Use of the Global Registration Identifier for Donors [Data Structure 037]

Transcription

1 IMPLEMENTATION GUIDE Use of the Global Registration Identifier for Donors [Data Structure 037] Version September 2015 Tracking Number ICCBBA IG-038 Published by: ICCBBA in Collaboration with WMDA PO Box 11309, San Bernardino, CA USA

2 Use of the Global Registration Identifier for Donors, [Data Structure 037], v Warranty Disclaimer and Limitation of Liability ICCBBA provides no representation or warranty that the Licensee s 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 Licensee. ICCBBA s liability is limited to that specified in the ICCBBA License Agreement which is available on the ICCBBA website. Under no circumstances shall ICCBBA s liability to licensee or any third party under any theory or cause of action exceed the current annual license fee payable by the licensee to ICCBBA hereunder, and ICCBBA will in no circumstances be liable for any direct or indirect damages whatsoever, including without limitation special, incidental, consequential, or punitive damages or damages for loss of data, business or goodwill or any other consequential losses of any nature arising from the use of ISBT 128 or the marks. COPYRIGHT NOTICE Copyright 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 Guidance. Any use of this Guideline, or the accompanying database tables, by other than registered organizations, WMDA members, 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.

3 Use of the Global Registration Identifier for Donors, [Data Structure 037], v Contributors The following people served on the committee to develop the GRID. Paul Ashford ICCBBA United Kingdom Ian Britton WMDA United Kingdom Pat Distler ICCBBA United States Felix Bussman WMDA Switzerland Lydia Foeken WMDA The Netherlands Martin Maiers WMDA United States Julia Pingel WMDA Germany Sergio Querol WMDA Spain Editor Pat Distler Technical Expert, ICCBBA

4 Use of the Global Registration Identifier for Donors, [Data Structure 037], v Table of Contents 1 Introduction Purpose Scope Intended Audience Normative References Other References Background Format of the GRID Electronically-Readable Presentation Eye-Readable Presentation Check Character Lookup Tool Calculation of Check Character Usage GRID Assignment Rules Using Current Donor Identifiers within the GRID Using a Cord Blood Donation Identification Number within the GRID Donors who Move to a Different Registry / Merging of Registries Use of GRID on a Product Label Time Line for Implementation Software Developers...17 Figures Figure 1 Eye-Readable Presentation of the GRID... 9 Figure 2 Check Character Lookup Tool Figure 3 Label Example with GRID Figure 4 GRID Structure... 17

5 Use of the Global Registration Identifier for Donors, [Data Structure 037], v Purpose 1 Introduction This document specifies the format and use of the Global Registration Identifier for Donors (GRID), which is represented in ISBT 128 by Data Structure 037. The guidance has been developed jointly by the WMDA and ICCBBA under the terms of a Memorandum of Understanding. The GRID applies to hematopoietic progenitor cell (HPC) donors and potential donors, and to registry listings for cord blood stem cell products. The purpose of the GRID is to: Reduce the risk of misidentification of HPC donors or their donations, or listed cord blood products, due to the lack of global uniqueness of identifiers and Provide a standard machine-readable format for the GRID that can be used by electronic process control systems. Throughout this document where the word shall is used, it represents a requirement; where the word should is used, it represents a recommendation; and where the word may is used, it represents an option. 1.2 Scope This document provides specific guidance in the implementation and on-going use of the GRID. This document also addresses specifications for software developers. It is intended as a supplement to the ISBT 128 Standard Technical Specification (ST-001). 1.3 Intended Audience The intended audience of this document is staff working at unrelated HPC donor registries, outcome registries, donor centers that recruit adult volunteer donors, collection and apheresis centers, cord blood banks, and transplant centers, as well as software developers, label vendors, and other organizations that provide products or services to these facilities. 1.4 Normative References ISBT 128 Standard Technical Specification (ST-001) ISBT 128 Standard Labeling of Cellular Therapy Products (ST-004)

