lisgriggs

If you use a PPID computer system for specimen collection for transfusion does the system need to be 510K cleared. We are looking at EPIC/Beaker BPAM. EPIC uses ROVER for specimen collection which is not 510K cleared. Our LIS team does not think the specimen collection piece has to be 510K cleared.

Thanks, I did that.

I am validating shipping boxes for platelets and red cells. I am validating for the maximum number of products that will be packed in the shipping container right now. Do I need to validate the box for one product? I am using a data logger with a probe that I am sandwiching between the blood product bags. I am not sure how I can do this with one unit of red cells. Liz

If I purchase ThermoSafe insulated shipping boxes that are prequalified at room temp for 24 hours do I need to validate them for shipping apheresis products? The model is E38PLATE. The website says that a "Qualification Report" is included. Thanks.

Are apheresis platelets acceptable if the room temperature of the collection facility was 26 degrees celsius at the time of collection? AABB standard 5.6.5.1 says that "Apheresis platelets shall be transported and stored in a manner intended to cool the Apheresis platelets toward a temperature range of 20 to 24 celsius". The platelets were 26 degrees celsius when they reached the processing lab.

Should we validate our coolers sent to the Operating Rooms and nursing floors with red cells and than again separately with thawed plasma? We validated them with red cells.