Improving Patient Safety and Supply Chain Efficiency with Data Standards: The basics of GS1 Standards in healthcare Jean Sargent, CMRP, FAHRMM Director,

Improving Patient Safety and Supply Chain Efficiency with Data Standards: The basics of GS1 Standards in healthcare Jean Sargent, CMRP, FAHRMM Director, aspen Healthcare Metrics A MedAssets Company

Jean Sargent… Currently, Director at Aspen Healthcare Metrics,
A MedAssets Company Past President of the Association for Healthcare Resource and Materials Management of the American Hospital Association (AHRMM) GS1 Healthcare US® & Global GS1 Healthcare Leadership Team A recognized leader in supply chain management, having presented at many conferences at the national, state and local levels. Over 35 years experience in hospital Central Service / Materials Supply Chain Management.

Introduction to GS1 & GS1 US
Who is GS1®? GS1 Healthcare – Global Standards Who is GS1 US™? GS1 Healthcare US® – Standards Implementation

gs1 By the numbers 2 million companies around the world use GS1 Standards More than 5 billion GS1 barcodes are scanned every day 5 million products are assigned U.P.C.s in the GS1 Data Driver® item management tool 5 million products are registered by brand owners in the 1SYNC Data Pool

110+ member organizations serving business around the world

31 Local Healthcare user groups driving adoption of GS1 standards worldwide
As proof of the growing importance GS1 Standards play in Healthcare, let me show you where Local User Groups are active around the globe. Today GS1 Healthcare has implemented 31 healthcare User Groups Worldwide – representing a 30% increase in the last 3 years.

GS1 Healthcare LT 2012/2013 LT Members Dennis Byer, Novation
Monica Kryzer, 3M Peggy Staver, Pfizer Bruno Cambounet, Axway Joe Pleasant, Premier Nathan Habeck, Baxter Peter Tomicki, Zimmer Volker Zeinar, B Braun Robert Matsubayashi, GS1 Brasil Christian Riediger, Bayer Alicia Duval, GS1 Canada Dennis Black, BD Nicolas Florin, GS1 in Europe John Abrams, Cardinal Health Micho Hamano, GS1 Japan Clemens Haas, Fresenius Siobhan O’Bara, GS1 US Margot Drees, GHX Alaster Purchase, GS1 UK Grant Courtney, GSK Tom Werthwine, J&J Tri-Chairs Ron Bone, McKesson Mike Wallace, Abbott Jackie Elkin, Medtronic Grant Hodgkins, Alcon Labs Steve Capel, Covidien

GS1 Standards in Healthcare
Enable traceability and authentication systems Fight counterfeiting Effective & efficient product recalls Improve supply chain efficiency Enable AIDC systems all the way to the point-of-care or point-of-sale Ensure the 5 patient rights Reduce medication errors Enable regulatory compliance Pedigree legislation Five Patient Rights Right Patient Right Drug/Device Right Time Right Dose Right Route

Why Global Standards? The package has:
6 machine readable codes (5 barcodes, 1 Data Matrix). 17 flags (UK, Ireland, Malta, Netherlands, Belgium, Germany, Austria, France, Spain, Portugal, Greece, Cyprus, Norway, Sweden, Denmark, Iceland, Finland) (not Italy) 12 different language texts (English, French and German are used in more than one country).

SAME PRODUCT– DIFFERENT NUMBERS*
Nearly every hospital has a different Product ID for 3M ! Makes ordering, recalls, and proper identification to the patient difficult. Industry Distributor Numbers for 3M Product # 8630: Allegiance - M8630 Owens & Minor BBMC-Colonial BBMC-Durr Kreisers - MINN8630 Midwest - TM-8630 Pacific - 3/M8630 UnitedUMS A significant problem in the Healthcare supply chain is the fact that the same product has many different numbers as it flows through the supply chain. This actual example from the Department of defense synchronization study shows the number for 3M product #8630 as it flows through the distributor system. As can be seen the product numbers change. This results in nearly every hospital having a different number for the same product. To make the issue even worse many hospitals actually place their own product number on the item for internal identification purposes which contributes to the problem of tracking a product for recalls and for identification in an EHR system. * Source: Department of Defense Data Synchronization Study

Same Number Different Products*
Makes Sourcing of needed products difficult and increases errors in ordering and distribution to the patient. Part Number: 10313 refers to: Medtronic‘s "NEEDLE CARDIOPLEGIA ADULT 16GA 5/8IN TIP 10IN" Hantover's "CARTRIDGE REPLACEMENT STUNNER YELLOW F/CALVES/HEAVY HOGS" Chattanooga Group's "ACCESSORY TRACTION REPLACEMENT STRAP XL FOR HALTER THORACIC RESTRAINT" HF Scientific's "TEST KIT WATER FREE CHLORINE DPD 25ML SAMPLE PHOTOMETRIC 1000/PK" Not only do we find multiple numbers for the same product but we also have the same number for different products which creates confusion and incorrect ordering and shipments throughout the supply chain. In this example from the Premier Inc. Product Item Master we find four different products for number These products vary from a laboratory test kit to a needle. This contributes to the inefficiencies within the supply chain and often results in ordering the wrong product. Part Number: 1050 refers to: 3M Company's "DRAPE INCISE 35 3/8X 17 5/8IN" Tyco's "PAD TELFA 3 X 4IN STER" * Source: Premier Inc. Product Item Master

