healthcare provider tool kit global trade item number(gtin)

7/30/2019 Healthcare Provider Tool Kit Global Trade Item Number(GTIN)

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Healthcare Provider Tool Kit

Global Trade Item Number (GTIN)

Improving Patient

Safety and Supply

Chain Efficiency


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All contents copyright GS1 US 2012 Page 1 of 46

Improving Patient Safety and Supply Chain Efficiency

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Release 3.0Published: March 2012


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Table of Contents

EXECUTIVE SUMMARY ......................................................................................................................................... 4

ABOUT GS1 ......................................................................................................................................................... 5INTRODUCTION TO STANDARDS ....................................................................................................................... 6

WHYARE STANDARDS NECESSARY? ...................................................................................................................... 6ABOUT THE STANDARDS ......................................................................................................................................... 7

Global Location Number (GLN) ........................................................................................................................ 7Global Trade Item Number (GTIN) ............................................................................................................. 8Global Data Synchronization Network (GDSN) .......................................................................................... 8United Nations Standard Products and Services Code (UNSPSC) ........................................................... 8

HOW DO THE GS1STANDARDS RELATE TO EACH OTHER? ...................................................................................... 8

THE CASE FOR THE GLOBAL TRADE ITEM NUMBER

(GTIN

) .................................................................... 11

THE PROBLEM:PRODUCT IDENTIFICATION ............................................................................................................. 11

Patient Safety Issues ...................................................................................................................................... 11Supply Chain Management Issues ................................................................................................................ 11THE 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.............................................................................................................................. 14LINK TO PRODUCT INFORMATION........................................................................................................................... 14

ADVANTAGES OF USING GTINs IN THE HEALTHCARE SUPPLY CHAIN..................................................... 15

BENEFITS TO HEALTHCARE PROVIDERS ....................................................................................................... 16

PATIENT SAFETY BENEFITS................................................................................................................................... 16SUPPLY CHAIN BENEFITS...................................................................................................................................... 17

IMPLEMENTING GTINs IN YOUR ORGANIZATION .......................................................................................... 17

STEP ONE: ESTABLISH EXECUTIVE SUPPORT ....................................................................................................... 18STEP TWO: FORM A GTINMANAGEMENTADVISORY GROUP ................................................................................. 18STEP THREE: ESTABLISH YOUR GTINOPERATIONAL TEAM................................................................................... 19STEP FOUR: DEVELOP &INITIATE PROJECT COMMUNICATION................................................................................ 19STEP FIVE: INITIATE EDUCATION FOR THEADVISORY GROUP &OPERATIONAL TEAM .............................................. 20STEP SIX:ASSESS INFORMATION SYSTEM ISSUES &MAKE NECESSARY CHANGES................................................. 20STEP SEVEN: IDENTIFY/OBTAIN GTINS ................................................................................................................ 21STEP EIGHT: ESTABLISH IMPLEMENTATION STRATEGY .......................................................................................... 21STEP NINE: ENGAGE SUPPLIER INVOLVEMENT...................................................................................................... 22

STEP TEN: CONDUCT TRANSACTIONAL TESTING WITH SUPPLIERS......................................................................... 22STEP ELEVEN: MAKEADJUSTMENTS TO INITIAL GTINIMPLEMENTATION PLAN........................................................ 22STEP TWELVE: CREATE STANDARD OPERATING PROCEDURES.............................................................................. 23

ANALYZING GTIN ROI FOR YOUR ORGANIZATION ........................................................................................ 23

BACKGROUND INFORMATION RE:ROI FROM GTINUSE IN OTHER INDUSTRIES........................................................ 23LEVELS,READINESS AND IMPACTS MODEL (LRIM) ................................................................................................ 24HOT SPOTS FOR ROI ........................................................................................................................................... 24

Supply Chain Management ............................................................................................................................ 24Purchasing Management ............................................................................................................................... 25


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Labor Management ........................................................................................................................................ 25

LESSONS LEARNED & BEST PRACTICES ....................................................................................................... 26

FREQUENTLY ASKED QUESTIONS (FAQs) ..................................................................................................... 27

GLOSSARY ........................................................................................................................................................... 29REFERENCES ...................................................................................................................................................... 31

APPENDIX A: GTIN DATA FORMATS ................................................................................................................ 33

APPENDIX B: INTEGRATION OF NDC/NHRIC INTO GTINs ............................................................................. 36

CREATING A 14-DIGIT GTIN .................................................................................................................................. 36CREATING A 12-DIGIT GTIN .................................................................................................................................. 37

APPENDIX C: GS1 APPLICATION IDENTIFIERS .............................................................................................. 38

APPENDIX D: ILLUSTRATIONS OF BAR CODED GTINs ................................................................................. 39

GS1SYMBOLOGIES ENCODING GTIN .................................................................................................................... 39GS1SYMBOLOGIES ENCODING GTIN WITH SERIAL NUMBER.................................................................................. 40

GS1SYMBOLOGIES ENCODING GTIN WITH LOT NUMBER....................................................................................... 41GS1SYMBOLOGIES ENCODING GTIN WITH EXPIRATION DATE ............................................................................... 42GS1SYMBOLOGIES 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 standardizedproduct 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 identificationacross 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 providesdetailed steps for implementing GTIN in your organization.

