sgoertzen

I like Lisa's idea.... call the home page LabTalk.com, then name each of the sections accordingly as BloodBank Talk, Micro Talk, Pathology Talk, etc.

We have MediTech and have begged them to add a "Label Verify" (scanning system) at the end of the "Make Aliquots", "Make Components" (aka Modify), and "Pool Units" routines. Until they do, we are still documenting the required 2nd label check by a 2nd tech on a paper log. We are a children's hospital so modifying, splitting and relabeling is what we do all day and night. You would think our computer system could be built/enhanced to capture this required information.... especially now that this could be done with simple scanning. So infuriating!

Susan - where is that routine located? We are on C/S 5.62 and I am not finding it. Thanks! Sheri

Boooooooo!!!!! Why doesn't MediTech listen to us and build a label check function into the Make Aliquots, Make Components, and Pool Units routines?????? SO FRUSTRATING!!!! We have to use a manual log which is so NOT a part of the operational flow and is just asking for errors, incomplete documentation, etc.

We never formally QC'd our saline each day until we realized the manufacturer states you should do it right on the outside of the cube of saline. Ours details what needs to be done. Also, ours states on the cube that it should be given a 30 day expiration from the date it is opened. I came up with a daily Saline QC sheet for each workstation. Kind of a pain, but you don't want to get cited for not following the manufacturer's instructions.

I also supervise the Transfusion Service at a pediatric hospital and our procedure is very similar to Elizabeth's. Our donor center quit collecting whole blood derived platelets over 10 years ago and so we use only leukoreduced irradiated plateletpheresis units and aliquot them using sterile connecting devices just like we do PRBCs and Thawed Plasma. We rarely end up throwing away any left over "pieces" of a plateletpheresis. Our oncology doctors would much rather approve giving 3/4 or 1/2 unit to their patient than have us throw it away, and since we have all sizes of patients, it usually works out.

I would treat it like an "Unidentified" trauma patient - using downtime bands (like a Typenex), downtime forms, and uncrossmatched O neg blood. Once the newborn is born and registered in the computer, you can go back and enter all the information into the system, including a name change and ID band change (i.e. from the typenex number & band to whatever name they enter into the computer system and regular band they generate for the infant). At our hospital, they let us "Pre-Reg" 20 or so of these "Unidentified" typenex bands into the computer, so that when a crisis patient shows up with no ID or no time for registration, they only have to activate that armband account in the computer and attach the band to the patient, then everything can be ordered, entered, and issued in the computer, and then later... when the dust settles... everything can be reconciled to the patient's real name and information.

I believe this is the history: At the 2007 AABB meeting, the FDA inspector at the "Ask the FDA" session said that if a cooler is used for temporarily storing blood, then the FDA would consider that to be a "storage" device and would require the 1-6 C temp limits. (That is when I changed my temp limits on the coolers from 1-10 C, down to 1-6 C) At the 2008 AABB meeting, speakers from the AABB stated in variours sessions that if the FDA now considers temporary storage coolers as "storage" and not "transport", then the standards would also apply for taking the temperature at least every 4 hours. (That is when I changed the expiration on my coolers from 6 hours down to 4 hours so we could take & record the temperature every 4 hours.) Finally, at this most recent 2009 AABB meeting, speakers from the AABB are now back-pedaling (I think they had some major complaints for the very reasons you state above) and they are now stating that if you have validated your cooler to maintain acceptable temperatures for more than 4 hours, you don't need to record the temperature every 4 hours, but you would need to perform some sort of periodic QC to ensure it is still able to perform at the level it was validated. (So now I am changing my procedure back to allow the 6 hour expiration of the coolers, but now we will be taking the temp of each returned unit with the IR thermometer.) I'm still confused about the whole 1-6 C or 1-10 C acceptability limits. Its the same cooler and the same units ... if it is sitting still it must be 1-6 C and if it is moving it can be 1-10 C? That still makes no sense to me.

