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Giovahna Haro - December 08 VIEW RECORDING - 14 mins (No highlights): https://fathom.video/share/n2xxytbVbxJez-yx7eA8DgxYvAWKt14b --- 0:00 - Haro, Giovahna (Abbott) Doing great. It's a little chilly here. 0:02 - Andrew Hartmann (UTAK Laboratories) It's like 32 today. I don't know what it's like in California right now. Oh, man, I thought we had it bad. 0:08 - Haro, Giovahna (Abbott) We're like at 40. 0:10 - Andrew Hartmann (UTAK Laboratories) I love how it's relative. I was talking to somebody the other day, and they're like, oh, it's freezing. And I was like, what's freezing to you? He's like, oh, it's in the 60s right now. I think we were like 19 degrees that day. Oh, my gosh. Remind me where you're located? I'm in St. Louis. So, like, we get kind of all of the weather. We have, like, hot, humid summers, just brutally cold winters, and, like, a couple of weeks in between where it feels kind of nice to be outside. Yeah. Well, we're going through kind of a cold spell here. 0:39 - Haro, Giovahna (Abbott) It's been in the 40s, which for us is pretty cold. But I guess hearing where you're coming from, I'm glad we're at 40 at this point. 0:49 - Andrew Hartmann (UTAK Laboratories) I would agree. would agree. That's still cold. Yeah. So how's it going? It's going really well. I got your request in just... I I wanted to learn a little bit more about what's going on, because I just feel like if I quote you all of these to like minimum order size as a custom, it's probably not going to be what you're looking for. So I just wanted to, you know, kind of hear from you, like, what are you trying to accomplish here? 1:16 - Haro, Giovahna (Abbott) Okay, so basically, we need to verify the accuracy of all our analytes twice a year. And in the past, we've done in-house solutions, and we're trying to move away from that. So we're trying to do, if possible, split testing with another lab, and then if that's not an option, look for externally prepared materials. So I did go on your website, and some of the things, some of those controls that said it, that they were discontinued, but available through the custom process. So I didn't, I just kind of like went through what you had on your website in order to kind of get an idea of what... What's available or what analytes you guys advertise that you spike. I don't know if you would be able to do any that aren't on there, but just as like a starting point. But yeah, if it makes more sense to combine them into less controls, if that's cheaper and something that you offer, then I would definitely want to discuss that further. 2:28 - Andrew Hartmann (UTAK Laboratories) Yeah, think definitely going to be a more cost-effective option because, you know, each of these controls that you listed, it looks like you're just kind of listing a couple of the analytes within each one. And if we just quoted you straight, like it's going to have all of the analytes, minimum order size is like 50 ml. So I think you would just be buying a lot of extra material that way. A couple of questions to help us home in on design. Is this all in urine or are you looking for like a variety of matrices? 2:57 - Haro, Giovahna (Abbott) Most of it's in urine. Let me pull up the... The list I sent you real quick, let me see, I think there's only one that's in oral fluid, and that's the pentobarbital, so the SAMHSA confirm level 2 that I had asked for, that's the only one that would need to be in oral fluid. Everything else is urine. And you do want that pentobarbital actually in oral fluid, not in urine. 3:30 - Andrew Hartmann (UTAK Laboratories) Right. 3:31 - Haro, Giovahna (Abbott) Okay. 3:32 - Andrew Hartmann (UTAK Laboratories) So that one, might be better for you to stick with stock, since it's just kind of one analyte and it's already in there. So I'll send you some pricing on that one, but then we can also explore if a different option works better for you. Okay. As far as analyte availability, we can pretty much do any analyte that you guys are looking for, as long as it's available from like a Cerulean, Sigma, Lipomed, you know, any of those kinds of vendors, we can get in sort of. You're-hmm. Any analyte you're looking for. So would this be kind of a complete list right now, or would this be kind of just what you thought we had, but you might want to add to it? 4:10 - Haro, Giovahna (Abbott) This would be, as of right now, this would be the list that we would want to work with. 4:20 - Andrew Hartmann (UTAK Laboratories) And then we do this actually quite a bit with some labs. We have the option to do, we call it a blind sample. So what we would do is, you would kind of tell us, you know, what your clinical range is for each of these analytes, and then our team will assign a value, but when we quote it, we won't tell you what that value is. We can do this in like a single product. We also have people going with like three products or five products where they don't know which analytes are going to be in which sample, or at which concentration. So they get the samples as blinds, they run them, and then they come back to us and say, you know, we're ready for the info. And at that time, we send you the IFU that tells you. You know, what's in each of the products and the concentration we spiked. Does that seem kind of like a path you'd want to look into, or would you want a known concentration for each of these? 