Resources to Prepare for FDA Final Guidance Deadline on Bacterial Mitigation in Platelets

On September 30, 2019, FDA released Final Guidance “Bacterial Risk Control Strategies for Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion” (“Final Guidance”) and provided an implementation deadline of March 2021. Below are resources to help you prepare for implementation as well as previous communications on this topic from Vitalant.

Previous Communications from Vitalant

September 2020 Update from Vitalant on Final Guidance
February 2020 Update from Vitalant on Final Guidance

Large Volume Delayed Sampling (LVDS) and Pathogen Reduction Technology (PRT) Codes and Labels

Apheresis Leuko-reduced platelets – LVDS 36 (HIGH priority to enter)
Description ISBT 128 Code Label Example
Apheresis PLATELETS|ACD-A/XX/20-24C|ResLeu:<5E6|Bacterial monitoring >=36h EA007V00*  
Apheresis PLATELETS|ACD-A/XX/20-24C|ResLeu:<5E6|1st container|Bacterial monitoring >=36h EA008V00*  
Apheresis PLATELETS|ACD-A/XX/20-24C|ResLeu:<5E6|2nd container|Bacterial monitoring >=36h EA009V00*  
Apheresis PLATELETS|ACD-A/XX/20-24C|ResLeu:<5E6|3rd container|Bacterial monitoring >=36h EA010V00*  
Apheresis PLATELETS|ACD-A/XX/20-24C|ResLeu:<5E6|<3E11 plts|Bacterial monitoring >=36h EA011V00*  
Apheresis PLATELETS|ACD-A/XX/20-24C|ResLeu:<5E6|1st container|<3E11 plts|Bacterial monitoring >=36h EA012V00*  
Apheresis PLATELETS|ACD-A/XX/20-24C|ResLeu:<5E6|2nd container|<3E11 plts|Bacterial monitoring >=36h EA013V00*  
Apheresis PLATELETS|ACD-A/XX/20-24C|ResLeu:<5E6|3rd container|<3E11 plts|Bacterial monitoring >=36h EA014V00*  
PLATELETS|ACD-A/XX/20-24C|Irradiated|ResLeu:<5E6|Bacterial monitoring >=36h EA015V00*  
Apheresis PLATELETS|ACD-A/XX/20-24C|Irradiated|ResLeu:<5E6|1st container|Bacterial monitoring >=36h EA016V00*  
Apheresis PLATELETS|ACD-A/XX/20-24C|Irradiated|ResLeu:<5E6|2nd container|Bacterial monitoring >=36h EA017V00*  
= Apheresis PLATELETS|ACD-A/XX/20-24C|Irradiated|ResLeu:<5E6|3rd container|Bacterial monitoring >=36h EA018V00*  
Apheresis PLATELETS|ACD-A/XX/20-24C|Irradiated|ResLeu:<5E6|<3E11 plts|Bacterial monitoring >=36h EA019V00*  
Apheresis PLATELETS|ACD-A/XX/20-24C|Irradiated|ResLeu:<5E6|1st container|<3E11 plts|Bacterial monitoring >=36h EA020V00*  
Apheresis PLATELETS|ACD-A/XX/20-24C|Irradiated|ResLeu:<5E6|2nd container|<3E11 plts|Bacterial monitoring >=36h EA021V00*  
Apheresis PLATELETS|ACD-A/XX/20-24C|Irradiated|ResLeu:<5E6|3rd container|<3E11 plts|Bacterial monitoring >=36h EA022V00*  
*Divided Code: VA0 – VE0

