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Posts posted by sgoertzen
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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.
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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.
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We've been using the electronic crossmatch with MediTech Client Server 5.62 (LIVE system) since October 1, 2009. We are loving it!
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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.
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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.
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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.
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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
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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?
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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.
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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.
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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:
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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.
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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
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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.
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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!
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We are using HCPCS codes P9017 for the regular thawed plasma, and P9044 for cryopoor thawed plasma.
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Franklyn, what exact kind of IR thermometer are you using? I bought one (not too expensive)and it consistently reads 2 degrees too warm. I hear there are good ones out there, but I haven't had any luck so far.
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I work at a pediatric hospital and we still continue to do the following:
Perform Cold Screen at 4 C first. If 2+ positive or greater, we then set up a thermal amplitude study starting at Room Temp (23 C), then taking it colder to 20 C, 18 C, 12 C, 10 C and we also run a cold titer.
I am hoping to drop this to just a Room Temp, 15 C and 4 C along with a cold titer whenever any patient shows a 2+ or greater on the initial cold screen. I've asked the anesthesiologists whether this is really being used, and they said yes, and they are still hesitant to have us stop doing it. It would be nice if they just ordered it on the cases where they know it will be really important, rather than making it a part of the their pre-printed orders they use for all of the cardiac pump surgeries.
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Hi jcoburn!
When do you get a copy of this validation plan from Immucor? We are only a couple weeks out from getting our Echo delivered and installed, and I have a paper copy of the "Preparing for Better Blood Banking", and the CD of Recommended SOPs and Validation Guide. Is the validation plan you mention in your 3-19-09 note the validation guide on the CD?
Thanks!
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Has anyone seen or heard of a stand-alone software that will capture the information that we currently have to manually write down on a log each time we make an aliquot?
Examples: Date, Time, Donor Number, Product Code, Lot Numbers of sterile welder wafer, tubing, bags, syringes, etc. and then the relabeling double-check?
I stumbled upon something on a web-page back several months ago, gave the company a call, the rep said she would get back to me after the holidays and she never has. Now I can't remember the name of the company, and I am interested in submitting something like this for our budget next year (which we are already having to put together now!)
Our hospital uses MediTech and they don't offer anything like this as part of their aliquot or components (modify) routines. Apparently, they have no plans to add this feature to MediTech either. Now that most of this information is barcoded and could be scanned, it seems like such a waste of time (and opportunity for error) to have to hand-write it all each time.
Thank you! Sheri
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Our facility doesn't issue blood in the pneumatic tube, but we do make them bring "something" with the patient's name and medical record number on it when they come to pick up blood. We do not have any one official "pick-up" slip that must be used. We are in the process of implementing a Pre-Printed MD Order Form for BBK tests and products (and orders to transfuse) and we have been batting around the idea of making them bring that when they come to pick up blood. That way the BBK tech could actually check the MD orders for themselves as part of the issue process (to ensure they were transcribed by the unit coordinator correctly into the computer). The courier would take the order form back with them to be used for more units (if more than one unit was ordered) and the form is eventually scanned into the patient's electronic record. They are hoping to move to physician order entry within a couple of years.
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Franklyn, what data loggers do you use? How expensive are they? How often do you have them set to read a temperature?
At the recent AABB meeting in Montreal, they specifically mentioned at the assessor training that temps had to be recorded every 4 hours, regardless of how long your cooler is validated for. I'm thinking I'll have to move to data loggers, or either have SURG/ICU/ED staff bring them back to us every 4 hours so we can read a thermometer inside and manually record a temperature.
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We are in the process of purchasing an Echo, but have been using the Capture method for almost 2 years. Our blood bank techs love it. We also perform antibody ID testing for several very small local hospitals who prefer to send out any screens that come up positive using their ProVue. What we have seen is consistent weak positives being detected by the ProVue. When they send us their specimens, we repeat the antibody screens using first the Capture method, and if negative, we repeat with tube LISS/PEG methods. So often we find that there is nothing there. I can't imagine that all of these patients actually have weak "real" clinically significant antibodies that neither Capture or tube methods can pick up.
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There is so much more involved than just getting your staff fingerprinted. Carefully read the NRC Order EA-05-090 from 2005 when this all began. Then add to it the NRC Order EA-07-305 dated December 5, 2007. There are pages and pages of instructions on the security program you must create. Someone at your institution (whoever "owns" your radioactive materials license) received both of these letters (or your State's version of these same orders if you live in an "Agreement State"). Too bad they didn't take the required actions when they got the letters, because now you will be scrambling.
The fingerprints with the FBI is so that they can compare them with their list of possible terrorists. The FBI assured us that our fingerprints do not get "added" to this list. You must also do criminal background checks, and have a sophisticated program (written in policy) whereby your appointed Trustworthy & Reliability Official deems people either acceptable or not acceptable to have unescorted access to your irradiator. We formed a team to work on the whole thing that includes the blood bank supervisor, the lab manager, the hospital legal counsel, the HR director, the HR recruitment manager, our executive director, our security director, and our radiation safety officer (and you also must include your local law enforcement). Also, you must further secure physical access to your irradiator. Its been a rather large project. Apparently, non-compliance is not something you want to experience when they come to inspect you. Good luck!
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We used to monitor 100% of the returned transfusion forms but after several years and after we were satisfied that we were getting compliance consistently up to our targets, we have dropped it to 100% review for only one month per quarter. The nursing managers all get this Quality Monitor report for their areas each quarter, so they know we are still watching. I'm sure if we dropped it altogether, the noncompliance would sky-rocket back up. I'm looking forward to moving to the bedside electronic transfusion record, so that we can just run reports for our data and not hassle with inspecting each form and trying to figure out illegible handwriting.
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At the AABB meeting in Montreal last week, it was explained at the Assessor Day training session that coolers used for temporary storage (like we use them at my facility in the ED, OR, ICU) must have a temperature "recorded" at least once every 4 hours as per standard 5.1.8.1.2 "For storage of blood products, the temperature shall be continuously monitored and the temperature shall be recorded at least every 4 hours." We have our igloos all validated for 6 hours, use a temp bag inside (take temp at issue and return) and also use HemoTemp indicators on the blood bags, but this apparently still doesn't fulfill the standard. We've decided that we are going to have to buy some loggers that we will program to take the temp every 30 minutes or so, and place one in each igloo at the time it is issued.
Does anyone have some good suggestions on temp loggers that are fairly inexpensive but that perform really well? We have seven Cell-Safe Igloos and on some busy days they are all being used, so we don't want to spend a fortune on loggers.
Thanks! Sheri
Storage vs. Shipping/ Validation
in Education / Quality
Posted
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.