I know this topic has been beat up so many times but recently an Ortho rep visited our lab and told us that Ortho revised the IFU for the Panel A and B removing the requirement periodically testing the panel cells for weak antibodies and that we don't really need to do QC.

We've been doing QC for years using diluted antisera and seems like we're only proving the reaction or presence of those antigens. I never had a CAP inspector asked me about panel cells QC. I also called CAP and they agreed that QC on panel cells are not required. 

Are you still performing QC on panels cells on your facilities?

 

Edited March 18, 20223 yr by bman2k

5 hours ago, bman2k said:

I know this topic has been beat up so many times but recently an Ortho rep visited our lab and told us that Ortho revised the IFU for the Panel A and B removing the requirement periodically testing the panel cells for weak antibodies and that we don't really need to do QC.

We've been doing QC for years using diluted antisera and seems like we're only proving the reaction or presence of those antigens. I never had a CAP inspector asked me about panel cells QC. I also called CAP and they agreed that QC on panel cells are not required. 

Are you still performing QC on panels cells on your facilities?

 

My experience is a little different. We actually had a CAP inspector cite us for not performing qc (1 pos, 1 neg control) on our in lot, unexpired panel cells (Immucor Panel 16) with each run about 7 years ago. We have been doing it since. We only use the liquid panels when we need to rule out additional antigens that the ECHO (solid phase) panel did not exclude. Since we are going from solid phase to ECHO, it does make sense to be sure that the antibody does react in the additional matrix via controls. However, I still disagreed with the need to run a positive and negative control on an in date panel.

In all my years (30+) in blood banks and transfusion services I never QC'd panels and it was never addressed in any inspections/assessments.  When ever the subject came up I figured that if you were not QCing every antigen on every cell you were doing little more than providing some random inspector with smoke and mirrors so they would think you are doing something worth while.  A some point you need to trust the manufactures to do their job.  

John C. Staley, in my 30+ years also, we have never QC'd panels and have never been cited )we are AABB, CAP and FDA inspected).

It seems a waste of time and resources as I cannot see how a lab could possibly QC a pannel even approaching what the manufacturer is required to do. 

14 hours ago, Ensis01 said:

It seems a waste of time and resources as I cannot see how a lab could possibly QC a pannel even approaching what the manufacturer is required to do. 

I could NOT agree more, particularly as most of the antibodies available are exceedingly strong monoclonal antibodies, which will QC NOTHING, and as the equilibrium constant of a truly weak antibody is quite different from that of a diluted strong antibody, particularly a strong monoclonal antibody, so just what do these inspectors think we are "QCing" using such antibodies.  It is utter nonsense.

On 3/18/2022 at 11:21 AM, John C. Staley said:

In all my years (30+) in blood banks and transfusion services I never QC'd panels and it was never addressed in any inspections/assessments.  When ever the subject came up I figured that if you were not QCing every antigen on every cell you were doing little more than providing some random inspector with smoke and mirrors so they would think you are doing something worth while.  A some point you need to trust the manufactures to do their job.  

Agreed. Anything less than a full phenotype is useless. We don't even do that for Screening Cells, which are arguably a lot more important.

So our sister lab was cited last week (September 2022) by TJC for not QCing panel cells. That lab had at one time been a branch of a reference lab so of course they never QC'ed panel cells for reasons given above.  We are arguing back that it is a procedural QC process that we would never do a panel if the screen was negative.  So if they don't react when they expect them to then we do other processes.  (ie repeat, check for gel junk/misc reactivity in the screen, run it on tube, etc).  Our lab does QC our panels on receipt (because a TJC surveyor told us to years back) to make sure they are reactive, but we currently do not Qc them every day of use.  And the IFU now states that we need to look at our "regional and national guidance, standards, regulations and professional preferences. and Each lab must develop specific procedures..."  All AABB states is to have a QC policy that works basically.  

I told our manager to ask them exactly what they want.  (I am sure every surveyor will be different, and  we may just have to satisfy them with the smoke and mirrors QC unfortunately.)

Edited September 30, 20222 yr by ElinF

22 hours ago, ElinF said:

So our sister lab was cited last week (September 2022) by TJC for not QCing panel cells. That lab had at one time been a branch of a reference lab so of course they never QC'ed panel cells for reasons given above.  We are arguing back that it is a procedural QC process that we would never do a panel if the screen was negative.  So if they don't react when they expect them to then we do other processes.  (ie repeat, check for gel junk/misc reactivity in the screen, run it on tube, etc).  Our lab does QC our panels on receipt (because a TJC surveyor told us to years back) to make sure they are reactive, but we currently do not Qc them every day of use.  And the IFU now states that we need to look at our "regional and national guidance, standards, regulations and professional preferences. and Each lab must develop specific procedures..."  All AABB states is to have a QC policy that works basically.  

I told our manager to ask them exactly what they want.  (I am sure every surveyor will be different, and  we may just have to satisfy them with the smoke and mirrors QC unfortunately.)

Do you think it too passive aggressive to ask if you are required to QC ALL the low and high incident antigens on the panel especially those that you have no antisera for (or the cells to QC that antisera)? You could also ask them if and how you should QC the antigen variants on each panel!

I use to work for a blood bank that QC'd expired panel cells when it is in use. We used the expired panels as selected cells, for rule outs/ins. 

Edited October 2, 20222 yr by SbbPerson

A lot of the standards list "Or as recommended by the manufacturer."  CAP for example.  This is usually my out, as manufacturer insert does not suggest reagent reds be QC'd.  They are quality controlled by the manufacturer as part of the FDA compliance.