Sonya Martinez

We recently switched to MaxQ coolers which are pre-validated by the company at storage temp. Then we validated at transport temp and storage temp and use that for when the cooler needs to be returned for fresh ice. Our policy specifically states this and that we consider them transport coolers. We really like the MaxQ coolers and have seen a huge decrease in waste due to temp issues on return of the coolers. The lids close by themselves. They even have coolers that have temp monitoring integrated but they're super expensive.

I've attached our policies for preparing aliquots in general and our platelet policy. Hope this helps. Oh, we decided all aliquots in syringes expire 4 hours after being made to make it easier for both blood bank and nursing staff to remember. We used to let the RBC and FFP syringes expire in 24 hours but nursing in particular would think all syringes expire 24 hours and we wasted a lot of syringe aliquots until I changed it. BBI0015 Preparation of Aliquots.04.03.2020.doc BBI0017 Platelets 04.03.2020.doc

Oh, I forgot we discard are returned products in syringes regardless of how long they've been out since we can't take the temp.

We use Blood Temp 10 devices plus if we forget to put an indicator on the unit or it's a room temp product we use a an infrared thermometer which are calibrated annually.

We created a no charge, blood bank only test called ABO2 which contains an ABO and Rh. We have been trying a long time to get all the surgical clinics to order an ABORh the day they schedule surgery and then have the patient come back 1-3 days prior to the surgery for their type and screen. However, with COVID and the required testing TAT being no more than 48 hours before surgery and most clinics doing telemedicine this has been problematic. We do require a second sample, collected at a different time, and we use other specimens collected for other lab testing like CBCs, Coag, etc. We will perform gel or LISS crossmatches on those patient's without a second type using only type O RBCs and will only use electronic crossmatch if they have 2 ABORh results. Because we're a children's hospital we also give only type AB plasma containing products if we don't have ABO confirmation (the ABO2). We still get pushback from surgeons about this but when we can't get AB platelets they will comply.

slsmith is correct. We don't have the mom's here only the babies. So we do full type and screen on the baby, IgG DAT by gel (if pt <14 days) and any RBCs that are autologous regardless of the blood type are Gel IgG crossmatched to the patient. This covers all AABB standards for neonatal testing and transfusion.

Yes it's been off and on not being able to get pipette tips. Fortunately, or maybe unfortunately, when we had the problem last fall I had not cancelled our original order with ThermoFisher but our supply chain management placed an order with Cardinal Health and another with some other company. Well I received all the backorders so now our entire lab, that uses the same universal type 200uL tips, now has enough for months to come. I think we ended up with close to 13,000!

Thanks Joanne P Schannell. It is a new tech for us that also works next door at an adult hospital (we're a children's hospital) and his experience is limited. On his last 'positive' I let him work it up and run a panel, nothing else ended up positive so we decided to result the antibody screen as negative. I will make sure to add the part about stored red cells and steric hindrance maybe that will help him stop overcalling these very weak, probably negative, reactions.

What about in gel if one tech swears they see very weak agglutination (grainy) at the bottom of the well but no one else sees it? We have one tech I swear has magnifiers in his glasses!

I would suggest you contact both of your local blood centers and see if they are either able to accommodate an on-site or virtual/simulated educational program. If nothing else they probably have tours you can attend to get things going. I know it's a drive but experience does help on the exam. I found this on line: https://laboratories.vitalant.org/Education.aspx

Weird. I put in 2 new Hematrax printers from Digi-trax last summer and we don't have the diamond on our labels. Could be the printer company or something in the set up. I would contact the printer vendor.

Does anyone have online competency forms (word or excel preferably) that went through CAP inspection without deficiencies they would be willing to send me? I'm specifically looking for something easy to use that's not more than a couple of pages. Our last CAP we as a lab got hit again, not that are staff aren't competent but because our paperwork was not consistent between departments. Now we started using a packet that contains 6 different forms: Competency Summary Form (one for each patient test method), Patient Testing Direct Observation Checklist (one for each test method), Instrument maintenance Direct Observation Checklist (one for each piece of equipment used in patient testing), Problem-Solving Skills form (one for each test method), Authorized Test System Form plus for BB only I have a non-testing competency summary form/checklist to cover non-testing procedures. This seems excessive and it's really time consuming filling out paperwork especially I have to bench as well.

