Townsend

Sounds like an amazing program - Congrats to your team!

We use both pre-pooled cryo from our blood supplier and in-house pooled cryo. We are a pediatric hospital, so we may pool only one or two units depending on patient weight. We do not add saline to the pooling process, and there is very little cryo left in each bag. I am curious - what diagnosis or indication requires 36 units of cryo? I would like to learn a bit about that.

1. How many beds in your facility? About 450 with additional offsite NICUs, level 1 pediatric trauma center  2. What is your TAT? We only monitor T&S from the Emergency dept- 45 minutes or less (goal is 95% resulted within 45 min. We are usually 97-99% and perform around 120-150 samples from ED per month) 3. Is the TAT calculated from order to result or receipt to result? From receipt to result only  4. Who collects your specimens? RNs, phlebotomists, others? RNs or IV team 5. Do you have any automation in your Blood Bank? Yes- one Vision; it has not impacted our TAT for these ED samples. We set a timer when a STAT is placed on the Vision so that it can be resulted as soon as results are available.

You may want to check with the FDA on this, or you may be able to find the answer in previous "Ask the FDA" sessions from AABB - I am fairly certain that this does not require FDA registration.

We do our titers in gel (ABO titers only as we are not a delivering hospital; pediatric only). Any positive reaction seen in gel should be interpreted as 1+ since there is no w+ interp in the MTS gel interp. guide - there is also no w+ on the Vision. So, our end-point is the dilution with the last 1+ positive. Our results have correlated well with the CAP samples done in tube when looking at all of the methods reported, but we have only done these for about a year now (only about 3 CAP survey's so far). We haven't looked at bringing this onto the Vision yet..... all though I am aware that it is now able to do the dilutions for both the buffered card and IgG titer reactions; so maybe with the next software upgrade??? Would love to hear back if you successfully implement the titers on the Vision! Stephanie

We currently do as you described - the techs add a credit irradiation charge if the patient doesn't need it, but then we have to go into the account and manually credit the irrad RBC and bill for the correct non-irradiated RBC instead. You could set up a charge edit rule in Sunquest to do this automatically (I have been thinking about this as well). Sunquest should be able to help you with charge edit rules if you've never done them before. Basically you create a rule so that anytime Sunquest sees the credit irradiation code AND the irrad RBC charge together, then the resulting charge would be the regular LR RBC charge code instead. We haven't set this up for crediting the irradiation, but we bill this way for some of our manipulations like aliquots so we can charge for the split P9011 product instead of a whole product. You might even be able to do this without the charge edit rule. Set up a new charge (we'll call it CRIR for credit irradiation). In the billing maintenance for CRIR, define a CREDIT for the IRRAD RBC charge code and a CHARGE for the LR RBC. The techs would still have to add the CRIR charge at the time of issue (when an irradiated RBC is issued to a pt who doesn't need irradiation), but it would adjust the charges automatically. We have gotten pretty creative learning how to bill for manipulated/divided products at our pediatric transfusion service - feel free to send me a message:) Stephanie

We use the 24 hours regardless of how the red cell was entered (sterile connection device or spiking unit). I hadn't really considered the possibility of extending to 5 days with the use of thawed plasma. I will also be interested to hear if anyone else is doing this. Stephanie

The thawed code we are using for E2619 is E2737; this is from CP2D whole blood. You may also need these: Plasma, fz within 24 hours, from CPD = E2555 (frozen) and E2701 (thawed) Plasma, fz within 24 hours from CPDA-1 = E2587 (frozen) and E2719 (thawed)

We preform our own acid elutions in-house, but this flowsheet may still be of use on whether or not to sendout for an elution. I've attached our flowsheet here: Stephanie Elution Flowsheet COMPAT SER FS4.doc

