Healthcare Provider Tool Kit

Global Trade Item Number® (GTIN®)

Improving Patient Safety and Supply Chain Efficiency

Improving Patient Safety and Supply Chain Efficiency
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GS1 Healthcare US

®

HEALTHCARE PROVIDER TOOL KIT Global Trade Item Number® (GTIN®)
Release 3.0 Published: March 2012

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Table of Contents
EXECUTIVE SUMMARY......................................................................................................................................... 4 ABOUT GS1® ......................................................................................................................................................... 5 INTRODUCTION TO STANDARDS ....................................................................................................................... 6 WHY ARE STANDARDS NECESSARY? ...................................................................................................................... 6 ABOUT THE STANDARDS ......................................................................................................................................... 7 Global Location Number (GLN) ........................................................................................................................ 7 Global Trade Item Number® (GTIN®) ............................................................................................................. 8 Global Data Synchronization Network® (GDSN®) .......................................................................................... 8 United Nations Standard Products and Services Code® (UNSPSC®) ........................................................... 8 HOW DO THE GS1 STANDARDS RELATE TO EACH OTHER? ...................................................................................... 8 THE CASE FOR THE GLOBAL TRADE ITEM NUMBER® (GTIN®) .................................................................... 11 THE PROBLEM: PRODUCT IDENTIFICATION ............................................................................................................. 11 Patient Safety Issues ...................................................................................................................................... 11 Supply Chain Management Issues ................................................................................................................ 11 THE SOLUTION: STANDARDIZED TRADE ITEM IDENTIFIERS ...................................................................................... 12 WHAT IS A GTIN? ................................................................................................................................................ 12 HOW ARE GTINs ASSIGNED TO PRODUCTS? ................................................................................................ 13 HOW IS A GTIN USED? ....................................................................................................................................... 14 IDENTIFICATION OF PRODUCTS .............................................................................................................................. 14 LINK TO PRODUCT INFORMATION ........................................................................................................................... 14 ADVANTAGES OF USING GTINs IN THE HEALTHCARE SUPPLY CHAIN..................................................... 15 BENEFITS TO HEALTHCARE PROVIDERS....................................................................................................... 16 PATIENT SAFETY BENEFITS................................................................................................................................... 16 SUPPLY CHAIN BENEFITS...................................................................................................................................... 17 IMPLEMENTING GTINs IN YOUR ORGANIZATION .......................................................................................... 17 STEP ONE: ESTABLISH EXECUTIVE SUPPORT ....................................................................................................... 18 STEP TWO: FORM A GTIN MANAGEMENT ADVISORY GROUP ................................................................................. 18 STEP THREE: ESTABLISH YOUR GTIN OPERATIONAL TEAM ................................................................................... 19 STEP FOUR: DEVELOP & INITIATE PROJECT COMMUNICATION................................................................................ 19 STEP FIVE: INITIATE EDUCATION FOR THE ADVISORY GROUP & OPERATIONAL TEAM .............................................. 20 STEP SIX: ASSESS INFORMATION SYSTEM ISSUES & MAKE NECESSARY CHANGES ................................................. 20 STEP SEVEN: IDENTIFY/OBTAIN GTINS ................................................................................................................ 21 STEP EIGHT: ESTABLISH IMPLEMENTATION STRATEGY .......................................................................................... 21 STEP NINE: ENGAGE SUPPLIER INVOLVEMENT ...................................................................................................... 22 STEP TEN: CONDUCT TRANSACTIONAL TESTING WITH SUPPLIERS ......................................................................... 22 STEP ELEVEN: MAKE ADJUSTMENTS TO INITIAL GTIN IMPLEMENTATION PLAN........................................................ 22 STEP TWELVE: CREATE STANDARD OPERATING PROCEDURES .............................................................................. 23 ANALYZING GTIN ROI FOR YOUR ORGANIZATION........................................................................................ 23 BACKGROUND INFORMATION RE: ROI FROM GTIN USE IN OTHER INDUSTRIES ........................................................ 23 LEVELS, READINESS AND IMPACTS MODEL (LRIM) ................................................................................................ 24 HOT SPOTS FOR ROI ........................................................................................................................................... 24 Supply Chain Management ............................................................................................................................ 24 Purchasing Management ............................................................................................................................... 25
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Labor Management ........................................................................................................................................ 25 LESSONS LEARNED & BEST PRACTICES ....................................................................................................... 26 FREQUENTLY ASKED QUESTIONS (FAQs) ..................................................................................................... 27 GLOSSARY........................................................................................................................................................... 29 REFERENCES ...................................................................................................................................................... 31 APPENDIX A: GTIN DATA FORMATS ................................................................................................................ 33 APPENDIX B: INTEGRATION OF NDC/NHRIC INTO GTINs ............................................................................. 36 CREATING A 14-DIGIT GTIN .................................................................................................................................. 36 CREATING A 12-DIGIT GTIN .................................................................................................................................. 37 APPENDIX C: GS1 APPLICATION IDENTIFIERS .............................................................................................. 38 APPENDIX D: ILLUSTRATIONS OF BAR CODED GTINs ................................................................................. 39 GS1 SYMBOLOGIES ENCODING GTIN.................................................................................................................... 39 GS1 SYMBOLOGIES ENCODING GTIN WITH SERIAL NUMBER .................................................................................. 40 GS1 SYMBOLOGIES ENCODING GTIN WITH LOT NUMBER ....................................................................................... 41 GS1 SYMBOLOGIES ENCODING GTIN WITH EXPIRATION DATE ............................................................................... 42 GS1 SYMBOLOGIES ENCODING GTIN WITH SERIAL, LOT & EXPIRATION DATE ......................................................... 43 APPENDIX E: SAMPLE VENDOR LETTER ........................................................................................................ 44

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Executive Summary
The purpose of this document is to provide guidance to healthcare providers about the need for standardized product identification in order to support patient safety and supply chain management. To that end, it introduces and explains the GS1 Global Trade Item Number (GTIN), and how it facilitates reliable product identification across your facility. In addition, the benefits to both patient safety and supply chain management are discussed, and guidance for assessing GTIN ROI for your organization is included as well. Finally, this document provides detailed steps for implementing GTIN in your organization. Using this document, you will better understand how the use of GTINs for product identification will best fulfill your need for reliable product information in order to support patient safety and effective supply chain management. And, using this document, you will learn how to get that effort underway today!

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About GS1®
About GS1
GS1 is a leading global organization dedicated to the design and implementation of standards and solutions to improve the efficiency and visibility of supply and demand chains, both globally and across sectors. GS1 is a fully integrated global organization, with 108 Member Organizations (like GS1 US™) serving over a million companies doing business across 150 countries. Together, GS1 and its subsidiaries and partnerships connect companies with standards-based solutions that are open, consensus-based and universally endorsed.

About GS1 US
GS1 US is the Member Organization of GS1 that serves companies in the United States. As such, it is the national implementation organization of the GS1 System dedicated to the adoption and implementation of standards-based, global supply chain solutions in the United States. GS1 US currently serves over 200,000 U.S. member companies -- 16,000 of which are in healthcare.

About GS1 Healthcare
GS1 is the leading global standards organization in the healthcare industry, supporting the healthcare community through its GS1 Healthcare global initiative. GS1 Healthcare is a voluntary, global user community that brings together all healthcare stakeholders, including: pharmaceutical and medical devices manufacturers, wholesalers and distributors, group purchasing organizations, hospitals, pharmacies, logistics providers, governmental and regulatory bodies, and associations. The mission of GS1 Healthcare is to lead the healthcare industry to the successful development and implementation of global standards to enhance patient safety and supply chain efficiencies. GS1 Healthcare drives the development of GS1 Standards and solutions to meet the needs of the global healthcare industry, and promotes the effective utilization and ® implementation of global standards in the healthcare industry through local support initiatives like GS1 Healthcare US in the United States.

About GS1 Healthcare US®
GS1 Healthcare US is an industry group that focuses on driving the adoption and implementation of GS1 Standards in the healthcare industry in the United States to improve patient safety and supply chain efficiency. GS1 Healthcare US brings together members from all segments of the healthcare industry to address the issues that most impact healthcare in the United States. Facilitated by GS1 US, GS1 Healthcare US is one of twenty-four local GS1 Healthcare user groups around the world that supports the adoption and implementation of global standards developed by GS1.

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Introduction to Standards
Trading partners in the healthcare supply chain need to share many and complex pieces of data in order to transact business and support their work. For example, manufacturers and distributors need to communicate product information and company location, and hospitals need to share location information. In order to be efficient and effective in that effort, a common language and globally accepted standards are essential. Without such standards, supply chain partners face high, unnecessary costs due to inaccurate data and supply chain information inefficiencies. Unfortunately, the healthcare industry has experienced the harsh reality of this lesson. In the first comprehensive analysis of this topic in 1996, the Efficient Healthcare Consumer Response study found that $11 billion is wasted each year in the healthcare supply chain primarily because data standards are either entirely lacking or not as widely used or well-developed as in other industries1 Worse yet, a groundbreaking report on patient safety issues by the Institute of Medicine in 1999 cited staggering statistics about medical error, and found that hand written reports or notes, manual order entry, non-standard abbreviations and poor legibility lead to substantial errors and injuries.2 Those findings and conclusions were reinforced five years later when the authors of that groundbreaking report revisited the status of the healthcare system and once again echoed their findings of widespread systemic problems.3 In response, a movement has been building in the healthcare supply chain to adopt and implement data standards to support patient safety and improve supply chain management. A growing number of companies, hospitals and healthcare organizations have chosen the GS1 System to help them improve collaboration with their supply chain partners. For over thirty-five years, the GS1 System has provided globally accepted identifiers and a common language for the communication of supply chain information about products, services and locations. The GS1 System is the most widely used supply chain standards system in the world, utilized in twenty-three sectors and industries including GS1’s core sectors of Healthcare and Fast Moving Consumer Goods (FMCG), as well as Transport, Defense and many others.