Here's the remaining 'open' product codes that I was missing form before in case anyone needs them. · EA473 = Apheresis PLATELETS|ACD-A>PAS-C/XX/20-24C|Open|ResLeu:<5E6|1st container|<3E11 plts · EA474 = Apheresis PLATELETS|ACD-A>PAS-C/XX/20-24C|Open|ResLeu:<5E6|2nd container|<3E11 plts · EA475 = Apheresis PLATELETS|ACD-A>PAS-C/XX/20-24C|Open|ResLeu:<5E6|3rd container|<3E11 plts · EA476 = Apheresis PLATELETS|ACD-A>PAS-C/XX/20-24C|Open|Irradiated|ResLeu:<5E6|1st container|<3E11 plts · EA477 = Apheresis PLATELETS|ACD-A>PAS-C/XX/20-24C|Open|Irradiated|ResLeu:<5E6|2nd container|<3E11 plts · EA478 = Apheresis PLATELETS|ACD-A>PAS-C/XX/20-24C|Open|Irradiated|ResLeu:<5E6|3rd container|<3E11 plts I know when we first went up on HCLL Transfusion in 2013 my first FDA inspection afterward reviewed our build and the inspector commented on the fact that we were compliant with ICCBBA standards and guidance by changing the product code for every modification which for us means irradiation, washing (RBC only) and placing products in an open system (syringe, spiked unit, or if the seal breaks using the sterile docker). All the other inspections after that haven't looked as closely. I'm sure it might be okay to just change the expiration date/time however, since there are product codes specifically for an open system and I have a process I will continue to build the same way.

I wish it were easy to change the expiration date/time, but because of the way our computer system, WellSky Transfusion, works if we change the expiration date/time it requires about 3-4 exception overrides (quality capture for doing something outside normal). I tried building the modifying to a syringe process for these codes but because they have the same formula if I change the build just for these products it changes for every product with the same attributes. ICCBBA did email me back, however, yesterday after I tried to expedite the request and: Bacterial Monitoring attribute values cannot be combined with the System Integrity attribute value "Open." These attributes contradict one another, as "Open" shortens the product's expiration and "Bacterial monitoring" extends the product's expiration. For your platelet products with an “Open” system integrity, you will need to use a code that omits the “Bacterial monitoring” attribute. Codes for these already exist: E3014 = Apheresis PLATELETS|ACD-A/XX/20-24C|Open|ResLeu:<5E6 E8365 = Apheresis PLATELETS|ACD-A>PAS-C/XX/20-24C|Open|ResLeu:<5E6 But then when I was looking for open codes for our >36 hour bacterial monitoring units (EA141-EA143 and EA157-EA159) I found those codes missing. So I requested 6 codes to be build. Hopefully they will fill this request or at least tell me how to make it work.

I ended up requesting new codes through ICCBBA yesterday. Hopefully they can expedite the request since one of our vendors is implementing their LVDS platelets Feb 1. Once I get the codes I will attach them for all to use.

Our primary vendor is only adding an increase to the normal platelet charges for LVDS so I just have our revenue cycle team update the pricing and still use the P9035 code. However, our secondary vendor (for platelets only) has multiple billing codes so I will have one for PLATELETS, PHERESIS, LEUKOREDUCED, one for PAS PLATELETS, APHERESIS, LEUKOREDUCED, one for PLATELETS PHERESIS PATHOGEN REDUCED, and one for LARGE VOLUME DELAYED SAMPLING PLATELET all using P9035 except the PRT which is P9073. We irradiate in house so we have a separate procedure code using CPT 86945. We use that even if our irradiator is down and our vendors are doing the irradiation. HLA matched platelets we use P9052. You should be able to use that same code for SDP and PRT units. I didn't see a code specifically for HLA matched PRT last week when I figured out my billing.

I am currently building new products for the LVDS and PRT platelet units we will be receiving in early spring 2021. We are not performing PGD testing. I have a lot of codes to build because we are a children's hospital who irradiates, divides and aliquots into syringes. Therefore I need the original product code, the irradiated product code and a product code in an open mode for both the original product (in case someone spikes a unit) and the irradiated product. I can't find on the ICCBBA website where there are product codes for the open mode for my LVDS products. There are open codes for the PRT. Do you guys think it will be acceptable to instead of changing the product code to an open code that instead we just change the expiration date to 4 hours? I've asked ICCBBA via email on 11/27 but no reply to date and I'm on a time crunch since I'm also upgrading our HCLL Transfusion 2016 to WellSky Transfusion 2020 at the same time!!

