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DebbieL

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DebbieL last won the day on May 21

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  • Birthday 08/30/1955

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  1. We got the same song and dance from our infection department some years ago. Our manager told them the instruments would not work correctly if the saline/reagents were not in the manufacturer's container, the interior plastic bag would droop and possibly break without the cardboard support to contain it. The solution/compromise was to make a notebook of "acceptable" cardboard containers, e.g. saline/reagent cubes. If an inspector questioned, we would show them the book with pictures of what had to be in cardboard to maintain lot numbers or integrity of the reagent. I agree, the rule is to reduce incoming exterior dirt and insect infestation for patient areas but the lab is not a patient care area. Some committees make a mountain out of a molehill and go too far.
  2. There was a FAQ on the CAP site a few years ago that basically said BB did not have to do lot to lot testing, that our regular QC was sufficient. I know the exception was fetal kits or other kits that had positive and negative controls as part of the kit. I was concerned about this standard regarding our regular reagents after it was revised so I wrote to CAP so I could get an understanding if things had changed so we did have to start doing lot to lot. This was my answer for my question about COM.30450 The way I read this we do not have to do lot to lot except for something like a fetal kit. You can perform QC on the day of use. Part of our QC is to check the shipment upon arrival, is the appearance normal, did it arrive at the proper temp, was the shipping container damaged, etc. I like having an answer in writing with the CAP logo if an inspector seems like they are going to site me. I can whip the email out and show them. Might help, also might make them mad.
  3. Thanks Malcolm! I looked closely at my screening cell package insert and was surprised that it no longer says to perform immediate spin. It says to perform a spin at 37C but if potentiators are used to follow their instructions. We actually use PEG instead of LISS and PEG is not supposed to be spun after incubation. I have looked at those inserts for years and never REALLY saw this wording and have no idea when these instructions changed. I knew we didn't really care about RT antibodies anymore but I thought the immediate spin was required. We have so many rules in BB and we just follow them without question. I feel like I am in an alternate universe right now.
  4. This is news to me. Is there a reference to remove the IS and 37 reading. Is it only with a particular enhancement media? We currently use LISS. I would love to get rid of unnecessary steps.
  5. I agree with jayinsat. Explain to your people that all the info can be accessed in Medistat and make sure every tech can show you how to access the info during downtimes. Pump it up that they will no longer have to complete the cards and how much better the whole process will be. It is hard to change when you have done things the same way for years and the techs who have been doing this process the longest, will have the most problem. It will take them a bit of time to realize the BB world will not crumble around them to not fill out these cards. They will come around and be more accepting of new changes you will make in the future. Just don't do too many things too fast at first. We had file cabinets full of years of old cards back in the day. I am trying to remember but I think my old boss had us go thru the cards when it was slow and discard all the cards that had not been updated in 5 years to decrease the number. When that was completed she basically packed them up and sent them to storage for a period of time. They were still there but not easily accessible. We were not too sad because we pretty much hated the cards.
  6. Even if you don't store RhIG in BB, you need to check the storage requirements of your BB reagents. We assume all reagents are 1-8C or 1-10C but there are some that are 2-8C. We borrowed some Anti-E from a local hospital that was from a different manufacturer that we use. I happened to look at the package insert just before our recent CAP inspection. I had to adjust the fridge until the reagent was used up. Just be aware.
  7. We have 2 sister hospitals in our system and we share the same database. When they enter a blood type, it updates our database to show the patient has a blood type. In fact it can be confusing to us when one of their patients has a crossmatch completed and then are transferred to us. If we look in the computer when a nurse calls and it looks like the patient has blood ready here. In fact I called CAP once to ask if we had to perform a new T/S when a patient is transferred to us from one of these sister hospitals. She said no, as long as we shared a database of info and if the patient had a transfusion reaction, we had a process to get the original specimen to do the workup. We always get a new sample but you know how exciting it can get when a bleeding patient is transferred. It is nice to know we have the option to do a quick computer crossmatch. As far as accepting an ABORH from another hospital, never, nope, nada! Type O until we get a second type. We don't trust ABO's from hospitals who are not part of our system.
  8. We no longer have L/D but when we did, Heme performed all KB and would enter the patient results in the computer system. We would base our number of RhIG injections based on the result and the package insert. As far as PT, the BB would get it first and perform the Fetal Screen. We would enter our results on the forms and then give the PT to heme to perform the KB. That way we both performed the portion of the PT we actually did in our departments. Since heme did the majority of the work, the department lead would enter the results into the CAP website. I agree with John. Some inspectors think if you don't do it the way they have been doing it, you are doing it wrong. There are lots of roads to the same destination, but some are better paved.