ABOUT gs1 us GS1 US serves more than 300,000 businesses across 25 industries in the United States. Leading industry initiatives in Apparel / General Merchandise, Consumer Packaged Goods / Grocery, Foodservice, Fresh Foods and Healthcare Administrating the GS1 System of standards Providing support services, tools, education and training Connecting communities through events and online forums GS1 US is the pioneer of the Universal Product Code (U.P.C.) and the Electronic Product Code™ (EPC®).

– GS1 Healthcare US – Standards Implementation

2013 GS1 Healthcare US® Leadership Team
Healthcare Category Term ends 12/31/13 Term ends 12/31/14 Acute Care Provider Cynthia Shumway Intermountain Healthcare Michael Innes Kaiser Permanente Alternate Site Provider Craig Short Good Shepherd Rehabilitation Network Karen Wolfe Mayo Clinic Distributor Ron Bone McKesson Corporation Danielle Fink Cardinal Health Group Purchasing Organization Dennis Byer Novation, LLC Pat Klancer Amerinet Healthcare Associations, Education, Government 1 Deb Sprindzunas AHRMM Curtis Rooney HSCA Medical Device Manufacturer Dennis Black BD Corwin Hee Covidien Pharmaceutical Manufacturer Michael Ventura GlaxoSmithKline Peggy Staver Pfizer, Inc. Retail Pharmacy Vacant Solution Provider 1 Keith Lohkamp Lawson Software Josh Skiba GHX Member–at–Large John Terwilliger Abbott Laboratories Jean Sargent MedAssets Regulatory/Advisory Rep Jay Crowley FDA Ex-Officio 1 (1 year term) Dennis Orthman SMI 1 Non voting members 14

157 Member Companies AS OF 3/10/13
Industry Associations (25) • AIM North America • MITA - Medical Imaging & Technology Alliance • AAP - American Academy of Pediatrics • NACDS - National Association of Chain Drug Stores • AHA - American Hospital Association • NCPD - National Coalition of Pharmaceutical Distributors • AHRMM - Association for Healthcare Resource and Materials Management • NCPDP - National Council for Prescription Drug Programs • AORN – Association of periOperative Registered Nurses • Planned Parenthood (ND, SD, MN) • ASAP – American Society for Automation in Pharmacy • SMI - Strategic Marketplace Initiative • ASHP - American Society of Health-System Pharmacists • CHPSO - California Hospital Patient Safety Organization • CHSCR - Center for Healthcare Supply Chain Research • Dental Trade Alliance • ECCMA • GHVRHIO - Greater Hudson Valley Regional Health Information Organization • GPhA - Generic Pharmaceutical Association • HDMA - Healthcare Distribution Management Association • HIDA - Health Industry Distributors Association • HISCI - Healthcare Industry Supply Chain Institute • HSCA – Healthcare Supply Chain Association • MedSC LLC • MHIA – Material Handling Industry of America

Manufacturers (33) • Abbott Laboratories, Inc. • Medical Action Industries • Action Products, Inc. • Medical Packaging, Inc. • AliMed, Inc. • Medline • Amgen • Medtronic, Inc. • Baxter International, Inc. • Merck & Company, Inc. • B Braun Medical, Inc. • Monaghan Medical Corporation • BD • Novartis Pharmaceuticals Corporation • Boston Scientific Corporation • Patterson Medical Supply, Inc. • Bristol-Myers Squibb Company • Pfizer, Inc. • Consensus Orthopedics • Sage Products, Inc. • Covidien • Stryker Sustainability Solutions • C.R. Bard • Grifols Therapeutics, Inc. • Ecolab • Terumo Medical Corporation • Edwards Lifesciences • WL Gore and Associates • Endologix, Inc. • Gilead Sciences, Inc. • GlaxoSmithKline • Johnson & Johnson • Kimberly-Clark Corporation

Group Purchasing Organizations (5) Academic Institutions (6) • Amerinet • CIHL - Center for Innovation on Healthcare Logistics • HealthTrust Purchasing Group • Michigan State University • MedAssets • Ohio University • Novation LLC • Rider University • Premier, Inc. • University of Texas at Arlington • Wright State Research Institute Distributors (4) Government Agencies (8) • AmerisourceBergen Drug Corporation • CA Dept. of Health Care Services • Cardinal Health • DMSB - Defense Medical Standardization Board • McKesson • DoD/DMLSS - Defense Medical Logistics Standard Support • Owens & Minor • Dept. of Veteran Affairs • Dept. of Health & Human Services • US Air Force Medical Service • US Food and Drug Administration (FDA) • USP – United States Pharmacopeia