Why Are Standards Necessary?
Healthcare providers need to communicate product and location information with their supply chain partners, and with the various sites and departments within their own enterprise. Without a common language and globally accepted standards, healthcare providers, companies and/or industry associations are left to develop their own identifiers and data formats, resulting in numerous proprietary “standards” for healthcare providers and companies to manage. However, as discussed in the Efficient Healthcare Consumer Response study, this is the cause of billions of dollars of waste in the healthcare industry. Moreover, the existence of numerous “standards” causes supply chain inefficiencies and inaccurate data that inserts cost and confusion into healthcare business processes, threatening quality of care and patient safety. This is why global standards are so important. Global standards provide simplicity and consistency by promoting universal applicability and optimal functionality across the globe for all industry sectors. In today’s complex markets, supply chain lines are blurring and channels of distribution for various sectors are overlappng.
Efficient Healthcare Consumer Response (EHCR), Improving the Efficiency of the Healthcare Supply Chain, November 1996. Produced by CSC Consulting, Inc. Copyright 1996, American Society for Healthcare Materials Management, Health Industry Business Communications Council, Health Industry Distributors Association, National Wholesale Druggists’ Association, and GS1 US (formerly the Uniform Code Council), jointly and severally. 2 To Err Is Human: Building a Safer Health System. Institute of Medicine (1999). The National Academies Press. 3 Lucian L. Leape, M.D., Donald M. Berwick, M.D., Five Years After To Err Is Human: What Have We Learned?, Journal of the American Medical Association, May 18, 2005, 293 (19): 2384–90.
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This is especially true of the healthcare industry where manufacturers of healthcare products often supply both hospitals and consumer goods retailers; pharmacies and hospitals purchase consumer goods as well as healthcare products; and the pharmaceutical supply chain has expanded to include supermarkets and consumer goods retailers in addition to traditional pharmacies. Global standards that can be used by all supply chain partners, independent of industry sector or location, are essential in this environment. Global standards support healthcare business processes and can bring about many benefits for patient safety and supply chain management, such as:                Reduction in medication errors through efficient automatic identification: the right product for the right patient at the right time through the right route and in the right dose Efficient traceability Efficient product authentication Less time spent on manual documentation, leaving more time to consult directly with patients Cost reduction through increased supply chain efficiency Improved order and invoice process Optimized receiving Reduced inventory Increased productivity Improved product recall Improved shelf management Improved service levels/fill rate Improved benchmarking and management of supply cost Elimination of the need for re-labeling and proprietary codes Regulatory compliance (where applicable)

About the Standards
The GS1 System is an integrated suite of global standards that provides for accurate identification and communication of information regarding products, assets, services and locations. Using GS1 Identification Numbers, companies and organizations around the world are able to globally and uniquely identify physical things like trade items, assets, logistic units and physical locations, as well as logical things like corporations or a service relationship between provider and recipient. When this powerful identification system is combined with the Global Data Synchronization Network (GDSN), the connection is made between these physical or logical things and the information the supply chain needs about them. Global Location Number (GLN) The Global Location Number (GLN) is the globally unique GS1 Identification Number for locations and supply chain partners. The GLN can be used to identify a functional entity (like a hospital pharmacy or accounting department), a physical entity (like a warehouse or hospital wing or even a nursing station), or a legal entity (like a health system corporation). The attributes defined for each GLN (e.g., name, address, class of trade, etc.) help users to ensure that each GLN is specific to one, very precise location within the world.
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Global Trade Item Number® (GTIN®) The Global Trade Item Number® (GTIN) is the globally unique GS1 Identification Number used to identify “trade items” (i.e., products and services that may be priced, ordered or invoiced at any point in the supply chain). GTINs are assigned by the brand owner of the product, and are used to identify products as they move through the global supply chain to the hospital or ultimate end user. The attributes defined for each GTIN (e.g., size, weight, packaging, etc.) help users to ensure that each GTIN is specific to one, very precise trading unit configuration (e.g., a blister of two aspirin tablets; a bottle of 100 aspirin tablets; etc.). Global Data Synchronization Network® (GDSN®) Each user not only defines and maintains its own GLNs and GTINs with their associated attributes, but is also responsible for sharing this information with its supply chain partners. To support those efforts, the Global Data Synchronization Network (GDSN) provides an efficient and effective approach to (1) storing GS1 Identifiers with their associated attributes, (2) checking to make sure that the identifiers and attributes are properly defined and formatted, and (3) sharing that information with supply chain partners. The GDSN offers a continuous, automated approach to data management that ensures that supply chain information is identical among trading partners, increasing data accuracy and driving costs out of the supply chain. United Nations Standard Products and Services Code® (UNSPSC®) The United Nations Standard Products and Services Code® (UNSPSC®) is a hierarchical set of product categories used by supply chain partners worldwide to classify their products and services. The UNSPSC provides a single, global classification system for all products and services in all industry sectors. Use of the UNSPSC enhances company-wide visibility of spending analysis, and promotes cost-effective procurement. As a result, the UNSPSC is used extensively around the world in electronic catalogs, search engines, procurement application systems and accounting systems.

How Do the GS1 Standards Relate to Each Other?
GS1 Identification Numbers provide the link between an object and the information pertaining to it. When a user assigns a GS1 Identification Number, they define a set of standardized information (known as attributes) about the object to which that identifier relates (e.g., size, weight, location, etc.) The GS1 System specifies the list of attributes that must be defined for each GS1 Identifier, and provides a precise definition as well as acceptable values and data formats for each attribute. Standardized attributes about products include core data like selling unit, item dimensions, and UNSPSC product classification. Standardized attributes about commercial entities include core data like location information about a warehouse or hospital. Once defined by the user, those attributes are then stored in a GDSN-certified Data Pool and shared with supply chain partners using the GDSN. Through this process, GS1 Identification Numbers not only identify an object, but also provide a link to information about that object. That linkage is tremendously valuable. In fact, twenty-three industry sectors have used GS1 GTINs, GLNs and the GDSN as the foundation for a wide range of efficiency building solutions that have improved their operations and supported their business processes for decades. Likewise, with GTINs, GLNs and the GDSN, healthcare providers can lay the foundation for a wide range of solutions to enhance patient safety and supply chain management within their facilities and across their organizations, as demonstrated in the illustration below. As shown, patient safety and supply chain efficiency are the ultimate goals (shown as the roof of the house). There are numerous and ever-evolving tools to support providers in improving patient safety and supply chain management (shown as the pillars supporting the roof). However, in order to work, those applications must be
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built on a strong foundation. This is where the standards come into play. Standardized product identification, standardized location identification and standardized product definitions (shown as the foundation of the house) provide the foundation for developing the tools and applications that healthcare providers use to improve patient safety and supply chain management. Figure 1: Building Patient Safety

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Problem: Supply chain partners use different Organization and Location IDs. Example: Manufacturer uses GLN. Distributor uses DUNS number. Hospital uses its own proprietary identification system. This causes rebates and claims to be misapplied and/or lost, and frustrates direct deliveries in the facility. Healthcare Industry Solution: Global Location Number (GLN)

Problem: The same product has different identification numbers assigned to it. Example: Nearly every hospital has a different Product ID for 3M Item #8630 -- making proper product identification, ordering and recalls difficult. Healthcare Industry Solution: Global Trade Item Number (GTIN)

Problem: The same identification number is assigned to different products. Example: “Part Number 10313” refers to several different manufacturers/items. This increases errors in ordering and distribution to patients, and makes sourcing of needed products difficult. Healthcare Industry Solution: Global Trade Item Number (GTIN)

Problem: There is no standard for unit of measure and no distinct identifier for different product packaging levels. Example: You may order “50” and receive 500 because they are sold in units of 10, or you may order 20 “cases” and receive 20 “boxes.” This results in inventories of wrong products and increased returns processing, driving up costs and creating cash flow issues. Healthcare Industry Solution: GTIN Allocation Rules for Product Hierarchy and Package Measurement

Problem: No central source of party/location and product information. Example: The numerous systems across the healthcare facility (e.g., inventory systems, billing/accounts payable, Barcode Point of Care (BPOC) systems, prescription drug systems, etc.) each have their own database. This is a problem because there is no way to ensure that the information used in one system is the same as the information used in another. Healthcare Industry Solution: Global Data Synchronization Network (GDSN)

Problem: No standards for classifying or grouping products in order to analyze spending activities. Example: Providers need to manage their purchasing volume with suppliers in order to achieve the best pricing for which the hospital is eligible. However, most provider systems are not structured to provide insight into purchasing activities and patterns based on product categories, products and/or vendors. Healthcare Industry Solution: United Nations Standard Products & Services Code (UNSPSC)

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The Case for the Global Trade Item Number® (GTIN®)
The Problem: Product Identification
Today, there is no universally adopted standard identification system utilized by all healthcare providers to identify all of the products used in their facilities. The absence of universal, standards-based product identification leads to problems in patient safety and supply chain management in healthcare facilities. Patient Safety Issues In 1999, the National Academy of Sciences Institute of Medicine published a report titled To Err is Human: Building a Safer Health System. The report cited staggering statistics about medical error and the consequential adverse healthcare events associated with medical errors: from 44,000 to 98,000 preventable deaths occur annually due to medical error - more annual deaths than highway accidents, breast cancer or AIDS. Equally disconcerting was the assertion that widespread systemic problems either caused or compounded many medical errors. For example, the report found that hand written reports or notes, manual order entry, non-standard abbreviations and poor legibility lead to substantial errors and injuries. Five years after the release of To Err is Human, several authors of that groundbreaking report revisited the status of the healthcare system, and reinforced their findings of widespread systemic problems. The findings related to hand written notes, manual data/order entry and non-standard abbreviations still apply at many healthcare facilities today where doctors, nurses and staff continue to handwrite and manually enter nearly everything. Other factors like poor legibility and overworked, timeconstrained staff only increase the risks of errors and omissions. Hand written notes, manual data entry (with resulting input errors) and confusing markings on product packages all threaten patient safety. For example, manual data entry systems may create the following problems:   Increase the likelihood that a wrong product is given to a patient. Undermine “patient rights” (i.e., the right product/drug is being administered to the right patient via the right route in the right amount at the right time). Inhibit the ability to introduce a reliable tracking system for healthcare products at the facility.

