David Saikin

I QC reagents before I put them into use; usually not upon receipt.

I QC reagents before I put them into use; usually not upon receipt.

When gel was our primary testing method a reaction w anti-D of 1+ or less was called Rh negative.  I know of folks who call 3+ rxs or weaker Rh negative.  This was determined by the Medical Director.

It has always been an unspoken rule for me to gently mix it once before every centrifugation. For the Jka/b, you mixed it once then incubate and then centrifuge. 
For the CEce you mixed it once for the IS before centrifuge. Then for the RT incubation part, you mixed it once before centrifuge. 
The gentle mixing before centrifugation allows cells to resuspend and bind to any possible "unbound" antibodies and then latticed together in the centrifuge. 
I attached the Ortho Instructions for Use for Anti-CEce. Good luck. 
Ortho_CcEe_.pdf

Hello
So, to my knowledge and 3 decades of experience, there is no specific Standard that will specifically tell you how long reagents can be stored outside of the environment suggested by the manufacturer of that reagent.
There are a few relevant standards on reagent receipt, use, handling, and storage in the AABB 32ND edition, pgs. 7, 10, 12, 15, 35, 39.  Page 10 also refers to reagents meeting or exceeding FDA...
One standard - (AABB 5.1.8) Handling, Storage, and Transportation only states that you shall have a process to ensure that critical materials (including reagents) are handled, stored, and transported in a manner that prevents damage, limits deterioration,...
Bottom line, the manufacturer in most cases are very specific about what not to do ( do not freeze, dilute, or use beyond expiration date.), and will not entertain a question about how long one can leave the reagents outside of what they have already stated (store at 1 to 10 C when not in use).
In the old days, we use to have working reagent racks out all day, with tiny cool packs embedded in the racks.  The concern was really with the reagent red cells growing bacteria causing a lot of false positive antibody screens.  Sorry for long email. I hope you get something out of this.
Connie

I just answered this question.

My Score FAIL  

I believe the product code doesn't need to change if it's directed donation. But of course if it was autologous, it needs to be changed. 
https://www.iccbba.org/isbt-128-basics/frequently-asked-questions/national

Mine states the units are incompatible and gives the reason for the incompatibility.  

You can store reagents and patient specimens in the same fridge as blood but you need to make sure that the range is set to accommodate both.  Our fridges are set with 2.5-5.5 C which meet both blood product guidelines and those of our reagents and specimens.  

When you say assay, that is, to me, a test, like Type and Screen.   Yes, we are using the same reagents but they are being used differently (automation vs manual).  Your QC in this instance validates the entire test system. 

When you say assay, that is, to me, a test, like Type and Screen.   Yes, we are using the same reagents but they are being used differently (automation vs manual).  Your QC in this instance validates the entire test system. 

When you say assay, that is, to me, a test, like Type and Screen.   Yes, we are using the same reagents but they are being used differently (automation vs manual).  Your QC in this instance validates the entire test system. 

Here is my response from CAP today, 4/28/2022:
 
Good afternoon David;

Thank you for contacting the CAP. Each test platform/system must have QC performed each day of testing. Regardless of the lots of reagents, the two systems you mentioned are separate. When I worked in the Blood Banks, we used the same Immucor reagents for the Echo instrument and the bench. We still performed the QC for each system. If you have any further questions, please feel free to reach out. Happy Lab Week!

Linda Whaley, MLS (ASCP)
Take a tour of our accreditation resources!

JCAHO in California.  I agree with this only because the manual QC not only qcs you gel cards but your manual pipets, manual pipetting and your mts centrifuge.  It is a different system.  However, if CAP says what you are doing is fine you should have that documented because if I was inspecting you I would cite.
 
 

We QC the reagents.  The assay gets the QA treatment during its implementation.

Once it's in place, I suggest taking the internal temp with an independent device for 24 hours.  If it held temp, I'd be satisfied.
Are you using the on-device data recorder?  We used a Rees system, so we never validated the temp display, nor the recorder.  That would be a whole separate validation.

Here is my response from CAP today, 4/28/2022:
 
Good afternoon David;

Thank you for contacting the CAP. Each test platform/system must have QC performed each day of testing. Regardless of the lots of reagents, the two systems you mentioned are separate. When I worked in the Blood Banks, we used the same Immucor reagents for the Echo instrument and the bench. We still performed the QC for each system. If you have any further questions, please feel free to reach out. Happy Lab Week!

Linda Whaley, MLS (ASCP)
Take a tour of our accreditation resources!

JCAHO in California.  I agree with this only because the manual QC not only qcs you gel cards but your manual pipets, manual pipetting and your mts centrifuge.  It is a different system.  However, if CAP says what you are doing is fine you should have that documented because if I was inspecting you I would cite.
 
 

JCAHO in California.  I agree with this only because the manual QC not only qcs you gel cards but your manual pipets, manual pipetting and your mts centrifuge.  It is a different system.  However, if CAP says what you are doing is fine you should have that documented because if I was inspecting you I would cite.
 
 

So in that case John, does each tech have to do their own QC because the human factor varies amongst humans. We view the Vision as just a hard working tech that works 24/7 and rarely takes vacation and that always scans its specimen barcodes without fail (the specimen verification is the human part of the equation I feel safer having the Vision performing).

An important aspect of this conundrum to remember is that physicians do not treat newborns just because of a positive DAT, they treat infants who are anemic or hyperbilirubinemic regardless of the DAT results.

Anti-M comes to mind most often, esp w Ortho gel cards.  It is possible to work up cold abs.  I've used the buffered gel cards to do so.   I've also used 2 stage papain pretreatment of panel cells (in gel). 

We have to sign a statement that the product was maintained appropriately.  It is part of the transfer process.

Anti-M comes to mind most often, esp w Ortho gel cards.  It is possible to work up cold abs.  I've used the buffered gel cards to do so.   I've also used 2 stage papain pretreatment of panel cells (in gel). 

Anti-M comes to mind most often, esp w Ortho gel cards.  It is possible to work up cold abs.  I've used the buffered gel cards to do so.   I've also used 2 stage papain pretreatment of panel cells (in gel).