Solution Providers (34) • 1WorldSync • Omega Design Corporation • Acsis, Inc. • Omnicell • Ariba • Optel Vision • AXWAY • Oracle America • Champion Medical Technology • Pharma Logic Solutions, LLC • COVECTRA • PharmTech, Inc. • Craneware, Inc. • Product Identification & Processing Systems, Inc. • D2 Pharma Consulting LLC • rfXcel Corporation • DataPros for Healthcare • ROC-IT • Deloitte Consulting • SciQuest • ECRI Institute • Syncnicity, Inc. • Ernst & Young, LLP • Systech International • FSEnet+ • Tecsys, Inc. • GHX • TraceLink, Inc. • Lansa, Inc. • Vendormate • Lawson Software • Vuetura, Inc. • Medical Packaging, Inc. • MediClick, Inc.

Hospitals/IDNs (42) • Mayo Clinic • Advocate Healthcare • Memorial Health System • Allina Health System • Mercy / ROi • Ascension Health • Ministry Health Care Inc. • Atlantic General Hospital • Munroe Regional Medical Center • Atlantic Health • New York Presbyterian Hospital • BJC Healthcare • OSF Healthcare • Buchanan County Health Center • PeaceHealth • Carolinas Healthcare • Premier Health Partners • Catholic Health Initiatives • Sentara Healthcare • Centegra Health System • SSM Healthcare • Christiana Care Health System • Thomas Jefferson University Hospital • Christus Health • UK Healthcare • Cleveland Clinic • University of Colorado Hospital Authority • Geisinger Health System • University of Mississippi Medical Center • Good Shepherd Rehabilitation Network • University of Toledo Medical Center • Greenville Hospital System University Medical Center • University of Virginia Medical Center • Henry Ford Health System • UPMC • Intermountain Healthcare • WellSpan Health • Johns Hopkins Health Systems • Wexner Medical Center • Kaiser Permanente • Kettering Health Network • Maury Regional Medical Center

GTIN® GLN GDSN UNSPSC® The GS1 System 3 G’s and U…
Global Trade Item Number GTIN® Product Identification Global Location Number GLN Location Identification Global Data Synchronization Network GDSN Data Attribute Accuracy U.N. Special Products and Service Code UNSPSC® Product Classification

Gs1 standards in healthcare
The mantra of the GS1 system is identify capture and share . The GS1 system identifies products uniquely with a GTIN and then encodes this information on GS1 barcodes. GS1 has standardized only a few Symbologies that carry the GS1 data structures. GS1 has patented these barcodes and then placed them in the public domain. A common mistake that is being seen now are manufacturers using the generic rather than the GS1 standard barcodes.

Gs1 standards in healthcare
Identify , capture and share. The GS1 system uniquely identifies products and locations with GTIN and GLNs , captures them in GS1 barcodes. These GTINs and GLNs are then placed in specific fields in data bases so that they can be shared with trading partners via business methods. This standardization allows for interoperability of systems across many enterprises and will allow in healthcare greater supply chain efficiency, and data mining. The US FDA has basically copied the GS1 system in their UDI approach.

healthcare

Legislators / Regulators
GS1 Standards: U.S. Healthcare Adoption Strategy Legislators / Regulators UDI Act FDA Pharma Act (Serialization ) California Board of Pharmacy (2015) Buyer - Matheson Bill GTIN GDSN GLN GTIN GDSN GLN Commercial Suppliers GTIN GDSN GLN Retail Pharmacies Associations IDNs & Hospitals (Integrated Delivery Networks) GLN (Global Location Number) Sunrise 2010 GTIN (Global Trade Item Number) Sunrise 2012 GDSN (Global Data Synchronization Network) Healthcare Providers GTIN GLN GDSN Distributors Pharmaceutical Manufacturers GLN GTIN GDSN Distributors Medical Device Manufacturers GLN GTIN GDSN GPOs

What is GLN? Global Location Number
A globally unique 13-digit number that identifies: Legal entities Whole companies, health systems, divisions Functional entities Specific department within a legal entity, (e.g., pharmacy, receiving department, etc.) Physical locations Clinics, units, warehouses, loading docks, etc. Used instead of phone numbers, store numbers, DUNS+4, etc. A global standard of the GS1 System for collaborative commerce 26

What is the “location” pain?
Too many identifiers for the same healthcare location = Confusion, finger pointing, & inefficiency SAINT JOHN'S QUEENS HOSPITAL ST JOHN'S QUEENS HOSPITAL SAINT JOHNS QUEENS HOSPITAL JAOE SAINT JOHN'S QUEEN HOSPITAL SAINT JOHN'S QUEEN’S HOSPITAL CA2053 ST. JOHN'S QUEENS HOSPITAL OM 12345 Many different names and location numbers for 1 hospital 27

