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DebbieL

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Everything posted by DebbieL

  1. I listened to the same webinar. Basically what I heard is.... if the kit has positive and negative controls, then the new kit will have to be compared to the old kit. If the kit does not have controls, then they will not have to be compared. So according to that, we must compare Fetal kits but do not have to compare Elu-kits (no internal controls.) I have my people take the old controls and run with the new kit and the new controls to run with the old kit. This is supposed to be done while the old kit is still in-date, in that week of overlap. (We have had a few bumps in the road on that part). I made up a form showing the results for current kit with new controls and new kit with the current controls. Both tests should be about the same. Acceptable or not acceptable. I would attach the form but I think I am blocked here from attaching forms and procedures.
  2. Something similar happened to us about 2 or 3 years ago. One of my techs used a panel cell for the positive C control for antigen typing. The positive control was negative, so she thought she had selected the wrong bottle by mistake. She repeated testing again. Same answer of negative. So she tested the panel cell with anti-C and it was negative. She tested it with a different lot number from the same company and it was also negative. She tested the antisera with a different panel cell to see if it was a problem with the antisera. It wasn't. The panel cell that said it was C+ was not. So I looked thru all the patient antibody ID to see if we had ruled out Anti-C based on that one panel cell. All was OK. I wrote it all up and filed it away. Emailed Immucor and never heard anything from them.
  3. Do you have to be registered with the FDA to pool plasma? To pool single cryo? I would think the answer is no since a new product is not created just like products put together.
  4. We have pooled plasma for many years. Our computer was fine as long as we had Coda-bar numbers. ISBT has been a horrible problem. The therapeutic apheresis operators really really want us to pool because it is so much easier on them while they are running the instrument and taking care of the patient. It is a total pain to us and takes a tech almost an hour to pool once the units are thawed. We get the night techs to thaw when we know we have a patient the next morning. We have pooled as much as 7000ml each day for days on end. Ugg! We use 1000 and 2000ml transfer bags. We have to do it in two steps, 1) thaw but don't print an ISBT label at this point, 2) pool and then print the pool label. Our computer is built to only thaw CPD units but the blood center sends us other Ecodes which throws a monkey wrench in the whole process. We ask them not to send us anything but CPD when we are dealing with pooling but you know how that goes. We recently got this built in our system and these are the codes we have used: Pool FPCR TH CPD makes FPCR TH CPD P E5304 (cryo-reduced) Pool TH PLAS CPD makes TH PLAS CPD P E5275 Good luck
  5. Our Lab Director wanted each department to copy and paste one CAP standard on a page, write our response below and provide a copy of evidence (policy, form, QC, ect) behind the standard. We highlight the parts of the evidence to make it easy to find. We have to turn in 1/12 of our standards each month to the Medical Director who looks them over (Yeah, right), signs them and then give them to the Lab director for approval. I really hated this at first because it was so much work and he was so picky but after having gone through it a few years, we each know where we don't quite meet the standard. We also have a book that we can use when an inspector asks a question and our mind goes completely blank. At some point, when the inspectors arrive we will just hand them our evidence book so they can look at how we have satisfied the standard. I download the Word form of standards from CAP to my computer. I type in my response in the square below the standard. Then I just copy and paste all of that to a blank page to put in my evidence book. When we get new standards, I copy and paste my answers to the new Word Standards. It is a pain but easier than writing everything again. I highlight the new or revised standards to look at them closer since they need more attention. Yes, this is all a pain but I have very good confidence that we meet the standards when an inspector arrives. I also have a book that my people could use if I was out sick. I love the idea that Webersl uses and I think I will incorporate that into my future volume of work. It never ends!
  6. 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
  7. We only do a Weak D on the mom if the FMH screen is very positive. Mom almost always turns out to be Weak D positive in these situations. If Weak D pos then we order HgB-F. If mom and baby are both Rh negative, then we test the baby for Weak-D. If baby is Weak-D pos then we order a HgB-F on the mom because the FMH kit might not detect Weak-D. We use 55 as the cutoff for childbearing. I wanted 50 but the CMO wanted 55 so he naturally won. I think he wanted the possiblity of childbearing out of the realm of possibility. We use that number when deciding whether to give Rh pos blood in a trauma situation. So if a woman is 56 she might get Rh Pos.
