jshepherd

Technically, any sample you don't know the answer to is "blind" to you, so any regular patient with no history can be used for a blind blood type for example. Yes, for DAT and FMH it's harder, but we typically use the CAP samples as Bet'naSBB said, rather than try to make up samples that are not quite right.  

The FDA Guidance on Computer Crossmatching calls out that patients with an ABO typing discrepancy should not be allowed to qualify for computer crossmatches. 
" If ABO typing discrepancies exist, you should not rely on a computer crossmatch. This is particularly important if there is mixed field red cell reactivity, missing serum reactivity, or apparent change in blood type following hematopoietic stem cell transplantation. Under those circumstances, your procedures should provide for compatibility testing using serologic crossmatch techniques." 
I wrote our policy to include any non-straightforward ABO types for any reason will be required to get an IS or IAT crossmatch. 

The FDA Guidance on Computer Crossmatching calls out that patients with an ABO typing discrepancy should not be allowed to qualify for computer crossmatches. 
" If ABO typing discrepancies exist, you should not rely on a computer crossmatch. This is particularly important if there is mixed field red cell reactivity, missing serum reactivity, or apparent change in blood type following hematopoietic stem cell transplantation. Under those circumstances, your procedures should provide for compatibility testing using serologic crossmatch techniques." 
I wrote our policy to include any non-straightforward ABO types for any reason will be required to get an IS or IAT crossmatch. 

The FDA Guidance on Computer Crossmatching calls out that patients with an ABO typing discrepancy should not be allowed to qualify for computer crossmatches. 
" If ABO typing discrepancies exist, you should not rely on a computer crossmatch. This is particularly important if there is mixed field red cell reactivity, missing serum reactivity, or apparent change in blood type following hematopoietic stem cell transplantation. Under those circumstances, your procedures should provide for compatibility testing using serologic crossmatch techniques." 
I wrote our policy to include any non-straightforward ABO types for any reason will be required to get an IS or IAT crossmatch. 

The FDA Guidance on Computer Crossmatching calls out that patients with an ABO typing discrepancy should not be allowed to qualify for computer crossmatches. 
" If ABO typing discrepancies exist, you should not rely on a computer crossmatch. This is particularly important if there is mixed field red cell reactivity, missing serum reactivity, or apparent change in blood type following hematopoietic stem cell transplantation. Under those circumstances, your procedures should provide for compatibility testing using serologic crossmatch techniques." 
I wrote our policy to include any non-straightforward ABO types for any reason will be required to get an IS or IAT crossmatch. 

Neil Blumberg, I'll leave this one to you!

As far as I know there is no FDA requirement for two people to issue blood.  Obviously some hospitals have only one person working night shift in the lab, so that isn't happening realistically. There is a traditional requirement for two people to identify the recipient and the transfused product, but this is only if positive patient identification is not used these days. 

My facility is not AABB accredited, just Joint Commission and FDA, and I have an individual membership. I am the supervisor, and we are a large level 1 metropolitan trauma hospital. I have gained so much from my membership. Everything Cliff mentioned about resources is true, and I can't tell you how many times we've taken advantage of the discount on books for my pathologists (none of whom are transfusion medicine specialists). 
AABB membership also opened up all the subcommittees and sections, and I now sit on 9 subsections and lead one of them. I am also a mentor in the program Cliff mentioned above. 
I would say it's worth it for at least one year, so you can try it out and see what you get from it. Pro tip: if you love it, they do offer a 3 year membership option that knocks some of the cost down.  

Same! We were AABB accredited long ago, so still follow the standards, just not quite to such a rigorous degree. We are now TJC and FDA inspected. To my knowledge, FDA doesn't require an associated procedure the way AABB does. As long as there is document control for everything, I think you're covered. I've been in my job 10 years with this inspection setup and not had any issues with my procedures or policies with FDA.  

Hey Randi, 
I would push back on your medical director if you can. To Dr. Blumberg's point, low-yield platelets are an FDA approved product, so there's no real reason to require notification to providers, especially if half the infusions are just topping up people for a procedure, but I won't rant about that one right now.  
Agreed that Vitalant was not clear about how often they expect to have these, and their cost being the same. We don't order from Vitalant much, but we haven't seen any of the new E-codes for low yield. 
Janine

Well, there are several things you can reference, besides AABB standard 5.29.1, which nursing won't care about.  
Joint Commission (Hospital): PC.02.01.01
Ep 10. Before initiating a blood or blood component transfusion, the hospital follows a process to correctly identify patients that includes the following:
- Matching the blood or blood component to the order
- Matching the patient to the blood or blood component
- Using a two-person verification process or a one-person verification process accompanied by automated identification technology, such as bar coding
By logic, you can't match the blood component to the patient or order without documenting the "lot number", in this case the DIN. 
 
eCFR :: 42 CFR 482.27 -- Condition of participation: Laboratory services. See (b)(5) on this page regarding recordkeeping. For lookbacks, the HOSPITAL must maintain records, therefore a DIN must be documented from receipt to final disposition, including in the transfusion record. 
eCFR :: 21 CFR Part 606 -- Current Good Manufacturing Practice for Blood and Blood Components this is a general list of all the required records, but you can say that (c) is the most helpful for requiring a DIN documentation
Hope these help! 