Apheresis Leuko-reduced platelets – LVDS 36 PAS-C (MEDIUM priority to enter)
Description ISBT 128 Code Label Example
Apheresis PLATELETS|ACD-A>PAS-C/XX/20-24C|ResLeu:<5E6|Bacterial monitoring >=36h EA136V00*  
Apheresis PLATELETS|ACD-A>PAS-C/XX/20-24C|ResLeu:<5E6|1st container|Bacterial monitoring >=36h EA137V00*  
Apheresis PLATELETS|ACD-A>PAS-C/XX/20-24C|ResLeu:<5E6|2nd container|Bacterial monitoring >=36h EA138V00*  
Apheresis PLATELETS|ACD-A>PAS-C/XX/20-24C|ResLeu:<5E6|3rd container|Bacterial monitoring >=36h EA139V00*  
Apheresis PLATELETS|ACD-A>PAS-C/XX/20-24C|ResLeu:<5E6|<3E11 plts|Bacterial monitoring >=36h EA140V00*  
Apheresis PLATELETS|ACD-A>PAS-C/XX/20-24C|ResLeu:<5E6|1st container|<3E11 plts|Bacterial monitoring >=36h EA141V00*  
Apheresis PLATELETS|ACD-A>PAS-C/XX/20-24C|ResLeu:<5E6|2nd container|<3E11 plts|Bacterial monitoring >=36h EA142V00*  
Apheresis PLATELETS|ACD-A>PAS-C/XX/20-24C|ResLeu:<5E6|3rd container|<3E11 plts|Bacterial monitoring >=36h EA143V00*  
Apheresis PLATELETS|ACD-A>PAS-C/XX/20-24C|Irradiated|ResLeu:<5E6|Bacterial monitoring >=36h EA152V00*  
Apheresis PLATELETS|ACD-A>PAS-C/XX/20-24C|Irradiated|ResLeu:<5E6|1st container|Bacterial monitoring >=36h EA153V00*  
Apheresis PLATELETS|ACD-A>PAS-C/XX/20-24C|Irradiated|ResLeu:<5E6|2nd container|Bacterial monitoring >=36h EA154V00*  
Apheresis PLATELETS|ACD-A>PAS-C/XX/20-24C|Irradiated|ResLeu:<5E6|3rd container|Bacterial monitoring >=36h EA155V00*  
Apheresis PLATELETS|ACD-A>PAS-C/XX/20-24C|Irradiated|ResLeu:<5E6|<3E11 plts|Bacterial monitoring >=36h EA156V00*  
Apheresis PLATELETS|ACD-A>PAS-C/XX/20-24C|Irradiated|ResLeu:<5E6|1st container|<3E11 plts|Bacterial monitoring >=36h EA157V00*  
Apheresis PLATELETS|ACD-A>PAS-C/XX/20-24C|Irradiated|ResLeu:<5E6|2nd container|<3E11 plts|Bacterial monitoring >=36h EA158V00*  
Apheresis PLATELETS|ACD-A>PAS-C/XX/20-24C|Irradiated|ResLeu:<5E6|3rd container|<3E11 plts|Bacterial monitoring >=36h EA159V00*  
*Divided Code: VA0 – VE0

Apheresis Leuko-reduced platelets – LVDS 36 PAS-F (LOW priority to enter)
Description ISBT 128 Code Label Example
Apheresis PLATELETS|ACD-A>PAS-F/XX/20-24C|ResLeu:<5E6|Bacterial monitoring >=36h EA023V00*  
Apheresis PLATELETS|ACD-A>PAS-F/XX/20-24C|ResLeu:<5E6|1st container|Bacterial monitoring >=36h EA024V00*  
Apheresis PLATELETS|ACD-A>PAS-F/XX/20-24C|ResLeu:<5E6|2nd container|Bacterial monitoring >=36h EA025V00*  
Apheresis PLATELETS|ACD-A>PAS-F/XX/20-24C|ResLeu:<5E6|3rd container|Bacterial monitoring >=36h EA026V00*  
Apheresis PLATELETS|ACD-A>PAS-F/XX/20-24C|ResLeu:<5E6|<3E11 plts|Bacterial monitoring >=36h EA027V00*  
Apheresis PLATELETS|ACD-A>PAS-F/XX/20-24C|ResLeu:<5E6|1st container|<3E11 plts|Bacterial monitoring >=36h EA028V00*  
Apheresis PLATELETS|ACD-A>PAS-F/XX/20-24C|ResLeu:<5E6|2nd container|<3E11 plts|Bacterial monitoring >=36h EA029V00*  
= Apheresis PLATELETS|ACD-A>PAS-F/XX/20-24C|ResLeu:<5E6|3rd container|<3E11 plts|Bacterial monitoring >=36h EA030V00*  
Apheresis PLATELETS|ACD-A>PAS-F/XX/20-24C|Irradiated|ResLeu:<5E6|Bacterial monitoring >=36h EA031V00*  
Apheresis PLATELETS|ACD-A>PAS-F/XX/20-24C|Irradiated|ResLeu:<5E6|1st container|Bacterial monitoring >=36h EA032V00*  
Apheresis PLATELETS|ACD-A>PAS-F/XX/20-24C|Irradiated|ResLeu:<5E6|2nd container|Bacterial monitoring >=36h EA033V00*  
Apheresis PLATELETS|ACD-A>PAS-F/XX/20-24C|Irradiated|ResLeu:<5E6|3rd container|Bacterial monitoring >=36h EA034V00*  
Apheresis PLATELETS|ACD-A>PAS-F/XX/20-24C|Irradiated|ResLeu:<5E6|<3E11 plts|Bacterial monitoring >=36h EA035V00*  
Apheresis PLATELETS|ACD-A>PAS-F/XX/20-24C|Irradiated|ResLeu:<5E6|1st container|<3E11 plts|Bacterial monitoring >=36h EA036V00*  
Apheresis PLATELETS|ACD-A>PAS-F/XX/20-24C|Irradiated|ResLeu:<5E6|2nd container|<3E11 plts|Bacterial monitoring >=36h EA037V00*  
Apheresis PLATELETS|ACD-A>PAS-F/XX/20-24C|Irradiated|ResLeu:<5E6|3rd container|<3E11 plts|Bacterial monitoring >=36h EA038V00*  
*Divided Code: VA0 – VE0

