Labeling of Cellular Therapy Products

Transcription

1 ISBT 128 Standard Labeling of Cellular Therapy Products Version August 2013 Tracking Number ICCBBA ST-004 Published by: ICCBBA PO Box 11309, San Bernardino, CA USA

2 Labeling of Cellular Therapy Products, v Acknowledgement We wish to thank the members of the Cellular Therapy Coding and Labeling Advisory Group for their contributions in the development of this standard. The members were: Ineke Slaper Cortenbach (Chair) Sallie Allman Boris Calmels Giovanna Cameron William Janssen Mickey Koh Stella Larsson Kathy Loper John Miller Leigh Sims-Poston Sergio Querol Zbigniew Szczepiorkowski Daphne Thijssen-Timmer Phyllis Warkentin Ellen Lazarus, FDA Liaison Safa Karandish, FDA Liaison

3 Labeling of Cellular Therapy Products, v Editor Pat Distler, MS, MT(ASCP)SBB Technical Director, ICCBBA Standards Committee John Armitage, Prof., BSc, PhD Paul Ashford, MSc. CEng. CSci. Wayne Bolton, B.App.Sc., M.App.Sc Suzanne Butch, MA, MT(ASCP)SBB Pat Distler, MS, MT(ASCP)SBB Jørgen Georgsen, MD Suzy Grabowski, BA, BB(ASCP)SBB Mario Muon, MD Stefan Poniatowski, BSc, MIBMS Leigh Sims-Poston, BS, MT(ASCP) Ineke Slaper-Cortenbach, PhD Izabela Uhrynowska-Tyszkiewicz, MD, PhD Ruth Warwick, MB ChB Diane Wilson, BSN, MSN/MHA United Kingdom ICCBBA Australia United States of America ICCBBA Denmark United States of America Portugal Australia United States of America The Netherlands Poland United Kingdom United States of America

4 Labeling of Cellular Therapy Products, v Warranty ICCBBA provides no warranty that the use of ISBT 128 is suitable for any particular purpose and the selection, use, efficiency, and suitability of ISBT 128 is the sole responsibility of the Licensed User. There are no guarantees or warranties attached to this Standard other than that ICCBBA agrees to furnish registered and licensed end-users with the most up-to-date information available. Successful implementation of this Standard, and use of any accompanying database table(s), depend(s) upon the correct incorporation of the rules and table contents into the software used by or provided to the registered and licensed facility. ICCBBA makes no other warranties of any kind, whether expressed or implied, including any implied warranty of merchantability or fitness for any particular purpose. Further information can be found at Liability ICCBBA liability is limited to that specified in the ICCBBA License Agreement which is available on the ICCBBA Website. Under no circumstances shall ICCBBA liability exceed the current annual license fee, and ICCBBA will in no circumstances be liable for any damages whatsoever, including without limitation damages for loss of data, business or goodwill, or any other consequential losses of any nature arising from the use of ISBT 128. ICCBBA manages the ISBT 128 Standard. ICCBBA is not an accrediting organization and is not responsible for adherence to the standard, the selection of Product Codes, or product labeling by facilities registered for its use. COPYRIGHT NOTICE AND LICENSING INFORMATION ISBT 128 is not in the public domain and is protected by law. Implementation of ISBT 128 requires the end-user to register with ICCBBA and to pay an annual license fee. License fees are established by the ICCBBA Board of Directors to cover the expenses of maintaining and extending ISBT 128, and making available current versions of the documents and database tables that are needed to implement this Standard. This Standard is intended for the use of those implementing ISBT 128, regulatory agencies, and software developers and other manufacturers that support end-users. National Guidelines describing the use of ISBT 128 in a particular country may be an additional source of information for the enduser. If such Guidelines exist, they must be consulted because there are options in ISBT 128, and country-specific information pertaining to the particular use of such options, will only be found in such Guidelines. Any use of this Standard, or the accompanying database tables, by other than registered and licensed facilities, or facilities that have obtained their computer software from a registered and licensed developer, is strictly forbidden. Copying any portion of the Standard, or of any accompanying database table, either in electronic or other format, without express written permission from ICCBBA is strictly forbidden. Posting of any portion of the Standard, or of any accompanying database table, to any online service by anyone other than ICCBBA is strictly forbidden.

