SMILLER

You may be able to finding something in a textbook, but I think this is just the kind of thing you set up and follow your procedure (approved by pathologist). I don't think you are going to find any manufacturer or regulator recommendation. Here, the pathologist is ultimately responsible for dictating when something is or is not significant regarding precision. So if you want to write into the procedure "replicates acceptable when within 10% or 5 cells" or something like that, you should be OK I think. Scott

The problem with any QC being done on the last day of anything as it expires, is: if the QC is bad, what do you do with all of the results that you have reported out using that reagent? It seems the question of QC on panel cells comes up every couple of months or so in this forum. It has been noted that according to CLIA and other regulators (at least in the US), every lab must AT LEAST follow manufacturer's recommendations regarding QC for ANY test -- including those used in Blood Bank. (And not doing QC because the panel expires before the 30 day QC period is up? - I dare you to ask your inspector about that one!) As has been pointed out above, most manufacturers (like Ortho) state in the insert that periodic testing for weak Ags "should" be done. Testing for one or two weak antigens is not going to garauntee ALL significant antigens are good, but I suppose the idea is that if the weaker ones are still reactive stronger Ags should be OK as well. The big issue here that I see is that it is simply impractical as being both time consuming and expensive. But ALL QC takes time and adds cost--BB seems to be the only area in the Lab that is able to fudge on this one test that I know of. Bottom line (in my opinion for what it is worth) is that I have yet to hear of anyone anywhere being cited for not running QC as recommended by the manufacturer or by any other standard used by inspectors. If anyone has heard of this happening, or has had a specific comment on this from some regulator--FDA, JCAHO, etc.--THAT would be interesting to hear! Scott

Good point, Terri. At some point here, we have to remind younger trainees that when things get busy, that's the time you have to extra careful to SLOW DOWN to ensure mistakes aren't made. We remind them that people tend to get flustered when they try to speed things up to keep up with a heavy workload. This just create more errors. At McDonalds, you may burn a few fries or mess up an order. But this type of thing cannot happen in a hospital. Calling for help is emphasized. Scott

I agree! Less work! More distractions! Scott

Just have the administration buy everyone an ipod with ear buds. Then we can all listen (or not listen) to whatever we want! Scott

Up to now, we do weak Ds on prenatals. If the coombs result is 2+ or greater, we would report it out as D Pos. Recently we had a problem with how our reports are interpreted. We did a ABO/Rh/Ab screen for another lab that was weak D positive based on our protocol. However, this particular patient has had testing done at another hospital that never does weak D for prenatals, so we know that the doc already has previous reports saying the patient is D neg. Sent out the report with a comment, but we are not going to be surprised if the doc calls back for clarification. Now we are debating talking to our pathologist about dropping weak D testing altogether. Any comments on that? Thanks, Scott

I am not sure, but we do not usually worry too much about these units. We once asked our blood center about it once, and it has more to do with labeling requirements than otherwise. The point being that plasma from these "known AB" patients is not to be used for transfusion. I believe that the little bit of residual plasma is not supposed to be an issue with patients even if they are Ag positive for a particular AB. If I am mistaken about this, I would like to see a reference. Scott

Still, any non-permanent armband, PPID-full or not, can be removed and maybe end up on the wrong bedpost or whatever. I am hoping that when the time comes, we go directly to tatooed barcodes. At least until the get the microchip thing figured out. Scott

We are still converting to an EMR, BB is not really connected as of yet. We are reluctantly looking forward to issues like these and other problems when the time comes! The big question seems to be how cross-checking and recording of vitals, etc. for blood transfusions is going to take place. Scott

I agree with Deny. Have a nurse or unit secretary or both do the education if at all possible. Do this after making sure that they have a policy that explains appropriately how they process orders for irradiated blood. For your Quality Improvement project, you can show how much better htings are before and after the education. Scott

We usually require orders put in for additional products for all but OR. When OR calls to ask for units in a cooler or whatnot, we put in the orders ourselves in BB, supposing that someone in the OR has documented the order on the chart for a surgeon or anesthesiologist. Like many trauma centers, we also have a massive transfusion protocol where we order and process blood products per a set schedule until the MTP is called off. Scott

