GENERAL FAQS ABOUT ISBT 128
FREQUENTLY ASKED QUESTIONS: ALL SECTIONS
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?
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.
4. What benefits would facilities see after implementing ISBT 128?
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
Registration & Licensing
1. Does my facility need to register with ICCBBA?
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?
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?
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 email@example.com. 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 firstname.lastname@example.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?
7. Where is the Registered Facilities Database?
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?
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?
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 email@example.com.
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?
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?
3. How do I obtain a new Product Description Code?
4. What is a local product code?
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?
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?
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.
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.
9. What are Flag characters and why are they used?
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.
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?
1. I am a transfusion service that only thaws Fresh Frozen Plasma. Will I be required to re-label that unit?
2. When modifying a product where does the US License Number appear?
3. Am I required to specify in the ISBT 128 Product Code data structure (Data Structure 003) whether the unit is autologous or directed?
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.
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)?
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?
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)?
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?
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?
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?
5. What is the minimum information required to appear on a partial 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?
9. How should I select/request a Product Description Code for combinations of cells from different donors?
"4" [Designated] OR
"6" [Designated, biohazard]
10. Which ISBT 128 terminology could I use for identifying an adipose-derived stromal vascular fraction (AD-SVF)?
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?
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?
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?
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 Facility Identification Number (assigned by ICCBBA when the facility registers to use ISBT 128)
A facility-defined product code
This element is optional. A default value of “000000” (zeroes) is used if the facility chooses not to define their own product code.
A standardized ISBT 128 Product Description Code
Product Description Codes can be found on the Product Description Codes table in the ISBT 128 Product Description Code Database.
9. Additional Information
The following document clarifies some misconceptions regarding the use of ISBT 128 for tissue and tissue-based products:
1. What are the registration fees and how are they calculated?
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 firstname.lastname@example.org.
4. My organization has multiple recovery locations. Does each recovery location need its own Facility Identification Number (FIN)?
5. My organization has multiple processing locations. Does each processing location need its own Facility Identification Number (FIN)?
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.