UDI and Interoperability · UDI and Interoperability . June 25, 2015 . ... All supplies that flow through Lawson with GTIN are in scope ... Activity Sequencing Process Flow Map ;

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UDI and Interoperability June 25, 2015

James Phillips

Franciscan Missionaries of Our Lady Health System

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• James Phillips is leading the UDI project for The Office of Data Standards & Interoperability team with Franciscan Missionaries of Our Lady Health System (FMOLHS). As a member of the MMIS team James managed data files that included contracts and pricing for the Health System. He joined FMOLHS last year after a progression of positions involving supply chain services, logistics, inventory management, purchasing, project management and Material Manager for a DOD contractor.

• James is a Louisiana native and earned his Bachelor of Science in Business Management and

Entrepreneurship from Louisiana Tech University in Ruston, LA. He has completed an Intermediate Project Management course through LANtec of Louisiana and holds a Certification in GS1 Standards.

• He also supports projects such as: implementing GS1 U.S. data standards and interoperability,

integrating Global Location Numbers (GLN) and Global Trade Identification Numbers (GTIN), “touchless order” with seven pilot manufacturers, implementing Unique Device Identifier (UDI) capture, track and trace, and Global Data Synchronization Network (GDSN) implementation. Currently James is supporting a GE Lean Six Sigma Black Belt Project for the Operating Room Supply Chain Redesign across the FMOL Health System.

James Phillips Office of Data Standards and Interoperability – Unique Device Identifiers, Franciscan Missionaries of Our Lady Health System

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The Franciscan Missionaries of Our Lady Health System’s service area is diverse and encompasses over 2.4 million people, over 50% of the State’s population. As a nonprofit, mission-focused Catholic healthcare ministry, we give special attention to our citizens who are most in need. During the most recent fiscal year, we provided more than $39 million in unreimbursed care and community support to the underprivileged.

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FMOLHS - Our Story • Where do we begin…it was easy • Having the right tools in place

– GS1 Toolbox – Master Project Plan – Master Network Diagram – Master Process Document

• Aligning our GLNs with our manufacturers • Getting the GTINs into our ERP now & later • Parallel Projects, CDC, Charge-Master, ERP, etc. • Trading information with our GPO

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Our Story… Where we started Who we partnered with What did we do first What was the initial output How the structure designed When did we know we were ready How did we build our GLN Hierarchy What did we do to begin loading our manufacturing partners’ GTINS and GLNs into our ERP

graphic courtesy of FMOLHS

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Our Story… What departments were involved How did we get buy in What automation was used How did we adjust to the technology constraints Where are we now OR Supply Chain Project What will we do next

graphic courtesy of FMOLHS

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Our Partners Our 7 Pilots – Manufacturers

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Our Partners Our Technology Partners Infor Lawson

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Our Partners US Healthcare Systems

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Our Partners Advisory Groups

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GS1 US Data Standards

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Documentation to Share • The Master Project Plan that can be used as a foundation easily adaptable to insert any

unique areas you have within your Health System. We built it based on PMI methodologies and Lean Six Sigma methodologies specific to implementing GS1 US Standards in the Health System. An updated version of the Master Project Plan that includes the additional work elements discovered while the pilots were active, will be completed before the end of June 2015.

• This is the final version of the Master Network Diagram for direct and distributed items. • The Master Process Document was finished in February 2015 and is ready for

distribution. As new documents are completed, I will share those with you as well.

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Resource UtilizationMelissa Brouillette GHX SMEAngela BarkerRebecca Williams Process Engineer - Green BeltPatrice Cahn LogisticsMichelle Boatner PurchasingJennifer Aldridge Lawson Application AdminLynette Thibeau NuVia, LawsonJessica Sharp APAngela Gautreau EDICarol Kitts EDI

Blue Belt Name: Sandi Michel

%Time Req.Phase 1: All implantables w ith UDI

Phase 1: Implantables w ithout UDISandi Michel Project Management

Name Subject Matter Expertise

IN OUT Black Belt/Instructor Stephen Griffin

Standardize the Health System to GS1 global data standards by populating the Lawson System with GLN, GTIN, and UDI; transitioning to use GTIN or UDI for purchasing and Logistics.

