I also listened to the Immucor webinar. What I got out of it was BB does not have to do lot to lot for our reagents, rare or otherwise. We do daily QC and the reagents must pass before use. We do have to compare current FMH kits to incoming FMH kits. You must make sure the controls on the current kit work on the new kit and vise-versa. This is to make sure the controls on the new kit work as expected and that the shipping conditions did not cause the cells to deteriorate. We had also been comparing Elu-Kits but someone specifically asked if those needed to be compared and they do not. I think I heard that it is because there are not any controls in the kit. I am grateful for small favors so I am getting rid of the Elu-kit comparison portion of my procedure.
When it comes to comparison of panel cells, look carefully at the package insert instructions. Does it say you HAVE to QC? Then you must. Does it say you MAY test, then it is up to the facility if testing is done. I personnally take that as a legal loop-hole and will run with it. Besides how could you ever compare one panel to another since you would be comparing different donors?
I had talked to CAP in the past about this subject. They said you must check all incoming shipments for proper shipping conditions AND must be checked prior to use and these checks must be documented. I made up a form that reagents are listed as they come in (date arrived, #, lot number,etc.) and I added a column for checking the shipping container. Acceptable Yes or No. At the bottom of the page in small writing I listed what was acceptable and what was not so there was not question. All of this checking must be documented. We all know if it is not written down, it hasn't been done.
Below is the next slide from the Immucor presentation:
TRM.31241 All new lots of reagents and critical materials (e.g. blood collection sets) are inspected and tested, as applicable, before use with records of acceptance.
- If manufacturer’s instructions require testing prior to use (e.g. panel cells, antisera) then lab is expected to test
-If manufacturer’s instructions recommend testing prior to use, it is up to the discretion of the laboratory to test
-Once reagents are put into use, TRM.31400 applies