Supply Chain Management Issues In addition to patient safety issues, the absence of standards-based product identification also leads to problems in supply chain management at healthcare facilities. For example:  Inconsistent inventory levels (i.e., excess of products not needed, and lack of products that are). This leads to:     Hoarding of products by healthcare staff. Supply disruption when products run out.

Lack of a sustainable, reliable ordering system (e.g., inability to effectively use: bulk buying, cyclical/seasonal forecasting, etc.). Inability to leverage UNSPSC to establish ordering patterns.

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 

Purchases of the wrong product, which lead to excess inventories of wrong products. Inaccurate product/inventory returns, and inefficient returns processing.

These problems inhibit healthcare providers from properly identifying costs and efficiently managing inventory, and as a result they drive up supply chain costs and create cash flow issues. In addition, they promote inefficient use of a limited and valuable resource: clinical professionals’ time.

The Solution: Standardized Trade Item Identifiers
The solution to these problems is standards-based product identifiers. The use of standards-based identifiers enables a healthcare organization to efficiently and effectively manage information about all of the various products used in their healthcare facilities. Moreover, the use of a globally accepted, standardized approach to identifiers provides a common language to facilitate the communication of product information among supply chain partners. This promotes the efficient exchange of accurate product information with supply chain partners to support orders, returns and recalls. Moreover, it facilitates the flow of accurate product information within the healthcare organization itself. This enhances patient safety [e.g., by supporting Barcode Point of Care (BPOC) Systems] and facilitates supply chain management (e.g., inventory replenishment and distribution). The GS1 System provides globally accepted identifiers, standards and a common language for the communication of supply chain information. The GS1 Identifier for products is the Global Trade Item Number® (GTIN®). For decades, this GS1 Identifier has facilitated the sharing and communication of product information among supply chain partners in twenty-three industry sectors. Moreover, it has provided the foundation for innovative improvements in supply chain management for many American industries, including the impressive and well-documented advances in the retail and grocery industries directly attributable to their adoption and implementation of GTINs in particular and the GS1 System in general.

What is a GTIN?
A Global Trade Item Number (GTIN) is the globally unique GS1 Identification Number used to identify “trade items” (i.e., products and services that may be priced, ordered or invoiced at any point in the supply chain). GTINs are used to identify individual trade item units (like a box of 15 Brand X tissues), as well as all of their different packaging configurations (like a carton of six boxes of Brand X tissues). GTINs are assigned by the brand owner or manufacturer of the product, and are used to identify products as they move through the global supply chain to the hospital or ultimate end user. In today’s complex markets, supply chain lines are blurring and channels of distribution for various sectors are overlapping. Global standards that can be used by all supply chain partners, independent of industry sector or location, are essential in this environment. This is especially true of the healthcare industry where manufacturers of healthcare products often supply both hospitals and consumer goods retailers; pharmacies and hospitals purchase consumer goods as well as healthcare products; and the pharmaceutical supply chain has expanded to include supermarkets and consumer goods retailers in addition to traditional pharmacies. As a standard that can be used by all supply chain partners, independent of industry sector or location, GTINs support providers in navigating complex healthcare supply chains. In fact, GTINs are already being used across the healthcare sector today, from prescription drugs, to medical devices, to healthcare supplies.

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How are GTINs Assigned to Products?
The GTIN is a number – a globally unique, standards-based, identification number for trade items. Manufacturers are responsible for generating GTINs for their products (known as allocation). The GS1 System provides clear, structured data standards and allocation rules that manufacturers follow when allocating GTINs in order to ensure that their GTINs are globally unique and in a consistent format. It should be noted that some healthcare products are assigned identification numbers for regulatory purposes. For example, pharmaceutical products are assigned a National Drug Code (NDC), and medical/surgical products are assigned a National Health Related Item Code (NHRIC). GS1 allocation rules give pharmaceutical and medical/surgical manufacturers the option of integrating these regulatory identifiers into their GTINs, and many manufacturers opt to do so. There are two basic steps for allocating a GTIN: (1) First, GS1 US assigns a GS1 Company Prefix to the manufacturer. The GS1 Company Prefix is part of the data structure for all GS1 Identifiers (e.g., GTIN, GLN, etc.) and provides the foundation for generating all of the GS1 Identification Numbers. (2) Second, the manufacturer assigns/generates their own GTINs based on their GS1 Company Prefix and the GS1 Standards and allocation rules. When a manufacturer allocates a GTIN, they also define a prescribed set of data about the product to which that GTIN relates. These product description attributes define master data that is consistent across all instances of the product (e.g., size; color; brand information; etc.). The GTIN and its associated attributes are then saved in a database (like a GDSN-certified Data Pool) and shared among supply chain partners. The final step for the manufacturer is to mark all of their products with the applicable GTIN so that they can be properly identified as they move through the supply chain. In order to do this, manufacturers encode the GTIN into data carriers [i.e., bar codes and/or Radio Frequency Identification (RFID) tags], and then affix a data carrier to each product. Data Carriers provide symbolic representations of GTINs that facilitate automatic identification and data capture (e.g., the black bars and spaces on the bar code). In addition, most data carriers include a human readable version of the GTIN as well to facilitate manual data entry when necessary (e.g., the numbers below the black bars of the bar code). The graphic below provides an example of a bar coded GTIN.
Figure 2: GTIN Bar Code Although this graphic shows a GTIN embedded in a GS1 GTIN-12 bar code, the healthcare industry has been increasingly using GS1 Data Matrix to marking their products with GTINs. Appendix D provides graphical illustrations of GTINs encoded onto each of the GS1 bar codes, including the GS1 Data Matrix.
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14141 00044

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Manufacturers can not only encode a GTIN into data carriers, but they can also encode item specific information on the data carrier as well (e.g., expiration date; lot number; batch number; etc.). Encoding item specific attributes into data carriers enables manufacturers to communicate item specific information (in addition to a GTIN) wherever the data carrier is scanned. This can be especially important with healthcare-related products like prescription drugs where lot number and serial number are required.

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This section is intended to provide some basic information about the processes involved in GTIN allocation. Further information about the topics touched on in this section can be found in the various appendices of this document, specifically:     Appendix A: GTIN Data Formats Appendix B: Integration of NDC/NHRIC into GTINs Appendix C: GS1 Application Identifiers Appendix D: Illustrations of Bar Coded GTINs

Readers seeking more detailed information about how to create a GTIN should consult the GS1 US Product Catalog and GTIN Allocation Rules. (See the References section of this document for links.)

How is a GTIN Used?
As described above, GTINs are assigned by the manufacturer of a product. Once assigned, GTINs are used by supply chain partners to (1) identify products as they move through the supply chain, and (2) to provide a link to the information pertaining to a product.

Identification of Products
Manufacturers mark their products with the applicable GTIN in order to support supply chain partners in accurately identifying products. Using a globally accepted, standardized product identifier supports supply chain partners in accurately identifying products as they move through the supply chain to the hospital or ultimate end user. Accurate product identification is especially important for healthcare providers whose product catalog includes prescription drugs, surgical supplies, and medical equipment – items that can affect health and patient safety. Providers can enter GTINs into their computer systems either by manual data entry (i.e., typing) or automatically via the data carrier (i.e., bar code scanners or RFID readers). The option of entering a GTIN into an IT system automatically using data carriers (as opposed to typing it in) enables users to record a GTIN with as minimal manual intervention as possible, increasing both speed and accuracy. This facilitates a safer and more secure supply chain, and can be especially useful for providers using BPOC Systems. This has many benefits to public health and patient safety, including reducing medical errors, facilitating recalls, and improving prescription drug administration.

Link to Product Information
The GTIN not only identifies a specific trade item, but also provides the link to the information pertaining to it. This enables supply chain partners to simply reference a GTIN in supply chain communications, as opposed to manually entering all of the necessary product information. Using a GTIN to reference trade item information promotes efficiency, precision and accuracy in communicating and sharing product information. For this reason, a GTIN is required in many types of e-commerce transactions, and is commonly used on purchase orders, as well as delivery and payment documents.

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Advantages of Using GTINs in the Healthcare Supply Chain
Standards-based numbering systems are essential for efficient and effective communication of product information in supply chains. In today’s complex markets, supply chain lines are blurring and channels of distribution for various sectors are overlapping. This is especially true of the healthcare industry. Global standards that can be used by all supply chain partners, independent of industry sector or location are essential in this environment. The GTIN is a global standard that delivers trade item data in a consistent format and structure based on the globally accepted GS1 System. The GS1 System is the most widely used supply chain standards system in the world, utilized in 150 countries and twenty-three industry sectors, including our core sectors of Healthcare and Fast Moving Consumer Goods (FMCG). GTINs provide hospitals with a method of identifying products that is simple and able to be used by any industry. In fact, GTINs are being used across the healthcare sector today to identify pharmaceuticals, medical devices, and many other healthcare products. Advantages of using GTINs include:   

International: GTINs are a global standard that can be assigned and used anywhere across the globe. Unique: The GTIN can be used to uniquely identify healthcare trade items,
including every packaging configuration of a product.

Multi-sector: GTINs can be used by all business sectors, enabling a

healthcare product, a grocery product, a retail product, and 99% of the items found in a healthcare environment to be identified with the same standardized identification number. That makes inventory systems, ordering systems and accounting systems compatible across different industries, thereby supporting healthcare providers navigating overlapping supply chains.