6 Use of the Global Registration Identifier for Donors, [Data Structure 037], v Other References ICCBBA Website ( WMDA Website ( Implementation Guide: Global Registration Identifier for Donors, Issuing Organization Number (IG-039) 1.6 Background Given the global nature of the work done by unrelated hematopoietic progenitor cell donor registries and cord blood banks, a system to uniquely identify potential donors or cord blood products on a global scale was needed. WMDA worked with ICCBBA, in its role as an issuing agency for globally unique identifiers under ISO 15459, to create the needed identifier. A committee with representatives from both WMDA and ICCBBA met to develop a standardized donor identifier in electronic- and human-readable formats. The requirements for the identifier were that it: Be globally unique Be of a fixed length Supports the assignment of a unique donor identifier for unrelated hematopoietic stem cell transplantation Supports the use of existing donor identifiers through a transition period Utilizes a check character to improve quality of manual data entry The committee also identified design characteristics that the identifier must have. These were: Alphanumeric using uppercase alpha characters only (no symbols or punctuation) 4-digit issuing organization number 15-character donor identifier A structure was proposed in October 2014 that met these requirements. Appropriate committees and the Executive Board from WMDA reviewed and approved the proposal. It is believed that the GRID will improve electronic communication, traceability, and accuracy in unambiguously identifying potential donors by standardizing systems of donor identification across the globe. It should be noted that the GRID is very different from the ISBT 128 Donation Identification Number (DIN) and the Donation Identification Segment of the Single European Code, as outlined in Table 1.

7 Use of the Global Registration Identifier for Donors, [Data Structure 037], v Table 1 Comparison of GRID and DIN Purpose Scope of application Number of characters Facility identified within the structure GRID ISBT 128 DIN SEC Donation Identification Sequence (DIS) To uniquely identify a hematopoietic progenitor cell donor, potential donor, or a cord blood product that is listed in a registry. To uniquely identify a donation event [collection or recovery] To uniquely identify a donation event [collection or recovery] Global Global Europe The organization that assigned the GRID. The identifier assigned to this organization is called the GRID Issuing Organization Number (ION). The ION is assigned by ICCBBA in collaboration with WMDA. The facility that assigned the DIN. The identifier assigned to this organization is called the Facility Identification Number (FIN). The FIN is assigned by ICCBBA. The facility that assigned the DIS. The identifier assigned to this organization is called the Tissue Establishment Code (TEC). The TEC is assigned by the appropriate competent authority within each country. As noted in Section 4.2, it is possible to use the DIN from a cord blood unit within the GRID. However, the GRID and the DIN are two different identifiers with two different purposes.

8 Use of the Global Registration Identifier for Donors, [Data Structure 037], v Format of the GRID 2.1 Electronically-Readable Presentation When the GRID is represented electronically, it shall be encoded as Data Structure 037 in the ISBT 128 Standard. Purpose: Structure: Data Structure 037 shall specify a globally unique identifier for HPC donors or potential donors or listed cord blood products. &,3nnnnaaaaaaaaaaaaaaa Element Length Type & 1 data identifier, first character, 1 data identifier, second character 3 1 data identifier, third character nnnn 4 numeric {0 9}, first character shall not be 0 aaaaaaaaaaaaaaa 15 alphanumeric {A Z; 0 9} The data content string shall be 19 characters and shall be encoded and interpreted as follows: nnnn aaaaaaaaaaaaaaa GRID Issuing Organization Number (ION) that shall be encoded and interpreted by reference to the ICCBBA GRID Issuing Organizations table published and maintained by ICCBBA on the ICCBBA Website. Registration Donor Identifier that shall specify a sequence number identifying a donor, potential donor, or registry listings for cord blood stem cell products within the registration organization. If the GRID is to be represented in a linear barcode, Code 128 shall be used and comply with ISO/IEC 15417: 2007(E): Information technology Automatic Identification and data capture techniques Code 128 bar code symbology specification. If the GRID is to be represented in a 2D code, Data Matrix shall be used and comply with ISO/IEC 16022:2006(E): Information technology International symbology specification Data Matrix (and correction ISO/IEC 16022:2006/Cor 1:2008). The GRID may be combined with additional information in the 2D code as part of an ISBT 128 Compound Message. Additional information about the Compound Message data structure and requirements for the use of Code 128 and Data Matrix may be found in the ISBT 128 Standard Technical Specification (ST-001).

