation to highly manual process

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Critical Step

Mercy Device Data Flows

Mercy UDI Research Database Data Model

Assessing UDIR Data Completeness

Performance of Coronary Stents by Device Attribute (Drug)

“Real World” Performance of Coronary Stents

UDI Issues • • • • • • • •

DI or PI or both?

Barcode scanning and workflow Software limitations (the double scan) Not a single standard (GS1 and HIBC) Multiple barcodes – Which one is UDI? Link to GUDID Link to supplemental data (AUDI) Supply chain partnership

The MDEpiNet Public Private Partnership

  

Part of the Epidemiology Research Program (ERP) at the FDA Center for Devices and Radiological Health (CDRH) Collaborative program through which CDRH and external partners share information and resources to enhance understanding of the post-market safety and effectiveness of medical devices Migrated to a Public Private Partnership (including industry) in 3/14

GUDID/AccessGUDID Records and Submission Compliance Deadlines Data Current as of April 3, 2017

1,500,000 1,400,000 1,300,000 1,200,000 1,100,000 1,000,000 900,000 800,000 700,000 600,000 500,000 400,000 300,000 200,000 100,000 0

Class I & Unclassified

Class II

I/LS/LS

U.S. FDA

Sep-18

Jun-18

Mar-18

Dec-17

Sep-17

Jun-17

Mar-17

Dec-16

Sep-16

Jun-16

Mar-16

Dec-15

Sep-15

Jun-15

Mar-15

Dec-14

Sep-14

Jun-14

Mar-14

Dec-13

Sep-13

Class III

The BUILD Initiative BUILD – Building UDI into Longitudinal Data Next Steps in Supply Chain Innovation & Medical Device Evaluation Key: BUILD brings to the device evaluation system both EHR and device data captured at the point of care, enabling rapid assessment of device performance

The BUILD Initiative

Current Projects: FDA Grant Number 1U01FD005476-01 REVISED

BUILD combines 3 of 6 projects developed by the MDEpiNet SMART Informatics Think Tank  Extension of UDI Implementation pilot  Medical Device Data Capture and Exchange: Leading Practice and Future Directions (The BUILD Consortium)  Electrophysiology structured reporting: Providing UDI for Leads and devices using industry Standards to Electronic Health Records and CVIS Systems (ePulse)

MDEpiNet BUILD Investigator Leaders Extend the Mercy Health coronary stent UDI model to two other health systems  Drs. Joe Drozda (Mercy) and James E. Tcheng (Duke Coordinating Center) will co-lead this subtask  Drs. Jove Graham at Geisinger and Brent J. Muhlestein at Intermountain will lead their core teams

Medical Device Data Capture and Exchange; Leading Practices and Future Directions  Dr. Natalia Wilson will lead this sub task – Arizona State University – Tempe, AZ  Core team consists of ASU investigators; Dr. David Kaufman and Dr. Davide Sottara and consultant Mike Schiller (AHRMM)

ePulse    

Dr. David Slotwiner – New York Presbyterian Hospital – Queens, NY Nick Gawrit of heartbase® Core team consists of clinicians, IT experts and scientists Implementation of ePulse is on hold pending additional funding

MDEpiNet BUILD Goals

Unique Device Identifier Strategic Objectives

 Create a solution to collect encompassing data on implanted devices from manufacturer to point-of-use  Link the data of devices implanted in patients with clinical data from the Electronic Health Record  Link the device and EHR data with other data sources, e.g., device registries and ultimately insurance claims data

Benefit

 Methodology developed will be extensible to all implanted medical devices  BUILD will create a road map for health systems to replicate the methodology  Potential to add other health systems to the distributed data network and to similar networks for other devices

BUILD Research Plan  Extend the Mercy Demonstration Project (UDI linked with clinical data), using AccessGUDID and supplemental device attributes to the UDIR.  Extend the Mercy approach to Intermountain and Geisinger  Create a distributed data network across the 3 health systems, using the NCDR CathPCI registry as hub  Bring together a consortium of hospital organizations, manufacturer and other stakeholders to collaboratively describe the current UDI environment and develop best practice solutions for capture and exchange of implantable device data from supply chain to registry  Use the ePulse project to demonstrate use of industry standard nomenclature (including UDI) to capture critical data at the time of device implantation and at follow-up, for patient care, device surveillance, quality improvement and registry submission  Coordinate activities with other MDEpiNet initiatives (RAPID, VANGUARD)