Using this document, you will better understand how the use of GTINs for product identification will best fulfillyour need for reliable product information in order to support patient safety and effective supply chainmanagement. 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 theefficiency and visibility of supply and demand chains, both globally and across sectors. GS1 is a fully integrated globalorganization, with 108 Member Organizations (like GS1 US) serving over a million companies doing business across 150countries. Together, GS1 and its subsidiaries and partnerships connect companies with standards-based solutions that areopen, consensus-based and universally endorsed.

About GS1 USGS1 US is the Member Organization of GS1 that serves companies in the United States. As such, it is the nationalimplementation organization of the GS1 System dedicated to the adoption and implementation of standards-based, globalsupply chain solutions in the United States. GS1 US currently serves over 200,000 U.S. member companies -- 16,000 ofwhich are in healthcare.

About GS1 HealthcareGS1 is the leading global standards organization in the healthcare industry, supporting the healthcare community through itsGS1 Healthcare global initiative. GS1 Healthcare is a voluntary, global user community that brings together all healthcarestakeholders, including: pharmaceutical and medical devices manufacturers, wholesalers and distributors, group purchasingorganizations, hospitals, pharmacies, logistics providers, governmental and regulatory bodies, and associations. Themission of GS1 Healthcare is to lead the healthcare industry to the successful development and implementation of globalstandards to enhance patient safety and supply chain efficiencies. GS1 Healthcare drives the development of GS1Standards and solutions to meet the needs of the global healthcare industry, and promotes the effective utilization andimplementation of global standards in the healthcare industry through local support initiatives like GS1 Healthcare US

in the

United States.

About GS1 Healthcare USGS1 Healthcare US is an industry group that focuses on driving the adoption and implementation of GS1 Standards in thehealthcare industry in the United States to improve patient safety and supply chain efficiency. GS1 Healthcare US bringstogether members from all segments of the healthcare industry to address the issues that most impact healthcare in theUnited States. Facilitated by GS1 US, GS1 Healthcare US is one of twenty-four local GS1 Healthcare user groups aroundthe 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 totransact 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 beefficient and effective in that effort, a common language and globally accepted standards are essential. Withoutsuch standards, supply chain partners face high, unnecessary costs due to inaccurate data and supply chaininformation inefficiencies.

Unfortunately, the healthcare industry has experienced the harsh reality of this lesson. In the firstcomprehensive analysis of this topic in 1996, the Efficient Healthcare Consumer Response study found that $11billion is wasted each year in the healthcare supply chain primarily because data standards are either entirelylacking or not as widely used or well-developed as in other industries1 Worse yet, a groundbreaking report onpatient safety issues by the Institute of Medicine in 1999 cited staggering statistics about medical error, andfound that hand written reports or notes, manual order entry, non-standard abbreviations and poor legibility leadto substantial errors and injuries.2 Those findings and conclusions were reinforced five years later when theauthors 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 datastandards 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 withtheir supply chain partners. For over thirty-five years, the GS1 System has provided globally accepted identifiersand a common language for the communication of supply chain information about products, services andlocations.

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 andglobally accepted standards, healthcare providers, companies and/or industry associations are left to developtheir own identifiers and data formats, resulting in numerous proprietary standards for healthcare providers andcompanies to manage. However, as discussed in the Efficient Healthcare Consumer Response study, this is thecause of billions of dollars of waste in the healthcare industry. Moreover, the existence of numerous standardscauses supply chain inefficiencies and inaccurate data that inserts cost and confusion into healthcare businessprocesses, threatening quality of care and patient safety.

This is why global standards are so important. Global standards provide simplicity and consistency bypromoting universal applicability and optimal functionality across the globe for all industry sectors. In todayscomplex markets, supply chain lines are blurring and channels of distribution for various sectors are overlappng.

1Efficient Healthcare Consumer Response (EHCR), Improving the Efficiency of the Healthcare Supply Chain, November1996. Produced by CSC Consulting, Inc. Copyright 1996, American Society for Healthcare Materials Management, HealthIndustry Business Communications Council, Health Industry Distributors Association, National Wholesale DruggistsAssociation, and GS1 US (formerly the Uniform Code Council), jointly and severally.2To Err Is Human: Building a Safer Health System. Institute of Medicine (1999). The National Academies Press.

3Lucian L. Leape, M.D., Donald M. Berwick, M.D., Five Years After To Err Is Human: What Have We Learned?, Journal ofthe American Medical Association, May 18, 2005, 293 (19): 238490.

The GS1 System is the most widely used supply chain standards system in the world, utilizedin twenty-three sectors and industries including GS1s core sectors of Healthcare and FastMoving Consumer Goods (FMCG), as well as Transport, Defense and many others.