Exactly! This is especially true at our pediatric hospital where issued units come in widely variable sizes. That's why we are opting to just take the temp of each one that comes back before assuming its OK and re-entering it into inventory. I agree that verifying the HemoTemp AND taking the temperature with the IR thermometer is probably overkill (we could skip taking the IR temp if the indicator is OK), but talking with my techs, they would prefer to build a uniform method into the process and use it for everything that comes back. I don't want to give up using the HemoTemps because I don't trust that they won't take a unit out for awhile, warm it up, and then try to sneak it back into the cooler to send back to us. Added note: Based on our most recent FDA inspection, we also are now verifying the acceptability of the packing/transport methods used by our donor center by taking the temperature of units at the time of delivery using the IR thermometer. Our inspector said we didn't need to do it for every delivery, but should probably hit each type of product (RBC, PLT, FFP, CRYO) periodically, so currently, we are doing each one at least once per month.

We purchased two "Fluke 561" IR Thermometers from Global Sensors for $175. We are happy with them so far. They have a +/- 1 degree variability compared to many that advertise +/- 2 degree variations. At the AABB meeting in Oct., it was brought up both in the assessor training day and also during one of the sessions I attended about the 30 minute "rule" having no real foundational basis, and that there isn't (and has never been) any "rule" or regulation about this. There are however, temperature limits that are clearly defined and should be regulated. The 30 minute deal has been more of a widespread common practice over the ages that no one has challenged. They stated that if you want to use a 30 minute limit (or any limit based on time), then you have to show studies and evidence that proves your units are still within allowed temperatures at that predefined time at room temp (or outside temp, or where ever that unit traveled) after issue.

We initally validate each cooler to maintain temperatures for 6 hours. For ongoing QC of each cooler issued, we apply a HemoTemp indicator to each RBC and Thawed Plasma unit issued in a cooler and verify & document the HemoTemp is OK if the unit is returned (to ensure it was not removed, warmed up, then placed back into the cooler). We will soon also add that if units are returned in the cooler, in addition to verifying the acceptability of the HemoTemp, we will also take the temperature of one of the units in the cooler with an infrared thermometer gun and record it on our cooler Issue/Return log. By adding this process, we will be essentially QC'ing every cooler's ability to maintain its temperature each time it is sent out and brought back. (We issue all of our blood to surgery in Cell-Safe coolers, so we get a lot of practice with cooler issues & returns!) I would suggest the investment in a high-quality infrared thermometer since eliminating the 30 minute rule for returning an issued unit is the next big change coming. You will only be able to accept an issued unit back into inventory if you have verified (by either documented pre-validation or documented measurement) that its temperature has not exceeded 10 degrees. Since I think it would be impossible to validate the issue/return temp of different sizes of units at 30 minutes post-issue during each season of the year to every single area of the hospital & outpatient clinics on campus, I think taking the temp each time a unit is returned is the best and easiest way to go for us. I foresee discarding many more units, since in reality, my experience has been that units warm up to 10 degrees faster than 30 minutes. We are currently validating our new infrared thermometers, training staff to use them, and updating our procedures to do away with the 30 minute return policy.

The way it is currently set up in our system... no, it will not trigger on any specimen older than 72 hours. We also draw some "extended use" specimens on selected pre-op patients (we only extend up to 7 days), and we are unable to use the EXM for those patients. We are also unable to use the EXM on repeated transfusions for infants < 4 mo. where we don't get a specimen. (We still have to use our "home grown" computer crossmatch for those.) Its an "all or none" thing ... once the EXM is turned on, it will automatically try to envoke on the crossmatch you have it attached to (ours is attached to the immediate spin crossmatch) using the one set of parameters you have set in the BBK Custom Parameters dictionary (page 1). Since the "Elec Xmatch Expire Hours" is only a 2 character data field, I'm guessing it can only be extended up to 99 hours. We have ours set at 72 hours so that we don't risk compromising the 3 day rule for patients who have been transfused within the past 3 months - AABB Std. 5.13.3.2). You can also define if you require a "2nd User for Blood Type" if you are a facility that requires 2 different people do the ABO/Rh. It would be really nice if MediTech allowed us to match the expiration of the EXM with whatever we have defined as the expiration for each blood bank specimen - so that when we changed the expiration of the specimen, the EXM trigger expiration would change with it as well.

