Roadmap for Implementation - GS1 Standards and UDI

Transcription

1 Roadmap for Implementation - GS1 Standards and UDI - Global Trade Item Number (GTIN) - Use of Standards for Unique Device Identification (UDI) Fall Meeting - NESHMM October 25, 2017

2 Antitrust Caution GS1 US is committed to complying fully with antitrust laws. We ask everyone to refrain from discussions in areas of antitrust such as pricing, deal-making, selling, promoting or other activities which could be viewed as anti-competitive. If anyone believes the discussion is approaching these boundaries, please inform a GS1 US representative. Please remember to make your own business decisions and that all GS1 standards are voluntary and not mandatory. Please review the complete GS1 US antitrust policy at: 2

3 Legal Disclosure GS1 US, Inc. is providing this presentation as a service to interested parties. Although efforts have been made to assure that this presentation is correct, reliable, and technically accurate, GS1 US MAKES NO WARRANTIES, EXPRESS OR IMPLIED, AND ANY SUCH WARRANTIES ARE EXPRESSLY DISCLAIMED, CONCERNING THE ACCURACY OR RELIABILITY OF ANY PRESENTATION CONTENT, NONINFRINGEMENT, MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE. GS1 US shall not be liable for any consequential, special, indirect, incidental, exemplary or punitive damages of any kind or nature whatsoever, or any lost income or profits, or other theory of liability, arising out of the use of this presentation content, even if advised of the possibility of such loss or damage or if such loss or damage could have been reasonably foreseen. GS1 US employees are not representatives or agents of the FDA. 3

4 Learning Objectives Learning Objective I Roadmap for implementation of Global Trade Item Numbers (GTINs). Implementing GTIN in item master file and in supply chain transactions Learning Objective II Using the Unique Device Identifier (UDI): GTINs and encoded production identifiers for inventory management, meaningful use of EHR. 4

5 110+ Member Organizations Serving Business Around the World 5

6 The Global Language of Business GS1 Standards make it possible to identify, capture, and share information automatically and accurately about products, business locations, and more. 6

7 Benefits of Standards Key benefits Improving patient safety Lowering costs through increased efficiency Reducing medication errors Enabling supply chain visibility Facilitating effective product recalls Tracking of pharmaceutical products/medical devices Reducing introduction of counterfeit products Enhancing inventory management Linking critical product data to the patient record Supporting regulatory compliance Optimizing order, invoice, sales reporting, and chargeback/rebate processes 7

8 GS1 US

9 About GS1 US GS1 US serves more than 300,000 businesses across 25 industries in the United States. Leading industry initiatives in Apparel and General Merchandise, Foodservice, Healthcare, and Retail Grocery Administrating the GS1 System of Standards Providing support services, tools, education, and training Connecting communities through events and online forums GS1 US is the pioneer of the Universal Product Code (U.P.C.) and the Electronic Product Code (EPC ). In this presentation, the letters U.P.C. are used solely as an abbreviation for the Universal Product Code which is a product identification system. They do not refer to the UPC, which is a federally registered certification mark of the International Association of Plumbing and Mechanical Officials (IAPMO) to certify compliance with a Uniform Plumbing Code as authorized by IAPMO. 9

10 GS1 By The Numbers 2 million companies around the world use GS1 Standards. More than 5 billion GS1 barcodes are scanned every day. 10 million products are assigned U.P.C.s in the GS1 US Data Driver tool. Over 15 million products are registered by brand owners in the GS1 Global Data Synchronization Network (GDSN ). 10

11 GS1 Standards in Healthcare 11

12 GS1 Standards in Healthcare In this presentation, the letters U.P.C. are used solely as an abbreviation for the Universal Product Code which is a product identification system. They do not refer to the UPC, which is a federally registered certification mark of the International Association of Plumbing and Mechanical Officials (IAPMO) to certify compliance with a Uniform Plumbing Code as authorized by IAPMO. 12

13 Regulations Driving Change The FDA Unique Device Identification (UDI) Rule and Drug Supply Chain Security Act (DSCSA) are being implemented Packaging Changes for Products Serialization Requirements for drugs Track and Trace Initiative in Rx EHR Meaningful Use from CMS and EHR Certification Rules from ONC 13

