1. © GS1 US® 2013 GS1 HEALTHCARE US “ ASK THE EXPERTS” SEMINAR ~ THIS SESSION IS NOT BEING RECORDED ~ JOHN ROBERTS AND SCOTT BROWN Directors, GS1 Healthcare US MARCH 2013 Dial-In: 719-387-5500 PC: 423684

2. © GS1 US® 2013 The anti-trust reminder requires that we ask everyone not to engage in discussions regarding pricing, deal-making, selling, promoting or other activities which could be viewed as anti- competitive. If anyone believes the discussions are approaching these boundaries, please say so and the discussion will be halted while a GS1 US 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. 2 ANTI-TRUST CODE OF CONDUCT

3. © GS1 US® 2013 Anti-Trust Questions & Answers Barriers to Implementation If no questions: UDI GS1 Keys GTIN Allocation Rules GEPIR GS1 Initiative Metrics Identify, Capture, & Share Efficiency Sunrise Patient Safety 3 Dial-In: 719-387-5500 PC: 423684

4. © GS1 US® 2013 Live and on Demand Educational suite Simply log on and register to learn the basics of GS1 System Standards Live monthly: Ask the Experts Seminar (monthly) The Basics of GS1 Standards in Healthcare: presented by Jean Sargent On demand: GS1 System Explained GS1 Company Prefix GTIN: Product Identification Number GDSN: Global Data Synchronization Network ® (Three sessions) GIAI: Global Individual Asset Identifier GLN 101: Location Identification Number GLN Registry Tutorials GDTI Global document Type identifier SSCC: Serial Shipping Container Code Technical GS1 and HIBCC explained GS1 Datamatrix Barcoding is an Art & a Science Scanner Versus Verifier Under development UPN (HIBCC and GS1) UDI (a musical) Education Registration: http://www.gs1us.org/hcedu 4

5. © GS1 US® 2013 5 April 10 th 12:30pm - 5:00pm GLN Implementation Workshop Who should attend: Healthcare provider data managers, master data managers, EDI professionals, & other healthcare supply chain professionals responsible for GLN implementation COMPLIMENTARY HEALTHCARE IMPLEMENTATION WORKSHOPS Co-Sponsored by AHRMM, HSCA, SMI and GS1 Healthcare US Complimentary training sessions for GS1 Standards implementation in healthcare April 10-11, 2013 Gaylord National Resort National Harbor, MD April 11 th 8:00am – 12:00pm GTIN/FDA UDI Implementation Workshop Who should attend: Healthcare provider & medical device supplier material managers, packing engineers, data managers, purchasing managers & other healthcare supply chain professionals responsible for GTIN & FDA UDI implementation. April 11 th 1:00pm – 5:00pm The GDSN/FDA UDI Database Implementation Workshop Who should attend: Healthcare provider & medical device supplier master data managers, e-business managers, and other healthcare supply chain professionals responsible for GDSN implementation. Register Today: gs1us.org/HCworkshops2013gs1us.org/HCworkshops2013 Save the Date for GS1 Connect June 10-13, 2013, click here for more detailsclick here

6. © GS1 US® 2013 RECENT Are finished good kits labeled with their own UDI? Argument or counterpoint is all finished goods components (or children) within the kit are individually transact able and have their own UDI. direction on reporting finished good kits to the new FDA GUDID database? 6

7. © GS1 US® 2013 REPLY 1.The UDI is still a draft regulation with 280 responses to be reviewed and replied to by the FDA; 2. GS1 workgroups that are close to resolution but must be viewed in an entirety for a cohesive reply; –non reuse of healthcare GTINs; –level below the each ( in healthcare ) –healthcare kits components workgroup. –Issuing agency discussion 3. There is also the GDSN / UDID test. 7

8. © GS1 US® 2013 QUESTION TODAY FROM SME MFR We are is the process of ordering new printer on our production lines to be able to incorporate the information we need in our bar code, (GTIN, lot number, expiration date) using a GS1 DataMatrix bar code. Do you know if additional software will be needed to be purchased for the printer to “talk to” the UDI database? Or if that is even needed? 8

