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Apheresis Collection Requirements and Guidance for Apheresis Centers

The goal of this effort is to create a standard document outlining recommendations for product manufacturers/sponsor requirements for apheresis cell collection. Part of this effort includes the creation of a standardized template for the leukapheresis manuals/SOPs written by product manufacturers/sponsors for the apheresis centers.

This combined effort will work to reduce the burden upon the collection centers and in doing so, reduce errors, and increase output and reduce the variation in apheresis collection requirements by establishing standard approaches to reduce the number of variable steps.

Data will be only be viewed/used in aggregate and will not be used outside of the standards effort. 
1.Do you have requirements and/or guidances for your apheresis centers?
2.Format of communications
What format do you provide these requirements in?
What format do you provide these guidances in?
SOP
Clinical Trial Protocol 
Apheresis Manual/Leukapheresis Manual
3.Apheresis Cell Collection Parameters (Please select all that apply)
We have requirements for specific ranges and/or actions for this parameter.
We have guidances for specific ranges and/or actions for this parameter.
We require that this parameter be documented.
We require that this parameter be reported back to the company.
We do not have requirements, guidances, or required documentation or reporting of this parameter.
Prefer not to say
Patient Identification
Health status
Infectious disease markers (IDM) status
Infectious disease markers (IDM) testing method(s)
Patient weight
Patient total blood volume
Medications
Peripheral blood counts/Hematology specs
Other patient readiness
Verification of label(s)
Number of total blood volume to be processed
Absolute liter volume to be processed
Apheresis system/equipment used
Equipment identifier
Reagents/kits used
Expiration dates of reagents/kits
Manufacturer/supplier of reagents/kits
Lot number of reagents/kits
Start time
End time
Flow rate (inlet)
Anticoagulant used
Anticoagulant infusion rate
Anticoagulant ratio
Product volume collected
Plasma volume collected
Tubing parameters
Length of tubing
Clamping/heat seals of bag
Product expiration
Additional local requirements
4.Are you willing to provide additional details on your required parameters? This information will be used only for the drafting of the PDA standard. If yes, please provide details or an email address below.
5.As a company do you apply different IDM requirements in different regions? 
6.What post-collection activities do you require for apheresis collection?
7.What format do you ask the hospital staff to use to document apheresis collection data?