14 Industry Compliance Timeline Hospital Providers need to start preparing for requirements coming up in 2018 related to Meaningful Use 3 objectives 14

15 Industry Compliance Timeline 15

16 FDA Unique Device Identification (UDI) MARK Label devices with AIDC (barcode) UDI=Device Identifier(DI)+Production Identifier(PI) DI=GTIN in GS1 Standards Label plain-text ISO format date YYYY-MM-DD SUBMIT Publish DI plus required data attributes to the Global UDI Data Base (GUDID) GDSN is one mechanism to publish that data once to both the FDA and customers COMPLY Year 1 (2014):Class III and devices under PHS Act Year 2 (2015):Class II/I implants and lifesupporting/sustaining Year 3 (2016):Remainder of Class II Year 5 (2018):Class I For Direct Marking - Compliance dates are extended by 2 years except for FDASIA implants and life-supporting/sustaining UDI Final Rule Posted to Federal Register Sept 24, 2013 GS1 US website: FDA UDI Website: and click on UDI Help Desk 16

17 FDA Unique Device Identification (UDI) The FDA UDI Rule of 2013 instituted the requirement for all medical devices to be uniquely identified The UDI Rule s intent is to provide increased patient safety by uniquely identifying every medical device in order to have traceability to each patient with each medical device 17

18 What is a UDI? Code on the device label, packaging or product, in both easily readable plain-text and automatic identification and data capture (AIDC) format Two parts : UDI = DI+PI - Device Identifier (DI) (static) specific to a device version or model - Production Identifier(s) (PI) (dynamic) one or more currently used control/production information, such as lot/batch, serial number, manufacturing date, expiration date 18

19 UDI Components UDI = Device Identifier (DI) + Production Identifiers (PI) GTIN + Application Identifiers (AI) GTIN Global Trade Item Number Expiry Date Lot Number Serial Number *Another Production Identifier is Manufacture Date 19

20 UDI Components Reference: 20

21 UDI Example of GTIN Plus Expiry Date, Lot, and Serial Number Healthcare best practice is to utilize the GS1-128 and/or GS1 Data Matrix to carry the UDI for Class III and Class II items. GTIN with Serial, Lot & Expiration Date encoded in a GS1-128 Barcode GTIN with Serial, Lot & Expiration Date encoded in a GS1 DataMatrix * Symbols are not to scale for illustration only Note: UPC and ITF-14 barcodes can only encode the GTIN and not Application Identifiers 21

22 How is UDI documented? The product is scanned, the data is sent to the EHR, which parses the data to the respective data fields. 22

23 Implementing Standards Provider Systems A caregiver scans the barcode on a medical device to record the UDI in the patient s medical record (EHR system) The EHR sends the information to the inventory management and replenishment system to deduct the used quantity from inventory quantityon-hand The EHR also sends the information to the claims/billing system based on usage 23

24 Benefits of UDI Helps providers identify patients implanted with recalled products using a standardized identifier Enables patients and providers to submit more precise adverse event reports Supports care coordination by providing physicians with precise information on the devices implanted in patients Allows hospitals to perform analyses comparing devices used in that facility Allows providers to submit information to device registries Provides a foundation to address counterfeiting of products Source: ofaudisystem/default.htm 24

25 GS1 US and UDI GS1 has been accredited by the FDA as an Issuing Agency for the assignment of UDIs in the context of the U.S. FDA Unique Device Identification System, and GS1 US serves as the first point of contact for the FDA. 25

26 Provider Steps for UDI Implementation Step 1: Establish Executive Support Step 2: Form a UDI Implementation Team (Clinical, Supply Chain, IT) Step 3: Develop Project Communication - Internal and External with suppliers Step 4: Assess Information Systems (ERP and EHR) Step 5: Identify/Obtain UDI Product Data - Select source (GDSN, GUDID, GPO, Supplier) Step 6: Engage Suppliers for Pilot & Testing Step 7: Conduct Transactional Testing Step 8: Create Standard Operating Procedures 26