Identify and capture GLN and GTIN for Cook Medical throughout Supply Chain Process

Scope FMOLHS TEAM MEMBERS/Resources

Project Y: Target of what you want to change Goal

Sub-Process: Capture GLNs and GTINs for Cook Medical in LawsonBusiness Case: Problem Statement:

Project Number: GS12014

6/26/2013 Project Manager:

Core Process: Transacting using GLN and GTIN to support the Touchless Ord

We do not have GS1 Data Standards implemented at FMOLHS GLN, GTIN and UDI are not currently captured in Lawson for items purchased by FMOLHS.FMOL will align with all aspects of the GS1 data standards. Currently, most of the ship-to facilities have a GLN number, GTINs are captured in IC11 and UDIs are mandated at the manufacturer level to provide to businesses.

Location: All FacilitiesShort Name: GS1 Data Standards

Phase 1: All supplies that flow through Lawson with GTIN are in scope

Phase 1: All supplies that do not flow through Lawson without GTIN are not in scope

Sandi Michel

Project Name: GS1 Data Standards- Cook Medical Executive Sponsor: Bill MosserProject Charter Start Date:

The Charter

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Master Project Plan

Task Name Duration Start Finish Predecessors Resource Names Initiation 94 days Tue 10/8/13 Fri 2/14/14 Project Sponsor Create Charter 1 day Tue 10/8/13 Tue 10/8/13 Project Sponsor Develop the Charter 1 day Tue 10/8/13 Tue 10/8/13 Project Sponsor Charter Completed 0 days Tue 10/8/13 Tue 10/8/13 3 Project Sponsor OUTPUT: Charter 0 days Tue 10/8/13 Tue 10/8/13 Project Sponsor Create the Project Initiation Documentation (Optional) 85 days Mon 10/21/13 Fri 2/14/14 Project Sponsor Develop the Project Initiation Documents 3 days Mon 10/21/13 Wed 10/23/13 Project Sponsor Complete the Project Initiation Documents 0 days Fri 2/14/14 Fri 2/14/14 25 Project Sponsor Planning 125 days Tue 10/8/13 Mon 3/31/14 GS1 Assessment of Current State 56 days Mon 11/11/13 Tue 1/28/14 Project Manager Contact GS1 to arrange for assessments 2 days Mon 11/11/13 Tue 11/12/13 Project Manager

3 days Wed 11/13/13 Fri 11/15/13 11 Project Manager Tour each facility 5 days Mon 11/18/13 Fri 11/22/13 12 Project Manager

3 days Mon 11/25/13 Wed 11/27/13 13 Project Manager Large Team Kickoff Meeting to communicate expectations 0.5 days Mon 11/11/13 Mon 11/11/13 14 Project Manager Assessment begins first facility 3 days Tue 11/12/13 Thu 11/14/13 15 Project Manager,GS1 Prepare Readout 5 days Fri 11/15/13 Thu 11/21/13 16 GS1 Complete Assessment & Readout 0 days Tue 1/28/14 Tue 1/28/14 GS1 Develop Project Management Plan 125 days Tue 10/8/13 Mon 3/31/14 Project Manager Scope Planning 96 days Tue 10/8/13 Tue 2/18/14 Project Manager Develop Preliminary Project Scope Statement 1 day Mon 10/21/13 Wed 10/23/13 Project Manager Scope Definition 1 day Tue 10/8/13 Thu 10/24/13 21 Project Manager Complete Preliminary Project Scope Statement 1 day Fri 10/25/13 Fri 10/25/13 22 Project Manager Create the WBS 1 day Thu 1/30/14 Fri 1/31/14 Project Manager Create Definition of Terms or Glossary 10 days Mon 2/3/14 Fri 2/14/14 24 Project Manager Finalize Preliminary Project Scope Documents 2 days Mon 2/17/14 Tue 2/18/14 25 Project Manager Complete Project Scope Management Plan 0 days Tue 2/18/14 Tue 2/18/14 26 Project Manager OUTPUT: Scope Management Plan 0 days Tue 2/18/14 Tue 2/18/14 27 Project Manager Schedule Development 12 days Fri 2/28/14 Mon 3/17/14 Project Manager Activity Resource Estimating 3 days Fri 2/28/14 Tue 3/4/14 Project Manager Activity Duration Estimating 3 days Fri 2/28/14 Tue 3/4/14 Project Manager Activity Definition 3 days Fri 2/28/14 Tue 3/4/14 Project Manager Activity Sequencing 3 days Fri 2/28/14 Tue 3/4/14 Project Manager Activity Sequencing Process Flow Map 3 days Wed 3/5/14 Fri 3/7/14 33 Project Manager

