healthcare transformation group supply chain summit

Healthcare Transformation GroupSupply Chain Summit

May 3, 2011

H T G

> Geisinger > Kaiser Permanente > Intermountain Healthcare > Mercy Health System > Mayo Clinic >> Kaiser Permanente > Intermountain Healthcare > Mercy Health System > Mayo Clinic > Geisinger >> Intermountain Healthcare > Mercy Health System > Mayo Clinic > Geisinger > Kaiser Permanente >> Mercy Health System > Mayo Clinic > Geisinger > Kaiser Permanente > Intermountain Healthcare >> Mayo Clinic > Geisinger > Kaiser Permanente > Intermountain Healthcare > Mercy Health System >

Welcome and Introductions• Welcome & Housekeeping• What is HTG?• Why is our work important – Quality & Efficiency• Expectations

• Working meeting – focus on the common good• Our work in no single entities issue – cross bounds• Focus on what we can agree – variation reduction• All issues will not be resolved – much work to do

• Outcome• Clear and common understanding of the issues• Exposure of hidden issues and concerns• Commitment to work on issues• Better understanding of success timeline

Anti-Trust and Code of Conduct

Anti-Trust and Code of Conduct

HTG follows all US laws relating to antitrust and competition and there shall be no conduct that could artificially increase price, reduce output, or result in any type of boycott. If anyone believes the discussions are approaching antitrust boundaries, please say so and the discussion will be halted while a HTG participant checks with legal counsel before proceeding.

You are also reminded that the Code of Conduct requires we respect one another’s differences in opinion, act professionally and engage to work together for the common good of the community.

Anti-Trust and Code of ConductThis means:• Participation must be voluntary, and failure to participate shall not be used to

penalize any company.

• There shall be no discussion of prices, allocation of customers or products, boycotts, refusals to deal, or market share.

• If any participant believes the group is drifting toward impermissible discussion, the topic shall be tabled until the opinion of counsel can be obtained.

• Meetings shall be governed by an agenda prepared in advance, and recorded by minutes prepared promptly after the meeting. Agendas, where appropriate, and minutes are to be reviewed by counsel before they are circulated.

• Tests or data collection shall be governed by protocols developed in consultation with and monitored by counsel.

• The recommendations coming out of a HTG committee, task force, work group or task group are just that. Individual companies remain free to make independent, competitive decisions.

• Any standards developed must be voluntary standards.

Day 1

12:00-12:10 Welcome and Introduction Vance Moore, Brent Johnson, Deb Templeton

12:10-12:45 Lunch All

12:45-1:15 Why Collaboration Lynn Britton - Mercy

1:15-3:45 Provider Report OutProviders to report out on current status in adoption of GS1 Standards

Providers

3:45-4:00 Break All

4:00-5:00 Using the GTIN Beyond Point of Care Natalia Wilson - ASU

5:00-5:30 Wrap-up and Review Day 2 Agenda Curtis Dudley - ROi

6:30-8:30 Dinner at Villa Farotto All

H T G ROUPAGENDA

HTG Group SummitTuesday, May 3

Agenda

Day 2

7:30-8:00 Breakfast at Corporate Plaza All

8:00-8:30 Suppliers and Providers Enablement to use GS1 Standards

MJ Wylie - GHX

8:30-9:00 Software Vendor ReadinessSoftware providers to report out on readiness to adopt GS1 Standards

Keith Lohkamp - Lawson

9:30-10:00 Supplier Best Practice of GS1 Standards Dennis Black – Becton Dickinson

10:00-10:15 Break All

10:15-11:45 Suppliers Report Out on Readiness Suppliers

11:45-12:00 Conclude Meeting HTG Sponsors

12:30-2:30 HTG members working session and lunch HTG Members and Sponsors

H T G ROUP AGENDAHTG Group SummitWednesday, May 4

Agenda

Source to Consumption Vision – Michael Innes/Curtis Dudley

Source to Consumption

Vision

Source to Consumption Vision – Michael Inness/Curtis Dudley

The application of the GS1 standards will be used in all areas in the Source to Consumption model…

Pay Consume / CompareReceiveOrderSource

Data Synch

• Perfect Order• EDI / xML Orders• Replenishment• One Shot / Off Contract• 4 way validation

• Enables electronic invoice processing

• Speeds payment process• Reduces discrepancies• Enables account statement

reconciliation

• Point of Care Optimization

• Electronic Health Records• Standardization• Product Recalls• Comparative

Effectiveness• Reimbursement• Patient Safety

• Product Identification• Distribution Method• Supplier identification• Demand / Forecasting• Data Transparency

• Correct identification of product

• Transportation & Logistics• Error Identification• Pick Pack and ship• Kitting• Reverse Logistics

• Enables transactional accuracy

• Reduces labor cost• Enables end to end

process efficiency

Enables end to end transactional efficiency

Master Data Synchronization

Source to Consumption Vision – Michael Inness/Curtis Dudley

Vision Breakdown by Area

Source to Consumption Vision – Curtis Dudley

ProviderSupplier

Supply Chain

System

Supply Chain

System

GTIN

GDSNData Pool

GTIN

GLN Healthcare RegistryGLN GLNGLNGLN

Price / Contract Update


Data Synch


Source to Consumption Vision – Curtis Dudley

• Mater data synchronization enables supply chain transactional accuracy

• GS1 standards enable accurate data synchronization

• Elimination of transactional errors will reduce the investment of labor for both providers and suppliers


Data Synch


Source to Consumption Vision – Brent Johnson

Source, Order, Receive, Pay & Consume• Data Synch – Tying it together• Source - Visibility drives accuracy• Order – Speed & Accuracy• Receive – Catching errors • Pay – Eliminating the touch points• Consume – Driving patient safety


Data Synch

Source to Consumption Vision – Karen Wolfe

Value Points• Product Identification• Distribution Method• Supplier identification• Demand / Forecasting• Data Transparency

Strategic sourcing starts with data transparency giving insight into product utilization. A common data standard will provide clarity to what is used, from whom and how much allowing providers to intelligently analyze and predict future use


Data Synch

Use of GS1 Standards brings transparency to the Demand Forecasting process enabling;

• An understanding into variables impacting product usage

• Application of forecasting models• Enterprise wide applications

Demand Forecasting



Data Synch

Product OrderProduct Order utilizing Data Synch

• Order processing speed within Supply Chain

• Order processed to correct supplier entity

• Correct product at the correct time at the correct location


Data Synch



• Price management allowing for correct order pricing

• Improved rebate reconciliation• Improved end-user confidence• Patient Safety and Satisfaction

Product Order utilizing Data Synch


Data Synch

Source to Consumption Vision – Mark Olson

Receiving• Correctly identify product by utilizing

GTIN

• Accurate receiving speeds the payment process

• Enables providers to quickly identify shipping errors

• Enables line level reconciliation against the purchase order

• Possibility to receive on ASN


Data Synch


Payment

• Touch less – no labor points• Supplier is paid sooner• Increased Payment Discount

Eligibility• Possibility to eliminate invoice –

ERS (evaluated receipts settlement)


Data Synch


EA or PK or PC

PaymentPain Points• Catalog- order catalog # does not match the shipped catalog # which does not match the invoice catalog # (3643 Invoice lines touched for catalog errors in the past 12 months)

Provider sent PO with catalog 45687Supplier invoices catalog 45687IL or 45687KY depending on where it the product shipped from

• Unit of Measure – often the invoice unit does not match the purchase unit (3715 Invoice lines touched for UOM errors)


Data Synch


PaymentPain Points Continued

•Price – Price on the PO doesn’t match price on Invoice (8929 Invoice lines touched for price errors)


Data Synch


Payment


Data Synch

Consumption (consume) starts at the Point of Care (POC) and moves beyond the four walls of an organization supporting patient safety throughout the delivery of care and beyond


Data Synch

Source to Consumption Vision – Michael Innes

Value Points• Data standardization • Enablement of process optimization • Streamlining product recalls and tracking

Application of GS1 Standards to medical devices, items & implants consumed at POC will drive data

standardization;

• Preference card standardization• Increase charge capture opportunities • Activity Based Costing model for procedures• Population of patient logs• Shortened cash to cash cycle• Medical records portability


Data Synch


Application of GS1 standards enable process optimization opportunities in the following areas;

• Barcode Scanning• Consistent application of product attributes• Reduces ‘Supply on the Fly’ requests• Reduced manual intervention to close Patient logs

Free up clinicians time to provide patient care


Data Synch


GS1 standards will streamline the product recall tracking process ensuring patient safety at the

POC and beyond

• Eliminates need for translation among all parties• Ability to track at and beyond the POC• Claims facilitation


Data Synch


Source to Consumption Vision – Deb Templeton / Kevin Capatch

Scorecard

Source to Consumption Vision - Scorecard

• Reason for Scorecards• GS1 Scorecards• HTG Scorecards

• Provider Group• Supplier Group

• Examples• Geisinger – GLN & GTIN• ROi – Perfect Order


"If you're not keeping score, you're just

practicing“

~Vince Lombardi

Source to Consumption Vision - ScorecardGS1 Supplier Scorecard

Source to Consumption Vision - ScorecardGS1 Provider Scorecard

Source to Consumption Vision - ScorecardGS1 Software Suppliers

Source to Consumption Vision - ScorecardGLN Transactions

Source to Consumption Vision - ScorecardGTIN Transactions

A Perfect Order is defined by SMI as a purchase order processed electronically (from order to payment) without

human intervention, which is delivered to the correct location, on time, undamaged, at the correct price – i.e., the provider’s

purchase order price matches the supplier invoice price -with the desired quantity, on the first attempt. When a trading relationship is able to consistently achieve Perfect Orders, all partners will be efficiently utilizing their available resources through elimination of errors and maximization of available

technology.


Perfect Order

Source to Consumption Vision - ScorecardPerfect Order

Provider Status – Individual Report Outs

Provider Report Out

• Largest vertically integrated IDN• 8.5m members• 164K employees• $42B Revenue• California, Georgia, Hawaii, Mid Atlantic States, Ohio, Oregon, & Colorado

• 36 Hospitals, 449 Medical Office Buildings• 2nd Largest employer in Calif.• 2nd largest real estate owner in the Calif.• 5th largest construction company in the U.S. • Average vendor spend individually ~$40M • Cumulatively ~ $500m

FactsProvider Status – Kaiser Permanente

https://www.kpbrandextranet.org/dl.php?file=assets/logos/Standard/horizontal/PMS_307/KPhor_307pc.eps

Provider Status – Kaiser PermanenteKP see the use of GS1 data standards as a pillar

in our Supply Chain Transformation;

• Demand Forecasting Capabilities• Core Procurement (eHub) • Point of Care

The Supply Chain extends into the Point of Care andand supports patient care and safety

Manufactures / Suppliers

GPO

Product Info(incl. GTIN)

(PSOC)

Product(incl. GTIN)

Item Master Info.(incl. GTIN)

Interface

OneLink (PeopleSoft)

Interface

Currently Component Interface willhandle upload of GTIN info. MassLoader Phase II will incorporateGTIN functionality

DataCleansingServices

HealthConnect

Change Request has beensubmitted to accommodate GTINFlow into KPHC

Leveraging HTC subgroup to beginGTIN labeling and pass thru of dataprior to 2012 Sunrise

GDSN(Global Data Synchronization

Network)

GTINGTIN

Provider Status – Kaiser Permanente

Kaiser’s continues to build momentum around GS1 standards from the clinical side of our business and will drive implementation from both

the clinical and the business side

Provider Status – Kaiser Permanente

Core Procurement

Danville, PA

Wilkes Barre, PA

Provider Status – Geisinger


Implementation Team

• HSCSC Member• GLN pilots started in 2008• Currently utilizing the GLN registry• Lawson ERP upgrade complete 5/1/11• GTIN – Test pilots• Track & Trace