Automatic Data Capture: One of the key benefits of the GTIN is that it can be encoded in many automatic data capture technologies (such as bar codes or RFID tags). This supports automatic data capture using both current and emerging technologies. Automatic data capture enables users to enter a GTIN into an IT system with as minimal manual intervention as possible, increasing both speed and accuracy. Data Integrity: Use of the GTIN for product identification enables users to leverage the Global Data Synchronization Network (GDSN) for product information. The GDSN offers a continuous, automated approach to data management that ensures that product information is identical among supply chain partners, increasing data accuracy and driving costs out of the supply chain.
GS1 provides a registry service (i.e., a search tool) that enables subscribers to look up the owner of a bar code. That service, available on the GS1 website, is known as GS1 GEPIR. With GS1 GEPIR, users simply enter the GTIN displayed with a bar code, and GEPIR will identify the owner of that bar code/GTIN.
(A link to GS1 GEPIR is provided in the References of this document.)

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Benefits to Healthcare Providers
Beyond business, beyond the supply chain, healthcare is about much more than supply and demand. There is perhaps no other industry where accuracy and speed are more important. In healthcare, caregivers need the right products, in the right location, at the right time to ensure the proper patient treatment. GTINs provide the foundation for that effort. GTINs enable healthcare providers to efficiently and effectively manage information about all of the various products used in their facilities using a unique, global standard for product identification. This facilitates communication of accurate product information among supply chain partners and within the provider as well, translating to significant benefits for supply chain management and patient safety.

Patient Safety Benefits
Caregivers need the right products, in the right location, at the right time to ensure the proper patient treatment. GTINs provide the foundation for that effort by facilitating accurate product information among supply chain partners and within the organization as well. Correct product identification and accurate product information about all of the various products used in healthcare facilities has many benefits for public health and patient safety, including: 

Right product: Use of the GTIN within healthcare facilities provides accurate identification of products, facilitating caregivers’ efforts to ensure that the right product is delivered and used for patient care. BPOC systems: Many hospitals have leveraged automated bar code identification and technologies in their processes supporting patient care (i.e., BPOC Systems). Use of GTIN in such systems facilitates identification of the products used/administered at bedside to ensure that they are correct. Pharmaceutical and biological products: GTIN is already used by the pharmaceutical sector to identify pharmaceutical and biological products at both the individual unit and orderable case level. Use of those GTINs in BPOC Systems for prescription drug administration can help enhance those systems and reduce medical errors. Medical devices: Many medical devices are already
identified using GTINs, providing an opportunity for providers to leverage those identifiers to improve medical device reporting.

 

Product recalls: Using GTINs facilitates a streamlined product recall process. Supply chain integrity: GTINs support accurate identification of products from point of origin to point of care. This promotes a safe and secure supply chain by providing greater visibility, accuracy and efficiency.

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Supply Chain Benefits
Use of the GTIN facilitates communication of accurate product information among supply chain partners. In addition, it enables healthcare providers to efficiently and effectively manage information about all of the various products used in their healthcare facilities. This promotes more efficient business practices and helps to drive down supply chain costs for both healthcare providers and suppliers. As a result, there are many supply chain benefits to using a GTIN: 

Better cash flow: Use of GTIN streamlines chargeback and rebate processing, reducing the amount of money sitting in unresolved sales accounts. Reduced labor costs: Use of GTIN frees staff time by eliminating the need to build and maintain cross reference tables in order to keep track of multiple proprietary identification numbers. Improved information quality: Using the GTIN as the link to product information improves information quality by ensuring that product information is identical among supply chain partners. This benefits both internal and external business processes. Simplified supply chain management: GTIN strengthens
business communications among supply chain partners by accurately identifying specific products with specific numbers. This facilitates the global flow of healthcare trade items and associated information.

More efficient payment and reporting processes: With the use of GTINs, sales can be reported to providers automatically and with fewer errors, improving Electronic Data Interchange (EDI) and eBusiness transactions. Enhanced inventory management: GTINs provide positive product identification, ensuring that receivers can easily identify items for distribution and use, and supporting replenishment operations.

Implementing GTINs in Your Organization
GTIN implementation provides the essential foundation for larger initiatives aimed at improving patient safety and supply chain management in hospitals, including BPOC Systems, GDSN, product classification and contracting. The main focus of the provider implementation effort is to create a GTIN database, and to integrate GTIN into IT systems like purchasing, inventory, BPOC, Electronic Medication Administration Records (eMAR), etc., as well as to ensure interoperability with electronic patient records. So, what exactly does it take to implement GTINs in a healthcare organization? What are the steps and who is involved? This section answers these questions with detailed, step by step instructions for implementing GTINs. These steps involve critical areas such as establishing executive support, determining implementation strategy, forming cross-functional teams, creating internal and external communication strategies, initiating supplier involvement, and establishing standard operating procedures. For links to all of the Tools listed in the implementation steps, please refer to the References section of this document.

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Step One: Establish Executive Support
The goals in this step are to inform and educate executive management on standards adoption and the need for industry-wide implementation, and to obtain executive approval to proceed with implementation. As with any project that will impact the business processes of the organization, the support of senior management is critical.

Actions
 Prepare a presentation on the value of GTIN and a GTIN implementation plan.

In your presentation:  Cite the benefits identified in these materials.  Include language to speak to specific stakeholders as necessary (e.g., reinforce enhanced benefits as GTIN use becomes more robust; speak to the business side of pharmaceuticals and medical device systems; etc).

Tools
 GTIN materials from the GS1 Healthcare US Website  GTIN materials from the GS1 Healthcare US Document Library

 Emphasize that business should drive technology, and determining the best way to implement GTIN requires examination of current business processes.
 Deliver the GTIN presentation and implementation plan to senior management.  Secure approval to initiate the project and form the needed teams (i.e., GTIN

Management Advisory Group, and the GTIN Operational Team).

Step Two: Form a GTIN Management Advisory Group
The goal in this step is to establish an Advisory Group. Formation of a multi-disciplinary Group including members outside of supply chain functions promotes buy-in, supports communication efforts, and ensures proper input from the areas most impacted by implementation.

Actions
 Recruit and solicit commitments for participation. The Group should

include:

Tools
 GTIN presentation materials (prepared in Step 1 above)

 Financial Controller
 Legal Counsel  Supply Chain  Information Systems (business & operational)  Accounts Payable  Public Relations (internal)  Group Purchasing Representative  Primary Distributor Representative  Pharmacy Head  Nursing/Clinicians  Clinical Engineering

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Step Three: Establish Your GTIN Operational Team
The goal in this step is to establish a GTIN Operational Team. The day-to-day utilization and maintenance of the GTIN as a support tool will require the involvement of multiple individuals.

Actions
 Identify and select participants.  Establish the role of each participant.  Update job descriptions to reflect the new responsibilities of the

Tools
 GTIN presentation materials (prepared in Step 1 above)  GTIN materials from the GS1 Healthcare US Website  GTIN materials from the GS1 Healthcare US Document Library  GS1 US Website & Product Catalog  GS1 Healthcare US Web Seminars

team members.
 Provide education and training.

Step Four: Develop & Initiate Project Communication
The goal in this step is to inform your internal and external community. Utilize internal communication tools such as newsletters, intranet, websites and vendor letters to introduce the concept of the GTIN to your organization, including the supplier community. The Advisory Group member from Public Relations should be enlisted in this effort.

Actions
 Announce organizational commitment to GTIN in newsletters

and other media.
 Announce commitment to implement the GTIN to your

Tools
 GTIN presentation materials (prepared in Step 1 above)  GTIN materials from the GS1 Healthcare US Website  GTIN materials from the GS1 Healthcare US Document Library  Supplier/Vendor letter template (see Appendix E)

suppler community.

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Step Five: Initiate Education for the Advisory Group & Operational Team
The goal in this step is to educate participants. A base level of knowledge about GTINs and GS1 is necessary for all active participants.

Actions
 Participate in web seminars.  Train staff.

Tools
 GTIN presentation materials (prepared in Step 1 above)  GTIN materials from the GS1 Healthcare US Website  GTIN materials from the GS1 Healthcare US Document Library  GS1 US Website & Product Catalog  GS1 Healthcare US Web Seminars

Step Six: Assess Information System Issues & Make Necessary Changes
The goal in this step is to evaluate the readiness of your information systems, and make the appropriate system changes required to accommodate the use of GTIN. The capability of your information system to contain and utilize GTIN numbers must be assessed, and the necessary changes made.

Actions
 Meet with your IS system experts (including different disciplines within the IS department),

internal and external, to review implementation strategy and understand implications for your information systems.
 Establish a collaborative plan to make the necessary changes and prepare information

systems.
 Develop a plan to populate your internal systems with GTINs.

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Step Seven: Identify/Obtain GTINs
The goal in this step is to gather GTINs for each of the products used/purchased at your facility. Hospital databases already contain many GTINs assigned to products by their manufacturers. Therefore, this effort will encompass assessing the GTINs you already have, and then requesting suppliers to forward any/all GTINs you do not have for all of the packaging levels they supply to your facility.

Actions
 Identify the level of depth (i.e., packaging level) that your GTIN numbering system will

need to accommodate to support operations.
 Contact manufacturers, distributors, and/or suppliers for GTINS for each packaging

Tools
 At the Heart of Healthcare – Product ID Brochure

configuration they supply to you.
 If a supplier has not assigned a GTIN for a product, advise them to contact GS1 US.

Step Eight: Establish Implementation Strategy
The goal in this step is to establish data storage referencing GTIN. At this point, you are ready to establish a GTIN utilization strategy and corresponding data packaging level chart. The establishment of your organization’s GTIN packaging level is a critical step in the implementation process. It is necessary to consider not only how business is currently conducted, but also future business processes and supply system possibilities. In order to do that, current and possible distribution and billing systems must be clearly understood. The Group must decide which tables/databases in the hospital’s IT systems that must contain GTINs. The question that must be asked is: where are proprietary numbers used today that can be replaced with GTINs? At a minimum, the Group should consider the tables/databases in the following IT systems: purchasing, replenishment, recall, ebusiness, rebates and chargebacks, classification [i.e., United Nations Standard Products and Services Code (UNSPSC)], inventory management, transportation, controlled substances, vendor scorecard, payer systems (e.g., Medicare), patient records, etc.