I think the point here is that gel testing is not reliable to show ABO incompatibilities. Not sure if the FDA ever put that into a reg, but there is something somewhere by AABB or somebody where it came up and an opinion was issued on it. Thing is, the reg says "procedures to demonstate incompatibility". If you are not using a method that is reliable for ABO incompatabilities, I would say you are in violation of the reg. At least, that's the gist of what our FDA inspector told us last year. Scott

Our systems are simular (HCLL for BB, McKesson for Lab), except that we are in the process of converting to Sunrise for the Hospital system (orders still are generated by the legacy system) The hospital system prints any BB order to a label printer in BB. That way, we are aware of the order even if they do not call us. Scott

Why don't you call the FDA and ask them? Seriously, I am pretty sure that your regular Lab regulators and the FDA would freak if they found out you knew about a reportable and did'nt report it. Even if it was an honest mistake, I am pretty sure you would have citations in store. Self-reporting is the cornerstone of regulation for the FDA. That's why we pull out the regs for pretty much any incident that occurs due to a protocol error in BB--to ensure that we do or do not have to send it into the FDA. Scott

Simular to Barbarakym. If an outpatient looses an armband and comes back for the transfusion, we start all over again. And most of our surgeries have the T&S done the same day (which causes other problems!) Scott

We have our criticals starting at the top of our therapeutic range for APTTs. I was wondering how other labs set thiers. If we are only one second outside the range, we have to make a critical call. Scott

We had an FDA inspecter (or maybe a JCAHO) bring this up a few years ago, now we are doing the IS in addition to the AHG. I believe the thinking was that with just a AHG, there is no RT test to r/o an ABO incompatibility. We did come across a case from another institution where an ABO incompatible unit did NOT show up at AHG, so it does seem to be a good idea. Scott

Please be very careful what you post here, if some of what your facility is currently doing (or more to the point--NOT doing) is discovered by regulatory agencies, this would be documentation they could use against your hospital. Having said that: Check your regulatory agencies requirements (FDA and whoever does your inspections). If your supervisors and administrators do nothing with whatever evidence you collect, you should have a corporate compliance officer to report to. Good luck! Scott

If a historically positive anti-E (or whatever) patient is coming up on all screening cells as negative, I don't seeaproblem in using them as rule-outs. In this situation, I would just go to a coombs crossmatch with the appropriatly screened units. On the other hand: if you are getting some positive E cells negative AND some positive, either on the screening cells or in a panel, even if all else is ruled out, I agree you would have to look at it a bit closer. Scott

Iam not sure about other inspectors, but if our JCAHO inspector sees a "should be" in a manufacturer's instructions, and we are not doing it, we would be at risk for a citation. Scott

Thank goodness, all of our platelets are in 5-packs from our supplier, pooled in some magic aseptic way that does not require us to do any type of testing here such as pH. In the old days, when we had to pool individual units, we simply used pH paper (and also had to document QC for the paper every day of use by using a standard). If the pH was above something like 6.0, it was OK to pool and transfuse. But check current AABB and FDA regs! Scott

Yes, but what is the argument against it? Scott

We have a Helmer CW but I am pretty sure we have never had this problem. I am not sure if there is a setting that can be used that would cause this sort of thing even if you wanted it to. Make sure that the rotor is fully seated. The thing is spinning between cycles, right? The cell button should stay in the bottom of the tube when they are tipped and dumped after spinning. Has anything else changed recently that might have caused this (like new test tubes or something)? Other than that, you have to call Helmer back and ask for more help. They are responsible to make sure that thier products are being used effectively. You should be able to find someone who can explain what is being done wrong. Good Luck, Scott

We have had the same experience as LCoranado. We refer to our pherisis units as "5-packs". It makes it a little easier for them when ordering to think of each order as five times what they used to order. Scott

Well, if we ever get a local NHSBT supply depot in Michigan, I'll be sure to go out there to check it out. And I'll drive on the left side of the road! Scott