9. © GS1 US® 2013 GS1 US ANSWER You would not connect your printers to the UDID. You would connect your master data system (Item files or Product Catalog) to the UDID. The printers will need more individual instance data (Production Information) which is not needed in the UDID. There are also other elements which will be needed in the UDID which will never be on the packaging such as the market authorizations. The loading of UDID can be accomplished manually with a direct interface to the UDID, electronically through the creation of a specific SPL7 message from your backend to their backend, or through the use of the Global Data Synchronization Network (GDSN). More details on these will be available when the rule is released. 9

10. © GS1 US® 2013 GS1 GEN SPECS … 10 No matter what you think you heard on this call… the best source of expert knowledge is the current version ( V13) as of this webinar) of the GS1 General Specifications www.gs1us.org

11. © GS1 US® 2013 GTIN ALLOCATION RULES FOR HEALTHCARE V.7 AS OF THIS WEBINAR Voluntary standards developed by GS1 Healthcare providing simple examples tailored for the global Healthcare sector Consistent with the general GTIN Allocation Rules Products in scope: –Pharmaceuticals (OTC and Rx) –Medical devices Local regulations may apply and take precedence over this voluntary guideline Available online at www.gs1.org/healthcare 11

12. © GS1 US® 2013 DATA FLOW VIA THE GLOBAL DATA SYNCHRONIZATION NETWORK, GDSN 12 Data Pools provide data that is standards conformant, and interoperable in the GDSN. The data pool performs the transactions of sending and receiving validated product information between partners inside or outside the data pool. Step 1: Load Data Select one data pool as a SINGLE point of entry to the GDSN. GS1 Global Registry: A single repository where basic data is registered – identifies the data pool location of source data Step 3: Subscription Request Step 4: Publish Data Step 2: Register Data Step 5: Recipient Confirmation

13. © GS1 US® 2013 UDID POPULATION USING GDSN Manufacturers can use the GDSN as a single point of entry for publishing an item’s master data –Supply Chain and Market data to GPOs and Providers –UDID data to the FDA and other similar UDI databases globally Benefits to the approach –Single entry platform –Population of data one to many –GPOs and Providers receive public UDID data elements GDSN has begun modifications for UDID –Additional attributes needed –Process flow for data pools to generate and send SPL messages to the FDA 13 GDSN MANUFACTURER GPO HOSPITAL/PROVIDER FDA UDID

14. © GS1 US® 2013 UNSPSC GS1 US manages the United Nations Standard Products and Services Codes (UNSPSC) for the United Nations Development Programme (UNDP). UNSPSC is a classification codeset which can be used to classify products and services to assist with spend analytics. To review the codeset to determine the appropriate code for your items, you have several choices available all from our website- www.unspsc.org.www.unspsc.org Use the search feature on the main webpage. You can search using words for the code name. The wildcard is the % key. Download the pdf file of the latest version for use on your system. This is a free file. Download from the Codeset-Download page. Download the Excel spreadsheet file of the latest version for use on your system. This file costs $100. Download from the Codeset-Download page. Join as a member for as low as $350 per year. Your company would utilize one of the Corporate membership types. This will provide you with a larger array of search and download capabilities as well as the ability to vote on changes to the codeset. This can be accomplished on the membership page. 14

15. © GS1 US® 2013 QUESTION FOR GROUP 15 Barcode on tube and box GTIN same on both GTIN different on both Why with rationale ? Ordering Recall

16. © GS1 US® 2013 COMPANY PREFIX EXAMPLES 16 GS1 Company PrefixU.P.C. Company Prefix 614141 0614141

17. © GS1 US® 2013 GS1 HEALTHCARE US “ASK THE EXPERTS” SEMINARS A forum where GS1 Healthcare US experts freely share their knowledge and expertise and address attendee questions. "Ask the Experts" seminars are designed to help YOU with your organization’s GS1 Standards implementation – wherever you’re positioned in the supply chain (from labeler to distributor to provider). 17

18. © GS1 US® 2013 ABOUT GS1 GS1 brings together stakeholders from across an industry to develop, adopt, and use information standards that revolutionize the way they do business. GS1 Standards make it possible for companies to leverage the power of information by identifying, capturing and sharing data about products, locations and more. GS1 is a global, not-for-profit organization with more than 110 member organizations (MOs) serving businesses around the world. GS1 is neutral, user-driven and user-governed. 18