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Network Diagram

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Master Implementation Process

First Edition- Supply Chain

Sandi Michel James Phillips

Matthew Kurtz


FMOLHS-GS1 US DATA STANDARDS MASTER PROCESS IMPLEMENTATION PLAN A global plan for the implementation of the GS1 Standards for Health Systems around the United States.

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TABLE OF CONTENTS PROCESS IMPLEMENTATION TEAM CONTROL TABLES ................................................ 2

Document Revision Control ........................................................................................................ 2

Circulation List ............................................................................................................................. 2

Change Control Log ..................................................................................................................... 3

Document Approval .................................................................................................................... 3

1. EXECUTIVE SUMMARY ............................................................................................ 7

2. PROCESS IMPLEMENTATION ................................................................................... 8

2.1. Objective .............................................................................................................................. 8

2.2. FDA Unique Device Identification (UDI) Regulation ............................................................ 8

2.4. GS1 ..................................................................................................................................... 10

2.5. Master Project Plan and Subprojects ................................................................................. 11

2.6. Process Management Plan ................................................................................................. 11

3. HOW TO INITIATE THE PROJECT ............................................................................ 14

3.1. Develop Charter ................................................................................................................. 14

3.2. Identify Stakeholders ......................................................................................................... 14

3.3. Implementation Plan .......................................................................................................... 14

4. HOW TO PLAN THE PROJECT ................................................................................. 16

4.1. Acceptance Requirements ................................................................................................. 16

4.2. Project Timelines ................................................................................................................ 17

4.2. Financial Resources ............................................................................................................ 19

4.3. Expected Project Deliverables: ........................................................................................... 19

4.4. Project Implementation Roles............................................................................................ 20

4.5. Process Flow Development ................................................................................................ 22

4.6. Communication Plan .......................................................................................................... 25

5. HOW TO EXECUTE THE PROJECT PLAN .................................................................. 26

5.1 Process Implementation Structure ..................................................................................... 26

5.2. Picking Organizations to Pilot ............................................................................................. 27

5.3. Implementing GLNs ............................................................................................................ 27

5.4. Implementing GTINs ........................................................................................................... 28

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The UDI allows you to more efficiently and effectively manage your supply chain in a number of ways

including: • Better cash flow: Using UDI simplifies your chargeback and rebate processing, thereby decreasing

the amount of money your organization has in unresolved sales accounts. • Reduced labor costs: Adoption of UDI reduces the amount of time staff spend building and

maintaining tables in different systems to track all your proprietary account numbers. • Simplified supply chain management: Using a common number (UDI) facilitates information

exchange between various supply chain partners. • Efficient payment and reporting processes: Using UDIs allows sales to be automatically reported to

providers with fewer errors, thereby improving electronic data interchange (EDI) and ebusiness dealings.

• Enhanced inventory management: UDIs provide a consistent way of identifying items. This means that receivers are in a position to correctly identify the items for distribution and use by reducing the number of items sent in error, thereby supporting efficient replacement of these items throughout the organization.