We started adding 10mL of sterile saline which comes in a syringe already and we spike the first unit in the pool with a device that has a spike on one end and a syringe port on the other. The reason we started is because it's in the Circular of Information for the Use of Human Blood and Blood Components "Cryoprecipitate AHF may be transfused as individual units or pooled. For pooling, the precipitate in one or more concentrates should be mixed will with 10 to 15 mL of diluent to ensure complete removal of all material from the container. The preferred diluent is 0.9% sodium chloride." This was noted (not a deficiency) in my last CAP inspection in fall 2019 but on by AABB inspection the spring 2020 the inspector was really surprised. I showed her the circular and she said she'd have to look into it for her institution. We pool anywhere from 3-10 units in a single pool because we're a children's hospital. We could get pre-pooled from our blood center but they only come in 5 and 10 unit pools. We have a heart surgeon that likes pools of 4.

We don't do IUT (we get them after they're born) but we wash red cells all the time. Our red cell override is set at 3 minutes but all other settings match ours. When's the last time the unit was primed and the RCD cleaned? Maybe there's a bubble in the line to the hydraulic fluid. You could also add a manual spin followed by super out after the program ends to ensure a majority the saline is removed. That's what we have as troubleshooting if the excess pressure light comes on or the lid will not open because the bag is overfull.

I think this came from the AABB Primer for Blood Administration. We have it in our policy to check all vital signs 1 hour after transfusion and if it meets requirements of a transfusion reaction then they start the transfusion reaction workup. We put this added vital sign check after instituting the Hemovigilance Surveillance through the CDC (NHSN) after we started seeing a lot of hypotensive reactions and because being a children's hospital we see a lot of allergic reactions that aren't necessary happening during the transfusion but some times right after. It hasn't significatntly increased the number of reactions reported.

When we started using Epic we had to have the physicians change from ordering the nurse to transfuse over 4 hours to over 3.5 hours or 3 hours 45 minutes because of the way it's documented in the BPAM. We use the completion of the entire transfusion, blood and saline, as the end of the transfusion.

David Saikin - I'm in charge of the Isensix monitoring system for the entire lab, histology, and microbiology so I review logs at least weekly plus get paged for every every 2nd level and 3rd level alarm (email for 1st level). Staff know if they don't respond, even in the middle of the night, I will call them. Plus our hospital made it a requirement for Joint Commission readiness to have a report of all alarms and accordance to responding to the alarms so I have to look at it at least monthly.

DebbieL - THANK YOU!!! Now to figure out what they mean about temperature mapping during installation, after repairs or after moving the fridge in TRM.42600!!

We received our CAP pre-inspection packet recently (version 06.04.2020) and I have a question. TRM.42750 states "All component storage units are equipped with an alarm system that is monitored 24 hours/day (in laboratory or remote) with alarm checks (for both low and high settings) performed according to the manufacturer's recommended intervals, or at least quarterly if not specified, with results recorded." Under notes it states "The laboratory must demonstrate that all components of the alarm setting (including chart/graph recordings) work as expected and that there is a process to ensure a timely response to alarms, including remote alarms. When facilities perform alarm checks, the temperature at which the alarm sounds must be compared to the temperature on the recording chart/log. Examples of recording systems include: Paper chart records, paper graphs, electronic records, even logs." My question is we have a continuous monitoring system called Isensix but when I do alarm checks I utilize the alarm tests built into the equipment. For example on our Helmer's with i.C3 APPS, Temp alarm test and in our freezers there's a specific alarm test that simulates the warm alarm. Is this CAP standard now stating that we are required to perform an alarm check using hot and ice water baths just so our Isensix alarm goes off and I can document it's a test?

Malcolm Needs - Thanks so much for the quick response. There's no ethnicity on the patient yet but I doubt she is Japanese by her last names (very Hispanic). We are not planning on antigen typing the red cells for M at this point since it only showed up at immediate spin. We didn't do the workup on the mom so although the other BB said they ruled M out we don't know for sure if they use the 3/3 homozygous rule that we use. You are definitely correct about the M still possibly being IgG, I do realize, thanks for correcting me. It's been a very weird year, since last July when we had our first true anti-U, then an huge increase in the number of extremely strong WAA, an anti-hrB at Christmas, and now this newborn. I hope this doesn't become standard for us but with our Hematology/Oncology clinic growing each year and all the solid organ and HPC transplants I'm sure we're only touching the surface. I miss the days when a children's hospital blood bank worried more about making smaller aliquots than dealing with rare antibodies.