5 Labeling of Cellular Therapy Products, v Table of Contents 1 Introduction Purpose Scope Intended Audience Normative References Other References Background Changes in This Version Data Structures General Labeling Considerations General Principles Label Size Minimum Requirements for ISBT 128 Labels Other Minimum Label Requirements National Labeling Guidelines Electronically Readable Symbols Bar Code Placement Base Label mm by 100 mm Product Label Partial Labels Text Definitions Data Content Text Donation Identification Number [001] Bar Code Text Facility Blood Groups [ABO and RhD] Product Descriptions Dates Additional Text Label Examples Full 100 mm x 100 mm Label Labeling Containers Smaller than 100 mm by 100 mm Glossary Annex Joint Statement...39

6 Labeling of Cellular Therapy Products, v Figures Figure 1 Minimum ISBT 128 Information...13 Figure 2 Additional Minimum Information Requirements Linear...13 Figure 3 Additional Minimum Information Requirements 2-D...14 Figure 4 Comparison of 2-D and Linear Bar Codes...15 Figure 5 Placement and Nominal Size of Bar Codes on Base Label...17 Figure 6 Placement and Nominal Size of Bar Codes on Final Label...20 Figure 7 Text Terminology...21 Figure 8 Representation of Flag Characters...23 Figure 9 Upper Left Quadrant Facility Bar Code Text...23 Figure 10 Upper Left Quadrant for Matched Unrelated Donor...24 Figure 11 Upper Right Quadrant for Designated or Directed Donation...24 Figure 12 Upper Right Quadrant for Non-Specified Donation...24 Figure 13 Example of Relative Size of Class and Attributes Text...25 Figure 14 Printing of Yes/No Attributes...26 Figure 15 Collection Label...29 Figure 16 Label at Time of Release of Product (Designated)...30 Figure 17 Label at Time of Release of Product (Autologous Biohazard)...30 Figure 18 Label at Time of Release of Product (Autologous, Not Biohazard)...31 Figure 19 Flexible Date and Time...32 Figure mm x 76 mm Final Label (Designated)...33 Figure mm x 76 mm Final Label (Autologous Biohazard)...33 Figure mm x 38 mm Final Label (Designated)...34 Figure mm x 38 mm Final Label (Autologous, Biohazard)...34 Figure 24 Cryo Vial Label...35 Figure 25 Other Small Labels...35 Tables Table 1 Positioning Bar Codes on the Base Labels [RT020]...16 Table 2 Final Label Quadrants and Bar Codes [RT022]...18 Table 3 Required Positioning of Bar Codes on Final Labels [RT032]...19 Table 4 Recommended Positioning of Bar Codes on Final Labels [RT024]...19

7 Labeling of Cellular Therapy Products, v Purpose 1 Introduction This document is intended to help facilities, label vendors, and software developers design appropriate ISBT 128 labels for cellular therapy products. 1.2 Scope This document provides guidance in the design of labels for cellular therapy products following the standards described in the ISBT 128 Standard Technical Specification. Because container sizes for these products vary considerably, only a sampling of possible label designs is provided. This document addresses affixed labels in the ISBT 128 format. It does not address the design of attached labels or accompanying documents. 1.3 Intended Audience The intended audience of this document is staff at facilities of cellular therapy collection and processing centers, as well as the hospitals that receive these products (management, information technology, quality, validation, and laboratory), auditors, software developers, and label vendors. 1.4 Normative References ISBT 128 Standard Technical Specification (ST-001) ISBT 128 Standard Terminology for Blood, Cellular Therapy, and Tissue Product Descriptions (ST-002) ISO Data elements and interchange formats Information interchange Representation of dates and times 1.5 Other References ICCBBA Implementation Guide: Use of Product Code [Data Structure 003] - Cellular Therapy (IG- 022] Implementation Guide: Use of Flexible Date and Time [Data Structure 031] (IG-024) AABB: AABB Standards for Cellular Therapy Product Services (available from AABB at