We use blood administration sets that are BD syringes with in-line filters (standard 150 micron size). I know of two manufacturers (links below; there may be more) that make these syringes and have used both with or without a Sterile Connection Device; both perform well and one has a "spikeless" option if you will always have the SCD. We have never used an 18 micron size filter for blood product preparation and discontinued the use of a 20-40 micron filter years ago - we used to use for factor prep and neonatal transfusions before these in-line sets were available. http://marianmedicalonline.com/products/blood-administration-set/ http://chartermedical.com/blood-transfusion/neonatalpediatric-products-syringe-sets/ Stephanie

We do not do any culture on the product or aliquot as a part of QC when aliquotting platelets. The original unit would have been cultured by the blood supplier. We do document that the seal was made properly and inspected for any bubbles/leaks when making the aliquot using the sterile connection device. Stephanie

I've attached our validation plan that we used last year. Some of it is Sunquest-specific, but hopefully you find it useful. You will find more detail regarding Ortho's guidelines in their Validation Manual. Our plant was to ensure we were doing approximately one week's worth of samples, but we ended up doing a lot more than that to work out some kinks we found during testing and to ensure that we had a good assortment of antibodies and scenarios. Stephanie Vision Validation Plan.doc

We use a sterile connection device to attach either a transfer bag or a syringe (the syringe has an in-line filter attached). We label the bag/syringe with the 4x4 ISBT label from the Hematrax label printer containing the new division number. After mixing the contents of the platelet component, you open the weld and transfer the needed volume into the bag/syringe. We add an extra 5ml to a syringe or about 15-20ml extra for a bag aliquot (since the bag still has to be filtered prior to transfusion). All platelet aliquots are given a 4 hour expiration time from preparation. Stephanie

We use a sterile connection device so that a closed system is maintained (and no hood is used our Transfusion Service for any component prep procedure). If you use an open system such as spiking the port directly with a syringe set, the parent (A0) unit will expire 24 hours from entering. All of our syringe products prepared are given a 4 hour expiration. Stephanie

When we initially instituted our MTP in 2007, we had our packs (based on weight) that included splitting/aliquotting for the smaller patients. However, after a couple of years with that practice, we realized that it just took too long to do all of that preparation to get the products out. Now the packs include full units of all products - We use a smaller pediatric plasma unit (about 70-100ml) that is prepared prior to freezing by our supplier for the little ones under 10kg. We are a free-standing pediatric hospital (level 1 trauma center), about 500 inpatient beds and 25-30 MTPs each year - just to give you an idea of our patient population. Stephanie

We also prepare in-house pos DAT control - this is from our procedure (we use AlbaQ vial 4 for the neg DAT control): Preparation of Pos DAT QC Sample: Select an Rh Positive red cell unit with a good outdate from the available inventory. Complete a label with the lot “DPMMYY” (using MMYY as the month and year of preparation; i.e. “DP0516”). Add the expiration date equal to the expiration date of the red cell unit as well as the date prepared and your initials. Place a barcoded P10000 LIS accession label on the vial so it can be scanned onto the Vision. Connect a syringe set to the red cell using the Sterile Connection Device and remove approx. 5mL of packed cells. Place the red cells into a plastic 12x75mm test tube labeled with the label made above. Add 2 drops of Anti-D (Ortho Bioclone) to the packed cells, mix well, and incubate for 30 minutes at 37°C. Mix again about half-way through incubation. The in-house reagent is now ready for QC testing. Validation has been performed and shown that this control reacts 1-3+ in the Poly IgG,C3 Card and is stable until the expiration of the red cell unit. Print the BIQ unit history for the unit used for Pos DAT QC preparation. Add the lot and expiration assigned to the QC sample, the date and time of preparation, and your initials on the print out. Submit print out to the Specialist II. Stephanie

We are implementing the ROTEM (same type of testing, different manufacturer). We were told by the manufacturer that cpt 85396 is what should be used. Makes sense - "Coagulation/fibrinolysis assay, whole blood (eg, viscoelastic clot assessment)". Problem is that this cpt code is only a charge of once per day. Looking to see what others are doing for billing... Stephanie

