butlermom

We are about to become the blood bank (and laboratory) for another hospital that is being built across the street from us, but is not part of our "system." Because of this we are going to register with the FDA. The other hospital will be storing a few O negative packed cells from us in an under counter refrigerator in their ER. My question is: When we get inspected, will the FDA need to go see their refrigerator? The reason I ask is that I am beginning the process of registration, but don't want to do it too early and have an inspection before the other hospital is open for business. Do I wait until closer to their opening to submit my application, or will the FDA likely not want to go see their fridge with my 2 or 3 units of blood in it? Thanks for any feedback! Kathryn

I know this is an old post, but we are about to apply to become registered with the FDA, and I was wondering how long it takes after we submit our application to be notified of approval/registration.

6 months ago we had an Rh negative OB patient who delivered an Rh positive infant, and subsequently required 4 doses of RhoGAM. I'll also mention that we re-collected and re-tested to be sure. We also tested for weak D and she was indeed Rh negative. Her antibody screen was negative prior to her pregnancy. Now, 6 months after delivery and 4 RhoGAM doses, she is still exhibiting a strong anti-D. I contacted the manufacturer to see if they had any literature or information regarding how long the 4 doses could still be detected. They only sent me a link to some online information that I had already read! I know the half-life is only about 3 weeks, and everything I've read says it may be detected up to 12 weeks post injection. Additionally, we did a titer on the anti-D and it was 8, which leads me to believe this is an immune anti-D and not passive from RhoGAM since RhoGAM normally will not titer beyond 4. The physician and I have discussed it and the patient will be tested again in another 3 months. Has anyone had a similar experience? At this point my only explanation is that she could have developed the anti-D AFTER our initial testing and PRIOR to her 28-week prenatal dose.

I get what you're saying, but remember, with the antibody screen and panel you are using sensitive methods to detect the presence (and i.d.) of a clinically significant antibody. The titer is merely measuring the "concentration," if you will, of the antibody in solution. They are really two unrelated attributes. We use gel method for screens and i.d., but perform the tube method titer in saline using the CAP recommended Uniform Method.

It doesn’t appear that anyone answered this 4 years ago. I am at a level 2 trauma center, functioning as a level 1 in hopes of getting designated as such this summer. You’ve given me something to think about for sure. I do have a question about the second sample type prior to switching to type specific blood. We are about to implement this policy and I’m wondering, when and who draws your 2nd blood type sample?

Thank you, Henry. This helps a lot!

Our digitrax printer needs a software upgrade to be able to print the labels for the newer CCP products as well as the new platelet products that will be available soon. We have contacted Henry at digitrax and we have to have some sort of credentials to be able to do this. We are up to date with our registration for the ICCBBA database, so is it the same username and password that we have for ICCBBA? Thanks, Kathryn

John, no, there were no temperature monitors attached. Also, our supplier says they cannot accept it back because it was transferred within facilities. I do hate wasting the units, however, I cannot 100% guarantee the storage conditions of the units during transport. Specifically, were they removed at any time for a prolonged period of time then put back into the cooler. As much as I hate to discard them, I believe the safety risk outweighs the benefit of keeping them. Thank you all for your responses.

What do you do when you receive blood from another facility that comes with a trauma patient who is brought to your facility? The blood came in a Styrofoam cooler with the solid ice packs that our supplier uses in their red cell transport boxes. The units are from the same blood supplier that we use. Thanks for your insight. Kathryn

I will add some info here to clarify our situation further: We do not have a helicopter. It is a local company that wants us to provide the blood to them and administration wants us to do this. If our blood is on the chopper but they pick up a patient and take him/her to another hospital, the patient would not be registered here and there would be no record of us giving the blood. Possibly we could have documentation from the helicopter personnel with patient info and the unit they gave and we could have some sort of quick-registration process on our side so we could at least show the patient received the blood in an emergency situation. I guess asking the crew to bring a sample back to us would be asking too much, huh?!

We are being asked to supply blood for a helicopter. My question is, how do we properly account for the unit(s) if a patient is picked up from an accident scene, transfused in flight, but taken to another hospital? The patient would never be registered at our facility so would we then make a “transfer” of the unit(s) to the receiving hospital? I’m just trying to figure out how to keep track of the blood since it’s from our inventory.