  8. The only time I have ever done correlations between antisera was when the manufactuer switched from AHG to RT. I had a few select people compare a few samples with the poly and then the mono and write results on a nice little form. Did training and got everyone's signatures. But really this was more of a process change. I do have something to show an inspector which is always a good thing! The CAP standards state that reagents must be correlated. I somewhat freaked out about this so I called CAP to get the scoop. The lady at CAP said BB reagents were different and correlations were not required. BB reagents must meet FDA potency requirements and we do QC on each day of use. I think Chem and Heme must correlate because QC is not done every day or their results are more of a range. With BB you are either positive or negative, not alot of gray area. She said some reagents were very expensive and it would waste reagents to do correlations. She did say that we must correlate "kits" which would include FMH and Elu-kit and any other kits we use in BB. Bummer, but better than having to do all the rare and not so rare reagents. I really wish CAP would be a bit more clear on the standards. If BB is exempt I wish that would be stated in the fine print. I want to do what I should for patient safety but I surely do not want to do more than is necessary. It is a waste of tech time and reagents. That is all for my rant!
  9. If we are getting different answers from CAP about the same thing, there is no hope for us all. We are doomed to total confusion if the experts can't agree. I think if you call and you get a CAP person that is a Chemistry expert they would say you had to compare because that makes perfect sense to them. If you get a person that is a BB expert, they would know more about the nature of our work and reagents. The person I talked to even said that BB was different and our reagents were different. Our reagents are QC'd everyday of use. If it doesn't work, we don't use it. The person I talked to about this said we didn't have to compare reagents or antisera BUT we did have to compare "kits to kits" to show that the new kit gave comparible results as the old kit. I guess kits are different because there are several parts or steps that could fail to work correctly. I am going to stick with comparing my kits (FMH and Elu-kit) and not comparing my regular and rare antisera until forced.
  10. I called CAP and this is not a requirement for regular BB reagents because we do QC each day of use. Plus think of all the drops of precious rare antisera we would use trying to compare lots. This comparison requirement is mostly for Chem or Hemo because they are not required to perform QC each day and their tests are more of a "range" test. They have to make sure that the "range" is the same between lot numbers or they could report out erroneous results. With BB you are either positive or negative. You either have it or you don't. CAP did tell me we must compare "kits" lot to lot. This would be FBS kits and Elu-Kits or any other kits you might use. I was sad we had to do this but happy that we didn't have to compare all other reagents.
  11. On our previous computer system we had the option to write in the lot number and expiration date of the antisera when we were antigen typing. But it was really cumbersome and time consuming. It was also hard to tell if someone had done QC on a particular antisera for the day and if we didn't know we would have to repeat it. So, we went back to writing on paper and it seemed to work better for us. We can flip open the book and tell at a glance if we need to do QC on JkB antisera no matter what shift you are working. The computer is a great aid but not always the best answer.
  12. We enter the units we are testing in the computer and we can enter our results. QC for antigen typing is maintained on a paper log so other techs can see that controls have been done for the day on a particular type and lot number of antisera. We don't want to waste those precious drops by having to repeat it. I keep those logs for at least a full 10 years. On that log I have a column to indicate that the antisera was visually acceptable on the day of use and a column to write the panel lot # used for Ag controls and if the panel cells were visually acceptable. The column for panel lot # was my way of documenting that the panel performs as expected with the antisera used. This shows the panel is QC'd multiple times over the life of panel. (TRM.31234) Probably overkill but I have something documented if they ask if I QC my panel. If something didn't work right, I would hear about it!
  13. Many years ago, my hospital decided to start a therapeutic apheresis program and gave it to the BB. (!!??!!) We had a few regular out patients with myasthenia gravis that we could schedule according to our workload. The ones that were a problem were the patients that arrived in a bad state due to TTP or ITP and needed their first treatment STAT. They would have to get a port placed and then the treatment would begin. We might have to start the procedure at 11 PM by the time the port was in. Only about 4 of us were competent and we could be called in at any time during the night or weekend for the first treatment. Some physicians would order the procedure when they didn't have anything else to offer the patient. It was the new miracle treatment. The pathologists we had then would allow them to order daily or every other day procedures for weeks at a time. We hated every minute of it. My thoughts were, we were not nurses and we were messing with ports that we shouldn't be messing with. (Think clots close to the heart) We didn't know what we didn't know. If a patient crashed, we would not have been able to deal with it other than push the button and call a nurse or call a code. Thankfully, dialysis came to us and said they wanted to add it to their procedures. We celebrated when they were out of earshot, we didn't want them to know how happy we were that they took it from us. Think very carefully before you take this on because dialysis will give it all to you and your department because it sounds like they don't want it either. It will take one person out of your department for 4 to 6 hours or someone will have to be called in. The machine has to be set up and then the procedure could take about 2 to 4 hours. Dialysis nurses are the most qualified because it is somewhat similar to dailysis and nurses are better qualified to deal with a crashing patient. I really don't think a med tech is qualified to deal with the same things nurses deal with. I wouldn't want them trying to ID antibodies. Think very carefully and go into it with open eyes. My opinion, I would run as fast as I could in the other direction. According to CAP standard TRM.42245, there has to be a physician in charge of the program and they also have to meet specific qualifications so check on that too.