8 Labeling of Cellular Therapy Products, v AHCTA: Alliance for Harmonization of Cellular Therapy Accreditation (AHCTA) labeling crosswalk FACT: Foundation for the Accreditation of Cellular Therapy (FACT) Standards JACIE: Joint Accreditation Committee of ISCT and EBMT Standards Netcord-FACT Standards WMDA: World Marrow Donor Association (WMDA) Standards Position Paper: Introduction and Importance of a Globally Unique Identity and Labeling Format (ISBT 128) Background A Specification, ISBT 128, for labeling blood products was developed by the International Society of Blood Transfusion Working Party on Automation and Data Processing (WPADP) [now called the Working Party on Information Technology] and published by ICCBBA in Countries around the world are in various stages of implementation, and the model originally developed by the WPADP has demonstrated its suitability by accommodating regional changes without substantial structural change. It was recognized almost immediately that the ISBT 128 Standard would be useful for cellular therapy products as well as blood products. A small number of facilities began using ISBT 128 for these products in the late 1990s. However, greater international standardization in terminology and labeling was needed to allow the use of the Standard to become widespread. This goal was met through the co-operative endeavor of the following organizations: AABB, American Society for Blood and Marrow Transplantation (ASBMT), American Society for Apheresis (ASFA), Asia Pacific Blood and Marrow Transplant (APBMT), European Group for Blood and Marrow Transplantation (EBMT), Foundation for the Accreditation of Cellular Therapy (FACT), ICCBBA, International Society of Blood Transfusion (ISBT), International Society for Cellular Therapy (ISCT), Joint Accreditation Committee of ISCT and EBMT (JACIE), National Marrow Donor Program (NMDP), and the World Marrow Donor Association (WMDA). Representatives from these organizations, as well as additional technical experts and regulatory liaisons, comprise the Cellular Therapy Coding and Labeling Advisory Group (CTCLAG). Through this group, global consensus is reached for the on-going development of terminology and label design for cellular therapy products using the ISBT 128 Standard. See the Annex Joint Statement for a message from these groups in support of ISBT 128.

9 Labeling of Cellular Therapy Products, v Standard terminology will help to ensure a common understanding of product definitions. Use of the ISBT 128 Standard will provide: Unique global identification of cellular therapy products An international reference table for product descriptions Label designs that are consistent worldwide The organizations supporting this standard believe that its adoption will significantly improve the quality, safety, and traceability of cellular therapy products. 1.7 Changes in This Version The following table indicates the major changes between Version and Version Actual changes or additions to requirements of the ISBT 128 Standard are in bold print; changes to formatting or organization, or additional guidance, are in regular print. Section in Version Section in Version Change 1 Throughout Throughout Label examples were updated to reflect new cell therapy nomenclature 2 Throughout Throughout Label examples were updated the term recipient ID or RID instead of Medical Records Number or MRN Added reference to guidance document on Flexible Date and Time [Data Structure 031] Added Class Name as a minimum labeling requirement Added Flexible Date and Time [031] to tables indicating where specific bar codes appear Indicated modifiers are no longer used to describe cellular therapy products Rationale Nomenclature changes are described in 1.6. Recipient ID is a broader description than Medical Record Number and thus covers more situations. This terminology is recommended, not required. New data structure This should be in clear text as well as coded. To support use of the Flexible Date and Time Data Structure. The difference between modifiers was not great and this is in line with how tissues are coded.

10 Labeling of Cellular Therapy Products, v Section in Version Section in Version Change Indicated abbreviations of class name may be used on partial labels if permitted by regulatory authorities. 8 7 Added example label for Flexible Date and Time [Data Structure 031] Rationale Some cellular therapy class names are too long to fit on partial labels New data structure

11 Labeling of Cellular Therapy Products, v Data Structures The data structures that will commonly be used to label cellular therapy products include: Donation Identification Number [Data Structure 001] Blood Groups [ABO and RhD] [Data Structure 002] Product Code [Data Structure 003] Expiration Date and Time [Data Structure 005] Collection Date ]Data Structure 006] or Collection Date and Time [Data Structure 007] Detailed information for all data structures is found in the ISBT 128 Standard Technical Specification.

12 Labeling of Cellular Therapy Products, v General Labeling Considerations 3.1 General Principles There are two general types of labels to consider for cellular therapy products. The base label which is applied by the manufacturer of the container. Product labels that are applied by cellular therapy facilities. Different types of product labels include: o o o o The label at the completion of product collection The label at the completion of processing The label at distribution for administration A partial label, which FACT and JACIE define as The minimum essential elements that must be affixed to all cellular therapy product containers at all times. The partial label, therefore, can either be an in process product label or the label on a product that is ready for administration. The following general principles apply to label design: Primary considerations in label design shall include improving the safety of the product and the efficiency of processing/administering. If these two considerations conflict, safety shall take precedence over efficiency. Critical information on the container shall dominate the label via position and prominence and shall take precedence over information that is of less importance to the end-user (clinician, nurse, laboratory staff, and other hospital personnel). Because of differences in languages and regulations, text that appears on the label, as well as the location of that text, is left to national authorities. However, examples are provided for guidance in determining where text may be placed. Bar code placement is more strictly standardized. 3.2 Label Size The size of an ISBT 128 label for cellular therapy products will vary primarily depending upon the size of the container. Factors such as the amount of information that a facility wants to encode using ISBT 128 data structures, the symbology (linear versus 2-D symbols) chosen to convey machine readable information, the number of languages that may be required for text, and the requirements for other information on the label may influence the size of the label. The ISBT 128 Standard therefore does not specify a particular size of label. However, a 100 mm by 100 mm label is considered a routine label size when the size of the container permits. This allows label stock typically used for blood banks to be used for cellular therapy products.