The way the EXM works in MediTech is that it will automatically invoke on a crossmatched product whenever all the following criteria are met: 1. You must have 2 separate ABO/Rh typings on the patient, one must be within the past 72 hours. (You can set whether or not you require 2 different specimens and/or 2 different people running the typings.) If you don't have 2 typings, it will warn you that the crossmatch does not qualify for electronic crossmatch and why. 2. You must have a negative Ab screen within the past 72 hours. (You define which antibodies you consider to be clinically significant in the Ab dictionary.) It checks the patient history against that and if there is or has ever been a clinically significant antibody, it will not allow the EXM to invoke, and the warning message tells you why. 3. If you crossmatch at the same time you perform your type & screen (that's how we do it), the product gets crossmatched then, so there really isn't any "holding" units. We tag our units at the time they are set up, so that part is actually working the same as when we did I.S. XMs. The doctors/nurses have no idea which units were electronically crossmatched, immediate spin crossmatched, or coombs crossmatched. The tag on the unit looks the same regardless of what kind of crossmatch was done. It says: Compatible? Y You don't actually develop an electronic crossmatch "test". MediTech flips the EXM switch in your system and it will automatically try to invoke each time a regular crossmatch is ordered with a product. If it passes all the criteria, when you put the unit number in that you want to crossmatch, it just automatically completes the electronic crossmatch and you are done. If it doesn't pass EXM criteria, you get a pop-up warning box telling you that it is ineligible for EXM and the exact reason why. Whichever way you end up crossmatching, the interpretation is "compatible" and you get the same crossmatch card and Issue form.

We've been using the electronic crossmatch with MediTech Client Server 5.62 (LIVE system) since October 1, 2009. We are loving it!

We are now implementing a new pick-up slip that the transfusing nurse has to fill out and sign stating he/she is sending for "this" specific product for "this" specific patient after reviewing the doctor's orders for transfusion. (The unit coordinators will no longer be allowed to do this for the nurse.) This is due to a recent incident where the unit coordinator in ICU placed an order for PLTs, we set it up, issued it and the nurse administered it without ever checking the MD orders that were actually written to give FFP. Rather than hold the nurses accountable, our Patient Safety Chair wanted to make it the BBK tech's responsibility to actually "see" the written MD orders from the chart and compare it to the orders placed in the computer before preparing any products (his idea was that someone on the floors would fax the written MD orders to us), but PLEASE... this wouldn't work for at least 1/3 of our orders! What about surgery where there are no written orders to transfuse, or the outpatient clinics where they use a generic standing order for 6 months for both RBCs and PLTs dependent on drops in Hgb and PLT counts? Or orders written in the chart that look like a scribble? Or Pre-Op orders where they order 3 different products all at the same time for the same patient? When they come to pick something up, how would WE know which product they "should" be coming for? My medical director and operations director (and me) are all saying no. The person transfusing the blood has to be the one who double-checks the orders to transfuse to make sure he/she is sending for the right product on the right patient (as per their policy/procedure). We are planning to move to CPOE within a year, where if the orders are placed for the wrong product, the doctors won't have anyone to blame but themselves.

Yes, MediTech product groups are your friend, not your enemy! You still need to have a separate product dictionary built for each product you ever need to print an ISBT label for, but that goes fairly quickly when you can copy one product to the next as you build your dictionaries. The product groups allow you to fill an order for PC, or PLT, or FFP with any of the products within that product group, and you don't have to build from scratch the compatibility tables for every single product vs. every single blood type. It greatly improved our ability to keep our dictionaries up to date as we needed to add more products, and to validate appropriately as we moved from Codabar to ISBT 128.

