TRM.30700

[DAWNA1983 10]

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)

[R1R2 267]

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. 

[John C. Staley 945]

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.

[David Saikin 1,188]

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. 

[Cliff 322]

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.

[Patty 26]

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

[AMcCord 1,055]

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.

[David Saikin 1,188]

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.

[DebbieL 138]

You do not need to register with the FDA if you are just pooling, thawing, changing FFP to Thawed Plasma or splitting units like for pediatric use. The end product is basically the same as the beginning product.

However, if you take a product and make a new product then you would need to register with FDA. An example would be combining RBC with FFP to make whole blood for an exchange transfusion. The end product is different from the starting product.

I found a good explanation for this on the AABB site. 2012 ASK THE FDA and CLIA Transcript question #29. You can access and print these transcripts even if you are not a member of AABB. Hard to find on the site but persist.

A CAP inspector once told me I had to register with FDA because we used Thawed Plasma. He had a VERY superior attitude that he knew ALL things BB and his mission was to impart his wisdom to someone so inferior to him. I knew he was totally wrong but I wasn't going to call him out during an inspection. I'm dumb but not stupid. LOL