27 Global Unique Device Identifier Database (GUDID) Website Operated by the FDA to collect information on Medical Devices Public facing website to share data with anyone ( 27

28 UDI in Hospital Provider Systems

29 Implementing Standards Provider Systems GDSN Obtain GTINs & Product Master Data from suppliers using GDSN Communicate/share your GLNs & Location Master Data with trading partners using the GLN Registry GLN Registry Obtain trading partner GLNs & Location Master Data from the GLN Registry and store in Trading Partner Master Database MMIS Product Master Database (GTINs & Product Master Data) Add a field for GTIN in the Product Master Database in your MMIS Assign GLNs to locations & define location data Store GLNs & Location Master Data in Location Master Database and the GLN Registry MMIS Location Master Database (GLNs & Location Master Data) Add a field for GLN to Trading Partner Master Database MMIS Trading Partner Database (GLNs & Location Master Data) EDI Interface Purchase Order Invoice Inventory Management System EHR sends message with product GTIN to the Inventory System to update quantity on hand EHR EHR sends message with product GTIN to Claims/Billing System to add product to patient bill and prepare claim Adds products to the Inventory Management System using product GTIN Enters product GTIN (& any additional data) into EHR Products are delivered with barcodes encoding GTINs & additional data Product barcodes are scanned for receiving and distribution Product barcodes are scanned at POC 29

30 GUDID Operated by the FDA to collect information on Medical Devices - A public facing website to share data with anyone ( 30

31 GUDID Global Unique Device Identifier Database (GUDID) - Operated by the FDA to collect information on Medical Devices - A public facing website to share data with anyone - Some information submitted to the GUDID will be private (for FDA only) All medical devices which are regulated under the UDI regulations will be required to be listed in the GUDID - Sunrise for each class is the same for GUDID as assigning a UDI Class III devices- 1 year from final rule publication (September 24, 2014) (complete with extensions) Class II life sustaining devices- 2 years from final rule publication (September 24, 2015) (GUDID extended to October 24, 2015) (complete with extensions) Class II remaining devices- 3 years from final rule publication (September 24, 2016) Class I devices- 5 years from final rule publication (September 24, 2018) 31

32 GUDID Basics Device information is - Loaded/supplied by the Labeler - Exists only once in the database - Only for FDA and the US Target Market Data Retrieval is - Online viewing - Pull download from website Full database- first of each month Weekly update- weekend batch for each week back to the last full database file Daily update- daily batch for each day back to the last weekly update file Only contains information about Medical Devices - Does not contain information on Pharmaceuticals, Office Supplies, Food, Janitorials, Textiles, Others 32

33 UDI Attributes MDM The UDI Rule requires a minimum of 18 required attributes and up to 44 additional attributes as shown below. ce/uniquedeviceidentification/globaludidatabasegudid/ucm htm Total Attributes Required Attributes 18 - Conditional Attributes 24 - Auto-populate 7 - Optional 13 Important to understand the definition of each attribute Utilize Design History File and FDA Filling to collect required data to fill in attributes 33

34 Global Trade Item Number (GTIN)

35 Issue #1 - Problem with Item Identification Manufacturer Product # Distributor Product # Hospital Product # (GTIN = ) Artwork Courtesy of GS1 and BD 35

36 Issue #2: Catalog Numbers Not Unique Cat # BD Product Other Supplier G x 3.25 in. BD Angiocath peripheral venous catheter (2.1 mm x 83 mm) made of FEP polymer. (10/sp, 50/ca) 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) BD E-Z Scrub surgical scrub brush impregnated with 4% CHG. Color coded red. (30/sp, 300/ca) ml BD SafetyGlide syringe with 23 G x 1 in. shielding intramuscular injection needle, regular bevel, regular wall. Detachable needle. (50/sp, 400/ca) Dentsply SS GLD 018X022 14IN PKG 10 Mallinckrodt CHEMICAL DRY SODIUM PHOSPHATE DIBASIC Codman DEBAKEY BULLDOG CLAMP RING HANDLE ANGLED 90? STRAIGHT SHAFT 41MM JAW 4 3/4'' (120MM) CARL ZEISS FLOORSTAND S-1 COMPLETE, W/ARTICULATED ARM SYSTEM FOR OPMI & ACCESS KG. 36

