Michele Herman Posted August 29, 2017 Share Posted August 29, 2017 How are people checking new blood bank reagent lots and shipments to satisfy CAP standard com.30450 "New reagent lots and shipments are checked against old reagent lots or with suitable reference material before or concurrently with being placed in service." What kinds of samples are you using? Is anyone using patient samples or external QC materials? Link to comment Share on other sites More sharing options...
SMILLER Posted August 30, 2017 Share Posted August 30, 2017 I would say that for many BB applications, the bit about "or with suitable reference material" would include adequacy by using standard QC materials before testing patients. Scott John C. Staley and AuntiS 2 Link to comment Share on other sites More sharing options...
Malcolm Needs ☆ Posted August 30, 2017 Share Posted August 30, 2017 1 hour ago, SMILLER said: I would say that for many BB applications, the bit about "or with suitable reference material" would include adequacy by using standard QC materials before testing patients. Scott Who defines what is suitable? The person being inspected or the person doing the inspection? Sadly, in my experience, some of those doing the inspecting, particularly if blood transfusion is not their primary discipline (or, in one famous case, had never worked in blood transfusion in his entire life) are not up to speed with what is or is not suitable, and, as far as their knowledge of blood transfusion is concerned, are not the "sharpest knife in the canteen of cutlery", but have all the power, and are determined to use it at all costs. John C. Staley, Marilyn Plett, SMILLER and 1 other 4 Link to comment Share on other sites More sharing options...
SMILLER Posted August 30, 2017 Share Posted August 30, 2017 Malcolm makes a good point -- at least so far as you really do need to check with your regulators (CAP, JCAHO, FDA) before committing yourself to any P&P. I have found that CAP inspectors are knowledgeable (they use acting lab people for inspectors) and do indeed like to work with labs on questions like these, and are not necessarily keen on proving anything. Anyway, check your standards, be they CAP or whatever, they should have examples of compliance with each one. Scott AuntiS and Malcolm Needs 2 Link to comment Share on other sites More sharing options...
jalomahe Posted August 31, 2017 Share Posted August 31, 2017 All reagents are QC'd in accordance with the package inserts. We use Immucor reagents so our we use "corQC" to QC traditional reagents (ABO, Rh, antibody screen). We use reagent screen or panel cells for Pos/Neg QC for antigen typing sera. The only lot-to-lot QC we do is for Fetal Bleed Screen Kit with a lot-to-lot QC. We haven't had any problems with CAP inspectors with this QC plan. Link to comment Share on other sites More sharing options...
Michele Herman Posted August 31, 2017 Author Share Posted August 31, 2017 Thanks for your replies. I posed this question to CAP and their reply was in line with your response above in that this standard (com.30450) is relevant to the fetal blood screen kits which contain controls. Do you have an external control material that you are using to compare lots for the FMH kits? We have thought of using patient specimens, but we rarely encounter a positive patient. Link to comment Share on other sites More sharing options...
TreeMoss Posted August 31, 2017 Share Posted August 31, 2017 When we receive new reagents, we crosscheck with the current anti-sera and use cells currently in use as well as the cells that most recently expired. Crosschecking the fetal bleed screen kits (we use FMH RapidScreen - Immucor), we use the new anti-D with the old kit cells (controls and indicator cells) and the old anti-D with the new kit cells. We crosscheck the antibody panels when they are received against the panel currently in use using diluted anti-D reagent to give 1+ reactions. AuntiS 1 Link to comment Share on other sites More sharing options...
exlimey Posted September 1, 2017 Share Posted September 1, 2017 13 hours ago, TreeMoss said: We crosscheck the antibody panels when they are received against the panel currently in use using diluted anti-D reagent to give 1+ reactions. How does that process "qualify" the Rh- cells ? Malcolm Needs 1 Link to comment Share on other sites More sharing options...
TreeMoss Posted September 5, 2017 Share Posted September 5, 2017 As long as the panel in in date, CAP says that we only need to check to make sure the reactivity matches the previous panel. If you are using expired cells as rule-out cells, you would need to check them for reactivity on that positive antigen. Link to comment Share on other sites More sharing options...
Recommended Posts
Create an account or sign in to comment
You need to be a member in order to leave a comment
Create an account
Sign up for a new account in our community. It's easy!
Register a new accountSign in
Already have an account? Sign in here.
Sign In Now