We are a 540-bed Hospital functioning as a Level I Trauma Center. I need help with setting up an MTP for infants and small children. Recently we had a two-year-old who had been hit by a car. They could not use the rapid infuser on her because it would be too much too fast for her weight so they pulled blood from the bags with syringes and pushed it in. The trauma team is asking me what supplies they need to handle pediatric traumas. All we have are syringes with an in-line filter that we aliquot for our NICU babies. How do others handle small pediatric patients? Do the nurses use syringes to pull and push the blood as I have described? Is that allowed? I’m pretty sure there was no filter involved either. So far we have only had older children and adults for MTPs and we have a good process in place—just need to provide for the smaller patients too. Thank you for any suggestions/recommendations.

We are a 540-bed Hospital functioning as a Level I Trauma Center. I need help with setting up an MTP for infants and small children. Recently we had a two-year-old who had been hit by a car. They could not use the rapid infuser on her because it would be too much too fast for her weight (which I don’t remember)so they pulled blood from the bags with syringes and pushed it in. The trauma team is asking me what supplies they need to handle pediatric traumas. All we have are syringes with an in-line filter that we aliquot for our NICU babies. How do others handle small pediatric patients? Do the nurses use syringes to pull and push the blood as I have described? Is that allowed? I’m pretty sure there was no filter involved either. Is there such a thing as a syringe blood warmer? So far we have only had older children and adults for MTPs and we have a good process in place—just need to provide for the smaller patients too. Thank you for any suggestions/recommendations. Kathryn

I tried validating antibody titers when we first got our Visions. I had the same issue as you due to the sensitivity of the gel. I listened to a webinar on the subject once and those who have successfully done it recommend contacting the clinicians to inform them of this significant change in test method. This would come from your blood bank medical director and he or she would have to work closely with the OB/GYNs. Therefore, I decided to continue doing titers by tube method. Good luck if you do decide to pursue this further.

Malcolm, thanks so much for the article. It was very helpful. As it turned out, we sent mom's sample to our reference lab for MMA testing, and we also antigen typed her 2 brothers and her father. One of the brothers matched her Duffy and Kidd antigen types and was Coombs crossmatch compatible with her. He donated two units of packed red cells (at one donation) and was also confirmed to be Diego b negative. The patient's anti-Dib came back as clinically significant based on the MMA test. She did have a C-section after all and did not require any blood! The baby had a negative direct coombs so there were no issues there either!

Our Reference Lab has informed us that a patient's sample we sent to them has anti-Dib (Diego b), anti-Fya, and anti-Jka! The patient is pregnant and due the end of July. All 3 antibodies are capable of causing HDFN, although usually mild from what I have read. My concern is if we have to transfuse the mother. The prospect of getting blood is problematic. Most likely the units would be frozen and our local supplier would have them shipped in already thawed and deglycerolized, plus the time of flying them here is a challenge with flight schedules to our area. From my reading the Diego antibodies are more commonly associated with HDFN than transfusion reactions, and anti-Dib typically causes mild HDFN. Therefore, my strategy is to have units that are at least antigen negative for Fya and Jka for the mom in case we cannot obtain units that are negative for all 3 antigens. If we can get units that are antigen negative for all 3 that's great, but the patient is not a scheduled C-section so the timing will be next to impossible. Any thoughts or ideas for a different strategy? Thanks for any input!

Does anyone know a vendor that sells a heat block that will reach a temperature of 120C? Our pathology department is looking for one. Thanks.

Does anyone know if there is another company in the U.S. that distributes the plasma thawing devices, i.e. microwave? We have been wanting to order two more (we currently have one), but there is an FDA hold up on it right now for the device that comes from Canada. It has something to do with paperwork, nothing to do with the device itself!