GLN Registry SAINT JOHN'S QUEENS HOSPITAL One standard locator GLN with address rationalized through US Postal Service 28

GLN Registry: Health System Example
29

Combined length is always 12 digits
GS1 Member GLN 13-digit number Components: GS1 Company Prefix - Varies in length Location Reference number Assigned by the company Check Digit Can also be assigned randomly by GS1 US No intelligence Combined length is always 12 digits 32

GLN industry goals GLN Adoption in U.S. Healthcare
(Formerly 2010 GLN Sunrise) Industry-wide use of Global Location Numbers* (GLNs) in lieu of custom account/location numbers, which means: GLNs are assigned by location owners GLN hierarchy is defined and maintained by location owners GLN Registry for Healthcare® is used to facilitate correct location identification GLNs are used in appropriate business transactions and processes between trading partners *Unique Standardized Location Identifiers 33 33

GLN Benefits for Providers
Simplifies location identification with a single identifier used across all supply chain partners Enables providers to define and manage their own account and location information to ensure accuracy Provides an accurate view of the organization as a customer to ensure correct contract pricing eligibility and to streamline rebate processing Reduces mis-shipments and time spent resolving order and invoice errors Provides the foundation for traceability to improve product recall processes

GLN Benefits for suppliers
Improves customer data management processes Streamlines sales tracing, administration fee reporting, rebate and chargeback processes Reduces time spent resolving order, pricing and invoice errors Improves customer satisfaction by enabling a smooth purchasing experience Provides a competitive advantage in meeting customer contract requirements Provides the foundation for traceability to improve product recall processes

Benefits being realized today
Reduction in supplier account numbers for providers, reported between 40% to 60% Elimination of duplicate GPO member records for providers on rosters, reduction estimated at 10% Elimination of 50,000 unnecessary, obsolete, duplicate and bad address records Based on the top 5 GPOs and the Registry measures, therefore cleaned up by GPOs and suppliers Increase in EDI business transactions, up to 20% Improved alignment of GPO rosters implementing a standardized format and system for reporting Increase in accuracy of reporting for rebates and charge backs resulting in increase of revenue for the provider Decrease in mis-shipments due to accurate location identification Reduction in pricing discrepancies resulting from better organizational alignment Increase in collaboration between providers, GPO’s, distributors and suppliers

“Adoption of GLN in Healthcare”
Phase One Awareness Phase Two Enumerate Phase Three Reconcile Phase Four Transact Phase Five Maintain One business partner at a time Organization accesses the GLN Registry, establishes users/approvers and reviews their hierarchy. Organizations commit to utilize the GLN Registry for rosters/membership maintenance. Organizations use GLNs in transactions to identify themselves and their business partners, replacing the use of proprietary account numbers. Data is maintained in the GLN Registry in “real” time to facilitate ongoing data quality and transactional efficiency. Provider An organization’s supply chain leaders and staff know about GLNs, their benefits, and standards in general and commit to implement. * Certifies accuracy of data and maintains in real time as business partners rely exclusively on the accuracy of this data. * Assumes responsibility for enumeration of locations to ship-to, bill to, and pay from level with GLNs. * Provider maintains data in registry “real” time. * Begin to utilize GLN to identify business partners in internal systems. * Work with business partners to align existing account numbers to GLN. 1. Agreements between the manufacturer/distributor and GPO should have membership rosters submitted with the GLN as the identifier and the applicable demographics for their membership and that payments back to the GPO include the GLN and demographics. 2. Agreements between the manufacturer and IDN/Single Facility should reference the customers covered using their GLN and demographics. 3. Agreements between the manufacturer and distributor/wholesaler should detail electronic transactions. The use of 832 (Price Sales Catalog) & 845 (Price Authorization) should reference GLNs Agreements between the distributor/wholesaler and IDN/Single Facility should use GLNs. Provider agreements with their trading partners should include locations (address) listing as appropriate Recommend GLNs replace custom identifiers with GLNs in these processes for both electronic and EDI transactions (purchase orders, Advance Ship Notice, etc.): (Purchase Order[PO])/855 (Reply to PO)/810 (Invoice) later in process/856 (Advanced Ship Notice) first priority, scalable and repeatable 6. Replacement of GLNs in paper transactions should follow as business partners are technically capable. * Maintain GLN hierarchy in registry “real” time, resulting in database or record for business partners’ communication. * Becomes final arbiter of GLN and all disputes are adjudicated via provider. Supplier * Certifies accuracy of data and maintains real time. * Enumerates the order from and pay to locations with GLNs. * Begin to utilize GLN to identify business partners in internal systems. * Work with business partners to align existing account numbers to GLN. * Align existing account numbers and GPO proprietary ID to GLNs, where applicable. * Maintain info in systems utilizing GLN, ship/order/sales tracing/contracts. * Access registry to maintain location information and accept final judgment of provider on accuracy of GLN. GPO * Initially enumerates locations at ship-to level until the provider assumes responsibility. * Assists provider members with education, hierarchy design and general enumeration strategy. * Display ship-to locations with GLNs within their roster. * Adjudication assistance to members, but final decision is made by provider. * Work with business partners to align existing internal account numbers to the GLN number. * Maintain roster membership lists using only GLN, reporting/fees done by GLN. * Adjudication assistance to members, but final decision is made by provider. v

