ISBT 128: From the Big Picture to Practical Issues. Pat Distler ICCBBA

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1 ISBT 128: From the Big Picture to Practical Issues Pat Distler ICCBBA

2 Agenda Impact of new terminology to ISBT 128 Product description code database Labeling Resources to help transition to new terminology Global status of ISBT 128 Slide 2

3 Summary of Changes to Terminology August 2013 Classes Some classes given a new name Some classes retired Some classes had no change to names (HPCs and Concurrent Plasma) Modifiers were converted to attributes Some attributes were put into new groups Some new attributes were added Slide 3

4 New Terminology - Classes Consistent format for class names Type of Cells, Source Example: MNC, Apheresis Consistent format for definitions Slide 4

5 New names: Translation from old to new class name (1 to 1 relationship) Old Name TC, Apheresis NC, Adipose Cells NC-MSC WJD TC, Cord Blood TC, Marrow New Name MNC, Apheresis NC, Adipose Tissue MSC, Wharton s Jelly NC, Cord Blood NC, Marrow Slide 5

6 1:1 Translation from old to new class names Product Description Code ( S Code) retained and description changed Product Description Description Code Old S1703 TC-MSC MD None/XX/rt Cultured 3rd Party Comp:Yes Other Additives:Yes Became: New S1703 MSC, MARROW None/XX/rt 3rd Party Comp:Yes Other Additives:Yes Cultured:Yes Slide 6

7 Retired Codes: Not a 1 to1 relationship between old and new names Old Name TC-T CELLS New Name T CELLS, APHERESIS T CELLS, CORD BLOOD T CELLS, MARROW T CELLS, WHOLE BLOOD Slide 7

8 When a1:1 relationship did not exist Old codes retired Still in database so may be used ICCBBA recommends these codes not be used for newly collected products (as soon as feasible for the facility) New codes have been or will be issued ICCBBA proactively replaced the most common codes (T Cells, Apheresis and T Cells, Whole Blood) Many more still need to be requested Users have started the process As of April, 548 new codes have been requested/issued since September 2013 Slide 8

9 Active CT Product Description Codes Jul-08 Jul-09 Jul-10 Jul-11 Jul-12 Jul-13 Apr-14 Slide 9

10 Replaced codes T Cells Old Code Old description New Codes S1218 Cryopreserved TC-T CELLS NS/XX/<=- 120C 10% DMSO S2021 S2022 New Descriptions T CELLS, APHERESIS NS/XX/<=- 120C 10% DMSO Cryopreserved T CELLS, WHOLE BLOOD NS/XX/<=- 120C 10% DMSO Cryopreserved Slide 10

11 Class Names In August 2013, 1972 cell therapy codes in database of which 1122 had already been retired 116 were renamed (14% of active codes) almost half of these were TC, Apheresis to MNC, Apheresis 188 additional codes retired (22% of active codes) 548 class names did not change (HPCs and Concurrent Plasma) (65% of active codes) Slide 11

12 Conversion of Modifiers to Attributes Cryopreserved Mobilized Non-Mobilized Pooled, Single donor Thawed Washed Slide 12

13 Conversion of Modifiers to Attributes By itself, did not require new codes Code Description Formula Old S1194 Cryopreserved HPC, APHERESIS NS/XX/<=- 120C 10% DMSO Became: New S1194 HPC, APHERESIS NS/XX/<=- 120C 10% DMSO Cryopreserved Mob ilized 5SM2 Slide 13

14 Eliminating Modifiers - Labels Old New Slide 14

15 Attribute Changes Changes include: Cultured in its own attribute group Mobilized and non-mobilized explicitly stated as attributes if appropriate and no longer a part of class definitions (primarily HPC, Apheresis and MNC, Apheresis) Divided Manipulation attributes into different groups (Cultured, Enrichment, and Reduction) By themselves would not change the Product Description Code ( S code) Slide 15

16 Break-up of Manipulation Group Old Group: Manipulation New Group: Enrichment Name αβ T cell reduced αβ T/B cell reduced B cell reduced Buffy coat enriched Name Buffy coat enriched CD4 enriched CD34 enriched CD56 enriched Slide 16

