- I am a transfusion service that only thaws Fresh Frozen Plasma. Will I be required to re-label that unit?
- When modifying a product where does the US License Number appear?
- 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)?
- 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)?
- 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?
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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.
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.
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).
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 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, 2nd container, etc.) 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 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.
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.
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).