jshepherd

We have the TempCheck device that SbbPerson linked above. It's pretty good. It's only single digit (5C, 6C) so there could be some error in accuracy. One downside, the little foam pad will basically assimilate room temp, and can cause some units on the cusp of 6C or 10C to be read as over temp, simply because the foam pad surrounding the sensor isn't cooled enough by the unit when taking a temp. We get around that by keeping a refrigerated polar pack on the unit, gotta replace it every few hours as it warms up, but its better than tossing units. The other option the company gave was to keep the TempCheck in the fridge until it was needed, but that isn't feasible for us.

Sorry, should have clarified - I am a hospital transfusion service. But that is an excellent point.

I seem to recall that an adult RBC unit must be at least 200ml, and a plasma unit at least 150ml, but I can't find any reference to corroborate my brain, nor can I find a standard, CFR or suggestion that says a minimum volume is required for either of these units. Can anyone help? Is there such a thing as a minimum volume? We are splitting our LTOWB into an RBC and a liquid plasma, and sometimes the plasma units are getting close to that 150ml mark. Just want to be sure I won't be sending out a too-small unit!

We are the same. We get a fresh <7 day old unit shipped in weekly from our blood supplier, so there is always an option for a fresh unit. We don't transfuse a ton of neonates, but our policy is to provide freshest possible, CMV safe/leukoreduced and HgbS neg to all babies. Those who have a very low birthweight or other indications for irradiated products will also require irradiated. Since the unit we get weekly is irradiated, pretty much all babies get irradiated because it's the freshest we have. We aliquot units to a syringe or bag, but in emergencies we will send the whole unit to the NICU if they can't wait. Same for platelet units.

My current hospital lab is JC and FDA inspected. My prior lab was CAP, with the hospital being JC. I honestly don't see a difference without the CAP inspection here, as we follow all AABB standards anyway. We used to be AABB inspected in BB, but dropped it in 2004 or 2005, before I got here, due to costs and not much gain for a hospital transfusion service that doesn't irradiate, wash or pool. My two cents: you don't need inspections by 4 organizations, just pick one.

This has been an ongoing Immucor issue for a couple months for us, spanning a couple lot numbers. The reactions are still macro positive at IS, so there isn't actually an issue per the package insert, but yes, they are weaker than normal. We haven't had to incubate anything that wouldn't normally be incubated.

We only type for the actual antigen corresponding to the patient's antibody for anything other than Rh. For those Rh antibodies, we will type for the C, c and E as appropriate genetic-inheritance wise, as you described above. We don't typically type for e unless the patient has an e antibody (to prove it's creation) or is E positive (checking for heterozygosity), since 98% of people are e positive (we assume e pos unless given reason to check that). We would do a full pheno with whatever sera we have in house (pretty much all common antigens) for those patients where it might be useful (sicklers, WAA, etc.).

Of course not Malcolm! To clarify - we only release for patients that are IS or electronic XM able, and only if the patient is stable with no impending procedures, and has a Hct above our threshold of 7. Patients with antibodies that require AHG crossmatch keep their units reserved for them for the life of the sample (3 days).

We did this exact process. We paid Haemonetics to extract the data and put it in the format that Soft needed. They were extremely less than helpful, so I feel your pain! Our internal lab IT team ended up having to modify so much of what Haemonetics provided us, we may as well have done it ourselves. Even though we were paying Haemonetics to do the extract, they took FOREVER to complete each part of it, requiring our LIS team to modify the files into the Soft formatting at the end, so we could stay on track with the project. Also, lesson learned: SafetraceTx filed all of our cord blood tests as a valid blood type, and these were all included in our extract. We started electronic crossmatch when we went to Softbank, and found out a few months in that cord blood types were being counted as a historical type.....so we are now in the process to remove those from the Softbank BSA, a process we are having to pay Soft to help us with. Our LIS team told me to make sure you review any files that Haemonetics extracts for you very carefully. There were formatting issues all over, and Soft's format for the upload is VERY specific, and a bit odd. Our LIS team says if you're not already familiar with the Safetrace tables, it might be more difficult to do this yourself. They also recommend getting Soft involved early, to ensure that the formatting is correct and the data you're intending to pull is valid. Our LIS thought they could have done this project themselves, in retrospect, but they also are very adept at Crystal report pulling from the SafetraceTx tables, so knew where to find the info. The concern was how long it would have taken them to do the extract themselves. Let me know if you have specific questions, we may be able to help guide you if you go it alone!

We routinely release blood products after 24 hours. There is a report we have that prints out daily with all the allocated units, the patient info for them, including the most recent H/H. The BB staff checks into each unit, why it was set up (usually hold for OR) and if the patient is currently stable with no impending procedures, we release it back to inventory. The patient's TYSC specimen is still valid, so another order for blood products can be placed at any time.