Actions
 Analyze your organization’s current and future supply chain models and

distribution systems.
 Consider organizational evolution (e.g., point of use system).  Each system should be surveyed as to GTIN use.  Once the initial survey is finished, it is recommended that the survey findings

Tools
 GTIN materials from the GS1 Healthcare US Website  GTIN materials from the GS1 Healthcare US Document Library  GS1 US Website & Product Catalog  GS1 Healthcare US Web Seminars

be re-circulated to the Group for review and validation.
 After completion of the survey review and validation, the Group should meet to

discuss the results and to identify the first areas/systems in which to implement GTINs based on patient safety, value added benefits, or both.

 Please give the following information to your technical team to support their work in this step:
Depending on the data carrier used, GTINs can be represented as 8 digits, 12 digits, 13 digits, or 14 digits in length. In order to accommodate each variation, it is highly recommended that a GTIN always be represented in software applications as 14 digits by right justifying and zero filling to the left as appropriate. In order to preserve any leading zeros that may be present, it is also recommended that the GTIN field be represented in a database as a text field, not as a numeric field. This information should be provided to systems engineers as they prepare to integrate GTINs into IT systems.

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Step Nine: Engage Supplier Involvement
The goals in this step are to prepare the supplier community and identify partner(s) for testing. Collaboration and communication with your supplier community is critical to implementation success. So, now that an implementation plan and initial database has been established, engage strategic suppliers in a process of communication about your organizational plans.

Actions
 Explain implementation and process.  Determine supplier capabilities.  Analyze impact to operations and staff.

Tools
 Supplier/Vendor letter template (see Appendix E)

Step Ten: Conduct Transactional Testing With Suppliers
The goal in this step is to successfully exchange purchase transactions with suppliers. At this point, you are ready to conduct transactional tests with your suppliers, manufacturers and/or distributors. The testing process will provide validation of information system capabilities and operational impact, and may include your MMIS, EDI transactions, contracts, etc. It is recommended that providers first perform this step with their top/key suppliers.

Actions
 Document critical success factors.  Make adjustments as identified.  Communicate with community.

Step Eleven: Make Adjustments to Initial GTIN Implementation Plan
The goal in this step is to review the initial plan and make corrections based on work group experiences and lessons learned. As a result of the testing process, potential adjustments must be made to all aspects of the program, from scanning through communications.

Actions
 Adjust plan to achieve the most benefits, either in terms of supply chain

Tools
 Project Implementation Plans

management, patient safety, financial benefits, or all of the above.

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Step Twelve: Create Standard Operating Procedures
The goals in this step are to document standard operating procedures and obtain sign off, both internally and externally. Following testing and the implementation of the necessary adjustments, it is necessary to prepare standard operating procedures for internal and external staff. The Advisory Group and Operational Team should be heavily involved in this process.

Analyzing GTIN ROI for Your Organization
In today’s dynamic healthcare environment of declining reimbursement and a reduced labor pool, healthcare organizations expressed a need to establish a return on investment (ROI) for the use of GTIN. Indeed, demonstration of positive ROI for GTIN supports organizations challenged daily by the allocation of scarce resources. This section provides guidance to help each organization determine their own return on investment based on their individual needs and circumstances. The section is provided as a starting point for any organization wishing to pursue ROI analysis.
It is good to note that beyond the analysis provided in this section for the ROI of GTIN alone, additional benefits and ROI can be found in the implementation of GTIN as part of the implementation of the full GS1 System of standards, including Global Location Numbers (GLNs) and the Global Data Synchronization Network (GDSN). (For more information about GLNs and the GDSN, please refer to the Healthcare Provider Tool Kits prepared on those topics by GS1 Healthcare US.) Moreover, most “early adopter” organizations have realized additional value in unanticipated areas like process improvement and infrastructure development. And, many have noted the value of a new “business philosophy” or way of doing business which places the organization in an advantageous position to address some of the upcoming challenges anticipated in healthcare over the next ten years.

It should be emphasized that the analysis provided in this section focus on ROI related to supply chain applications of GTIN, not patient safety applications of GTIN. Although there is no standard measure or baseline for improvements to patient safety, there will be obvious benefits to patient safety and each provider can assess patient safety ROI issues themselves and add them into their own model.

Background Information re: ROI from GTIN Use in Other Industries
The implementation of standards-based product identification in other industries has been found tremendously valuable, as discussed and analyzed at length in the article 17 Billion Reasons to Say Thanks. The following excerpt is provided to support your efforts to discuss the benefits of GTIN implementation and ROI: In October, 2001 AT Kearney was engaged by the Grocery Marketing Association (GMA) and the Food Marketing Institute (FMI) to evaluate and provide recommendations for e-commerce collaboration. Recommendations of this study included the adoption of an industry-wide, standardized numbering system, providing benefits and savings across the supply chain such as out of stocks, cost of reconciling invoice errors, receiving times, and speed to market. More significant, but more difficult to capture, were the benefits from supply chain visibility and collaboration, that can drive significant inventory reductions across the whole supply chain. In the book industry, the move to computerize book information led to the realization that a descriptive/alpha system was too cumbersome. In the grocery industry, the idea had been around, but the evolution of
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commercially viable scanning equipment signified an opportune moment. It is significant to note that both industries adopted an all-numeric schema. Only in the grocery industry have significant attempts been made to quantify the benefits of using GTINs. Net benefits (after implementation costs) were initially estimated at approximately 1% of sales, but more recently revised to 2.8% of sales, or US$8 billion. These benefits were primarily due to increased process efficiencies and productivity gains. The same studies also estimate that an additional US$15 billion of benefits could potentially be realized through improved collaboration. In the case of the book industry, the benefits and savings of using a standard product identification numbering system were considered so obvious that a cost/benefit analysis was not even done to quantify anticipated results. In conclusion, the agreement to adopt a standardized product identification numbering system provides the foundation to reap extensive benefits throughout the supply chain, not only for all the individual members but also in growing the whole industry.4

Levels, Readiness and Impacts Model (LRIM)
Center for Innovation in Healthcare Logistics (CIHL) at the University of Arkansas engaged in a Data Standards implementation project with a number of industry partners and provider sites to understand the costs, barriers and opportunities providers can expect in GS1 standards adoption. Together, they designed the Levels, Readiness and Impacts Model (LRIM). The LIRM is designed to provide a user-friendly, Excel-based spreadsheet tool to help providers meet their need to quantify the investments and benefits they can expect from GS1 adoption choices. LRIM does not attempt to estimate dollar costs and benefits. Instead, the model aims to provide quantitative foundations on which those economic assessments can be constructed for particular provider settings. (A link to the LIRM is provided in the References secrtion of thius document.) At this time, LRIM addresses only GS1 implications for supply chain operations in commodity medical/surgical products. In the near future the CIHL team plans to enhance LRIM or create sibling versions to address other categories of products including Pharmaceuticals, Implantable Devices, and Surgical Materials.

Hot Spots for ROI
There are various functions and business processes which will be directly impacted and improved through the use of GTIN. These functions and business processes serve as “hot spots” for capturing return on investment of GTIN implementation. In order to support your ROI analysis, a list of ROI hot spots is provided below. Begin your ROI analysis by determining the amount of staff time and resources currently allocated to each of these functions. In addition, determine the amount of manual error corrections being done in each function as well.

Supply Chain Management Record the number of items that cannot be automatically identified when received, and the amount of staff time it takes to track such an item down. Consider each of the following scenarios both before and after GTIN implementation: 
4

Wrong product received due to incorrect purchasing order

17 Billion Reasons to Say Thanks: The 25th Anniversary of the U.P.C. and Its Impact on the Grocery Industry, PriceWaterhouseCoopers, December 14, 1999.
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Right product, but:  No bar code  Incorrect bar code (i.e., bar code not scannable)  Not a GS1 bar code  Not in database

  

Off catalog purchases from non-preferred vendors (e.g., staff goes to a local outlet or store to purchase some supplies they have run out of). Error due to the wrong product being returned. Distribution of the wrong product in the facility.

Purchasing Management Track the number of times before and after GTIN implementation:     Product information from suppliers is not correct (e.g., unit of measure issues). Product information in purchase reports received from suppliers and their group purchasing organizations (GPOs) are incomplete. There is confusion about what the product is. There is incomplete and inaccurate supplier information.

Labor Management In terms of labor management, consider the following for both before and after GTIN implementation:   Hours devoted to tracking product identification numbers. Hours devoted to dealing with product problems and errors.

 Clinician time related to monitoring products for patient charges and product reordering.

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Lessons Learned & Best Practices
The following case studies illustrate lessons learned and best practices for GTIN implementation. The documents can be found in the GS1 Healthcare US Online Document Library. (Visit www.gs1us.org/healthcare to download.) In addition, links are provided in the References section of this Tool Kit.