• RX – Bedside• Barcoding & E-Pedigree • UDI – Unique Device Identifier

• Implications for RFID / RTLS


Supply Chain services contribution to patient safety via bedside barcode utilization and data integrity for Electronic Health Record


• Headquarters in Salt Lake City, UT• Largest employer in the state – more than

32,000 employees• Created in 1975 when LDS Church “gifted”

hospitals to the community• Modern Healthcare #1 or #2 for the last seven

years• Hospital Network

• 23 Hospitals; 2,500 + Licensed Beds• Medical Group

• 800 Employed Physicians; 150 Clinics• Select Health – Health Plans

• 500,000 Direct Enrollees• $3.1 Billion in Net Patient Services Revenue• $5 Billion in Assets• AA+ Standard & Poor’s; Aa1 Moody’s

• only system to receive highest rating from both S&P and Moody’s

• Average Spend per Supplier in Attendance $18 Million annually

Provider Status – Intermountain HealthcareAbout Intermountain

Healthcare

Brent T. JohnsonVice President Supply Chain & Imaging ServicesChief Purchasing OfficerIntermountain [email protected] 1100005442719GS1US – Intermountain Executive Sponsor

Cynthia ShumwayManager Supply Chain Systems and InformationIntermountain [email protected] 1100005442719GS1US – GDSN, GTIN, GLN

Mark OlsonSupply Chain AnalystIntermountain [email protected] 1100005442719GS1US - GTIN

Heidi TrimbleSupply Chain SpecialistIntermountain [email protected] 1100005442719GS1US – GLN

Provider Status – Intermountain Healthcare

Implementation Team

• Self Distribution (IMAT)

• Touchless (Perfect Order) - Source to Settle with out touching the Price File, PO, PO Acknowledgment and Invoice.

• Ability to Scan in the OR’s will drive efficiency, and patient safety.


Intermountain Healthcare is adopting the GS1 Standards and envisions these standards as best business practices.


Provider Status – Mayo Clinic

• 23 Hospital Organization about 3500 beds• Campuses:

• Rochester, MN• Jacksonville, FL• Scottsdale/Phoenix, AZ• 70 communities in the upper Midwest through Mayo Clinic Health

System

• 55,900 personnel caring for more then half a million people per year

• Primary Value The needs of the patient come first.

About Mayo Clinic


• Supply Chain Informatics• Procure to Pay• Reporting and Analytics• Supply Chain Operations• GPO• Distributor• Supplier

GS1 Standards Implementation Team


• Started with GLN Implementation 2008 with a current number of 40 Suppliers

• GTIN/GDSN Project kickoff 4thQ 2010 with implementation 2ndQ 2012. P2P process Upgrade Lawson ERP to utilize GS1 Standards Starting with 140 Johnson and Johnson Health Care

Systems Inc products purchase through Cardinal Health Additional product implementation shortly after the 2012

go live

Implementation

Provider Status – Mercy Health

26 ACUTE CARE HOSPITALS

3 HEART HOSPITALS

4,367 LICENSED BEDS

35,580 CO-WORKERS

385 PHYSICIAN PRACTICE LOCATIONS

4,626 MEDICAL STAFF MEMBERS

1,245 INTEGRATED PHYSICIANS

$4.05 Operating Revenue (Billions)


• Our point of care project is driving our need for standards

• Quality of care• Efficiency

• New model of care requires increased coordination

• Our Perfect Order project has led to many discoveries and helped us realize the need for supplier integration

Mercy utilizes the GLN and GTIN in all transactions from order to consumption but only for suppliers that support the standards


Summary

What do we need from Suppliers?

All HTG members are focused on the same target with common application…

Summary – What do we need from Suppliers

Summary – What do we need from Suppliers• Share your standards strategy• Subscribe to GLN registry and integrate into

operations• Begin GTIN enumeration and apply to products

at unit of use• Register your products with the GDSN• Prepare for FDA regulations on UDI• Commit to working with HTG group to resolve

issues and move forward quickly with full adoption

Parking Lot Issues

• Can we utilize GLN to track raw material providers

• How do we handle a GTIN that is not unique

• Should GTIN replace mfg catalog number

• How do we handle non-packaged products

• Can we auto populate product data in provider systems

• How do we handle different attribute standards across different countries

• How do we get to common / industry standard definition of unit of use

Baxter Healthcare

Update on GS1 Standards

HTG (Health Transformation Group)

May 2011

Program Team

Nathan Habeck – Program Manager – GS1 Global Leadership

Barb Zenner – Project Manager – GS1 Transaction Implementation

Marcia Kafkakis – Project Manager – Product Marking Implementation

Baxter

• Baxter is a Global Company that develops, manufactures and markets products

that save and sustain lives of people with hemophilia, immune disorders,

infectious diseases, kidney disease, trauma, and other chronic and acute

medical conditions.

– Manufactures Products in 27 Countries

– Markets in over 100 Countries

– 56 Manufacturing Plants Worldwide

Baxter Confidential Product Identification Deployment Plan DRAFT

– 56 Manufacturing Plants Worldwide

– Employ’s approximately 49,700 people Globally

Baxter’s Current Status – Standards Subscribed

Baxter has publically announced the support and direction of moving to GS1

standards:

Doing Business with Baxter

Baxter endorses and strongly supports the GS1 standards for healthcare. We

believe that industry-wide adoption of these standards will improve patient

safety and will drive increased efficiency and integrity within the healthcare

system.


system.

Customers, suppliers, providers, distributors and other supply chain

participants interested in learning more about Baxter's involvement and

adoption of GS1 standards can contact the Center for One Baxter at 800-422-

9837 (800-4Baxter) or 847-948-4770.

Baxter Sustainability

Baxter Training and Knowledge

Knowledge/Education

• Established a Baxter Global Council

• Internal Website – GS1 Global Standards

• Key Components

• Who is GS1?

Training

• Commercial Operations fully aligned with GS1 transactions


• Commercial Operations fully aligned with GS1 transactions

• Global attendance at GS1 Workgroup sessions

• Internal Website Under Development for Educating Baxter teams globally

Baxter GS1 Implementation – Sponsorship and Support

Executive Level Steering Committee (C-Level)

V.P. Global Manufacturing

V.P. Global Supply Chain

V.P. Quality

V.P. Regulatory/Safety Affairs

V.P. Government Affairs

Corporate Services

Executives at each Business Units (BioScience, Renal, Medication Delivery)


Functional Workgroup Support (SMEs and Steering Committee)• Supply Chain

• Finance

• Sales and Marketing

• Manufacturing

• eCommerce

Baxter’s Planned Pilot’s in the Procure to Pay Process

Status of GS1 Standards

• GLN (Global Location Number)

• GLN stored in Master Data at Account number that is searchable

• GLN used in EDI cross reference file to receive electronic transactions

• GLN returned on EDI transactions if received in EDI transactions

• GLN accepted for manual transactions if stored at account number

• GLN will be returned on paper invoices – rollout of ERP complete globally

• GLN process past pilot, live with approximately 6 customer IDNs

• Currently Reconciling with 5 providers


• Currently Reconciling with 5 providers

• GTIN (Global Trade Item Number)

• GTIN stored in Item Master

• GTIN map under development for ‘UK’ segment to be received and sent for

all electronic transactions

• GTIN accepted for manual and electronic transaction –ERP rollout

complete globally

• GTIN currently returned on paper (printed) invoices

• GTIN pilot will be conducted when electronic maps available – ERP rollout

Baxter’s GTIN Program and Approach for US

• Committed to meeting the GTIN requirements for sunrise

• Approximately 80% of Baxter Products have GTINs assigned today in ERP

• All Drugs have GTINs marked on unit of use and selling unit

• Assessed manufacturing current state for devices, waiting UDI ruling

• Most devices have GTIN today, waiting if variable information that will need to

be added based on ruling


be added based on ruling

• Upgrade path and cost have been presented to C-level steering committee

• Refining priorities to meet the needs of products based on risk level

Baxter Master Data Synchronization (GDSN, Flat File, etc….

• Approximately 32 GTINs stored at GDSN for Baxter US

• Uploaded via spreadsheet to data pool (Health ConneXion)

• Approximately 7 providers have requested synchronization

• Approximately 14 GTINs loaded in data pool for Baxter Canada

• Uploaded via spreadsheet

• Healthcare attributes have been established in Baxter’s GE (Global Enterprise)

item master


item master

• Additional country attributes will/or have been established at the regional level

• Baxter has an on-line product catalog export available with GTIN’s supplied

• Goal for 2012 is to use GS1xml to send Baxter data globally to our data pool

Global Enterprise

(Product Data)

Baxter’s Strategy of Loading Product Information to GDSN


AllSource GDSN FDA UDI

Data Pool

Health

ConneXion

Contact Information:

Barb Zenner

Baxter Healthcare

[email protected]

(847) 847-3922


(847) 847-3922

1

Adoption of GS1 Standards Adoption of GS1 Standards

Healthcare Transformation GroupSt. Louis, Missouri

5/04/11

Dennis BlackDirector, [email protected]

Agenda: Adoption of GS1 Standards

� Introduction

� Industry Sunrise Dates

� GLNs

� GTINs

� GDSN

� Practical Implementation Steps

� Discussion

2


� Introduction


� GLNs

� GTINs

� GDSN


� Discussion

BD Overview

BD is a leading global medical technology company that develops, manufactures and sells medical devices, instrument systems and reagents. The Company is dedicated to improving people's health throughout the world. BD is focused on improving drug delivery, enhancing the quality and speed of diagnosing infectious diseases and cancers, and advancing research, discovery and production of new drugs and vaccines. BD's capabilities are instrumental in combating many of the world's most pressing diseases. Founded in 1897 and headquartered in Franklin Lakes, New Jersey, BD employs approximately 29,000 associates in more than 50 countries throughout the world. The Company serves healthcare institutions, life science researchers, clinical laboratories, the pharmaceutical industry and the general public. For more information, please visit www.bd.com.

BD Influx™ Flow Cytometry System

BD Viper™ System with XTR Technology

BD Vacutainer® Push ButtonBlood Collection Set

BD PosiFlush™ Flush Syringe

BD Nexiva™ Closed IV Catheter System

BD SurePath™PAP Collection System

BD™ Insulin Syringes

3

BD Participation in Data Standards

• Member of GS1 Healthcare

• Member of GS1 US Healthcare

• BD participates in many GS1 Workgroups

• Focus has been on eliminating waste and errors

BD’s journey with GS1 and bar codes began in 1972

What is BD’s interest in Data Standards?

