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Everything posted by DebbieL

  1. 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.
  2. 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.
  3. 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.
  4. 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.
  5. 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.
  6. 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.
  7. 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.
  8. 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.
  9. 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.
  10. Here is the procedure that goes along with the form we made up. TS03.1025 Daily Reagent QC - Copy.docx
  11. 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
  12. 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.
  13. 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.
  14. Sonya Martinez- You are welcome! I was horrified that we had to revert back to messy ice and thermometers when we paid extra for the Helmer alarm system. If you figure out how to "map" a fridge, please share with the rest of us. I would guess sticking thermometers all over to see where the warm spots are located but who knows.
  15. Shelby56. Would you please give me an example of a "known" high titer commercial antisera? I'm thinking Anti-E or Anti-C since they usually give 4+ results. Or do you have something specific you order just for this evaluation? THX
  16. I know when CAP revived the standard, I was upset because I also thought I had to revert back to ice and water to make the chart move on my Helmer fridges and PLT incubator during alarm checks. That was moving backward as far as i was concerned. I called Helmer and finally received a PDF regarding Helmer and TRM.42750. I was also sending email questions to CAP at the same time. Our equipment is older and doesn't have printouts but CAP stated a photo of when the alarm sounded should be OK to proof. (I am keeping that email for a future inspection, just in case.) I take a photo of the electronic screen showing the temp at which the alarm sounded and add to my Alarm Check QC sheets. I can't answer the part about Isenix so you probably need to contact CAP about that part but I have attached what I have from Helmer if that would be a help to you or anyone else. If you can't open the attachment, let me know and I will email it to you. 202001 TRM.42750 Helmer Solution for Alarm Checks.pdf
  17. We also do a second type on all patients without a history in the computer. We try to use a stored Hemo specimen collected at a different time to save the patient another stick. If there are no previous specimens, we order an "ABO Recheck" in the computer. Only the Lab can place this order to keep nursing from ordering this by mistake which they used to do. We used to only do the rechecks on any type but O. We got a new Lab Director who didn't like that practice so we moved to retyping all new patients.
  18. I searched the operator's manual for info and also contacted Immucor about carryover. They basically said there could be carryover but it would be extremely rare since the patient's titer would have to be higher than 5120 and humans do not reach that level. So I decided to use the CAP JAT or J series and test 2 or up to 5 in the same run. The positives are generally pretty strong (4+) and there is always at least 1 negative in the bunch. I also look thru the past patient testing and find at least 3 strong positive (3-4+) patients with either a negative patient in the same run or the next patient is negative and print their results. I write it all up on a form and attach the printouts to prove there is no carryover. I haven't been inspected since I came up with this but it seems reasonable, is not too hard to do. The only alternative is to use straight antisera and I'm not willing to do that twice a year. I would be interested in what others are doing to meet this standard.
  19. Brenda, So glad you gave some possibilities about how to QC an expired panel. We actually have been doing something similar for several years. In your example, when we needed to use an expired panel to rule out E we would use the patient's plasma with a Jka+E= panel cell to prove the panel would detect the antibody we suspected as proof it was viable to use. Looks like it would be just as easy to use Jka antisera and officially meet the standard. I groaned when I saw they revised the standard because, at first glance, I thought we would have to QC the antigen we were trying to rule out or in and we don't have all rare antisera listed on a panel. I like the way you think about how to meet the standard but still have some wiggle room. Wiggle room is always a good thing
  20. My hospital is not AABB but I will put in my 2 cents for what it is worth. The way I read this: The collecting/pooling facility will put a DIN on the product. The receiving facility will not change, alter, or remove the number (on that bag). Reading between the lines if you take those units and combine them in a different way with a NEW number, in a new bag, you are not altering the numbers on the original bags. You have a new bag with a new number and the next facility (should there be one) should not change your new number. Your computer system should be able to retain the original product numbers under the new facility number for posterity. You can locate who received either original number in the pool should there be a lookback in the future. It might depend on your computer system. Can you print a ISBT label with the new facility number? I would think that is the only number you would need on the new created unit. If you have several numbers on the bag it is going to confuse the nurses at the bedside and we don't need to confuse them. I do remember back in the olden days before computers when we made exchange blood, the bag and paperwork had both the plasma and RBC numbers on it because that was the only way we could do it and keep up with the DIN. We pool large quantities of plasma for Therapeutic Plasma Exchange. We just use the newly created ISBT facility number on our bag and paperwork. We have never been dinged for this.