Apheresis Leuko-reduced platelets – LVDS 48 (HIGH Priority to enter)
Description ISBT 128 Code Label Example
Apheresis PLATELETS|ACD-A/XX/20-24C|ResLeu:<5E6|Bacterial monitoring E5030V00* Label Example
Apheresis PLATELETS|ACD-A/XX/20-24C|ResLeu:<5E6|1st container|Bacterial monitoring E5031V00* Label Example
Apheresis PLATELETS|ACD-A/XX/20-24C|ResLeu:<5E6|2nd container|Bacterial monitoring E5032V00* Label Example
Apheresis PLATELETS|ACD-A/XX/20-24C|ResLeu:<5E6|3rd container|Bacterial monitoring E5033V00* Label Example
Apheresis PLATELETS|ACD-A/XX/20-24C|ResLeu:<5E6|4th container|Bacterial monitoring E9930V00* Label Example
Apheresis PLATELETS|ACD-A/XX/20-24C|Irradiated|ResLeu:<5E6|Bacterial monitoring E5034V00* Label Example
Apheresis PLATELETS|ACD-A/XX/20-24C|Irradiated|ResLeu:<5E6|1st container|Bacterial monitoring E5035V00* Label Example
Apheresis PLATELETS|ACD-A/XX/20-24C|Irradiated|ResLeu:<5E6|2nd container|Bacterial monitoring E5036V00* Label Example
Apheresis PLATELETS|ACD-A/XX/20-24C|Irradiated|ResLeu:<5E6|3rd container|Bacterial monitoring E5037V00* Label Example
Apheresis PLATELETS|ACD-A/XX/20-24C|Irradiated|ResLeu:<5E6|4th container|Bacterial monitoring E9931V00* Label Example
Apheresis PLATELETS|ACD-A/XX/20-24C|ResLeu:<5E6|<3E11 plts|Bacterial monitoring E5075V00* Label Example
Apheresis PLATELETS|ACD-A/XX/20-24C|ResLeu:<5E6|1st container|<3E11 plts|Bacterial monitoring E5370V00* Label Example
Apheresis PLATELETS|ACD-A/XX/20-24C|ResLeu:<5E6|2nd container|<3E11 plts|Bacterial monitoring E5371V00* Label Example
Apheresis PLATELETS|ACD-A/XX/20-24C|ResLeu:<5E6|3rd container|<3E11 plts|Bacterial monitoring E5372V00* Label Example
Apheresis PLATELETS|ACD-A/XX/20-24C|ResLeu:<5E6|4th container|<3E11 plts|Bacterial monitoring E9932V00* Label Example
Apheresis PLATELETS|ACD-A/XX/20-24C|Irradiated|ResLeu:<5E6|<3E11 plts|Bacterial monitoring E5073V00* Label Example
Apheresis PLATELETS|ACD-A/XX/20-24C|Irradiated|ResLeu:<5E6|1st container|<3E11 plts|Bacterial monitoring E5532V00* Label Example
Apheresis PLATELETS|ACD-A/XX/20-24C|Irradiated|ResLeu:<5E6|2nd container|<3E11 plts|Bacterial monitoring E5533V00* Label Example
Apheresis PLATELETS|ACD-A/XX/20-24C|Irradiated|ResLeu:<5E6|3rd container|<3E11 plts|Bacterial monitoring E5534V00* Label Example
Apheresis PLATELETS|ACD-A/XX/20-24C|Irradiated|ResLeu:<5E6|4th container|<3E11 plts|Bacterial monitoring E9933V00* Label Example
*Divided Code: VA0 – VE0