  14. I wrote a policy that had the different types of orders the physicians might order and a brief description of each type, e.g. DAT, RBC request, CMV negative, Miscarriage workup,etc. How we expect the specimens to be labeled and signed. How they should be signed during a downtime when things fall apart and why specimens are rejected. I also included the amount of time until products or tests would be ready and I was very liberal with the time. I pretty much doubled the usual time so they would not hold the time against us. I included what forms are required to dispense blood products, who transports what to where, etc I tried to cover anything that a nurse or physician would have a question about. I had the Lab Director and the CMO sign. It was posted online for all personnel to view.
  15. We do an eluate only IF the patient has been transfused in the last 3 months. I think the reasoning is it could be the early stages of the formation of a complement dependent antibody. If it is only complement and the patient has not been transfused, we do not perform the eluate. We would put in a comment for BB eyes for future reference. This was implemented by my previous supervisor and I have not changed it. As you can guess this scenario doesn't happen often because these people have always been transfused. I will be interested in what others do.
  16. We implemented the "extended crossmatch" several years ago after we had a very angry physician with a scalpel in his hand and a patient on the table with multiple antibodies that we found just before he started cutting. The patient had been prescreened for everything but BB about a week before. By the time we got our specimen and had completed the T/S, the patient was draped in surgery. Surprise! This process has made our mornings much easier and we get very few bad surprises now. We only do this process for pretest surgery patients and only if they have not been pregnant or transfused in 3 months. It took a lot of education and some missteps to get the nurses and physicians to understand there was a process that had to be followed exactly. This is a process with lots of steps that has evolved over a long period and we seem to have it pretty much perfected now. Everyone knows what needs to be done but it wasn't easy to get to this point. 1. We have a form that is used at pretest if the physician wants a crossmatch or T/S for surgery. The nurse will ask the patient about pregnancy and recent transfusions. The nurse must sign the form indicating that they asked the patient the specific questions and send the form with the pretest specimen. 2. We do a T/S and historical check. We put a comment in the computer that the patient has an extended crossmatch. We put a colored round sticker on the top of the specimen as a sign that the sample should be held for longer than all the other regular specimens. 3. Two days before the expected surgery we fax the same form to surgery holding so the form can be placed on the patient's chart. The holding nurses know to look for the form when the patient arrives. If we need a second specimen for ABO recheck, we have a place to indicate that we need a new sample. 4. The morning of surgery, the holding nurse will ask the patient the same questions and sign the form in a different spot and collect any specimens we indicated we needed. They fax the form back to us with the second signature. We have the answers to the questions and any specimens we need before the patient goes back to surgery. We remove the comment from the computer and order a specific computer test for the extended XM if everything is signed and looks OK. We locate the pretest sample and remove the sticker from the top. The crossmatch now has a 3 day limit. 4. If the patient is found to have antibodies at pretest, we know prior to the morning of surgery. We indicate on the form that is sent early to holding that a new sample is needed. We have time prior to surgery to screen or order antigen negative units and are able to crossmatch them with the new sample without much stress. 5. If there are any problems or concerns, we want a new specimen collected the morning of surgery and we start over with a new T/S. If the patient name or identification has changed, we can't find the pretest sample, the nurse didn't sign the pretest form and we didn't notice, etc. 6. We tried to go with different lengths of extending (10 days, 14 days, etc) but finally settled on one month. Some patients would cancel surgery and come back after the extended date. It is easier for the techs to look at the pretest day and make a quick decision on the fly if we need a new sample. If it is close to one month we just tell holding we need a new sample but we already know the patient is negative for antibodies. Holding knows to call us if the patient had surgery cancelled so we can let them know if the sample was discarded or if it is close to or past a month. Most surgery is done within a week or maybe two of having the pretesting performed. Very few stretch it out to close to a month If any of the steps are not followed as we require, the patient can't be extended. They have to follow our rules for all of us to be happy. The physicians are happy because they don't have to make a decision to continue surgery without crossmatched compatible blood. We have found the occasional autoimmune problem prior to surgery using this process and we can easily discuss with the physician at his office and have all the medical release forms waiting in holding. It is easier than trying to explain autoimmune to a physician with a scalpel in his hand.