I started doing this kind of data dig before COVID, looking at appropriateness of transfusions in the ED. Similar to you, it's usually 1 unit transfusions, often in emergent settings but not MTP. I agree with @exlimey that the shotgun approach is usually what happens, and our retrospective looking is not comparable to the ED's initial read of the patient. Most often the dreaded "hypotension" is the reason for pushing products, regardless of H/H or active bleeding. We've done education to this point with our ED, and that includes our trauma patients, that a onesy-twosy red cell transfusion for low blood pressure is not appropriate. We haven't tracked the number of TYSCs ordered, but in our concurrent reviews, these are typically ordered for patients who may be pre-surgical, or to be admitted. I feel like they order TYSCs better than blood products at this point!

We are similar to others, male traumas and women over 50 get O pos immediately, children and women under 50 get O neg until we have a type, but still no more than 10 units of O neg if they are on MTP. A critical shortage could be handled the same way. Place a limit on how many O neg units each patient should get, based on your available inventory, and write this in to your policies, both internal BB and the hospital versions.

We do not have a statement like this in our policy. That said, this feels like a nursing directive, and shouldn't be part of a blood bank policy. It sounds pretty specific, and since we know all patients don't read the instruction manual, this statement could be very restrictive when it's not meant to be. I would recommend generalizing this more into something like "flows must be adequate for transfusion".

We have Epic with BPAM, Beaker and SoftBank. I haven't run into this issue or ever heard of it! Similar to @applejw, we have dummy patients that our traumas start out with, and those get reconciled after the urgent event. We do also do MTPs using the patient's MRN and real info. We are not creating orders in Epic for these extra products though, we order them in Softbank, in Order>Modify and just lines of product orders to the existing order. The original order must come from Epic, and everything we add in Order>Modify is considered an unsolicited order. Our policy allows this of course, but anything we order unsolicited does not have the matching Epic Transfuse order, meaning that BPAM will NOT work with those units. That said, our OR's OpTime module in Epic does not utilize BPAM, so they don't have issues with scanning these unsolicited products. Anywhere else in the hospital would not be able to scan the products using BPAM, because there is no Transfuse order and no matching product order in Epic. All of the unsolicited products are visible in Epic, they just bypass the BPAM process. We have a paper form that is used for charting in these instances where it's not being done in the OR, and the staff prefer this because Epic's transfuse module is NOT set up for massives, the paper is quicker! We also only crossmatch the first 10 units in a massive anyway, essentially making everything beyond that type compatible emergency release. @Eagle Eye - we had Safetrace before we switched to Softbank last January, and yes, when you got to 100 units it would crap out and you'd have to order a new product order. (insert eye roll here!)

Agree with David. I have scanned my "long keep" type of documents into our secure drive. WAY less paper to handle, and you can keep them longer too. 5 or 10 year keep depends on what you are auditing.

The FDA responded! See below if you're interested. It sounds as though this IS allowed, provided I follow the regs mentioned, which I had planned on doing of course! Dear Janine, Thank you for your inquiry. Please see our responses below: I would like to start splitting donor whole blood (originally collected by the ARC) into a packed red cell and a liquid plasma unit. I am unclear on if the creation of a liquid plasma unit is allowed? Response: Yes, it is allowed to separate Liquid Plasma from the Red Blood Cells, provided it is performed in a closed system using a bag attached to the original blood collection set or using a bag attached by a sterile connecting device. Per 21 CFR 640.35(c), Liquid Plasma shall be separated from the Red Blood Cells and stored at a temperature of 1-6○C within 4 hours of filling the final container or within the timeframe specified in the directions for use for the blood collecting, processing, and storage system. I would like to split the WB 5 days before it expires, creating a red cell with the same expiration, and a liquid plasma with essentially a 10 day expiration. It seems as if this CAN be done by the regulations I’ve been able to find, but I also cannot find anyone who is ALREADY doing this, which makes me concerned that it’s not allowed. CFR 640.34 dictates that the liquid plasma must be separated from the red cells “within 4 hours after filling the final container”, and I wonder if this is why it seems that liquid plasma unit cannot be made from WB that has been anticoagulated and stored at 1-6C? Response: Please note in 21 CFR 610.53(b), Liquid Plasma must be stored at 1-6○C and has an expiration date of 5 days from the end of the Whole Blood dating period. I understand that I can make a red cell from a WB unit, but I would like to be able to attempt to use both portions of the units if possible, hence my questions about the validity of making a liquid plasma. Response: As stated above, this is allowed. Also, I am already registered with the FDA, but I believe doing this splitting of WB will also require me to change my registration to “prepare” both RBC and liquid plasma. Can you confirm that? Response: You are correct. Transfusion Services who routinely perform component preparation (e.g., separate whole blood into RBCs, Liquid Plasma) must be registered and the blood establishment registration will need to be updated to reflect that information. In addition, please note the following Regulations: Subpart B - Red Blood Cells. Per 21 CFR 640.11 General requirements Storage. Immediately after processing, the Red Blood Cells shall be placed in storage and maintained at a temperature between 1 and 6 °C. Per 21 CFR 640.16 Processing Separation. Within the timeframe specified in the directions for use for the blood collecting, processing, and storage system used, Red Blood Cells may be prepared either by centrifugation… Subpart D - Plasma. Per 21 CFR 640.32 Collection of source material Whole Blood must be collected, transported, and stored as prescribed in § 640.4. When whole blood is intended for… Liquid Plasma, until the plasma is removed, the whole blood must be maintained at a temperature between 1 and 6 °C or as specified in the directions for use for the blood collecting, processing, and storage system…The red blood cells must be placed in storage at a temperature between 1 and 6 °C immediately after the plasma is separated. Per 21 CFR 640.34 Processing ( c) Liquid Plasma. Liquid Plasma shall be separated from the red blood cells and shall be stored at a temperature of 1 to 6 °C within 4 hours after filling the final container or within the timeframe specified in the directions for use for the blood collecting, processing, and storage system. Subpart F – Dating Period Limitations Per 21 CFR 610.53 Dating periods for Whole Blood and blood components Table of dating periods. Product Storage temperature Dating period Liquid Plasma Between 1-6○C 5 days from end of Whole Blood dating period. We hope this information is helpful. Let us know if you have further questions.

