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Question about TRM.30700 - QC Records - The records indicate that when components are prepared that do not meet the quality control requirements, corrective action is taken and records maintained.

We are a small hospital that does not "prepare" components.....Is this question for bigger hospitals that might collect donors?  Or does this refer to "blood inspection" as the units enter the blood bank and units that are issued?

Maybe I'm reading too much into this....

Dawn Arnett-Wingham, MT(ASCP)

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For a smaller hospital that does not "prepare" components this could apply to  FFP that is thawed and a clot is present what steps do you take. 

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For me this would come down to how either you or an inspector chooses to define prepare realizing the inspector will change with every inspection.  It will be interesting to see how an current inspectors/assessors will respond to your question.  Personally, for a small facility that does nothing more than the occasional thawing of FFP, I would not worry about it.

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As an inspector for >20 yrs:  unless you are making packed cells, modified WB, splitting unit, drawing donors - I would mark this question as NA. 

If, as noted above, you had a thawed plasma with a clot - you would note that in your inspection prior to release and deal w it appropriately. 

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I have never read CAP Standards.  Does the section header that Standard is listed under give a clue as to whether they are talking about the actual manufacture of products from WB?  I consider performing a crossmatch to be preparing, along with washing, pooling, thawing...

The Standard as you stated talks about quality control.  That leads me to believe it refers to manufacture from WB.  One inspects the integrity of a product at issue, not perform quality control.

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Thawing FFP is not considered preparing components so I would mark it NA.   FYI.. You need an FDA license/inspection if you prepare components.

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I have marked that one N/A for years - we don't prepare (manufacture) blood products. Just get them ready for transfusion, which is crossmatching, thawing, pooling (if you do that), etc. No inspection problems.

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22 hours ago, Patty said:

Thawing FFP is not considered preparing components so I would mark it NA.   FYI.. You need an FDA license/inspection if you prepare components.

You only need to be registered unless shipping interstate.

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