My facility is not AABB accredited, just Joint Commission and FDA, and I have an individual membership. I am the supervisor, and we are a large level 1 metropolitan trauma hospital. I have gained so much from my membership. Everything Cliff mentioned about resources is true, and I can't tell you how many times we've taken advantage of the discount on books for my pathologists (none of whom are transfusion medicine specialists). 
AABB membership also opened up all the subcommittees and sections, and I now sit on 9 subsections and lead one of them. I am also a mentor in the program Cliff mentioned above. 
I would say it's worth it for at least one year, so you can try it out and see what you get from it. Pro tip: if you love it, they do offer a 3 year membership option that knocks some of the cost down.  

My facility is not AABB accredited, just Joint Commission and FDA, and I have an individual membership. I am the supervisor, and we are a large level 1 metropolitan trauma hospital. I have gained so much from my membership. Everything Cliff mentioned about resources is true, and I can't tell you how many times we've taken advantage of the discount on books for my pathologists (none of whom are transfusion medicine specialists). 
AABB membership also opened up all the subcommittees and sections, and I now sit on 9 subsections and lead one of them. I am also a mentor in the program Cliff mentioned above. 
I would say it's worth it for at least one year, so you can try it out and see what you get from it. Pro tip: if you love it, they do offer a 3 year membership option that knocks some of the cost down.  

My facility is not AABB accredited, just Joint Commission and FDA, and I have an individual membership. I am the supervisor, and we are a large level 1 metropolitan trauma hospital. I have gained so much from my membership. Everything Cliff mentioned about resources is true, and I can't tell you how many times we've taken advantage of the discount on books for my pathologists (none of whom are transfusion medicine specialists). 
AABB membership also opened up all the subcommittees and sections, and I now sit on 9 subsections and lead one of them. I am also a mentor in the program Cliff mentioned above. 
I would say it's worth it for at least one year, so you can try it out and see what you get from it. Pro tip: if you love it, they do offer a 3 year membership option that knocks some of the cost down.  

My facility is not AABB accredited, just Joint Commission and FDA, and I have an individual membership. I am the supervisor, and we are a large level 1 metropolitan trauma hospital. I have gained so much from my membership. Everything Cliff mentioned about resources is true, and I can't tell you how many times we've taken advantage of the discount on books for my pathologists (none of whom are transfusion medicine specialists). 
AABB membership also opened up all the subcommittees and sections, and I now sit on 9 subsections and lead one of them. I am also a mentor in the program Cliff mentioned above. 
I would say it's worth it for at least one year, so you can try it out and see what you get from it. Pro tip: if you love it, they do offer a 3 year membership option that knocks some of the cost down.  

My facility is not AABB accredited, just Joint Commission and FDA, and I have an individual membership. I am the supervisor, and we are a large level 1 metropolitan trauma hospital. I have gained so much from my membership. Everything Cliff mentioned about resources is true, and I can't tell you how many times we've taken advantage of the discount on books for my pathologists (none of whom are transfusion medicine specialists). 
AABB membership also opened up all the subcommittees and sections, and I now sit on 9 subsections and lead one of them. I am also a mentor in the program Cliff mentioned above. 
I would say it's worth it for at least one year, so you can try it out and see what you get from it. Pro tip: if you love it, they do offer a 3 year membership option that knocks some of the cost down.  

agree with @Neil Blumberg.  We courier blood / platelets to our off site infusion centers on a daily basis and also to our small sister facilities that might need products.  none of them have a separate FDA registration.  We also send out WB, Plasma and RBC's on neighboring county EMS units and our in house Air units and none of them need FDA registration.  Our medical director checked with his FDA "connection" and they sent an email stating as such.

If the infusion center is part of the hospital and served by the hospital transfusion service, they do not need a separate FDA registration because they are not a transfusion service.  The FDA does not regulate nor inspect infusion centers. They regulate and inspect transfusion services and blood banks.
Provision of products to an infusion center would not require FDA registration per se. That is determined by what services you provide overall.

I'm with Dr. Blumberg, we cap our LTOWB for trauma MTP at 4 units. This is due to inventory as well as not wanting to give non-ABO identical as little as possible. We have had zero adverse events thus far. The more O you give a non-O patient, the harder it is to determine their true type as well, especially if you don't get a sample drawn ASAP. Switch to patient's ABO type as soon as you can, and only fall back to type O red cells if inventory is in trouble. 
Also agree with Bet'na - the patient has to live to have a problem, but we can mitigate the problems by capping how much potentially incompatible plasma we give. 
There is an AABB standard 5.27.2 that states that your SOPs must indicate the maximum volume/units allowed per event. You can define that yourself, there isn't really a guide as to how much is too much. There are facilities out there that have no limit and some that have a limit, as evidenced by the responses in this thread. Standard 5.15.4 applies to this as well, which states that you have to have a policy concerning transfusion of significant volumes of plasma containing incompatible ABO antibodies, ie type O plasma to non-O patients. 
I've been doing level 1 trauma for almost 20 years, and it can feel like the wild west, reach out if you need clarification or real-life examples of things. Happy to help.