The BUILD Distributed Data Network

BUILD Year 2 • • • • •

Extending to other device types Industry partnerships UDI implementation roadmap development Distributed data network platform MDEpiNet & Learning UDI Community (LUC)

Clinically Relevant Size Workgroup Device Classification Workgroup Augmented UDI Data (AUDI) Workgroup UDI to Registries Subgroup of the LUC ROI for UDI Workgroup – RAPID and VANGUARD – – – –

BUILD Year 3 • Complete data model – Sentinel common data model modifications – BUILD CDM

• Complete database & distributed data network development • Data analyses (DELTA) • Hips and knees and the OR • Medtronic CRT project

BUILD Related Activities • Collaborations

– SCAN Health (Anne Snowdon, University of Windsor) – Linking UDIs to Insurance Claim Pilot (Joel Weissman, Ph.D, principal investigator)

• Future BUILD work – – – –

Data standards and validation Methodology development Robust connections to registries Patient Reported Outcomes

Vision for the Future • Generalize to other implanted devices • Extend work to Kaiser, Mayo, and others • Robust linkages to national registries (Coordinated Registry Networks) • Refine analytic methods • More industry partnerships • Challenge: Funding

Thanks!

Joseph P. Drozda, Jr., M.D., F.A.C.C. Director, Outcomes Research Mercy 14528 South Outer Forty Chesterfield, MO 63017 314-628-3864 Mobile: 314-308-1732 Joseph.Drozda@Mercy.net BUILD: http://mdepinet.org/build/ References: 1. Tcheng JE, Crowley J, Tomes M, Reed TL, Dudas JM, Thompson KP, Garratt KN, Drozda Jr. JP. Unique device identifiers (udis) for coronary stent post-market surveillance and research: A report from the FDA’s Medical Device Epidemiology Network (MDEpiNet) udi demonstration, American Heart Journal, 2014;168(4);405-13,e2., doi: 10.1016/j.ahj.2014.07.001.

2. Drozda JP Jr, Dudley C, Helmering P, Roach J, Hutchison L. The Mercy unique device identifier demonstration project; implementing point of use product identification in the cardiac catheterization laboratories of a regional health system. Healthcare 2016;4:116-119. doi:10.1016/j.hjdsi.2015.07.002. Originally published on-line July, 2015.

3. Drozda JP Jr, Roach J, Forsyth T, Helmering P, Dummitt B, Tcheng JE. Constructing the informatics and information technology foundations of a medical device evaluation system: a report from the FDA unique device identifier demonstration. J Am Med Inform Assoc.

Published on-line May 3, 2017. https://doi.org/10.1093/jamia/ocx041

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Annual SCAN Health Global Networ king Event: Mapping the Global Journey to Supply Chain Excellence GLOBAL PANEL SPEAKERS: Dr. Charles Alessi, General Practitioner, Senior Advisor, Public Health England Dr. Stan Huff, Chief Medical Informatics Officer, Intermountain Healthcare Mr. Brent Diverty, Vice President of Programs, Canadian Institute for Health Information (CIHI) Dr. Peter W. Vaughan, Chair of the Board, Canada Health Infoway, Deputy Minister of Health, Nova Scotia (Retired) 1

Setting the standards for safer care

Scan4Safety

Setting the standards for safer care

1

PROGRAMME OBJECTIVE

To improve patient safety, increase clinical productivity and realise operational efficiencies across the NHS. By: Driving the adoption of international standards that are commonplace in other sectors into healthcare.

2

Right Patient

Right Product

Right Place

Right Process

Setting standards to know who our patients are and what treatment has been given.

Setting standards to make sure staff have what they need, when they need it.

Setting standards to make sure that products and patients are in the right place.

Setting standard ways of working to deliver better, repeatable patient care.

DH – Leading the nation’s health and care

HOW TO ACHIEVE THE OBJECTIVE

Making sense of multiple parameters and dependencies. Providing structure to a complex area.

Data Carriers

The way in which a standard is encoded to the 'thing' (e.g. 2D data matrix, linear barcode, RFID).

Use Cases

The practical application of the standards and outcome of the core building blocks below (i.e. what you can 'do' when you have an underlying technological solution capturing data carriers, have adopted the standards and driven them across a number of 'Enablers‘).

Technology

The underlying systems that enable the data carriers to be 'identified, captured and shared' (usually multiple system providers will be required to achieve all three of these steps).

Enablers

The 'how'. What needs identifying/coding. The more enablers, the more standards are adopted across an organisation.