Just today we had our first case (that we know of) where we got a negative screen and negative panel on the Echo, a negative screen in the tubes using LISS/PolyAHG, but the patient's Anti-Kell showed up a perfect 2+ positive pattern with Gel. Not sure what to think about that! The Capture and tube methods both missed this Kell.

We have product groups built for RBC, FFP, PLT, CRYO, WB, GRAN. We then built separate product dictionaries for each kind of product you receive from your donor center that falls into each of these product group categories. You have to do it this way if you are going to print ISBT labels. We make all of our products non-orderable from the floors. We only allow the floors to order generic dummy products (our menu offers RBC, FFP, PLT, CRYO, WB, GRAN). We then edit the correct product (the one we choose to set up) on to the patient's requisition in the blood bank. All products within each product group are substitutable for each other (example: you can fill the order for the generic RBC with any red cell product like LDAS1, LDAS3 or LDCPDA, etc.) We do a lot of splitting and modifying at my hospital (we are a Children's Hospital), so it is VERY important for each product code to have its own product dictionary and we could not "lump" lots of products codes to map to the same product. Feel free to email if you have questions: sgoertzen@childrenscentralcal.org

I would love to say it isn't so, but this was a hot topic at the AABB Assessor Training in Montreal last October. There was some disputing going on between the AABB accreditation "experts", but in the end, they determined that the 4 hour requirement for temp recording goes for all storage devices/areas which now includes igloos as defined by the FDA. I am an AABB Assessor and I came away from that Assessor Training Day with the clear impression that if you don't take temps of your igloos at least every 4 hours, you are not meeting the standard. It is interesting to read the post from clmergen above that quotes clarification from an AABB Standards Committee member that does not jive with what they told us last October. I truly hope that this gets clarified once and for all... hopefully at the AABB meeting in New Orleans coming up in a couple of months. I agree, it is quite ridiculous to use two sets of temp & recording standards for the same exact container: one set if it is being used to transport, and another if it is being used for temporary storage. I would love to go back to 6 hours for my igloos because we validated them for 6 hours, and this 4 hour thing is a lot of extra work for.... what?

Yep, we spin them in a temperature controlled centrifuge at: Speed in RCF = 2000 RCF Temperature = 22 C Time = 10 minutes Then we express off all the plasma except about 50 mL. Leave the bag at 20-24 C, without agitation, for 1 hour. At the end of this "rest" period, resuspend the platelets by either: A. Gentle manual massage for 5 to 10 minutes until the platelets are evenly suspended. B. Rotating the bag on a standard platelet rotator/agitator for 1 hour. We tried to avoid spinning if at all possible. We also avoid giving Rh positive platelets to any of our Rh negative patients (male or female, birth through 21 yr). When we must, we always recommend that the MD give a mini-dose of RhIG.

Our policy is that we allow retyping the same specimen as the 2nd typing for only group O's and neonates < 4 mo. (who will get O blood regardless of type). If the patient is over 4 mo. and is A, or B or AB, a new specimen must be used for the 2nd typing that was collected at a separate time. If they refuse to collect us a 2nd specimen (we are a pediatric hospital), then they get group O blood until a 2nd specimen is obtained. They rarely refuse (unless it is an emergency) since they prefer type specific. Our computer (MediTech) checks to see if the patient has 2 verified blood typings on file for the patient, a negative Ab screen history, and also a fresh negative Ab screen (< 72 hours old) to trigger the electronic crossmatch. We are currently charging for the 2nd typing, but not for the electronic crossmatch. We may want to rethink that and switch it, since we could charge multiple times for multiple units electronically crossmatched, whereas we can only charge once for the type recheck.