37 Issue #3: Trading Partner Numbers ( /2 ml BD Lo-Dose U-100 Insulin Syringe) Business Name Item Number Type Item Number BD Mfg Catalog Number BD GTIN BD GTIN BD GTIN CARDINAL HEALTH PV Order Number BF OWENS & MINOR PV Order Number OWENS & MINOR PV Order Number AMERICAN MEDICAL DEPOT Vendor Catalog Number AMERICAN MEDICAL DEPOT Vendor Catalog Number GOVERNMENT SCI SOURCE Vendor Catalog Number FSC CS GOVERNMENT SCI SOURCE Vendor Catalog Number FSC PK ALLIANCE JOINT VENTURE Vendor Catalog Number THOMAS SCIENTIFIC Vendor Catalog Number 8938M25 THOMAS SCIENTIFIC Vendor Catalog Number 8938M28 VWR INTERNATIONAL Vendor Catalog Number BD

38 Solution Global Trade Item Number A unique 8, 12, 13, or 14-digit number - identifies products and services of the GS1 System, as an unambiguous global standard for collaborative commerce A 14-digit GTIN can be encoded as - a GS1-128 / GS1 DataMatrix / GS1 DataBar / EPC/RFID GS1-128 (14-digit GTIN) DataMatrix (14-digit GTIN) Databar (14-digit GTIN) EPC/RFID 38

39 GTIN Introduction The Global Trade Item Number (GTIN) is an identification key in the GS1 System of Standards. The GTIN is used for uniquely identifying trade items, which includes both products and services that are priced, ordered, and invoiced at any point in the supply chain worldwide. GTINs are placed on trade items as barcodes: GTIN = A pointer that identifies product characteristics Always numeric and to be stored as text Barcode = Symbology that carries the GTIN A non-intelligent number Allocated according to the GTIN ALLOCATION RULES 39

40 GTIN for Each Packaging Level 40

41 Questions 41

42 Data Flow via GDSN The GS1 Global Registry is a single repository where basic data is registered. The GS1 Global Registry identifies the data pool location of source data. 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 Select one data pool as a SINGLE point of entry to the GDSN 5 4 Step 1 : Load Data Step 2 : Register Data Step 3 : Subscription Request Step 4 : Publish Data Step 5 : Recipient Confirmation FDA GUDID 3 rd Party Government Database Loading: The FDA utilizes the HL7 SPL message to receive machine to machine feeds of product information. To accomplish this the source data pool can act as a 3 rd Party Provider of data on behalf of a Data Supplier. Data confirmation messages will be returned to the Source Data Pool. The Source Data Pool will communicate these return messages to the Data Supplier. 42

43 GTIN Adoption and Usage Model

44 GTIN Adoption and Usage Model Levels of GTIN Implementation Maturity IDENTIFY L1 L2 CAPTURE L3 L4 SHAR E L5 Level 1 GTIN not in use. Using manufacturer catalog number/sku to identify products and devices. Level 2 GTINs assigned to all packaging levels (including lowest saleable unit), and stored in item master file. Level 3 GTINs used in pilot projects to test transactions for key business processes with key supply chain partners. Level 4 GTINs are used in transactions to actively trade with key trading partners. Level 5 GTIN are used in transactions to actively trade with a critical mass of trading partners; GTIN attributes are shared through a standard data source such as GDSN; systems are integrated both internally and externally. 44

