1. Why do I need to be licensed by ICCBBA?

Licensed status allows access to password-protected areas of the ICCBBA website and grants the right to use ISBT 128 data structures and the ISBT 128 number(s) beginning with the assigned Facility Identification Number (FIN) on blood products, cellular therapy products, tissues, and other Medical Products of Human Origin (MPHO).

2. Why must I pay to use ISBT 128?

In order to maintain and enhance the ISBT 128 Standard so it continues to meet the needs of its users, it must be professionally managed. Of particular importance are the following:

• stability – users must be confident that a standard is stable for the period of time that it is required (EC requires data to be stored and traceable for 30 years);
  
• user focus – the user community are the experts in their field and the information standard needs to meet, rather than dictate, their needs;
  
• flexibility – as clinical and scientific knowledge grows there is rapid development with changing information needs. The standard must be flexible enough to accommodate these needs;
  
• responsiveness – with a rapidly developing field the standard needs to be able to respond to user needs in a timely manner;
  
• globalization – there is a need for a truly international standard with endorsement worldwide;
  
• implementation – a standard is only of value if it is widely used;
  
• compatibility – standards do not work in isolation but need to interface with equipment, software and other standards.

3. Who is using ISBT 128?

ISBT 128 has been implemented in many countries. We maintain a map of all the countries that have implemented ISBT 128 and those who have registered with ICCBBA. Check out more details about who is using ISBT 128 here.

4. What benefits would facilities see after implementing ISBT 128?

ISBT 128 offers immediate benefits to your organization as well as the ongoing benefits of achieving greater safety, accuracy, and efficiency in your service delivery. Core benefits include:

• The entire Donation Identification Number (which includes the facility identification) is encoded in a single bar code
  
• No duplication worldwide of a Donation Identification Number in 100 years
  
• Fewer system and identification errors
  
• Fewer misreads on automated instruments
  
• More specific identification of products and the ability to use the same codes for billing products as those used on the component label
  
• Ability to bar code the expiration time
  
• No tracking and renumbering problems when blood is imported from another facility when the unit number is not in the same format as that used by the blood center's computer system
  
• Other long term benefits include the ability to build in more process controls and continue to use the same data structures whether using bar codes or radio frequency tags (or other new technology)
  
• The efficiency and ease-of-use benefits that the grocery industry has seen with bar code standardization that results in lower operating costs

1. Does my facility need to register with ICCBBA?

Registration and licensing with ICCBBA are required if you apply ISBT 128 labels. This encompasses facilities that pool, aliquot, or modify products and label them with ISBT 128 bar codes. Even if it may not be required, your facility may also wish to register and pay licensing fees in order to receive all ISBT 128 documentation and updates and access the password-protected areas of the ICCBBA Website. All new Product Description Codes, other updates and current copies of the ICCBBA databases are maintained in this section. The annual license feeing for transfusion services is maintained as low as possible to encourage such facilities to maintain regular contact with ICCBBA and remain fully informed about updates and changes to the ISBT 128 Standard.

2. Where will I find a step-by-step process for registration with ICCBBA?

The registration section of the website presents information about fees and the registration process, as well as a convenient registration form that you can download. The How to Register page provides guidance in the registration process. After completing the Facility Registration Form, you may fax, mail, or email it together with the appropriate licensing fee to the ICCBBA office. Vendors need to complete a separate registration form which can be found here.

3. If the name of my facility changes, will I need to re-register with ICCBBA?

If the name of your facility changes, and the only change is in name, your facility does not need to re-register; the Facility Identification Number (FIN) does not need to change. However, if the change involves more than just a name change (e.g., change in ownership), ICCBBA may assign a new FIN.

4. If my software vendor has an ISBT 128 package available, why do I need to register with ICCBBA?

A software vendor can only go as far as providing you with the capability to use the ISBT 128 Standard. In order to exercise these capabilities of applying an ISBT 128 label, an initial one-time registration fee and an annual licensing fee must be received by ICCBBA. This fee permits your facility to be licensed to use the ISBT 128 data structures. However, if your facility will only be scanning ISBT 128 bar codes (without applying new labels); your software vendor can provide you with updates to the ISBT 128 Product Description Codes Database without your facility having to be registered.

