DebbieL

I bit the bullet and called CAP about QC on panels. I asked what QC needs to be done to a new panel lot # when we first get it from the supplier with regards to COM.30450. Answer- You must follow the manufacturer's QC requirements. What does the manufacturer say needs to be done? You must look at the shipping container. Was it shipped under proper shipping conditions? Yes or No. It needs to be visually inspected. Does it look normal? Is it hemolyzed? If it passes, it is OK to use without QC. If you use in-date panel cells as controls for antigen typing, it could be considered as QC to show that the cells work as expected. However special QC does not need to be done on new sets of panel cells. ( We use Immucor which says QC MAY periodically be performed. It doesn't say it has to be done.) What about expired panel cells, what if any QC must be done? (TRM.31250) Answer- As long as you are performing the identification with in-date panel cells and only using the expired panel cells when the indate panel cells cannot provide what you need to rule-out or rule-in, the only thing that must be done is a visual examination. If it is not hemolyzed, it can be used without extra QC being done. She said the key to both questions is antibody detection vs antibody identification. QC is done on the screening cells (detection) and does not need to be done on panels (identification). And while I had her on the phone I also asked about IQCP on panels (just to make sure). IQCP does not need to be done on panels. Blood Bank will get off easy for the most part because IQCP mostly deals with kits with internal controls such as POCT and Rapid Strep kits where controls are not done each day. I also asked about IQCP for tests such as Lui Freeze but she said IQCP was not needed. The reagents used for Lui would be QC'd the day of use, so IQCP is not needed. I really wish the standards were a bit clearer on some of these things we stress over. I hope this helps answer some questions.

We have only validated with it open. I place several expired units in the bottom, use a thermometer with a wire probe between the units and set ice over every thing. Temps every 30 minutes. Never had anyone question this but we are not inspected by AABB so they may be more ticky about such things. We have been sending blood to surgery for years and the blood doesn't come back too cold. We send coolers to ER for trauma too. Yesterday we went to pick up the cooler. The cooler was open ( ) but the blood was still below the ice and within temp. Hoo-ray! We dont know what they do with the coolers once they take them from our sight. I figure they are open more than they are closed. I think that is another reason we like the wet ice covering the units because the freezer packs would require the cooler to be closed at all times. I know I can't guarantee they leave them closed.

We use the same Igloo Playmate Max-Cold coolers. We use bags of wet ice on top of the units and have not had any problems. We have an\ handy ice machine in BB. The freezer packs didn't work for us because our freezer was too cold and brought the temp too low. Also they would disappear. (!?!) We currently have validated for 8 hours but the surgeons are now wanting to keep the coolers with the patients for an extra period of time. I plan on validating next time for 10-12 hours. We also validate with the lid open the whole time as the next to the worst senario. The worst is that they take the unit out and lay it on the counter. I am considering the dots but really hate to mess with them until forced to. We ordered ours online from Target and they were cheaper than Amazon. I think around $28

The way I read the standard, we need to keep records of certain problems indefinitely. To my way of thinking, these records of problems are kept indefinitely in the computer system and are easily accessible. We bring that patient up in the computer and we know instantly that there is an antibody problem or special requirements. The CAP Standards say to keep the immediate evaluation/interpetation of a transfusion reaction for 10 years but keep the transfusion reaction problem indefinitely. Keep the paper 10 years, keep the problem forever. To be on the safe side, we keep the paper panel sheets for 10 years because most other patient records are kept for 10 years. If an inspector want to see a panel sheet from 9 years ago, I will be able to produce. Because of the amount of paper, some are stored off-site in some vast warehouse never to be seen again. I will discard the paper at the beginning of the 11th year. I don't know if this is right but I am sticking with it until told otherwise.

I received an email that the written transcript was available on the CMS MLN (Medicare Learning Network). I went to the transcript and was pretty disappointed that my question was not included in the written transcript. I asked my question late in the 2nd hour and there were many questions that didn't make it to the final transcript. I wanted to see it in writing. Not sure if this link will work for you but I followed this link and typed in IQCP July 15. But since the answer to my question is not written there, the July 15 write up won't help you. You can search using just IQCP in the search box and find work books and flow charts that might help. Medicare Learning Network® We also have an Echo and I had the same concerns about gel and tube panels.

If we get a call, we tell the nurse to call the physician and see if they want to call a transfusion reaction. About a third of the time we never hear back from them so I suppose the physician didn't want to call a reaction. If the physician does want to call a reaction, then the order is placed in the computer system and we get the ball rolling. All of the info of what a nurse should do is in the nursing procedures but we have a sheet that we can fax to them with clear instructions because they are sometimes somewhat freaking out. It helps us to get what we need from them in a timely fashion.