Apheresis Leuko-reduced platelets – volume reduced (Medium priority to enter)
Description ISBT 128 Code Label Example
Apheresis PLATELETS|ACD-A/XX/20-24C|Open|ResLeu:<5E6|Plasma reduced E3015V00*
Previously provided
 
Apheresis PLATELETS|ACD-A/XX/20-24C|Open|ResLeu:<5E6|Plasma reduced|1st container E3017V00*
Previously provided
 
Apheresis PLATELETS|ACD-A/XX/20-24C|Open|ResLeu:<5E6|Plasma reduced|2nd container E3018V00*
Previously provided
 
Apheresis PLATELETS|ACD-A/XX/20-24C|Open|ResLeu:<5E6|Plasma reduced|3rd container E3019V00*
Previously provided
 
Apheresis PLATELETS|ACD-A/XX/20-24C|Open|ResLeu:<5E6|Plasma reduced|4th container E3020V00*
Previously provided
 
Apheresis PLATELETS|ACD-A/XX/20-24C|Open|Irradiated|ResLeu:<5E6|Plasma reduced E2984V00*
Previously provided
 
Apheresis PLATELETS|ACD-A/XX/20-24C|Open|Irradiated|ResLeu:<5E6|Plasma reduced|1st container E2986V00*
Previously provided
 
Apheresis PLATELETS|ACD-A/XX/20-24C|Open|Irradiated|ResLeu:<5E6|Plasma reduced|2nd container E2987V00*
Previously provided
 
Apheresis PLATELETS|ACD-A/XX/20-24C|Open|Irradiated|ResLeu:<5E6|Plasma reduced|3rd container E2988V00*
Previously provided
 
Apheresis PLATELETS|ACD-A/XX/20-24C|Open|Irradiated|ResLeu:<5E6|Plasma reduced|4th container E2989V00*
Previously provided
 
*Divided Code: VA0 – VE0

Apheresis Leuko-reduced platelets – Washed (Medium Priority to enter)
Description ISBT 128 Code Label Example
Washed Apheresis PLATELETS|None/XX/20-24C|Open|ResLeu:<5E6 E3556V00*
Previously provided
 
Washed Apheresis PLATELETS|None/XX/20-24C|Open|ResLeu:<5E6|1st container E3558V00*
Previously provided
 
Washed Apheresis PLATELETS|None/XX/20-24C|Open|ResLeu:<5E6|2nd container E3559V00*
Previously provided
 
Washed Apheresis PLATELETS|None/XX/20-24C|Open|ResLeu:<5E6|3rd container E3560V00*
Previously provided
 
Washed Apheresis PLATELETS|None/XX/20-24C|Open|ResLeu:<5E6|4th container E3561V00*
Previously provided
 
Washed Apheresis PLATELETS|None/XX/20-24C|Open|Irradiated|ResLeu:<5E6 E3541V00*
Previously provided
 
Washed Apheresis PLATELETS|None/XX/20-24C|Open|Irradiated|ResLeu:<5E6|1st container E3543V00*
Previously provided
 
Washed Apheresis PLATELETS|None/XX/20-24C|Open|Irradiated|ResLeu:<5E6|2nd container E3544V00*
Previously provided
 
Washed Apheresis PLATELETS|None/XX/20-24C|Open|Irradiated|ResLeu:<5E6|3rd container E3545V00*
Previously provided
 
Washed Apheresis PLATELETS|None/XX/20-24C|Open|Irradiated|ResLeu:<5E6|4th container E3546V00*
Previously provided
 
*Divided Code: VA0 – VE0

Apheresis Leuko-reduced platelets – Psoralen Treated (HIGH priority to enter)
Description ISBT 128 Code Label Example
Apheresis PLATELETS|ACD-A/XX/20-24C|ResLeu:<5E6|Psoralen-treated E8331*  
Apheresis PLATELETS|ACD-A/XX/20-24C|ResLeu:<5E6|1st container|Psoralen-treated E8332*  
Apheresis PLATELETS|ACD-A/XX/20-24C|ResLeu:<5E6|2nd container|Psoralen-treated E8333*  
Apheresis PLATELETS|ACD-A/XX/20-24C|ResLeu:<5E6|3rd container|Psoralen-treated E8334*  
Apheresis PLATELETS|ACD-A/XX/20-24C|ResLeu:<5E6|<3E11 plts|Psoralen-treated E8335*  
Apheresis PLATELETS|ACD-A/XX/20-24C|ResLeu:<5E6|1st container|<3E11 plts|Psoralen-treated E8971*  
Apheresis PLATELETS|ACD-A/XX/20-24C|ResLeu:<5E6|2nd container|<3E11 plts|Psoralen-treated E8972*  
Apheresis PLATELETS|ACD-A/XX/20-24C|ResLeu:<5E6|3rd container|<3E11 plts|Psoralen-treated E8973*  
*Divided Code: VA0 – VE0