9 Use of the Global Registration Identifier for Donors, [Data Structure 037], v Eye-Readable Presentation When printed in an eye-readable format, the GRID shall be divided into blocks of 4,4,4,4,3 to assist manual transcription. Spacing between the blocks shall be sufficient to ensure the blocks are clearly separated. The GRID shall be printed in a sans-serif font and the font must be selected to clearly distinguish between similar letters and digits (i.e. 0 and O, 1 and I). A modulus 37-2 check character shall be added in a box at the end of the number. This check character is calculated from the GRID and is designed to identify errors in transcription. Check character values are 0-9, A-Z, and the asterisk character. This character does not form part of the GRID. An example of the full GRID eye-readable format is shown in Figure 1. Figure 1 Eye-Readable Presentation of the GRID

10 Use of the Global Registration Identifier for Donors, [Data Structure 037], v Check Character While keyboard entry of the GRID is not recommended, it is sometimes essential. The check character is used for process control to verify accurate keyboard entry of the GRID. It is not a part of the data content of the GRID data structure and so is not included in the bar code or in databases or electronic messages. This is because it is not intended for use when the GRID is scanned electronically. It is calculated and printed whenever the GRID is printed on a label or form, and is calculated and verified against the entered information in the event of keyboard entry of the GRID. The check character is calculated on the 19-character GRID; the data identifiers (&,3) are not included in the calculation. 3.1 Lookup Tool A look-up tool for calculating a check character that is useful for validations is available on the ICCBBA Website. It is found by going to the home page, selecting the Lookup Tools tab, then the Quick K Calculator, and then downloading the program onto a computer. The program is used by entering a GRID into the search field with no spaces. See Figure 2. Figure 2 Check Character Lookup Tool 3.2 Calculation of Check Character Checksum characters are based on the ISO 7064 Mod 37-2 algorithm. This section shows how to calculate the checksum character for any given GRID. The calculation is based on the GRID nineteen-character data string. The steps in the process are as follows: 1. For each character in the string, determine its check value as required by ISO 7064 from Table 2 (e.g. character F has value 15); 2. For each character in the string, determine its weighted check value by multiplying the check value from Table 2 by the nth power of 2 where n is the position of the character from the right hand end of the string; 3. Sum the weighted check values from step 2;

11 Use of the Global Registration Identifier for Donors, [Data Structure 037], v Find the modulus 37 value of the sum from step 3 (the value remaining when the weighted sum is divided by 37); 5. Subtract the value obtained in step 4 from 38; 6. Find the modulus 37 value of the result of step 5 (the value remaining when divided by 37); 7. Using the value in Step 6, determine the check character by again referring to the Table 2 (this time read the character from the value) this is the modulo 37-2 checksum character. Table 2 Mapping from Characters to ISO/IEC 7064 Check Values and Calculated Values to the Checksum Character [RT035]

12 Use of the Global Registration Identifier for Donors, [Data Structure 037], v Example of Check Character Calculation GRID is Position from right (n) 2 n (a) Character ISO 7064 value (step 1) (b) Weighted value (step 2) (a x b) Step 3: sum of last column = Step 4: modulo 37 of = 26 Step 5: = 12 Step 6: modulus 37 of 12 = 12 Step 7: Lookup 12 in the table gives character C Thus, the mod 37-2 check character is C.