GLN Scorecards Vince Lombardi
“Unless you keep score, it is just practice”. Vince Lombardi Voluntary GLN Scorecard Reporting: 3,814 hospitals and other healthcare provider facilities 36 healthcare manufacturers and distributors 6 leading GPOs 11 healthcare software suppliers December 31, 2012

What is a GTIN? GTIN is Global Trade Item Number®
Used on any item upon which there is a need to retrieve pre-defined information and that may be priced, or ordered, or invoiced at any point in any supply chain. A globally unique 8, 12, 13, or 14-digit number that uniquely identifies products and services An identification number of the GS1 System, therefore unique and unambiguous A global standard for collaborative commerce A 14-digit GTIN is encoded in a GS1-128/ GS1 DataMatrix / GS1 DataBar DataMatrix (14-digit GTIN) Databar (14-digit GTIN) GS1-128 (14-digit GTIN) DataBar Limited & Composite EPC/RFID

GTIN: Healthcare Example
Serial Number GTIN (Global Trade Item Number) Expiry Date Lot Number 41

“Adoption of GTIN in Healthcare by 2012*”
2012 GTIN Sunrise “Adoption of GTIN in Healthcare by 2012*” Global Trade Item Numbers (GTINs)** GTINs are assigned to healthcare products GTINs are used in business transactions GTINs are marked on appropriate packaging levels GTINs are scanned at points-of-delivery to enhance clinical process GTINs are used in product returns and recalls GTINs are registered in a GS1 GDSN-certified Data Pool *December 2012 **Unique Product Identifiers 42 42

GTIN Scorecards Vince Lombardi
“Unless you keep score, it is just practice”. Vince Lombardi Voluntary GTIN Scorecard Reporting: 2,732 hospitals and other healthcare provider facilities 112 healthcare manufacturers and distributors 4 GPOs 4 Solution Providers December 31, 2012

Traceability Ladder of Precision
GTIN and Serial Number identifies a precise product and packaging size (21) Pharma or medical device product Serial Number GTIN and Lot Number identifies Products within a defined group (10) 05724f Lot number 05724F GTIN identifies product and package 45

Micro Logistic example: Instrument Reprocessing Cycle
Order of new instruments Stock scan on set level (Linear Barcode or RFID) Case carts Transport Cleaning Desinfection After Desinfection OR Instr. check Stock Assembling Repair stock Batch release Sterilization Batch loading scan on instrument level (Data Matrix) External mandantory

Device Information Lifecycle
GPOs Clinical Substitution Manufacturer Rentals Distributor Device X Lot Y Exp Date Z Sold Reuse Hospital Direct Recall Availability Off-master purchase Reorder Reduce Medical Error Clinical Use Unit Sales Rep Hoarding Reimbursement Population Databases Postmarket Surveillance EHR Registries AE Reporting Anticounterfeit Emergency Preparedness Cost Effectiveness Supply Chain Efficiency Shortage/ Substitution

Future Information Lifecycle
Re/order Reimbursement Hospital Expiration date? Distributor Clinical Use Effectiveness Device X Lot Y Exp Date Z Recalled? Manufacturer EHR Safe? AE reporting Recall Registries Surveillance Population databases Counterfeit Closed System

Unique Device Identification www. fda
Unique Device Identification

FDA Amendments Act of 2007 September 27, 2007, the FDAAA signed into law: The Secretary shall promulgate regulations establishing a unique device identification system for medical devices requiring the label of devices to bear a unique identifier, unless the Secretary requires an alternative placement or provides an exception for a particular device or type of device. The unique identifier shall adequately identify the device through distribution and use, and may include information on the lot or serial number.

Establishing a UDI System
Combination of 4 distinct steps: Develop a standardized system to develop the unique device identifiers (UDI) Place the UDI in human readable and/or AutoID on a device, its label, or both Create and maintain the UDI Database Adoption and Implementation

Limitations of UDI and UDID
UDI is a foundational element – it unambiguously identifies a specific device (at its unit of use). Benefits accrue only if used by all stakeholders. UDID contains only “static” identifying and product information. UDID does NOT contain production information, such as lot or serial numbers – and is NOT for track/trace or other similar purposes requiring the full UDI. UDID provides link to product information- not a replacement for Recalls/Adverse Event Databases.