45 GTIN Adoption and Usage Model Level One Awareness Level Two People and Process Level Three Systems and Partners Level Four Transact and Extend Level Five Optimize Communicate and Educate Enumerate and Develop Accuracy Processes Align Systems and Attributes Use GTINs instead of Proprietary Numbers Maintain and Share People Assess impending regulatory requirements, and ability to meet or exceed requirements. Commit to implement. Inform organization and supply chain partners. Educate Customer Service, Sales Reps, and Procurement teams on GTIN as well as company requirements and capabilities. Prioritize trading partners for implementation of standards in transactions. Identify any new skill sets required and include in succession planning and hiring. Develop Subject Matter Experts and transition skills appropriately. Tie KPI s to standards adoption / utilization in respective area of responsibility. Process Understand the benefits beyond compliance. Enumerate all products. Develop and maintain SOPs for master data management. Include contract terms and conditions that call for GS1 Standards on all products. Use GTINs and other GS1 Standards in a majority of, if not all, transactions. Maintain, share, & access products and attributes via a shared data catalog (e.g. GDSN). Technolo gy Assess current technology capabilities for standards usage. Develop process to promote accuracy and usability of GTIN at all packaging levels. Align IT capabilities internally and externally. Assure technology infrastructure and plan can support standards across various systems. Develop and integrate systems to synchronize with master data using GTIN. 45

46 Communicate and Educate Level 1 Awareness: Communicate and Educate Manufacturer/Distributor Provider/GPO Solution Provider Have a basic understanding of GS1 Standards for Healthcare. Have a basic understanding of GS1 Standards for Healthcare. Have a basic understanding of GS1 Standards for Healthcare. Knowledge of impending regulatory requirements (e.g., FDA UDI, Meaningful Use, DSCSA, etc.). Knowledge of impending regulatory requirements (e.g., FDA UDI, Meaningful Use 3, DSCSA, etc.). Knowledge of impending regulatory requirements (e.g., FDA UDI, Meaningful Use 3, DSCSA, etc.). People Commit to implement identification standards. Assemble a project team. Develop communication plan (internal & external), and share with all responsible departments. Develop communication plan (internal & external), and share with all responsible departments. Commit to implement identification standards. Develop communication plan (internal & external), and share with all responsible departments. Commit to implement a solution that includes identification standards. Process Assess organizational ability to meet regulatory requirements. Assess and understand the benefits beyond compliance. Understand how standards will be used by downstream business partners. Trading partners are identified and notified of need for GTIN and any Application Identifiers. Determine trading partner ability to meet the need. Develop metrics to track % of items with GTIN in Item Master. Have a basic understanding about the use of standards by trading partners. Capture customer requirements at a high level. Allow contract terms and conditions to include provisional language for GS1 Standards. Specify requirement for GS1 Standards (specifically GTIN) in contract terms and conditions. Assess clinical and non-clinical processes for GTIN use. Technolo gy Assess current technology capabilities for implementation and use of identification standards (e.g., ERP, EDI, Inventory Management, Contract Management, etc.). Assess systems (e.g., ERP, EHR, EDI, contract management, billing, point of use, etc.). IT staff begins aligning internal systems to GS1 Standards. Assess technology solutions to understand capabilities with regard to supporting standards. Align 2017 GS1 IT capabilities US All Rights Reserved internally and externally. 46

47 Enumerate and Develop Accuracy Processes Level 2 People & Process: Enumerate and Develop Accuracy Processes Manufacturer/Distributor Provider/GPO Solution Provider People Inform organization & trading partners of standards strategy. Educate implementation team and relevant staff on GS1 Standards specifically within the context of meeting regulatory requirements. Align resources to GTIN development and use. Identify trading partner resources and develop engagement plan. Educate internal staff on GS1 Standards (e.g., requisitioners, buyers, IT, etc.). Identify supplier partner resources & develop a plan with key suppliers. Educate supplier contracting resources, customer service, sales representatives, and account management teams. Educate internal departments about UDI regulation. Educate sales staff and solution development team on GS1 Standards basics (GTIN, GLN, GDSN). Align resources to develop solution systems within the context of standards. Identify trading / implementation partner resources and develop a plan with key accounts. Process Understand the benefits beyond compliance. Begin enumerating all products and all packaging levels. Develop master data management strategy. Review, develop and maintain SOPs for GTIN assignment, master data management and data quality. Begin initial testing with key trading partners. Assess use of GTIN in internal supply chain processes (e.g., contracting, requisitioning, purchasing, receiving). Assess existing process for device data capture at point of use, and impact of using GTIN in same. Assess existing Item Master to Charge Master mapping process and use of GTINs. GTINs not yet used in transactions with suppliers but process has been established for sourcing. Develop project plan including basic requirements, capture, and technology roadmap. Work with key accounts and industry leaders to document detailed requirements. Technolo gy Identify data sources (internal and external). Develop reporting metrics to selfmanage implementation efforts (accuracy of data, penetration of portfolio). Add available GTINs to item master Identify data sources for obtaining GTIN data (GUDID/GDSN/Supplier). Obtain GTINs as part of sourcing process and store in item master. Develop MDM strategy. Begin initial testing with select Develop and implement with select key accounts for functionality related to GTIN and GLN storage and transactional capabilities. 47