I am still trying to wrap my brain around IQCP but the way I understand it, you don't have to do IQCP as long as you follow the manufacturer's instructions. I think as long as you do QC on the day of use following manufacturer's instructions, you are good to go. So I think BB will be OK, for the most part, with daily QC on our regular reagents as long as we do a negative and a positive for all reagents. (I beefed up my daily QC to add negatives for this part.) Rare antisera will need QC on day of use but we already do that. If you have automation, as long as you follow their plan, you are OK. We have an Echo and it won't work if QC is not done when it is supposed to be done. I'm glad it shuts down because my people would try to stretch it for a few more hours. I think the things that will need IQCP are the possible odd things such as Lui-Freeze or auto absorption. These are procedures from a book, not a kit with instructions, so these sorts of tests will need IQCP. If you have a lab created test or something you do that doesn't follow the manufacturer's insert, you will have to do IQCP. I went thru my procedure book and got rid of things that we never do anymore (auto absorption) and came up with a very small list. Lui Freeze is the only thing I can up up with that might need one and we are doing a study to possibly go to acid elution when a physician requests more work on a cord DAT. Just so you know, I listened in on a long webinar from CMS about IQCP on July 15. At the question and answer portion where you write in a question and they answer after a few minutes, I asked specifically if we must do an IQCP for for panels for antibody identification. They had a very short answer. NO. (Whew!) The write up for that webinar should be on the CMS site somewhere. The title was IQCP for CLIA Laboratory Non waived Testing: Workbook Tool. There were workbooks to work thru the process that might be helpful. I really think BB will come off easy on this IQCP process. The department that will be hit hard would be Micro. Evidently, micro tests media once per batch or once per week or something. So to keep from doing QC everyday of use, they will have to write IQCPs for a ton of procedures.

Maristelgp, I thought of something else after I hit "Post." I'm too quick on the draw. If you test for the antigen you are working on, what do you do if you don't have antisera such as Anti-LuA?

Please let us know exactly how you QC the expired panel cells. Do you use a diluted antibody such as Anti-Fya or do you use antisera for the antigen you are working on? Some other method? Thanks in advance

John, I do wish you would offer your services to TJC and other agencies. They have a severe lack of knowledge when it comes to BB issues. We would bow down and pay you hommage. Blood Bankers across the country would sing your praises. Your name would be spoken with reverence. (I know it is getting deep) I was cited by CAP in 2013 for using expired panel cells. I challenged it and said we did not use them routinely, only as an aid in identification when the in-date panels couldn't provide what was needed to complete an ID. I also started having my people run a positive with the patient's serum on the same panel to show that the antibody would be detected using the method (gel or tube). It was expunged, thank goodness. I think CAP has a much better understanding of the situation than TJC.

We have been known to use O negative RBC units with antibodies when the blood supplier can't provide units without antibodies. We would only use them when we absolutely had no other option, usually around a major holiday. Most would be Anti-D and remember there is not much plasma on a RBC. We need blood and the supplier can't give us with what we need. We used to wash these but we got rid of our washer years ago to keep the FDA at arms length. We would place a note in the patient's BB comment so if the patient's screen was positive a short time later we would know it wasn't a real antibody. Not great but you do what you have to do for bleeders. I would rather give an Rh negative person a unit with anti-D which will be diluted in the body and not cause an issue than have to give them an Rh+ unit.

We are also having issues with R630 mostly in #2. We changed the indicator cells but it didn't help much. Must be a bad lot#.

I searched a CLIA site and found this from the following site: State Operations Manual Appendix C - Survey Procedures and Interpretive Guidelines for Laboratories and Laboratory Services Table of Contents (Rev. 140, 05-29-15) (493.1271) There generally are no daily quality control requirements for reagent red cell panels used in antibody identification. However, we encourage laboratories to follow the manufacturer’s recommendations for QC. I printed this part so if an inspector tries to to say I HAVE to do QC I can show this. I think the red was what was revised in May 2015. I want to do what is good for the patient but I don't want to go overboard and use up all my panel cells trying to satisfy a nebulous requirement. I use Immucor and the manufacturer's insert says "the reactivity may be checked periodically with a weakly reactive antibody." (??) MAY doesn't mean the same as HAVE TO. We get hung up on every word of standards, why not the package insert too? After reading what Dr. Pepper wrote when he talked to CAP, I included a column on on our antigen typing form to add the panel lot # since we use panel cells for antigen controls. They should work as expected to show the panel is QC'd multiple times weekly. (Thank you Dr. Pepper, it was an easy fix)

I am interested in scanning the old completed antibody workups to some sort of file for long term storage. We have a printer that will scan to email and then that could be moved to another file. Does anyone out there have a good way of being able to reliably access the file by name or medical record number in the future? Any help would be appreciated. We do not keep blank antigrams. When that panel is gone we get rid of the blank sheets. But how long do you keep the completed antigrams with patient information? I am keeping for 10 years but would like to keep them for less amount of time.

Yes, that is our life. Validate everything, keep the records and be able to find them when an inspector asks to see them. Document, document, document!