5. Why must I pay to use ISBT 128?

In order to assess the ‘value for money’ of the ICCBBA fees, it is necessary to identify the user community needs that an international standard must deliver. Of particular importance are the following: 1) Stability – users must be confident in the stability of a standard as it is required over for a long term application (EC requirements for data to be stored and traceable for 30 years); 2) User Focus – the user community are the experts in their field and the information standard needs to meet, rather than dictate, their needs; 3) Flexibility – as clinical and scientific knowledge grows there is rapid development with changing information needs. The standard must be flexible enough to accommodate those needs; 4) Responsiveness – with a rapidly developing field the standard needs to be able to respond to user needs in a timely manner; 5) Globalization – the need for a truly international standard with endorsement worldwide; 6) Implementation – a standard is only of value if it is widely used; 7) Compatibility – standards do not work in isolation but need to interface with equipment, software and other standards. Clearly meeting these needs will have a cost. Stability and flexibility requires a robust organization that can manage the development and maintenance of the standard, and one that is not over dependent on key personnel. To support its activities ICCBBA charges a licensing fee for the use of the ISBT 128 Standard. As a tax-exempt, non-profit organization, all of this income is directed to achieving the ICCBBA mission: "to enhance safety for patients by managing the ISBT 128 international information standard for use in transfusion and transplantation."

6. My facility collects tissue, processes it, and then distributes the processed unit as a cellular therapy product. What type of facility do we mark on the registration form?

For tissues collected with intent of being processed into a cellular therapy product, please mark Cellular Therapy Collection Facility.

7. How can I update my facility’s contact information?

To update your facility’s contact information, visit https://www.iccbba.org/registration-licensing/update-contact-information. Alternatively, you can e-mail your updates to iccbba@iccbba.org. Upon request, a member of our team will confirm the changes once your form has been processed.

8. How can I add an activity (e.g. cell therapy, milk bank, tissue bank) to a previously obtained registration?

To add a new activity, you can complete an Annual Returns form by visiting https://www.isbt128.org/facility-vendor-annual-returns and choosing the appropriate registrant type (Facility or Vendor). This form can also be used to update contact information. Alternatively, you can e-mail your updates to iccbba@iccbba.org. Upon request, a member of our team will confirm the changes once your form has been processed.

1. How do I return to the homepage?

The homepage can be navigated to by clicking on the "ISBT 128 More than Identification" logo at the top-left corner of each page.

2. Where do I log in?

We are currently working on a members only login page. Currently the login feature does not work.

3. Where is the Site Map?

It is located on the footer of every page.

4. Where is the ISBT 128 Product Description Code Database?

The Product Description Code Database can be found under the "Tech Library" dropdown menu—hover your mouse cursor over "Tech Library", then "Databases/Reference Tables", and click on "Product Description Codes". Keep in mind that you must be logged in to see view this navigation link.

5. Where is the ISBT 128 Product Lookup Web Application?

The Product Lookup Web Application can be found under the “Lookup Tools” section of the navigation. Click on "Find Product Information" to access the Product Lookup Tool.

6. How do I request a new Product Description Code?

A product request can be submitted via the ISBT 128 Product Lookup Web Application. If the requested product description code can be sufficiently described with current ISBT 128 terminology, you would select the applicable terminology on the Product Lookup Web Application, enter the facility contact information on the form, and click the submit button once. To get to the web application, navigate to the “Lookup Tools” tab and select "Find Product Information", then scroll down and click “ISBT 128 Product Lookup Web Application".

7. Where is the Registered Facilities Database?

The Registered Facilities Database can be found under the "Tech Library" dropdown menu—hover your cursor over "Tech Library", then click on "Databases/References Table". Keep in mind that you must be logged in to see the Registered Facilities Page.

8. Where is the Facility Identification Number (FIN) Information Search feature?

The Facility Identification Number Information Search feature (or colloquially known as the FIN Lookup Tool) can be found under the "Lookup Tools" dropdown menu.

9. Where can I find ICCBBA's contact information?

To find ICCBBA's contact information, click "Contact ICCBBA Staff" from the ‘About ICCBBA’ dropdown menu.

10. Where is the search function?

The search bar is found at the top of the page in the header bar next to the ICCBBA logo.

11. Where can I find training materials?

Various training material can be found under the "ISBT 128 Basics" dropdown menu—hover your mouse cursor over "ISBT 128 Basics", and click on " Educational Materials".

12. Where are the Introductory Booklets?

Introductory booklets can be found under the "ISBT 128 Basics" dropdown menu—hover your mouse cursor over "ISBT 128 Basics", and click on "Introductory Booklets".

13. How do I get an ICCBBA website password?

Typically, ICCBBA licensed facilities/vendors that are up to date on licensing fees are eligible to receive a password. Please contact us at iccbba@iccbba.org to request an account and password. Keep in mind that password assignment can take up to two working days. An email confirmation will be sent to the password requestor upon completion of the password assignment.

14. How do I change my password?

Changing a password involves the same process of requesting a new password. To change a password, simply follow the instructions outlined in question #13 (directly above).

15. Where do I update my facility's account information?

You must be logged in to update your facility's account information. Updating this information requires completing the Update Contact Information Form. Or send the staff an email at iccbba@iccbba.org.