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DH – Leading the nation’s health and care

Organisations The NHS organisations that have adopted / are adopting the ‘Standards’.

Standards

The individual standard keys that are universally identify something (e.g.

GTIN, GLN).

A STANDARDISED PROCESS – APPLICABLE FOR ALL

The approach and process followed by the Demonstrator Sites are repeatable and replicable across all other acute NHS trusts.

Key success characteristics of the Scan4Safety approach:

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•

A standardised, modular approach to the adoption of standards: • 4 x defined phases, within Level 1

•

A set of core ‘milestones’ for attainment within each Phase • A core programme document setting out the milestones that trusts are required to meet by the end of each of the four phases

•

Central grant funding: • Graduated distribution of funding to participating NHS hospitals upon satisfactory completion of each phase

•

Governance structure that includes a Phase Review Panel, which: • is centrally located in the Department of Health and holds and releases the funds to participating trusts; • reviews the performance of participating NHS hospitals against stated milestones; • signs off each hospital one-by-one as it reaches the end of each phase.

•

A standard assurance process, which measures compliance in a neutral and repeatable manner: • End of level audits led by the central programme team to include independent members of the audit team.

DH – Leading the nation’s health and care

NHS TRUST (HOSPITAL) ENGAGEMENT

Six NHS trusts have been funded to adopt GS1 and PEPPOL standards and measure the impact.

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•

6 x NHS acute trusts selected through a competitive bidding process to prove the benefits of applying standards in healthcare: • Derby Teaching Hospital NHS Foundation Trust – approaching the end of Phase 4 audit process • North Tees and Hartlepool NHS Foundation Trust • Royal Cornwall Hospitals NHS Trust • The Leeds Teaching Hospital NHS Trust • Plymouth Hospitals NHS Trust • Salisbury NHS Foundation Trust

•

19 months into a 24 month project, the current financial benefit realisation position is: • £4.4m actual savings • Saving expected by March 2018 = £9m

•

Some early evidence that patient care and safety is being improved as a result of Scan4Safety: • Salisbury NHS Foundation Trust: o Surgical team now alerted if expired stock is scanned to a patient at point of care; o 93% of implantable devices accurately tracked to patient; o Two hours a week of a radiographer released back to patient care.

• Leeds Teaching Hospital NHS Trust: o Faulty product recalls now performed in under an hour, down from over eight hours (in Ophthalmology) DH – Leading the nation’s health and care

SUPPLIER ENGAGEMENT

Scan4Safety has focused on engagement with MD and IVD suppliers to the NHS. Medical Device and In-Vitro Diagnostic Device companies: •

Scan4Safety engagement with MD & IVD suppliers to the NHS to date: • 29 suppliers up-to-date as of September 2016 • 66 suppliers up-to-date as of March 2017 • Out of the 118 suppliers that proactively declared compliance status

•

These engagement figures represent: • 25% of NHS acute spend compliant up to March 2017 • 33% of NHS acute spend compliant up to September 2016

•

Supplier Compliance Status 19%

Next round of supplier compliance declarations opens 1st October 2017 Mar-17

Medicines and Pharmaceutical companies: • •

Initial timeline for compliance published in July 2017 Major industry trade associations consulted

Other sectors in scope: • • • 6

Office and IT Estates and Facilities Services DH – Leading the nation’s health and care

Sep-16 Other

25%

56%

INCREASING BREADTH – THE REST OF THE NHS ACUTE SECTOR

MD&IVD Supplier Milestones

Indicative timeline for programme rollout across the other 148 acute trusts in the NHS, with supplier milestones

30 Sept: Label products for: Class III, Implantables & Class D IVD

30 Sept: Label products for: Class IIa, IIb & Class B&C IVDs

30 Sept: Label products for: Class I, & Class A IVDs

154 30 Sept: Publish GTINs for: Class III, Implantables & Class D IVD

30 Sept: Publish GTINs for: Class IIa, IIb, & Class B&C IVDs

30 Sept: Assign a GTIN to: Class IIa, Class IIb & Class B&C IVDs

30 Sept: Assign a GTIN to: Class I, & Class A IVDs

30 Sept: Publish GTINs for: GDSN for Class I, & Class A IVDs

Wave 4 x23 30 Sept: Assign a GTIN to: Class III, Implantables & Class D IVDs

(April 2021)

Wave 3(b) x25 (Oct 2020)

106 Wave 3(a) x25 (Apr 2020)

Wave 2(b) x25 New Trust Enrolment

(Oct 2019)

56

Wave 2(a) x25 (April 2019)

31

Supplier Milestone

(Apr 2018)

Demonstrator Sites x6 (Jan 2016)

2016

2017

Trust adoption curve

2018

2019 YEARS

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KEY

Wave 1 x25

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DH – Leading the nation’s health and care

2020

2021

2022

PROGRAMME BENEFITS “Scan4Safety is a world first in healthcare – and a vital part of this government’s drive to make the NHS the safest and most transparent healthcare system in the world.”