  9. Our Blood Bank dispenses albumin and RhIG which we call derivatives. The blood consent states lumps blood and blood derivatives together as either the patient accepts or refuses. I think if these products were dispensed from the pharmacy, I'm not sure a consent would be required. Pharmacy used to have albumin but gave it to us probably 30 years ago, long before computers and barcode scanners. I would love to give it back to pharmacy but it is not in the stars.
  10. I found this on the 2012 AABB Ask the FDA and CLIA Transcript. Kind of old but I think still relevant. I saved because I once had an inspector that stated I had to be registered with the FDA to thaw FFP. (??!?) I knew it wasn't right but I didn't want to argue in the middle of an inspection and I didn't have anything in writing. Basically if you don't make a completely new different product, you don't have to register. If you take a product and make something completely different, you do have to register, e.g irradiating a unit creates a totally different product. Hope this helps Question 29: When is a transfusion service required to be FDA registered? Do the following processes require the facility to be registered? These examples were received from 4 different facilities. thaw plasma and split RBCs receive washed red cells from the blood supplier and then add plasma for an exchange transfusion divide red cell or platelet products for pediatric use re-label thawed fresh frozen plasma to thawed plasma MS. CIARALDI: There's an easy answer, which is no, yes, no, no, but what I'd like to do is just take some time to explain why. The regulation that states who must or who is required to register is 21 CFR 607.20. It says specifically any establishment that manufactures a blood product must register, and there are some other criteria, but that's the main one that applies here. Additionally, there is a regulation 21 CFR 607.65(f), that lists some exceptions under which a transfusion service does not need to register, but that's a very limited and specific list. Now, to go on to the specific examples here, what I'd like to do is bunch bullets one, three, and four together. In those three situations, a transfusion service would not need to register. Thawing plasma to prepare it for a transfusion we don't consider the manufacturing of a product. So that is why that particular practice is exempt. In addition, splitting or dividing units for whatever reason, usually pediatric reason, is also not manufacturing a product. The end product is the same as the starting product. It's just smaller volumes. So that is the rationale behind why that would also not need registration. However, in the second bullet, washed red blood cells has plasma added to it, and the final product, which is sometimes called reconstituted whole blood or reconstituted red cells, is used for exchange transfusion. The answer to this is that, yes, registration is required, because the transfusion service is making a new product. The reconstituted whole blood is the new product. The final product, the whole blood product, is different from the two original starting products. So there is manufacturing of a product going on in this particular situation. MODERATOR: Thank you, Judy.
  11. I highly suggest you change the 6 month Competency to "Semi-annual." Our lab got dinged several years ago by a "by the book" inspector. Some of the leads had the 6 month evaluation at 6.5 or 7 month. If you have a OCD inspector with no grace, you could get cited for every competency that is one day over 6 months. I had an inspector a few years ago that was going to cite me for completing the thermometer checks 10 days later than the year before. She took "annual" literally. To her, 10 days later than the year before was past due. I protested and told her the lab performs all thermometer checks in the month of April, sometimes early and sometimes later in the month. She went to ask her pathologist for clarification before she cited me. Thank goodness he reigned her back to reality and she didn't cite me.
  12. Here is the procedure that goes along with the form we made up. TS03.1025 Daily Reagent QC - Copy.docx
  13. Here is my daily QC form. We use 2 racks of reagents each day. We only actually QC one rack each day alternately and check the other rack to make sure the reagents match. Once the lot numbers are written, we just put check marks in the boxes if the lot # is on the rack. One rack has Anti-D4 and the other has Anti-D5 and we QC both each day. The blank lines are in case a new lot # is added during the week. I have added the things we don't QC (*) everyday just so there is a record of what could have been used. It gets a bit confusing on the saline cubes.... The cube has an expiration but once it is opened it has a month expiration. So OCD me wants both expiration dates on the sheet. They write the cube expiration in the designated spot and then write the month expiration in the square under the day opened. A little confusing when trying to write about it. It is a bit over the top but hopefully no one can ding me for not doing enough. We do positives and negatives on all reagents. Hope you can get something out of it to help you. QC003 Daily Reagent QC (1902).docx
  14. I don't think BB testing is analytical so I also mark this as NA. When it comes to BB testing, the patient is either positive or negative.
  15. We print a report each night that tells us how many of each type of product are available. We just count the number of each and it almost always matches. We can usually get this done without the alarm sounding. If our counts doesn't match what the computer says we have, then we dig into the weeds to see which unit is missing. Then we print the list of all the ISBT numbers to find the one in question.
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