13 Labeling of Cellular Therapy Products, v Minimum Requirements for ISBT 128 Labels Regardless of the size of the label, the minimum ISBT 128 information content of the label shall be: Electronically readable Donation Identification Number (DIN). If a 2-D label is used, both the DIN and the Product Code shall be electronically-readable. The eye readable Donation Identification Number, flag characters when required (rotated 90 clockwise), and the boxed manual check character. The eye readable Product Code (Product Description Code, Donation Type Code and Division Code). If this text does not appear in conjunction with a bar code (e.g., there is no linear bar code for Product Code or a 2-D symbol is used), the word Product shall precede the Product Code (see Figure 2 and Figure 3). The product Class name. Figure 1 Minimum ISBT 128 Information 3.4 Other Minimum Label Requirements Applicable regulations and standards should be consulted for other minimum requirements for labels (see Section 1.5). Typically, intended recipient information is required. Labeling requirements may vary based on the stage of the product (at completion of collection, at completion of processing, and at distribution for administration). The Alliance for Harmonization of Cellular Therapy Accreditation (AHCTA) has published a convenient table on its Website that outlines the requirements of AABB, FACT, JACIE, WMDA, and Netcord for cellular therapy labels ( This table also summarizes which information must appear on the affixed label versus information that may be included on attached labels or accompanying documents. Figure 2 Additional Minimum Information Requirements Linear

14 Labeling of Cellular Therapy Products, v Figure 3 Additional Minimum Information Requirements 2-D 3.5 National Labeling Guidelines National bodies may publish guidelines for labeling which adhere to the ISBT 128 Standard. ICCBBA maintains on its Websites examples of such national documents. For assistance in creating such national guidelines, or to share a national guideline on the ICCBBA Website, contact the ICCBBA office (tech.director@iccbba.org).

15 Labeling of Cellular Therapy Products, v Electronically Readable Symbols Either linear bar codes (Code 128) or two-dimensional (2-D) symbols (Data Matrix), or both, may be used to label cellular therapy products. 2-D symbols have the advantage of allowing a great deal of information to be encoded into a very small amount of space. See Figure 4. They have the disadvantage of requiring a more modern type of scanner, an imaging scanner, to read them. Imaging scanners may not be widely available in hospitals at the current time. Specifications (quality, dimensions, etc.) for the printing of electronically readable symbols may be found in the ISBT Standard Technical Specification. Figure 4 Comparison of 2-D and Linear Bar Codes

16 Labeling of Cellular Therapy Products, v Base Label 5 Bar Code Placement Where the container is of sufficient size, it should carry a 100 ± 2 mm by 106 ± 2 mm base label. The base label should carry the two manufacturer s information bar codes: the Container Manufacturer and Catalog Number [017] bar code in the lower left quadrant and the Container Lot Number [018] bar code in the lower right quadrant. The recommended position for these bar codes on 100 ± 2 mm by 106 ± 2 mm label is indicated in Table 1 and shown on Figure 5. Table 1 Positioning Bar Codes on the Base Labels [RT020] Bar Code Vertical Alignment Horizontal Alignment 3 mm from bottom of Bar code right edge should Left Quadrant be at 4 mm from right edge [or 9 mm from bottom of Left Quadrant of label] Container Manufacturer and Catalog Number [017] Container Lot Number [018] 3 mm from bottom of Right Quadrant [or 9 mm from bottom of label] Bar code left edge should be at 4 mm from left edge of Right Quadrant

