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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

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."

right next to your post is an ad for digitrax temp-check. I do not accept returns after 15 minutes. My study shows rbcs achieve >10C after that amount of time.

Definitely enough story lines for a mini-series! These are all possible stories that could happen to any of us. Being in direct contact with physicians (who know everything) and nurses (who believe policy is not practice) and providing products that could be life saving or harmful to patients and parts of the process is out of BBs control can be very stressful for technologists. And sometimes is hard to get new technologists to work in our field. With providing administration with some of these "real" scenarios and the possible medical-legal-pr implications I was able to acquire an additional salary % for techs working full time in the transfusion service. When other department techs thought it was unfair, I asked them to apply for a BB position (no takers). Might be worth a try if you need techs. Thanks to all who are sharing your experiences.

I've been searching for the powerpoint I made of the occurrence I wanted to share but I must have stored it on an external hard drive that crashed and was unrecoverable. (That's my excuse anyway.) Consequently it was long ago and my memory is fuzzy on the details but in this case the details is not the point I'm attempting to convey. Bottom line was that 2 units of blood were sent via pneumatic tube to ICU for 2 different patients. No, the units were not in the same tube, they were sent 10-15 minutes apart. The units went to the wrong patients and the proper patient identification protocol was not followed. Both units were transfused and the paper work was sent back to the transfusion service. I do remember a very white faced staff member coming to my door to tell me what they had discovered. Luckily both patients were type O+ with no problems and recrossmatching showed that each was compatible with the unit they had received. We had dodged a bullet! The ensuing investigation discovered that the patient identification protocol used by the ICU nursing staff had morphed into something I did not even recognize. A couple of years earlier the nursing department had taken over all training of new nurses as well as annual reviews for current staff. They basically told me my services were no longer needed in a training capacity. When the details of the occurrence came out the assistant CNO (chief nursing officer) who was filling in for the CNO on sick leave wanted to severely punish the two nurses involved and then sweep everything under the rug. Heaven forbid that word got out that a couple of HER nurses had made a mistake. Much to my surprise and delight I was able to convince the ICU nurse supervisor that the problem was much deeper than just human error and the protocols the nurses were following were deeply flawed. We did extensive retraining for the entire ICU staff. When the CNO returned to duty I had a long talk with her. I had always had a very good relationship with her and she trusted me. From that point on I was actively involved in the training a new nurses as well as the annual refresher courses for current staff. During those training sessions I was not surprised that other areas had "adjusted" the pretransfusion patient identification protocols to be easier and quicker for them. Using this occurrence as an example I was able to convince them of just how critical patient identification was. As a side note, I one time had a labor and delivery nurse tell me that it was impossible for her to transfuse the wrong blood to her patient and nothing I could say would convince her otherwise. Some times I wonder how I ever got out with my sanity intact! My wife (a nurse) reminds me that I didn't!

Get to know your staff, but remember that you are not there to be their buddy.

One of my many too!

Let me play the devils advocate when it comes to using the historical type. What happens if the patient is not really the patient that the original ABO was performed on? What about the times when the ID number is bought and used by multiple people especially where there is a large community of people who are not necessarily legal to be here? For these reasons and a few more, we require a current type.

We require a second sample for ABO confirmation if the patient's initial type is other than group O before we can issue blood. It is ordered separately, so I believe the patient is billed for it.

We require a second speicmen be drawn if there is no history and if the current sample type is not O. We will use a specimen in the lab that was drawn at a different time (ex. CBC drawn earlier in the day). We do not currently charge for the test.

It was decade ago, a nurse kindly gave the blood crossmatched for A to B after A passed away without having it . Because she thought they were both type O pos. Luckly, B had no transfusion reaction.