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DebbieL

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Everything posted by DebbieL

  1. We have an Extended T/S form used in Pretesting. The nurse will ask the patient if they have been transfused or pregnant in the last 3 month. Nurse signs the form and answers Yes or No. The form along with T/S specimen is sent to BB. We do the testing that day and indicate on the form if the patient has a BB history. If not, we will need an ABO Recheck specimen collected the morning of surgery. We put a round sticker on top of the specimen so we don't discard accidently. We place a comment in the computer that the patient has an Extended T/S for our info on the day of surgery. Two days before scheduled surgery, we fax the forms to Surgery Holding. Holding wants these early so they can make up the charts the afternoon before surgery when it is not so hectic. Day of surgery-Nurse asks the transfusion and pregnancy questions again, signs the form and collects the ABO Recheck specimen if needed and faxes the signed form to us. We also send a list to Surgery Holding of all the patients we know needs an ABO Recheck collected while IV is being placed so we can be sure they get the message before the patient is rolled away The BB will find the preadmit specimen in storage & test the ABO Recheck, if needed. We have a special BB order we place in the computer to answer some of the questions about the pretesting. The XM now gets 3 days and the preadmit specimen has the sticker pulled off the top and is placed in storage with all of today's specimens. In this process, we remove the comment from the computer. We will extend up to a month, so 30/31 days so we don't have to count on our fingers. LOL. If the patient comes in for surgery past the 30/31 days, we request a new order and specimen. If the patient turns out to have an antibody, we will ID and write the info on the form and hang the form up for all BB to see. We will scan for Ag- neg units prior to surgery. We write a BIG note on the form that we want a FULL pink top collected on the day of surgery and redo the T/S and crossmatch the units. We don't redo the AB panel as long as the screen appears as expected, plus the patient hasn't been transfused. It takes 3 departments completing their tasks but it works like a charm after the initial learning curve. We do not use BB armbands so I'm not sure how that would work. I don't see people wearing an armband for a month or requiring a patient to bring the armband with them on the day of surgery. Maybe some of this info can help you.
  2. Things I have listed in my procedure: 1. If we have discovered an antibody on a patient who is about to go to surgery, we call the nurse in charge of the patient in Surgery Holding to let the physician know blood may not be available. The doc needs to know before the patient goes under the knife. Sometimes they delay the surgery and sometimes they proceed with caution. (This issue can be avoided with a pretesting process that not all physicians use) 2. If we have a serious transfusion reaction due to ABO incompatibility, we would contact the patient physician and our pathologist immediately. 3. We can't ID the antibody and the physician has requested RBC transfusion. Depending on the condition of the patient, they may still proceed with incompatible or least incompatible blood and sign a Medical Release or will probably wait until we can ID. It is up to the physician to make the call based on the patient. 4. When we had babies, we considered a positive DAT as a critical result from the BB side and would call L/D.
  3. I think that is still in effect. The last time I ordered rolls of 4x4 labels for modified products, the description stated they were acceptable for placing on blood products.
  4. We use a paper tag with a pre-attached sticky label. The tag has all kinds of info printed on it for the nurses edification, such as transfusion rxn info, only use saline, etc. The computer prints all the patient/donor info on the tag and also on the sticky label which we place on the unit at issue. The tag is primarily used at the bedside for the required checks but the unit itself is scanned into the computer and completed in the computer. If the computer is down or goes down, the nurse will revert back to the paper tag to complete the transfusion. The label stays on the unit throughout the transfusion. That has been beaten into their heads over the years. The tags are a specialty type print and are expensive but it is what it is. It took months of committee meetings to approve the tag we have now and every nurse had an opinion about what should be on the tag.
