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HKEH QA Forum 2012. HA Lions Eye Bank. Barcode System on Ocular Transplant Tissue. Galen Chow. 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. Labeling. What is Labeling
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HKEH QA Forum 2012 HA Lions Eye Bank Barcode System on Ocular Transplant Tissue Galen Chow
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
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
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
Previous Workflow Since 1992 Handwritten Label Recovery Preservation Evaluation Distribution Delivery
0001 Potential Risk • Handwriting Error • Mix-up or Mislabeling • Blurred Character • Label Lost Identification Error Wastage Harmful
Risk Management Risk ↓ Computerized Label
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
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’
Schedule Phase II 2D Barcode Pending Phase I 1D Barcode Jan 2012 Phase III RFID Pending
Phase I- 1D Barcode System Implemented in Jan 2012 Self-develop
Computerized Barcode Label • Label paper: waterproof, anti-scratch and anti-freeze • Direct information transfer from Eye Bank Information System
Enhanced Workflow Eye Bank Information System • Data Entry • Tissue No • Donor Info • Output • Barcode Printer • Laser Printer • 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 • Logs • Record • Audit Data Entry Verification
Labels – Ocular Tissues • for cornea • for sclera
Verification Staff Name 1 2 Staff 3.1 Cross Checking 2 Donor Evaluation Tissue Identification Real-time Alert 3.1 3.3 3.2 2 3.2 Info Verification Delivery Notice & Receipt Tissue Label No Pass EBIS Dispatch Yes Next Tissue 3.3 Packing Form Record Receipt one graft at a time
Phase I mini project Benefits Quality Assurance Easy Auditing Cost Effective International Standard Minimize Error Team Spirit ↑
Quality Assurance 1. Logs for Audit – Available 2. Cross Checking & Verification - Available 3. Standardized Procedure 4. Service Enhanced
Planning: Phase II – 2D Barcode System • Eliminate Error • More Information Stored than 1D Barcode • Enhance Identification Process Internal Audit Report (HA 2011)
Planning: Phase II – 2D Barcode System 2D Barcode (Datamatrix) • Tissue No. • Donor Name (English) & ID • Donor Age and Gender
Planning: Phase III – RFID system • 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) RFID Tag (embedded in Label)
Phase I - Limitations Self-Develop Security End-user Enhancement • Simple programs (MS Access) • DataBase limitation • Overloaded • No server • Self maintenance • Tissue • Donor info • EB Internal use only • Not available for receiving party • → QA not completed • Difficult transition into 2D barcode and RFID system • No resources IT Support
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