 The Case for Global Data Standards in the Healthcare Supply Chain  Perfect Order and Beyond: How BD and Mercy/ROi Achieve Far-Reaching GS1 Standards Integration  Seton Family of Hospitals / BD Success Story  RSS Study - Pharmacia and Dept. of Veterans Affairs  RSS Study - Abbott Laboratories and St. Alexius Medical Center  RSS Study - Alcon Laboratories

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Frequently Asked Questions (FAQs)
What is a Global Trade Item Number (GTIN)? The GTIN is the GS1 System standard term for product and process identification. The GTIN is used for the unique identification of trade items worldwide. A trade item is any product or service upon which there is a need to retrieve predefined information and that may be priced, ordered, or invoiced at any point in the supply chain. A Global Trade Item Number may be 8, 12, 13, or 14 digits in length, represented as GTIN-8, GTIN-12, GTIN-13, and GTIN-14 respectively Is a unique GTIN required for every level of packaging? Yes. There should be a unique GTIN identifying the consumer unit, an inner pack, multi-pack, case, or pallet where applicable. What is GTIN Compliance? Because of history and technical changes, barcodes can be 8,12,13 or 14 digits. A company/organization that is able to process, store, and communicate information about their products with trading partners using all GTINs, whether 8, 12, 13, or 14 digits, is considered to be GTIN compliant. To be current, a GTIN should be stored in a data base as 14 digits. Companies/organizations can become GTIN compliant by expanding the appropriate systems and applications to 14-digits. This will support the GTIN on products at all levels of packaging (consumer, inner packs, multi-packs, cases, and pallets, etc.) It is necessary to become GTIN compliant to take advantage of the benefits of data synchronization using the Global Data Synchronization Network (GDSN). If a change is made to the product does the GTIN need to change? A separate unique GTIN is required whenever any of the pre-defined characteristics of an item are different in any way that is relevant to the trading process. The guiding principle is if the customer is expected to distinguish a new item from an old item and purchase accordingly, a new GTIN should be assigned to the new. For complete information, refer to the GTIN Allocation Rules for Healthcare. What can be identified using the GS1 Identification Numbers? Trade items: Products and services upon which there is a need to retrieve pre-defined information at any point in the supply chain (Global Trade Item Number/GTIN). Logistic units: Physical units established for transport and storage of products of any kind that need to be tracked and traced individually in a supply chain (Serial Shipping Container Code/SSCC). Assets: Fixed or returnable assets (Global Individual Asset Identifier/GIAI, Global Returnable Asset Identifier/GRAI). Locations: Physical, functional, or legal entities requiring a permanent identification, such as a provider, department, or warehouse (Global Location Number/GLN). Service Relations: Public or private service provider to track any entity’s service requirements and needs over a continuing relationship (Global Service Relation Number/GSRN). Note: All GS1 identifiers use the same GS1 Company Prefix assigned to the company or organization.

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What are Application Identifiers? The GS1 System uses a bar code that can carry special prefixes to identify and separate multiple identification (ID) numbers. These two-, three-, or four-digit numbers, are called Application Identifiers (AI’s). When a scanner sees this special bar code, it automatically knows to look for AI’s in order to separate and interpret ID numbers properly. The information that comes after the AI’s can contain numeric (n) or alphanumeric (an) data characters.

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Glossary

Term
AI Application Identifier (AI) Attribute Bar Code Company Number

Glossary Definition
Acronym for Application Identifier (defined below). The field of two or more digits at the beginning of an element string that uniquely identifies its format and meaning within the GS1 System. A piece of information reflecting a characteristic of the object to which an identification number (i.e., GLN, GTIN, etc.) relates. A precise arrangement of parallel lines (bars) and spaces that vary in width to represent data. A number allocated by the GS1 Numbering Organization. It is combined with the GS1 Prefix (for the GS1 Member Organization) to create the GS1 Company Prefix. The GS1 Company Prefix (i.e., the GS1 Prefix + the Company Number) uniquely identifies a provider. A physical or electronic mechanism that carries data (e.g., a bar code or RFID tag). Required structure for the numerical string of a GS1 Identifier (e.g., text, length, spacing, punctuation, etc.) The entirety of all GS1 System data standardized in meaning and structure. The GS1 System data structures defined in the various lengths required for the different identification purposes, which all share a hierarchical composition. Their composition blends the needs of international control with the needs of the user. Acronym for Electronic Data Interchange (defined below). A method of business communications and management using electronic methods, such as electronic data interchange and automated data collection systems. The computer-to-computer exchange of structured information, by agreed message standards, from one computer application to another by electronic means and with a minimum of human intervention. Acronym for the GS1 Global Location Number (defined below). The globally unique GS1 System identification number for legal entities, functional entities, and physical locations. The GLN is 13 digits, comprised of a GS1 Company Prefix, Location Reference, and Check Digit. Supply side trading partner locations generally include corporate headquarters, regional offices, warehouses, plants, and distribution centers. Demand side trading partner locations generally include corporate headquarters, divisional offices, stores, and distribution centers. The globally unique GS1 System identification number for products and services. A GTIN may be 8, 12, 13, or 14 digits in length, represented as GTIN-8, GTIN-12, GTIN-13, and GTIN-14 respectively. A globally unique number assigned to companies/organization by GS1 Member Organizations to create the identification numbers of the GS1 System. It is comprised of a GS1 Prefix and a Company Number. The specifications, standards, and guidelines administered by GS1. GS1, through the Global Standards Management Process, manages the GS1 System to maintain the most implemented standards in the world.
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Data Carrier Data Format Data Standard Data Structure

EDI Electronic Commerce Electronic Data Interchange (EDI) GLN Global Location Number

Global Trade Item Number GS1 Company Prefix GS1 System

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Term
GS1-128 Bar Code Symbol

Glossary Definition
A subset of the Code 128 Bar Code Symbol that is utilized exclusively for GS1 defined data structures. UCC/EAN-128 Symbols can be printed as stand-alone linear symbols or as a composite symbol with an accompanying 2D Composite Component printed directly above the GS1128 linear component. Acronym for the GS1 Global Trade Item Number (defined above). A numerical designation that uniquely identifies an object in the supply chain. Identification numbers are used to retrieve information previously exchanged between trading partners and stored in their computer database files. See GLN (defined above). A number within a GLN assigned by various parties to identify a different entity. A party to transactions in the supply chain, such as a supplier (seller) or a customer (buyer). Any item (product or service) upon which there is a need to retrieve predefined information and that may be priced or ordered or invoiced at any point in any supply chain. A bar code symbol that encodes the GTIN-12, Coupon-12, RCN-12, and VMN-12. An open, global, multi-sector standard for efficient, accurate classification of products and services, managed by GS1 US for the United Nations Development Programme. Companies and organizations use the UNSPSC to analyze various procurement and purchasing functions to reduce organizational costs and improve supply chain efficiencies. The United Nations Standard Products and Services Code structure has four categories: Segment, Family, Class, and Commodity. Acronym for the United Nations Standard Products and Services Code (defined above).

GTIN Identification Number (ID)

Location Number Location Reference Supply Chain Partner Trade item U.P.C. symbol United Nations Standard Products and Services Code (UNSPSC)

UNSPSC

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References
 GTIN Workgroup
To learn more about the GTIN workgroup, contact GS1 US at GS1HealthcareUS@gs1us.org

 GTIN Attributes for Healthcare Interactive Spreadsheet
http://www.gs1us.org//DesktopModules/DNNCorp/DocumentLibrary/Components/FileDownloader/FileDownloaderPage.aspx?did=714&ift=1

 Sample GTIN Attribute Data for GDSN
http://www.gs1us.org//DesktopModules/DNNCorp/DocumentLibrary/Components/FileDownloader/FileDownloaderPage.aspx?did=709&ift=1

 GS1 Global Data Dictionary (GDD)
http://gdd.gs1.org/gdd/public/

 GDSN Package Measurement Requirements
http://www.gs1us.org/resources/standards/package-measurement-standards

 GS1 Data Quality Framework Including the Data Quality Protocol
http://www.gs1.org/gdsn/dqf/data_quality_framework

 GS1 GEPIR
http://gepir.prod.gs1us.org/GEPIR/jsp/client.jsp

 Online Healthcare Provider Tool Kits
http://www.gs1us.org/industries/healthcare/tools-and-resources/healthcare-tool-kits

 Standardization …Stat! Industry Awareness Video
http://www.gs1ushealthvideo.com/

 Industry Sunrise Dates
http://www.gs1us.org/industries/healthcare/standards-and-initiatives/industry-sunrise-dates

 GTIN Adoption by Top Global Healthcare Suppliers
http://www.gs1us.org//DesktopModules/DNNCorp/DocumentLibrary/Components/FileDownloader/FileDownloaderPage.aspx?did=803&ift=1

 Levels, Readiness and Impacts Model (LRIM) (from the Center for Innovation in Healthcare Logistics)
http://cihl.uark.edu/5174.php

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 17 Billion Reasons to Say Thanks: The 25th Anniversary of the U.P.C. and Its Impact on the Grocery Industry
http://www.gs1us.org//DesktopModules/DNNCorp/DocumentLibrary/Components/FileDownloader/FileDownloaderPage.aspx?did=330&ift=1

 The Case for Global Data Standards in the Healthcare Supply Chain
http://www.gs1us.org//DesktopModules/DNNCorp/DocumentLibrary/Components/FileDownloader/FileDownloaderPage.aspx?did=354&ift=1

 Perfect Order and Beyond: How BD and Mercy/ROi Achieve Far-Reaching GS1 Standards Integration
http://www.gs1us.org//DesktopModules/DNNCorp/DocumentLibrary/Components/FileDownloader/FileDownloaderPage.aspx?did=999&ift=1

 Seton Family of Hospitals / BD Success Story
http://www.gs1us.org//DesktopModules/DNNCorp/DocumentLibrary/Components/FileDownloader/FileDownloaderPage.aspx?did=866&ift=1

 RSS Study - Pharmacia and Dept. of Veterans Affairs
http://www.gs1us.org//DesktopModules/DNNCorp/DocumentLibrary/Components/FileDownloader/FileDownloaderPage.aspx?did=344&ift=1

 RSS Study - Abbott Laboratories and St. Alexius Medical Center
http://www.gs1us.org//DesktopModules/DNNCorp/DocumentLibrary/Components/FileDownloader/FileDownloaderPage.aspx?did=312&ift=1

 RSS Study - Alcon Laboratories
http://www.gs1us.org//DesktopModules/DNNCorp/DocumentLibrary/Components/FileDownloader/FileDownloaderPage.aspx?did=314&ift=1

 GS1 Healthcare US Website
https://www.gs1us.org/healthcare

 GS1 Healthcare US Tools & Resources
http://www.gs1us.org/industries/healthcare/tools-and-resources/resources

 GS1 Healthcare US Webinars
http://www.gs1us.org/industries/healthcare/education

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Appendix A: GTIN Data Formats
Data carriers may or may not restrict the data format of GTINs that can be encoded (e.g., GTIN-12 in UPC-A symbols; GTIN-13 in EAN-13 symbols; all GTIN data structures in GS1-128; GS1 DataBar; GS1 DataMatrix). Because some GTIN fields in databases, IT systems and bar codes require storage as a 14 digit number, it is important to understand how to encode and/or store all GTIN data structures inclusive of NDC/NHRIC as a 14digit field length (see page 36 for step by step instructions). Regardless of the specific data format, all of the GS1 Data Standards implement structured, hierarchical numbering schemes in which each identifier is actually a numerical string comprised of several distinct segments. To that end, GTINs are numerical strings that consist of four segments:

GS1 Indicator Digit: The indicator digit identifies packaging levels. The field consists of a numeric
value from 1 to 9. (The number “0” is used as a fill character when GTIN-13, GTIN-12, or GTIN-8 are stored in 14 digit fields or bar codes.)

