HA Lions Eye BankGalen Chow

HKEH QA Forum 2012

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

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

HKE QA Forum 2012

BackgroundHA– 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

HKE QA Forum 2012

 Previous Workflow

Recovery Preservation Evaluation Distribution Delivery

Since 1992Since 1992

HKE QA Forum 2012

Potential Risk

• Handwriting Error

• Mix-up or Mislabeling

• Blurred Character

• Label Lost

Harmfu

l Wasta

ge

Identification Error

0001

HKE QA Forum 2012

Risk Management

Computerized LabelComputerized Label

Risk ↓Risk ↓

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

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’

Schedule

Phase I1D Barcode

Jan 2012

Phase I1D Barcode

Jan 2012

Phase II2D Barcode

Pending

Phase II2D Barcode

Pending

Phase IIIRFID

Pending

Phase IIIRFID

Pending

Phase I- 1D Barcode System

• Implemented in Jan 2012• Self-develop

Facilities Cost (HK$)

Barcode Printer 4499.00

Barcode Scanner 2347.00

Barcode Label (2cm x 5cm) 480.00

Eye Bank Information System 00.00

Total 7326.00

HKE QA Forum 2012

Computerized Barcode Label

• Label paper: waterproof, anti-scratch and anti-freeze

• Direct information transfer from Eye Bank Information

System

 Enhanced Workflow

Data Entry

Verification

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

HKE QA Forum 2012

Labels – Ocular Tissues

• for cornea

• for sclera

HKE QA Forum 2012

Label - Donor Evaluation Form

HKE QA Forum 2012

Label - Delivery Notice

HKE QA Forum 2012

Label – Delivery Pack

HKE QA Forum 2012

Next Tissue

Next Tissue

Verification

Tissue Label

Packing Form

Donor Evaluation

Delivery Notice & Receipt

2 Staff

Cross Checking

1

2

3.1

3.2

3.3

one graft at a time

Staff Name

Tissue Identification

2

3.1 3.2 3.3

Info Verification

EBIS Dispatch

ReceiptReceiptRecordRecord

Real-time Alert

PassNo

No

YesYes

HKE QA Forum 2012

Cross Checking and Verification

HKE QA Forum 2012

Delivery Record

mini project

MinimizeError

Cost Effective

Phase IPhase I

BenefitsBenefits

Team

Spirit ↑

Quality AssuranceQuality Assurance

Easy Auditing

International Standard

Quality Assurance

1. Logs for Audit – Available1. Logs for Audit – Available

2. Cross Checking & Verification - Available2. Cross Checking & Verification - Available

4. Service Enhanced4. Service Enhanced

3. Standardized Procedure3. Standardized Procedure

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)

HKE QA Forum 2012

2D Barcode (Datamatrix)• Tissue No.• Donor Name (English) & ID• Donor Age and Gender

Planning: Phase II – 2D Barcode System

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)

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

IT Support

• Tissue• Donor info

Self-DevelopSelf-

Develop SecuritySecurityEnd-userEnd-user EnhancementEnhancement

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

HKE QA Forum 2012

Thanks