Apheresis Leuko-reduced platelets – Psoralen Treated Volume Reduced (Low priority to enter)
Description ISBT 128 Code Label Example
Apheresis PLATELETS|ACD-A/XX/20-24C|ResLeu:<5E6|Plasma reduced|Psoralen-treated E8728*  
Apheresis PLATELETS|ACD-A/XX/20-24C|ResLeu:<5E6|Plasma reduced|1st container|Psoralen-treated E8729*  
Apheresis PLATELETS|ACD-A/XX/20-24C|ResLeu:<5E6|Plasma reduced|2nd container|Psoralen-treated E8730*  
Apheresis PLATELETS|ACD-A/XX/20-24C|ResLeu:<5E6|Plasma reduced|3rd container|Psoralen-treated E8731*  
Apheresis PLATELETS|ACD-A/XX/20-24C|ResLeu:<5E6|Plasma reduced|<3E11 plts|Psoralen-treated E8732*  
Apheresis PLATELETS|ACD-A/XX/20-24C|ResLeu:<5E6|Plasma reduced|1st container|<3E11 plts|Psoralen-treated E9272*  
Apheresis PLATELETS|ACD-A/XX/20-24C|ResLeu:<5E6|Plasma reduced|2nd container|<3E11 plts|Psoralen-treated E9276*  
*Divided Code: VA0 – VE0

Apheresis Leuko-reduced platelets – Psoralen Treated Washed (Low priority to enter)
Description ISBT 128 Code Label Example
Washed Apheresis PLATELETS|None/XX/20-24C|Open|ResLeu:<5E6|Psoralen-treated E8695*  
Washed Apheresis PLATELETS|None/XX/20-24C|Open|ResLeu:<5E6|1st container|Psoralen-treated E8696*  
Washed Apheresis PLATELETS|None/XX/20-24C|Open|ResLeu:<5E6|2nd container|Psoralen-treated E8697*  
Washed Apheresis PLATELETS|None/XX/20-24C|Open|ResLeu:<5E6|3rd container|Psoralen-treated E8698*  
Washed Apheresis PLATELETS|None/XX/20-24C|Open|ResLeu:<5E6|<3E11 plts|Psoralen-treated E8727*  
Washed Apheresis PLATELETS|None/XX/20-24C|Open|ResLeu:<5E6|1st container|<3E11 plts|Psoralen-treated E9275*  
Washed Apheresis PLATELETS|None/XX/20-24C|Open|ResLeu:<5E6|2nd container|<3E11 plts|Psoralen-treated E9279*  
*Divided Code: VA0 – VE0

Apheresis Leuko-reduced platelets – Psoralen treated PAS-C (HIGH priority to enter)
Description ISBT 128 Code Label Example
Apheresis PLATELETS|ACD-A>PAS-C/20-24C|ResLeu:<5E6|Psoralen-treated E8340*  
Apheresis PLATELETS|ACD-A>PAS-C/20-24C|ResLeu:<5E6|1st container|Psoralen-treated E8341*  
Apheresis PLATELETS|ACD-A>PAS-C/20-24C|ResLeu:<5E6|2nd container|Psoralen-treated E8342*  
Apheresis PLATELETS|ACD-A>PAS-C/20-24C|ResLeu:<5E6|3rd container|Psoralen-treated E8343*  
Apheresis PLATELETS|ACD-A>PAS-C/20-24C|ResLeu:<5E6|<3E11 plts|Psoralen-treated E8344*  
Apheresis PLATELETS|ACD-A>PAS-C/20-24C|ResLeu:<5E6|1st container|<3E11 plts|Psoralen-treated E9138*  
Apheresis PLATELETS|ACD-A>PAS-C/20-24C|ResLeu:<5E6|2nd container|<3E11 plts|Psoralen-treated E9139*  
Apheresis PLATELETS|ACD-A>PAS-C/20-24C|ResLeu:<5E6|3rd container|<3E11 plts|Psoralen-treated E9140*  
*Divided Code: VA0 – VE0