Premier Research Institute – The Pew Charitable Trusts

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Including the UDI in your clinical suite software and EHRs can provide a number of possible benefits for

your organization, including: • Facilitating easier recalls when devices malfunction. • Enabling clinicians and researchers—particularly at large health

systems—to conduct analyses on device performance. • Allowing more accurate reporting, reviewing and analyzing of adverse

event reports so that problem devices can be identified and corrected more quickly.

• Preventing medical errors by enabling health care professionals and others to more rapidly and precisely identify a device and obtain important information concerning the characteristics of the device.

• Reduce manual and unstandardized methods of data entry to record device use with an electronic system.

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Continued • Fully implementing UDIs will take time and require addressing a number of challenges. A

key challenge is that UDIs may initially be captured in any of a variety of clinical, inventory, registry, or other IT systems. Robust adoption and use of UDIs will require bridging these different components and changing IT and administrative processes to, among other things, ensure that UDIs are properly captured and associated with patients’ electronic health records.

• In December 2014, the Brookings Institution with collaboration from FDA published a detailed roadmap for effective UDI implementation. Significantly, the roadmap’s recommendations stated that “while the path to full implementation is complex, there are relatively straightforward steps that can be done now” to begin realizing the benefits of UDI implementation across the health care system. The roadmap’s recommendations specifically urged ONC to support the incorporation of UDIs into certification criteria for health IT.

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Automatic identification and data capture Automatic identification and data capture (AIDC) refers to the methods of automatically identifying objects, collecting data about them, and entering that data directly into computer systems (i.e. without human involvement). Technologies typically considered as part of AIDC include bar codes, Radio Frequency Identification (RFID), biometrics, magnetic stripes, Optical Character Recognition (OCR), smart cards, and voice recognition. AIDC is also commonly referred to as “Automatic Identification,” “Auto-ID,” and "Automatic Data Capture."

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Interoperability Incorporate UDI into various electronic databases, including supply chain, electronic health records, claims, and billing systems; the benefits greatly exceed the costs.

Two key trusted data sources are: GDSN GUDID

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Global Data Synchronization Network • The Global Data Synchronizations Network (GDSN) enables

trading partners to globally share trusted product data. You can exchange product information with business partners in an automatic and efficient way that ensures brand integrity.

• To be able to exchange product data on GDSN, you must join a data pool that’s been tested and certified to meet GS1 global standards.

• It’s important to remember this is a business project, not just an IT project, so you’ll need to engage stakeholders at all levels within your company to get it off the ground.

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Tips from GS1 US • Step 1 – Getting buy-in

• Set up a core business team with subject matter experts and technical experts . • ‘Sell’ your strategy –you will need to get commitment from senior management within the business. It’s a good idea to

make sure your partners get this too, so each business is working towards the same goal. • Step 2 – Building your strategy

• Build a business case for your company – make sure you link it to key performance indicators so you can track the progress of your strategy. Start by looking at how your business currently operates and work from there to identify how GDSN will benefit your business. You’ll also need to look at your IT resources and identify costs so you can spread the investments you’ll need to make.

• Choose an implementation team – at this stage you’ll need to choose the GDSN Data Pool. • Step 3 – Setting the standard for your data

• Check the quality of your data – make sure you’re not synchronizing incorrect or wrongly classified data. • Step 4 – Getting started

• Begin with small steps – before rolling it out to the whole business or all of your suppliers, start working with a few key items and just a few trading partners to test the water.

• Test it out – try to set up pilot tests with some of your partners. This will help you monitor the results and make any necessary changes before you go ahead with full production.