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This is especially true of the healthcare industry where manufacturers of healthcare products often supply bothhospitals and consumer goods retailers; pharmacies and hospitals purchase consumer goods as well ashealthcare products; and the pharmaceutical supply chain has expanded to include supermarkets and consumergoods retailers in addition to traditional pharmacies. Global standards that can be used by all supply chainpartners, 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 safetyand supply chain management, such as:

Reduction in medication errors through efficient automatic identification: the right product for the rightpatient 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 timeto 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 andcommunication of information regarding products, assets, services and locations. Using GS1 IdentificationNumbers, companies and organizations around the world are able to globally and uniquely identifyphysicalthings like trade items, assets, logistic units and physical locations, as well as logical things like corporations or aservice relationship between provider and recipient. When this powerful identification system is combined withthe Global Data Synchronization Network (GDSN), the connection is made between these physical or logicalthings 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 locationsand supply chain partners. The GLN can be used to identify a functional entity(like a hospitalpharmacy or accounting department), aphysical entity(like a warehouse or hospital wing or even anursing station), or a legal entity(like a health system corporation). The attributes defined for eachGLN (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 toidentify trade items (i.e., products and services that may be priced, ordered or invoiced at anypoint 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 isspecific to one, very precise trading unit configuration (e.g., a blister of two aspirin tablets; a bottle of 100 aspirintablets; 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 thoseefforts, the Global Data Synchronization Network (GDSN) provides an efficient and effectiveapproach 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 supplychain 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 ofthe supply chain.

United Nations Standard Products and Services Code (UNSPSC)

The United Nations Standard Products and Services Code (UNSPSC) is a hierarchical set ofproduct 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 allindustry 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 inelectronic 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 userassigns a GS1 Identification Number, they define a set of standardized information (known as attributes) aboutthe object to which that identifier relates (e.g., size, weight, location, etc.) The GS1 System specifies the list ofattributes that must be defined for each GS1 Identifier, and provides a precise definition as well as acceptablevalues and data formats for each attribute. Standardized attributes aboutproducts include core data like sellingunit, item dimensions, and UNSPSC product classification. Standardized attributes about commercial entitiesinclude core data like location information about a warehouse or hospital. Once defined by the user, thoseattributes 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 toinformation about that object.

That linkage is tremendously valuable. In fact, twenty-three industry sectors have used GS1 GTINs, GLNs andthe GDSN as the foundation for a wide range of efficiency building solutions that have improved their operationsand supported their business processes for decades. Likewise, with GTINs, GLNs and the GDSN, healthcareproviders can lay the foundation for a wide range of solutions to enhance patient safety and supply chainmanagement 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 chainmanagement (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 patientsafety and supply chain management.

Figure 1: Building Patient Safety


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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 bestpricing for which the hospital is eligible. However, most provider systems are not structured to provideinsight into purchasing activities and patterns based on product categories, products and/or vendors.Healthcare Industry Solution: United Nations Standard Products & Services Code (UNSPSC)

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

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

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: 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 productidentification, ordering and recalls difficult.Healthcare Industry Solution: Global Trade Item Number (GTIN)

Problem: Supply chain partners use different Organization and Location IDs.Example: Manufacturer uses GLN. Distributor uses DUNS number. Hospital uses its own proprietaryidentification system. This causes rebates and claims to be misapplied and/or lost, and frustrates directdeliveries in the facility.

Healthcare Industry Solution: Global Location Number (GLN)


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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 toidentify all of the products used in their facilities. The absence of universal, standards-based productidentification 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 consequentialadverse healthcare events associated with medical errors: from 44,000 to 98,000 preventable deaths occurannually due to medical error- more annual deaths than highway accidents, breast cancer or AIDS. Equallydisconcerting was the assertion that widespread systemic problems either caused or compounded many medicalerrors. 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 ofTo Err isHuman, several authors of that groundbreaking report revisited the status of the healthcare system, andreinforced their findings of widespread systemic problems.

The findings related to hand written notes, manual data/order entry andnon-standard abbreviations still apply at many healthcare facilities todaywhere doctors, nurses and staff continue to handwrite and manually enternearly everything. Other factors like poor legibility and overworked, time-constrained staff only increase the risks of errors and omissions. Handwritten notes, manual data entry (with resulting input errors) and confusingmarkings 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 beingadministered to the right patient via the right route in the rightamount at the right time).

Inhibit the ability to introduce a reliable tracking system forhealthcare products at the facility.

Supply Chain Management Issues

In addition to patient safety issues, the absence of standards-based product identification also leads to problemsin supply chain management at healthcare facilities. For example:

Inconsistent inventory levels (i.e., excess of products not needed, and lack of products that are). Thisleads 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 identifiersenables a healthcare organization to efficiently and effectively manage information about all of the variousproducts used in their healthcare facilities. Moreover, the use of a globally accepted, standardized approach toidentifiers provides a common language to facilitate the communication of product information among supplychain partners. This promotes the efficient exchange of accurate product information with supply chain partnersto support orders, returns and recalls. Moreover, it facilitates the flow of accurate product information within thehealthcare 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 thecommunication 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 informationamong supply chain partners in twenty-three industry sectors. Moreover, it has provided the foundation forinnovative improvements in supply chain management for many American industries, including the impressiveand well-documented advances in the retail and grocery industries directly attributable to their adoption andimplementation of GTINs in particular and the GS1 System in general.

