Supply Chain Standards – GS1 Sunrise dates approaching rapidly

Are you ready?

The Strategic Marketplace Initiative (SMI) twice announced its support for the GS1 Healthcare US data standards, last year and again earlier this year. Just prior to the GHX Supply Chain Summit a few months back, GHX announced it was launching its certified data pool "GHX Health ConneXion," to provide data in accordance with GS1 standards1 to healthcare trading partners. Meanwhile, Novation recently announced its commitment to use GHX Health ConneXion for clean data for its trading partners. More recently, several meetings and conferences highlighted the momentum building around GS1 data standards use, specifically at the GS1 Healthcare Conference in June and the annual conference of the Association for Healthcare Resource & Materials Management in July.

Following all of these developments and the emphasis on standards leads to the obvious follow-up question, "What do I need to do to get ready?"

Simply following the news does not adequately prepare an organization for the coming changes in standards. Clearly, there is a need for supply chain continuum end-users from manufacturers, distributors, group purchasing organizations and providers to have some level of knowledge as to what the recent escalation in standards development and the clamor for adoption means to their organization.

The theme for the GS1 conference held June 16-18 in Washington was "Raising the bar on patient safety and efficiency." More than 250 people from 22 countries attended this conference that brought together speakers on healthcare data standards from around the world. During this three-day conference, speakers highlighted the growing importance, impacts and benefits of global data standards on supply chain efficiency.

The program focused on accelerating growth and acceptance of GS1 as the standards organization, and use of Global Location Numbers (GLNs) and Global Trade Identification Numbers (GTINs) through the Global Data Synchronization Network (GDSN). These are referred to as the "3Gs" by GS1 Healthcare US and represent the most important elements of the standards adoption process for meeting e-commerce requirements in the global environment. The GS1 approach is visually summarized in the graphic "Building Patient Safety,"(See Figure 1) showing the relationship of standards to healthcare activities. Supply chain efficiency is achieved through the use of the GTINs, GLNs and the GDSN with the pillars representing data capture, e-commerce, electronic health records, asset and equipment tracking and accountability, and traceability.

Figure 1

During the first day of the GS1 conference, the focus was on pharmaceuticals with presentations highlighting the needs for e-pedigrees for manufacturing – especially for pharmaceuticals – and FDA Unique Device Indicator (UDI) and comparable activities in the European Union. The need for data standards for pharmaceutical e-pedigrees has been fostered by the growth in counterfeit drugs that frequently look like the real product, but are imposters. E-pedigrees are based on using data standards to track and document transactions, or the "chain-of-custody," as product moves through the manufacturing process and distributors to the consumer via an authorized pharmacy or clinician cleared to administer or dispense the drug.

Daniel Schultz, M.D., director of the FDA’s Center for Devices and Radiological Health, provided an introductory keynote presentation on the importance of the standards effort. He noted the focus previously was primarily on products "before market" and is shifting now to "post market," emphasizing the needs to develop a single global system for UDIs for all medical products. Speakers that followed Schultz emphasized needs for ensuring a secure pharmaceutical manufacturing and distribution environment. These included Ilisa Bernstein, FDA’s director of pharmacy affairs, and Alan Goldhammer, Ph.D., vice president of scientific and regulatory affairs, the Pharmaceutical Research and Manufacturers of America (PhRMA). A third presentation by Rob Van Exan and Sanofi Pasteur focused on costs and benefits from using bar codes and related data standards for a Canadian vaccine project, highlighted the global nature of the GS1 data standards with our Canadian neighbors.

Jay Crowley – well known for his efforts guiding development of FDA regulations for UDIs to improve patient safety – and Rodolphe Muñoz from the European Commission, spoke on global efforts related to UDIs and the importance of data standards and harmonization. Dr. Muñoz indicated European activities are echoing the development of American UDI regulations for enhancing track and trace capabilities for medical products. All of these efforts were summarized in a panel discussion on pedigree, UDIs and traceability.