Jeremy Hunt, Secretary of State for Health

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1. Patient Safety

3. Financial

Administering the right care to the right patient, reducing ‘never events’ • Never-event reduction • Positive impact on NHS litigation costs

Financial benefit for the NHS from improved operational productivity recurs in perpetuity • £1,034m over 7 years • 4:1 return on investment

2. Operational Productivity

4. Supply Chain Efficiency

Enabling clinicians to focus on patient care.

Patient and procedure-level costings and outcome variance reduction • Event data enabling clinical productivity

Knowing what inventory is where and enabling more efficient procurement • Supply chain visibility and management • Asset tracking and benchmarking

DH – Leading the nation’s health and care

The Canadian and CIHI Perspective SCAN Health Global Networking Event, 26 Sept 2017 Brent Diverty, Vice President, Programs Canadian Institute for Health Information

cihi.ca

@cihi_icis

CIHI’s Strategic Plan 2016 to 2021

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In Canada….

• 1/3 of medical tests, treatments and procedures might not be needed • 5 percent of patients experience harm while in hospital • 1 in 5 seniors admitted to residential care might have been

able to remain at home with more support

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Canadian challenges (not all unique to Canada) • Multiple systems • Siloes within the systems • Minimal standardized, timely supply chain data

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Where do we go from here?

More data – efficiently collected through automation

More standards – set internationally and embedded in HIS

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More predictive analytics – for making the best use of available data

Contact us bdiverty@cihi.ca cihi.ca

SCANH Global Panel St. Louis Sept 26, 2017 Stanley M. Huff, MD

Why? “To help people live the healthiest lives possible.�

Eileen

FHIR Profiles from CIMI Models (using standard terminology)

Heterogeneous Systems

Commercial EHR

Home Grown System

VISTA

Others‌

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The Supply Chain Imperative Photo by Patrick Stephan on Unsplash

Dr. Peter W. Vaughan

The Healthcare Black Hole

The Opportunity

Real-time Health Ecosystem

Leadership Drivers

Mobilize

Real-Time Vision

Global Collaboration

Photo by rawpixel on Unsplash

Health IoT • • • • • • • • • Photo by Drew Hays on Unsplash

Quality Outcomes Access Universality Standards Privacy Security Regulation Cost

The Bridge

Dr. Peter W. Vaughan

Nova Scotia trail (photo by Tim Foster on Unsplash) Halifax, Nova Scotia, Canada

SCAN Health Networ king Event Concluding Perspectives Dr. Anne Snowdon | Scientific Director & CEO, SCAN Health

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Key Findings • Every global health system faces similar challenges, collaboration is an opportunity to create global impact, question is how best to mobilize global leadership • Role of Policy makers: • Important leadership role to play, political support likely needed, timing is important to achieve alignment • Need for Pull model vs. Push model?

• How policy makers may align across global jurisdictions • No policy framework for supply chain: “patchwork quilt” • Consumers are an important opportunity to drive change: • Consumers offer an important lobby and key influence role • “Yelp” approach already happening © SCAN Health

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Key Findings (cont’d) • Safety: How is it acceptable that 200,000 to 400,000 people die in health systems in the US, 100,000 people in Canada • 3rd leading cause of death in many OECD countries • Seems impossible this is largely “accepted” across systems today

• Data is the key enabler: ways to mobilize data to create transparency for health system stakeholders will be required in “Real Time” • • • •

inform clinician teams, patients to make decisions Track and trace outcomes are critical for determining value Data is required to better understand variation, and ways to reduce variation Focus on strategy: need for an integrated and automated supply chain transformation to clinical team priorities and perspectives.

© SCAN Health

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Key Findings • “Language of Supply Chain” : few clinicians understand what it is, or why supply chain is important….. Until it fails, creating environments for clinicians to thrive, and identifying risk to inform proactive prevention.

