jshepherd

The response I got from ARC is that it is up to our medical director. There is no FDA exception needed, as the FDA doesn't have a regulation on shipping duration or transit time. They only care about temp, and since the temps are in range, there is nothing to seek a variance from. I heard from people who use other blood suppliers, and the general consensus is that if the packing is correct, ice is still present and the units are in temp range, they are acceptable, as long as there is documentation of this deviation from the hospital's normal policy. I ended up adding this tidbit to my SOP as an allowed deviation by our medical director, just need to fill out the deviation documentation form and have him sign, but this way, we can accept the units in immediately and not delay having them be available. Especially important for platelets!

Our blood is shipped to us from Omaha and St. Paul (ARC), and sometimes arrives to Denver later than the transport boxes are validated for, which is 48 hours. These units are frequently still in the acceptable transport temp range, be they platelet or red cells. Historically, we have tossed these units since they did not arrive to us within the validated time frame, but I am looking for a way to stop doing that. The FDA publishes exceptions to 21CFR640, which are publicly available, and has many exceptions listed where they have allowed the use and distribution of products when they were stored outside of the required temperature ranges for a specified amount of time, ranging from a few minutes to several hours. I cannot find in any FDA regulations where I would be allowed to accept the products in the situation described above, when units are in temp, but over the validated time frame of the transport container. Has anyone encountered this before, and what do you do about it? Is this simply a decision for the Medical Director of my hospital, or does this require an FDA exception?

Exactly!! The answer is because the FDA says we have to..... I have never seen a mistyped unit from any blood supplier in 17 years. ABO or ag typing.

We do not recheck ag typing. One and done. If our supplier sends us antigen neg units, they are either typed in the moment by the supplier or labeled as "historically negative" which means the donor has been typed twice by the supplier and will not be typed again. As @NicolePCanada said, you're still going to do the AHG XM, so no need to cause undue stress. Also agree fervently with @exlimey that you should not make something like this optional.

@Neil Blumberg Exactly. We've all had the odd cases that survive when it doesn't seem they should, and I agree that it's certainly case by case and dependent on hemostasis and coagulation like @Auntie-D said above. We use TEG for coagulation eval as well. I think my trauma surgeons are looking for a prompt to make them aware of how many products they've used, so they can evaluate the futility of continuing versus stopping. Anesthesia is the group transfusing these products, and they can easily lose track as well, so we're looking for an estimate of when the blood bank staff might give them a nudge to let them know they've hit a threshold, and to evaluate the entire picture of the patient with that knowledge, rather than being tunnel visioned into fixing the damage only. I have heard 30-50 units of red cells is the sweet spot as well. We consider more than 30 units of red cells to be a super massive transfusion, so that would jive.

Hello everyone! Controversial topic coming up here: Is there a point in an MTP where the further transfusion of blood products does more harm than good? I know some facilities have published studies on this issue, and some have assigned their own lethal dose, or LD50, to blood products, to say that once a patient is transfused X number of red cells or X number of total products that resuscitation is futile and MTP should be discontinued. We are exploring doing this research ourselves, but I was asked if anyone out there has an actual policy or SOP on this topic. For ethical reasons it gets really touchy, so here's the disclaimer that I'm not trying to rile anyone up, just wondering what everyone else is doing! And......go!

Excellent points from Neil and Malcolm as always! Most of us are slaves to the standards though, and/or don't have pathologists willing to take this same point. @RRay Lots of food for thought here! I think we will be implementing something similar here, adding an "antibody" to the patient file in the BB LIS only that will require an AHG XM when additional drops of plasma are used to resolve a blood type.

This was an issue here as well, the full address of the hospital was in the header of all of my SOPs. I removed them all one by one as updates/reviews were required. There is nothing in JC/FDA or AABB that says you need the location of the lab in an SOP. You are correct that this needs to be on reports. I left the name of the hospital and Department of Pathology and Laboratory Services in my header, that's it.

I'm working from home today, so the AABB standards are not at my right hand, but I'm pretty sure AABB requires a front and back type to be resulted to count as a full blood type for adults. There are exceptions for peds of course. No full blood type means you should be giving type O red cells and type AB plasma, which no one wants to do unless warranted!

Agree with Neil and Malcolm, might adopt that here! You could have an "antibody", or some other way to require the system to prompt techs, that you add to the patient in your blood bank LIS, which will direct staff to perform an AHG crossmatch. That way, there isn't an antibody actually resulted in the HIS, but the staff will be alerted to the need for an AHG XM rather than relying on them catching that there was a weak backtype.

This is mentioned as "increasing the serum to cell ratio" in tech manuals and guides, but it is SUPER vague! I agree that you should not allow your techs to do this if it's not in the SOP. I have RT and 4C incubations as things to try to resolve blood type discrepancies in my SOP. The only place we mention increased serum to cell ratio is to enhance weak antibody screen reactions by using 3 drops plasma and 3 drops PEG to one drop cells. We don't change serum to cell ratio for blood types or ISXM.

There is a recommendation, or maybe a standard I can't put my finger on right now, that says that access to the blood bank should be controlled. Meaning people can't just walk in and take blood. Nothing that says it must be a separate room. My entire lab is behind badge access doors, and the blood bank is semi-separated by a counter and some swinging half doors (saloon doors) so that people picking up products would certainly be noticed if they just popped into the actual department.

Same. Many of our SOPs refer to the manufacturer's manual for things, easier that way.

Purchasing a liquid in glass thermometer still requires validation, even when it comes with a certificate. We measure it at the single point temp it will be used at, so if it's a platelet rotator thermometer, in the range of 20-24, if a fridge thermometer, in the range of 1-6. We re-validate our thermometers annually at the temp they are used at. If the thermometer can be used at multiple temps (like a min/max thermometer), we validate each range. Electronic thermometers..... that is SO broad. Thanks FDA! Honestly, I would say an infrared is electronic, but I would also say that a system like Rees or Primex (what we use) is also electronic. But calibrating the thermometer MONTHLY is unreasonable. Primex actually verifies their electronic probes for 2 years, and they provided me a statement to this effect, that the probes are very stable, even beyond 5 years. Otherwise, they were wanting probes to be replaced every 2 years, and a new temp probe would mean a new validation for each piece of equipment. If the company can provide you a statement or certificate about their probes, perhaps you can get around the monthly calibration? I'd also query the FDA as to what, exactly, do they consider an electronic thermometer......and then tell us what they say!

We usually have enough expired units for this, but if we don't we use real units. The coolers are checked so often, you should be aware that it might fail, and just like a fridge, you'd bail any real units out before that happens.