The second day of the program focused on activities in the U.S. to enable adoption of GS1 data standards to support healthcare. Speakers highlighted lessons learned from early implementation of GTINs for manufacturing and GLNs for transactions. Speakers included: Joe Dudas, director, supply chain informatics, Mayo Clinic; Dennis Orthman, project director, Strategic Marketplace Initiative; Dennis Black, director, e-Business, BD; and Jean Sargent, director, supply chain management, USC Health Sciences. Their presentations included results of pilot studies and lessons learned about adopting the standards for GLNs, GTINs and the use of the GDSN, and they highlighted the difficulties in healthcare today, due to increasing globalization, need for track-and-trace capabilities and the overarching benefits from e-commerce using data standards to enhance trading efficiencies and supply chain management effectiveness.

In the afternoon of the second day, Ron Bone, McKesson Corp.’s senior vice president, distribution support, talked about the importance of data standards for security and their impact on patient safety as well as Congressmen Buyer’s and Matheson’s bill (H.R. 5839) "Safeguarding America’s Pharmaceuticals Act" to provide uniform federal e-pedigree regulations. He noted standards for efficiency are dependant on use of auto ID, including data matrix, bar codes and radiofrequency identification labeling. Johnson & Johnson’s Michael Rose spoke to key considerations for industry-wide interoperability and broad operational impacts, along with growing regulatory diversity and our dependence of expanding global economy. Finally, Dennis Harrison, president, GS1 Healthcare US, summarized the elements of the "House" (see Figure 1), building on data standards, providing support for informatics solutions, and supporting patient care with safety, security and efficiency.

During the Global Data Synchronization Network (GDSN) discussions, several speakers focused on use of GLN and GTIN standards, and the use of the GDSN as the means of keeping data for GLNs and GTINs "clean" for e-commerce. Covidien’s Corwin Hee commented that a major difficulty is that standards in GDSN cannot be used by current provider IT systems and noted it will be several years for these systems to be capable of using all the GTIN, GLN data and attributes. AdvaMed’s Jeff Secunda highlighted the importance of the database. The UDI needs to be human readable because scanners are not always available, and the key to the database is ownership and governance. Secunda indicated that hospitals aren’t ready because the systems can’t handle the data standards. In addition, there needs to be consensus on the core elements. Organizations should start with a few items as a base and then build the data standards into their systems.

Vish Sankaran, program director for Federal Health Architecture, Office of the National Coordinator for Health Information Technology, spoke on the issues of Health Information Exchange related to pending healthcare reform legislation. In response, Joe Pleasant, Premier Inc.’s Chief Information Officer commented on needs for materials management information systems to pass medical device information to the electronic medical record (EMR) or the electronic health record (EHR), and industry requires these data standards for data sharing and interoperability. Novation’s Dennis Byer, speaking on a subsequent panel, noted that data standards will provide a "win-win" with efficiencies to be gained by manufacturers, distributors, GPOs and providers for such issues as patient safety, medical device recalls and drug error reductions.

There were several other speakers and programs during the GS1 conference. Topics included the use of HL7 standards and use of GS1 standards as a code set for pharmaceuticals (NDCs) and medical devices. Speakers from England and Japan spoke on AutoID labeling (e.g., bar codes or RFID tags) and data capture used for tray-level and individual instrument marking with data matrix labels, laser-etched and sterile process tracking – again with the focus on use of standards to enhance patient safety.

Toward the end of the GS1 Healthcare U.S. conference, programs focused on the issues associated with implementing the GS1 data standards. Discussions included a review of the 40 core product attributes recommended for global implementation and more specificity for the "3Gs."

The Association for Healthcare Resource & Materials Management’s conference theme this year was "Mapping the Future." While the topics presented ranged from strategic planning, finance and purchasing to distribution and clinical contracting, the GS1 data standards were the focus of a pervasive educational track. Several different educational programs on the GS1 standards were presented or repeated so that all conference attendees would have an opportunity to learn more about the standards that have been embraced as a key pathway to the future for AHRMM members.

The programs in the GS1 Data Standards educational track were structured to ensure participants understood the current state of the standards adoption process, the benefits to industry trading partners and the steps to getting started. Central to the track themes were a solid foundation in the "3Gs" – the GTIN, GLN and GDSN. During one of the presentations, speakers emphasized that the GS1 standards are focused on developing a viable "system of data," and not the data carriers, such as bar codes or RFID tags. Further, the GS1 standards provide multiple components that are used in information systems for efficiency. Using GLNs to identify specific locations for manufacturers, distributors and end-use customers and using item numbers (GTINs), and the GDSN for the associated attributes will provide significant benefits to the healthcare industry.

