1. HA Lions Eye Bank Galen Chow HKEH QA Forum 2012

2. HKE QA Forum 2012 Acknowledgements Dr Victoria Wong Ms Janice Wong Ms Jessie Ng Ms Jenny Yeung All the staffs of Eye Bank All eye teams of HA and Private Sector

3. HKE QA Forum 2012 Labeling What is Labeling – A recording system – Handwritten or Computerized What is Barcode – 1D: Encoded data by varying the width and spacing of parallel lines – 2D: Rectangles, dots, hexagons and other geometric patterns represented in two dimensions

4. HKE QA Forum 2012 Background HA – 1D barcode with Unique Patient Identification, in 1999 – 2D barcode system in all hospital, start from 2008 – Radio Frequent Identification (RFID) System, start from 2010 HA Lions Eye Bank – Simple handwritten labeling of ocular transplant tissue over 20 years 0001

5. HKE QA Forum 2012 Previous Workflow Recovery Preservation Evaluation Distribution Delivery Since 1992

6. HKE QA Forum 2012 Potential Risk Handwriting Error Mix-up or Mislabeling Blurred Character Label Lost H a r m f u l W a s t a g e Identification Error 0001

7. HKE QA Forum 2012 Risk Management Computerized Label Risk ↓

8. HKE QA Forum 2012 Why Computerized Label? Risk of Misidentification ↓ Comply with guidelines and standards – Patient Master Index Guidelines (HA) – Guidance for Industry - Current Good Tissue Practices (FDA) 2011 – Medical Standard of Eye Bank Association of America (EBAA) 2011 For Quality Assurance – Audit – Safety and Quality Control Eye Bank Accreditation

9. HKE QA Forum 2012 Proper Labeling for Ocular Transplant Tissue Medical Standards of Eye Bank Association of America (EBAA-J1.000) – Eye Bank name – Tissue identification number – Type of tissue (e.g. cornea, sclera) and preservation medium – Label for pre-cut – Date and time of donor’s death, – Date and time corneal / scleral preservation – Expiration date of tissue – ‘the tissue is intended for single patient application only and that it is not to be considered sterile’

10. Schedule Phase I 1D Barcode Jan 2012 Phase II 2D Barcode Pending Phase III RFID Pending

11. Phase I- 1D Barcode System Implemented in Jan 2012 Self-develop FacilitiesCost (HK$) Barcode Printer4499.00 Barcode Scanner 2347.00 Barcode Label (2cm x 5cm) 480.00 Eye Bank Information System 00.00 Total 7326.00

12. HKE QA Forum 2012 Computerized Barcode Label Label paper: waterproof, anti-scratch and anti-freeze Direct information transfer from Eye Bank Information System

13. RecoveryPreservationEvaluationDistributionDelivery Enhanced Workflow Data Entry Verificatio n Data Entry Tissue No Donor Info Data Entry Tissue No Donor Info Output Barcode Printer Laser Printer Output Barcode Printer Laser Printer Apply to Ocular Tissues Blood Specimens Lab Form Donor Evaluation Form Delivery Notice Packing Apply to Ocular Tissues Blood Specimens Lab Form Donor Evaluation Form Delivery Notice Packing Cross Checking Verification Real-time alert One graft at a time Cross Checking Verification Real-time alert One graft at a time Logs Record Audit Logs Record Audit

14. HKE QA Forum 2012 Labels – Ocular Tissues for cornea for sclera

15. HKE QA Forum 2012 Label - Donor Evaluation Form

16. HKE QA Forum 2012 Label - Delivery Notice

17. HKE QA Forum 2012 Label – Delivery Pack

18. HKE QA Forum 2012 Next Tissue Verification Tissue Label Packing Form Donor Evaluation Delivery Notice & Receipt 2 Staff Cross Checking 1 1 2 2 3.1 3.2 3.3 one graft at a time Staff Name Tissue Identification 2 2 3.1 3.2 3.3 Info Verification EBIS Dispatch Receipt Record Real-time Alert Pass No Yes

19. HKE QA Forum 2012 Cross Checking and Verification

20. HKE QA Forum 2012 Delivery Record

21. mini project Minimize Error Cost Effective Phase I Benefits Team Spirit ↑ Quality Assurance Easy Auditing International Standard

22. Quality Assurance 1. Logs for Audit – Available 2. Cross Checking & Verification - Available 4. Service Enhanced 3. Standardized Procedure

23. HKE QA Forum 2012 Planning: Phase II – 2D Barcode System (a) Eliminate Error (b) More Information Stored than 1D Barcode (c) Enhance Identification Process Internal Audit Report (HA 2011)

24. HKE QA Forum 2012 2D Barcode (Datamatrix) Tissue No. Donor Name (English) & ID Donor Age and Gender Planning: Phase II – 2D Barcode System

25. HKE QA Forum 2012 Planning: Phase III – RFID system RFID Tag (embedded in Label) * Safeguard in tissue stocktaking and tracking –Alarm system to prevent inadvertent moving out of tissues from eye bank –Streamlining stocktaking and real-time tracking: both the number and allocation (GPS)

26. Phase I - Limitations Simple programs (MS Access) DataBase limitation Overloaded No server Self maintenance EB Internal use only Not available for receiving party → QA not completed Difficult transition into 2D barcode and RFID system No resources I T S u p p o r t Tissue Donor info Self- Develop Security End-userEnhancement

27. HKE QA Forum 2012 Reference SOP for Patient Identification and Handling of 2D Barcode Wristband (NTWC 2007) Enhancement of Patient Safety Application of 2D Barcode Technology for Correct Identification (HA 2009) Medical Standard of Eye Bank Association of America 2011 Procedures Manual of Eye Bank Association of America 2011 Guidance for Industry - Current Good Tissue Practices (FDA) 2011 - Labeling Controls KCC Wiser Program and Tools

28. HKE QA Forum 2012 Thanks