16. How long does it take for my message to post on a message board?

On a weekday, your post should appear within 24 hours. ICCBBA needs to review posts before they go online to ensure accurate information regarding ISBT 128 gets posted on the site. Any posts made on a weekend will typically be published on the following workday.

17. Can I get notifications when the message boards are updated?

Unfortunately, because passwords are associated with facilities rather than individuals, it is not possible to subscribe to message boards at this time. The message board would need to be checked periodically, in order to view answers/comments to questions.

1. How do I access the databases and documents available only to licensed facilities?

Databases (e.g. the ISBT 128 Product Description Code Database) and documents are located in the Tech Library section of the website. Databases and certain documents are only accessible to registered facilities that are current on their annual licensing fees.

2. Where do I find the Product Description Codes that I need?

Product Description Codes are published in the form of a database—this is the "ISBT 128 Product Description Code Database". Registered facilities can download the database, so long as they are current with their licensing requirements. In addition, the "ISBT 128 Product Lookup Program" can be used to search for existing Product Description Codes. The ISBT 128 Product Description Code Database gets updated approximately ten times per year. It is essential to update your copy regularly to have the most current ISBT 128 Product Description Codes. You can subscribe to ICCBBA's mailing list to be notified of updates via email.

3. How do I obtain a new Product Description Code?

To request a new Product Description Code that is not already in the database (and can be described sufficiently with current ISBT 128 terminology), a product request can be submitted via the ISBT 128 Product Lookup Tool. For further information on how to obtain a new Product Description Code, click here.

4. What is a local product code?

Local product codes are primarily used for "boutique" or research products. They are also used for in-process products that a system may require to track. Local codes are defined and maintained by the facility—ICCBBA does not maintain or keep track of these codes.

• Codes A0000 through D9999 that are not reserved for national use may be used for local codes.
  
• Codes beginning with D, and have alpha characters within positions 2-5 (e.g., DAX12), shall be reserved as locally-defined codes.

5. What are national product codes?

National product codes are codes reserved by a national agency for use within a country. National agencies may reserve a range of values in the block A–D for national assignment.* Where this is done, it shall be the responsibility of the national agency to ensure that definitions are provided for use within the country and that products bearing such codes are not transferred outside the national boundary.
*The following range of codes are available for assignment by a national authority:

• Codes beginning with A–C, and have alpha characters within positions 2–5 (e.g., AE134, BT123, CRA12), shall be reserved as national codes.
  
• Codes that begin with A–D followed by numeric characters (A0000–D9999) are open for national assignment. National authorities have the responsibility to communicate codes reserved in this range so that it does not conflict with locally assigned facility codes within the same range.

6. We are doing research on new blood components. How do I get a Product Description Code for these products?

ISBT 128 permits any facility (licensed with ICCBBA) to assign a "local code" to products in development. These codes should be made known to blood centers doing the research and any facility or facilities using the new products in clinical trials, etc. Outside of this group, these codes may have a different meaning. See the ISBT 128 Standard Technical Specification (ST-001) for details.

7. How do I label intraoperatively collected autologous blood?

If the products will be stored in the laboratory, a local code (first letter A-D) should be used. For example, A0001 could be "Intraoperative Washed Red Blood Cells". Other labeling should follow national requirements.

8. What is the purpose of the check character? Is the use of the check character an ISBT 128 requirement?

The check character (also referred to as check character K) is intended to confirm the accuracy of a manual keyboard entry when the code cannot be scanned. The check character is calculated using the ISO/IEC 7064 modulo 37-2 checksum method—additional information can be found in the ISBT 128 Standard Technical Specification(ST-001):

• Appendix A.1 provides information on the overall process of calculating the keyboard entry check character.
• Appendix A.2 provides information pertaining to computer programs for calculating the check character K.

The Quick K Calculator can be used as a tool to calculate the modulo 37-2 check character. The Quick K Calculator shows that the check character on the DIN "A999914123458" is the letter "J". When printed, the check character shall be clearly distinguished from the corresponding data content. The check character shall be printed with a box drawn around it:

With regard to the Donation Identification Number (DIN), the check character is based off of the 13-character DIN itself. The DIN’s check character must not include the flag characters as part of the calculation. Appendix A.1 of the ISBT 128 Standard Technical Specification (ST-001) provides an example of calculating the check character for a DIN. The inclusion of the check character with a DIN is an ISBT 128 requirement.

Please see Section 7.4.2 of ST-001 for the "Keyboard Entry Check Character Requirements for ISBT 128 Data Structures Utilizing Code 128" table [RT002] for the applicable data structures in which the Check Character is used.

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9. What are Flag characters and why are they used?