  5. I'm annoyed! Yes, there are differences in results between automation, GEL and tube testing. Automation is the most sensitive and tube testing is the least sensitive (but the BB gold standard method), with GEL in-between. I wrote that bit of information in my procedure so an inspector would know I am aware of the possible differences. We are doing this exercise to make sure the methods compare, if the specimen is positive in automation, it should also be positive in GEL and tube testing and should appear to be the same antibody on the antigrams. If I am doing an antibody screen and an AB ID, I am using the same METHOD whether I am testing using 3 screening cells or a panel of 10 or more cells. Yes, we have the rare antibody screen that gives wonky results in automation and and is stronger in GEL. That tells me we need to do the ID in GEL so we can actually get an answer we trust. Different antibodies work differently in different methods but the screen and AB ID should be the same within the same method. Our screening cell method in tube is the exact same method as our panel tube testing. If I am doing the comparability testing, I am using a strong antibody that has a 3-4+ result so I can be assured I will get similar results across all 3 methods. I'm not going to use a weak or wonky antibody that would give shady results an inspector could question when they view my forms at an inspection. This is Method Comparability, not Test Result Comparability. Does CAP have to have a quota of standard changes they have to meet? I'm on a soap box and I am sorry to rant but this seems unnecessary and extra work for the same AB screen results across the different methods.
  6. This is awesome! As many times as our freezer has gone done over the years, we never thought of putting dry ice in the freezer. Your dad is awesome!!!
  7. I get so annoyed when CAP "experts" give different answers to different people. It seems to me they also bring in their own personal opinion on things, like some inspectors we have to deal with. She stated she "suggests" doing ID on all methods I would have to argue they we are testing the "method." If you get a positive AB screen using automation, do you also get a comparable positive AB screen using GEL and tube? Does the antigram for the same antibody across the 3 methods appear to be the same antibody. It shouldn't look like an anti-E on automation, a anti-K in Gel and an M in tube. They are not going to match in strength because the different methods vary in sensitivity. I would include the antigrams of each method to show it appears to be the same antibody across all methods. A set of screening cells is just a mini AB panel. If you feel like you must do an antibody panel using each method, I would just do an extra cell or two on each method and say it is not a set of screening cells but a mini selected panel. If we find a patient with a good, strong, clear antibody it is sometimes hard to come up with lots of extra plasma to do unnecessary testing. (My opinion only) Gr-r-r-r-r!
  8. We do not perform repeat antigen typing on units sent from the reference lab. If it says historical antigen type, we are OK with that. We enter the extra Ag typing into the computer when we receive the unit. We do not waste the time and antisera to retype units the techs type here at our BB. If I did that then why not go back and repeat everything else they did. The units would be AHG XM and should catch it if the antigen is showing up. If a tech did mislabel an Ag, they would be written up when it was found for causing patient harm. We once had a sickle cell frequent flier with an anti-E. Her antibody couldn't be detected after several years. Then she came in a few weeks later with a roaring 4+ ant-E. My first thought was we has mistyped a unit we had given her. After investigating, it seems she went to a wedding out of state and while she was there, she popped into a hospital to get juiced up. She neglected to tell them she had an antibody, even though we give out antibody cards. They didn't see the anti-E so just transfused her. That is the closest we have ever come to thinking we mistyped someone. I agree with Exlimey about repeating the ABO/Rh. I have worked for over 40 years and not once have I ever had a mistyped unit or even heard about a mistyped unit. I am guessing blood centers probably have multiple people type each unit to prevent labeling with the wrong type. It has always seemed like a waste of time to me. But it is a rule and we follow rules.
  9. My previous boss always said they had to come up with new rules to justify their jobs. When they can't find the "low hanging fruit" because we all try hard to do the right things and follow the rules, they start digging deeper and come up with stupid stuff. As long as they keep coming up with new rules, they keep their jobs.
  10. I had to look it up. I had never heard the word before but very relevant to the topic
  11. Keep a copy of the initial validation handy for CAP inspections. I was asked by an inspector to see it years after we had gone live. I had to dig through previous computer files from my previous boss to find it. It was my first inspection as a lead and made me so nervous. I think she was just messing with me to make me more of a basket case than I already was. Also anytime you have a major computer upgrade, you need to test all the computer elements again to prove the rules still work as expected. It doesn't take too long after you have the initial work down.
  12. 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.
  13. 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.
  14. 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.
  15. 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.
  16. 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.
  17. 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.
  18. 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.
  19. 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.
  20. 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.
  21. 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.
  22. 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.
  23. Here is the procedure that goes along with the form we made up. TS03.1025 Daily Reagent QC - Copy.docx
  24. 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
  25. 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.
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