17 Labeling of Cellular Therapy Products, v Figure 5 Placement and Nominal Size of Bar Codes on Base Label 1 2 Manufacturer s Bar Codes 1 Container Manufacturer and Catalog Number 2 Container Lot Number mm by 100 mm Product Label When space permits, the size of the product label is 100 (+/-2) mm by 100 (+/-2) mm. The affixed label may be applied as a single 100 mm x 100 mm label or may be built up with smaller labels applied at different stages during the process. The design shall be based upon the concept of four equal 50 (+/-1) mm by 50 (+/-1) mm quadrants. The bar codes shall be placed in these quadrants as shown in Table 2 on page 18. Bar codes for Data Structures 001 (Donation Identification Number), 002 (ABO and RhD Blood Groups, when known), and 003 (Product Code) shall be present and positioned as described in Table 3, page 18. The bar code for Data Structure 005 (Expiration Date and Time), when applicable, will be as described in Table 3, page 18. This design places these bar codes in an ideal position for concatenation.

18 Labeling of Cellular Therapy Products, v Linear bar codes for other Data Structures found on the final label, and the Data Matrix symbol, should be positioned as described on Table 4, page 19. When present, the Data Matrix symbol shall include the three data structures (DIN, Product Code, and ABO/RhD when known) required for linear bar codes and the Expiration Date and Time data structure when applicable. Any additional ISBT 128 data structures (excluding nationally defined structures) may also be included. Figure 6, page 20, shows a final label printed according to these tables. To assist in label design, if more than one linear bar code is to be placed in a quadrant (e.g., DIN and Collection Date), some adjustment of the absolute position of bar codes other than those for Data Structures 001, 002, 003, and 005 is permissible. Additionally, depending on the amount of text that is required, it may be necessary to reduce bar code height in accordance with bar code height requirements described in the ISBT 128 Standard Technical Specification. Quadrant Table 2 Final Label Quadrants and Bar Codes [RT022] Data Structure [Reference number] Upper Left Donation Identification Number (required) [001] Collection Date and Time (optional) [006, 007] or Production Date and Time (optional) [008, 009] or Flexible Date and Time (optional) [031] encoding Collection or Production Date and Time Lower Left Product Code (required) [003] Upper Right ABO and RhD Blood Group (required) [002] Lower Right Expiration Date and Time [005] or Flexible Date and Time [031] encoding Expiration Date and Time (inclusion of an expiration date bar code is strongly recommended when expiration date is applicable)

19 Labeling of Cellular Therapy Products, v Table 3 Required Positioning of Bar Codes on Final Labels [RT032] Bar Code Vertical Alignment Horizontal Alignment Donation Identification Number [001] Product Code [003] ABO and RhD Blood Groups [002] Expiration Date and Time [005 or 031] 3 mm from top of Upper Left Quadrant 3 mm from top of Lower Left Quadrant 3 mm from top of Upper Right Quadrant 3 mm from top of Lower Right Quadrant Bar code right edge should be 4 mm from right edge of Upper Left Quadrant Bar code right edge should be 4 mm from right edge of Lower Left Quadrant Bar code left edge should be 4 mm from left edge of Upper Right Quadrant Bar code left edge should be 4 mm from left edge of Lower Right Quadrant Table 4 Recommended Positioning of Bar Codes on Final Labels [RT024] While these barcodes shall be placed in the quadrants indicated, their exact placement within the quadrant is not mandated. Bar Code Vertical Alignment Horizontal Alignment Collection Date (and Time ) [006, 007, or 031] or Production date (and Time) [008, 009, or 031] Data Matrix symbol 20 mm from top of Upper Left Quadrant As close to the bottom of the label as practical in the Lower Right Quadrant Bar code right edge should be at 4 mm from right edge of Upper Left Quadrant Not specified.

20 Labeling of Cellular Therapy Products, v Figure 6 Placement and Nominal Size of Bar Codes on Final Label Gray lines marking quadrants are for reference only and should not be printed on the label 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 and Time 6 2-D bar code with all 5 data structures 5.3 Partial Labels When the container size is small, partial labels must be used. The placement of electronically readable information on a partial label will be entirely dependent on the size and shape of the label. For linear labels, the DIN bar code should appear before (above) the Product Code bar code (if present). Because of size constraints, 2-D labels may be preferred. Appropriate regulations and standards should be followed when determining what information will appear on the partial affixed label and what information will be carried on attached labels or accompanying documentation.