For ISBT 128, flag characters (also referred to as a flag or flags) are used with the Donation Identification Number (DIN) and are intended to be used for added process control when there is a need to differentiate multiple applications of the same DIN.

Flag characters, while part of the data content of the Donation Identification Number (DIN) data structure, are not part of the 13-character DIN itself and do not contribute to unique identification of the product.

There are three types of flag characters: Type 1: A two-character code used for process control and defined by ICCBBA (as shown in the figure below).
Type 2: A two-character code used for process control but locally defined. These characters should only be interpreted by the facility that has defined them or within the group of facilities that have agreed on a common definition.
Type 3: A weighted ISO/IEC 7064 modulo 37-2 check character on the DIN itself, which acts on the DIN as a secondary check [in addition to the printed Check Character] within the bar code. Additional information on flags can be found in Section 2.4.1 of the ISBT 128 Standard Technical Specification (ST-001). For examples of the use of flag characters, see Technical Bulletin 7: Use of Flags in the Donation Identification Number for Process Control of Critical Points During Processing and Distribution (IG-010). The "01" flag characters indicate that the label applies to "Container 1" of a set. The interpretation of Type 1 flags and the values allotted for Type 2 and Type 3 flags, can be found in table RT004 (see Section 3.1 of ST-001).

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10. Where can I find ISBT 128 labels for validation?

Sample bar codes (both valid and invalid), which can be used for validation purposes, can be found in IG-013 Implementation Guide: ISBT 128 Bar Codes: Valid and Invalid Examples and IG-043 Implementation Guide: A Validation Tool for ISBT 128 Data Structures.

11. Is the use of concatenation required?

Concatenation is a method by which the information held in two bar codes is combined in the scanner into a single string of data before being sent to the host computer. The use of concatenation is encouraged but not required. When set up properly, concatenation can be a powerful process control tool used to ensure information is scanned from the same product label.

12. We are having difficulty getting our scanner to read concatenated ISBT 128 bar codes. What can I do?

The user’s manual for your bar code scanner should have the information you need (in the form of bar codes) to turn on and off the different types of bar code symbologies and concatenation features. It is recommended that you turn off all other symbologies that are not being used. You may need to contact your bar code scanner supplier if you require additional assistance.

13. Can ISBT 128 be used with 2-D bar codes or RFID tags?

ISBT 128 data structures can be delivered using a number of different technologies including Code 128 bar codes, two-dimensional (2-D) bar codes, Reduced Space Symbology (RSS) bar codes, wireless radio frequency identification transponders (RFID tags), and EDI messages.

14. Can I use ISBT 128 bar codes to label a Red Cell product as antigen-negative based on historical antigen testing of the donor?

The ISBT 128 Standard does not create standards for testing. Rather, ISBT 128 provides information on how a product can be labeled or how information should be transmitted electronically. ICCBBA defers to national authorities to determine when a unit may be labeled as antigen-negative—click here* for practices in some countries. *The information provided in the table is based on an informal survey of ISBT 128 users and may reflect only a single facility within a country.

1. I am a transfusion service that only thaws Fresh Frozen Plasma. Will I be required to re-label that unit?

If your facility thaws Fresh Frozen Plasma and transfuses it within 24 hours, then you are not required to re-label the unit and can just handwrite the new expiration date/time. However, if your facility does not transfuse the product within 24 hours, you would have to re-label the unit as "Thawed Plasma". The Thawed Plasma unit should be given an expiration date set for 5 days from the time of thaw.

2. When modifying a product where does the US License Number appear?

The original processing facility (e.g., Facility A) will have their US License Number in the upper left quadrant of the label or the lower left quadrant. The modifying facility (e.g., Facility B) will have their US License Number in the lower right quadrant. Please reference Section IV, C of the FDA Guidance for Industry – Cooperative Manufacturing Arrangements for Licensed Biologics November 2008. The FDA guidance states that the US License Number must appear on the label. It is an ISBT 128 recommendation that the license numbers appear in the upper left/ lower left quadrant (for the original processing facility) and the lower right quadrant (for the modifying facility). If the unit is modified into an unlicensed product, neither US License Number shall appear on the modified unit.

3. Am I required to specify in the ISBT 128 Product Code data structure (Data Structure 003) whether the unit is autologous or directed?

Autologous donations are required to be encoded in the Product Code. At this time, Directed units are not required to be encoded in the Product Code, but can be if desired. However, the Americas Technical Advisory Group (ATAG) has decided to mandate the use of the "Directed" donation type in the Product Code in the next version of the US Consensus Standard. It is required that a donation type is specified in the Product Code—FDA does not permit the use of the default value of "0" (not specified) to be used in the Product Code for products intended for transfusion. However, recovered Plasma and Source Plasma units may have the "0" donation type.