• Meet Customer Needs

- Patient Care/Safety

- Operational

• Perfect Order

• Reduce Operating Costs

• Meet Regulatory Requirements

4

Everyday Use of Standards

Data Standards = Collaboration/Efficiencies and Patient Safety

Data Standards Can Enable Tremendous Opportunities

Manufacturer Product # Distributor Product # Hospital Product #Hospital Product #Hospital Product #Hospital Product #

Product Data Product Data Product Data Product Data Product Data Product Data

Location Data Location Data Location DataLocation DataLocation DataLocation Data

Artwork Courtesy of GS1

5

Potential Benefits of Using GS1 Data Standards(Fully Adopted State)

• Reduce errors

• Reduce back office, non-value added activity

• Optimize supply chain

• Growth of e-Business transactions

• Patient safety initiatives

• More accurate transactional data

• Global harmonization of products/labels

We will not see a benefit without complete adoption

Dust off the EHCR Study

EHCR Assumptions:

• $83B of applicable Products/Services

• $23B in Process Costs

• 48% of Process Costs Considered Waste

Annual Supply Chain Costs: EHCR Estimate

Product Cost

(72.29%),

$60,000,000,000

Process Waste

(13.25%),

$11,000,000,000

Process Cost

(14.46%),

$12,000,000,000

Product Cost (72.29%)

Process Cost (14.46%)

Process Waste (13.25%)

The Three Strategies are: The Four Enablers are:

-Efficient Information Sharing -Partnership and Alliances

-Efficient Product Movement -Change Management

-Efficient Order Management -Information Technology-Activity-Based Costing

EHCR

6


� Introduction


� GLNs

� GTINs

� GDSN


� Discussion

© GS1 US 2010

*December 2010

2010 GLN Sunrise

“Adoption of GLN in Healthcare by 2010*”

Global Location Numbers (GLNs)

� GLNs are assigned by location owners

� GLNs are used in appropriate business transactions and processes between trading partners

� GLN hierarchy is defined and maintained by location owners

� GLN Registry for Healthcare® is used to facilitate correct location identification

7

© GS1 US 2010

* December 2012

2012 GTIN Sunrise

“Adoption of GTIN in Healthcare by 2012*”Global Trade Item Numbers (GTINs)

� GTINs are assigned to healthcare products

� GTINs are used in business transactions

� GTINs are marked on appropriate packaging levels

� GTINs are scanned at points-of-delivery to enhance clinical process

� GTINs are used in product returns and recalls

� GTINs are registered in a GS1 GDSN-certified Data Pool


� Introduction


� GLNs

� GTINs

� GDSN


� Discussion

8

Challenge: Location Identification

• St. Michaels

• St Michaels

• St. Michael’s

• Saint Michaels

• 100084547

• JAOE

• CA2053

• 50003000431

• Etc.

Just 1 Hospital

Sales Tracing/RebatesSales Tracing/Rebates

Provider GPO Distributor

Order Placement

Order PlacementDrop Ship

GPO Membership

Rebates

Pricing

Administration Fees

Product ShipmentProduct Shipment

Manufacturer

GLN: Simple Concept/Difficult Implementation

Contracting

9


� Introduction


� GLNs

� GTINs

� GDSN


� Discussion

Current Product Numbers are Not Unique

Other SupplierBD ProductCat #

CARL ZEISS 305905 FLOORSTAND S-1

COMPLETE, W/ARTICULATED ARM

SYSTEM FOR OPMI & ACCESS 2.5-7 KG.

305905 - 3 mL BD SafetyGlide™ syringe

with 23 G x 1 in. shielding intramuscular

injection needle, regular bevel, regular wall. Detachable needle. (50/sp, 400/ca)

305905

Codman 371073 DEBAKEY BULLDOG

CLAMP RING HANDLE ANGLED 90?

STRAIGHT SHAFT 41MM JAW 4 3/4''

(120MM)

371073 - BD E-Z Scrub™ surgical scrub

brush impregnated with 4% CHG. Color

coded red. (30/sp, 300/ca)

371073

Mallinckrodt 3817-05 CHEMICAL DRY

SODIUM PHOSPHATE DIBASIC

381705 - 18 G x 1.16 in. BD Angiocath™

Autoguard™ shielded IV catheter (1.3

mm x 30 mm) made of FEP polymer.

(50/sp, 200/ca)

381705

Dentsply 03-822-68 SS GLD 018X022

14IN PKG 10

382268 - 14 G x 3.25 in. BD Angiocath™

peripheral venous catheter (2.1 mm x 83

mm) made of FEP polymer. (10/sp,

50/ca)

382268

10

777127218Vendor Catalog NumberAMERICAN MEDICAL DEPOT

FSC1482679CSVendor Catalog NumberGOVERNMENT SCI SOURCE

777127217Vendor Catalog NumberAMERICAN MEDICAL DEPOT

FSC1482679PKVendor Catalog NumberGOVERNMENT SCI SOURCE

00382903294619GTINBD

30382903294610 GTINBD

50382903294614GTINBD

VWR INTERNATIONAL

THOMAS SCIENTIFIC

THOMAS SCIENTIFIC

ALLIANCE JOINT VENTURE

OWENS & MINOR

OWENS & MINOR

CARDINAL HEALTH

BD

Business Name

888021932 Vendor Catalog Number

8938M25Vendor Catalog Number

8938M28Vendor Catalog Number

0723329461PV Order Number

0722329461PV Order Number

BD329461Vendor Catalog Number

BF329461

329461

Item Number

Mfg Catalog Number

PV Order Number

Item Number Type

Distributors and Hospitals Assign Additional

Product Numbers


� Introduction


� GLNs

� GTINs

� GDSN


� Discussion

11

10-20%5-15%3-12%0%Incomplete Item Descriptions

20-25%5-10%5-10%0%Missing Product Brand Names

5-15%1-8%2-5%0%Obsolete Products

30%1-4%2-5%0%Manufacturer Name Problems

2-5%2%1%<1% 0%Hard “Packaging Quantity” Errors

15-25%20-25%1-4%2% <1%Missing Middle Levels of Pkging

CustomerGPODistributorBD

(Before/After)

Challenge: Product Data Synchronization(Sample Results: DoD Data Synchronization Study)

Challenge: Manufacturer Identification

BD HOSPITAL DIVBD BIOSCIENCES PHARMIGEN

BDB-D SHARPS DISPOSAL SYSTEMS

B-D BIOSCIENCES

BD FALCONBD BIOSCIENCESBBECTON DICKINSON

B-D PRIMARY CARE DIAGNOSTICS

B-D BIOSCIENCE

BD ELASTIC HEALTH SUPPORT

BD BIOSCIENCE PHARMIGEN

BBD DIAGNOSTIC SYSTEMS

B-D PRIMARY CARE DIAGNOSTI

B-D ACUTECARE DIV. OF B-D

BD DIAGNOSTIC SYSTEMS

BD BIOSCIENCEBAUER & BLACKB-D PRIMARY CARE DIAG

B-D / VISITEC

BD DIAGNOSTIC INSTRUMENT SYST

BD BIO SCIENCESBARD-PARKER RESPIRATORY SYSTEMS

B-D PRIMARY CAREB-D

BD DIAGNOSTICBD BIO SCIENCEBARD-PARKERB-D MICROBIOLOGY SYSTEMS

B&D

BD DBA BECTON DICKINSON AND CO

BD ACUTECARE DIV.BARD PARKERB-D MICROBIOLOGYB DICKINSON

BD CRITICAL CAREBD ACUTECARE DIVB.D. MICROBIOLOGY SYSTEMS

B-D MICRO BIOLOGY SYSTEMS

B D DIAGNOSTIC

BD CONVENTION NEEDLES

BD ACUTECAREB-D VASCULAR ACCESS

B-D LABWAREB D ACUTECARE

BD BLOOD COLLECTION PRODUCTS

BD / ELASTIC HEALTH SUPPORT

B-D SUP CHAIN SVCSB-D DIAGNOSTICSB D VACUTAINER DIV.

How many ways can you spell BD?

12

Multiple Manufacturer NamesMultiple Manufacturer Names

What you “see” may not bewhat you want or get

What you “see” may not bewhat you want or get

Bad Data Leads to Multiple Supply Chain Problems

What is it?What is it?

Difficulty in orderingDifficulty in ordering

Order 50 receive 500

or

Order 20 cases, receive 20 boxes

Order 50 receive 500

or

Order 20 cases, receive 20 boxes

Multiple Product NumbersMultiple Product Numbers

Inconsistent Item DescriptionsInconsistent Item Descriptions

Packaging IssuesPackaging Issues

Old Product DataOld Product DataAttempting to orderobsolete products

Attempting to orderobsolete products


� Introduction


� GLNs

� GTINs

� GDSN


� Discussion

13

BD is Not Interested In:

• Overreaching Product ID Requirements

• Impractical/Premature Location ID Requirements

• Non-Value Added Data Requirements

Accelerating Adoption

How can we move past the theoretical discussions and move forward?

Criteria Should Include:

• Eliminate Waste/Improve Processes

• Improve Patient Care

Can we focus on the “basics” without over-engineering

future solutions or requirements?

14


� Introduction


� GLNs

� GTINs

� GDSN


� Discussion

Project Planning: Prioritization

• Healthcare needs clarity on scope/prioritization

• There is a real relationship

between Schedule, Scope, and Resources

• Can implementation help to clarify needs and set priorities?

Scope

Schedule

Resources

Is NotIs

Boston Scientific Report Out

Healthcare Transformation Group SummitHealthcare Transformation Group Summit

May 3-4, 2011

GS1 Standards Implementation Team

Boston Scientific is committed to the GS1 standards initiative as it is

instrumental to improving patient care and benefits our customers in

their respective supply chain.

• BSC has been actively involved in GS1, UDI Pilots, USAN, and has

strong expertise in labeling, bar code standards, and e-Commerce

• 2010 Corporate Team established

Boston Scientific Confidential -- For Internal Use Only. Do Not Copy, Display or Distribute Externally 2

• 2010 Corporate Team established

– Executive Oversight

– Quality Management Board

– Sponsored by Corp Operations

– Cross-Functional, Global

• Site and Business Unit

involvement continuing

to expand throughout 2011

Project

Manager

K. Usher

Regulatory

Corporate Sales /

International Sales

e-Commerce &

Customer

Fulfillment

Global

Supply

Chain &

Distribution

Corporate

Labeling

D. Knox

F. Patel

J. Penta /

L. DeRosaD.

Stevens /

R. Jensen

G. Olen /

C.

Griffeth

K. Desjardins/

S. Geddes

B. Cooley

Information

Systems

BSC is meeting current and upcoming GLN needs in 2011-2012.

Starting to see GLN uptake which will require IS system changes.

Current:

• eCommerce [EDI] Department handles GLN requests case-by-case with GLN numbers in place of BSC proprietary account numbers:– Accepting EDI orders [850] and Providing confirmations [855]

• Hospitals and Facilities Live GLN users with BSC EDI:

Current Status of GLN


• Hospitals and Facilities Live GLN users with BSC EDI: – Mayo Foundation (2010), and Intermountain and Ohio Health (2011)

– Scheduled in 2011: Franciscan Alliance, Wellspan, and Geisinger

• GPO requests to include GLN numbers of member hospitals on the Sales & Tracing Reports [867], can be done manually as requested.

Future:

• Additional eCommerce transaction (Projected 2012 Implementation):– Electronic invoices [810], Advanced ship notices [856], and Sales Tracing Report [867]

It is important to note Boston Scientific has applied unique device identifier (UDI) bar codes to all product labels for over 10 years.

HIBC/UPN:

• The majority of “Legacy” BSC products currently have Health Industry Bar Codes (HIBC) on the label.

• The company is actively engaged in a project to implement the GTIN

Current Status of Bar Code Standards


• The company is actively engaged in a project to implement the GTIN on product labels for all “Legacy” product lines.

GS1/GTIN:

• The entire CRM product line is already fully compliant with the GS1 GTIN on the labels.

• Legacy BSC products do have a GTIN allocated, but are not yet labeled world wide.

• We are currently applying the GTIN to “Legacy” products as part of a relabeling activity to support the countries of Japan and Spain, as well as select customers in some other countries as required.

Changing from HIBC to GS1 is a major undertaking given the quantity of products Boston Scientific manufactures and distributes.

• Goal is 2012 completion.

• GS1 Implementation Workstreams– Leadership in each workstream

– Corporate oversight

– Customer transition

GTIN Implementation Program

Overall

Project

GS1Standards

Global Prod

Database

IS Systems Customer


– Customer transition

• GS1 Implementation requires labeling system and changes– Recently completed global labeling system implementation

– Implementation of GS1 system changes to be complete by end of 2011

• Phased approach to implement GTINs on all labels– Classification, product families & manufacturing lines

• Product transitions will be underway by early 2012;

– Detailed product line completion timelines are not yet available.

