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Traceability Issues

A European Coding System for Tissues and Cells Presented by Ruth Warwick on behalf of S Poniatowski, M Reynolds, E Trias, R Warwick Project Group of CEN ISSS Workshop. Traceability Issues. Hundreds of Tissues from a single donation 7-8 organs Tissue engineered products

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Traceability Issues

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  1. A European Coding System for Tissues and CellsPresented by Ruth Warwick on behalf of S Poniatowski, M Reynolds, E Trias, R Warwick Project Group of CEN ISSS Workshop

  2. Traceability Issues • Hundreds of Tissues from a single donation • 7-8 organs • Tissue engineered products • International sharing of substances of human origin • Risk of disease transmission is not zero • Adverse events/reactions – surveillance • Recovered, processing & applied in different countries • National Biovigilance models • Fast and Efficient Communication

  3. The Challenge of the Cross-border Era Bone Recall • Oral surgeon • Lost his license to practice • BTS to obtain and sell tissues • New York cadavers • No family consent • Nearly 1,000 bodies • > 20,000 recipients • US, Canada, Europe, Japan & elsewhere • Bones, skin, arterial valves, ligaments and tendons 2006 - bone from U.S. tissue bank recalled by FDA 2008 - Michael Mastromarino prison 18 - 54 years

  4. Airedale General Hospital, Keighley BUPA Hartswood Hospital, Brentwood BUPA Hospital, Cardiff Derriford Hospital, Plymouth Doncaster Royal Infirmary, Doncaster Guy's Hospital, London Llandough Hospital, Mayday University Hospital, Croydon North London Nuffield Hospital, Enfield North Staffordshire Royal Infirmary, Stoke-on-Trent Northern General Hospital, Sheffield Northwick Park and St Marks Hospital, Harrow Parkside Hospital, Wimbledon Royal London Hospital Royal National Orthopaedic Hospital, Stanmore Scunthorpe General Hospital Somerset Nuffield Hospital, Taunton Southend Hospital St George's Hospital, London Taunton & Somerset Hospital, Taunton Torbay Hospital University Hospital of Wales, Cardiff Warrington Hospital Wellington Hospital, London Wessex Nuffield Hospital, Eastleigh

  5. Global nature of transplantation EU HPC import and export by country, demonstrating the impact on patients of inability to import and export effectively both internally within the EU and externally from outside the EU

  6. Obligations & Requirements for EU CEN Workshop Traceability Coding

  7. CEN/ISSS Workshop, Coding of Information & Traceability of Human Tissues & Cells,April 2007 - March 2008 • Identify how standardization could play a role in fostering effective implementation of the 2004/23/EC requirements for coding of information and traceability of human tissues and cells • Propose guidelines and recommendations for implementation of the EC Coding system • The CWA, proposals and recommendations will be submitted to the EC and to Committee of MS. • Could progress towards a European Standard or an International Standard and/or additional Workshop activities may be undertaken at later stages.

  8. Traceability Robust Coding Robust Records Robust Traceability + =

  9. Collisions

  10. Unique identification • ‘Uniqueness’ underpins Traceability. • ID numbers - no conflict with other systems: '=' at the start of the donation number identifies ISBT 128 - GS1 international bar-coding standards. • If many tissues donated by the same donor and processed by different TEs, the donation code used by the TE must identify the single donation event. • Unique identification for traceability is a combination of the donation number and the product code plus a new concept – the “key code”.

  11. Definition of a donation & location A deceased donor could: • donate organs through one establishment, • another establishment recovers eyes later • another establishment recovers bone later . 1 or 3 donation events? Multiple donations e.g. cord blood, pancreatic islet may constitute one patient ‘dose’. Multiple donations? – or Multiple establishments? Autologous cells seeded onto donor matrix: • Which is the donation? • Code string extending as the number of establishments extends? Batches, constituent elements, repeat donations, multiple recipients, pooling, secondary processing

  12. What is a coding system? • Classification of information – nomenclature (definitions). • Relate the elements of a data set to those of another set (reference tables): • Structured systems relate concepts (e.g. as a hierarchy – reference tables). • Short means of representing textual information (data structure): • Prevent meaning-shift between languages; • Embodying meaning in a code imposes later constraints. • Human interpretability may be desirable in use too (labelling), but symbology permits computer processing.

  13. Is a coding system a nomenclature? No, but: • A coding system can represent a nomenclature (e.g. of product descriptions); • Nomenclature is a method of assigning (unique) names; • Cells, tissues and organs assigned unique names have the makings of a nomenclature; • Nomenclature based on sound principles may relate to other nomenclatures describing physical properties, preservation, donation information and recipient data; • If designed in a coordinated manner then a data model will have been constructed; • If the names are well related to the structure the information model represents data and process.

  14. What is a coding management system (CMS)? • Manages the relationship between coding and nomenclature: • Ensures codes are assigned appropriately to the agreed concepts - avoids ambiguity as use evolves; • The effectiveness of a CMS is determined by the accuracy of the data model under-pinning the nomenclature and code assignment; • If the data model is inadequate then the ability of the CMS to address change is compromised. • Typically the responsibility of a non-profit organisation with agreement of major stakeholders (e.g. IHTSDO for SNOMED). • Usually a committee with representative overseeing of the organisation governance.

  15. What is a database management system (DBMS)? • DBMS is a software program controlling organisation, storage, management and retrieval of data. • In the current context we have 2 DBMS concepts: • reference tables to describe nomenclature and its codes; • operational database (using the codes from 1) to manage data related to donors, donation(s), donated materials, processing, products, & destination – a traceability system database.

  16. Symbology: delivery system • Most common is readable text! • Subject to language and length problems. • Includes encoding of: • single digits/characters of the message • start and stop markers into bars and space • quiet zone before and after the barcode • computation of a checksum • Various symbologies: Bar coding (linear & 2D), Radio frequency tags (RFID). • Need the barcode scanner output to be interpretable by an information system.

  17. What can a Coding System do? - 1 1 Unique identification - underpins traceability. 2 Represents Product Description, Tissue Establishment and processing information which facilitate: - product exchange; - stock control; - understanding of product for clinicians; - integration of information in hospitals; - analysis of outcome data by type of tissue or its attributes.

  18. What can a Coding System do? - 2 • Overcomes language barriers. • Supports regulatory/ethical control: • The Facility Identification Number provides a 'License Plate‘ - this may help reduce trafficking. • Facilitating Reporting Requirements - TEs and Cas. • Traceability and Biovigilance links: • Link all products relating to a certain donation; • Track donations from a single donor; • Enable analysis of outcomes by type of processing, etc.; • Support communication between differing software systems including software embedded in testing equipment, etc.

  19. The Challenge • Local, National, European, Global • Different sectors have different needs • Regulators v Operators/Professions • EUTCD v Voluntary Accreditation • Large v Small • High Technology v Simple Manual • Coding v Database • Compliance v Complexity • Future developments • Traceability can have its downside • Short term solutions on long term planning • Prior work • Cost • Interface between SOHO

  20. The Principles –Rome Feb 2008, Dr Nanni Costa – CNT Director Italy In Italy as in some other countries it is an absolute requirement for traceability code allocation to be via CAs • Traceabilty must start at the donor, continue to TE and hence to product and patient • Coding systems must not be imposed on MSs but be a recommendation • MSs should be free to adopt or continue systems already developed • Without high level consensus standards do not succeed (MR) • Any option, implementation plan should acknowledge possible phases of transition

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