5:10 - Haro, Giovahna (Abbott) Yeah, I think that would be great, because that's kind of like the proficiency testing that we do with – we try to get proficiency testing as a first choice, and it can be kind of limited in terms of which analytes are available. So that seems like a great option, honestly. Yeah, we fill that void for quite a lot of labs, so we hear this quite a bit. 5:34 - Andrew Hartmann (UTAK Laboratories) Like, the only thing we don't have is, like, partner labs that can help you run it. So if you have, like, other labs you can share your samples with and that kind of stuff, you know, we always encourage that. But as far as making the material, you know, that's well within our wheelhouse. I'm assuming you just need a smaller amount of this. Is that right? You guys don't need, like, a bulk? 5:55 - Haro, Giovahna (Abbott) Right, because we only technically have to do this twice a year. year. Okay. So we would need it at the beginning and in the middle of the year. I mean, if we just ordered it once at the beginning, then we could, well, if you're sending us, would you be able to do this process where you send us this blind twice a year? We could, yeah. 6:19 - Andrew Hartmann (UTAK Laboratories) In order to make up a batch of the material, the smallest amount we'll manufacture is going to be 50 ml. So, you know, kind of figuring out how you'd want that to be aliquot, would you, you know, would you want 10 ml vials and just five of them? Or do you have any kind of idea how you'd like that packaged? 6:37 - Haro, Giovahna (Abbott) I'd kind of have to look at what the aliquot sizes are for each of the assays that we're going to be running it on. So let me get back to you on the, on the total volume, but it would be great to have one formulation done up in. Um, in, in January, and then a different formulation done up in July, where we don't know what's in there and how, what the, what the concentrations of each thing is, that would be, um, perfect. 7:16 - Andrew Hartmann (UTAK Laboratories) And then everything but the Pento is okay to put kind of together, is that right? Uh, yeah. 7:25 - Haro, Giovahna (Abbott) And would you want just a single product with all of these in it, or would you want us to split it between a couple of products? 7:32 - Andrew Hartmann (UTAK Laboratories) Just keep in mind, the more that we split it, it's kind of like the higher the cost, because we're making, is that a one product, it would be two products, or five products, or? 7:41 - Haro, Giovahna (Abbott) Um, actually, in terms of whether we can put everything together, let me follow up with Brent about that. I don't know if any of this stuff interferes. Okay. Um, but if it, if, I mean, I don't mind having more than one. Um. Um, more than one control that we make up. Um, yeah, I'll have to follow up, too, about interfering compounds. Okay. 8:09 - Andrew Hartmann (UTAK Laboratories) Yeah, I mean, we can do whatever you'd like. We see labs kind of do, like, one, three, and five for whatever reason. Uh, that's usually how we see people proceed. See, they'll put it all in one. Some people like to have it split up between three, and then others tell us it's, like, five is what's required. I think it just depends on, like, the different regulations and how you guys are accredited, if there's, like, a minimum or, you know, whatever your lab deems, like, best practice. 8:35 - Haro, Giovahna (Abbott) Yeah, and I think, um, we, we probably want to have as many analytes covered as possible. Um, I don't know that there has to be a positive for a given analyte within the year. It just has to be potential, because the way that proficiency testing works is that there'll be, um, a list of analytes, but they don't always have a positive for every single analyte that's listed. But let me get back to you on that as well, whether we should do one, three, or five. I think it's going to kind of depend on whether we can put all this stuff into one. Let me talk to Brent about that. Okay. 9:17 - Andrew Hartmann (UTAK Laboratories) Yeah, if we're going to make it for you, we don't, you know, we don't leave anything out. So whatever drugs you tell us you want in there, we're going to put all of those in each time. Does that kind of make sense? Oh, okay. 9:28 - Haro, Giovahna (Abbott) I thought you were saying that there could potentially, we wouldn't know which drugs were in there and we wouldn't know which concentrations. That's true. 9:36 - Andrew Hartmann (UTAK Laboratories) So like if, let's