DebbieL

We rarely elute anything significant either. I am just going to go with everything pos or neg on both eluates and say they compare. You have to go with what you have.

I have an update for this thread. I went to the source and called CAP and a blood bank person called me back. This is what I got out of the conversation regarding COM.30450. This deals mostly with kits. 1. We need to compare the current fetal screen kit to the new fetal screen kit. This can be done by using the current kit's pos/neg/indicator cells with the new kit to compare. 2. We need to compare the current Elu-kit to the new Elu-kit. (!!??!) Unfortunately, this will involve performing and eluate on a patient with the current kit and then performing another eluate on the same patient with the new kit. Two eluates in the same patient. This means I will order more kits at a time to cut the number of times this has to be done. 3. If you run out of a reagent during the day and have to use a new lot number, that reagent must be QC'd. 4. As part of your daily QC on your rack of reagents, you can use one indate antisera to make sure the screening cells work. Anti-D, Anti-K, etc. 5. We do not have to compare new lot numbers to current lot numbers on rare antisera. It is a waste of expensive antisera. Sanity reigns!

Do you think this also applies to other reagents such as Anti-A, Anti-D, Anti-K, etc.? One of the other hospitals in town was cited for not performing a comparison on these too. I guess we will be starting this as soon as I can wrap my brain around it. I don't want to go thru the ordeal of having to address this after an inspection. My opinion is these reagents must meet FDA potency requirements. That seems like a higher calling to me than testing known cells against these one time when they arrive. We also do controls each day of use. If they don't work, we can't trust them. What about panels and screening cells? Yes, you can test a known antibody patient with old and new screening cells and panels to compare that particular antibody but that doesn't cover all possible antigens on the cells. How can you test that? This seems like a waste of tech time and resources to me. Who thinks up these things? It can't be a person that actually knows blood bank. This is not chemistry where we have to make sure the results of a new lot # are in a particular range. It either works or it doesn't. The patient is either positive or not. My 2 cents. If others are doing this, please let us know how you are satisfying this requirement.

I only have one experience with bone flaps. The surgeon performed the original surgery at our hospital and the bone flap was in our surgery Ultra Low. Then the surgeon decided he wanted to do the second surgery at a different hospital and he wanted to take the bone with him. Oops, sorry, you can't carry bones from one hospital to another becasuse that makes us a "supplier" with all the regs that go along with that. I told them we would be in deep with FDA and they would be crawling all over us. That was the last I heard of it.

We repeat a panel once a month if the patient meets certain criteria. We perform a screen (3 cell) and it must match what we expect it should. The cells that should be negative are negative. We crossmatch antigen negative units and they should be AHG negative. If the patient meets this criteria, we only do a panel once a month. The techs are always hoping the last panel was within the previous month so they don't have to do one. If the screen shows a cell as positive that we weren't expecting to be positive, repeat the panel. If the antigen negative units are crossmatch positive, repeat the panel. If the patient has a warm autoimmune antibody, panels and eluates are done every three days. My previous boss put this in place many years ago. I thought we were going to have reactions right and left when we started this but it works very well. It is a big time saver, frees up the techs and we save money.

We were cited for this at our last CAP inspection. We primarily use Echo automation for antibody ID and then use Gel and/or tube testing as backup. The CAP inspector was very insistent that we absolutely could never use expired panel cells no matter what. We would never use an expired panel as the primary ID for an antibody. We only use them to help us rule-in or rule-out when we have multiple antibodies or if we have a suspected KpA or JsA since there may only be one cell on a panel. No amount of talking coud convince her. I rewrote my procedures to indicate that Echo was the most sensitive, followed by Gel and then tube testing. If we were using a less sensitive method to ID we would include a positive cell to prove the antibody could be identified using the less sensitive method. I indicated that indate panels were used first and expired panel cells were used only for ruling-out or ruling-in as an aid for ID. I sent the writeups off with a wing and a prayer and expected the worst. CAP dropped it as if I had never been cited for it. Whew!! If they hadn't dropped it, I would be stuck sending some of my workups to the local national reference lab which uses expired panels and doesn't do QC which is exactly what we had been doing. (I checked) That would have been ironic to say the least. We don't keep rare antisera such as anti-k, -LuA, -KpA, -JsA, etc. so how do other hospitals do QC on expired panel cells? In addition to that, our panel cells usually don't have much volume by the time they are expired. You need three drops of cells to test and do QC and we are sometimes sucking up the dregs out of the bottle. By the way, I have been enjoying this site for years but this is the first time I have written a response.