Discover the Best Billing Format for Client for Animal Science

Best billing format for client for Animal science

the folks at life tech asked me to come here today and talk to you a little bit about from the laboratory perspective uh what are the what are the perks what are the advantages to standardizing our testing workflows so I'm going to try to do that starting with the the problem well from our perspective part of the problem is the only testing that is really standardized as far as the Laboratories are concerned are there is the regulatory testing you know we have Federal regulatory testing where the standard operating protocols the step-by-step things that we do are very standardized very prescribed probably the best example of that is the the national animal health lab Network testing the foreign animal disease surveillance it is standardized right down to which reagents you can use or can't use which machine you can run that test on etc etc we are all tested at least annually with a proficiency panels which are a group of unknown samples that everybody runs and they compare your answers to what the the true answers are and tell you whether or not you're doing it right or not so there's this National oversight and harmonization of all of that testing but that's really kind of where it stops is those regulatory tests there are many many other tests that we run in the Diagnostic lab in fact if you were to add them up the vast majority I would say of the tests we run in the Diagnostic lab that are either home grown or we created them based on somebody's published research paper um you know there there's no no validation absolutely required there's not that kind of national oversight we don't have proficiency panels for them or interlaboratory comparison testing that's done on you really a little bit at the mercy of the individual laboratory as to how good that test is and how valid that test is how many folks out here have ever been in the situation where you've gotten supposedly the same test done at several different Laboratories in several different states and you get the results back and something just doesn't look right anybody ever had that experience you know uh one lab tells you that the positive cutoff is 37.5 and the other lab tells you it's 39 and you're stuck there sitting in your seats as a regulatory official which I was once upon a time and you're trying to make decisions that you know could cost you your job in some cases and here's this confusing mishmash of stuff well when you think of the testing that we do it's really a system of events processes that go on starting with the samples and there's all kinds of variables all the way along this system there's the sample type you know sometimes it's serum and they send you plasma sometimes it's supposed to be this organ and they send you some other organ there's the container and how it's handled you know is it is it in the right preservative uh did it get too hot or too cold while it was being sent to you once it gets there you're actually going to start doing some testing well for any given disease I know in our test catalog for some diseases that we test for we have half a dozen or more different kinds of tests and some of them are for antibodies and some of them are for antigens some of them use Eliza technology some of them use PCR technology it's all over the place validation verification I mean that's part of it we certainly hope that that that has been done and that there's good quality assurance good good quality control and that's part of the testing method then there's the results you get the results and what kind of form or format do those results come in um do you just get rows and numbers do you get numbers and a nice little graph or a picture are there interpretation statements that come along with it to help you figure out well is that Tighter and really in the positive range or not where is it do they give you benchmarks like I said cut off values and that sort of thing so I mean this is just a short list very short list of some of the parts of that system that process of testing that can vary tremendously from Lab to lab and even even submission to submission or sample to sample here's an example you probably heard talked about in the last few days so pedv our colleagues at Iowa State were lucky or unlucky enough however we want to characterize it to have to deal with this first and they did a brilliant job of actually figuring it out that it was something new and different and immediately there was uh interest to say the least by the industry in ginning up some new tests because the reality was we didn't have a test for this not really so we need to test and so all these great folks and all these different universities that that had the wherewithal to do it they went to work and in literally in a matter of days to weeks they started generating tests well they generated pcrs they generated some indirect fluorescent antibody tests some Eliza tests some and some of them use serum and some of them use feces a lot of them used feces at least in the early days which nothing makes a receiving section happier than get lots and lots of feces in some of them used oral fluids so look at all of these things here you've got at least three different technology platforms you've got multiple different kinds of samples coming in and the industry wanted to be able to run tests on all of these some of them for antibodies some of them for antigen to really address a disease outbreak problem you need multiple tools right you need antibody you need antigen testing etc etc these things were all largely home grown because there were there were no kits on the market there was nothing else to turn to these people did a fantastic job of generating this but if you sent the same set of samples for PCR to all these different places early on you probably got slightly different cutoff values for what's a positive and what's a negative and that sort of thing here's a here's the kind of variables you can see in just the PCR platform you've got extraction protocols you've got the different enzymes that are used you've got different sets of primers that are going after guess what different targets you've got different pieces of equipment when you run those equipments you might have different Heating and Cooling times and temperatures you've got those different cutoffs that I mentioned