21 Labeling of Cellular Therapy Products, v Definitions 6 Text There are three types of text for ISBT 128 labels: Data content text: The eye readable representation of the data characters in a bar code printed left justified immediately below a linear bar code (unless otherwise specified). Data content text is required with all linear bar codes. For 2-D symbols, data content text may only be present for the Donation Identification Number and Product Code. Bar code text: The interpretation of the data content of the bar code. Additional text: All other information on the label that is not associated with a bar code. Figure 7 Text Terminology

22 Labeling of Cellular Therapy Products, v Data Content Text Linear Symbols: Every Code 128 (linear) bar code on a container label shall be accompanied by data content text. Bar code data identifiers shall not appear in the data content text. Except for the DIN (see section 6.2.1), data content text shall appear immediately below, but not touching, the bar code; commence in line with the leftmost bar of the bar code and be represented in sans serif type with a maximum height of 2 mm. 2-D Symbols: While data content text generally is not associated with Data Matrix (2-D) symbols, the DIN and Product Code shall appear in eye-readable text when Data Matrix symbols are used. This is necessary to ensure adequate traceability since a product is uniquely identified based on the DIN and the Product Code. It is therefore essential that this information be available to the receiving facility in a human readable format Donation Identification Number [001] The data content text for a Donation Identification Number is unique in that it is the sole means of presenting the data content of the bar code, i.e., it serves the dual role data content text and bar code text. As bar code text it shall be printed using a sans serif typeface in the Upper Left Quadrant beneath its corresponding bar code. A national authority should determine how it should be displayed, for example: W V All data characters shall be printed (in this instance only, the second data identifier character is also a data character). The flag characters ff may be used to convey specific information other than the unique identification of the product and shall be distinguished from the Donation Identification Number. When Type 1 or Type 2 flag characters are used they shall be printed as either: Numeric Presentation: The two-digit values of flags ff shall be printed rotated 90º clockwise to make them visually different from the Donation Identification Number. Non-numeric Presentation: A graphical icon or other representation of the value of ff, e.g., for flag 07 printing an icon showing a small test tube.

23 Labeling of Cellular Therapy Products, v Figure 8 Representation of Flag Characters 6.3 Bar Code Text Bar code text is the interpretation of the data content of the bar code. Bar code text is nationally defined to allow for differences in language, regulatory requirements, and preferences. Where needed, bar code text may appear in multiple languages on a label. Particular font sizes and types are not specified for bar code text but designers shall ensure clarity of all text and use larger fonts to emphasize critical information. The font chosen should clearly differentiate between similar characters (e.g., O and 0; I and 1). For Latin alphabets proportionally spaced sans serif fonts should be used Facility The name and the address of the facility that corresponds to the Facility Identification Number (FIN) may appear beneath the eye readable DIN. Figure 9 Upper Left Quadrant Facility Bar Code Text In the situation of a Matched, Unrelated Donor where confidentiality of the collection facility is needed, it is recommended by the WMDA ( that the facility name NOT appear in text on the label. See Figure 10. Note: It is also recommended that facilities not publish their FINs on their Websites or other materials in order to keep the link between FIN and facility name less easily discoverable.

24 Labeling of Cellular Therapy Products, v Figure 10 Upper Left Quadrant for Matched Unrelated Donor Blood Groups [ABO and RhD] The ABO and RhD blood groups should be printed beside (Autologous, Directed, or Designated donations) or beneath (donation type not specified such as a public Cord Blood donation) the corresponding bar code in the Upper Right Quadrant. Figure 11 Upper Right Quadrant for Designated or Directed Donation Figure 12 Upper Right Quadrant for Non-Specified Donation

25 Labeling of Cellular Therapy Products, v Product Descriptions On a 100 mm by 100 mm label, product description bar code text shall be in the Lower Left Quadrant beneath its corresponding bar code. It shall be left justified. Class, and Attributes (except default Attributes) bar code text should be printed on the label when space allows. Product description bar code text should be printed with the Attributes proportionally smaller than the Class name. Modifiers are no longer used with cellular therapy products. For facilities that have not moved to the new terminology, the previous version of this document (version 1.0.0) should be consulted for instructions on how to print modifiers. This document is available in the archive section of the ICCBBA website. (ICCBBA webpage, Tech Library, ICCBBA documents, Archived Documents). Figure 13 Example of Relative Size of Class and Attributes Text On smaller labels, the full product description may not fit on the label. The Class shall appear. Abbreviations of class name (described in Standard Terminology for Blood, Cellular Therapy, and Tissue Product Descriptions) may be used on partial labels if space does not permit the full name and if allowed by regulatory authorities. If abbreviations are used, the full class name will be used in the accompanying documentation. If space does not permit, the Attributes may be included on attached labels or accompanying documentation. Where space allows, a phrase such as See Attached Documentation for Details should appear when the Attributes are not printed on the label. Relative size of Class and Attributes should be as described above, if space permits. Two attributes may appear on the same line to conserve space. Some Attribute groups encode only yes/no information. For example: Preparation: Other Additives Group. Default: other additives: NO Other additives: YES Default. No additives other than as part of the anticoagulant solution at the time of collection Other additives. See accompanying paperwork In this situation it would be appropriate to print an interpretation on the label such as, Other Additives Present and See Attached Documentation for Details. See Figure 14, page 26.