48 Align Systems and Attributes Level 3 Systems & Partners: Align Systems and Attributes Manufacturer/Distributor Provider/GPO Solution Provider People Internal staff are assigned, educated, and know GS1 Standards. Collaborative relationships with trading partners to align and manage GTINs are intact. Internal staff is educated about GS1 Standards and engaged in transactional testing with key suppliers. All departments (e.g., supply chain, IT, clinical) champion GTIN use. Sales staff is actively discussing standards capabilities with key accounts to establish further adoption & use of functionality. Development team has a prioritized roadmap for product development to meet needs for GTIN storage & transactional functionality. Process GTINs are actively managed. GTINs are used in some transactions with major customers as a result of pilots. SPOs are updated to include new use case scenarios as they become known. Basic implementation metrics are established (e.g., % of item master enumerated; % packaging level enumerated) GTINs are actively managed in the Item Master. Metric of % of total item master with GTIN is used to drive further adoption. Systems assessment is complete and partners identified of status. Pilot projects are executed with key suppliers & metrics to quantify ROI. Product development is working directly with key accounts to understand potential gaps in functionality or potential enhancements based on user acceptance testing results. Basic implementation metrics are established (e.g., % of transactions using GTIN). Contract terms and conditions specify requirements of applicable GS1 Standards, specifically GTINs. Technolo gy Systems are upgraded (as needed) and ready to transact using GTINs. Testing continues/expands around using GTINs in a majority, if not all, transactional areas internally & externally (e.g., EDI, Order to Cash, Inventory Management, Contract/Chargeback). Systems are upgraded & ready to transact using GTINs (e.g., clinical, non-clinical, inventory, recall, EDI, contract management, point of care systems) Testing continues to use GTINs and other GS1 Standards in a majority of transactions. System integration between key functional areas (e.g., ERP, EHR, Inventory mgmt., data capture through scanning) has started. Steps have been taken to make standards functionality readily available (e.g., patches, partial upgrades, enhancements, etc.). 48

49 Use GTINs instead of proprietary numbers Level 4 Transact & Extend: Use GTINs Instead of Proprietary Numbers Manufacturer/Distributor Provider/GPO Solution Provider Continuing education/ certification of assigned resources. Continuing education or certification of assigned resources. Continuing education or certification of assigned resources. People Strong cross-functional knowledge of GTIN strategy & use in various functional areas. Standards training is an established part of employee on-boarding in key areas. Standards training is an established part of employee on-boarding in key areas. Knowledge transfer process is in place to support standards focus. SOPs and resources are defined to assure awareness of pending regulations that may impact solution provider technology development roadmap. Process GTINs are stored in item master. Proprietary numbers are becoming obsolete both internally and externally. Relevant Application Identifiers are encoded, scanned and captured at receipt points along supply chain. GTINs are used in transactions with critical mass and key trading partners. GTINs are stored in item master. GTINs are used in transactions with critical mass suppliers in POs and EDI transactions. ROI metrics now include discrepancy tracking so that manufacturers and product accuracy can be managed. Actively driving the need for standards adoption & utilization within strategic accounts. Several key accounts using system standards capabilities in key functional areas. An SOP and process exists to train implementation partners on GS1 Standards and the solution s capabilities around those standards. Technolo gy Systems are integrated internally and externally with respect to GTIN in key functional areas. Systems are becoming integrated across multiple standards (GTIN and GLN). Clinical & EHR systems can handle GTIN data and GTIN capture at point of care. Scanning technology is in place for GTIN capture in the OR. GTIN data is captured at point of care for all device categories (Class I, II, III). Technology solution is well established and meets the needs of the industry with regard to its capabilities around standards. System integration is established across key functional areas. A majority of key accounts are using system versions with full standards capabilities. 49