What is a GTIN?

A Global Trade Item Number (GTIN) is the globally unique GS1Identification Number used to identify trade items (i.e., products andservices that may be priced, ordered or invoiced at any point in thesupply chain). GTINs are used to identify individual trade item units (likea box of 15 Brand X tissues), as well as all of their different packagingconfigurations (like a carton of six boxes of Brand X tissues). GTINs areassigned by the brand owner or manufacturer of the product, and areused to identify products as they move through the global supply chainto the hospital or ultimate end user.

In todays complex markets, supply chain lines are blurring and channelsof distribution for various sectors are overlapping. Global standards thatcan be used by all supply chain partners, independent of industry sectoror location, are essential in this environment. This is especially true ofthe healthcare industry where manufacturers of healthcare productsoften supply both hospitals and consumer goods retailers; pharmacies

and hospitals purchase consumer goods as well as healthcare products; and the pharmaceutical supply chainhas 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, GTINssupport providers in navigating complex healthcare supply chains. In fact, GTINs are already being used acrossthe 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 Systemprovides clear, structured data standards and allocation rules that manufacturers follow when allocating GTINsin order to ensure that their GTINs are globally unique and in a consistent format. It should be noted that somehealthcare products are assigned identification numbers for regulatory purposes. For example, pharmaceuticalproducts are assigned a National Drug Code (NDC), and medical/surgical products are assigned a NationalHealth Related Item Code (NHRIC). GS1 allocation rules give pharmaceutical and medical/surgicalmanufacturers the option of integrating these regulatory identifiers into their GTINs, and many manufacturers optto do so.

There are two basic steps for allocating a GTIN:

(1) First, GS1 US assigns a GS1 Company Prefixto the manufacturer. The GS1 Company Prefixispart 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 CompanyPrefixand 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 thatGTIN relates. Theseproduct description attributes define master data that is consistent across all instances ofthe product (e.g., size; color; brand information; etc.). The GTIN and its associated attributes are then saved ina 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 beproperly identified as they move through the supply chain. In order to do this, manufacturers encode the GTINinto 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 identificationand data capture (e.g., the black bars and spaces on the bar code). In addition, most data carriers include ahuman readable version of the GTINas well to facilitate manual data entry when necessary (e.g., the numbersbelow the black bars of the bar code). The graphic below provides an example of a bar coded GTIN.

Figure 2: GTIN Bar Code

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

6 91 4 1 4 1 0 0 0 4 4

Although this graphic shows a GTIN embedded in a GS1 GTIN-12bar code, the healthcare industry has been increasingly using GS1Data Matrix to marking their products with GTINs. Appendix Dprovides graphical illustrations of GTINs encoded onto each of theGS1 bar codes, including the GS1 Data Matrix.


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This section is intended to provide some basic information about theprocesses involved in GTIN allocation. Further information about thetopics touched on in this section can be found in the various appendicesof 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 GTINshould 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 bysupply chain partners to (1) identify products as they move through the supply chain, and (2) to provide a link tothe information pertaining to a product.

Identification of Products

Manufacturers mark their products with the applicable GTIN in order to support supply chain partners inaccurately identifying products. Using a globally accepted, standardized product identifier supports supply chainpartners in accurately identifying products as they move through the supply chain to the hospital or ultimate enduser. 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 patientsafety.

Providers can enter GTINs into their computer systems either by manual data entry (i.e., typing) or automaticallyvia the data carrier (i.e., bar code scanners or RFID readers). The option of entering a GTIN into an IT systemautomatically using data carriers (as opposed to typing it in) enables users to record a GTIN with as minimalmanual intervention as possible, increasing both speed and accuracy. This facilitates a safer and more securesupply chain, and can be especially useful for providers using BPOC Systems. This has many benefits to publichealth and patient safety, including reducing medical errors, facilitating recalls, and improving prescription drugadministration.

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 tomanually entering all of the necessary product information. Using a GTIN to reference trade item informationpromotes 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, aswell as delivery and payment documents.


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Advantages of Using GTINs in the Healthcare SupplyChain

Standards-based numbering systems are essential for efficient and effective communication of productinformation in supply chains. In todays complex markets, supply chain lines are blurring and channels ofdistribution for various sectors are overlapping. This is especially true of the healthcare industry. Globalstandards that can be used by all supply chain partners, independent of industry sector or location are essentialin this environment.