26 Labeling of Cellular Therapy Products, v Figure 14 Printing of Yes/No Attributes Dates When bar codes for dates (collection or expiration) are present, bar code text shall be printed in the Upper Left Quadrant for the collection date/time and Lower Right Quadrant for the expiration date/time. When linear bar codes are present, the information shall appear beneath the corresponding linear bar code. If bar codes for dates are not present, text information for collection/date time if present should appear in the Upper Left Quadrant and text information for expiration date/time if present should appear in the Lower Right Quadrant. Dates shall be printed in compliance with ISO extended format ( ) or in the format day month year. If the latter, the day shall be numerical and the month alphabetical, using a three-letter abbreviation. The year shall be a four-digit numerical representation. Times shall be printed based on a twenty-four hour clock with a colon placed between the hours and minutes. 5 JUN :15 or :15 When the default time of 23:59 is encoded, the time does not have to appear as bar code text, although it is acceptable if it does appear.

27 Labeling of Cellular Therapy Products, v JUN 2012 or or 05 JUN :59 or :59 If the product is to be shipped across time zones, AABB, FACT, and JACIE Standards require that the text expiration date and time include the local time zone. In addition, the ISBT 128 Standard requires that the label also include the Coordinated Universal Time (abbreviated UTC, and similar to Greenwich Mean Time, or GMT) when the product is to be shipped across an international time zone. The UTC shall be printed beneath the local time in parentheses with the designation UTC. Italics may also be used to clearly differentiate UTC from local time. For example: Expiration Date/Time: 15 JAN :15 EST (15 JAN :15 UTC) OR :15 EST ( :15 UTC) Note: It is recognized that local time zone designations may have little meaning internationally since two time zones may have the same abbreviation (e.g., CST can be China Standard Time (UTC+08 hours) or Central Standard Time in North America (UTC-06 hours). However, the Cellular Therapy Coding and Advisory Group (CTCLAG) believe that local time zones are more readily interpreted within a continent. For products shipped to different continents, UTC should be used to interpret time. A new date and time data structure, Flexible Date and Time [Data Structure 031] has been added to the ISBT 128 Standard. This data structure allows the UTC to be encoded. With the right software, the local date and time can be calculated from the UTC. See Implementation Guide, Use of Flexible Date and Time [Data Structure 031].

28 Labeling of Cellular Therapy Products, v Additional Text Additional text is defined as text not associated with a bar code. Additional text includes warnings (e.g., Do Not Irradiate) and information such as the name of the intended recipient. In designing their labels, facilities may add additional text to the label where space permits. The placement of this information is not standardized, although examples in Chapter 7 provide some suggestions.

29 Labeling of Cellular Therapy Products, v Label Examples The following labels are provided as examples only. National regulations and appropriate Standards must be consulted to ensure full compliance with requirements. 7.1 Full 100 mm x 100 mm Label Figure 15 Collection Label

30 Labeling of Cellular Therapy Products, v Figure 16 Label at Time of Release of Product (Designated) Figure 17 Label at Time of Release of Product (Autologous Biohazard)

31 Labeling of Cellular Therapy Products, v Figure 18 Label at Time of Release of Product (Autologous, Not Biohazard) Note: This example shows both linear and 2-D bar codes. When space allows, this may be desirable. Linear bar codes are useful if the product is shipped to a facility that does not have imaging scanners; 2-D bar codes are more efficient since all information is entered with a single scan.

32 Labeling of Cellular Therapy Products, v Figure 19 Flexible Date and Time

33 Labeling of Cellular Therapy Products, v Labeling Containers Smaller than 100 mm by 100 mm Figure mm x 76 mm Final Label (Designated) Figure mm x 76 mm Final Label (Autologous Biohazard) Note: With linear bar codes, there was not space to include Attribute text.