UDI Database Synopsis UDI Database
There are currently no immediate plans to increase the UDI Database attributes Attributes are expected to grow beyond the initial set in the future to support product description needs The “FDA Listings Code” was shown as a potential attribute (new) UDI Database Pilot Report to be release on the FDA website within the next week

Standards initiatives
US FDA Pharmaceutical Regulation Comments UDI Regulation SNI Guidance Global GHTF( IRSTR) UDI Guidance State California Pedigree Industry mandate GLN Sunrise (2010) GTIN Sunrise (2012) Customer Healthcare Transformation Group

Why Are These Standards Important?
A few examples … Electronic commerce, such as EDI – ensures accurate product data to be used for more types of business transactions and interoperability Data Synchronization – healthcare needs to be able to synchronize product data – globally Serialization – ability to know where and when a trade item is, based again, on a global standard Decreasing counterfeiting of grey and black market sales – therefore improving patient safety Contracting and compliance – sourcing product data with improved accuracy Enables regulatory compliance with less costs and more efficiencies: Medical device recalls, adverse reporting, track and trace, disaster/terror preparation and device shortages, reduce medical errors, and document medical device use in patient’s EHR/PHR And much more … …but trading partners must facilitate this data!

Cost of Inaccurate Data
The use of inaccurate supply chain information costs the healthcare industry $2 to $5 billion dollars annually: 24% to 30% of administration time is spent on data cleansing and corrections everyday 30% of the hospital product information in buyer systems is inaccurate – each transaction error costs $60 to $80 to correct 60% of all invoices generated in the healthcare supply chain have errors – each invoice error costs $40 to $400 to reconcile Erroneous data increases supply costs 3% to 5% The use of inaccurate supply chain information costs the healthcare industry $2 to $5 billion dollars annually: The healthcare supply chain spends 24% to 30% of administration time everyday on data cleansing and corrections. Although hospital product information is constantly being updated, 30% of buyer systems are inaccurate. As a result, many healthcare buyers are sourcing products using old information – and each of the resulting erroneous transactions costs $60 to $80 to correct. 60% of all invoices generated in the healthcare supply chain have errors – and each invoice error costs $40 to $400 to reconcile. Erroneous data increases supply costs 3% to 5%. Hospitals, GPOs and suppliers spend more than $5 million annually to “align” product information (i.e., ensure that all of them have and are using the same information The problem is that these efforts often rely on “non-authoritative sources” of information that may be inaccurate and/or out of date -- undermining the effectiveness of the effort and the value of the investment. The problem is actually two-fold: 1. Healthcare providers need one central source of supply chain information that all systems rely on for information about products and supply chain partners. 2. Healthcare providers need a process for ensuring that the information in that central source is reliable, accurate, properly formatted, and up-to-date. Source: William L. Rosenfeld & John L. Stelzer, Data Synchronization in Healthcare: A Solvable Problem, Sterling Commerce,

What is GDSN®? The GS1 Global Data Synchronization Network™ connects customers and suppliers, via their selected GDSN-certified Data Pools, to the GS1 Global Registry®. The GS1 GDSN is an automated, standards-based global environment that enables secure and continuous data synchronization, allowing all trading partners to have consistent item data in their systems at the same time. The solution is the Global Data Synchronization Network. Read the 2 bullets in the chart 57

Key Elements of the GDSN
GDSN-certified Data Pools Electronic catalogues of standardized item data, serving both as a source and/or recipient of master data. Can be run by a GS1 Member Organization, supplier, customer, exchange or service provider. There are two key elements that make up the GDSN: 1. GDSN – certified Data Pools 2. The Global Registry Now you’ll notice I said “certified”. This is because we need to ensure that the data that is being exchanged is clean, accurate and properly formatted. Any organization that wishes to become a GDSN-certified Data Pool must be audited and meet specific GDSN criteria. Data pools are essentially electronic catalogues of standardized item data, serving as a source and/or recipient of master data. Many are run by a GS1 Member Organization, supplier, customer, exchange or service provider, just as long as the entity is able to comply with the criteria for GDSN certification . 58

Key Elements of the GDSN
GS1 Global Registry The GDSN acts as a "yellow pages directory" that: Provides information for subscription sharing Enables Data Pool interoperability Guarantees uniqueness of the registered items and parties Ensures that all Data Pools in the network comply with a common basic set of validation rules that support data integrity in the system Holds the information about who has subscribed to trade item or party data GS1 Global Registry 1SYNC GS1 US SA2 Worldsync GmbH Big Hammer Commport GS1 Argentina GS1 Australia GS1 Canada GS1 Columbia GS1 DAS GS1 France Gs1 Hong Kong GS1 Malta GS1 Mexico GS1 Slovakia GS1 Spain GS1 Taiwan GS1 UK GS1 Venezuela GXS KOEB SINFOS GHX The second key element is the GS1 Global Registry. The Registry acts as a …. Read the slide almost verbatim. 59