4. Must I encode the donation type in the ABO/Rh data structure (Data Structure 002)?

The "autologous" donation type must be encoded in the ABO data structure (Data Structure 002).

5. For facilities located in the US, how should the labeling of Reconstituted Red Blood Cells be handled?

In the US, there are several different labeling scenarios for Reconstituted Red Blood Cells. A short document was prepared that reflects the current thinking on labeling these products in the US. Again, this applies to US facilities only and is subject to change.

6. My facility is in the US. I have a platelet apheresis collection with a platelet count of 5.8 x 10^11. I have divided it into two products. One has a count of 3.1 x 10^11 and the other has a count of 2.7 x 1011. What Product Codes should I use?

In the US, this must be labeled as a divided product because one resulting product has less than the required 3.0 x 1011 platelets. That is, the character in the 7th position of the Product Code must change from a 0 (zero) to an upper case A for one product and an upper case B for the other. Additionally, the product that contains 2.7 x 10^11 platelets must include the Attribute "<3E11 plts" in the Product Description Code. For example:

• Beginning product: E3077V00 (Apheresis PLATELETS|ACD-A/XX/20-24C|ResLeu:<5E6, undivided)
  
• Product with 3.1 X 10^11 platelets: E3077VA0 (Apheresis PLATELETS|ACD-A/XX/20-24C|ResLeu:<5E6, divided)
  
• Product with 2.7 x 10^11 platelets: E4643VB0 (Apheresis PLATELETS|ACD-A/XX/20-24C|ResLeu:<5E6|<3E11 plts, divided)

7. How do I label Red Blood Cell products with the additive AS-7 (Solx)?

Section 6.1 of the United States Consensus Standard for the Uniform Labeling of Blood and Blood Components Using ISBT 128 v3.0.0 (IG-002) specifies that, "Additive solutions shall be listed on the line immediately after the Component Class (or proper name if different) and before the intended use cautionary statement, if applicable." Below is the label example for AS-7 (Solx) Note: Additive Solution AS-7 (Solx) has been approved for use by the FDA.

8. If I have an Octaplas product and I thaw it, is it acceptable to cross out the original expiration and handwrite the new expiration?

Yes, it is acceptable to cross out the expiration and handwrite the new expiration date and time. The thawed product must be used within 24 hours if stored at 1-6 °C or within 8 hours if stored at 20-25 °C.

9. How do I label my psoralen-treated products?

The PSORALEN-TREATED attribute shall appear in all caps in the attribute section of the lower left quadrant. Attributes shall appear in the same order as the Attribute Groups listed in the ISBT 128 Standard Terminology for Medical Products of Human Origin. See label example below. This serves as specific guidance for labeling psoralen-treated products that is not provided in v3.0.0 of the "United States Consensus Standard for the Uniform Labeling of Blood and Blood Components Using ISBT 128" (IG-002).

10. How do I label products that use the Bacterial Test attributes (e.g., Bacterial test D6)?

Product Description Codes that include the attributes “Bacterial test D5,” “Bacterial test D6,” or “Bacterial test D7” are available for use. These attributes indicate that a unit was bacterially tested on a sample taken X days after collection. For example, if a platelet product was sampled on the sixth day for bacterial testing, the “Bacterial test D6” attribute would apply. These attributes are not intended to indicate any specific expiration, as product expiration is nationally defined. The attributes simply indicate the day in which it was sampled for testing. Therefore, it is imperative that the user’s system assigns the appropriate expiration date and that the date does NOT exceed 7 days from the collection of the platelet product. The “Bacterial Test Day [X]” attribute shall appear in all caps in the attribute section of the lower left quadrant of the label. Attributes shall appear in the same order as the Attribute Groups listed in the ISBT 128 Standard Terminology for Medical Products of Human Origin. For example: Note: The “Bacterial Test Day [X]” attribute does NOT specify a testing methodology. Such information would be included in the accompanying documentation.

1. How do I assign the Donation Identification Number for a pooled product?

The pooling facility should assign a new Donation Identification Number (DIN) to the pooled unit. The DIN assigned to the pooled unit should contain the Facility Identification Number of the pooling facility. The facility performing the pool should maintain records of all DINs comprising the pool.

2. What information am I required to have bar coded on my 100 mm by 100 mm final label?

At a minimum, linear bar codes for the Donation Identification Number (positioned in the upper left quadrant), Blood Groups [ABO and RhD] (positioned in the upper right quadrant), Product Code (positioned in the lower left quadrant), and Expiration Date and Time* (positioned in the lower right quadrant) shall be present. Please reference the ISBT 128 Standard Labeling of Blood Components (ST-005) document for detailed information regarding the requirements for a 100 mm by 100 mm label. *In some countries, the updated expiration date and time is not required to be bar coded for further processed products.

