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A team aims to establish a global standard for automatic identification of healthcare products to enhance patient safety. They analyze business and data requirements for vaccines, pharmaceuticals, and more.
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HUG Auto-ID Data Work Team - Update Berlin, 1st Feb 2007 Mark Hoyle, Tyco Healthcare & Mark Walchak, Pfizer
AIDC Data Work Team’s Objective “Because there are no Global Application Standards for the Automatic Identification of data related to Healthcare, this team will identify the Business Requirements and Data Requirements to be used for the development of a global standard for the automatic identification of vaccines, biological, pharmaceuticals, therapeutic nutritional products, medical devices, instruments and implants with the goal of improving patient safety.”
AIDC Data Work TeamProblem Statement…..! (S) Healthcare Provider The Wholesalers Global AIDC The Patient Local AIDC The Distributors (S) The Manufacturer
The GTIN – Fixed Information Other AI’s – Variable Information • Application Identifier – GTIN (Global Trade Item Number) • Application Identifier -Lot Number • Indicator Digit • Lot Number • Separator Digit – Always Zero • Application Identifier - Expiry Date • GS1 Company Prefix (Manufacturer ID) • Expiry Date • Product Number • Calculated Check Digit Globally Unique Product IdentificationProblem Statement….! Localised Problem Self Built Systems Requiring Something Different to the Intended Solution Provided by Present and Future Standards. Imposed Limitation rather than Standardising on Data Structure, Data Content and Data Symbology or Carrier. AI(01)? AI(02)? AI(10)? AI(21)? AI(37)? AI(17)?
“AIDC Application Standards ” AutoID Data Work Team AutoID Data Introduction – Work Teams versus Roadmap 2006 2007 2008 GTIN Allocation Carriers AutoID Data Packaging/ Direct Marking Serialisation AIDC Application Standards
AIDC Data Work TeamDeliverables Business & Data Reqmt’s* AutoID Data Carriers Serialisation Application Standard AIDC Application Standards * Final report
AIDC Data Work TeamMembers • Abbott • Aexxdis • Aesculap • Baxter • Behring • B. Braun • Boston Scientific • Celesio • FDA • Pfizer • GSG Northern University Hospitals • Johnson & Johnson • Medtronic • Merck Germany • NHS Chelsea & Westminster • Novartis • Procter & Gamble • Sanofi-Aventis • St. Jude • Tyco Healthcare • Japan • New Zealand • Spain • Switzerland • UK • USA • Australia • Austria • Canada • China • France • Hong Kong • Hungary • Italy
AIDC Data Work TeamProject Plan 2006 2007 Sept Oct Nov Dec Jan Feb Mar Apr Review Mission & Vision Establish Team Approve Objective & Scope Approve Business Requirements Approve Data Requirements Submit Final Report Paris Philadelphia Berlin key physical meetings task scheduled task complete
AIDC Data Work Team’s Scope • The starting point on the supply chain will be at the manufacturer and the point of finished goods, because marking only starts at the point of finishing. Upstream from this point will be out of scope. • Food services will not be included but therapeutic nutritional products will be included. Note: Therapeutic nutrition is defined as “Therapeutic Nutrition business means enteral and parenteral nutrition of products and services to treat patients who require feeding on that specific route because of a specific disease or to prevent a potential disease.” • Adverse events related to data capture shall be considered within scope and used as an input to preparing the deliverable. • Animal healthcare will not be in scope at this time, but input will be considered. • Equipment used to transport patients is out of scope. • A facility’s assets used by a patient such as tables, lights, etc. is out of scope.
Finished Goods To End of Treatment Scope Supply Chain Illustration – Packaging/Direct Marking Manufacturing Distribution Care Facility These are the boundaries From: Finished Goods To: End of Treatment Mfg Item Case Pallets Trucks Distributor Trucks Pallets Case Item Hospital User Looking for Common Ground
AIDC Data Work TeamBusiness Requirements • For this task the work team has: • Gathered Business Requirements • Compiled and Condensed • Agree upon Content (team consensus) • Next Steps: • The approved business requirements will be used to establish the DATA requirements.
AIDC Data Work TeamBusiness Requirements Cont…. • Hospital Survey • VA Hospital • Input by individuals
OUR METHODOLOGY SUB TEAM AND OUT REACH LISTS CREATE MASTER LIST KEY WORD GROUPING ROLE GROUPING 3 PASS ANALYSIS
GOOD & APPROVED BY CONCENSUS OUT OF SCOPE – MOVE TO PARKING LOT NEEDS ADDITIONAL WORK 3 Pass Analysis
NEXT STEPS • Finalise approval of business requirements • Hospital survey analysis • Master list analysis • Start data requirements analysis and recommendations • Leadership team • GS1 Staff • Present recommendations to full team • Existing data available • Gaps • Close gaps • Approve data requirements • Prepare report