The GTIN is a global standard that delivers trade item data in a consistent format and structure based on theglobally accepted GS1 System. The GS1 System is the most widely used supply chain standards system in theworld, utilized in 150 countries and twenty-three industry sectors, including our core sectors of Healthcare andFast Moving Consumer Goods (FMCG). GTINs provide hospitals with a method of identifying products that issimple and able to be used by any industry. In fact, GTINs are being used across the healthcare sector today toidentify pharmaceuticals, medical devices, and many other healthcare products. Advantages of using GTINsinclude:

IInntteerrnnaattiioonnaall::GTINs are a global standard that can be assigned and usedanywhere across the globe.

UUnniiqquuee:: The GTIN can be used to uniquely identify healthcare trade items,including every packaging configuration of a product.

MMuullttii--sseeccttoorr:: GTINs can be used by all business sectors, enabling ahealthcare product, a grocery product, a retail product, and 99% of the itemsfound in a healthcare environment to be identified with the same standardizedidentification number. That makes inventory systems, ordering systems andaccounting systems compatible across different industries, thereby supporting healthcare providersnavigating overlapping supply chains.

AAuuttoommaattiicc DDaattaa CCaappttuurree:: One of the key benefits of the GTIN is that it can be encoded in manyautomatic data capture technologies (such as bar codes or RFID tags). This supports automatic datacapture using both current and emerging technologies. Automatic data capture enables users to enter aGTIN into an IT system with as minimal manual intervention as possible, increasing both speed andaccuracy.

DDaattaa IInntteeggrriittyy:: Use of the GTIN for product identification enables users to leverage the Global DataSynchronization Network (GDSN) for product information. The GDSN offers a continuous, automatedapproach to data management that ensures that product information is identical among supply chainpartners, 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 knownas GS1 GEPIR. With GS1 GEPIR, users simply enter the GTIN displayed with abar 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 isperhaps 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 thefoundation for that effort.

GTINs enable healthcare providers to efficiently and effectively manage information about all of the variousproducts used in their facilities using a unique, global standard for product identification. This facilitatescommunication 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 informationabout all of the various products used in healthcare facilities has many benefits for public health and patientsafety, including:

RRiigghhtt pprroodduucctt:: Use of the GTIN within healthcare facilities provides accurate identification ofproducts, facilitating caregivers efforts to ensure that the right productis delivered and used for patientcare.

BBPPOOCC ssyysstteemmss:: Many hospitals have leveraged automated bar code identification and technologiesin their processes supporting patient care (i.e., BPOC Systems). Use of GTIN in such systemsfacilitates identification of the products used/administered at bedside to ensure that they are correct.

PPhhaarrmmaacceeuuttiiccaall aanndd bbiioollooggiiccaall pprroodduuccttss:: GTIN isalready used by the pharmaceutical sector to identify

pharmaceutical and biological products at both theindividual unit and orderable case level. Use of thoseGTINs in BPOC Systems for prescription drugadministration can help enhance those systems and reducemedical errors.

MMeeddiiccaall ddeevviicceess::Many medical devices arealreadyidentified using GTINs, providing an opportunity forproviders to leverage those identifiers to improve medicaldevice reporting.

PPrroodduucctt rreeccaallllss:: Using GTINs facilitates a streamlinedproduct recall process.

SSuuppppllyy cchhaaiinn iinntteeggrriittyy::GTINs support accurateidentification of products from point of origin to point ofcare. This promotes a safe and secure supply chain byproviding 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. Inaddition, it enables healthcare providers to efficiently and effectively manage information about all of the variousproducts 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 chainbenefits to using a GTIN:

BBeetttteerrccaasshh ffllooww::Use of GTIN streamlines chargeback andrebate processing, reducing the amount of money sitting inunresolved sales accounts.

RReedduucceedd llaabboorrccoossttss:: Use of GTIN frees staff time byeliminating the need to build and maintain cross reference tablesin order to keep track of multiple proprietary identificationnumbers.

IImmpprroovveedd iinnffoorrmmaattiioonn qquuaalliittyy::Using the GTIN as the link to

product information improves information quality by ensuring thatproduct information is identical among supply chain partners. Thisbenefits both internal and external business processes.

SSiimmpplliiffiieedd ssuuppppllyy cchhaaiinn mmaannaaggeemmeenntt::GTIN strengthensbusiness communications among supply chain partners byaccurately identifying specific products with specific numbers.This facilitates the global flow of healthcare trade items andassociated information.

MMoorree eeffffiicciieenntt ppaayymmeenntt aanndd rreeppoorrttiinngg pprroocceesssseess::With the use of GTINs, sales can be reportedto providers automatically and with fewer errors, improving Electronic Data Interchange (EDI) andeBusiness transactions.

EEnnhhaanncceedd iinnvveennttoorryy mmaannaaggeemmeenntt::GTINs provide positive product identification, ensuring thatreceivers 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 safetyand supply chain management in hospitals, including BPOC Systems, GDSN, product classification andcontracting. The main focus of the provider implementation effort is to create a GTIN database, and to integrateGTIN 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 isinvolved? 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 supplierinvolvement, and establishingstandard operating procedures.

For links to all of the Tools listed in the implementation steps, pleaserefer to the References section of this document.