GTINLabeling

Data Collection

IS SystemsReadinessGTIN/GLN

DatabaseCustomerTransition

Process

GLNProcess

BSC GlobalProduct Master Data

Master Data Synchronization Status

A Master Data Management Strategy will gather data from all BSC

Businesses and Sites to achieve a Global Approach.


Status:

• An internal master data strategy is proposed

• Information feeds from across the organization

• Data gathering in 2011

• Data synchronization in 2012

GHX Health

ConneXion®

Allsource®GDSN

FDA UDI

Additional Information and Feedback

Customers who require additional information or would like

to provide their feedback on GS1 GLN/GTIN may contact:

Boston Scientific eCommerce (EDI) Department:

877-272-3340


877-272-3340

Or Email: [email protected]

© Copyright 2011, Cardinal Health, Inc. or one of its subsidiaries. All rights reserved.

May 4, 2011

Implementing Data Standards- Cardinal Health

Jan DwyerIT Manager

© Copyright 2011, Cardinal Health, Inc. or one of its subsidiaries. All rights reserved.2

Purpose

• Objective: Review the Cardinal Health approach for

support of adoption of supply chain standards for the

Medical Segment

• Discussion Approach: • Cardinal Health Overview

• GS1 Implementation Team

• Data Standards Alignment

• Knowledge, Training

• Current and Planned Pilots

• GTIN

• Master Data Synchronization


• Leading provider of products and services across the healthcare supply chain

• Extensive footprint across multiple channels

• Serving >40,000 customers with renewed focus

• Approximately 30,000 employees with direct operations in 10 countries

• >$99B FY10 pro forma revenue*

• Number 17 on the Fortune 500

Cardinal Health Essential facts

*An estimate of the pro forma revenue for fiscal 2010 in accordance with generally accepted accounting principles

with adjustments expected to reflect each company as a stand-alone entity. The estimate is based on assumptions

that management currently believes are reasonable, but actual revenue may vary materially from the estimate.

Broadest view of the healthcare supply chain



Essential role

Extensive offering of products and services

MedicalPharmaceutical

Two focused segments:



Essential role

Medical Segment

Category Management Channel Management


Global Manufacturing and Supply Chain


Medical Segment strategy

Integrated Supply Chain Excellence

Unique value creation for supplier partners and customers• Present throughout the care continuum • Unrivaled scale in distribution breadth• Leading clinically essential product portfolio • Significant consultative role

Generating value up and down the supply chain

6

Cardinal Health

Hospital

PhysicianofficeAmbulatory Care

LaboratoryScientific products

SurgerycenterAmbulatory Care

an

AmAmHomehealthcareAmbulatory Care

Private brand(Sourced)

Toll-manufactured

National brand

Self-manufactured



GS1 Implementation Team – Medical

Cardinal Health’s Medical Segment GS1 Data Standards Implementation is a

multi-disciplinary approach which is lead by the IT organization.

Key Medical Segment Executive Project Sponsors

Mike Duffy – EVP Supply Chain

Mike Groesbeck – SVP QRA

Jim Bach, VP Inv – CAH

John Abrams, VP EIT CAH

Quality and Regulatory

Stacey Henning – QRA Sup Mfg

Shari Bouche – QRA Mgr, Presource

Guillermo Galindo – Mfg

Jacqueline Maldanodo - Mfg

Michelle Duffey, Private Label

IT –Supply Chain

Jan Dwyer – IT Mgr/GS1 Lead

Karen Lewis – Bus Analytt

Norm Powell- Sr Consultant

Roger Honan – IT Architect

BoonChye Kuan – Bar code Lead, Mfg

Data Management

Dave Fister – Dir, Data Strategy

Erin Egan - Inv Mgr

Lisa Klemz – Inv Analys

Chris McGee – MBT Product

Gerrie Brand – MBT Customer Danielle Fink - Supplier


Cardinal Health Endorses GS1 Standards

• On March 18th 2010, Cardinal Health publicly

announced its support for GS1 standards for

location and product identifiers as the foundation of an

efficient healthcare supply chain…


Depth of Knowledge and Training on GS1

• The depth of knowledge of GS1 and data standards across Cardinal Health’s Medical Segment is primarily

at a state of “recall and/or recognition.”

• Internal Training:– Full Day Training sponsored by Abbott Labs, March 2011

• Multiple business units engaged– Inventory/Planning, IT, Category Mgmt, Sourcing, QRA, Mfg

– Sales Training – Targeting National Meeting Aug 2011– Currently no structured training program; plan being developed

Level 1 Level 2 Level 3

Recall and Recognize

Skill and Concept

Strategic ThinkingRecognizeRecognizeRecognizeRecognizeRecognize ConceptConceptConcept ThinkingRecognize


GTIN GS1 Pilots

• Project Ice Auger

– Collaborative project with the Mayo Clinic and Johnson &

Johnson Health

• Scope

– GTIN enumeration for a portion of J & J products

– Data synchronization using GDSN

– Mayo procure-to-pay transactions with Cardinal Health

• EDI Transaction Testing

– Medical Business Transformation project (ERP Upgrade)

– Trading partners (BD and J&J ) requested to participate in a

pre-pilot test of transactions (850, 855, 856, 810, 867) which

include GS1 standards (GLN /GTIN)

• Dialogue w/BD on Master Data Synchronization

– Review of BD’s GTIN structure, GTIN hierarchy validation, data

sharing process defined


Cardinal Health GTIN Program Scoreboard

GTIN Assignment Owner Milestone Status Comments

GTIN Assignment Mfging - Pkging

Gaps

Labeling Teams -

QRA July-11 GTIN - 14 is use todayGTIN Assignment Private Label-

Pkging Gaps

Labeling Teams -

Sourcing July-11 GTIN - 14 is use today

GTIN Assignment Presource

Labeling Team -

QRA July-11 GTIN - 14 is use today

GTIN Assignment - Distributed Inventory February-11 Only 3300 validated

SAP Upgrade - GTINs in Master Data

&Transactions MBT Team October-11 Pilot - Hawaii

February-11 Big Bang - Continguous U. S.

GTIN - Package Label - MFG

Labeling Teams -

QRA Static data on label today

GS1 Barcode Scanning - Presource IT June-11 Receive & Pick and Outbound to US Distribution

GS1 Barcode Scanning - Mfging IT February-12 Outbound case label to US Distribution

GS1 Barcode Scanning - USD IT 11-Jul

AIMS 8 Accept GTIN & GLN; on packing list &

manifest

2013 -2014 Phased Roll out: AIMS 10 Accept GTIN, Lot # & Exp #

Key Initiatives

GTIN on Label

GTIN in Transactions

GTIN Scanning

Initiative

Cardinal’s Health GTIN program’s approach is by business unit – Self-

Manufactured, Private Label, Presource and Distribution.



• Master Data Management

– From a material master perspective we will have the ability to

capture GTINs using default functionality with SAP

– Current State

• We are requesting GTINs from suppliers on the Product

Information Request Form (PIRF).

• We are validating and converting over any GTINs that we

currently have in our legacy SAP ERP

– Future State

• SAP Supplier Portal capability

• Data exchange partnership – GDSN data pool provider (GHX)


Q&A


Thank you!

H T Group:GS1 STANDARDS READINESS

Dave Reed, Cook Medical

VP Operations & VP Healthcare Business Solutions

May 3-4, 2011

•GS1 Implementation Team - Members, Departments Represented, Executive Level of

Support, etc...

• 6 Vice Presidents

• 3 Operational Directors

• QA Resources

• IT Support in all manufacturing and SCC’s• IT Support in all manufacturing and SCC’s

•Current data standard:

• EAN-128 Standard for bar-coding, consistent with

GTIN standard prescribed by GS1.

• Fully converted to the GS1, GTIN standard

– Currently working on centralizing the storage of – Currently working on centralizing the storage of

packaging configuration for each GTIN for

reporting to GDSN.

•Level of knowledge, training within your organization around GS1 / GTIN Standards

• Executive level understanding high, have been in

process of adoption for 5+ years

• Implementation of GTIN in Cook organization in terms

of integration is thoroughof integration is thorough

• Still working to educate some areas of the enterprise

•Current or planned pilot(s) using GTIN #'s in the Procure to Pay through to Point of Use

(POU) data capture with current customer/business partners

• Working with Premier Healthcare solutions to pass

product information through the GDSN

• Australian branch of Cook working on GTIN upload of

information into GDSNinformation into GDSN

•Report on status of your GTIN program and approach to assign, support and re label

product - Milestones, Detailed approach (Phased, Big bang, etc...), Strategy (Business

Unit, Category, etc...)

• Label clean up for box quantities, global

• Collection of packaging information into global

repository

• Preparing for uploading of global repository into the • Preparing for uploading of global repository into the

GDSN

• Once packaging information is centralized, Cook will

be ready to synchronize data with interested partners

• Using GTIN to transact through EDI and report GTIN

data to packslips, invoices and order

acknowledgement will require minor changes in Cook

EDI systems and order/distribution systems

•Master Data Synchronization status (Product Ref# / GTIN mapping, Use of GDSN, Flat

files, spread sheets, etc...)

• Currently contracted with 1Synch for synchronization

of data to GDSN

Covidien Data Standards StatusCovidien Data Standards Status

Healthcare Transformation Group (HTG) Meeting

St. Louis, MO May 4, 2011

The Covidien Data Standards Team

Three Key Members

• Bill Croisetiere, AIDC Manager (Project Leader) Corporate AIDC

• Steve Capel, Director E-Business (EMEA) Global data standards issues

• Corwin Hee, Director E-Business Standards Database and US standards

2

• Corwin Hee, Director E-Business Standards Database and US standards

A Covidien data standards steering committee is being developed to focus on

global data standards implementation.

There is strong executive-level support for the adoption of GS1 standards.

Covidien Data Standards Achievements

• Full membership in GS1 Global and GS1 US Healthcare groups

• Elected members on both GS1 Global and GS1 US HUG Leadership Teams

• Participation in all relevant GS1 Workgroups

3

• Actively training artwork design and packaging personnel

• Held three separate supplier/vendor/customer training sessions covering the Covidien

implementation of GS1 standards

• Using GLN in GPO reporting

Rebranding at Covidien

• Due to the magnitude and complexity of the current global rebranding initiative,

Covidien is not actively participating in GTIN pilots

– 30,000+ SKUs

– 100,000+ GTINs

• The current rebranding campaign will result in GTINs allocated to all products

4

• The current rebranding campaign will result in GTINs allocated to all products

• Project consists of a mixed approach (phased and Big Bang)

• Project scheduled to be completed by December 2011

• Global regulatory registration issues may impact the timeline


• GHX Health ConneXion will be our data pool

• Steering committee will determine further project details (TBA)

5

GS1 Report to

HTG Supplier Summit

Michael Sarachman

Manager, Industry Standards Adoption

May 4, 2011

Johnson & Johnson GS1 Position

• Supports the adoption of GS1 standards, including

– Global Trade Item Number (GTIN)

– Global Location Number (GLN)

– Global Data Synchronization (GDSN)

– Electronic Product Codes (EPC)

– EPC Information System (EPCIS)

| CUSTOMER & LOGISTICS SERVICES

SUBGROUP NAME: REGION AND/OR PROJRCT | Confidential | Month 00,

0000

| 2

• GS1 system of standards forms the foundation for improving supply

chain visibility

• Successful GS1 adoption will take time, committed resources

(people and funding) and industry collaboration

Johnson & Johnson GS1 Leadership and Team

• Leadership engagement– Ajit Shetty, Corporate Vice President, Enterprise Supply Chain – GS1 Global Board of Governors

– John Hogan, Vice President, Customer & Logistics Services – GS1 US Board of Governors

– Mike Rose, Vice President, Supply Chain Visibility – EPCglobal Board of Governors

– Tom Werthwine, Director, Industry Standards – GDSN BOG and GS1 Global Healthcare Leadership Team