for negative suspect positive you've got different controls that are being used or maybe not being used early on because what's a control well it's usually a well characterized set of positive and negatives from the field but if you don't have a test to characterize positive and negatives you kind of have to make it up a bit as you're going along so lots of variables lots of people trying to do the right thing but you all and the producers as consumers are stuck in the position of trying to get all of these results in some cases from multiple Laboratories that have different cutoffs that have different conditions under which they were run so what's the solution to this sort of situation well one is valid validation or verification being absolutely required and the good news is these Laboratories you saw up there they are generally accredited by one or more external accrediting bodies like the aavld and aebld as part of their accredit crediting requirements requires that if you create a new test or you bring a new test into your lab that you in fact demonstrate its validation or or verification validation in general is you kind of created it from scratch and you really have to prove everything that works about it works the way you think it does verification is generally you've taken somebody's kit or somebody's published way to do it already and you've just verified that it works the same way in your lab that it did in the handout or in the publication type of thing so these Labs the good news is I think all of more under these requirements from aubld among others to do validation to do verification so that should give you some sense that you can rely on the results that they've turned out still doesn't mean you would get the same cutoff values from every one of those labs for their pcrs then there's something called harmonization which is between Laboratories essentially where you would agree that these are the target sequences that we're going after this is the way we're doing the extractions the amplifications we're all going to do it the same way that certainly wasn't the case at least early on with pedv still as as the example it has certainly gotten to be more that way because a lot of labs have a lot of labs that weren't some of those original Labs like ours in Texas have adopted one of those protocols from one of those other labs and so you do have some harmonization going on there now probably the best thing is is what I'll call demonstrated equivalency and that means in a way I don't care that you made up your own and you made up your own um you know you've got in-house QC and qqa what I need you to do is demonstrate that if I send the same set of samples kind of like that proficiency panel to both of you that you can in fact get the same result and when I say the same result I don't necessarily mean the same CT value at that level of same result but in fact the same actions would be taken in other words you call it positive when I call it positive you call it negative when I call it negative even if my positive is a different absolute CT value if I tell you the interpretation is positive which gives you the action it lets you do the actions you need to do as a regulatory official that you're going to get the same thing from the other labs that run it so that's demonstrated equivalency sometimes it's done with these proficiency panels you blind proficiency panels sometimes it's done with an interlaboratory comparison which is pretty similar to a proficiency panel but it's not just measuring your performance against the set of unknowns it's really looking at a whole bunch of labs performances and and how they they stack up against those unknowns so what's the benefit of doing this sort of these sorts of things or trying to harmonize things of trying to settle on on a set way of doing these things well it actually allows the Laboratories to to conduct those processes those systems in a more streamlined more efficient workflow it cuts down on our costs we're able to train people very consistently it's uh as an example for the national animal health lab Network for The Fad testing that's done you should be able to take any technician from any laboratory that's certified to run an fmd PCR under the national animal health lab Network and drop them into any other laboratory in the U.S that's certified to do that and they will know exactly how to run that test because it is that standardized same reagents same equipment same way to run it everywhere so it helps with consistency and training it helps you design a good QA and QC system that you know is going to instill confidence in in your users what's the benefits for the clients well it's that confidence it's knowing that regardless of whether I send it to Texas Minnesota Iowa that I can rely on those results and I'm not going to be misled I'm not going to make a decision that is the wrong decision uh for the for my clients for the folks that I'm supposed to be there serving and it's being able to understand and apply those results and again whether it isn't always so critical whether the CT values are the same but what's the actual actionable interpretation that comes from that test are those going to be the same I told him I'd keep it short tonight that's basically it I think uh it's almost a no-brainer in a way for me to stand up here and tell you all that this is a good thing is to have workflows that are harmonized that are equivalent uh that you can be sure that when you get that result from five different Labs that you know it's going to be good I what I would ask you as a laboratory director is when something new does come along that you keep that in mind and in fact that you insist on demonstration of equivalency that you insist that you get that kind of confidence out of those laboratory results pedv was a good example but another one at least in the southwest that's that's bedeviled us a little bit is Trick and right now you have a lot of different Labs running different trick protocols there hasn't been the kind of national oversight and standardization for running that that you might like to have and you should have so that you have that confidence that no matter where your producer got his trick sample run that you you can interpret the result correctly and you can apply fairly you can apply the same standards to those results that you would the results from anywhere else