say we did a three level, just hypothetically here, you know, we've got around 20, 24, 25 drugs, something in that range. So if we do three levels, we probably put like, you know, eight, eight, nine drugs in, you know, so each drug is going to be present within one of the three samples, but not all three. Does that make sense? Yes. But like everything on your list will be in one. 10:01 - Haro, Giovahna (Abbott) But we won't know which one it's in, and we won't know what concentration until we've analyzed it. 10:11 - Andrew Hartmann (UTAK Laboratories) Yeah, so our team breaks them up, and then the quotes, they do look kind of lacking in information because, you know, we want everything to be blind to you, so it more just comes as like, you know, here's your price. But then behind the scenes, we've got it already split up into like which drugs are going to go into which control, and then what concentrations we're going to put in. Okay, that sounds good. So, go ahead. Oh, no, go for it. 10:36 - Haro, Giovahna (Abbott) I was just going to say, so then I guess at this point, I need to discuss this with Brent, and then we can move forward with how we're going to break it up and actually getting a quote for this stuff. Yeah, so what I'm going to want from you is confirmation on your fill size per vial. 10:55 - Andrew Hartmann (UTAK Laboratories) So, how much material do you want in each vial? Minimum order. is going to be 50 ml, so we'll quote you for that unless you need more material than that. If you do need more, just tell me how many ml in total you want, then I can do the math of how many vials that is. We'll need to know your range for each of these analytes, so that Excel you sent over, if you could just add your lower and upper limit, and then if there's anything that you don't want combined together in the same product. So let's just say, for instance, like cottoning and trazodone don't react well together in your method. You know, just tell us that these two need to be in separate products, and then we can split those at work. Okay, sounds good. And then that should be all we need to quote it. After this call, I'll go ahead and just send you a little recap of what those questions are so you have it. And I'll also provide you our pricing for our stock oral fluid control that has that phenobarbital, because I do think if it's just that single analyte that you're doing an oral fluid, our stock product is going to be... By far the most cost-efficient, as long as the other analysts that are in there aren't going to be an issue for you. Okay, and then one more question. 12:08 - Haro, Giovahna (Abbott) What's the turnaround time on something like this? Like, would it be realistic to have this done by January, or do you guys need more time to, like, plan it out and everything? 12:22 - Andrew Hartmann (UTAK Laboratories) We do shut down for kind of like the last week and a half of the year. Basically from, like, Christmas Eve to New Year's, we're gone. If we get on this quickly, say you get me the information back later today, I can probably have the quote to you tomorrow or the day after at the latest. And then our standard lead time would be around 15 business days, but we can try to rush it if necessary. Is there a hard deadline of when you need it by? 12:47 - Haro, Giovahna (Abbott) Well, we have to do the first, we have to do this first semi-annual verification for 2026 by the end of January. 12:58 - Andrew Hartmann (UTAK Laboratories) Oh, yeah, that would be an issue. If it's end of December, we'd be a little bit tight, but possible, but end of January, you know, we have no issue there. 13:06 - Haro, Giovahna (Abbott) Well, we actually have to have all the testing completed, so we would need it like probably like the first or second week of January. 13:21 - Andrew Hartmann (UTAK Laboratories) Yeah, if you can get me all that stuff, do you think it's reasonable in the next day or two to have that all to me? 13:26 - Haro, Giovahna (Abbott) Yeah, I can talk to Bren about it today and then fill in the list and get it sent over to you by tomorrow. 13:34 - Andrew Hartmann (UTAK Laboratories) Yeah, I think as long as we get, you know, keep it moving, don't let it get hung up on anything, you know, hitting those kind of timelines shouldn't be a problem for us. Okay, sounds good. 13:44 - Haro, Giovahna (Abbott) Well, thank you so much for bringing all this to my attention and, you know, setting up this call. Yeah, appreciate you hopping on. 13:53 - Andrew Hartmann (UTAK Laboratories) Always great to kind of learn and, you know, I see things that I'm just like, what are they trying to do? And sometimes it's, you know, rather than back and forth email, which is easier to chat about. 14:01 - Haro, Giovahna (Abbott) Yeah, thank you so much. I appreciate it. Also, I'll send that stuff out over to you tomorrow. Awesome. 14:07 - Andrew Hartmann (UTAK Laboratories) Well, you keep warm out there. Thank you. You too. Bye. Bye.