  17. We also thaw all plasma straight to 5 day thawed plasma. Thankfully my previous boss did this years ago so I didn't have to go thru the process of explaining to the heart doctors the difference between thawed FFP and thawed plasma. Everyone gets thawed plasma except for neonates. Neonates get 24 hour expiration plasma. We have very few neonates that get any type of blood products much less plasma. We have an ISBT printer that prints the correct everything on the label. There was a ton of validation that had to be done for every type of anticoagulant that might show up before the printer went into service. It is cost effective to use thawed plasma because we waste very little. We keep two type A and one type B thawed at all times for possible trauma. Our computer is set so we can give type A to a patient of unknown blood type during a trauma.We rotate the thawed plasma thru surgery and thaw more as needed. Surgery is happy because they can get plasma in a hurry when they need it. They don't have to wait for us to thaw what they need. If a physician changes their mind about giving plasma after we got the order to thaw, we have 5 days to find another patient to give it to. We are happy to not waste.
  18. In our last CAP inspection, I was told that we had to have FDA registration to thaw plasma and to extend the expiration to 5 days. I knew it wasn't right but didn't have anything to pull out to prove my point. I didn't want to argue my point too much and make him too mad. At least he didn't ding me. Later, I dug around on the AABB site and found this that I have included below. I hope it helps someone. It is still available. I downloaded the whole thing to my computer in case I should ever need it in the future. 2012 Ask the FDA and CLIA Transcript Page ContentAsk the FDA and CMS/CLIA October 8, 2012 AABB 2012 Annual Meeting Boston, Massachusetts 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 transfusiondivide red cell or platelet products for pediatric usere-label thawed fresh frozen plasma to thawed plasmaMS. 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.
  19. I have been there. There is probably a template that your laboratory uses. Look at your current P/P book in your area or in other areas of the lab and see if there is a pattern to all the P/P. Some regulatory agencies require specific things in all the procedures so you don't want to have to rewrite it. You want to write it so that a person could follow along and be able to do what is required but you don't want it to be so specific that you get dinged because the techs don't follow the steps as written. Do what you say, say what you do. Slightly vague, slightly specific. I tend to be specific and I have to pull myself back. We are CAP inspected. I look at the standards and find anything that may relate to the P/P I am writing and try to include the points to hit. Don't forget about Commons and General standards. Write it, then put it aside for a few days. when you come back to it, it may sound totally dumb. Give it to the people in your department and have them critique it. Can they follow the steps as written? I copied and pasted my procedure for checking the blood storage temps. Hope this helps. Cutting and pasting caused it to lose it's format but you will get the gist of it. PRINCIPLE AND CLINICAL SIGNIFICANCE: All Temperature Dependent Equipment (TDE) in the Blood Bank are continually monitored to ensure that blood products are maintained within proper temperature ranges. POLICY: The Blood Bank equipment in which blood products are stored must maintain temperatures in the following ranges: Blood Bank Refrigerator 2-6° C FFP Freezer -18° C or colder Platelet Incubator 20-24° C If the continuous automated monitoring chart system is not operational, temperatures must be taken and documented every 4 hours to ensure that products are maintaining the correct temperatures. Equipment and Materials: Refrigerator, freezer or platelet incubator to be checked Refrigerator, freezer or platelet incubator temperature chart. Safety Precautions: All blood products should be treated as potentially infectious. Use universal precautions. PROCEDURE: Daily Checking of Continuous Monitored Chart System: Temperatures of TDE are documented daily at about the same general time of day. Document the temperature of each TDE on Blood Bank Temperature Check form. Assess that the chart is turning properly, is within the temperature guidelines, and is currently at the appropriate day and time on the chart. The person taking the daily temps should initial the chart each day when it is checked. This verifies the proper day/time setting was checked Weekly Chart Change – Temperature charts are changed weekly at about the same general time. Information listed on the back of each chart should include the equipment identification number and the date, time the chart is placed on the equipment and initials of the person replacing the chart. Completed charts should have the date and time removed and should be initialed. Weekly charts are paper-clipped together and placed in the file for review. Procedure for Abnormal Results:Audible Alarm Sounds – The audible alarm for the refrigerators and