Education sessions highlighted numerous benefits of using the GS1 standards. At the forefront is the ability to enhance patient safety closely followed by improved efficiency in all supply chain management information system activities. The sessions provided a "drill down" into the details of the data structures so that attendees could understand how the parts of the data structures were designed for implementation. The GTIN as defined is a globally unique 14-digit number for items or services. The GTIN information and the accompanying attributes are provided to trading partners via certified data pools to the Global Data Synchronization Network (GDSN). The GTINs are used for product identification in product catalogs, on purchase orders and invoices, in electronic data interchange transaction sets, and are printed on product packaging in human readable formats as well as used in bar codes or electronic product code (EPC) tags. Plans call for the GTINs to be ready for full adoption by 2012.

A GLN is designed to provide specific information about legal entities and physical locations. The GLN is a unique 13-digit number that is designed to be used as a replacement for such data elements as DUNS numbers, phone numbers and store numbers. The GLN is created by a subscriber as a unique reference to a specific location that can be used for all e-commerce activities. During the past couple of years, many of the GPOs have been moving to adopt GLNs for their members by registering them with GS1 Healthcare U.S. This is the first step in implementing the "3Gs" since the GLN provides the identification key to the GDSN for access to the GTINs that the organization uses or wants to purchase. At the conference, speakers noted that a number of GPOs, including Amerinet, Ascension Health, Consorta, Iowa Health Systems, MedAssets, Novation, Premier and Sisters of Mercy/ ROi have purchased GLNs to register all of their members.

During AHRMM, there was considerable discussion among the attendees regarding the "sunrise date of 2010" for GLNs. While it is fairly easy to understand the use of GLNs for e-commerce business transactions between trading partners, what is less clear is how the GLNs are defined and maintained by the "location owners." Mayo Clinic and Cardinal Health Inc. collaborated on a white paper they are offering via the AHRMM website on the process of implementing GLNs and the benefits achieved2. This white paper highlights the accuracy of pricing achieved through GLN implementation. The paper also highlights the need that healthcare organizations may have for several GLNs to be associated with each entity whereas commercial organizations typically only have one or two.

Vance Moore, president, ROi, said that while he and his organization are enthusiastically committed to using the standards, they are constrained by current information systems operational capabilities. ROi is the GPO and support service organization for Sisters of Mercy Health System and handles $560 million in contract purchases annually, making it one of the top 10 medical/surgical product distributors in the country. Moore noted that the wheels are turning but very slowly. The real need is to be able to transact using GLNs and GTINs and when that is achieved, the use of standards will move forward rapidly. Further, GPOs could support development of standard "terms and conditions" for use in GPO contracts.

Consequently, the key question that we all must consider is "how best to move forward with the standards?" Where does the data come from for the e-commerce transactions, and which source is cleaner? The story line is clear, the use of the "3Gs" hold great promise for improved efficiency, enhancing patient care and enabling track and trace to ensure product integrity from manufacture to consumption. While it is all too easy to avoid spending time understanding the issues, as Novation’s Dennis Byer noted during a panel discussion at the GS1 Conference, "The devil is in the details." It is time for all to take some time to ensure you have a basic understanding of the standards and why they have been endorsed as part of a growing movement to support our growing global economies. Sunrise is coming! Will you be ready?

References

1. GHX Health ConneXion data pool, a healthcare-focused data pool certified by GS1’s Global Data Synchronization Network (GDSN). There are several other data pools that are not exclusive to healthcare, including 1Sync used as a data pool by Premier Inc. For more information on these data pools visit http://www.ghx.com, http://www.1sync.org/home.html, and www.gs1.org.

2. White Paper on Mayo Clinic / Cardinal Health GLN Implementation – http://www.ahrmm.org/
ahrmm/ext/standards/files/Mayo_Cardinal_GLN_White_Paper_v11200_May_2009_hr.pdf.