50 Maintain and Share Level 5 Optimize & Maintain: Maintain and Share Manufacturer/Distributor Provider/GPO Solution Provider People Internal resources are well versed in GS1 System and embrace use of standards. KPIs are tied to standards use in respective areas of responsibility. There is a high level of awareness of the organization s standards strategy. Internal resources are well versed in GS1 System. Clinical staff use GTIN at point of care. Sales, marketing, development, and implementation staff see standards as part of the norm and as a strategic advantage/differentiator when facing new business opportunities. Standards use and management is part of the norm. GTINs are used in transaction with >75% of trading partners. GTINs are used in transactions with >75% of products. Adoption and utilization of standards is evident in a majority of accounts. Process GTINs enumerated, stored and shared is >75% and covers all packaging levels. Enumeration and attribute accuracy is >75%. GTINs and critical product attributes are available via a shared data catalog (e.g., GDSN). GTINs % of item master is >75%. GDSN used to receive GTIN attributes for all packaging levels. MDM strategy and SOPs are in use & maintained. GTINs are captured at point of use. SPOs are well formed, inclusive and followed. Technolo gy All products and packaging levels are marked in accordance with GS1 Standards. GTINs are actively passed to relevant systems for inventory management, order to cash processes, invoicing, Contracts/Chargebacks. GTINs are actively passed to relevant systems for inventory management, order to cash processes, EHRs, Patient Billing systems. Technology solutions are readily available through cloud based version updates. 50

51 Who is GS1 Healthcare US GS1 US is dedicated to the adoption and implementation of standards-based, global supply chain solutions in the U.S., serves >300K companies -- 16,000 of which are in healthcare GS1 Healthcare, with the Global Office in Brussels, Belgium is a voluntary group of stakeholders including manufacturers, wholesalers & distributors, as well as hospitals and pharmacy retailers, regulatory agencies and trade organizations GS1 Healthcare US began our journey in We focus on driving the adoption and implementation of GS1 Standards in the healthcare industry to improve patient safety and supply chain efficiency 51

52 GS1 US Resources and Workgroups Healthcare Initiative Workgroups: EDI Implementation Workgroup: Supports development of a common healthcare industry approach for implementing Electronic Data Interchange (EDI) using GS1 Standards Provider Advisory Workgroup: Provides a forum for healthcare provider member organizations to collaborate Price Accuracy Initiative Workgroup: Supports the use of the Global Location Number (GLN) in the medical device chargeback process, customer identification and best practices using the GLN to improve pricing accuracy between stakeholders Rx Secure Supply Chain Workgroup: Supports pharmaceutical supply chain members in their efforts to use GS1 Standards for business and regulatory purposes requirements in the Drug Supply Chain Security Act (DSCSA) 52

53 Implementation Resources GTIN Maturity Model and Industry Roadmap Provider GLN Tool Kit, Provider GTIN Took Kit, Provider GDSN Tool Kit GS1 US Implementation Guideline: Applying GS1 Standards for DSCSA and Traceability Release 1.2 Best Practice Guide for Implementing GLN in Trace, Chargeback & Rebate Processes GS1 Standards - Overview of Global Data Synchronization Network (GDSN) GLN 101 for Healthcare Location Identification Improving Healthcare Business Processes GS1 Standards & Hospital Supply Chain Operations Website: 53

54 Contact Information Salil Joshi Senior Director, Industry Development GS1 US Corporate Headquarters Princeton Pike Corporate Center 1009 Lenox Drive, Suite 202 Lawrenceville, NJ T E sjoshi@gs1us.org 54