I supervise the Transfusion Service at a Children's Hospital so we give lots of platelets to lots of neonates and small kids. We use plasma compatible platelets for everyone up to 45 kilos. If we cannot get plasma compatible (our donor center supplies only leukoreduced-plateletpheresis), our policy is to volume reduce and remove the incompatible plasma. We also aliquot and irradiate almost everything, so we spend a lot of "quality time" with our products. :juggle:

We use the Cell Safe Igloos and we have validated all of them, and we revalidate all of them every couple of years. We always find one or two that don't pass that must have warped a bit or something from the last time they were validated and need to be replaced. As for QC'ing them at least twice a year, we use a thermometer inside each igloo and HemoTemp indicators on every product placed in an igloo, so every time a product comes back to us and the temperature and HemoTemp is OK or not OK, I would consider that "QC'ing" the storage ability of the igloo and the acceptability of the product. If an igloo comes back after the igloo expiration time, the HemoTemp and internal igloo temperature are used to determine whether the product should be placed back into inventory or be discarded. The big issue now is the AABB requirement for temperatures to be monitored and RECORDED every 4 hours for any storage device. Now that an igloo is considered a "storage device" instead of a "transport device", this means igloos need their temp taken at least every 4 hours. Our igloos are all validated to maintain temperatures between 1-6 C for 6 hours, but we have shortened their expiration period to 4 hours, since someone/something needs to record the temperature of the igloo every 4 hours. We either had the option to buy a temperature data logger for each igloo (and we have many) or change our policy and make them bring the igloo back to us at 4 hours (we can't trust them to take temps every 4 hours in SURG or in the ED or on the floors). We opted for the latter. If they need it longer, we take the internal temperature of the igloo, re-ice it, and give it back to them. We log all of this information on an Igloo Log.

Daily, we QC each opened saline cube being used and write the information on a log for each workstation. We check 1) saline appearance 2) printed expiration of the cube 3) 1 month expiration from date of opening 4) IDCT results and Check Cells (see procedure copied below) 5) We check the pH daily of the buffered saline for our Capture workstation ********************************************************************** Saline (To be done each day of use) 3. Observe Saline Appearance & Check Expiration of Cube • Inspect one of the tubes of saline. The saline should be clear, colorless and have no signs of microbial growth or particulate matter. • Check the expiration on the cube and the date it was opened to ensure it is not expired and is within 1 month of being opened. • Document acceptability of both of these with the symbol “” on the form. 4. Refill Saline Bottle • Pour the saline from the saline bottle at the workstation down the drain. • Using the “prime” mode of the cellwasher at that workstation, refill the bottle. • Document this was done with the symbol “” on the form. 5. Indirect Coombs Test (Cell #12 in Daily RQC may serve in place of this Negative Control) • Add one drop of the Pooled Screening Cells to a 10 x 75 test tube. • Add 2 drops of saline from the saline bottle at the work station and 2 drops N-Hance. Mix well. • Incubate at 37 C for 15 minutes. • Wash the tube (x 4 cycles) with the saline & cellwasher of the workstation being tested. • Add one drop Antihuman Globulin (polyspecific), spin, and read reaction (should be negative). • Document the reaction interpretation : Neg (Ø), Pos (+), Hemolysis (H) • Add one drop of AHG Check Cells, centrifuge, and read the tube for agglutination. If the saline and cellwasher are functioning properly, the tube should now show 1-2+ agglutination. • Document this check cell reaction interpretation : 1+, 2+ = Pos (), Neg (Ø) NOTE: Immediately discontinue use of the saline if the Indirect Antiglobulin results are positive, hemolysis occurs, or if visual inspection detects any signs of microbial growth or a change in color or clarity. ***************************************************************** I wrote a Cellwasher / Saline QC procedure and would be happy to share the whole thing along with a sample of our QC logsheet if you are interested. Just let me know! sgoertzen@childrenscentralcal.org

We are using HCPCS codes P9017 for the regular thawed plasma, and P9044 for cryopoor thawed plasma.