– Mike Sarachman, Manager, Industry Standards – GS1 US Healthcare AIDC work team co-chair

– Steve Robba, Business Architect – GDSN Business Requirements Group and Global Standards

Management Process (GSMP) organization



0000

| 3

• Resource commitment and expertise

– Dedicated department support from Master Data Management and eCommerce

– Sector-wide GS1 deployment team with FTEs from franchises and regions

– GTIN Specialists being trained in each Medical Device & Diagnostics affiliates

– SME’s made available to supply chain partners

Johnson & Johnson Standards Usage

• Consumer– GS1 compliant product labeling

– GDSN data synch with major customers

– Participated in EPC retailer programs

• Pharmaceuticals– Compliant with FDA Bar Code rule

• NDC bar coded on package that touches the product



0000

| 4

• NDC bar coded on package that touches the product

– Preparing for CA ePedigree (GS1/EPC standards based)

– Investigating customer need for GDSN

• Medical Devices & Diagnostics– Migrating from HIBCC to GS1 product labeling

– Subscribe to US GLN registry

– Preparing data for GDSN

Johnson & Johnson GS1 US Hospital Market Project

• Project Ice Auger

– Mayo Clinic

– Cardinal Health

– Johnson & Johnson

– Novation

– GHX



0000

| 5

– GHX

– Uses GS1 standards to

identify products from

manufacturing through

distribution and use

– Maps product and data flow

– Uses GDSN and EDI

Johnson & Johnson GS1 Implementation Status

• GTIN Sunrise Support– Over 100,000 GTINs assigned

– Manufacturing sites currently preparing label systems

• Independent affiliate label conversion timelines

• Target completion date Dec. 2012

– Distribution centers currently preparing data collection systems

– CAR being prepared to modify order-to-cash system



0000

| 6

http://www.commerce.jnjgateway.com/commerce/JJ_GS1.jsp

Johnson & Johnson GS1 GDSN Status

• Consumer product data available through 1SYNC™

• Medical device data available as spreadsheets on Web

– Limited fields

– Not published “up-to-the-minute”

– Not scalable or sustainable

• Preparing medical device data synchronization with

GHX Health ConneXion™



0000

| 7

GHX Health ConneXion™

Software System Support for GS1

StandardsKeith Lohkamp

Product [email protected]

May 4, 2011

Lawson – Simpler Is Better

� Goals

– Become the global leader in our targeted industries

– Offer our customers a superior experience

– Offer competitive prices with a fair profit

– Deliver a better approach to simplify complexity

Page 25/20/2011

� Key Statistics

– Over 4000 customers & employees worldwide

– FY10: $742m Revenue, $0.42 EPS

� Healthcare Statistics

– #1 Healthcare Supply Chain Software Solution (150+ beds)

– 4 of last 6 HPN SC Dept of Year Winners

– Over 1800 healthcare customers

Copyright 2011. Lawson Software.

Lawson Enters Into Agreement to be Acquired by an Affiliate of Golden Gate Capital and Infor

Lawson Involvement in Standards

� Since 2005, we’ve been involved in various standards initiatives and groups:

– Coalition for Healthcare eStandards

– HC Supply Chain Standards Coalition

– Department of Defense GDSN Pilot

� Current involvement

Page 35/20/2011

� Current involvement

– Strategic Marketplace Initiative

– Premier GLN Transaction Program

– GS1 Healthcare U.S. workgroups

� Represented by Keith Lohkamp on the GS1 Healthcare U.S. Leadership Team

� Industry education and advocacy

– Whitepapers on www.lawson.com/GS1standards

– Recorded webinars on GS1, available at www.lawson.com/win


2010 GS1 – AHRMM MMIS Survey Findings

�� Yardstick 1: Yardstick 1: Awareness of and intent to comply with GS1 standardsAwareness of and intent to comply with GS1 standards

– All four primary vendors are knowledgeable about GS1 standards

• 3 of 4 intend to meet the GLN sunrise date, increasing from 2 in 2009

� Secondary vendors are almost all aware and well on their way to meeting the Sunrise dates, compared to only “split evenly” in 2009

Page 45/20/2011

Sunrise dates, compared to only “split evenly” in 2009

• 80% are well on the way to meeting the GLN Sunrise date, 40% in 2009

• 80% at least started for GTIN Sunrise, 40% not even aware in 2009

– For up to the minute Sunrise Readiness, refer to the GS1 Healthcare US Scorecards and readiness self-declarations at:

– www.gs1us.org/healthcare


�� Yardstick Yardstick 2: Capability to support GS1 GLN and GTIN data standards 2: Capability to support GS1 GLN and GTIN data standards

� Approximately 78% (50%) of vendors support GTIN based barcodes now and 89% will be able to within the next two years. Most will support barcodes at all levels of packaging.

90%

100%

Support GS1 barcode standards or plan to, and at what packaging levels?

Page 55/20/20115

MMIS Responses*

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

Unit of Use Unit of Sale Case Pallet DK or NA

2009

2010

* The 8 MMIS vendors who responded to both 2009 and 2010 surveys did not show an increase in package level implementation


�� Yardstick Yardstick 3: Ability to employ GLN and GTIN in EDI transactions 3: Ability to employ GLN and GTIN in EDI transactions

� Some MMIS systems indicated they could process EDI transactions using GLN/GTIN: *

Systems support the GTIN within the EDI transaction

--- None 4 (6) 44% (43%)

810 Invoice 4 (6) 44% (43%)

816 Organization Relationships 1 (1) 11% (7%)

832 Price / Sales Catalog 3 (5) 33% (36%)

Page 65/20/2011

� Overall, 78% (50%) of MMIS vendors indicated that they could do some of these transactions using the GLN standards. *

MMIS vendors

2010 (2009)

832 Price / Sales Catalog 3 (5) 33% (36%)

850 Purchase Order 5 (6) 56% (43%)

855 PO Acknowledgement 5 (6) 56% (43%)

856 Ship Notice 5 (4) 56% (29%)

857 Invoice / Ship Notice 3 (2) 33% (14%)

860 Order Change – Buyer 2 (2) 22% (14%)

865 Order Change - Seller 2 (2) 22% (14%)

840 Request for Quotation 0 (1) 0% (7%)

845 Price Authorization 0 (1) 0% (7%)

* The 8 MMIS vendors who responded to both 2009 and 2010 surveys did not show an increase in EDI implementation

GS1 System Readiness Scorecard – April 2011

Page 75/20/2011Copyright 2011. Lawson Software.

Lawson Is Ready for GS1…

Enhancements released in 2009 & 2010 support GS1 Standards and are ready for

Sunrise Dates

� Store, Search, Transact using GLNs / GTINs, including via EDI.

� Load, Store and Use GDSN attributes.

� Option to configure individual trading partners for use of GS1 Standards.

� Scan manufacturer barcodes in Mobile Supply Chain Management and Point of Use.

� GS1 Standards supported in Financials (AP), Procurement (RQ, IC, PO), Strategic

Page 85/20/2011

� GS1 Standards supported in Financials (AP), Procurement (RQ, IC, PO), Strategic Sourcing, Contract Management, Requisitions Self-Service, MSCM, POU and EDI.

Benefits: Help healthcare

supply chain move from custom

account, item and product

identifiers to standardized

information, reducing errors,

streamlining processes and

enhancing patient safety.


Lawson’s Approach to GLN Within Applications 9.0.1.4+

� Assigned to:

– Requisition Locations

– Ship To Locations

– Company

– Vendor

– Vendor Purchase From

– Manufacturer

Page 95/20/2011

– Manufacturer

� GLN Hierarchies tracked

� Displays in multiple locations

� Available in most transactions including PO and sent via EDI

– ‘Natively’ or via Data Substitution

� Option to use GLN or not


Lawson’s Approach to GTIN within Applications 9.0.1.4+

� Set up within Inventory Control

– Assign a GTIN for each Item / UOM

– Captures additional attributes from GDSN

� Visible and available in:

– Requisitions

– Purchase Orders

Page 105/20/2011

– Receiving

– Issues

– Accounts Payable

– Various Interface Files

� Transact using GTIN

� Options to use GTIN or not


Barcode Scanning within GTIN and MSCM


GTIN Key Field for Requisitions and Purchase Orders


Lessons Learned From Early Implementations

� Coordination required among provider, supplier and solution providers

� Right version of software is critical

– MMIS and EDI software versions

– EDI processing scripts

Page 135/20/2011

� New scenarios and business needs still being discovered


Benefits

� Implementation of GLN can help eliminate or reduce the use of custom account numbers and location identifiers with trading partners.

� Use of GLN can reduce errors due to mis-shipments or missed eligibility.

Page 145/20/2011

� Storage of GTINs to uniquely identify products at each packaging level helps ensure the right product is used or ordered.

� GDSN attributes lay the foundation for future data synchronization.

� Allows you to implement GS1 standards at your pace.


Conclusions

� Provider system software should not be the roadblock

� Leading MMIS software providers are involved and supportive of GS1 standards

– Participating in GS1 activities

– Versions of software that support GS1 available or planned

Page 155/20/2011

� Many providers are already live, particularly with the GLN

� More work may be needed as new business scenarios arise


Medline Industries

1

Medline Industries

GS1 Standards Update

1

• Outline of your GS1 Implementation Team - Members, Departments

Represented, Executive Level of Support, etc...

• Current data standard your subscribe to (if full conversion to GTIN has not

been completed) GS1, HIBC, etc...

• Level of knowledge, training within your organization around GS1 / GTIN

Standards

• Current or planned pilot(s) using GTIN #'s in the Procure to Pay through to

Point of Use (POU) data capture with current customer/business partners Point of Use (POU) data capture with current customer/business partners

• Report on status of your GTIN program and approach to assign, support and

re label product - Milestones, Detailed approach (Phased, Big bang, etc...),

Strategy (Business Unit, Category, etc...)

• Master Data Synchronization status (Product Ref# / GTIN mapping, Use of

GDSN, Flat files, spread sheets, etc...)

• Please let us know what questions you have that we can answer at the Summit

(does not need to be in a presentation)

Outline of your GS1 Implementation Team - Members, Departments

Represented, Executive Level of Support

• Dave Rolston, VP E-Business

• Arden MacNaught – Director, Central Master Data

• Todd Ommen – Manager, Information Systems• Todd Ommen – Manager, Information Systems

Full support from the Executive Sales Management level

• The areas that involve order to cash and master data report up through

Medline Sales

3

• Current data standard your subscribe to (if full conversion to GTIN has not

been completed) GS1, HIBC, etc...

• Medline subscribes to GS1 standards.

• We have company prefix with GS1 and several series of GTIN’s assigned

by GS1

• Level of knowledge, training within your organization around GS1 / GTIN

StandardsStandards

• Areas most closely affected are “GS1 Standards” aware

• Field Sales Force receive updates, but rely on internal staff for detailed

questions, discussions, etc.

• Customer Service – on our plan to begin series of education for them.

• Current or planned pilot(s) using GTIN #'s in the Procure to Pay through to

Point of Use (POU) data capture with current customer/business partners

• Retail Model (Today)

• EDI transactions support use of UPC codes today for some retail

trading partners

• UPC codes are used as product ID for relevant transactions in the

Order to Cash Cycle (PO, PO Ack, Invoice, ASN)Order to Cash Cycle (PO, PO Ack, Invoice, ASN)

• GTIN Model (Future)

• Similar enhancements would support use of GTIN across all order

channels

• Make GTIN present on all partner-facing documents and non-EDI

transactions

• Starting efforts with our Inventory Managment team for supplier to supplier

transactions.

• Will require our importing of other mfr GTIN data.

• Report on status of your GTIN program and approach to assign, support and

re label product - Milestones, Detailed approach (Phased, Big bang, etc...),

Strategy (Business Unit, Category, etc...)