Just thought I would confirm from an earlier reply of mine that you can now load partial gel cards onto the Vision. This is after their software upgrade that came out near the end of 2016. You should not load partial cards that have had any columns run by manual testing, but you can load it back on if it was only used on the analyzer. The partial cards are loaded in the manual review rack (dual purpose drawer) and they are held in the middle incubator (not in the main gel card drawer). If the card is not used in 4 hours, it will get spit out again in the manual review rack. You can re-load it again if you would like to; or if it is a less frequently used card, like the Poly cards for us, then you can wait and re-load it once you need that type of card again. Hope this makes sense and is helpful. Stephanie

We would like to start looking at this, but I didn't think it was FDA approved yet for titrations in the US. Am I wrong Mabel? We are just starting ABO titrations for incompatible heart transplants. We are going to run in gel, and you are correct, that your cut off for gel will be 1+. That being said, there is no weak+ defined for any gel reaction results (technically even if read by manual gel), so if we see any agglutination, we are calling it 1+ (and that would be our titer result). Would love to hear back on how it goes for you. The note about requiring review if 1+ and lower; that is a setting that you can control on the Vision with your results cutoff on the analyzer, correct?

We have completed the Vision/Sunquest interface setup. I will not lie; it took quite some time to get it right. I think we were the first pediatric site to go up, so that might have made things more complicated for us. We have the antibody screen results interfaced to SQ as POS or NEG, but we were told that you can't interface the antibody identification. If the ab screen is positive, the tech manually adds the panel using the Vision's "create order" function. You can add either a whole panel or select only specific cells from the panel to run. An autocontrol will be run with it. Everything else is still done manually (i.e. write on the panel antigram and do rule-outs as well as resulting the ab ID with the correct ab in BOP). Stephanie

We are a pediatric hospital. We would give one dose of incompatible platelets (if ABO compat are not available) without obtaining any approval from the med director. If we need to give more than one dose (i.e. one pooled or one plateletpheresis for an adult), we would obtain MD approval and likely volume-reduce the plasma volume before issuing. We do not titer any platelet components.

Once you complete the newest software release, you will be able to modify QC results. This is very helpful since sometimes it is clearly a spec of dust/artifact that can be modified from a "?" to a negative result. You can also load partially used cards now, but they will be kicked off of the analyzer if not used in 4 hours (at which time you can reload if you want). There are still problems with the interpretations of the current lots of IgG cards and "?' results with specks on columns - see related post.

To say we are having problems is an understatement. This seems to only be an issue for Vision users; the camera is very sensitive and is picking up weak reactivity that the instrument is calling "?" reactions. Because the image is enlarged on the Vision screen, you can actually see specks in the column on reactions that should be negative (including negative QC). Multiple reports have been filed, and we have gone through about half a dozen IgG card lots. We are beginning to see these in our manual testing now as well (although you have to look VERY closely). It appears that the problem is something that changed with the gel card production, although nothing official has been released by Ortho yet. Older lots of IgG cards are fine, which proves that it is the gel cards. Hopefully this is resolved soon...

We currently have six different test systems defined, and it continues to evolve. I've attached our reference chart which states what will be used to fulfill each of the six elements per test system. Everyone seems to be doing thing differently, but this works for our lab. Transfusion Service Test System Elements PER FS6.doc

At this time you can't put partially used cards back on the Vision. This is something to consider if you are a smaller/med size hospital or if you are planning to use Poly IgG/C3 cards for DATs. They are willing to give customers a credit for unused wells, so don't let that stop you from making a decision about using (or not using) the Vision for a specific card/test. We are told that you will be able to put partially used cards back on the analyzer with the next software upgrade, so time is TBA. There is also supposed to be a change in how long partially used cards can stay on the machine until they are "kicked off" - right now it is only 4 hours. We are still validating, it has taken some time to get this set up for pediatrics and get the interface going with Sunquest. Stephanie