  21. I am also interested in how others are checking the Platelet incubator. Our probes are incased in some metal protective shield that makes them very difficult to get to. There are only some little nubs sort of sticking out about an inch or so.
  22. Our hospital system pays a Cerner subcontract team to validate the big upgrades. I am SO GRATEFUL for this!!!!!. It would be overwhleming for one person to have to go thru everything associated with BB. We get a huge notebook for our records of what the did. We still have to test a few things. For small upgrades that affect BB, I perform some type of testing with screen shots during testing and also after it goes in. These are usually not too much. I always test the electronic crossmatch after every validation so I have it on record so I won't get dinged by an inspector.
  23. We used to just document on the maintenance form and review at the end of the month. Then I read somewhere, it may have been on this site, that the software to read the backup disks on the Echo was proprietary and you must have their software to read the DVD backup disks. Our instrument was getting some age on it and I wasn't sure if we would remain with Immucor when we replaced it. So, I talked to Immucor and they said it could be read on Notepad even without the Echo computer. I tried reading it on my computer and it doesn't look anything like it does on the instrument. I sort of figured it out but it is a mess and it took a while. I even wrote a process on how to read the disks if we don't have the ECHO computer. I started having my people print the QC daily a few years ago so I will at least have it if asked by an inspector. I "review" and sign it within a month. I don't really review it because the Echo won't work if the QC doesn't pass but at least it looks like I reviewed it. I didn't want to be fumbling around trying to print QC for some random month during an inspection. Then to top it all off, our hospital came along about a year ago and switched out all our computer towers and took away the DVD/CD readers. I had to have a special one put in my office with a DVD reader in case we didn't have the ECHO and I needed to look at patient results. I guess what I am saying is pretend you don't have your instrument and see what your backup disks look like without the software to read it. Then make your decision on whether to print QC or not. I chose to print.
  24. Our QC was minimal several years ago based on the fact that the first ABO back type would confirm the antisera. The standard says the Anti-IgG reactivity is checked during crossmatching. I think our QC only had about 6 tubes and 1 gel card. Very minimal! But I started thinking that we didn't actually have proof the AHG worked on a particular day. (If it isn't documented you didn't do it) I thought proof needed to be added or some tech working that day would need to remember to mark the form hours later. I knew this would get missed multiple times in a year so I added these to the QC form. I even had them add the lot numbers of items that aren't QC'd like the saline cube or the AntiC3b,-C3b. If asked, I have a record of the lot numbers in use on that day if we should need cough up the lot number. Later I read that all reagents must have a check against known positives and negatives so I expanded the QC. It now has about 13 or 14 tubes and 2 gel cards. It is overkill but like I said they can't ding me for not doing enough. I would rather do too much than not enough.
  25. We have a dry erase board in an area that can be seen by all techs where we write general transient info such as 3 PLT ordered, # of available PLT, reserved PLT for heart surgery, etc. This info is erased as it is updated. Most of our issues seem to center around PLT. LOL I have a clipboard with basically a sheet with instructions on the top and basically lines and cues about date/time on the rest of the sheet. If we talk to a physician, nurse or blood center about an issue, we write the info on the clipboard. Some problems take up most of the page so they take as much of the sheet as they need to relate the issue. I'm sure some things are missed here and there but it seems to work for us. It is not perfect but nothing ever is. My techs are pretty good about writing on the clipboard.
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