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Device Identification Prior to UDI • Non-standard device identification systems; standards

used in different ways • Not necessary unique or unambiguous • Does not include all necessary levels of uniqueness • Manufacturers’ own number/catalogue number • Distributors’ – apply different, proprietary number;

lot or serial number not captured • Hospital – yet different identification number/code

• Information on use not usually captured • Control numbers rarely captured

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Unique Device Identifiers

• GUDID Integration support and mapping

• Drive GS1 standards / scanning in the ERP

• Drive GS1 standards / scanning in the EHR

• Vendor Relationship • Adverse Event Reporting

• Meaningful Use Reporting

• Value Analysis • CDM Team • Registries • Recalls • Real-time locating

systems (RTLS) / Asset Tracking

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Public Health Benefits The UDI system provides global visibility and supports:

• Medical device recalls • Adverse event reporting • Tracking and tracing • Supply chain security • Anti‐counterfeiting/diversion • Disaster/terror preparation • Shortages/substitutions • Reduction of medical errors (e.g., bedside scanning) • Easily accessible source of device information for patients and clinicians

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Implementation Steps • Facilitate incorporation of UDI into EHRs as part of EHR certification • Complete pilot demonstrating ability to incorporate UDI into hospital information systems • Complete collaboration as basis for initial UDI “roadmap” for incorporating UDI into EHRs and ensuring real-time access to device information across data sources

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MASTER DATA MANAGEMENT

GS1 Standards Adoption Roadmap •Identified process impacts/opportunities in a Process Flow with Product ID (SNI/UDI) capture from Procurement through Reporting •Included maintaining traceability of SNI and UDI in lower units of measure -barcoding, kitting, prepackaging in-house

System Integration Impacts •Overall systems context drawing with transition states completed •Re-visit when GDSN data pool solution in-place for mapping FDA Global Unique Device Identification Database (GUDID) data to internal systems and GS1 GDSN

Product Traceability –Solutions/Services for Interoperable Systems •High level design to align for MDM and technical environment to define robust solution designs by system and integration points (ERP, WMS, GDSN, EHR and related clinical, financial & reporting systems) and process (supply chain, pharmacy, central distribution center); engage applications and implementation partners.

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Next Steps

• Implementing access to the GDSN to provide attributes from the manufacturers with real-time updates.

• Integration of GS1 barcode labels/ scanning with IT systems and internal process changes to achieve true interoperability

• Develop Requirement Specifications for ERP, WMS, GDSN, and EHR systems, enhancements and interfaces.

• Define system implementation, training and system release project plans and organization impact.

• Lead or execute system implementations, enhancements and integration with selected partners

• External Integration –EDI, SPL • Publish documentation to other Healthcare Companies across the

US

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How to Establish an Office of Data Standards & Interoperability in Your Health

System

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Overview The Office of Data Standards & Interoperability was established to design, develop, establish, and implement standards and interoperability across FMOLHS, meet regulatory requirements and to share the documentation of processes, network designs, master project plans with other health systems across the United States. The foundation for GS1 US Standards is standardization and interoperability. FMOLHS has implemented GLNs and GTINs for seven pilot manufacturers and is now implementing data synchronization with access to the GDSN.

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Initiation

Defining the project Identifying and engaging a Sponsor Creating the Mission and Vision Statements Creating the Charter Identifying the Stakeholders Defining Roles & Responsibilities Writing the job descriptions Creating a functional organization chart

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Planning • Staffing Leadership Positions • Constructing the Master Project Plan • Producing the Master Process Documents • Developing a Proposed Network Diagram • Designing a SharePoint Site • Establishing the SharePoint Site

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Execution • Assigning subprojects to each Manager of DS&I • Creating materials list for initial tools and supplies • Ordering materials • Receiving and assigning "Assets" to Managers of DS&I" • Communicating Roles and Responsibilities • Establishing Contact List

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Monitoring & Controlling • Scheduling Weekly Status Meetings • Addressing Risks and Document Outcomes • Capturing Issues and Document Solutions • Communicating with Stakeholders • Communicating with Sponsor • Adjusting processes as needed • Evaluating progress • Finalizing documentation • Transitioning to Normal Operations Begins

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Closing Reviewing Lessons Learned Discovering Opportunities for Improvement Making improvements Setting up Operational Control Plan Setting Goals for 1 year, 3 years, 5 years Transitioning to Operations Completed

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