17 ISBT 128 Attributes As new groups are added, they are put at the end of the list Attributes appear in database description in the same order that they appear in the list The change to a new group therefore means the order of the attribute in the description changed Slide 17

18 Manipulation Attributes to New Groups Code Description Formula Old S1550 Thawed HPC, MARROW Citrate+Heparin/X X/refg buffy coat enriched 10% DMSO 3rd Party Comp:Yes G3SH2 Became: New S1550 HPC, MARROW Citrate+Heparin /XX/refg 10% DMSO 3rd Party Comp:Yes Thawed buffy coat enriched L2SP2 Slide 18

19 Attribute order on the labels May be national defined Often attributes appear in the same order as in the database Slide 19

20 Moving Attributes - Labels OLD NEW Slide 20

21 Created New Attributes to Support Cell Type, Source Format Old TC-CTL TC-Reg TC-TIL Proposed New T Cells, (Source) and CTL Enriched becomes an attribute T Cells, (Source) and T Reg Enriched becomes an attribute T Cells, (Source) and TIL-enriched becomes an attribute Slide 21

22 Mobilization ISBT 128 Database Name Not specified Mobilized Nonmobilized Definition Mobilization is not specified in the coding. Applies to cells that have been obtained from a donor treated with an agent to increase the concentration of the target cell population(s) Applies to cells that have been obtained from a donor not treated with an agent to increase the concentration of the target cell population(s). Slide 22

23 DOCUMENTS TO READ Slide 23

24 Code Old Description New Description Retire Date S1210 Cryopreserved HPC, CORD BLOOD NS/XX/<=- 120C 10% DMSO 3rd Party Comp:Yes HPC, CORD BLOOD NS/XX/<=- 120C 10% DMSO 3rd Party Comp:Yes Cryopreserved S1211 S1212 S1213 Cryopreserved HPC, CORD BLOOD NS/XX/<=- 120C 5% DMSO 3rd Party Comp:Yes Cryopreserved TC-T CELLS NS/XX/<=- 120C buffy coat enriched 10% DMSO Cryopreserved TC-T CELLS NS/XX/<=- 120C buffy coat enriched 5% DMSO HPC, CORD BLOOD NS/XX/<=- 120C 5% DMSO 3rd Party Comp:Yes Cryopreserved TC-T CELLS NS/XX/<=- 120C 10% DMSO Cryopreserved Buffy coat enriched TC-T CELLS NS/XX/<=- 120C 5% DMSO Cryopreserved Buffy coat enriched Slide AUG AUG 2013

25 Other Resources Action List Strategy (checklist of activities for changing terminology) Validation Strategy (high level plan for validation the changes) Both found on ICCBBA website (go to Subject Area, Cellular Therapy, then click on link: New Cellular Therapy Terminology Available Now! Click here to view the changes. Slide 25

26 Global Status of ISBT 128 Slide 26

27 What is ISBT 128? A well-established terminology, coding, and labeling system designed to provide traceability between donor and recipient for Medical Products of Human Origin (MPHO)* Endorsed by 21 professional societies and accreditation bodies *MPHO: includes organs, tissues, blood, cells, tissue engineering/regenerative medicine products, and milk

29 ICCBBA Non-profit organization that manages the ISBT 128 standard Member of the Eurocet 128 Consortium supporting the Single European Code for Tissues and Cells A nongovernmental organization (NGO) in official relations with the World Health Organization Slide 29

30 WHO organization-wide initiative for medical products of human origin (2013) Consists of three strategies for global governance including global use of ISBT 128 for all MPHO to ensure unique identification, optimal traceability and interoperability between countries and across all MPHO ISBT 128 is the sole global standard for the identification and coding of MPHO World Health Organization website

31 Facilities in 77 Countries are Registered to Use ISBT 128

32 ISBT 128 Provides tools to ensure the traceability link between donor and recipient globally for all medical products of human origin. Slide 32

33 ICCBBA Help Desk: Slide 33

CELLULAR THERAPY QUIZ. Correct answers and rationale

CELLULAR THERAPY QUIZ. Correct answers and rationale CELLULAR THERAPY QUIZ Correct answers and rationale In January 2018, registered cellular therapy (CT) facilities were asked to participate in the quiz to determine the educational needs of the users regarding