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