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Step One: Establish Executive Support

The ggooaallss in this step are to inform and educate executive management on standards adoption and the need forindustry-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.

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 tothe business side of pharmaceuticals and medical device systems; etc).

Emphasize that business should drive technology, anddetermining 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., GTINManagement Advisory Group, and the GTIN Operational Team).

Step Two: Form a GTIN Management Advisory Group

The ggooaall in this step is to establish an Advisory Group. Formation of a multi-disciplinary Group includingmembers outside of supply chain functions promotes buy-in, supports communication efforts, and ensuresproper input from the areas most impacted by implementation.

Recruit and solicit commitments for participation. The Group shouldinclude:

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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GTIN materials from theGS1 Healthcare USWebsite

GTIN materials from theGS1 Healthcare USDocument Library

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GTIN presentationmaterials (prepared

in Step 1 above)


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Step Three: Establish Your GTIN Operational Team

The ggooaall in this step is to establish a GTIN Operational Team. The day-to-day utilization and maintenance of theGTIN as a support tool will require the involvement of multiple individuals.

Identify and select participants.

Establish the role of each participant.

Update job descriptions to reflect the new responsibilities of theteam members.

Provide education and training.

Step Four: Develop & Initiate Project Communication

The ggooaall in this step is to inform your internal and external community. Utilize internal communication tools suchas 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 thiseffort.

Announce organizational commitment to GTIN in newslettersand other media.

Announce commitment to implement the GTIN to yoursuppler community.

AAccttiioonnss

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TToooollss

GTIN presentation materials(prepared in Step 1 above)

GTIN materials from the GS1Healthcare US Website

GTIN materials from the GS1Healthcare US DocumentLibrary

GS1 US Website & ProductCatalog

GS1 Healthcare US WebSeminars

TToooollss

GTIN presentation materials(prepared in Step 1 above)


GTIN materials from the GS1Healthcare US Document

Library Supplier/Vendor letter template

(see Appendix E)


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Step Five: Initiate Education for the Advisory Group & Operational Team

The ggooaall in this step is to educate participants. A base level of knowledge about GTINs and GS1 is necessaryfor all active participants.

Participate in web seminars.

Train staff.

Step Six: Assess Information System Issues & Make Necessary Changes

The ggooaall in this step is to evaluate the readiness of your information systems, and make the appropriate systemchanges required to accommodate the use of GTIN. The capability of your information system to contain andutilize GTIN numbers must be assessed, and the necessary changes made.

Meet with your IS system experts (including different disciplines within the IS department),internal and external, to review implementation strategy and understand implications for yourinformation systems.

Establish a collaborative plan to make the necessary changes and prepare informationsystems.

Develop a plan to populate your internal systems with GTINs.

AAccttiioonnss

AAccttiioonnss

TToooollss

GTIN presentation materials (prepared inStep 1 above)

GTIN materials from the GS1 HealthcareUS Website

GTIN materials from the GS1 HealthcareUS Document Library

GS1 US Website & Product Catalog

GS1 Healthcare US Web Seminars


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Step Seven: Identify/Obtain GTINs

The ggooaall in this step is to gather GTINs for each of the products used/purchased at your facility. Hospitaldatabases already contain many GTINs assigned to products by their manufacturers. Therefore, this effort willencompass 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.

Identify the level of depth (i.e., packaging level) that your GTIN numbering system willneed to accommodate to support operations.

Contact manufacturers, distributors, and/or suppliers for GTINS for each packagingconfiguration 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 StrategyThe ggooaall in this step is to establish data storage referencing GTIN. At this point, you are ready to establish aGTIN utilization strategy and corresponding data packaging level chart. The establishment of yourorganizations GTIN packaging level is a critical step in the implementation process. It is necessary to considernot only how business is currently conducted, but also future business processes and supply systempossibilities. 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 hospitals IT systems that must contain GTINs. Thequestion that must be asked is: where are proprietary numbers used today that can be replaced with GTINs? Ata 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 StandardProducts and Services Code (UNSPSC)], inventory management, transportation, controlled substances, vendorscorecard, payer systems (e.g., Medicare), patient records, etc.

Analyze your organizations current and future supply chain models anddistribution 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 findingsbe re-circulated to the Group for review and validation.

After completion of the survey review and validation, the Group should meet todiscuss the results and to identify the first areas/systems in which toimplement 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 orderto accommodate each variation, it is highly recommended that a GTIN always be represented in software applications as 14digits 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 numericfield. Thisinformation should be provided to systems engineers as they prepare to integrate GTINs into IT systems.

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At the Heart ofHealthcare Product ID

Brochure

TToooollss


GTIN materials from the GS1Healthcare US DocumentLibrary

GS1 US Website & ProductCatalog

GS1 Healthcare US Web

Seminars


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Step Nine: Engage Supplier Involvement

The ggooaallss in this step are to prepare the supplier community and identify partner(s) for testing. Collaborationand communication with your supplier community is critical to implementation success. So, now that animplementation plan and initial database has been established, engage strategic suppliers in a process of

communication about your organizational plans.