• “disconnect” between clinician and supply chain, learning each other’s language, translating the opportunity of supply chain into system quality, safety and performance that is proactive instead of reactive • Role of supply chain relevance for strategic transformation: “gift that keeps on giving” • Role of Regulatory vs Incentives: • System Mandate (Scan for Safety): “Top Down” NHS Franchise approach, must deliver outcomes to receive funding • Internal Incentives – focus on system savings, fiscal return on investment, quality • Regulatory Policy (FDA) to drive change in the sector: move beyond “Compliance” • Business case approach • Harmonize UDI worldwide © SCAN Health

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Key Findings • Move towards implementation, measuring common outcomes to build momentum across global jurisdictions • Opportunity to build global collaboration across registries (IMDRF), product registries, policy frameworks • System level focus: Continuum of Care vs. focus on a single phase of care (hospital); outcomes rather than transactions • “herding the cats”: importance of relationship building for engagement • How do you get “semantic interoperability” to really achieve transparency • “Begin with the End in Mind” (Covey) • Implementation at Scale • “Fighting for Visibility and Credibility”: reframing into clinical priorities, quality • Procurement: • Procuring Innovation, how do we negotiate innovation and change rather than price Supply chain information/outcomes to inform procurement using global standards © SCAN Health

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Key Findings • Bridge between supply chain and Safety • Global use cases as a tool to consider how implementation could be applied in different country contexts • Opportunity to learn from each other, building on each others’ strengths • Role for both competition and cooperation: shared objectives among partners, creating balance between competition and cooperation • Impact on Industry: • Need alignment across jurisdictions • Rely on government decision to mandate • Industry lobby to influence standards use across borders, rather than countries pursuing diverse strategies for supply chain which becomes very challenging to implement © SCAN Health

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Key Findings • Unit of Measure Challenge • Understanding product attribute information • Translation of Manufacturer data into how organization translates and understands that information at point of use • “Trust” of order using GDSN record and what is actually delivered which may be different • Grading system of suppliers: Platinum, Gold, Silver, Red (June 2017) • Visibility of the quality of the supplier data n(platinum) can accelerate hospital use and adoption standards • Collaboration across US, Australia, Alberta, UK on product data registries to accelerate UDI uptake • How IT platform providers to accelerate UDI adoption and integration into EMR systems © SCAN Health

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Key Findings • Industry: • No one noticed when GS1 standards identified products • UDI needs to move beyond compliance needed to achieve the value for patient outcomes • Variation in UDI requirements across jurisdictions “a killer” for industry • “Data rodeo”, have to work through as an industry to make sure it means the same thing to everyone • Current Situation: 40% waste, significant inertia to change, rush shipments, “trunk stock” ; lack of data standards for point of care use • What we All know: standardization saves lives and money, “dark assets” hide waste; division of supply chain is a killer; Money is there to fix it

© SCAN Health

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Key Findings

• Industry: • What Providers Need: clinically aware supply chain consultants, true supply chain analytics – complete control tower • Need to get ahead of government • Need an executive platform to manage supply chain as a strategy across the system • Need to find an allowance for true renewal: ex. Blackberry, palm pilot • Leadership capacity building for the next generation

© SCAN Health

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Health System Performance – “the gift that keeps on giving” Safety: every product, patient, provider, location is scanned across the system for full transparency linked to patient outcomes and value.

Effective: outcomes are tracked at the individual and system level, leaders know exactly what outcomes they are achieving, and at what cost Patient Centered: Patients are are notified for recalls directly, have access to care product information to report outcomes.

Timely: Safety outcomes are identified rapidly, improved efficiency increases system capacity, reduced stock outs and shortages.

Efficient: greater efficiency in inventory management, delays in securing equipment, reduced prevalence of expired products, accurate case costing Equitable: Traceability enables accurate case costing relative to value for every patient and population segment to ensure every patient achieves value.

Liability and Risk Management: reduced costs related to litigation

NEXT STEPS FOR SCAN HEALTH GLOBAL DESIGN COMPETITION – LAUNCHED NCE RESEARCH NETWORK OPPORTUNITY – NOVEMBER 2017 BUSINESS CASE COMPETITION – JANUARY 2018 SUPPLY CHAIN MATURITY TOOL – MARCH 2018

SCAN Health © 2017

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Thank you!

For more information about SCAN Health, please visit our website at www.SCANHealth.ca, and connect with us on social media: @SCANHealthNCE @SCAN_Health SCAN Health Supply Chain Advancement Network in Health | 401 Sunset Ave, Windsor ON N9B 3P4 www.SCANHealth.ca | info.SCANHealth@uwindsor.ca

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