Thanks Scott. We also use the the Immucor cor QC for our Echo. I never really thought about using it for my daily gel QC. We have just used diluted antisera. Thanks for the instructions. I am going to give this a try. I think CAP will be all up in our QC with lots of scrutiny starting next year because of IQCP and I want all my ducks in a row long before then.

I agree that the control needs to be diluted for gel testing. Seeing 4+ in gel doesn't tell me if the screening cells will detect weak reactions. We dilute until we get 1-2+ reactions. Is there some regulation that says we CAN'T dilute the antisera for QC? So many regulations, so little time!

I also got rid of my exchange transfusion procedure for this reason. Who wants the FDA lurking around the corner? We hadn't done one in years and no one was competent. I found out that if a baby needed an exchange here it would be sent to a children's hospital anyway.

I have a vague sort of general policy that I use to cover this standard. I have copied and pasted most of it here. I haven't been dinged on it. PRINCIPLE AND CLINICAL SIGNIFICANCE: Materials and supplies used as inputs to a process are considered “critical” if they affect the quality of products and services being produced. A critical material is a good, supply or service used in the collection, preservation, storage, preparation or testing of blood components that directly affects quality or patient safety. Suppliers must meet certain specifications in order to be considered as providers of critical materials. POLICY: Supplier Specifications:Any new suppliers of critical materials or services will be evaluated according to the following criteria: Traceability of materials. Availability of QC procedures and QC data for review. Quality management system in place. If applicable, evidence that current good manufacturing practices are in place. Current suppliers will be reevaluated if error, incident, and variance documents indicate that the products or services are not satisfactory. Supplier QualificationDetailed information about the nature or function of the product/service is important. If there are questions regarding licensure/registration, a statement from the supplier may be requested. This can include documentation that quality systems are in place in the manufacturing of the product/service. Contracts should include detailed information on shipping, storage requirements, and availability of services, cost, and technical assistance as applicable for the product/service. These contracts should be approved by the Laboratory Director, and if applicable, by the Hospital Administrator. Any changes of products/service require approval of the Laboratory Director and Blood Bank Medical Director. Inventory ManagementAs supplies, reagents and labels are received, they are inspected by the Inventory Coordinator. Blood components are inspected and placed into inventory through the laboratory computer system. SOPs are in place to document receipt of blood products. Records of returns will be recorded on the appropriate blood center form and in the Laboratory information System. Records of recalls will be maintained by the Blood Bank Lead Technologist.

It does not state in the CAP standards that QC must be done within +/- 30 minutes of each day. They just state that QC must be performed each day. Our QC form only has the date and no one has ever questioned the time. That must be the rule where the inspector works so therefore it must be the LAW!

We charge both patients. The way I look at it is patient #1 with an antibody requires the antigen charge so the unit is ready in case they need it. They didn't use it so it goes back on the shelf when the crossmatch expires. Patient #2 comes in and needs antigen negative units. We use the units that are already antigen typed and charge patient #2 for the antigen typing. If I had pulled a random unit off the shelf that was not antigen typed, I would have had to perform the testing and charge the patient. I have to provide antigen negative units for both patients whether they use them or not. It is to our benefit (and a blessing) that a unit was sitting there ready to be used. If you only charge the first person, what do you do when you antigen type several units and find extra antigen negative units. You can't charge the first patient for the extra units. It sounds like you wouldn't charge the second one either. I see missed charges and a lot of confusion.

We haven't done an exchange in so many years, I can't remember the last time we did one. I called ICN and questioned them about exchanges and they said they may still do them. So I can't get rid of my ancient procedure. I don't want to register with the FDA for a procedure that may never be used. That is a can of worms that I don't want to open. What do other hospitals do for these situations? Do the exchange and claim ignorance of the law?

I agree with CMCDCHI. We keep the paper panels for 10 years. The antibody ID, transfusion reaction,etc information is retained in the computer system indefinitely. We rarely look at panel sheets older than 5 years. Although we had to look at a patient panel result from 2007 the other day to see when she formed a particular antibody.

OMG! You can't remember having amnio??? I had one with my last pregnancy. They can deaden the skin so the shot doesn't hurt but they can't deaden the uterus. It is one big old muscle. Of course they told me that fact just before punching it thru. It was like getting punched with a big nail from a nail gun. Let me say it wasn't pleasant! It has been over twenty years ago and I still remember. I almost cried watching my little son trying to swim away from the intrusion into his space. I don't believe that she doesn't remember. I always suspect fraud. We had a mom that gave birth and then gave birth again 3 months later. ??? It also happened that her blood type was different the second time which is the reason we really started looking and investigating. ?? It turns out the first mom gave birth and the medicaid card worked so well she let her friend who was also pregnant use her card when it was time for her to give birth. (!?!?)

That sounds better than trying to squeeze more blood out of an anemic patient to run more cells. I would have thought of this eventually when I was actually doing it. That way we can show both pos and neg results to satisfy CAP. Thanks.