3. Our current system assigns a suffix to the parent unit number when aliquots are made. How will aliquots be handled with the ISBT 128 Standard?

The ISBT 128 Product Code is 8 characters long. For Blood and Cellular Therapy products, the first 5 characters is the Product Description Code, the 6th identifies the type of donation, and the 7th and 8th character identifies the divisions/splits. For divisions the 5-character Product Description Code remains the same, and the 7th and 8th characters of the Product Code, which comprise the Division Code, changes. These characters can change from 00 to A0, B0, C0, etc. as necessary. For example, if you have product E0164V00 and you perform a single first level division, resulting aliquots will be E0164VA0 and E0164VB0. If you further divide product E0164VB0 into three aliquots, the resulting second level divided products will be E0164VBa, E0164VBb, and E0164VBc.

4. The new year just started, but I still have a few DIN label sets left from the previous year. Do I need to discard them?

In practice, the year assigned to the DIN would be the year the DIN was assigned to a product. However, to cut down on wastage, DIN labels may be used for up to one month in the year before, and one month in the year after, the year shown on the label. Keep in mind that the combination of a DIN and Product Code should never be duplicated.

5. What is Octaplas?

Octaplas (manufactured by Octapharma) is pooled human plasma that has been solvent/detergent treated to inactivate pathogens.

1. Who are the ICCBBA licensed vendors that can provide me with software and label printing services for cellular therapy products?

A categorized list of ICCBBA-licensed vendors can be found here. Choose from vendors listed in the categories "Labeling (Cellular Therapy)" and/or "MIS/Information Technology". Many of the vendors listed in these sections provide contact information and a brief description of services provided.

2. After implementing ISBT 128, will I have to re-label all my existing products in my inventory with ISBT 128 labels?

You are not required to re-label the units in inventory with ISBT 128 labels at the time you implement ISBT 128.

3. Is there a deadline as to when my cellular therapy facility will have to implement ISBT 128?

Currently, AABB, FACT, JACIE, and NMDP require that ISBT 128 terminology be used when labeling cellular therapy products. AABB requires that all facilities shall implement ISBT 128 labeling by 01 July 2018. There are currently no labeling requirements for ISBT 128 set by the other accrediting organizations.

4. Who should be on my implementation team?

ISBT 128 may affect many departments in a facility. A representative from each affected department should be part of the implementation team to provide insight as to how they will be impacted by the change and to address the specific requirements for their department. The staff involved with administration of the product will need to know where to find specific information located on the new label; the laboratory personnel will need to be familiar with Product Codes when performing modifications; the accounting department will need to understand the products that they will be billing; medical records personnel will also be affected. A recognized team leader should be chosen to spearhead the project.

5. What is the minimum information required to appear on a partial label?

Partial labels, at a minimum, should contain a unique numeric or alphanumeric identifier, proper name of the product (ISBT 128 Terminology), and intended recipient name and identifier (if applicable), in accordance with FACT/JACIE requirements. In addition there may be other national regulatory requirements that must appear on the label.

6. Where can I find the ISBT 128 Cellular Therapy Product Codes that I need?  What if I don't find the one that suits my needs?

A complete list of ISBT 128 Product Description Codes can be found in the Microsoft Access file called ISBT 128 Product Description Code Database located in the password-protected area of the ICCBBA website. Blood, cellular therapy, tissue, and other MPHO Product Description Codes are all listed in the same table. Cellular therapy Product Description Codes begin with an "S" (e.g., S1234). Please note that S0001 through S1121 have been retired. Retired Product Description Codes should not be used to label new products. If there are no current Product Description Codes that fit your needs, you can submit a request for a new code using the online Request Form - Cellular Therapy located in Subject Area section of the ICCBBA website.

7. How should I label my in-process cellular therapy products?

In-process products that do not leave a facility do not need to be labeled using ISBT 128. Facilities can choose to follow an ISBT 128 format, using local Product Codes where standardized codes for in-process products do not exist. If a product is collected by one facility and processed by another, the products should be labeled following FACT/JACIE, AABB, and/or Registry Standards, and in compliance with any pertinent regulations.

8. How do I label products that are to be used for further processing?

If these products are intended for further processing and then for administration, they should be handled as described in the above question on in-process products. If these products are not intended for administration, the upper right quadrant should reflect this. Instead of a standard ABO/Rh code, the code "Mr" (for research use only) should be selected. The words "For Nonclinical Use Only" (in the local language) should appear. You may need to check national regulations, as well as FACT, JACIE and AABB Standards, for additional requirements.

