US Specific ISBT 128: Frequently Asked Questions                 

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

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

3. When modifying a product where does the US license number appear?

4. What information am I required to have barcoded on my label?

5. 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? 

6. Am I required to specify in the ISBT 128 product code data structure (data structure 003) whether the unit is autologous, or directed?

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

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 into the DIN itself and there is a long turnaround time for ordering more labels?

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

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 1011and the other has a count of 2.7 x 1011.  What product codes should I use?  

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

12. What is Octaplas?

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

US Specific ISBT 128: Frequently Asked Questions

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 hand write the new expiration date/time.  However, if your facility does not transfuse the product and plans to keep it over 24 hours then you will 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. How do I handle the Donation Identification Number for a pooled product?

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

 

 3. When modifying a product where does the US license number appear?

The original processing facility (Facility A) will have their US License Number in the upper left quadrant of the label or the lower left quadrant. The modifying facility (Facility B) will have their US license number in the lower right quadrant.

See 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 (original processing facility) and the lower right (modifying facility).

If the unit is modified into an unlicensed product, neither US License Number shall appear on the modified unit.

4. What information am I required to have barcoded on my label?

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).

 

5. 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? 

Although some computer systems append the unit number, it is incorrect. In ISBT 128, the product code data structure has 8 characters.  The first 5 are considered the "product description code", the 6th identifies the type of donation, and the 7th and 8th characters are for divisions and splits. 

For divisions the 5-digit product description code remains the same and the 7th and 8th characters of the product code, which comprise the division code, change. These characters 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 products will be: E0164VB0, E0164VBa, and E0164VBb. Third level subdivisions (and beyond) are not encoded by ISBT 128.

6. 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 coded in the product code.  At this time Directed units are not required to be coded in the product code. 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. Although it is not mandatory yet to code directed in the product code data structure (data structure 003), it may be in the facility’s best interest to do so for billing purposes.  It is also required in the product code data structure to specify the type of donation (volunteer or paid); FDA does not permit the default value of “0” (not specified) to appear on products intended for transfusion. Recovered Plasma and Source Plasma units may have the “0” donation type.

 

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

Your autologous units must be encoded in the donation type as part of 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 into the DIN itself and there is a long turnaround time for ordering more labels?

The year in the DIN is only for the purpose of making the DIN unique over a 100 year period.  If you reach a point in 2012 where you think you need to order more DIN sets to be prepared for emergencies, it would be reasonable to order 2013 label sets early.  In an emergency, using the 2013 labels in October would be the last thing people would need to worry about.  So, it is suggested that collection facilities figure out how many number sets they will need to carry them through their label supplier’s turnaround time during emergency conditions.  Then order your next year’s label sets at a time (and in a volume) needed to ensure readiness.

9. 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 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 1011and 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 1011platelets.  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 1011platelets must include the attribute “<3E11 Platelets” in the Product Description Code.

For example:

  • Beginning product:  E3077V00 (Apheresis PLATELETS|ACD-A/XX/20-24C|ResLeu:<5E6, not divided)
  • 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., container 1 or container 2) if one of the resulting products is low yield.

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

A: The US Consensus Document v2.0.0 section 5.2 specifies, “Additive solutions will be listed on the line immediately after the proper name (and before the intended use cautionary statement, if applicable).”

Below is the label example for AS-7 (Solx)

AS-7

Note: Additive Solution AS-7 (Solx) has been approved for use by the FDA. This approval did not come in time for inclusion in the US Consensus draft document.

We are providing this sample label to supplement the examples in the US Consensus draft.

12. Q: What is Octaplas?

A: 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.

13. Q: If I have an Octaplas product and I thaw it, is it acceptable to cross out the original expiration and hand write the new expiration?

A: Yes, it is acceptable to cross out the expiration and hand write 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.