Implementation of the ISBT 128 coding system in stem cell transplantation programmes
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1 Implementation of the ISBT 128 coding system in stem cell transplantation programmes Jessy Lardon ZNA Stuivenberg Antwerp
2 JACIE requirements JACIE 5th edition: Cellular therapy products shall be identified according to the proper name of the product, including appropriate modifiers and attributes, as defined in ISBT 128 Standard Terminology for Blood, Cellular Therapy, and Tissue Product Descriptions. implementation plan JACIE 6th edition: Cellular therapy products shall be identified according to the proper name of the product, including appropriate modifiers and attributes, as defined in ISBT 128 Standard Terminology for Blood, Cellular Therapy, and Tissue Product Descriptions (Standard D7.1.1) If coding and labeling technologies have not been implemented, the Processing Facility shall be actively implementing ISBT 128 (Standard D7.1.2)
3 JACIE requirements Standard D7.1.2: Evidence Organizations must, minimally, demonstrate a clearly documented infrastructure including: 1. Registration with ICCBBA. 2. Identification or creation of appropriate product codes. 3. Label designs according to the requirements of ICCBBA for Cellular Therapy Products. 4. Label validation. 5. Use of scanned information at the time products are released from collection, received into the laboratory, and at distribution from the processing facility.
4 Minimum Requirements for ISBT 128 Labels 1. Electronically readable Donation Identification Number (DIN). If a 2-D label is used, both the DIN and the Product Code shall be electronically-readable 2. eye readable Donation Identification Number, flag characters when required (rotated 90 clockwise), and the boxed manual check character. 3. eye readable Product Code (Product Description Code, Donation Type Code and Division Code) 4. The product Class name + requirements JACIE standard and local regulations
5 a 100 mm by 100 mm label four equal 50 (+/-1) mm by 50 (+/-1) mm quadrants Bar codes for Data Structures 001 (Donation Identification Number) 002 (ABO and RhD Blood Groups, when known) 003 (Product Code) 005 (Expiration Date and Time), when applicable (strongly recommended) Required Bar Codes 1 Donation Identification Number 2 Blood Groups [ABO and RhD] 3 Product Code Recommended Bar Code 4 Expiration Date and Time (when applicable) Optional Bar Codes and Symbols 5 Collection (or Production) Date andtime 6 2-D bar code with all 5 data structures
6
7 Label for autologous HPC, Apheresis - cryopreserved donor identification number + bar code ABO and RhD blood group + barcode collection date + time product class + attribute expiration date + time Missing: - Product code + proper name/attributes - barcodes for dates - correct position intended recipient information
8 Product Name and Code Class: cells, comma, source of cells HPC, APHERESIS HPC, CORD BLOOD HPC, MARROW CONCURRENT PLASMA, APHERESIS T CELLS, APHERESIS Attributes Core conditions anticoagulant nominal volume storage temperature ex: Citrate/XX/<=-150C
9 Attributes Groups and Variables Intended Use Manipulation Preparation - Cryoprotectant Preparation Blood Component from Third Party Donor Preparation Other Additives Genetically Modified Irradiation Modification Mobilization Pooled Single Donor Cultured Enrichment Reduction default variable for each group
10 Attributes Groups and Variables Intended Use default variable: For administration Manipulation default variable: Not specified Preparation - Cryoprotectant default variable: No cryoprotectant Preparation Blood Component from Third Party Donor default variable: 3 rd Party Comp:No Preparation Other Additives default variable: Other Additives:No Genetically Modified default variable: Genetically Modified:No Irradiation default variable: Irradiation:No Modification default variable: Not specified Mobilization default variable: Not specified Pooled Single Donor default variable: Not specified Cultured default variable: Cultured:No Enrichment default variable: Not specified Reduction default variable: Not specified
11 ISBT 128 data structure for the Product Code is: =<αooootds where - =<: data identifier for Product Code (barcode) - αoooo: Product description code - t: specifies type of donation - ds: information about unit divided
12 Product description code αoooo α = S for cellular therapy product describes the product: class attributes: core conditions groups and variables Examples: S1128: HPC, APHERESIS Citrate/XX/refg Mobilized S2081: T CELLS, APHERESIS Citrate/XX/<=-150C 6% HES + 5% DMSO 3rd Party Comp:Yes Cryopreserved
13 How to find the correct Product Description Code? Product Look Up program download via ICCBBA website full list of product description codes : in the ISBT 128 database on the ICCBBA website New code: Product Description Code Request Form - Cellular Therapy
14 Donation Identification number =αppppyynnnnnnff αpppp: FIN (facility identification number) yy: last 2 digits of year nnnnnn: sequence number ff: flag characters (not used = 00) via Quick K Calculator program (ICCBBA website)
15
16 ABO and RhD Blood group =%ggre gg cfr. table re 00 if no information about phenotypes
17 Barcode text for dates data identifier: differs per barcode type Example: Expiration Date and Time : &> cyyjjj (date) or cyyjjjhhmm (date and time) Example: Expiration Date and Time: c: the century of the year in which the product expires yy the year within the century in which the product expires jjj: the ordinal (Julian) date on which the product expires hh: the hour at which the product expires (00 to 23) mm: the minute at which the product expires (00 to 59) 05NOV : Barcode text : &>
18 Position of bar codes and text
19 Label for autologous HPC, Apheresis - cryopreserved software: IdentiLab printer: Brady BP-1344
20 Other examples: Labelling containers smaller than 100 mm by 100 mm S1152 = HPC, MARROW Heparin/XX/rt S1142 = HPC, APHERESIS Citrate+Heparin/XX/<=-150C 6% HES + 5% DMSO Cryopreserved Mobilized
21 "S1539" = HPC, CORD BLOOD Citrate/XX/<=-150C 10% DMSO 3rd Party Comp:Yes Cryopreserved "S1584" = HPC, CORD BLOOD Citrate/XX/<=-150C 10% DMSO Cryopreserved Cryo Vial Label S1142 = HPC, APHERESIS Citrate+Heparin/XX/<=- 150C 6% HES + 5% DMSO Cryopreserved Mobilized
22 Usefull ICCBBA documents access to documents after registration ISBT 128 Standard - Standard Terminology for Blood, Cellular Therapy, and Tissue Product Descriptions ISBT 128 Standard - Technical Specification ISBT 128 Standard - Labeling of Cellular Therapy Products Implementation guide - Use of the Product Code [Data Structure 003] Cellular Therapy Technical bulletin - Use of Flags in the Donation Identification Number for Process Control of Critical Points during Processing and Distribution
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