GS1 Company Prefix: The globally unique number assigned to a company/organization by GS1 US
(or by another GS1 Member Organization from around the world). GS1 Company Prefixes are assigned in varying lengths depending on the company/organization’s needs.

a trade item. The Item Reference varies in length as a function of the Company Prefix length. (Refer to the GS1 General Specifications and the GTIN Allocation Rules for the Healthcare Sector for additional information.)

Item Reference: The number assigned by the holder of the GS1 Company Prefix to uniquely identify

Check Digit: A calculated one-digit number used to ensure data integrity. To understand how this digit is calculated refer to www.gs1us.org/checkdig
The various GTIN data structures are presented below in the order most frequently found in U.S. healthcare:

GTIN-14:
Segments: 14 digits in total: One digit representing the Indicator Digit to denote packaging level Twelve digits consisting of: the GS1 Company Prefix Item Reference assigned by the manufacturer One digit representing the Check Digit
Table 1: GTIN-14 Data Format

Data Carriers using the GTIN-14 data format: ITF-14 GS1-128 (formerly UCC/EAN-128), GS1 DataBar (formerly Reduced Space Symbology (RSS)), GS1 Data Matrix bar codes GS1 EPC Tags

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GTIN-12: Required in U.S. Retail and Grocery point of sale.
Segments: 12 digits in total: Eleven digits consisting of: the U.P.C. Company Prefix Item Reference assigned by the manufacturer One digit representing the Check Digit
Table 2: GTIN-12 Data Format

Data Carriers using the GTIN-12 data format: UPC-A UPC-E

GTIN-13: Frequently required outside the United States.
Segments: 13 digits in total: Twelve digits consisting of: the U.P.C. Company Prefix Item Reference assigned by the manufacturer One digit representing the Check Digit
Table 3: GTIN-13 Data Format

Data Carriers using the GTIN-13 data format: EAN-13 bar codes

GTIN-8:
Segments: 8 digits in total: Seven digits consisting of: the GS1-8 Company Prefix Item Reference assigned by the manufacturer One digit representing the Check Digit * The GTIN-8 is available for items whose packaging does not include enough available space to permit the use an EAN-13 or UPC-A Symbol. GTIN-8s are individually assigned by GS1 member organization on request. Data Carriers using the GTIN-8 data format: EAN-8 bar codes*

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Table 4: GTIN-8 Data Format

Although the preceding discussion provides a high level description of the information represented by the GTIN segments, it is not intended to imply that GTINs are easily deconstructed into their component parts via visual inspection. The variability of the length of the Company Prefix and the unique methods companies use to create item reference and packaging indicators make such simple translation fruitless. Therefore, users should not use this explanation to attempt to deconstruct the GTIN into its component parts. Instead, the GTIN should only be treated in its entirety and not parsed.

The following table provides examples of GTINs providing unique product identification (1) at various packaging levels and (2) using various bar codes. In addition, it displays the data format of the GTIN as it appears (1) in the bar code, and (2) in a database.
Description Item 1 Unit 96 Units 1 Unit 6 Pack 12 Pack 2x12 Pack 4x12 Pack 1 Unit 12 Units 1 Unit 100 Units Level Consumer Case Consumer Consumer Consumer Case Case Syringe Consumer Unit dose blister * Consumer 100 blisters Bar Code UPC-A ITF-14 UPC-A UPC-A UPC-A GS1-128 GS1-128 GS1 Data Matrix GS1-128 GS1 DataBar UPC-A GTIN in Bar Code 614141000012 00614141000029 614141000777 614141000883 614141000999 10614141000996 30614141000990 00614141000074 10614141000071 00614141000050 GTIN in Database 00614141000012 00614141000029 00614141000777 00614141000883 00614141000999 10614141000996 30614141000990 00614141000074 10614141000071 00614141000050

Product A Product B Product C Product D

361414100058 00361414100058

Table 5: GTIN Examples and Data Formats

* a product that can be separated from others on its card

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Appendix B: Integration of NDC/NHRIC into GTINs
The National Drug Code (NDC) is used to identify pharmaceutical products, and the National Health Related Item Code (NHRIC) is used to identify medical/surgical products pursuant to FDA regulations. For over thirtyfive years, GS1 has supported manufacturers of healthcare products in integrating these regulatory identifiers into their GTINs. Integration of NDC/NHRIC into GTINs is optional, and not all pharmaceutical or medical surgical companies integrate their NDCs/NHRICs into their GTINs.

 A brief explanation of how to create a GTIN with an NDC or NHRIC is provided below.

For more information, please consult the document on this topic found in GS1 Healthcare US Document Library (Product ID folder).

The Labeler Code is an identifier assigned by the FDA and embedded into the National Drug Code (NDC) and the National Health Related Item Codes (NHRIC) to identify the company. GS1 US has reserved a placeholder in its Company Prefix numbering system so that GS1 Company Prefixes for pharmaceutical and medical/surgical companies is simply their Labeler Code with an “03” appended in front. For example: FDA-assigned Labeler Code Append GS1 US Placeholder GS1 Company Prefix 61414 03 0361414

This approach maintains the consistency of GTINs with the Labeler Code, as well as the NDC and NHRIC. In order to use a Labeler Code as a GS1 Company Prefix, manufacturers must first register their Labeler Code with GS1 US. Once the Labeler Code is registered, NDCs or NHRICs can be embedded into either 14-digit or 12digit GTINs. Steps for both are provided below.

Creating a 14-digit GTIN
There are five steps for creating the 14-digit GTIN with an NDC/NHRIC embedded: Step 1: When encoding an NDC/NHIC in a bar code, begin with the Application Identifier for a GTIN: (01). Step 2: After the GTIN Application Identifier, Position One is filled with 0 (i.e., zero) as NDC/NHRIC is a reserved number range that will not conflict with GTIN-12, and 0 is always used in the leading position of a 14-digit GTIN field (either database or bar code) when GTIN-12 is embedded. Step 3: The next two positions (2 and 3) must be 03 for products identified by NDCs or NHRICs. A numeric digit 3 in Position Three indicates that the 10 digits in Positions Four through Thirteen are either a NDC or NHRIC. Step 4: The NDC or NHRIC number consists of a variable length Labeler Code on the left (assigned by the FDA; either four or five digits long) and a variable length Product/Package Code on the right (assigned by the holder of the Labeler Code; either five or six digits long). Step 5: Position Fourteen is a Check Digit for the entire GTIN. This number is calculated using the 13 preceding digits. In our particular example, the calculated Check Digit 6 is placed in Position Fourteen. (NOTE: Because in Step 2 Position One is a 0 and in Step 3 Position Two is a 0, there is no impact on the calculation of the check digit.)

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Figure 3: Illustration of NDC embedded in GTIN using GS1-128 bar code carrier

(01) 0 03 12345 67890 6

AI for GTIN Indicator digit GS1 Prefix FDA labeler code product/package code check digit

GS1-128

Creating a 12-digit GTIN
There are three steps for creating the 12-digit GTIN with an NDC/NHRIC embedded: Step 1: Position One will always be 3 for products identified by NDCs or NHRICs. A numeric digit 3 in Position One indicates that the 10 digits in Positions Two through Eleven are either an NDC or NHRIC.
Figure 4: 12-digit GTIN with NDC/NHRIC Indicator Digit highlighted

Step 2: The NDC or NHRIC number consists of a variable length Labeler Code on the left (assigned by the FDA; either four or five digits long) and a variable length Product/Package Code on the right (assigned by the holder of the Labeler Code; either five or six digits long).
Figure 5: 12-digit GTIN with NDC/NHRIC Number highlighted

Step 3: Position Twelve is a Check Digit for the entire GTIN. This number is calculated using the 11 preceding digits. In our particular example, the calculated Check Digit of 6 is placed in Position Twelve.
Figure 6: 12-digit GTIN with Check Digit highlighted

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Appendix C: GS1 Application Identifiers
Beyond the product description attributes defined by the manufacturer and saved in a database, there may be certain item specific attributes that manufacturers or supply chain partners want on products themselves to provide item specific information at the point where the bar code is scanned (e.g., expiration date; lot number; batch number; etc.). In order to facilitate that, the GS1 System provides “Application Identifiers” (AIs) for encoding item specific attributes directly into GS1 bar codes and GS1 RFID tags [known as GS1 Electronic Product Code (EPC) Tags]. GS1 Application Identifiers (AI) are a finite set of specialized identifiers embedded within numerical string of a bar code. Each AI has a two, three, or four digit numeric prefix that appears in parentheses to signal a certain type of data in the bar code numerical string (i.e., identify what the data in the next string in the bar code sequence is conveying). For example, the AI for lot/batch number is it is (10). Thus, when “(10)” appears in the numerical string, it means a lot/batch number follows in the next segment. There are approximately 100 AIs. The complete definitions for all of the Application Identifiers reside in the GS1 General Specifications. However, an overview is provided in the table below:
Table 6: Overview of GS1 Application Identifiers

“AI” Categories GS1 Identifiers Trade Item Attributes Logistic Unit Attributes GLN Extensions Special Purpose

Total # 7 45 28 4 Approx. 20

Explanation There is one AI assigned for each of the seven GS1 Identifiers (i.e., GTIN, GLN, SSCC, GRAI, GIAI, GDTI, GSRN). Examples: count; net weight; lot number; expiration date; etc. Examples: count of trade items contained, gross weight, gross volume, routing code GLN physical location attributes. Shipment Identification, Consignment Identification, Coupons, Refund Receipts, Electronic Serial Identification for Cellular Mobile Telephones, Internal Use, Payment Slips, and Customer Specified Articles

GS1 AI’s commonly used in healthcare include: AI (01) AI (10) AI (17) AI (21) GTIN Lot/Batch Number Expiry Serial Number

GS1 AIs are standard throughout the world and are familiar to IT system developers. GS1-128, GS1 DataBar, GS1 Data Matrix, and Composite Component can all carry AIs, and more than one AI can be carried in one bar code. GS1 standardized attributes and AIs enable companies to communicate product information as well as item-specific information without embedding it in the identifier itself.