Explain implementation and process.

Determine supplier capabilities.

Analyze impact to operations and staff.

Step Ten: Conduct Transactional Testing With Suppliers

The ggooaall in this step is to successfully exchange purchase transactions with suppliers. At this point, you areready to conduct transactional tests with your suppliers, manufacturers and/or distributors. The testing processwill 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/keysuppliers.

Document critical success factors.Make adjustments as identified.

Communicate with community.

Step Eleven: Make Adjustments to Initial GTIN Implementation Plan

The ggooaall in this step is to review the initial plan and make corrections based on work group experiences andlessons learned. As a result of the testing process, potential adjustments must be made to all aspects of theprogram, from scanning through communications.

Adjust plan to achieve the most benefits, either in terms of supply chainmanagement, patient safety, financial benefits, or all of the above.

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Supplier/Vendorletter template(see Appendix E)

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ProjectImplementation Plans


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Step Twelve: Create Standard Operating Procedures

The ggooaallss in this step are to document standard operating procedures and obtain sign off, both internally andexternally. Following testing and the implementation of the necessary adjustments, it is necessary to preparestandard operating procedures for internal and external staff. The Advisory Group and Operational Team shouldbe heavily involved in this process.

Analyzing GTIN ROI for Your Organization

In todays dynamic healthcare environment of declining reimbursement and a reduced labor pool, healthcareorganizations 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 scarceresources. 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 anyorganization 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 benefitsand ROI can be found in the implementation of GTIN as part of the implementation of the full GS1 System ofstandards, including Global Location Numbers (GLNs) and the Global Data Synchronization Network (GDSN). (Formore information about GLNs and the GDSN, please refer to the Healthcare Provider Tool Kits prepared on thosetopics by GS1 Healthcare US.) Moreover, most early adopter organizations have realized additional value inunanticipated areas like process improvement and infrastructure development. And, many have noted the value ofa new business philosophy or way of doing business which places the organization in an advantageous positionto address some of the upcoming challenges anticipated in healthcare over the next ten years.

Background Information re: ROI from GTIN Use in Other Industries

The implementation of standards-based product identification in other industries has been found tremendouslyvaluable, as discussed and analyzed at length in the article 17 Billion Reasons to Say Thanks. The followingexcerpt 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 FoodMarketing 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 fromsupply chain visibility and collaboration, that can drive significant inventory reductions across the whole supplychain.

In the book industry, the move to computerize book information led to the realization that a descriptive/alphasystem was too cumbersome. In the grocery industry, the idea had been around, but the evolution of

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


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commercially viable scanning equipment signified an opportune moment. It is significant to note that bothindustries adopted an all-numeric schema.

Only in the grocery industry have significant attempts been made to quantify the benefits of using GTINs. Netbenefits (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 efficienciesand productivity gains. The same studies also estimate that an additional US$15 billion of benefits couldpotentially be realized through improved collaboration. In the case of the book industry, the benefits and savingsof using a standard product identification numbering system were considered so obvious that a cost/benefitanalysis was not even done to quantify anticipated results.

In conclusion, the agreement to adopt a standardized product identification numbering system provides thefoundation to reap extensive benefits throughout the supply chain, not only for all the individual members butalso 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 Standardsimplementation project with a number of industry partners and provider sites to understand the costs, barriersand 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-basedspreadsheet tool to help providers meet their need to quantify the investments and benefits they can expect fromGS1 adoption choices. LRIM does not attempt to estimate dollar costs and benefits. Instead, the model aims toprovide quantitative foundations on which those economic assessments can be constructed for particularprovider 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/surgicalproducts. In the near future the CIHL team plans to enhance LRIM or create sibling versions to address othercategories 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 theuse of GTIN. These functions and business processes serve as hot spots for capturing return on investment ofGTIN implementation. In order to support your ROI analysis, a list of ROI hot spots is provided below. Beginyour ROI analysis by determining the amount of staff time and resources currently allocated to each of thesefunctions. 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 ittakes to track such an item down. Consider each of the following scenarios both before and after GTINimplementation:

Wrong product received due to incorrect purchasing order

417 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 purchasesome 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 measureissues).

Product information in purchase reports received from suppliers andtheir 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 andafter 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 andproduct reordering.


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Lessons Learned & Best Practices

The following case studies illustrate lessons learned and best practices for GTIN implementation. Thedocuments 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.

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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 uniqueidentification of trade items worldwide. A trade item is any product or service upon which there is a need to retrievepredefined information and that may be priced, ordered, or invoiced at any point in the supply chain. A Global TradeItem Number may be 8, 12, 13, or 14 digits in length, represented as GTIN-8, GTIN-12, GTIN-13, and GTIN-14respectively

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 whereapplicable.

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 adata base as 14 digits. Companies/organizations can become GTIN compliant by expanding the appropriatesystems 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 ofthe 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 anyway that is relevant to the trading process. The guiding principle is if the customer is expected to distinguish a newitem from an old item and purchase accordingly, a new GTIN should be assigned to the new. For completeinformation, 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 inthe 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 trackedand traced individually in a supply chain (Serial Shipping Container Code/SSCC).