GDSN Pilot Participants
Manufacturers Distributors Providers GDSN Registry Data Pool Technology Payer Atlantic Health GPO DoD Healthcare GDSN Pilot Participants MMIS 64

United Nations Standard Products & Services Code® (UNSPSC)
An open, global, multi-industry standard used to classify products and services Provides a structure or framework for product classification Provides a way to categorize products and services to help users organize products for catalogs, databases and listings Owned by: United Nations Development Programme (UNDP) UNDP appointed GS1 US as code manager in May 2003 Designed to facilitate electronic commerce Help streamline the procurement process Help analyze spending Help customers find products 65

UNSPSC (Overview & Example)
Using the Codeset Hierarchy Category Number and Name Segment 44 - Office Equipment and Accessories and Supplies Family 10 - Office machines and their supplies and accessories Class 11 - Office and desk accessories 15 - Mailing supplies 16 - Desk supplies 17 - Writing instruments Commodity 04 - Ball Point Pens : Ball Point Pens 66

Need for Solution Providers
The need for more solution providers to get involved is ever present The use of standards without the updated systems will make the task more difficult Creation of interfaces, including bi-directional between systems In hospitals: MMIS to OR; MMIS to Cath Lab; MMIS to Pharmacy; MMIS to point of use systems Within manufacturing Within distribution The FDA will be mandating the tracking of information – there is a need

Imagine…every healthcare provider with a holster full of barcode scanners – we need technology to parse information!

Visibility, Traceability, Track and Trace, Pedigree Terms
All of Track & Trace / Traceability. Can also provide status or disposition of item. May include other attributes that provide insight as to whether the item is fit for use. Leverages separate Master Data management. Visibility Fit for use Additional Status data (Temp Profiles?) Traceability / Track and Trace: Interchangeable terms. GS1 uses Traceability while others (FDA) use Track & Trace). Provides ability to track forward to determine where the item currently is or trace back where it had been. Can leverage separate Master Data management. Track and Trace / Traceability Proof of Delivery Inventory Levels Pedigree Pedigree: Usually defined by U.S. State or Federal law. Information to “trace” the distribution history of an item. May include Chain of Custody and/or Chain of ownership. 69

U.S. Healthcare Industry Regulatory Drivers State and Federal Regulation
By 2016, Pharmaceuticals will: Be identified by the GTIN and a unique Serial Number Have dispositions associated with each item Be tracked through the Supply Chain In the near future*, Medical Devices may: Be identified by the GTIN and the Lot Number or a Serial Number Have states, or Dispositions associated with each item * Pending FDA Regulatory action

U.S. Pharmaceutical Industry Serialization & Pedigree Timeline
2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 2015 Readiness Pilots FDA N-120 FDA-2008-N-121 Comment Period Ends FDA SNI Guidance FDA Track & Trace Workshop FDA Track & Trace Comments Due * CA – Manufacturers: 1st 50% serialized CA – Manufacturers: Remaining 50% CA – Wholesalers CA – Pharmacies * Note: Manufacturers must provide CA with their plans to serialize, and the technology to be used before Jan 2015 71

2015 Readiness Pilots The main challenges are sharing data with systems and Trading Partners Policy Issues Regulation / risk decision Inference Policy Reasonable verification Data sharing policy Future usage or Pedigree only? Exception Processing Managing Serialized Data Provisioning a production line Provisioning a separate plant Provisioning a Contract Manufacturer Sharing Visibility, Track & Trace and Pedigree data Message format Data Attributes System Attributes

2015 Readiness Pilots What will companies be piloting?
Serialization at the lowest salable level, cases, pallets and totes (logistics units) Identifiers: SGTIN, SSCC, GLN Carriers: GS1 DataMatrix, GS1-128 (linear), EPC/RFID (UHF) Share (standards): Share chain of custody and chain of ownership data via EPCIS, Core Business Vocabulary (CBV) Test against: draft Traceability for Pharmaceuticals – U.S. Application Guideline, Traceability for Pharmaceuticals – U.S. Implementation Guideline, Healthcare Supplier Tool Kits (GTIN, GLN), Healthcare Provider Tool Kits (GTIN, GLN), HDMA Labeling Guideline Business processes: Basic Forward logistics (Labeling, packing, put away, picking, shipping, receiving, inspecting, quarantine, dispensing) Repackaging Kitting Returns Recalls Withdrawals Refusals Aggregation Inference Exception processes

