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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 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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  • 3 months later...

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

 

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  • 5 months later...
  • 2 years later...

I found this on the 2012 AABB Ask the FDA and CLIA Transcript. Kind of old but I think still relevant. I saved because I once had an inspector that stated I had to be registered with the FDA to thaw FFP. (??!?) I knew it wasn't right but I didn't want to argue in the middle of an inspection and I didn't have anything in writing. Basically if you don't make a completely new different product, you don't have to register. If you take a product and make something completely different, you do have to register, e.g irradiating a unit creates a totally different product.

Hope this helps

Question 29: When is a transfusion service required to be FDA registered? Do the following processes require the facility to be registered? These examples were received from 4 different facilities.

thaw plasma and split RBCs
receive washed red cells from the blood supplier and then add plasma for an exchange transfusion
divide red cell or platelet products for pediatric use
re-label thawed fresh frozen plasma to thawed plasma
MS. CIARALDI: There's an easy answer, which is no, yes, no, no, but what I'd like to do is just take some time to explain why. The regulation that states who must or who is required to register is 21 CFR 607.20. It says specifically any establishment that manufactures a blood product must register, and there are some other criteria, but that's the main one that applies here. Additionally, there is a regulation 21 CFR 607.65(f), that lists some exceptions under which a transfusion service does not need to register, but that's a very limited and specific list. Now, to go on to the specific examples here, what I'd like to do is bunch bullets one, three, and four together. In those three situations, a transfusion service would not need to register. Thawing plasma to prepare it for a transfusion we don't consider the manufacturing of a product. So that is why that particular practice is exempt. In addition, splitting or dividing units for whatever reason, usually pediatric reason, is also not manufacturing a product. The end product is the same as the starting product. It's just smaller volumes. So that is the rationale behind why that would also not need registration. However, in the second bullet, washed red blood cells has plasma added to it, and the final product, which is sometimes called reconstituted whole blood or reconstituted red cells, is used for exchange transfusion. The answer to this is that, yes, registration is required, because the transfusion service is making a new product. The reconstituted whole blood is the new product. The final product, the whole blood product, is different from the two original starting products. So there is manufacturing of a product going on in this particular situation.

MODERATOR: Thank you, Judy.

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