19. © GS1 US® 2013 GS1 STANDARDS IN HEALTHCARE 19

20. © GS1 US® 2013 ABOUT GS1 US Established 1973 (the U.P.C.) Promotes and Implements the GS1 System in the U.S. –Over 20 industries and 200,000 members in U.S. –Uniquely identifies products, assets and locations –Barcodes, Electronic Product Code™ (EPC), e-Commerce Voluntary, not-for-profit, neutral, member driven Part of the GS1 Global Organization –One million global members, 150 countries www.gs1us.org 20

21. © GS1 US® 2013 FDA / OTHER MINISTRIES OF HEALTH UNIQUE DEVICE IDENTIFICATION (UDI) 1.A standardized system to develop the unique device identification (UDI) numbers 2.Place the UDI in human readable and/or bar code/RFID on a device, its label, or both 3.Create and maintain the UDI Database (UDID) 4.Implementation and adoption 21

22. © GS1 US® 2013 UDI at a glance UDI DI (static data) PI (dynamic data) Static Data Elements DI = primary access key … AIDC Machine Readable Data Carrier Linear Bar Code 2D Bar Code RFID … DI = Device Identifier PI = Production Identifiers (i.e. lot/batch no., serial no., expiry [use by] date, date of manufacture)UDID (database) UDI/UDID - System 22

23. © GS1 US® 2013 GEPIR: Global Electronic Party Information Registry 23 Search by Barcode (GTIN) Search by Container Code (SSCC) Search by Location Number (GLN) Search by Company Name

24. © GS1 US® 2013 GS1 IDENTIFICATION KEYS 24 SSCC= Serial Shipping Container Codes Individual Logistics Units GSRN = Global Service Relation Number Recipient of services GRAI = Global Returnable Asset Identifier Returnable Assets GLN = Global Location Numbers Physical Locations and Legal Entities GIAI = Global Individual Asset Identifier Fixed Assets GTIN® = Global Trade Item Number Products or Services GSIN = Global Shipment Identification Number* Multiple Logistic Units for Trade (Shipper Assigned) GINC = Global Identification Number for Consignment* Multiple Logistic Units for Transport (Transport Company Assigned) GDTI = Global Document Type Identifier Document Type

25. © GS1 US® 2013 WHAT IS A GTIN ® ? “GTIN” is a Global Trade Item Number  A globally unique 8, 12, 13, or 14-digit number that uniquely identifies products and services One of the identification “keys” (numbers) of the GS1System Unique and unambiguous Uniquely identifies a product/service at every level of packaging –A non-intelligent number –Assigned according to GTIN Allocation Rules It is about the data, not the carrier 25

26. © GS1 US® 2013 EXAMPLE... ADDITIONAL LANGUAGE Type of Change to Trade Item Add an additional language on the packaging Healthcare GTIN Allocation Rules 26

27. © GS1 US® 2013 27 GS1 DATA CARRIERS GTIN – 12 (U.P.C.) ITF – 14 GS1 DataBar with Composite Component GS1 DataBar ™ GS1 – 128 GS1 Datamatrix EPC in RFD Tag

28. © GS1 US® 2013 Keys (such as a GTIN®) provide access to information held in computer files. KEY PLUS KEY ATTRIBUTE… THE KEY… GTIN – Global Trade Item Number Expiration Date Lot / Batch Number Serial Number Key Attributes (such as Expiry, Lot / Batch, Serial Number, etc.) provide additional direct information. 28

29. © GS1 US® 2013 Application Identifiers and UDI AI (01) Global Trade Item Number (GTIN) AI (17) Expiration Date AI (10) Batch/Lot Number AI (11) Production Date AI (21) Serial Number 29 GS1 Healthcare US “Ask the Expert” Seminar