My hospital blood bank has only been in existence for approximately 11 and a half years. I have been the only supervisor for 11 of those years. During this time we have grown so much so fast, that it has been all I could do to keep up and stay ahead of inventory, procedures, staff training, competencies, teaching students, all while moving 3 times, designing and implementing the blood bank section of our LIS, bringing in and validating two generations of automation (8 years apart), and working the bench when needed. We are a CAP accredited laboratory and it has always been my desire for my blood bank to eventually become AABB accredited. Other than the prestige that it would bring, how might I justify the cost to my administration of the benefits of becoming AABB accredited? Even though we have the latest and greatest tools in our lab, I need to be able to explain why spending $$$ dollars on a voluntary program is a good thing. Thanks in advance to those of you who are AABB accredited and can advise me! Kathryn

As for the signed Emergency Release form, we have always sent the original to the chart and kept a copy in the blood bank. CAP says that "records" of the emergency release must include the authorization of the physician; AABB says the "records" must contain a signed statement from the requesting physician, etc....... . Does this form actually need to be placed in the patient's chart or is our blood bank file a sufficient "record?" We are exploring the possibility of obtaining an electronic authorization and signature for emergency release. Thanks

I am currently trying to implement this at my hospital. I do have a question for all of you at trauma centers: do you use the same form that the physician signs for emergency release as you do for an MTP? At our hospital many MTP's start out as emergency release, but we do have MTP's on patients in surgery sometimes and there's already a type and screen so no need to sign a form there. We are also trying to have the form in an electronic format that the physician will electronically sign. How do others handle Emergency Release vs. MTP? Thanks in advance!

This thread is very timely as my hospital is a level 3 trauma center in active pursuit of level 1 trauma. (Yes, you read that right, we plan to skip level 2.) I am currently working with our trauma coordinator on an order set for MTP. She asked me just today if the emergency release form could be electronic with an electronic physician signature. We have always included the emergency released unit numbers on the form that the physician signs. Of course, this info is easy to obtain from our patient and unit history. After reading through this thread it seems reasonable that we really could eliminate this piece of paper and go to an electronic physician signature. I apologize for this being so lengthy, but I do have a question or 2– do any of you have order sets in your LIS for MTP? Also, in the midst of an MTP, how do you keep track of which “cooler” you are on? We give a plateletpheresis with every 6 RBCs and FFPs. Cooler 1 is 3 RBC & 3 FFPs, cooler 2 Is 3rbc, 3ffp, & 1 plateletpheresis (obviously not IN the cooler), cooler 3 is 3rbc & 3 FFPs, cooler 4 will have RBCs, FFPs, and platelet. My trauma coordinator is proposing to have this be electronic too, so that as soon as we verify the first order, it will reflex an order for the next set of products and so on until we get an order to discontinue. Does anyone have anything like this set up? Thanks for bearing with me. We have Cerner Millennium if you were wondering. Kathryn

The topic came up recently regarding specimen collections from patients while the patient is receiving a transfusion. In general the phlebotomists will not draw a patient for any lab test while they are being transfused, but is this an unnecessary practice? Does anyone have any information or a reference that addresses this? We have no policy on the subject, but it seems to be what is currently being practiced here.

Is there anyone with a Vision and Cerner Millennium who has upgraded to the new Vision software version 5.10 that was released in August 2017? If so, would you be able to share your experience, specifically, how many Visions do you have and did the upload go smoothly? Did you experience any major issues during or after the upload? Did you perform the upload through e-connectivity? We have 2 Visions and are getting ready to upgrade one instrument at a time (different weeks) through e-connectivity. We had major LIS issues before we went Live a year ago that delayed our plans almost a month! Thanks for any insight! Kathryn

We have Cerner and our test for neonates is called "Baby Type and Screen" and includes 2 orderables: "Baby ABORh," and "Mom ABSC" (mom antibody screen). Our workflow: Transfuse order for RBCs is received in blood bank We go find the pedi lavender from hemo and add-on a Baby Type and Screen and a Crossmatch. The Baby T&S consists of a blood type on the baby-"Baby ABORh" (just a forward type, of course) and the Mom's antibody screen-"Mom ABSC." Usually we have already performed cord blood testing so we have a blood bank comment which shows the mom's name and medical record number (our cords have both mom's and baby's label on the sample and we add the comment to the baby's profile while doing the cord blood workup) We look up the mom's record to see her antibody status If no antibodies, we result the "mom absc" as negative. We select a neonate crossmatch and it is "compatible" once we scan the unit number for the aliquot. No serological crossmatching is done. We only transfuse O pos and O neg to babies. If mom has an antibody, we use antigen negative blood for the baby. Again no serological crossmatch required. We use the "neonate protocol" to override the sample expiration so our neonate samples are good for 4 months (Cerner actually calculates it as 120 days from the date of birth.) I hope this is helpful.