• 49% of top selling skus have GTIN assigned as of 4/27/11

• 90+% will have GTIN assignment complete by Dec 2011

• Medline’s top items (approximately 6500 skus) will go through product

labeling audit and where necessary we will initiate labeling updates

starting in June 2011starting in June 2011

• Product labeling revisions will show up in stock on a phased in approach

depending on raw material inventories at the factories

• Remaining Medline items’ labeling will be updated with GTINs as the

artwork is revised by the Product Manager, or according to the Sales’

departments priority, whichever comes first

• Implementing automated Item Creation Process / System that will handle

automated GTIN assignment as new Medline labeled items are setup –

expected implementation Fall 2011

• Semi-automated GTIN assignment for existing Medline labeled items –

ongoing with expected completion Dec 2011

• Master Data Synchronization status (Product Ref# / GTIN mapping, Use of

GDSN, Flat files, spread sheets, etc...)

• Medline is subscribed to 1Sync for GDSN in retail space.

• Limited number of SKU’s for large retailers

• We would start with XLS integration initially with 1Sync.

• At April 2011 GS1 Workgroup Forum in Bethesda – talk of flat file process

while GDSN getting finalized.while GDSN getting finalized.

• Medline would participate in that approach (seemed majority in room

were in favor when polled by John Roberts.)

• Understand this would be interim approach – would not be impeding

our efforts, likely assist as we load data into item master from other

manufacturers (where Medline acting as distributor)

Medtronic

Standard Product Identification

“SPI”“SPI”

Jackie Rae Elkin

Medtronic, Inc.


Corporate SPI Policy - 035

SCOPE:

Medtronic Worldwide

PURPOSE:

Uniquely identify each Medtronic product offering to avoid duplication of product identifiers. The Standard Product Identifier structure must be the foundation upon which all Medtronic processes and

2 | MDT Confidential

be the foundation upon which all Medtronic processes and systems using product identification are built.

POLICY:

Specified product identifiers shall be standardized across Medtronic globally and must be registered in the Enterprise Resource Planning (ERP) system, i.e., SAP. The GS1 Global Trade Item Number (GTIN) shall be used as the Key for product identification both internally to Medtronic and externally to its global customers.

Pre-SPI Challenges

� Multiple ERP systems

� Diverse business rules for product identification

� Systems integration difficulty

� Multi-layered product identification scheme� 12345 = Model Number - family of product


� 12345 = Model Number - family of product

� 12345-67 = Product Number - the product (F,F,F)

� 12345-67C = Catalog Number - product and package configuration

� xxxxxxxx = Manufacturing Item Number - top level assembly/BOM

� xxxxxxxx = Batch/Lot or Serial Number - production identifier

� (01) 10681490224748 = GTIN

� *+M1261836105* = HIBC

� Two different standards for AIDC

Medtronic

Product Identification Hierarchy

Model

Legacy Today

Product Product

Medtronic Standard Product Identification (SPI)

Product identification has been intentionally streamlined to eliminate confusion both internally and externally.


Catalog

Number

Product

Number

Package

LevelMIN / PIN

UPN / GTIN

Product

Number

GTIN

Also called Customer Facing Number (CFN)

Production ID

�GTIN: Uniquely identifies a product AND its package

configuration

�Product Number: High level identifier used to facilitate

immediate recognition by customers and used in marketing.

�Production Identifier: Batch/Lot or Serial Number used to

identify a product at its lowest level. Use By Date



(01) GTIN (17)Use By Date (10)Batch No.(21)Serial No.

identify a product at its lowest level. Use By Date

or

Required on all Product Packages Globally in GS1 -128 format !

SPI Project Commitments

�Executive Support - COO/CEO

�Policy / Governance - rules for product identification creation and enforcement thereof

�Master Data analysis and clean-up


� Mapping GTIN/CFN according to SPI

�Centralized Master Data oversight and

enforcement (keep it clean)

�Standard Product Identification systems

integration where possible (verification & automated controls)

SPI Benefits

� Collision-proof identifiers allows seamless integration of acquisition identifiers (resolves issues of duplication)

� Prerequisite to effective systems integration (avoid x-reference tables/conversions/ custom interfaces)

� Allows automated transaction processing providing efficiencies and error reduction


efficiencies and error reduction

� Efficient inventory movement through entire supply chain

� Automated distribution processing and verification improves efficiency and enhanced inventory accuracy

� Alignment of identifiers on invoice, warehouse pick list, delivery note, package label, customs documentation, etc.

� Executive support critical – COO/CEO

� Requires all members of Product Lifecycle to be

engaged

�Finance

�Regulatory / Quality

Keys to Success


�Regulatory / Quality

�Businesses / Geographies

� Information Technology

�Supply Chain / Distribution

� Requires continuous governance

� It’s about the Master Data…………….data carrier is

trivial in comparison.


Jackie Rae Elkin

Global Process Owner - Standard Product Identification | Medtronic, Inc.

Global Regulatory Operations

710 Medtronic Parkway, LS 330 | Minneapolis, MN 55432 USA

Office: 1-763-505-2575 Mobile: 1-612-801-6615

[email protected]

Siemens Healthcare Diagnostics

GS1 Standards Overview

Healthcare Transformation Group Summit

St. Louis, May 2011

© 2011 Siemens Healthcare Diagnostics Inc. All rights reserved. David Leedam, Global eCommerce

St. Louis, May 2011

Holistic Strategy

Standards Team

Contents

© 2011 Siemens Healthcare Diagnostics Inc. All rights reserved.David Leedam, Global eCommercePage 2

Conversion vs. Multiple Standards

Program Status

Key Questions

GS1 Standardisation Team

Sponsors

Eric OlsonVP, Automation & IT

Dietmar Hein PhDHead, Global eCommerce


Business Coordination

David Leedam

eCommerce EMEA APAC

IT Coordination

Mike Barthorpe

IT BRM

Logistics Marketing Operations Master Data

Holistic Strategy is required

Transactions

Processes

� Corporate Ownership

� eCommerce Automation

� Rich Information

� Performance Metrics

Technology

� Central repository

Master Data

Ownership

� Data / Content

� Processes

� Governance

� Quality

Standards Initiatives

� GHX Health ConneXion™

Organization

Organization

� Leadership Buy In

� Change Management

� Governance & Funding

� Patient Safety

� Customer Excellence

Processes

� System Architecture

Supply Chain

Processes

� Labeling

� Track & Trace

� Planning

� Consistent documentation

from paper to electronic

Technology

� SSCC


� Central repository

� Multi Channel content

distribution

� Deep system integration

� GHX

A Strategic Approach to Data Standardization

� Take a leadership role and move forward

� Transformation of the corporate culture

� End to end process design

� Continuous improvement and incorporation of new technologies: Changes in Infrastructure to enable standardization

� Support of Industry Initiatives

� GHX Health ConneXion™

� GDSN

� GTIN

� GLN

� eCl@ss 7.0 / UNSPSC

� System Architecture

� Central Master Data

� Data Distribution

� Integrated off-line and on-

line channels

� SSCC

� Barcodes

� UDI database

Conversion vs. Multiple Standards

GTINSiemens Material

Number

GLN’sSAP Account

Numbers

UNSPSC

EDMA

eCl@ss

Siemens Material

Number


� GS1 Standards for Trading

� Continued use of existing material and

account numbers internally

� Support of multiple standards for

classification

� eCl@ss predominant in Europe

� UNSPSC predominant in Australia and US

� EDMA used for reporting purposes

Program StatusGS1 Program

GLN

� Mapping of Customer GLN to SAP account numbers

� Own GLN Enumerated

� Testing for eCommerce solution mid-May 2011

GTIN (on target for Sunrise)

� Master data from legacy companies cleaned and merged

� >17,000 products enumerated with GTIN


GS1 Program

Classification

� Supporting UNSPSC v13.0601 & eCl@ss v7.0

� Loading of classification data into test system underway

� Successful test load into GHX HealthConneXion®

GTIN (on target for Sunrise) � >17,000 products enumerated with GTIN

� Auto-assignment project in progress

GDSN

� US product catalogue with mandatory attributes published

� FR/DE catalogues in preparation

� Goal is automated feed to GHX HealthConneXion®

Key Questions

� Will the use of GS1 Standards accelerate the adoption of eCommerce?

� Are there any target dates/account conversions for eCommerce adoption?

� How can industry wide adoption of standards be achieved?

� What information do you use from the GDSN?


� What information do you use from the GDSN?

� Should the GDSN require only a defined set number of mandatory attributes

globally?

� What is the Suppliers perspective on the ROI of GLN implementation?

Leslie Logan, Christine Fiore and Larry Dooley

HTG Summit – St. LouisMay 3-4, 2011

H T G R O UPHealthcare Transformation Group

Our History

In 1856, Thomas James Smith opens a small chemist shop in Hull, England.

In 1896, Horatio Nelson Smith, (TJ Smith’s nephew), enters into partnership with his uncle; the firm becomes known as into partnership with his uncle; the firm becomes known as TJ Smith & Nephew. Medical dressings become part of the business.

Our Recent History

1986, Dyonics was acquired, world leading postoperative arthroscopic equipment manufacturer. Later to become Smith & Nephew’s Endoscopy Division

1986, Smith & Nephew expands into the US; acquires 1986, Smith & Nephew expands into the US; acquires Memphis-based Richards Medical Company. Later to become Smith &Nephew’s Orthopaedics Division

1988, United Medical Division of Pfizer Hospital Products Inc. was acquired, manufacturers of special surgical dressings. Later to become Smith & Nephew's Advanced Wound Care Division

Our Recent History

1999, Smith & Nephew enters a ten-year agreement with Seikagaku of Japan to market its joint lubricant, SUPARTZ◊(hyaluronic acid) and acquire EXOGEN◊ Inc., a US developer and manufacturer of devices for the non-invasive treatment of musculoskeletal injury and disease. Together treatment of musculoskeletal injury and disease. Together these products will become the foundation of our Clinical Therapies Division

2006, Smith & Nephew acquires Plus Orthopaedics a Swiss based Orthopaedic Company. Their offering of Hips, Knees & Shoulders are now incorporated into our Orthopaedics portfolio

Enabling people to live healthier, more active

lives

Smith & Nephew's overall strategy is to help improve people's lives by repairing and

healing the human body. To achieve this, the healing the human body. To achieve this, the Group is focused on four strategic pillars for

success

Customer ledEfficient

Investing for growthAligned

Global Reach

• #2 Global Orthopaedic Company (excluding Spine)

• Offices in 33 Countries• Offices in 33 Countries

• Sales in 90 Countries

• 8,800+ Employees

• $3.8 Billion Global Sales

• $12 billion capitalization

• Listed on LSE (SN.L), NYSE (SNN)

Global Business UnitsOrthopaedics: Recon & Trauma

Biologics

Advanced Wound Management

Visualization

Endoscopy

Biologics

GS1 Investigational Team:

SVP Global Mfg. Ops – Bob Gaydos

VP Operations – Geary Munroe

VP National Accounts – Larry Dooley

Group Director Global Packaging – David HardinGroup Director Global Packaging – David Hardin

Group Director GIS – Janet Scott

Group Director Global Distribution – Matthew Roberts

Group Director Offer Development – Christine Fiore

Sr. Project Manager Global Packaging – Leslie Logan

Manager EDI Business Systems & Reports – Linda Nelson

Current Standards

•GS1 standard for Advanced Wound Management business unit

•HIBC standard for Endoscopy, Orthopaedics and Biologics business units

•HIBC bar codes used throughout all S&N Global distribution systems S&N Global distribution systems

•GTIN’s assigned to all products for all business units

•GS1 bar codes added in distribution process for shipments to Spain, France, Belgium, Sweden, Korea, Japan

•GLN used for admin fee payments as required by GPO contracts

GS1 / GTIN Knowledge

• GS1 Investigational Team formed with the responsibility to determine Company action plan for GS1, GTN and GLN initiatives

•Global Operations Executive Staff – Presentations made to educate and gain approval to adopt GS1 bar code standard only.