platelet incubator is set to sound before the upper and lower temperature range is reached. If refrigerator or freezer temperature reaches unacceptable limits at any time, an alarm sounds in the blood bank and the power plant. When this situation occurs, the following steps should be taken: Compare Chart and Thermometer Readings- If these are within range, the probable cause is prolonged door opening. Limit entrance into the refrigerator or freezer and monitor the temperature which should begin to return to normal range shortly. The tech noting the alarm and deviation of temperature should initial and make a note on paper chart to reflect the cause of the alarm. Temperature of Equipment Does Not Return to Normal Range- Carefully monitor temperature of equipment so that products will remain within acceptable range. Call Maintenance Department for STAT assessment of equipment. If equipment temperature stays the same or continues to increase, blood products must be removed to prevent loss. It is not necessary to seek Lead Technologist approval before removing blood products to safer conditions. RBC units and reagents should be moved to another monitored refrigerator in the Blood Bank. The blood center should be called to provide insulated boxes and dry ice for frozen products before the freezer temperature reaches unacceptable temperatures. Frozen products should be placed in blood center insulated boxes with dry ice placed on top of the units. Platelets may be placed in RT platelet shipping boxes for up to 24 hours without agitation. Remove products when temperatures of equipment approach the following sustained temperatures: Refrigerator ≥6.0° C FFP above -18° C Platelets ≥24° C Surgery above -65° C Actions if System is Inoperable Power Failure- In the event of a power failure, make sure that auxiliary power is functioning. If this cannot be ascertained, call Maintenance. In the event of a complete power equipment failure, our current blood supplier or other area hospital facilities may be called to provide help with red cells. With an area power failure, red cells would be maintained in boxes with bags of wet ice placed on top. FFP would be maintained in boxes with dry ice placed on top of units. Platelets can be maintained in platelet shipping boxes for up to 24 hours without agitation. Reagents should be placed in insulated boxes with bags of wet ice placed on top. Refrigerator/Freezer/Platelet Alarm Inoperable – If blood products must be stored under unmonitored conditions, the temperature will be checked every four hours and documented on Manual Temperature Recording Log form. This will document that proper storage temperature has been maintained. If the Ultra-low Freezer in Surgery is Not Functional- The Surgery department is responsible for maintaining the temperature of the tissues stored in the ultra-low freezer. Blood Bank may help by obtaining insulated blood boxes from the local blood supplier and Surgery may obtain dry ice to pack around the tissues. Space may be available in the laboratory ultra-low that is located in Chemistry, however, this freezer generally does not have free space. When the Refrigerator /Freezer/Incubator is Back in Service- Before blood products and/or reagents are placed back into the TDE once it is repaired, the equipment must be temperature stable for at least 4 to 24 hours. Temperature and alarm checks on the TDE must be satisfactorily performed and recorded. Reagents and antisera should be inspected for quality concerns and must pass QC before patient testing is performed. Reagents and/or antisera that does not pass quality inspection must be discarded. SOURCES: AABB Technical Manual, Current Edition RELATED DOCUMENTS: Blood Bank Temperature Check form (QC002) Manual Temperature Recording Log (QC005)
  20. We also make our own diluted daily QC for testing in gel. We dilute antisera (anti-D and anti-c) with about 7 ml of 6% albumin until we get about 1+ reactions in gel. We put it in a cleaned reagent bottle, store at 1-6C and use until it is gone and then mix up more. We have done this for years without an issue. When we get low, we mix up another batch. I think the main object is to make sure the gel cards and daily reagents used will detect an antibody with each cell used for antibody detection (TRM.31400). I consider my homemade brew a "weak patient antibody" and the QC part is I can detect the weak antibody with the gel cards and screening cells I am using that day. This was started by my predecessor years ago and I have continued the process. I really don't want to spend a small fortune on a commercial QC product if I can make it up myself and still satisfy the standard. I do think the inspectors will be all up in our QC because of IQCP so I want all my ducks in a row.
  21. Our saline cube states that it is good for one month after opening. We write on the cube with a sharpie the open and expiration date. When we open a new saline cube we discard the saline in all the squirt bottles and refill with the new lot number. We do have stickers on the bottles that we are supposed to write the lot number but we are not always good. It is something I check when it gets closer to inspection time.
