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BloodBanker80

Daily QC Requirement

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Our hospital performs most testing on the Provue (Type/Screen/ Poly&IgG DAT's).  We do our antibody ID's in manual gel using a diluted 3% Immucor panel or 0.8% Ortho panel that we QC upon receipt. Our Provue testing is QC'd daily along with our tube reagents.  Is there any reason that manual gel antibody screens would need to be included in daily QC?  I just want to make sure I'm not missing anything?  Thanks!

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I would say Yes - you are using a different platform to perform manual testing. The volume delivered by the pipette for the manual test should be verified by performing the test manually.

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Not sure if it has changed but most daily QC was generally implied by the regulation statement of "day of use".  Obviously we did most tests every day so it became daily.  Other testing that was performed only on as as needed basis was QC'd on the day we did the testing.  So, based on this I would say your manual screens only needed QC'd on the day you tested.  This may have all changed but that's what I remember.   :coffeecup:

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Thanks everyone!  I'm just trying to wrap my brain around exactly what this would cover...  QC'ing the actual manual gel method and performance since we perform manual antibody ID?  Otherwise, technically I don't think there is anything we do daily that would cover that. 

What methods do you all use for these tests, and what QC is done daily?

 

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21 hours ago, BloodBanker80 said:

Our hospital performs most testing on the Provue (Type/Screen/ Poly&IgG DAT's).  We do our antibody ID's in manual gel using a diluted 3% Immucor panel or 0.8% Ortho panel that we QC upon receipt. Our Provue testing is QC'd daily along with our tube reagents.  Is there any reason that manual gel antibody screens would need to be included in daily QC?  I just want to make sure I'm not missing anything?  Thanks!

I remember seeing a blurb about QCing each methodoly in use but can't find it in CAP.  It might have been somewhere else.   But CAP does say that QC is required for only 1 vial reagent/lot in use  

 

TRM.31400 Antisera/Reagent Red Cell QC Phase II

There are records of acceptable reactivity and specificity of typing sera and reagent

cells on each day of use, including a check against known positive and negative cells or

antisera, or manufacturer's instructions for daily quality control are followed.

NOTE: Unless manufacturer's instructions state otherwise, the following apply:

Each cell used for antibody detection must be checked each day of use for reactivity of at

least one antigen using antisera of 1+ or greater avidity.

Typing reagents such as anti-D, anti-K, anti-Fy(a), etc. must be checked each day of

use.

Anti-IgG reactivity of antiglobulin reagents may be checked during antibody screening

and crossmatching.

Typing sera and reagent cells must be checked for reactivity and specificity on each day

of use, including a check against known positive and negative cells or antisera.

This checklist requirement can be satisfied by testing one vial of each reagent lot each day of

testing.

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18 hours ago, R1R2 said:

I remember seeing a blurb about QCing each methodoly in use but can't find it in CAP.  It might have been somewhere else.   But CAP does say that QC is required for only 1 vial reagent/lot in use  

 

TRM.31400 Antisera/Reagent Red Cell QC Phase II

There are records of acceptable reactivity and specificity of typing sera and reagent

cells on each day of use, including a check against known positive and negative cells or

antisera, or manufacturer's instructions for daily quality control are followed.

NOTE: Unless manufacturer's instructions state otherwise, the following apply:

Each cell used for antibody detection must be checked each day of use for reactivity of at

least one antigen using antisera of 1+ or greater avidity.

Typing reagents such as anti-D, anti-K, anti-Fy(a), etc. must be checked each day of

use.

Anti-IgG reactivity of antiglobulin reagents may be checked during antibody screening

and crossmatching.

Typing sera and reagent cells must be checked for reactivity and specificity on each day

of use, including a check against known positive and negative cells or antisera.

This checklist requirement can be satisfied by testing one vial of each reagent lot each day of

testing.

Thank you!  I'm still scouring the literature to find something definitive before adding this in to our SOP.  I've also found some other discussions on here where reasoning could be made it will QC the centrifuge/incubator/pipette?  We currently document temperature, RPM and timer check daily for these items as our "QC". 

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Performing a manual antibody screen, in addition to the temp, RPM and timer checks, would be checking your system (centrifuge/incubator/pipette) as well as reagents (strips). You could use 'serum' from the QC material you run on the ProVue for your positive control and inert patient plasma (previously tested & negative on the ProVue) for a negative control. As far as QC for the ID panel, that's a whole nother discussion. For tube testing, we run a weak antibody against an antigen positive and an antigen negative cell. That is not something we did when we were running gel, but that was more than 8 years ago and regulatory issues have changed since then.

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22 hours ago, AMcCord said:

Performing a manual antibody screen, in addition to the temp, RPM and timer checks, would be checking your system (centrifuge/incubator/pipette) as well as reagents (strips). You could use 'serum' from the QC material you run on the ProVue for your positive control and inert patient plasma (previously tested & negative on the ProVue) for a negative control. As far as QC for the ID panel, that's a whole nother discussion. For tube testing, we run a weak antibody against an antigen positive and an antigen negative cell. That is not something we did when we were running gel, but that was more than 8 years ago and regulatory issues have changed since then.

Thank you!  That's what I think, too.  Before implementation of additional work - I'm going to have some people looking at me for backup documentation.  We also use 2 bench top MTS systems - so technically we'd need to do the manual testing on both if that were the case, right? 

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It is 2 different systems.  they both need to be QC'd.  Had this problem at a recent client's facility.  Talked to the regulatory folks (JCAHO in this case).  Both systems need to be QC'd for the testing performed using them. 

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18 hours ago, David Saikin said:

It is 2 different systems.  they both need to be QC'd.  Had this problem at a recent client's facility.  Talked to the regulatory folks (JCAHO in this case).  Both systems need to be QC'd for the testing performed using them. 

That would be like back when everything was manual and we had multiple racks of reagents out being used by more than one tech.  Every rack had to be QC'd.

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