[Internal Blind Samples for Blood Bank]

How do you define a test system in your labs for competency assessment?  

[Donors taking Testosterone]

We have seen a great increase in the number of donors taking testosterone. 

 

We have been deferring anyone who says their provider suggested they donate to lower their HCT while on testosterone as we feel these donors should be therapeutic donors. 

 

How are other centers handling these donors?

[Refrigerator validation]

When you write your PQ do you include testing the maximum number of units that can be stored in the refrigerator or freezer? Currently we monitor empty and then with at least 20 units per shelf. The FDA investigator indicated that we need to validate for the maximum number of products we could store in any one unit. I'm not sure how to tackle this so any advice would be appreciated!

[Antigen testing donor units]

Does anyone use a molecular method, like the BioArray BeadChip, to phenotype your donor units. If so are you labeling them as antigen negative or using this as a screen only?

[Pneumatic Tube Users]

Our facility uses several of the procedures people have mentioned previously we use secure transactions and have the units returned if the canister is not retrieved within 5 minutes and validate the trip time and temperatures.

In addition to these we also include LDH and K+ levels in our validation for PRBC products and include a small bag of wet ice with every refrigerated product sent via pneumatic tube.

[Cooler Validation: winter simulation]

Is anyone willing to share how they validate coolers for transport of products during the winter? :fingerscrOur facilities are located in a mountainous area and we often experience extremely cold and unpredictable weather.

[Are consignees required to provide the final disposition of a product?]

Are there FDA requirements that require consignees to provide the final disposition of a product when the product is included in a recall or market withdrawal?

I am looking for a CFR citation or a guidance document. Thanks for your help in advance.

[Returning Washed/Deglyc blood]

How is everyone accessing the acceptability of washed/deglyc units if they are returned to the Blood Bank? We routinely place a Hemotemp on every unit that is issued but because washed/deglyced units are usually not be cold enough (4° C for 10 hours per the package insert) the Hemotemp will not activate correctly. I would really appreciate any suggestions.

[Platelet QC]

I'm wondering about apheresis platelets. What do you consider issue? We distribute platelets to transfusion services who then issue for patients. As a collection facility is "issue" the distribution to the transfusion service?

[Platelet QC]

Those of you who work at collection/manufacturing facilities that are not part of a transfusion service, how are you complying with the standard to test platelet count and pH at the end of storage or issue?

[Platelet QC]

Those of you who work at collection/manufacturing facilities that are not part of a transfusion service, how are you complying with the standard to test platelet count and pH at the end of storage or issue?