SusieQ132

Thank you, David! We have been able to watch the results go across from the BBIS into Beaker and vice versa, and it has been quite fast so far! I'll keep an eye out for it as we move forward. For this inquiry, we did reach out to the FDA. In case it's ever helpful for anyone else, here's what they sent back: :) "Thank you for your inquiry. Your request was forwarded to the FDA Devices Review Branch (DRB) and they provided the following response: According to 21 CFR 864.9165 Blood Establishment Computer Software (BECS) is a device used in the manufacture of blood and blood components to assist in the prevention of disease in humans by identifying ineligible donors, by preventing the release of unsuitable blood and blood components for transfusion or further manufacturing into products for human treatment or diagnosis, by performing compatibility testing between donor and recipient, or by performing positive identification of patients and blood components at the point of transfusion to prevent transfusion reactions. A FDA cleared BECS device is required for performing the functions that meet the definition above. According to the information you provided below, Kleihauer-Betke testing doesn’t fall under the definition of BECS. We are unable to comment on products that do not meet the definition of BECS, thus this decision falls under your discretion."

Quick summary of my question: Our organization is transitioning to Epic/Beaker for the main LIS and SafeTrace TX for the Blood Bank module. I understand that Beaker does not have FDA 510K clearance as a Blood Bank LIS, so we can't do "Blood Bank tests" there. However, does anyone have any resources on what is defined as "Blood Bank" when evaluating what can go into Beaker? In specific terms, do you think having Beaker built to automatically calculate the volume of a fetal bleed based on a Kleihauer-Betke stain is acceptable? What about automatically calculating the dose of Rh Immune Globulin (RhIg) should the patient be Rh negative? Longer version of the story: In our lab, Hematology / Manual Bench does the Kleihauer-Betke (KLEI) testing, and it has historically been resulted as a % / ML result only. Then, it gets handed off to Blood Bank where we answered a separate test code with the RhIg dosing comments with EVERY SINGLE KLEI, even when there is no RhIg ordered or when the mom is Rh positive. It's always felt a bit unnecessary to have Blood Bank result a separate test every single time, and the idea was proposed to have Beaker automatically calculate the RhIg dose based on calculations built into Result Entry. Then, the KLEI would go out with the mL of the bleed, and a comment: "If patient is Rh negative and Rh Immune Globulin is needed, then a ___ ug dose is recommended. Enter a Transfuse Rh Immune Globulin order if Rh Immune Globulin is to be administered." In this workflow, if a RhIg order is received after the fact (or before), Blood Bank staff would verify the appropriateness of the request, and review the KLEI for dosing requirements, then send the order to Pharmacy for fulfillment. I'm wondering if this is acceptable practice. I could reach out to the FDA as well if no one has a resource here, but hoping someone else has had the same idea! Thanks, Susan

No problem!! Thank you - I appreciate the feedback.

slsmith: do you like the RAD Control stickers? Just curious after you've actually switched. Specifically do you feel satisfied by the depth/completeness of the color change and the adhesion quality?

Hi all! I see that others have asked this question before, but not recently, and there are a few newer models on the market these days. My facility is in the market for new sterile welders. We have used Terumo TSCD devices for 10+ years, and have only had trouble with them recently. However, due to their cost, we are evaluating other options out there. Here are the models we're looking into, and what information I've gleaned so far: Terumo TSCD II Copper wafer-based (single use, cartridge-based loading) HIGH cost of device and wafers Genesis TCD Copper wafer-based (larger wafers, single use, single-load) LOW cost of device and HIGH cost of wafers Genesis RapidWeld STW Stainless-steel blade module (multi use - 250, 500, or 1000 welds each) MID-RANGE cost of device and wafers Fresenius Kabi CompoDock Sterile Tube Connection System Wafer-less welding (uses "counters" that are required to run the device, but I don't know WHY they're required) MID-RANGE cost of device and "counters" So, what I'm looking for now is anyone who has experience/reviews/likes/dislikes for the latest models of each of these devices! Especially the two newer models (Genesis RapidWeld STW and Fresenius Kabi CompoDock), since they would be completely different than what we've been using. Thank you in advance! Susan

Yes. I should be more specific in that the main patient population where this is an issue is for neonatal patients where the mother needs to be evaluated for Rhogam eligibility. Where treating the neonate as D negative is not enough. My question for this is when would I know to do this treatment? (Or send it out to have this performed, since we wouldn't have the resources to perform it in-house. ) Do you think I would know the Weak D was falsely negative due to other odd reactivity in the ABO/Rh typing, etc.? Or would I unknowingly result a neonate as Rh negative, and say that the mother is not eligible for Rhogam, only to later find out the mother developed Anti-D? Just trying to think about the risk of performing the Weak D in the presence of a positive DAT. I know it's more likely to cause a false positive, which is why we were thinking about performing it even if the DAT is positive, and only cancelling it as invalid if the Weak D is positive. But I don't want to cause patient harm by reporting it if it could be a false negative reaction. Hope this all makes sense. Trying to get all my thoughts into words is hard today!

Our facility is evaluating making a change to our process for Weak D testing for patients with a positive DAT. For years, if we were required to do a Weak D, but the patient had a positive DAT, we used to cancel the Weak D as invalid. Another hospital in our system mentioned that they tended to perform the Weak D, but then only cancel as invalid if the Weak D is positive. We are thinking about changing to this process, as we now have to result many babies as "Rh Unknown" and give their mothers Rhogam. Per our Anti-D's package insert: "Red blood cells coated with alloantibodies or autoantibodies of the same or similar specificity as the reagent (i.e. cells that are DAT positive) may give weak reactions. This is due to decreased availability of antigen sites because of antigen blocking or steric hinderance. In extreme cases false-negative results may occur." I'm worried about the "extreme cases" where a false negative could occur, but I cannot see this being common. Also, would you think that if the cells were coated with that much antibody, that we would see any other odd reactivity in the ABO/Rh? What do other facilities do? Thank you in advance, Susan

I just answered this question. My Score PASS

FYI - at our facility, we tried to validate CBCs from cord blood specimens, but the values were quite variable when compared to peripheral blood.