  22. I just went to the CAP site and logged in. I typed in IQCP in the search box and selected IQCP Webinar and found a current Q&A. I just copied the part that is relevant to BB below. This is basically the answer I got when I called CAP with several questions about QC on panels and expired panels used for rule-out/rule-in. You must follow what the manufacturer insert says is required for QC but also a visual inspection of the panel at receipt and BEFORE use. I added some columns on my antigen typing form for the panel lot # and a visual check prior to use. We have always looked at our red cells before use but have never documented that they were OK. Hope this helps. Topic: Individualized Quality Control Plan (IQCP) Frequently Asked Questions Date: May 5, 2015 (last updated October 20, 2015) 37. Do I need to implement an IQCP for my blood bank antibody identification panels? (NEW 10/20/2015) No, IQCP is not applicable to antibody panels used in the transfusion service laboratory. An antibody panel is considered a critical material and is subject to TRM.31241 for inspection and testing, as applicable, of new lots before use. This involves visual inspection of new lots and shipments for appropriate physical characteristics (e.g. no hemolysis) and quality control following manufacturer's instructions described in the product insert. If the manufacturer does not provide specific instructions for QC, the laboratory must define its own mechanisms to detect errors and monitor test performance. Because antibody panels are not used alone for identification of an antibody, laboratories typically have a variety of other control processes that are being used as part of the work-up, such as having specific rules for ruling in or ruling out antibodies based on panel reactions, correlating the results of the antibody screen to the antibody panel, and performing antigen typing on the patient to confirm the absence of the corresponding antigen. The control criteria used must be defined in the procedure
  23. Yes, we extend all our plasma to 5 day expiration. The info that I gave my Medical Director was from the Mayo clinic so he wasn't so hesitant. We keep the thawed plasma on the top shelf of our crossmatched refrigerator. We have these little squares of paper with several blank lines. We write the expiration date on the lines. When we hand them out, we immediately thaw more. If the expiration date changes when we thaw the replacements, we cross out the old exp date and write the new one down on the little square. If we are thawing FFP to replace, we use a magnet to clip the paper square to the waterbath so everyone knows the FFP is to replace the trauma plasma. Sending them to surgery as needed keeps us from discarding a bunch. If someone uses the FFP for a surgery, it is their responsibility to pop more in the waterbath. The little squares of paper have several lines so we could use them multiple times because we are cheap. That is how we deal with always keeping some ready and it works pretty well for us.
  24. We are a Level II trauma center. We keep 2 group A and 1 group B plasma thawed at all times. We rarely discard these thawed plasma because we rotate them to surgery as needed and thaw more. Surgery has gotten used to being able to get plasma faster so they are happy too. We only keep 6 AB FFP in the freezer at any time. Most traumas that pass thru our doors do not have previous blood types in the computer so there was always a delay to thaw group AB FFP until we had a blood type. I approached the main trauma physician and asked him if he had any issues with giving type A plasma. He was all for it since it would cut the time delay to almost nothing. I talked it over with the Lab medical director who was a bit hesitant but I provided information for him to read. My lab director almost croaked when I told him my plans. I had to reassure him by letting him know we have been issueing non-group specific platelets to patients for years without issues. It also helped that one of our sister hospitals had already gone to this policy Our policy states that we may issue up to 2 group A plasma to a patient of unknown type in an emergency. That should give us time to get a blood type on the patient to begin to start thawing type specific. The computer is set up to allow us to issue group A with a warning that we must override. I feel better because we can provide some thawed FFP in a hurry along with the RBC. We will always be behind in a massive trauma but at least we are not so far in the hole.
  25. Last week I called CAP with several specific questions about QC on panels. And while I had her on the phone I specifically asked if we needed to do IQCP on panels. Her answer was no. She said BB would get off very easy for IQCP for the most part. She said IQCP will mostly affect kits with internal controls such as POCT and rapid strep kits where QC is not performed each day. The only kit I can think of in my BB that has internal QC would be the Fetal Screen. The manufacturer says to run QC each day and we have always done that so no IQCP would be needed. I also asked her about Lui Freeze since I really thought I had to do one on that specific procedure but she also said IQCP would not be needed because all the reagents that would be used had been QC'd that day. If you have questions, call CAP. I was very happy with the answers I got to my questions, this time.
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