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Appendix D: Illustrations of Bar Coded GTINs
GS1 Symbologies encoding GTIN
AI (01) GTIN

Figure 7: GTIN encoded in a GS1-12 Bar Code

Figure 11: GTIN encoded in a GS1 DataBar (Limited)

Figure 8: GTIN encoded in a GS1-13 Bar Code

Figure 12: GTIN encoded in a GS1 DataBar (Stacked)

Figure 9: GTIN encoded in a GS1-128 Bar Code Figure 13: GTIN encoded in a GS1 Data Matrix

Figure 10: GTIN encoded in an ITF-14 Bar Code

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GS1 Symbologies encoding GTIN with Serial Number
AI (01) GTIN and AI (21) Serial Number

Figure 14: GTIN with Serial Number encoded in a GS1-128 Bar Code

Figure 15: GTIN with Serial Number encoded in a GS1 DataBar (Limited) & Composite

(NOTE: GTIN is encoded on the GS1 DataBar Limited, and Serial Number is encoded on the Composite.)

Figure 16: GTIN with Serial Number encoded in a GS1 DataBar (Stacked) & Composite

(NOTE: GTIN is encoded on the GS1 DataBar Stacked, and Serial Number is encoded on the Composite.)

Figure 17: GTIN with Serial Number encoded in a GS1 Data Matrix

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GS1 Symbologies encoding GTIN with Lot Number
AI (01) GTIN and AI (10) Lot Number

Figure 18: GTIN with Lot Number encoded in a GS1-128 Bar Code

Figure 19: GTIN with Lot Number encoded in a GS1 DataBar (Limited) & Composite

(NOTE: GTIN is encoded on the GS1 DataBar Limited, and Lot Number is encoded on the Composite.)

Figure 20: GTIN with Lot Number encoded in a GS1 DataBar (Stacked) & Composite

(NOTE: GTIN is encoded on the GS1 DataBar Stacked, and Lot Number is encoded on the Composite.)

Figure 21: GTIN with Lot Number encoded in a GS1 Data Matrix

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GS1 Symbologies encoding GTIN with Expiration Date
AI (01) GTIN and AI (17) Expiration Date

Figure 22: GTIN with Expiration Date encoded in a GS1-128 Bar Code

Figure 23: GTIN with Expiration Date encoded in a GS1 DataBar (Limited) & Composite

(NOTE: GTIN is encoded on the GS1 DataBar Limited, and Expiration Date is encoded on the Composite.)

Figure 24: GTIN with Expiration Date encoded in a GS1 DataBar (Stacked) & Composite

(NOTE: GTIN is encoded on the GS1 DataBar Stacked, and Expiration Date is encoded on the Composite.)

Figure 25: GTIN with Serial Number encoded in a GS1 Data Matrix

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GS1 Symbologies encoding GTIN with Serial, Lot & Expiration Date
AI (01) GTIN with AI (21) Serial Number, AI (10) Lot Number and AI (17) Expiration Date

Figure 26: GTIN with Serial, Lot & Expiration Date encoded in a GS1-128 Bar Code

Figure 27: GTIN with Serial, Lot & Expiration Date encoded in a GS1 DataBar (Limited) & Composite

(NOTE: GTIN is encoded on the GS1 DataBar Limited, and Expiration Date, Lot Number and Serial Number is encoded on the Composite.)

Figure 28: GTIN with Serial, Lot & Expiration Date encoded in a GS1 DataBar (Stacked) & Composite

(NOTE: GTIN is encoded on the GS1 DataBar Stacked, and Expiration Date, Lot Number and Serial Number is encoded on the Composite.)

Figure 29: GTIN with Serial, Lot & Expiration Date encoded in a GS1 Data Matrix

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Appendix E: Sample Vendor Letter
Supplier Name Supplier Address Supplier City, State, Zip Date RE: Requirement for the use of GS1 Global Trade Item Number (GTIN)

Dear Supplier: You are receiving this letter as a valued supplier/distributor to [insert your organization name]. In the last several years, there have been ongoing efforts to adopt GS1 commercial supply chain standards in U.S. healthcare. Government regulatory organizations, healthcare associations, group purchasing organizations and manufacturers have all supported the rapid adoption of these commercial standards. [Insert your organization name] has watched these efforts closely and has determined that now is the time to adopt GS1 Standards in all of our business processes. These GS1 Standards are the same as seen in the retail/grocery industries through the use of the Global Trade Item Number (GTIN) for accurate product identification, GLN for accurate location identification, the Global Data Synchronization Network (GDSN) for product definition and data accuracy and the United Nations Standard Products and Services Code (UNSPSC) for product classification. Beginning [insert date], we will modify the terms and conditions in our contract language to require the use of the Global Trade Item Number to identify your firm’s products at every level. The GTIN can be carried by different types of bar codes and RFID tags including: EAN/UPC; GS1-128; GS1 DataBar (formerly Reduced Space Symbology); Composite Component; GS1 Data Matrix and Electronic Product Code (EPC) RFID tag. GTIN – Global Trade Item Number A GTIN is an 8, 12, 13 or 14 digit numerical code registered by the GS1 organization and is used to uniquely identify products in 23 different industries including healthcare. The GTIN will be used as a replacement for Product Identification numbers in e-commerce transactions, specifically in the purchase order, reply to purchase order, advance shipment, contact and catalog transactions. In order to assist you in this transition process we have enclosed the necessary steps to be taken if you are not familiar with GTINs. If you need further assistance, contact GS1 US at www.gs1us.org for the applicable specifications and standards. Thank you in advance for your willing participation in this effort.

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Getting Started with Global Trade Item Numbers (GTINs) Step 1: Obtain a Company Prefix.
If you are a manufacturer/supplier, you will need a GS1 Company Prefix from GS1 US. Your GS1 Company Prefix will uniquely identify your firm to all supply chain partners. The Labeler Code portion of your National Drug Codes (NDCs) or National Health Related Item Code (NHRICs) can be used as your Company Prefix, but only after obtaining permission and registering with GS1 US. In order to do this, contact GS1 US via phone, e-mail or mail at: GS1 US, Inc. 7887 Washington Village Drive Suite 300 Dayton, OH 45459 Info@gs1us.org +1 937.435.3870 GS1 US Customer Service will ask you to fill out an application form and pay a fee based on the dollar sales of your company. You will receive a GS1 Company Prefix along with reference material. This GS1 Company Prefix can be used with all companies that participate in the GS1 System globally. This GS1 Company Prefix will be either six digits or eight digits, depending upon the number of items in your product line. GS1 US can explain the NDC/NHRIC rules.

Step 2: Assign a GTIN to products.
Once you have your GS1 Company Prefix, you need to assign a GTIN to each of your products. The packaging indicator, GS1 Company Prefix, the item number and a check digit will form the GTIN for each product. Assign GTINs down to unit of use (where applicable) and, most importantly, comply with the FDA bar code regulation.

Step 3: Communicate the GTINs for your products to us.
If you use the Global Data Synchronization Network (GDSN), please add our company as a subscriber to your data.

Step 4: Store the numbers in your database.
Depending on the data carrier used, GTINs can be represented as 8 digits, 12 digits, 13 digits, or 14 digits in length. In order to accommodate each variation, store all of your GTINs as 14 digits by right justifying and zero filling to the left as appropriate. In order to preserve any leading zeros that may be present, format the GTIN field as a text field, not as a numeric field.

Step 5: Determine the best bar code application method:
For guidance, see the GTIN Allocation Rules for the Healthcare Sector and Data Driver® on the GS1 US web site for details.

Step 6: Determine where the bar code will be placed on your product.
There are specific guidelines for placement; consult the GS1 US reference material.

Step 7: Verify that the bar code symbols meet scanning requirements.
Conduct an initial verification check, as well as routine audits to ensure the symbol is being printed clearly and consistently per ISO standard Code C or better.

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Disclaimer
GS1 US, Inc. is providing this document as a service to interested industries. This document was developed through a consensus process of interested parties. Although efforts have been made to assure that this document is correct, reliable, and technically accurate, GS1 US MAKES NO WARRANTY, EXPRESS OR IMPLIED, THAT THIS DOCUMENT IS CORRECT, WILL NOT REQUIRE MODIFICATION AS EXPERIENCE AND TECHNOLOGICAL ADVANCES DICTATE, OR WILL BE SUITABLE FOR ANY PURPOSE OR WORKABLE IN ANY APPLICATION, OR OTHERWISE. Each user of this document assumes all risk and responsibility for its use of the materials. Use of this document is with the understanding that GS1 US accepts no liability whatsoever for any direct, indirect, special or other consequential damages of whatever kind resulting from whatever cause through the use of the document or any information therein, even if GS1 US has been advised of the possibility of such damages.

IAPMO
In this publication, 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.

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CORPORATE HEADQUARTERS Princeton Pike Corporate Center 1009 Lenox Drive, Suite 202 Lawrenceville, New Jersey 08648 USA CUSTOMER SERVICE 7887 Washington Village Drive, Suite 300 Dayton, OH 45459-8605 USA T +1 937.435.3870 F +1 937.435.7317 email: info@gs1us.org www.gs1us.org/healthcare

© 2012 GS1 US

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