Assets: Fixed or returnable assets (Global Individual Asset Identifier/GIAI, Global Returnable AssetIdentifier/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 entitys service requirements and needs over acontinuing 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 (AIs). When a scanner seesthis special bar code, it automatically knows to look for AIs in order to separate and interpret ID numbers properly.

The information that comes after the AIs can contain numeric (n) or alphanumeric (an) data characters.


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Glossary

Term Glossary Definition

AI Acronym for Application Identifier (defined below).Application Identifier (AI) 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.Attribute A piece of information reflecting a characteristic of the object to which an

identification number (i.e., GLN, GTIN, etc.) relates.Bar Code A precise arrangement of parallel lines (bars) and spaces that vary in width

to represent data.Company Number A number allocated by the GS1 Numbering Organization. It is combined

with the GS1 Prefix (for the GS1 Member Organization) to create the GS1Company Prefix. The GS1 Company Prefix (i.e., the GS1 Prefix + theCompany Number) uniquely identifies a provider.

Data Carrier A physical or electronic mechanism that carries data (e.g., a bar code orRFID tag).

Data Format Required structure for the numerical string of a GS1 Identifier (e.g., text,length, spacing, punctuation, etc.)

Data Standard The entirety of all GS1 System data standardized in meaning and structure.Data Structure The GS1 System data structures defined in the various lengths required for

the different identification purposes, which all share a hierarchicalcomposition. Their composition blends the needs of international controlwith the needs of the user.

EDI Acronym for Electronic Data Interchange (defined below).

Electronic Commerce A method of business communications and management using electronicmethods, such as electronic data interchange and automated datacollection systems.

Electronic Data Interchange(EDI)

The computer-to-computer exchange of structured information, by agreedmessage standards, from one computer application to another byelectronic means and with a minimum of human intervention.

GLN Acronym for the GS1 Global Location Number (defined below).Global Location Number The globally unique GS1 System identification number for legal entities,

functional entities, and physical locations. The GLN is 13 digits, comprisedof a GS1 Company Prefix, Location Reference, and Check Digit. Supplyside trading partner locations generally include corporate headquarters,regional offices, warehouses, plants, and distribution centers. Demand sidetrading partner locations generally include corporate headquarters,

divisional offices, stores, and distribution centers.Global Trade Item Number The globally unique GS1 System identification number for products andservices. A GTIN may be 8, 12, 13, or 14 digits in length, represented asGTIN-8, GTIN-12, GTIN-13, and GTIN-14 respectively.

GS1 Company Prefix A globally unique number assigned to companies/organization by GS1Member Organizations to create the identification numbers of the GS1System. It is comprised of a GS1 Prefix and a Company Number.

GS1 System The specifications, standards, and guidelines administered by GS1. GS1,through the Global Standards Management Process, manages the GS1System to maintain the most implemented standards in the world.


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Term Glossary Definition

GS1-128 Bar Code Symbol A subset of the Code 128 Bar Code Symbol that is utilized exclusively forGS1 defined data structures. UCC/EAN-128 Symbols can be printed as

stand-alone linear symbols or as a composite symbol with anaccompanying 2D Composite Component printed directly above the GS1-128 linear component.

GTIN Acronym for the GS1 Global Trade Item Number (defined above).Identification Number (ID) A numerical designation that uniquely identifies an object in the supply

chain. Identification numbers are used to retrieve information previouslyexchanged between trading partners and stored in their computer databasefiles.

Location Number See GLN (defined above).Location Reference A number within a GLN assigned by various parties to identify a different

entity.Supply Chain Partner A party to transactions in the supply chain, such as a supplier (seller) or a

customer (buyer).

Trade item Any item (product or service) upon which there is a need to retrieve pre-defined information and that may be priced or ordered or invoiced at anypoint in any supply chain.

U.P.C. symbol A bar code symbol that encodes the GTIN-12, Coupon-12, RCN-12, andVMN-12.

United Nations StandardProducts and Services Code(UNSPSC)

An open, global, multi-sector standard for efficient, accurate classificationof products and services, managed by GS1 US for the United NationsDevelopment Programme. Companies and organizations use the UNSPSCto analyze various procurement and purchasing functions to reduceorganizational costs and improve supply chain efficiencies. The UnitedNations Standard Products and Services Code structure has fourcategories: Segment, Family, Class, and Commodity.

UNSPSC Acronym for the United Nations Standard Products and Services Code

(defined above).


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References

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To learn more about the GTIN workgroup, contact GS1 US at [email protected]

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http://gdd.gs1.org/gdd/public/

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http://www.gs1us.org/resources/standards/package-measurement-standards

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http://www.gs1.org/gdsn/dqf/data_quality_framework

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

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http://www.gs1us.org/industries/healthcare/tools-and-resources/healthcare-tool-kits

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http://www.gs1ushealthvideo.com/

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healthcare provider tool kit global trade item number(gtin)

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