ISBT 128 Labeling Overview. Fran Rabe University of Minnesota Molecular and Cellular Therapeutics

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1 ISBT 128 Labeling Overview Fran Rabe University of Minnesota Molecular and Cellular Therapeutics

2 ICCBBA u Not for profit organization u Formally: International Council for Commonality in Blood Banking Automation u Develops and manages ISBT 128 Standard - working in conjunction with professional groups and technical experts - group developed in 2005 u Is not an enforcing agency or group

3 Cellular Therapy Coding and Labeling Advisory Group CTCLAG Representation AABB American Society for Blood and Marrow Transplantation (ASBMT( ASBMT) American Society for Apheresis (ASFA)( European Group for Blood and Marrow Transplantation (EBMT( EBMT) Foundation for the Accreditation of Cellular Therapy (FACT( FACT) ICCBBA International Society of Blood Transfusion (ISBT( ISBT) International Society for Cellular Therapy (ISCT( ISCT) ISCT Europe Joint Accreditation Committee of ISCT and EBMT (JACIE) National Marrow Donor Program (NMDP( NMDP) World Marrow Donor Association (WMDA( WMDA)

4 ICCBBA Mission Define terminology uencode information ucreate/manage common database udesign label

5 ISBT Labeling u International standard for the labeling of (blood, tissue, cellular) products developed: - common terminology product describers product composition - consistent product codes - consistent label lay-out - independent to delivery systems linear bar code, 2 dimension - consistent information btwn.. eye and electronic

6 Key Concepts u Standard label is 100 mm by 100 mm Divided into 4 quadrants - Designed to allow flexibility in labeling process - Base label applied by manufacturer u Final label is applied during intermediate phase of manufacture (in case where product is shipped from one facility to another

7 ISBT 128 Label Divided into Quadrants 1 st Quadrant 2 nd Quadrant 3 rd Quadrant 4 th Quadrant

8 Example of ISBT-128 Label for HPC, Apheresis Product 1 st Quadrant DIN W1234 = facility (W = US) 06 = year = sequential number vertical # = process control code Last character = check digit ABO/Rh Bar Code with eye readable If Collection date is required, date and time format Warning Statements will be defined by US Labeling Standards when available 3 rd Quadrant PC ICCBBA assigns code Barcode with eye readable S = prefix for HPC products Standard Language for storage and anticoagulant Name and location of Processing facility if different from Collection facility Special Use & Biohazardous warnings Testing Information to be set by US Stds If Expiration date is required, date & time format Recipient Information dependent of type of donation

9 Encoded Information Unique identifier Manufacture/Registry Product description Donation type Special warnings Collection date/time Expiration date/time Patient identifier

10 Understanding the Donation Identification Number (DIN) u The DIN is specific to the donation/product/unit u Remains the same for all products collected from donor during one collection u Different DINs for different collections u Not the same as Donor Number (or local identification #)

11 W D u W0000 = Identifies facility (assigned by ICCBBA) u 06 = Year of collection u = Serial number associated with collection u Flags printed vertically for Process Control u D = Checksum digit generated by computer based on the DIN & is use to verify manual entry of DIN 00

12 Understanding the Product Code (PC) Product Code Criteria/Description Based on: u ICCBBA standards and is assigned according to the ICCBBA database S1128V00: S = Class of product (HPC) 1128 = Unique code that identifies class, attribute, modifier and product/additives as assigned by ICCBBA V = Donor type, V for Volunteer donor 00 = Unique identifier between bags - 00 is default where only 1 bag is collected - A0 is used for 1st bag, B0 for 2nd bag

13 Example Label Autologous HPC, Apheresis

14 ISBT 128 HPC, Cord Blood Label

15 Why ISBT 128 Labeling? u Emphasized quality and safety u Need for tracking and traceability of a specific unit of cellular products The ISBT 128 terminology & labeling standards are international and provide u A uniform data structure u Labeling guidelines that facilitate proper understanding of the content of the unit across language barriers u Identification information that can help in tracing and tracking the specific unit of cellular product u Minimize clerical reading and transcribing errors u Anticipating regulatory requirement of bar-coding cellular products

16 Benefits of ISBT 128 uprovided standardized easy-to to-read labels that included the requirements of the regulations and standards u Eliminated handwritten labeling information that could lead to identification and labeling errors u Use on-demand printer to ISBT 128 label product units.

17 ISBT Challenges u Determine if existing hardware and software can handle ISBT 128 barcode for data recording and labeling u Upgrade hardware and software ($) u Revise your existing procedures to use ISBT 128 labeling standards and to capture the data according to the Standards uvalidate systems and procedures u Provide training to staff

18 What Next? u Await US consensus standards for labels Confidentiality issues remain to be resolved u Should be finalized within the next month u ISBT 128 depends on incorporation with profession association standards for successful implementation u Where do the Agency Regulators stand today?

19 ISBT 128/ ICCBBA Information u

20 Fran Rabe University of Minnesota Molecular and Cellular Therapeutics Go Gophers!

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