I'm with Dr. Blumberg, we cap our LTOWB for trauma MTP at 4 units. This is due to inventory as well as not wanting to give non-ABO identical as little as possible. We have had zero adverse events thus far. The more O you give a non-O patient, the harder it is to determine their true type as well, especially if you don't get a sample drawn ASAP. Switch to patient's ABO type as soon as you can, and only fall back to type O red cells if inventory is in trouble. 
Also agree with Bet'na - the patient has to live to have a problem, but we can mitigate the problems by capping how much potentially incompatible plasma we give. 
There is an AABB standard 5.27.2 that states that your SOPs must indicate the maximum volume/units allowed per event. You can define that yourself, there isn't really a guide as to how much is too much. There are facilities out there that have no limit and some that have a limit, as evidenced by the responses in this thread. Standard 5.15.4 applies to this as well, which states that you have to have a policy concerning transfusion of significant volumes of plasma containing incompatible ABO antibodies, ie type O plasma to non-O patients. 
I've been doing level 1 trauma for almost 20 years, and it can feel like the wild west, reach out if you need clarification or real-life examples of things. Happy to help.

I'm with Dr. Blumberg, we cap our LTOWB for trauma MTP at 4 units. This is due to inventory as well as not wanting to give non-ABO identical as little as possible. We have had zero adverse events thus far. The more O you give a non-O patient, the harder it is to determine their true type as well, especially if you don't get a sample drawn ASAP. Switch to patient's ABO type as soon as you can, and only fall back to type O red cells if inventory is in trouble. 
Also agree with Bet'na - the patient has to live to have a problem, but we can mitigate the problems by capping how much potentially incompatible plasma we give. 
There is an AABB standard 5.27.2 that states that your SOPs must indicate the maximum volume/units allowed per event. You can define that yourself, there isn't really a guide as to how much is too much. There are facilities out there that have no limit and some that have a limit, as evidenced by the responses in this thread. Standard 5.15.4 applies to this as well, which states that you have to have a policy concerning transfusion of significant volumes of plasma containing incompatible ABO antibodies, ie type O plasma to non-O patients. 
I've been doing level 1 trauma for almost 20 years, and it can feel like the wild west, reach out if you need clarification or real-life examples of things. Happy to help.

Our Blood Bank uses Hemotemp II's but they are only good applied to the bag for about 2 days. They also have to be activated with a 40C incubator. We use those for units in OR coolers and trauma.
If you want tracking for the life of the unit, Safe-T-Vue's are pretty much the only option.
I second everyone's frustration with the Timestrip BT10's. We tried them for our trauma bay and they fell off all the time despite prepping with alcohol and wiping condensation off the bag. They'd also activate if you looked at it wrong. Our rep said the lots we got might be bad because they were in her hot car. 
@RRay I think the decline might be due to hospital networks going single source and racing to the bottom to get the cheapest things. There's no incentive to make a higher quality instrument/reagent/etc. if the hospital networks are only going to look at upfront costs and ignore the issues caused by low quality/bad service/insufficient supply.

Another update:
After I sent the experiment results I got an email for the rep to refund me of all my hemo-trac purchases and for me to find another product being that their product is not performing as intended and for my needs.  They also emphasized that these are mainly for transport and not intended to be left on its in storage (although that is allowed per the manuf. insert).  I think they should adjust their marketing strategy.
 
So, @JOJOER I think at this point I am going to look at cooler temp loggers instead.  Possibly Max Connect or LogTag.  In the long run, these are one time purchase +annual recal and that will be a fraction of the price we're currently spending having to replace sticker indicators or switching back to safeTvues.
 
*Rant incoming* Is it just me or has options for blood bank specific products in general really dwindled across the past 10 years?  Now, it's almost "This is what you get, you have to use THIS."  Want a blood irradiator?  Here's your 2 options.  Want a blood kiosk?  Hate haemonetics? Too bad, this is what you get.  

We have a Temp Check device. Temp-Check Rapid Response Thermometer For Healthcare| Digi-Trax®
This is what we use to take temps of all products being returned to us. 

Agree with Dr. Blumberg. If platelets are returned in an RBC cooler "on ice", we take a temp of the unit. If out of 20-24C range, we check for swirling, and if still swirling we will ask pathology if we can keep it, based on our current platelet inventory and the temp we got. Always up to them, but in general if it's only out of range by a degree or two, we'll accept it back. The coolers we use for RBCs are only out for 4 hours max, so these units are never in there very long, and they often come back within temp range (like they tossed the unit in the cooler right before bringing back the cooler).