Guess I should have mentioned that I am already inspected by the FDA. @applejw - you mention proficiency testing - of what? The hematocrit QC on the units, or do you mean something regarding the making of the red cell and possible plasma? I'm not aware of PT for expressing off plasma. We do not have the space for a refrigerated centrifuge, so our plan is to allow the unit to settle (this is expressly allowed in FDA regs), so there is no QC/QA on that equipment either. I agree that the circular makes it sound as though you could split the plasma off at any time, and that the plasma would expire 5 days after the whole blood, though I think there may be poor English at work there making me read it that way. Intended process would be to let the unit settle, express off the plasma, leaving about an inch of plasma on the red cell unit (since we will not be adding anything to the red cell), run a hct on each red cell we make, and relabel. If anyone sees a flaw or issue, please let me know! Still waiting on the FDA....

This may be old hat, but I couldn't find anything searching around here so here goes: We currently stock O pos LTOWB for trauma MTPs only. These are CPD 500ml units, with anticoagulant already added of course. When they are getting close to expiration (maybe about 5 days before), I would like to split the units into a red cell (with E code E0181) and a liquid plasma (E2457). I have been able to find that making the red cell is well documented, but I can't find anything about being able to keep the expressed plasma and label it as a liquid plasma and transfuse it! I have sent an inquiry to the FDA, but no response yet. The regulations I have come across make it sound like the liquid plasma is possible, but 21 CFR 640.34 (c) says the LP has to be separated from cells "within 4 hours of filling the final container", which makes me think I can't transfuse the LP when split from the whole blood unit so long after collection. Is anyone out there doing this, or have any insight as to what is possible? I am a transfusion service, so this would be a foray into manufacturing. I'm just looking to save as much of this product as possible, since most of our traumas are type O anyway. Thanks!

Our cell saver machines have an in-line optical Hct sensor. So we record that on our forms for documentation. There is a "line in" and "line out", so we get a good read on the low Hct coming in, and the high crit of the processed blood on the way out. If this is not recorded, or unable to be read, the perfusionists are supposed to collect a purple top for H/H determination in the lab. Once 10 units have been processed for the patient (this has never happened), they should be collecting a heparin level on the patient to ensure adequate washing of the processed blood. That is a manufacturer recommended QC step.

Unfortunately, the JC standards put cell saver under the QSA for Blood Bank. I'm not sure a disclaimer would help, though I like that idea! We have a contracted perfusion service that runs our cell savers in the OR, and I still oversee it. They must follow our processes, use our forms, etc. I get a copy of their annual training/competency from the perfusion company to prove they are capable. As far as QC/QA for the cell saver instruments, the OR and I have joint oversight of that, and we log every time the cell savers are used and document the QC for it.

While Malcolm is correct, I also agree with OneMore. I have worked with Immucor instrumentation for 17+ years, and always ruled out with a "double dose" cell, and never had issues.

The sand doesn't react to temp changes as quickly, like a door open too long, which causes a false alarm, especially on an ultra low freezer. It provides a bit of a buffer, better than ethylene glycol or glycerol.

Yes, upon opening or adding to the in-use rack, not on receipt.

Wow. Never heard this one. I agree with SbbPerson that it's a JC thing due to the dirt that could be on the box, but if you are keeping the boxes in an area where you are not doing testing (aka the storeroom) I don't see how they can enforce this. We keep our saline in the boxes as well, and they are just on a wire rack in the room next door. No one has batted an eye at this, between CAP, JC and the FDA. Can you make a case that when the saline bag is out of the cardboard it is less safe? Like, once the level of the saline gets too low in the bag, its too difficult to get the saline out, and therefore it's wasteful? Try to find a way to make them see the bad sides of having it out of the box. Good luck!

Would be happy to take any that perhaps don't get picked up!