9. How should I select/request a Product Description Code for combinations of cells from different donors?

ICCBBA thanks Josh Geary (Dana-Farber Cell Manipulation Core Facility) for providing the following information. Our laboratory processes a number of products under IND (US FDA) that include cells from different donors. Following the CTCLAG guidelines for creating product description codes, with the understanding that not all information about the product can be coded or included in an ISBT 128 product label, we identified the active component of the product and the intent of the therapy and used this information to request an appropriate product description code. All additional information regarding the identity of the secondary cellular components is indicated in attached or accompanying documentation. Examples: Co-cultured lymphocytes Cells from the donor and the recipient of a hematopoietic stem cell transplant are collected from apheresis or whole blood. Anergy (immune tolerance) is induced in a population of the donor’s lymphocytes by co-culturing them in the presence of inhibitors of T Cell co-stimulation and irradiated lymphocytes from the recipient of the transplant. Regulatory T cells are generated and purified for infusion. The product description code chosen for this product will describe the regulatory T cells, including the attributes “Cultured:Yes” and “T Reg enriched”, but not the “Irradiation:Yes” attribute because the active component of the product is not irradiated. Tumor vaccine Malignant Cell, Tumor product is co-cultured with a cell line that is capable of secreting a particular cytokine and subsequently irradiated prior to transfusion. The product description code chosen for this product will describe the Malignant Cell, Tumor including the attributes for cultured and irradiated. Due to the presence of allogeneic cells or cell lines, either of the following Donation Type codes should be used:

• "4" [Designated] OR
• "6" [Designated, biohazard]

10. Which ISBT 128 terminology could I use for identifying an adipose-derived stromal vascular fraction (AD-SVF)?

The initial product (obtained by surgical procedures)* This product would be named “ADIPOSE TISSUE” (classified under the ISBT 128 Tissues category). Selecting a Subcategory 1 class name* This product could be named " NC, ADIPOSE TISSUE". Example Product Description Code: S1941 = NC, ADIPOSE TISSUE|None/XX/refg|3rd Party Comp:Yes|Other Additives:Yes|Mononuclear cell enriched Selecting a Subcategory 2 class name*
This product could be named " MSC, ADIPOSE TISSUE". Example Product Description Code: S3082 = MSC, ADIPOSE TISSUE|None/XX/refg|3rd Party Comp:Yes|Other Additives:Yes|Thawed Washed|Cultured:Yes Selecting product attributes* Product attributes should be selected for coding critical information. While some attributes are more specific—e.g. “10% DMSO” (of the Cryoprotectant attribute group)—others are more general. For example, “Other Additives: Yes” (of the Preparation: Other Additives attribute group) could be selected to account for a number of additives—the details would be included in the product’s accompanying documentation. *Additional information on AD-SVF, and the rationale behind the selection of ISBT 128 terminology for this type of product, can be found here .

1. What types of medical devices do ISBT 128 UDIs apply to?

ISBT 128 UDIs apply to human cells, tissues, and cellular and tissue-based products (HCT/P) that are regulated as medical devices (e.g. an implantable suture with a human tendon component).

2. Why use ISBT 128 over the other standards approved for UDI?

ISBT 128 has been specifically designed to meet the special traceability needs of medical products of human origin to provide the donor to patient link of each product. In particular, it incorporates the identification of the donor within the standard to ensure this identification is globally unique and is presented in a standard format. The globally unique ISBT 128 Donation Identification Number (DIN) satisfies the FDA requirements for a distinct identification code as a production identifier for HCT/P.

3. How do I choose between ISBT 128 and GS1?

ISBT 128 focuses on coding and labeling HCT/P that are regulated as medical devices, whereas, GS1 applies to general medical devices. In a joint document by GS1 and ICCBBA, it is recommended by both GS1 and ICCBBA to use ISBT 128 for coding and labeling HCT/P.

4. What is the regulatory importance for the ISBT 128 Donation Identification Number (DIN) in labeling HCT/P medical devices as the distinct identification code?

Outside of the US, the distinct identification code is generally referred to as a donation number or donor number and corresponds to the donation identification number in ISBT 128. This number is an essential identifier in product recall and investigation of serious adverse reaction events and has to be reported to regulatory bodies in many countries as part of adverse event reporting. Some examples include:

• In the European Union it is a required item to be reported by the tissue establishment to the competent authority.
• In Australia, their Therapeutic Goods Administration (TGA) requires the donation number to be provided in the event of a tissue recall.
• Health Canada recall policy and associated legislation may regard the donation number as an essential data item in the report to Health Canada.

5. What is the importance of using the standardized ISBT 128 product description code when labeling HCT/P medical devices?

The standardized product description code (i.e. the last 5 characters of the device identifier) is very important to ISBT 128.