GS1 Healthcare US® - Workgroups
Workgroup Participants 1. Product Identification 145 2. Location Identification 191 4. Traceability Adoption 151 5. Hospital Implementation 65

healthcare GS1 Healthcare US
Programs / Initiatives GS1 Healthcare US Driving the adoption and implementation of GS1 Standards to improve patient safety and supply chain efficiency since 2008 Bringing together members from all segments of the U.S. healthcare industry to address the most pressing supply chain issues 2010 and 2012 Sunrise Dates To accelerate wide-scale adoption of GS1 Standards, "sunrise" dates were established by the industry: 2010 for location identification (Global Location Number – GLN) 2012 for product identification (Global Trade Item Number – GTIN)

healthcare 2015 Readiness and FDA Track and Trace Initiatives
Programs / Initiatives (CONT.) 2015 Readiness and FDA Track and Trace Initiatives GS1 Healthcare US works with members of the U.S. pharmaceutical industry to help prepare companies for product serialization, state drug pedigree requirements, and FDA track and trace initiatives using GS1 Standards. FDA Unique Device Identification (UDI) for Medical Devices The proposed FDA UDI regulation aims to transform disparate medical identification methods into a standardized system. The GS1 GTIN provides the foundation for companies to meet these requirements.

2008 – 2012 Accomplishments 418 Articles Published
2008 – 11; 2009 – 64; 2010 – 144; 2011 – 108; 2012 – 91 70 Industry Press Releases 388 Association Communications 2008 – 20; 2009 – 30; 2010 – 96; 2011 – 132; 2012 – 110 117 Webinars with 4,057 Attendees 2008 – 200; 2009 – 952; 2010 – 1,517; 2011 – 804; 2012 – 584 1975 Hours of Workgroup Sessions (3,000+ Man Hours) 152 Speaking Engagements 75 New Tools/Resources O:\GS1 Healthcare US\GS1HCUS Leadership Team\Presentation Library\GS1HCUS Forums\San Antonio Jul 77

2008 – 2012 Accomplishments 13 Surveys 11 Case Studies
19,000+ Views of the Healthcare Provider & Supplier Tool Kits 8 Conference Presentations of the “Standardization…Stat!” Video 3 New Healthcare Standards: AIDC Application Standards for Healthcare GDSN Healthcare Attributes Global Traceability Standard for Healthcare O:\GS1 Healthcare US\GS1HCUS Leadership Team\Presentation Library\GS1HCUS Forums\San Antonio Jul 78

New McKinsey & Company report quantifies supply chain issues in Healthcare
New McKinsey report “Strength in unity: The promise of global standards in healthcare” Highlights the cost savings and patient safety benefits of adopting a single global supply chain standard in healthcare Available at: Source:

Tool Kits: GLN, GTIN, and GDSN
Introduction to the Standards Implementation Steps Lessons Learned Benefits to Healthcare Providers ROI Hot Spots FAQs For Healthcare Providers For Healthcare Suppliers 80 80

Tools & Resources Industry Use Cases
CDC Case Study Better Immunization Management for Patient Safety Mercy / BD Case Study Perfect Order and Beyond Intermountain Healthcare GLN Success Story STERIS Corporation Success Story Right Products to the Right Places at the Right Times BJC HealthCare GS1 Standards Implementation Print Media GLN Success Story Mayo Clinic / Cardinal Health GLN Implementation White Paper Available on the GS1 Healthcare US website at Awareness Video: Standardization…Stat Developed the industry to create awareness, at all organizational levels, on the need for standards adoption and the industry-wide implementation initiative Available at

Educational opportunities 2013
Educational Information available at: Live Webinars: GS1 Healthcare US “Ask the Expert” Monthly Webinar Traceability Adoption Open Industry Call On-Demand Webinars: Foundational Sessions (9) GLN & GTIN Focused Sessions (8) New! GDSN Series Healthcare Workshops: April 11-12, 2013: Washington, DC 2015 Readiness Workshops: Lawrenceville, NJ April 17, 2013 May 22, 2013 June 19, 2013

CEUs AHRMM CEUs: Attendees may earn 1.0 Contact Hours toward CMRP Certification or .1 Continuing Education Units for this session. Distributed upon request. To request AHRMM CEUs for this session, please IAHCSMM CEUs: Attendees may earn 1.0 Contact Hours for this session. To request IAHCSMM CEUs for this session, please

Contact information GS1 HEALTHCARE US WEB Connect with the GS1 US community on:

Improving Patient Safety and Supply Chain Efficiency with Data Standards: The basics of GS1 Standards in healthcare Jean Sargent, CMRP, FAHRMM Director,

Similar presentations

Presentation on theme: "Improving Patient Safety and Supply Chain Efficiency with Data Standards: The basics of GS1 Standards in healthcare Jean Sargent, CMRP, FAHRMM Director,"— Presentation transcript:

Similar presentations

About project

Feedback

Log in

Auth with social network:

Improving Patient Safety and Supply Chain Efficiency with Data Standards: The basics of GS1 Standards in healthcare Jean Sargent, CMRP, FAHRMM Director,

Similar presentations

Presentation on theme: "Improving Patient Safety and Supply Chain Efficiency with Data Standards: The basics of GS1 Standards in healthcare Jean Sargent, CMRP, FAHRMM Director,"— Presentation transcript:

Similar presentations

About project

Feedback