30. © GS1 US® 2013 GS1 Application Identifiers & Data Structures AI (01) n2+n14 (14-digits; all-numeric) AI (17) n2+n6 (6-digits as YYMMDD; all-numeric) AI (10) n2+an..20 (1-20 characters; alphanumeric) AI (11) n2+n6 (6-digits as YYMMDD; all-numeric) AI (21) n2+an..20 (1-20 characters; alphanumeric) 30 GS1 Healthcare US “Ask the Expert” Seminar

31. © GS1 US® 2013 GS1 AI’s & Human-readable Data Examples AI (01): (01) 10312345678903 AI (17): (17) 071200 AI (10): (10) a301234 AI (11) : (11) 030114 AI (21): (21) ab12 31 GS1 Healthcare US “Ask the Expert” Seminar

32. © GS1 US® 2013 Universal Product Number (UPN) HIBC LIC 8-20 characters - alphanumeric - variable length Aztec Code Datamatrix QR Code Code 128 Code 39 PDF 417 EAN.UPC GS1-128 ITF GS1 Databar GS1 DataMatrix GS1 QR * Symbologies Data Content Bar Code GS1 GTIN 14 digits - fixed length - all numeric GS1 HC does not endorse GS1- QR code use in healthcare 32

33. © GS1 US® 2013 COMPONENT ELEMENTS GTIN Indicator Digit GS1 Company Prefix –Company Number Product Identifier Check Digit HIBC LIC + Flag Character Unit of Measure ID HIBC Labeler ID Code (LIC) Product or Catalog Number (PCN) Link Character 33

34. © GS1 US® 2013 GLN SCORECARDS “Unless you keep score, it is just practice”. Vince Lombardi 34 Voluntary GLN Scorecard Reporting: 3,814 hospitals and other healthcare provider facilities 36 healthcare manufacturers and distributors 6 leading GPOs 11 healthcare software suppliers December 31, 2012 www.gs1us.org/hcscorecard

35. © GS1 US® 2013 GTIN SCORECARDS “Unless you keep score, it is just practice”. Vince Lombardi 35 Voluntary GTIN ® Scorecard Reporting: 2,732 hospitals and other healthcare provider facilities 112 healthcare manufacturers and distributors 4 GPOs 4 Solution Providers December 31, 2012 www.gs1us.org/hcscorecard

36. © GS1 US® 2013 http://www.gs1us.org/healthcare

37. © GS1 US® 2013 Reference Material 37

38. © GS1 US® 2013 38 Benefits Achieved 30% reduction in days payable outstanding 73% reduction in discrepancies (part number and UOM) Improved sourcing of products (right product/right order number) Less calls to customer service Fewer stock outs Better charge compliance (scanning @ POU) BD / MERCY CASE STUDY Perfect Order and Beyond BD and Mercy/ROi Achieve Far-Reaching GS1 Standards Integration Learn how BD and Mercy/ROi implemented GS1 global standards – from manufacturing plant to patient bedside – illustrating ways the supply chain can impact patient safety and optimize healthcare operations with fully automated order processes and transactions. Download at www.gs1us.org/BDMercystudywww.gs1us.org/BDMercystudy

39. © GS1 US® 2013 SUPPLIER TOOL KITS: GTIN, GLN, GDSN Introduction to the Standards Implementation Steps Lessons Learned Benefits to Healthcare Providers ROI Hot Spots FAQs http://www.gs1us.org/industries/healthcare/tools-and- resources/healthcare-tool-kits 39

40. © GS1 US® 2013 PROVIDER TOOL KITS: GTIN, GLN, GDSN, UNSPSC Introduction to the Standards Implementation Steps Lessons Learned Benefits to Healthcare Providers ROI Hot Spots FAQs http://www.gs1us.org/industries/healthcare/tools-and- resources/healthcare-tool-kits 40

41. © GS1 US® 2013 CONTACT INFORMATION John Roberts Director, Healthcare - GS1 US jroberts@GS1US.org GLN 0614141 008766 http://www.GS1US.org/healthcare Connect with the GS1 US community on: 41

42. © GS1 US® 2013 15 years GS1 US® Program Manager: GLN Registry 2004 to 2010 Facilitator: GTIN Workgroup GLN Workgroup 2004 to 2012 Recipient: Way Paver Award Prior experience 26 years U.S. Dept. of Defense 42 JOHN ROBERTS