HUG

HUG Auto-ID Data Work Team - Update

Berlin, 1st Feb 2007

Mark Hoyle, Tyco Healthcare & Mark Walchak, Pfizer

©2006 GS12

GS1 HUG

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.”

©2006 GS13

GS1 HUG

AIDC Data Work TeamProblem Statement…..!

Healthcare Provider

The Patient

The Manufacturer

The Distributors

The Wholesalers

Local AIDC

(S)

(S)

Global AIDC

©2006 GS14

GS1 HUG

( 01) 10312345678903( 10) 200007ABCD( 17) 050727

•Calculated Check Digit•Product Number

•GS1 Company Prefix (Manufacturer ID)•Separator Digit – Always Zero

•Indicator Digit•Application Identifier – GTIN (Global Trade Item Number)

The GTIN – Fixed Information

•Expiry Date•Application Identifier - Expiry Date

•Lot Number•Application Identifier - Lot Number

Other AI’s – Variable InformationLocalised 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.

Globally Unique Product Identification Problem Statement….!

( 01) 10312345678903( 10) 200007ABCD( 17) 050727

AI(10)?AI(01)? AI(02)?

AI(21)?AI(37)?

AI(17)?

©2006 GS15

GS1 HUG

Introduction – Work Teams versus Roadmap

AutoID Data

GTIN Allocation

200820072006

Packaging/Direct Marking Serialisation

Carriers

AIDC Application Standards

“AIDC Application Standards ”AutoID Data Work Team

AutoID Data

©2006 GS16

GS1 HUG

AutoID Data

Serialisation

Carriers

AIDC Application Standards

Business & Data Reqmt’s*

Application

Standard

AIDC Data Work TeamDeliverables

* Final report

©2006 GS17

GS1 HUG

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

• Australia

• Austria

• Canada

• China

• France

• Hong Kong

• Hungary

• Italy

• Japan

• New Zealand

• Spain

• Switzerland

• UK

• USA

©2006 GS18

GS1 HUG

Review Mission & Vision

Establish Team

Approve Objective & Scope

Approve Business Requirements

Approve Data Requirements

Submit Final Report

Sept Oct Nov Dec Jan Feb Mar Apr

AIDC Data Work TeamProject Plan

physical meetingskey

task scheduled task complete

2006 2007

Paris Philadelphia Berlin

©2006 GS19

GS1 HUG

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.

©2006 GS110

GS1 HUG

Mfg Item Case Pallets Trucks Distributor Trucks Pallets Case Item Hospital Mfg Item Case Pallets Trucks Distributor Trucks Pallets Case Item Hospital UserUser

212345 6789072 212345 6789072

212345 6789072 212345 6789072

Scope Supply Chain Illustration – Packaging/Direct Marking

FinishedGoods

ToEnd of

Treatment

Looking for Common Ground

Care FacilityManufacturing Distribution

These are the boundariesFrom: Finished Goods To: End of Treatment

©2006 GS111

GS1 HUG

AIDC Data Work TeamBusiness Requirements

For this task the work team has:

1.Gathered Business Requirements

2.Compiled and Condensed

3.Agree upon Content (team consensus)

Next Steps:

The approved business requirements will be used to establish the DATA requirements.

©2006 GS112

GS1 HUG

Established Sub TeamsBy Product Areas

Product Area Sub-Lead

*Vaccines Peter Tomicki

*Biologicals

*Therapeutic nutritional

Pharmaceutical Mark Walchak / India Hardy

Medical Devices Mark Hoyle

Instruments Volker Zeinar

Implants Gunther Lamparter

©2006 GS113

GS1 HUG

AIDC Data Work TeamBusiness Requirements Cont….

• Hospital Survey

• VA Hospital

• Input by individuals

©2006 GS114

GS1 HUG

AIDC Data Work TeamBusiness Requirements

©2006 GS115

GS1 HUG

OUR METHODOLOGY

CREATE MASTER LIST

KEY WORD GROUPING

3 PASS ANALYSIS

ROLE GROUPING

SUB TEAM AND OUT REACH LISTS

©2006 GS116

GS1 HUG

3 Pass Analysis

GOOD & APPROVED BY CONCENSUS

OUT OF SCOPE – MOVE TO PARKING LOT

NEEDS ADDITIONAL WORK

©2006 GS117

GS1 HUG

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

©2006 GS118

GS1 HUG

QUESTIONS ?