34 Labeling of Cellular Therapy Products, v Figure mm x 38 mm Final Label (Designated) Figure mm x 38 mm Final Label (Autologous, Biohazard) Note: With linear bar codes, there was not space to include Attribute text.

35 Labeling of Cellular Therapy Products, v Figure 24 Cryo Vial Label This label is 38 mm wide by 19 mm high. Recipient Identification has been abbreviated RID. Figure 25 Other Small Labels These labels are 50 mm wide by 44 mm high.

36 Labeling of Cellular Therapy Products, v Glossary General Terminology Used in ISBT 128 Coding and Labeling Data Identifier The first two characters in a data structure that identify the data structure. These will always be present when the data structure is used as a bar code, but may be omitted when the data structure is used in situations in which the data structure identity is unambiguously and explicitly defined. (The Donation Identification Number is an exception to this rule. The second character of the data identifier can never be dropped because it is also part of the data content. See ISBT 128 Standard Technical Specification.) Data Content The characters in a data structure that encode the desired message (a Product Code, for example). Data Structure Defined format for information transfer within ISBT 128. The data structure defines the data identifiers, the data content, and the means to encode specific information within the data content. It specifies the context and structure and provides the links to the appropriate reference tables for conversion of codes to meaningful information. Label An independent entity that may carry one or more bar codes and also provides eye-readable information about the product. Affixed Label Attached Label Accompanying Documentation Base Label Final Label Partial Label A label that adheres in physical contact with the product container. A label that is fastened securely to the product container by means of a tie tag or comparable alternative. Documentation containing product information that is together with the product, or is available to the appropriate individual(s) electronically, but is not affixed or attached to the product. The label placed on a container by a manufacturer. It carries the manufacturer s identity, the catalog number of the container (or container set), and the lot number of the container (or container set) encoded as ISBT 128 data structures. Labeling as it appears on a product ready for release to another entity or for administration to a recipient. (A different entity in this context means an institution with different ownership/leadership than the facility that labeled the product.) A label that because of size or other constraints does not contain all the required information.

37 Labeling of Cellular Therapy Products, v Product Label Labeling applied to a product at various stages of processing by cellular therapy facilities. UTC Coordinated Universal Time, similar to GMT (Greenwich Mean Time), marks the starting point of every time zone in the World. UTC does not change based on daylight saving (summer) time; thus, the relationship of local time to UTC changes if daylight saving (summer) time is observed. Terminology Used in Donation Coding Donation Identification Number + Flag Characters + Check Character Donation Identification Number Donation Identification Number (DIN) Facility Identification Number (FIN) DIN Year Code DIN Sequence Number Flag Character A thirteen-character code that identifies products from a single donation event. This identifier allows each donation event to be uniquely identified globally for a period of 100 years. The DIN comprises three elements: the Facility Identification Number (FIN), DIN year code, and DIN sequence number. A five-character alphanumeric code assigned to facilities licensed to use ISBT 128 by ICCBBA. The code provides a globally unique identifier that is an essential element of a Donation Identification Number. A two-character numeric code assigned by the facility that is used to ensure uniqueness of a Donation Identification Number for a period of 100 years. A six-character numeric code assigned by a facility as part of the Donation Identification Number to ensure unique identification of each donation event. A two-character numeric code that is an element of the Donation Identification Number Data Structure. Flag characters can be used to identify the specific instance of a DIN label (e.g. distinguish between the mother and infant sample for a cord blood collection) and may be used to facilitate process control.

38 Labeling of Cellular Therapy Products, v Check Character A character used to ensure the accuracy of the data in a data structure when such data is entered manually via a keyboard. The value is calculated by applying an algorithm to the appropriate data (see ISBT 128 Standard Technical Specification for details). The check character is most often used in association with the Donation Identification Number but may be used with some other ISBT 128 data structures. Terminology Used in Product Coding Product Code S12124A0 Product Description Code Division Code Donation Type Code Product Code Product Description Code Donation Type Code Division Code An eight-character ISBT 128 code that comprises the Product Description Code, a Donation Type Code, and a Division Code. The Product Code makes each product from a collection unique. This is the Data Content for the Product Code Data Structure. A five-character alphanumeric code assigned to each unique product type listed in the ISBT 128 database. A one-character alphanumeric code indicating the type of donation (e.g., autologous, directed, or designated). A two-character code that uniquely identifies multiple products with the same Product Description Code and Donation Identification Number.

39 Labeling of Cellular Therapy Products, v Annex Joint Statement