- I am a transfusion service that only thaws Fresh Frozen Plasma. Will I be required to re-label that unit?
- How do I assign the Donation Identification Number for a pooled product?
- When modifying a product where does the US License Number appear?
- What information am I required to have bar coded on my label?
- 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?
- Am I required to specify in the ISBT 128 Product Code data structure (data structure 003) whether the unit is autologous, or directed?
- Must I encode the donation type in the ABO/Rh data structure (data structure 002)?
- In the chance of a catastrophic event that could result in my blood center receiving an unusually larger number of blood donations, how can we prepare ourselves to accommodate for the sudden need of extra Donation Identification Numbers (DINs) without stocking up and wasting the unused labels at the end of each year, since the collection year is incorporated in the DIN itself and there is a long turnaround time for ordering more labels?
- For facilities located in the US, how should the labeling of Reconstituted Red Blood Cells be handled?
- My facility is in the US. I have a platelet apheresis collection with a platelet count of 5.8 x 1011. I have divided it into two products. One has a count of 3.1 x 1011and the other has a count of 2.7 x 1011. What Product Codes should I use?
- How do I label Red Blood Cell products with the additive AS-7 (Solx)?
- What is Octaplas?
- If I have an Octaplas product and I thaw it, is it acceptable to cross out the original expiration and handwrite the new expiration?
- How do I label my psoralen-treated products?
US Specific ISBT 128: Frequently Asked Questions
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 then, 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.
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.
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 the FDA Guidance for Industry – Cooperative Manufacturing Arrangements for Licensed Biologics November 2008 (Section IV, C).
(View the document here) – PDF
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.
At a minimum, FDA requires machine-readable labels for a unique facility identifier, lot number relating to the donor (unit number), product code, and ABO/Rh. This is specified under 21 CFR 606.121(c)(13)(iii).
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.
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.
The "autologous" donation type must be encoded in the ABO data structure (data structure 002). If a "directed" unit cannot be crossed over, it should be encoded in the ABO/Rh data structure. If a "directed" unit may be crossed over, it should not be encoded in the ABO/Rh data structure in the U.S.
8. In the chance of a catastrophic event that could result in my blood center receiving an unusually larger number of blood donations, how can we prepare ourselves to accommodate for the sudden need of extra Donation Identification Numbers (DINs) without stocking up and wasting the unused labels at the end of each year, since the collection year is incorporated in the DIN itself and there is a long turnaround time for ordering more labels?
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.
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.
10. My facility is in the US. I have a platelet apheresis collection with a platelet count of 5.8 x 1011. I have divided it into two products. One has a count of 3.1 x 1011 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 1011 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 1011 platelets: E3077VA0 (Apheresis PLATELETS|ACD-A/XX/20-24C|ResLeu:<5E6, divided)
- Product with 2.7 x 1011 platelets: E4643VB0 (Apheresis PLATELETS|ACD-A/XX/20-24C|ResLeu:<5E6|<3E11 plts, divided)
It does not matter which product becomes A0 and which becomes B0. However, it is recommended that facilities develop a policy for which Division Code is assigned to the “standard” product and which is assigned to the low yield product, and then be consistent in following their policy.
Please note that this means you may not use container attributes (e.g., 1st container or 2nd container) if one of the resulting products is of low yield.
For more information regarding the labeling of Apheresis Platelets in the US, please reference TB-003 Apheresis Platelets - US Guidance.
Section 6.1 in IG-002 United States Consensus Standard for the Uniform Labeling of Blood and Blood Components Using ISBT 128 v3.0.0 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.
Octaplas (manufactured by Octapharma) is pooled human plasma that has been solvent/detergent treated to inactivate pathogens. More information may be found on the FDA website.
Yes, it is acceptable to cross out the expiration and handwrite the new expiration date and time. The thawed product must be used within 12 hours if stored at 2-4 °C or within 3 hours if stored at 20-25 °C.
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 document Standard Terminology for Blood, Cellular Therapy, and Tissue Product Descriptions. See label example below. This serves as specific guidance for labeling psoralen-treated products that is not provided in the US Consensus Standard for Blood v3.0.0.