• Smith & Nephew is investigating the possible • Smith & Nephew is investigating the possible usage of GS1 standard in the future

St. Jude MedicalGS1 Adoption


May 3 – 4, 2011

St. Jude Medical GS1 Implementation

� Implementation Project Structure

� Team

� Timeline

� Label Transition Approach

� Status

� GTIN

� Data Synchronization

� GLN

� Order Automation

St. Jude Medical GS1 Implementation TeamSponsorship and Direction

LeadershipPeter Blomberg Kevin Lapolt

SteeringCommitteeDave Hendrick

Sr . VP, Sales Operations

Executive Sponsor

James Ufford

VP, Supply Chain, CVD

Bob Berset

Director, Supply Chain, AFD

David Roosth

Director, Supply Chain, NMD

Bruno De Maeyer

Sr. Director, Supply Chain, EMEA

Jeff Chateau

VP, Supply Chain, CRMD

Mark Murphy

Sr. Director, SAP GCC

GTIN Working Group

Peter Blomberg

Sr. Mgr, Labeling and Tech Pub, AFD

Art Castronovo

Mgr, Packaging Engineering, CVD

Kevin Lapolt

Sr. Mgr, Documentation / Labeling, NMD

Andrew Willingham

Sr. Director, Architecture, EIT

Melissa Plicque

E-Commerce Program Mgr

Mark Trebilcock

Mgr, Distribution Operations, CRMD

Jeffrey McVay

Sr. Program Mgr, EIT

Bruno De Maeyer

Sr. Director, Supply Chain, EMEA

Business and Technical TeamsDoc Control, Customer Service, Packaging and Labeling, Contracts and Pricing, SAP

GS1 Implementation Timeline

Onboard Customers (US)

GLN Adoption

Develop Consistent GTIN Rules

Incorporate GTIN into Business ProcessesGTIN Adoption

2010 2011 2012

Identify Attributes

Design Process

Develop Publishing Technical SolutionGDSN Publication

Add GLN to Business Activities

Integrate to Other Systems

Core Business Systems

4

2011 2012

Product Labeling

AFD

CRMD

CVD

NMD

ICDs / Pacers Leads Accessories

Introducers / Catheters

Vascular Closure / Guidewires

Valves – Mechanical / Tissue

Miscellaneous

ICDs / Pacers Leads

Complete

Sylmar

Puerto Rico

Veddesta / Malaysia

Systems Spare PartsCatheters / Introducers Complete

Label Transition Strategy

� Nov. 2007

� Set Enterprise direction to replace HIBC with GTIN standard

on all product labels world-wide

� Defined Requirements for world-wide label standards

� Transition Strategy

� Change over product labels by product line� Change over product labels by product line

� Future products use new label with GTIN; existing inventory

addressed through depletion

� Support our customers by enabling business systems to

accommodate the GTIN transition at our customer’s pace

GTIN Implementation Status

� GTIN standards defined and adopted

� Allocation rules and label standards defined

� GTINs assigned to all customer products

� Product labeling underway; planned completion Q3 2012

for all divisions / products

� Core business systems updates Q4 2011 to support GTIN � Core business systems updates Q4 2011 to support GTIN

use in order flow

� Updating order-to-cash paperwork to include GTIN –

planned for 2012

Label Transition Status by Division

AFD CRMD CVD NMD

Current

Standard

GTIN GTIN+HIBC or

HIBC

HIBC GTIN

Future

Standard

GTIN GTIN+HIBC

(both)

GTIN GTIN

Transition

Status

96% Complete

Catheter /

Introducers

Completion: EOY

2011

Begin Transition

Q3 2011

100%

Introducers

Complete,

Balance Q2/2012

Complete

Transition Q4

2012

Rollout Add GTINs to

Capital Equipment

& Spare Parts to

complete

Manufacturing

Site and Product

Line

Product Line

Inventory

Transition

Strategy

Depletion Depletion Depletion

Master Data Synchronization Status

� Catalog Publication: Contracts, Price Sheets,

Spreadsheets

� Initial Planning Stages for GDSN Publication

� GDSN Synchronization is a planned 2012 project

GLN Implementation Status

� Currently GLN Ready

� GLN standard defined and adopted

� Core business systems for order-to-cash updated to support GLN

usage

� Registered SJM locations relevant for US through GS1 Registry

� Currently transacting with customers using GLNs upon request

� Upcoming:

� Integrate GLNs into Contracting Systems and reports

� Understand customer needs to utilize in other business activities

Order-to-Cash Automation

� Current Status:

� Support 850, 855, 856, and 810 through GHX

� Integrated with limited e-invoicing hubs, currently

� Upcoming:

� Consolidating GHX supplier structure to single supplier for

cardiology businesses – Completion Target August 2011 cardiology businesses – Completion Target August 2011

� Updating systems to support non-GHX electronic

transactions, including limited direct customer integration.

� Product Catalog, 832, planned for 2012

GS1 Data Standards UpdateGS1 Data Standards Update

Healthcare Transformation Group (HTG)

St. Louis, MO St. Louis, MO

May 4, 2011

Team Members

Will Probst, Director Supply Chain (GS1 Standards Leadership)

Ben Romanski, Program Manager (GS1 Transactions)

Stryker endorses the GS1 data standards and is developing

a committee to focus on meeting the requirements for global

implementation.

Active member of GS1 US Healthcare groups: GLN, GTIN, GDSN

GLN Achievements

• Assigned searchable data field in Address Book that cross-references

existing Ship To/Sold To account numbers

• Utilized GLN Registry to synchronize GPO rosters

• Over 2500+ GLNs assigned to internal legacy account numbers

• Successful participation in Premier GLN Pilot Phase II with multiple • Successful participation in Premier GLN Pilot Phase II with multiple

providers (Geisinger Health & Banner Health) using manual transactions

• Operating Procedures, Documents and Transactions implemented,

trained and utilized in daily account management

• GLN reference included in GPO sales trace reporting

• Transacting GLN on EDI using the “UL” qualifier on 850/856/810

• Achieved GLN Readiness in advance of Sunrise Date

• Mayo GLN Pilot via EDI: May 25th Go-Live

GTIN Status & Approach

• Identified storage location in ERP Item Master

• GTIN assignment to begin in Q3

• 4000+ SKU’s across 25 Product Families (Ascent)

• Limited Initial GTIN Assignment; 10-20 SKU’s across 3 PF’s

Design, develop and test system; setup/transactions• Design, develop and test system; setup/transactions

• Barcode, Packaging Hierarchy, Labeling, Procure to Pay Documents, EDI Maps

• Conduct GTIN Pilots: 1st Manual (Paper), 2nd EDI

• Assign GTIN’s to balance of SKU’s

• Achieve GTIN Readiness in advance of Sunrise Date


• Member of GHX Health ConneXion Data Pool

• Single pipeline feed via to multiple data sources

UDID

GDSNHealth

ConneXion GDSN

AllSource

Product

Data

QUESTIONS??QUESTIONS??


Will ProbstAscent: A Stryker Sustainability Solution

[email protected]

Synthes USA GS1 Implementation

Author / version / date / subject 1

– Mary Schafer, Vice President of Global Operations

– Mark Gordon, Vice President of Global Regulatory and Clinical Affairs

– Bob Strehl, Director of North American Materials Management

UDI US Steering Committee (includes GS1

implementation)



– Bob Strehl, Director of North American Materials Management

– Tami Benjamin, Manager of Global Sterility Assurance

– Scott Hall, Manager of Packaging Engineering

– Eric Brown, Manager of Labeling Technology

Current Data Standards

HIBC – North America (Synthes US)

GS1 – Europe, Latin America (Synthes EMEA)



GS1 – Europe, Latin America (Synthes EMEA)

Synthes EMEA is fully trained on GS1/GTIN

standards. Synthes US is beginning this process.

Synthes US GS1 Implementation planned to

coincide with rollout of global ERP system,

beginning Q2 2012.



beginning Q2 2012.

Confidence in your hands™

GS1 Implementation Status

HTG Summit

May 4, 2011


GS1 Sponsorship

• GS1 is jointly owned at Zimmer :

• Global VP of Operations is overall sponsor (Rick Stair)

• Global VP of IT is co-sponsor (Edwina Payne)

• Multiple departments also engaged in ensuring GS1 adoption is meeting the requirements of our customers and regulatory bodies

• Global VP of Regulatory (Shami Feinglass)

2

• Global VP of Regulatory (Shami Feinglass)

• VP of Sales Distribution (Dean Childers)

• Director of Packaging (Tim Early)

• Individuals across the Zimmer organization globally are involved as required


GS1 Journey

• Already in Place:

• Ability to transact with customers using GLN in US (December 2010)

• Central assignment of GTIN numbers for international usage (Spain, France, Germany and Australia)

• UDI and GS1 Awareness sessions for senior leadership

• Activities Underway:

3

• Activities Underway:

• Holistic review of GS1 customer and regulatory requirements to ensure firm understanding and support

• Recruitment of GS1 Project Leader

• Review of GTIN assignment “rules”

• Key Enabling Activities:

• Elimination of duplicate Finished Goods numbers

• Master Data Management – process and system

• Global Labeling system implementation (Prisym)


Upcoming Activities

• Continue to partner with key business customers and regulatory bodies on GS1 activities

• Onboard GS1 leader

• Complete GS1 Assessment and define project approach, timeline

4

• Complete GS1 Assessment and define project approach, timeline and milestones

• Begin GS1 rollout globally:

• GTIN transactional capabilities

• Bar code conversion from HIBC to GS1

• UDI compliance in US

• GDSN data synchronization


Addressing Your Questions

55

555

The Clinical Importance of

Unique Device Identification

Natalia Wilson, MD, MPH


May 3, 2011

The Patient

• Wherever we sit in healthcare, the patient is

in the center

• Our collective goals for that patient

– To receive optimal & quality care– To receive optimal & quality care

– To guard their safety

– To provide processes that allow efficiency in their

health care delivery

Outline

• Value of UDI

• Clinical Importance of UDI

• Global Importance• Global Importance

• UDI & Health Care Reform

Value of UDI

• Clinical

• Supply Chain

• Process Efficiency • Process Efficiency

• Setting a Standard

• Economic

Clinical Importance of UDI


1. UDI as the standard for record of products used in patient

care

2. UDI as the standard to identify devices implanted in patients

3. UDI as the standard to facilitate product information &

verification @ point of useverification @ point of use

4. UDI as the standard to enter device info into clinical

registries

5. UDI as the standard for product documentation to facilitate

efficiency & comprehensiveness in product recalls

UDI as the standard for record of

products used in patient care

• Currently lack a standard across health care

for record of products used in patient care

• Leads to a loss of comprehensive

documentation for clinical care documentation for clinical care

UDI as the standard for record of

products used in patient care

• What standard should be

– UDI on products

– Scan UDI when products received @ hospital

– Maintain record in IT system– Maintain record in IT system

– Scan UDI of product @ point of use = link to patient

– For implantable devices maintain UDI in standard

field in EHR

UDI as the standard to identify devices

implanted in patients

• Currently lack a standard across health care

to identify devices implanted in patients

• Leads to risk for patient and inefficiency of

health care delivery health care delivery



Revision Orthopedic Joint Replacement Surgery

• Current process

– Obtain operative report

– Paper or electronic records– Paper or electronic records

– Info may not be complete

– May go to other means for implant id: x-ray, rep or

colleague consultation, @ surgery



Revision Orthopedic Joint Replacement Surgery

• Impact

– Inefficiency for surgeon pre-operatively

– Patient could have more extensive surgery– Patient could have more extensive surgery



Spine Revision Surgeries

• Current process similar to orthopedic joint

replacement revision surgeries

• Additional importance is to know what • Additional importance is to know what

tools/devices need in OR to remove original

implant



Spine Revision Surgeries

• Impact

– Inefficiency for surgeon pre-operatively

– Potential inefficiency @ surgery or may need 2nd– Potential inefficiency @ surgery or may need 2nd

surgery scheduled



Interventional Cardiology

• Re-stenosed stent or patient needs 2nd stent

– Need information from the procedure report

– Getting device info not always straight-forward– Getting device info not always straight-forward

– Length of time since stent put in or standard of

documentation impact

– If cannot id original stent & diameter, may need additional

imaging such as fluoroscopy or ultrasound




• Impact

– Time factor under urgent circumstances

– Patient may need extra imaging– Patient may need extra imaging

– Inefficiency for cardiologist




• Patient with AICD in emergency

• How identify device?

