I am currently building new products for the LVDS and PRT platelet units we will be receiving in early spring 2021.  We are not performing PGD testing.   I have a lot of codes to build because we are a children's hospital who irradiates, divides and aliquots into syringes.  Therefore I need the original product code, the irradiated product code and a product code in an open mode for both the original product (in case someone spikes a unit) and the irradiated product.  I can't find on the ICCBBA website where there are product codes for the open mode for my LVDS products.  There are open codes for the PRT.  Do you guys think it will be acceptable to instead of changing the product code to an open code that instead we just change the expiration date to 4 hours?  I've asked ICCBBA via email on 11/27 but no reply to date and I'm on a time crunch since I'm also upgrading our HCLL Transfusion 2016 to WellSky Transfusion 2020 at the same time!!

I am at a pediatric hospital as well.  I requested open codes for the LVDS components our suppliers will be sending us.  After we irradiate them of course.

I ended up requesting new codes through ICCBBA yesterday.  Hopefully they can expedite the request since one of our vendors is implementing their LVDS platelets Feb 1.  Once I get the codes I will attach them for all to use.

At our hospital, when apheresis platelets are aliquoted in  the syringe we just change the expiration to 4 hours instead of changing the product code. 

I wish it were easy to change the expiration date/time, but because of the way our computer system, WellSky Transfusion, works if we change the expiration date/time it requires about 3-4 exception overrides (quality capture for doing something outside normal).  I tried building the modifying to a syringe process for these codes but because they have the same formula if I change the build just for these products it changes for every product with the same attributes.  ICCBBA did email me back, however, yesterday after I tried to expedite the request and:

Bacterial Monitoring attribute values cannot be combined with the System Integrity attribute value "Open." These attributes contradict one another, as "Open" shortens the product's expiration and "Bacterial monitoring" extends the product's expiration.

For your platelet products with an “Open” system integrity, you will need to use a code that omits the “Bacterial monitoring” attribute. Codes for these already exist:

• E3014 = Apheresis PLATELETS|ACD-A/XX/20-24C|Open|ResLeu:<5E6
• E8365 = Apheresis PLATELETS|ACD-A>PAS-C/XX/20-24C|Open|ResLeu:<5E6

But then when I was looking for open codes for our >36 hour bacterial monitoring units (EA141-EA143 and EA157-EA159) I found those codes missing.  So I requested 6 codes to be build.  Hopefully they will fill this request or at least tell me how to make it work.

Hello:

Below is the information we received from ICCBBA regarding the bacterial monitored Platelets in an open system. 

Product Descriptions cannot contain a Bacterial Monitoring/Testing attribute in combination with any of the following:

•             Washed modifier

•             Open system attribute

•             Plasma reduced attribute

The Bacterial Monitoring/Testing attributes are used to indicate an extension of the expiry date, whereas Washed, Open, and Plasma Reduced shorten the expiration. Any of these three would conflict with the Bacterial Monitoring/Testing attribute within the same product description. 

If you wash, plasma reduce, or specify the product as an open system, then the Bacterial Monitoring/Testing attribute value would need to be omitted. 

 

Thanks 

 

If you wash, plasma reduce, or specify the product as an open system, then the Bacterial Monitoring/Testing attribute value would need to be omitted. 

In Soft, our LIS system there is a field in the blood product setup to enter outdate for a open system. Every time product is divided, new label prints with product code with -A0, B0... and expiration D/T and label requires the label verification.

So I am wondering if divided LVDS platelets can be labeled with the same product code with A0, B0....division and 4 hours expiration or not.

 

 

49 minutes ago, NLiveris said:

Hello:

Below is the information we received from ICCBBA regarding the bacterial monitored Platelets in an open system. 

Product Descriptions cannot contain a Bacterial Monitoring/Testing attribute in combination with any of the following:

•             Washed modifier

•             Open system attribute

•             Plasma reduced attribute

The Bacterial Monitoring/Testing attributes are used to indicate an extension of the expiry date, whereas Washed, Open, and Plasma Reduced shorten the expiration. Any of these three would conflict with the Bacterial Monitoring/Testing attribute within the same product description. 

If you wash, plasma reduce, or specify the product as an open system, then the Bacterial Monitoring/Testing attribute value would need to be omitted. 

 

Thanks 

 

What do you do with a syringe aliquot that is made from a unit that has had bacterial testing?

Here's the remaining 'open' product codes that I was missing form before in case anyone needs them.  

·         EA473 = Apheresis PLATELETS|ACD-A>PAS-C/XX/20-24C|Open|ResLeu:<5E6|1st container|<3E11 plts

·         EA474 = Apheresis PLATELETS|ACD-A>PAS-C/XX/20-24C|Open|ResLeu:<5E6|2nd container|<3E11 plts

·         EA475 = Apheresis PLATELETS|ACD-A>PAS-C/XX/20-24C|Open|ResLeu:<5E6|3rd container|<3E11 plts

·         EA476 = Apheresis PLATELETS|ACD-A>PAS-C/XX/20-24C|Open|Irradiated|ResLeu:<5E6|1st container|<3E11 plts

·         EA477 = Apheresis PLATELETS|ACD-A>PAS-C/XX/20-24C|Open|Irradiated|ResLeu:<5E6|2nd container|<3E11 plts

·         EA478 = Apheresis PLATELETS|ACD-A>PAS-C/XX/20-24C|Open|Irradiated|ResLeu:<5E6|3rd container|<3E11 plts

I know when we first went up on HCLL Transfusion in 2013 my first FDA inspection afterward reviewed our build and the inspector commented on the fact that we were compliant with ICCBBA standards and guidance by changing the product code for every modification which for us means irradiation, washing (RBC only) and placing products in an open system (syringe, spiked unit, or if the seal breaks using the sterile docker).  All the other inspections after that haven't looked as closely.  I'm sure it might be okay to just change the expiration date/time however, since there are product codes specifically for an open system and I have a process I will continue to build the same way.