13 Use of the Global Registration Identifier for Donors, [Data Structure 037], v GRID Assignment Rules 4 Usage Organizations wishing to issue a GRID must apply to WMDA for allocation of an ION. See Implementation Guide: Global Registration Identifier for Donors, Issuing Organization Number (IG-039) for details. WMDA will submit the request to ICCBBA, who shall ensure an officially allocated ION is globally unique and shall maintain a register of ION allocations on the ICCBBA Website. The organization assigning the GRID shall use their allocated ION and shall ensure the Registration Donor Identifier is unique for each GRID assigned under this ION. While this element may be an entirely new unique identifier, it may also be as described in Sections 4.2 and 4.3. Once assigned, an ION or GRID shall never be reassigned. Long term, it is intended that the initially assigned GRID will remain with the donor/cord blood product through the entire life cycle (i.e. starting with the informed consent form at registration until the donor/product is no longer listed with any organization listing donors). The GRID then replaces all existing donor numbers. During the implementation phases it is recognized that there may be occasions where a new GRID has to be assigned when information is transferred from one registry to another. In such situations, it is desirable that the organization assigning the new GRID maintain a clearly documented mapping between the previous GRID and new GRID for full traceability when it is aware of the previous GRID. [See Implementation Guide: Global Registration Identifier for Donors, Issuing Organization Number (IG-039) for how Registration Issuer Numbers are assigned.] 4.2 Using Current Donor Identifiers within the GRID The GRID was designed to allow organizations to continue using existing donor identifiers by inserting these identifiers into the Registration Donor Identifier element of the GRID, providing that current identifiers are alphanumeric only, and alpha characters are only uppercase letters. If only lowercase letters are currently used, they would have to be converted to uppercase letters in the GRID. If mixed uppercase and lowercase letters are used, an entirely new GRID may need to be assigned to ensure uniqueness. Leading zeroes shall be used when the identifier has fewer than 15 characters. The following example shows the use of an existing donor identifier in the GRID: An organization has been assigned the ION Currently, donor identifier is A The GRID would be A12 345

14 Use of the Global Registration Identifier for Donors, [Data Structure 037], v Using a Cord Blood Donation Identification Number within the GRID For a cord blood bank, options include: the GRID may be assigned in the same manner as for an adult HPC donor (see above example), or the Donation Identification Number of the cord blood may be used as the Registration Donor Identifier element in the GRID. The following example shows the use of the ISBT 128 Donation Identification Number (DIN) in the GRID: Cord Blood Bank with assigned ION 1512 The DIN of the cord blood product is A The GRID would be A Donors who Move to a Different Registry / Merging of Registries When all phases of the GRID implementation have been completed, the GRID will be a lifetime identifier and will not change when a donor moves to a different registry. However, this will require changes to registry software and may not be possible during the earlier implementation phases. During phases 1-4 of the implementation timetable (see Section 5), if a donor should become associated with a different registry, a new GRID may be assigned. The ION of the new GRID should be that of the new registry acting as a registration issuing organization. The Donor Identifier element will reflect that numbering scheme of the new GRID issuing organization. For example, a donor living in country A has the GRID The donor moves to country B, which has a different registry. The donor is given a GRID by that registry which is XY A.

15 Use of the Global Registration Identifier for Donors, [Data Structure 037], v Use of GRID on a Product Label The use of the GRID on the label of a cellular therapy product is not required at this time. However, during Phase 3 (see Chapter 5), this will be required for products from adult donors. To help facilities plan, an example of f such a label using the GRID is shown in Figure 3. Figure 3 Label Example with GRID GRID More information about labeling of products may be found in ISBT 128 Standard Labeling of Cellular Therapy Products (ST-004).