• Currently

– First responders support patient

– ED will call programmer on call to interrogate but may be different

manufacturer

• If EMT could scan device w UDI & determine info, proper

programmer could be on way to ED



Patient needs emergency surgery

• Issues to consider

– What implanted devices does patient have?

– Can anti-coagulation be stopped?– Can anti-coagulation be stopped?



Primary Care

• Comprehensive knowledge of patient

• What implanted devices does patient have?

• What specialists needed for f/u?• What specialists needed for f/u?

• Is patient on the proper meds?

• If there is a recall knowledge that affects your

patient?



Many other Class III devices across medical specialties

to consider…

• Cochlear implants

• Neurostimulators

• Breast implants

• Implantable infusion pumps

• Various prostheses

• Etc., etc.



• Some Class II devices important to consider…

– Mesh

– Slings

– Bands– Bands

• Used in many general, urologic, gynecologic,

bariatric surgeries




–UDI on devices

– Scan UDI of device @ point of use

UDI in EHR–UDI in EHR

UDI as the standard to facilitate product

information & verification @ point of use

• Medication verification & administration @ bedside

(bar-code e-MAR)

– NEJM article 2010

– Compared medication dispensing pre & post e-MAR @

AMCAMC

– Captured data on errors: wrong medication, dosing, timing

– Outcome stat significant reduction of medication error

Poon, EG, Keohane CA, Yoon, CS, et.al. Effect of Bar-Code Technology on the Safety of Medication Administration. N Engl J Med 2010;362:1698-707.

UDI as the standard to facilitate product

information & verification @ point of use

• Extension to products

• Different from medication ordering because ordering of procedure generally not product specific

• But potential for• But potential for– Notification of allergy – latex or other

– Recalled product

– Other

UDI as the standard to enter device

info into clinical registries

• What are clinical registries?

– Capture data on clinical conditions, procedures,

devices

– Hospitals input info on patient, physician, hospital, – Hospitals input info on patient, physician, hospital,

procedure, diagnosis, device used, often extended

clinical info, etc.

– Patients followed to ascertain quality of life,

symptoms, activity, etc.



• Outcomes of clinical registries

– Provide data that may lead to recalls of devices

– Provide data that may change practice patterns

– Provide data for comparative effectiveness– Provide data for comparative effectiveness

– Provide data for research

– Provide information to enhance optimal & safe

patient care

UDI as the standard to enter device info into

clinical registries – US Cardiac Registries

• National Cardiovascular Data Registry (NCDR)

• Society of Thoracic Surgery (STS) National Database

• Kaiser Permanente Cardiac Device Registry (KPCDR)

• Kaiser Permanente Heart Valve Replacement Registry• Kaiser Permanente Heart Valve Replacement Registry

http://www.ncdr.com/webncdr/common/

http://www.sts.org/national-database

http://xnet.kp.org/permanentejournal/NIR/Registries/Cardiology.htm

http://xnet.kp.org/permanentejournal/NIR/Registries/Cardiac_Surgery.htm

UDI as the standard to enter device info into

clinical registries – US Orthopedic Registries

• American Joint Replacement Registry (AJRR)

• Kaiser Permanente Total Joint Replacement Registry

• Hospital for Special Surgery (HSS)/CERT Joint

Replacement RegistryReplacement Registry

• UMMS received an ARRA funded CER grant of $12m

to start a national joint replacement registryhttp://www.orthodoc.aaos.org/ajrr/grp_index.cfm

http://xnet.kp.org/permanentejournal/NIR/Registries/Total_Joint.htm

http://www.hss.edu/cert.asp

http://www.umassmed.edu/news/articles/2010/ahrq_grant.aspx

UDI as the standard to enter device info into clinical

registries – International Orthopedic Registries

• Swedish National Hip Arthroplasty Register

• Australian Orthopaedic Association National

Joint Replacement Registry

• National Joint Registry (NJR) of England & Wales• National Joint Registry (NJR) of England & Wales

• And many more…https://www.jru.orthop.gu.se/

http://www.dmac.adelaide.edu.au/aoanjrr/

http://www.njrcentre.org.uk/njrcentre/



• International Consortium of Orthopedic

Registries

– FDA & HSS led initiative

– Develop international registry network– Develop international registry network

– Mtg this spring

• Hopefully UDI & setting data standards early

discussions



• Currently lack a standard to enter device info into

clinical registries across health care

• Impacts

– ability to link data across similar registries– ability to link data across similar registries

– comparative effectiveness potential

– research opportunities

– speed to find out about early failing devices or those that

negatively impact patient quality of life




– UDI on devices

– Scan UDI of device @ point of use = link to patient

– Use UDI to enter device info into clinical registry– Use UDI to enter device info into clinical registry

– Option to link UDI Database product attributes for

extended info as needed on that device

DePuy ASRTM Hip Systems Recall 2010

• NJR of England & Wales 2010 data - higher than expected

revision rate @ 5-yrs in 2 DePuy hip systems

• Voluntary recall

• Clinical f/u of these patients extensive

– Annual visit & x-ray for 5 years– Annual visit & x-ray for 5 years

– Any problems…blood tests, MRI, U/S

– Abnormalities…frequent f/u or revisionDePuy Companies. ASRTM Hip System Recall Guide. Available at: http://www.depuy.com/usprofessional Accessed March 21, 2011.


Issues

• Extensive f/u for patients with these implants

• Patients may experience tissue inflammation & revision

may not be as successful

• Time consuming & extra cost for physician & physician • Time consuming & extra cost for physician & physician

office in handling recall

– patients calling to find out if they have that implant, calling patients

& sending letters, extra volume of patients for office visits, patient

anxiety, etc.


Issues

• Cost

– For patient follow up & tests

– For physician offices to handle recall

– Revision surgeries– Revision surgeries

– For DePuy – recall notifications, website with updated info, call

in available to speak with rep, litigation…

• Cost being covered by DePuy…but cost in one place comes

out as cost in another


• If NJR of England & Wales showed this, other

international registries probably did also

• UDI as standard to input device info into clinical

registries…link of registries

– More data

– Find out problem earlier

– Less patients impacted

Standard & Efficiency in product recalls

• The lack of a standard across health care in all

discussed to date impacts recalls

– Lack of standard for record of products used in patient

care

– Lack of standard to identify devices implanted in patients– Lack of standard to identify devices implanted in patients

– Lack of standard for product info & verification @ point of

use

– Lack of standard to enter device info into clinical registries

Alcohol Wipe Recall

• Triad Group alcohol prep pads, alcohol swabs

& alcohol swabsticks

• Used OTC & in hospitals

• Under many private labels• Under many private labels

• Potential contamination w Bacillus cereus

• Extensive recallhttp://www.fda.gov/Safety/Recalls/ucm239219.htm

Alcohol Wipe Recall

• Scanning UDI for product @ receiving would

provide record that in hospital

• Obviously alcohol wipes could be

over…patient rooms, shelves, pockets, etcover…patient rooms, shelves, pockets, etc

• But scanning @ receiving would provide

record that have that product

Recalls in Retail

• UPC on products

• Product entry into store captured by UPC

• Recalled product tracked quickly, removed from

shelves & info made publicly availableshelves & info made publicly available

• Warehouse membership

– UPC can be linked to member purchase data

– Member contacted if bought recalled product


• Implantable devices

– Rep generally in charge of consignment or trunk

stock

– Notification often bypasses hospital & goes to – Notification often bypasses hospital & goes to

physician for devices already in patients

– Different standards based on FDA tracking

requirement


• FDA Tracking Requirement– Manufacturers of certain devices must develop tracking

system to quickly remove/notify

– Higher risk devices

– Examples: AICD, implantable pacemaker electrodes &

generator, mechanical heart valve, silicone breast

implants, cerebellar & phrenic nerve stimulators

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/PostmarketRequirements/MedicalDeviceTracking/default.htm


• Eg/Boston Scientific CRM trackable devices

– GTIN on packaging

– Unique model serial # etched on device

– Extensive records of physician, patient, hospital

• Some do not utilize a true UDI

• Manufacturers for devices not on FDA tracking list

different standard…


What standard should be

• UDI on products

• Scan UDI of product @ receiving for traceability in hospital

• Scan @ point of use for info on device (recalled?) & link to use in

patientpatient

• Document UDI for implantable devices in EHR to link patient &

device

• Use UDI for device entry in clinical registries to facilitate network

of registry data…may indicate suboptimal performance


1. UDI as the standard for record of products used in patient care

2. UDI as the standard to identify devices implanted in patients

3. UDI as the standard to facilitate product information & verification

@ point of use

4. UDI as the standard to enter device info into clinical registries4. UDI as the standard to enter device info into clinical registries

5. UDI as the standard for product documentation to facilitate

efficiency & comprehensiveness in product recalls

UDI helps facilitate optimal patient care, patient safety,

physician efficiency

Global Importance

• Global manufacturers

– One standard for their products

• Patients move, travel & access care along the way

• Medical tourism• Medical tourism

• One standard in recalls

• One standard for clinical registries

UDI & Health Care Reform

Affordable Care Act

• Components

– Increase access

– Insurance regulation

– Cost-containment

– Improved quality

– Improved public health

HealthCare.gov http://www.healthcare.gov/law/introduction/

American Recovery & Reinvestment

Act of 2009

• HITECH Act

– $22.6b for adoption of health IT

• CER

– $1.1b to AHRQ, NIH, OS-HHS– $1.1b to AHRQ, NIH, OS-HHS

– Funding for research on spectrum of treatments for clinical

conditions

HHS.gov/Recovery http://www.hhs.gov/recovery/programs/

HITECH Act

• Goals = improve health care quality, safety, & efficiency thru

use of HIT

• Meaningful Use incentives by Medicare & Medicaid

• Ongoing discussions for UDI in EHR to be meaningful use

objective in Stage 2objective in Stage 2

• Current meaningful use core objectives include

– Provide patients with copy of EHR upon request

– Capability to exchange key clinical info among providers of care

electronicallyThe Office of the National Coordinator for Health Information Technology .

http://healthit.hhs.gov/portal/server.pt/community/healthit_hhs_gov__home/1204

CER

• Funding has included

– Registries: atrial fibrillation, national TJR registry

– PCI vs CABG

– Develop CV Surveillance System– Develop CV Surveillance System

– Develop data infrastructure for post-market CER:

linking large data sets across states

NIH RePORTER. http://projectreporter.nih.gov/reporter.cfm & AHRQ. Recovery Act Rewards. http://www.ahrq.gov/fund/recoveryawards/

Concluding Remarks

• Wherever we sit in healthcare, the patient is

in the center

• We want to support that patient

– Receiving optimal & quality care– Receiving optimal & quality care

– Being safe

– Having efficiency in their health care delivery

• UDI enabler of quality, safety, efficiency

Contact Information

Natalia Wilson, MD, MPH

Co-director, [email protected]

Website: http://wpcarey.asu.edu/hsrc-asu/