Jean Sargent, CMRP, FAHRMM - As most of you are aware, healthcare is lacking consistent supply chain standards with regard to labeling all supplies, including pharmaceuticals, medical equipment and instruments. In most cases, we cannot scan the bar code on the package or product and accept that information into our systems. That is what the GS1 standards initiative is about – getting to the same point where retail is in terms of bar code scanning, with the ability to perform quick and efficient product recalls.

The StandardsGS1 barcodes

GS1 is a not-for-profit, global organization responsible for the development of global data standards, called the GS1 System. GS1 US is responsible for standards implementation in the US. GS1 has been in business for more than 35 years, with more than one million member companies worldwide. More than 6 billion transactions a day are processed using the GS1 System. For example, look at the bar code (U.P.C.) on the soda or water bottle you have on your desk. Chances are that is a GS1 bar code. Many retail entities require the use of GS1 standards from their suppliers to facilitate more efficient business practices. GS1 has a global healthcare group of industry members (GS1 Healthcare) dedicated to the development and refinement of standards for use in healthcare. GS1 Healthcare US works with industry members on the implementation of standards specifically related to healthcare in the US.

GS1 Healthcare US is working toward the five rights: right patient, right drug/device, right time, right dose, right route, all in the pursuit of effective/efficient supply chain and patient safety. Healthcare has a need to standardize the electronic vocabulary, which will enable traceability of a product from manufacturer to distributor to provider to point of use to patient to medical record and, finally, to insurance (including Medicare) for payment. In order to gain optimal performance and return, each part of this healthcare information chain must be involved.

Healthcare Supply Chain Efficiency Puzzle

There are several pieces to this puzzle. The first is the Global Location Number (GLN), which will replace account numbers for the providers, manufacturers and distributors.

Today, providers have a single manufacturer listed in the vendor master multiple times. This duplication occurs when someone cannot determine the correct vendor number, and then they add another. The manufacturers have the providers listed multiple times -- also using the manufacturers account numbers, the distributors account numbers, and the GPO account numbers all for the same address. Use of GLNs will streamline the ordering/invoicing/payment process for all by requiring every entity to use one standard number, the GLN.

The next puzzle piece is the Global Trade Item Number (GTIN), the data structure in the bar code uniquely identifying the individual product. The GTIN may be encoded in a linear bar code (U.P.C. or GS1-128), a 2D bar code (GS1 DataMatrix) or an EPC/RFID tag. The bar code will be used by the provider to scan the item at point of receipt, and point of use with the patient armband at bedside. Or in the case of instruments, the specific instruments will be associated with the patient.

Next, is the Global Data Synchronization Network is the (GDSN), which is a synchronized data network [accessible by the entire supply chain] that will be responsible for transmitting updated standardized product information from the manufacturer to many providers at the same time.

Today, notification of new items or changes to items occur haphazardly through spreadsheets or other forms of paper, which then has to be key-entered into the materials system.This manual entry is where many mistakes are introduced. Accepting the product data electronically in a standardized manner will remove non-productive time for all the healthcare supply chain participants, not only the caregivers.

One of the main benefits I see in the implementation of GS1 standards will be the ability to receive an electronic recall to only those providers who actually received the product. Many countless hours are spent by the manufacturers sending out notifications to providers, then the providers and distributors searching for products that may never have been received -- or may have been received and used without tracing the product to the patient. This benefit is definitely a patient safety boost.

Regulation

By they way, Congress passed a bill in September 2007 mandating that the Food and Drug Administration (FDA) develop a standardized method to track all medical device products from manufacturer to the patient and through payment. The nomenclature being used by the FDA is Unique Device Identifier (UDI). The FDA has been working on developing the guidance document and it is believed that the draft regulation is due to be posted for comment in Spring 2010, with a 6-9 month response period, followed by enactment.

It is unfortunate that healthcare did not respond prior to the government becoming involved. However, as the FDA is working closely with standards organizations, manufacturers, distributors, providers, and software developers, I am confident that the regulation will not be as intrusive as one might expect.

The implementation of standards will change healthcare supply chain as we know it. I am very excited to say that I am involved with the organizations that will implement these changes. Years from now, when standards are routine in healthcare, we can say we were a part of changing our own history, and saving money and lives in the process.

For more information, contact GS1Healthcare US at www.gs1us.org/healthcare or the FDA at www.fda.gov/cdrh/ocd/udi

Jean Sargent serves as supply chain director for USC Health Sciences. She is Past President of AHRMM and a member of the GS1 Healthcare US Leadership Team.

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