16 Use of the Global Registration Identifier for Donors, [Data Structure 037], v Time Line for Implementation The GRID will be introduced in a number of phases over a 3-5 year period. The specific timeline for each phase will be determined and communicated by WMDA. The phases are: Phase 1 Registration identifier allocation rules, GRID format, GRID eyereadable presentation, and GRID data structure for electronic transfer are defined. Guidance for registries for mapping local identifiers to the GRID is developed. Phase 2 The European Marrow Donor Information System (EMDIS) and Bone Marrow Donors Worldwide (BMDW) support the GRID. Use of the GRID in communication between registries/cord blood banks/donor centers is recommended but not required. Phase 3 GRID is a mandatory field in communication with EMDIS and BMDW. It is introduced as an optional field in the communication between registries and their donor centers. GRID is used as the key donor identifier on search reports and is integrated in forms for donor request and outcome reporting. GRID is used on labels of products from adult donors when a donor identifier is required. Phase 4 GRID is incorporated into all Registry database systems as the key identifier for the donor and cord blood product. This is done in a manner that allows any GRID to be used as the key identifier (not only those GRIDs assigned by the Registry). Phase 5 GRID for life is introduced and donors transferring to other organizations retain the GRID they have previously been assigned.

17 Use of the Global Registration Identifier for Donors, [Data Structure 037], v Software Developers At a time determined by WMDA, the GRID must be used in all communication between organizations providing hematopoietic progenitor cell products. As noted in Chapter 5, there will be a phased approach to this requirement, and the exact timeline has not been determined. Currently, the GRID is assigned by an issuing organization to one of its potential donors. During implementation phases 1-4, should the donor move and become associated with a different organization, his/her GRID may change to reflect the new registry. However, once implementation phase 5 is reached a lifetime GRID must be supported to enable the records of the donor to follow him/her. Software shall be written to accommodate this. Organization software should: Use the full GRID as the donor identifier in the database, including supporting the full range of alphanumeric characters as specified in the GRID definition. Support the import and use of a GRID with a different ION element from its own. For example, if the organization s ION is 5348, it should support having potential donors in its register with an ION of Not use the ION within the GRID to determine the organization with which a donor is associated. This ION only identifies the organization that originally assigned the GRID. There should be a separate field to identify the organization with which the donor is currently associated. Figure 4 GRID Structure If a GRID issuing organization has a Donor Identifier of less than 15 characters, leading zeroes shall be used to create the fixed length GRID. These leading zeroes shall be printed in the text version as well as in the electronic version to ensure consistent calculation of the check character. For example, if the ION is 8888 and the local identifier is AC34400, then the GRID is AC the GRID must not be printed as 8888 AC If a registration organization continues to use its own donor identifier for internal purposes, it shall be mapped to the GRID within the database. This is true even if the GRID can be deduced because the local identifier was used to create the GRID (see Section 4.2). Regardless of how the GRID is created within a given organization, the GRID is the donor identifier and not a substitute means of transmitting the DIN or the ION. These pieces of information should be held in their own data structures. Software developers shall ensure that information is both coded and decoded in a manner that ensures semantic interoperability.

18 Use of the Global Registration Identifier for Donors, [Data Structure 037], v The GRID is intended to become the primary donor identifier and, if possible, the only one in use for inter-organizational communication. ICCBBA Standards Committee John Armitage Paul Ashford Wayne Bolton Suzanne Butch Pat Distler Jørgen Georgsen Suzy Grabowski Mario Muon Stefan Poniatowski Leigh Sims Poston Ineke Slaper-Cortenbach Zbigniew Szczepiorkowski Izabela Uhrynowska-Tyszkiewicz Diane Wilson United Kingdom ICCBBA Australia United States of America ICCBBA Denmark United States of America Portugal Australia United States of America The Netherlands United States of America Poland United States of America Etienne Baudoux Michael Boo Irina Evseeva William Hwang Pawinee Kupatuwintu Mary Laughlin Evelyne Marry Carlheinz Mueller Machteld Oudshoorn Julia Pingel Matt Prestegaard Jane Prior Sergio Querol Jon van Rood Rudolf Schwabe Jeff Szer WMDA Board Belgium United States United Kingdom Singapore Thailand United States France Germany The Netherlands Germany United States Singapore Spain The Netherlands Switzerland Australia