We use cord blood specimens for pretransfusion testing for some very small birth weight babies. We ran a validation to show that the results matched the peripheral blood specimens we were getting. As long as the people collecting them know where to draw it from to get baby's blood, you should be fine. We also give only O, Rh matched blood to our neonatal patients, so it's not as high risk as some on this thread make it seem. One item to watch out for if you do proceed with this: occasionally we'll see a mixed field result in the ABO/Rh. If we do, then we confirm the blood type using a peripheral blood sample.

From what I have been told by accrediting agencies here, different tests can only be combined into one test system if there are no unique aspects in testing or in problem solving when something goes wrong. I interpret that as meaning the antibody ID, DAT, and elution are all separate test systems because the testing method is very different. Different treatments, however, I could see being grouped into 1 test system (EGA, DTT, ficin) if you can "sell" them as being similar enough. Same goes for the adsorptions, in my opinion. I would rotate which treatment and which type of adsorption you do each year, but group them each into a test system (RBC Treatments as 1 test system and Adsorptions as a separate test system). If you group multiple tests into a test system, only one of the tests in that system need to have the 6 elements of competency assessed each year. However, you have to watch what you group into a test system! It seems crazy, but by the letter of the "law," we should be doing all 6 elements of competency for every test we perform if the procedure is not exactly the same. (I have read that even if the amount of a reagent is different, it would be a different test system. Crazy! ) In practice, this doesn't work for our site; we would spend more time assessing competency than doing real work! We decided to live on the edge and combine a few things into test systems, even though they are pretty different test procedures.

New information: The patient's post-RXN plasma reacts 1+ with the patient's pre-RXN red cells. (So whatever it is, it is in the plasma, too!) We performed an antibody screen on the plasma from the platelet unit, and that was negative. We have ruled out Anti-Jsa, -Kpa, -V, -Cw, and -Lua in the eluate. The eluate was performed using the Elu-Kit (acid elution). I know this isn't the best for picking up Anti-A, but we have picked it up using this kit in the past, so it was surprising not to see it this time. At this point, the patient doesn't show any signs of hemolysis, and the significance of this positive DAT is unclear. We are going to crossmatch at AHG for future RBC needs as a precaution, but we aren't going to pursue it further. My wild theory: The patient had received Zosyn (Tazobactam-Piperacillin) and Vancomycin, which have both been reported to cause drug-induced hemolytic anemia. These were given a few weeks prior to the transfusion reaction, and theoretically, the patient could have formed Anti-Piperacillin (or another drug antibody) that only reacts in the presence of the drug. Then, the platelet or RBC donor took the medication, and it was passively administered to the patient with the blood component. Then, the drug was introduced back into the patient's system and caused a positive DAT. Or maybe the donor has Anti-Piperacillin (or another drug antibody). Not very likely. But you never know!

That's what I think, too! It is a crazy task for our 40 staff members, so I really hope this goes okay. It is daunting to look at right now!

Thank you for the input! So I'm thinking that for anything that is not a test, we can put "N/A" for the other items that do not apply. That makes more sense now.

Yes, it was a CMS/CLIA regulation. This is the Q and A session that I was forwarded that goes over the details: If you have a tech that floats between 2 different hospital labs within the same health system do you need to perform competencies (6 mo. and annual) in both labs or just one and share documentation? Per CMS, each CLIA laboratory must complete training and competency assessment for all employees at each facility. Laboratories may not share training and competency assessment documentation, even if laboratories are related and share the same instrumentation, LIS and procedures. Must waived testing competency be repeated for all CLIA sites? Including CLIA waived? Yes, a competency must be assessed at the site where the staff is responsible for testing. Each site must be separately assessed and waived is included (remembering all six elements are not mandated for waived testing). Please clarify again competency documentations between sites that have different CLIA#, but are under the same system with the same test methods and instruments. Yes, a competency must be assessed at the site where the staff is responsible for testing. Each site must be separately assessed and waived is included (remembering all six elements are not mandated for waived testing). All permutations at each site need to be taken into consideration as part of competency at that site. Does the issue of not sharing competencies across hospitals within the same system, with different CLIA numbers also apply to Waived Testing? Yes, competencies for both waived and non-waived testing must be performed and kept at each site (under each separate CLIA number). If employees rotate between different CLIA numbers but are performing the same testing, does competency need to be assessed at each CLIA location? Per CMS, each CLIA laboratory must complete training and competency assessment for all employees at each facility. Laboratories may not share training and competency assessment documentation, even if laboratories are related and share the same instrumentation, LIS and procedures. If an employee is shared between 2 hospitals in the same system (different lab CLIA numbers) but the same instrument, same SOP, and same standardized competency is used at both sites, does the entire competency need to be performed at both sites? Per CMS, the entire competency assessment must be performed at each CLIA site. Or is it permissible to provide a copy of the entire competency packet to the 2nd site for them to review and keep? Per CMS, it is not acceptable to use a copy of a competency performed at a different CLIA site instead of performing training and competency assessment at the current CLIA site. Or is it permissible to use perhaps some pieces (like the Direct Observation, evaluation of knowledge, PT or blind samples) and maybe just use record reviews from the 2nd site? All six elements of competency assessment must be performed at each CLIA site the nonwaived laboratory testing is performed at.