• It is essential to providing uniqueness to each transplanted device. The Donation Identification Number (DIN) is common to all products from the same donor, so the product description code is essential for differentiating products from the same recovery event (e.g., differentiates bone, skin, corneas, etc., from the same deceased donor).
• It supports biovigilance. Since all suppliers use the same product code for what are essentially the same products, it allows organizations like the Center for Disease Control (CDC) to pool data across the US and across the world. The product codes correspond to descriptions with sufficient granularity to allow biovigilance studies to zero in on characteristics that might be associated with problems.
• It supports product management at the hospital. By having different suppliers use the same code for similar products, hospitals can create tables that allow appropriate substitution. If they want to differentiate similar products from different suppliers, they can still do it by using the facility-defined element of the device identifier.

6. In regards to UDI, will ISBT 128 requirements affect the proprietary image of my product’s outer packaging?

ISBT 128 only requires a portion of the package label to be standardized, carrying the ISBT 128 bar code and essential eye-readable information.

7. I want to assign ISBT 128 UDIs to my HCT/P medical devices. How do I get started? Where do I begin?

Your facility must first be registered with ICCBBA to use ISBT 128 and be assigned a unique Facility Identification Number (FIN) from ICCBBA. This FIN is incorporated into the elements that make up the UDI. Please refer to Coding and Labeling of Medical Devices Using ISBT 128 (ST-011) for additional guidance in the coding and labeling of medical devices containing an HCT/P. This material is locked behind a member account, and users can receive access once they have registered their facility. Register your facility with ICCBBA here.

8. How do I create a device identifier (DI) using ISBT 128?

The device identifier for the UDI is made up of the ISBT 128 Processor Product Identification Code (PPIC) Data Structure 034. See Section 2 in Coding and Labeling of Medical Devices Using ISBT 128 (ST-011) for more information regarding Data Structure 034. This material is locked behind a member account, and users can receive access once they have registered their facility. Register your facility with ICCBBA here. The PPIC data structure consists of the following elements:

• The Facility Identification Number (assigned by ICCBBA when the facility registers to use ISBT 128)

9. Additional Information

The following document clarifies some misconceptions regarding the use of ISBT 128 for tissue and tissue-based products: 10 Myths about ISBT 128 - PDF

1. What are the registration fees and how are they calculated?

The registration fee for facilities is a one-time charge of $200.00. This includes one Facility Identification Number (FIN). In addition, an annual license fee will be assessed based on the type of activity at your facility (based on a tiered structure). See FAQ #2 "How are annual license fees calculated" (below). If your organization would like more than one FIN, each additional FIN is a one-time fee of $175.00. License fees are based on the Annual Return Form sent out with your invoice each year. The numbers reported on this form are used to generate the license fees based on a tiered structure. For more information on the tiered structure, visit the page here.

2. How do I complete the Facility Annual Return form?

Annual returns for tissues are based on the number of individual labeled tissues distributed in the previous year for tissue intended to be released for transplant as well as those meant for interorganizational research. This means that if there were two tissues from a single donor that were distributed, it would count as two, even if both tissues had the same Donation Identification Number.

3. What does the note, "for tissues collected with intent of being processed into cellular therapy products, please fill out section 7.2 Cellular Therapy collections", on the Registration Form mean?

This note pertains to facilities that collect products like umbilical cord or placenta, which are tissues, with the intent of making stem cell products (e.g., mesenchymal cells). These facilities should register as cell therapy facilities rather than tissue facilities. If you are unsure about what type of facility to register as, contact our help desk at iccbba@iccbba.org.

4. My organization has multiple recovery locations. Does each recovery location need its own Facility Identification Number (FIN)?

No. If all tissues come back to the same location for processing, a single FIN is appropriate. However, if it is important for your organization to identify where the collection took place at a glance by using the Donation Identification Number, multiple FINs is an option you may consider.

5. My organization has multiple processing locations. Does each processing location need its own Facility Identification Number (FIN)?

Yes, it is highly recommended. In this case, there are two ways to handle registration: The organization can register at the "corporate" level and purchase an additional FIN for each processing location at $168.00 per FIN (a one-time charge). The annual license invoice is sent to the headquarters’ location and represents the total volume for the organization and its processing sites. Each processing location can register separately. In this case, each processing location will pay the $200.00 one-time registration fee, which includes one FIN. Each location will manage its own registration and annual license invoice.

6. Do I assign the same Donation Identification Number (DIN) to all tissues from the same donation event? If so, how would I differentiate between these tissues?

All tissues from the same donation event must be given the same DIN. This DIN, in addition to the Product Code, is what distinguishes each tissue uniquely. For example, a left and right cornea collected from the same patient will have the same DIN, but different Product Codes. DINs can be assigned at the time of recovery or after the tissues are back in the lab.