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LigoLab’s Fireside Chat on Covid-19

March 25, 2021



Below is a recording of of LigoLab’s Fireside Chat which originally aired as a webinar on May 12, 2020. The recording is followed by a transcript of the discussion that featured LigoLab CEO Suren Avunjian, Dr. Aaron Rossi (Reditus Laboratories), Thanasis Papaioanu (American Pathology Partners), Dr. Ryan Fortna (Northwest Pathology, and Jenny Bull (Northwest Pathology). 

SUMMARY KEYWORDS

tests, codes, testing, laboratories, lab, pipetting, capacity, reagent, assay, essay, specimen collection, patients, run, thermo fisher, samples, bit, pcr, supplies, reporting, process

Good morning, everyone.
Thank you for joining us today.

For such an important and timely topic. We have a large group of attendees and I really would like to ask everyone to remain on mute. until we reach the Q&A section. However, I urge you to send your questions in the chat window within zoom throughout the presentation, and we'll make sure to answer them all. So today, we have our esteemed clients, representing three different laboratories who have been running COVID-19 testing since March, and kind enough to share their experience and expertise with us. Dr. Rossi is with Reditus Laboratories based in Illinois, to Thanasis Papaioanu  with American pathology partners, running laboratories in Colorado, Florida, North Carolina and Texas. We also have with us Dr. Fortna and Jenny Bull, representing Northwest Pathology in Washington.

And I am honored to be your host today for the last 14 years legal apps team has been helping over 100 lab facilities nationwide to grow and thrive. I'd like to start today's discussion from really high level 30,000 feet and then dive into what we can do as a community to address our part for the pandemic.

So, we believe every conversation about reopening the country should be about testing. It's been said 1000 times throughout this crisis, but it bears repeating testing is a crucial component to getting control over the pandemic. Currently, we're barely meeting half the minimum capacity needed to safely reopen.

In fact, scaling up testing is part of the reason why we're all social distancing. Now, the idea is that shutting down large parts of the US is effectively a pause button, one that buys the country time while flattening the curve to build up health care and testing capacity. Therefore, lab workers are the unseen warriors fighting the Coronavirus and our debt to and gratitude can never be repaid.

So, this is a chart from mid-April, showing where we were as a country regarding COVID testing compared to other countries. As of yesterday, we've been doing fairly well catching up in the number of tests that we're running. However, experts say that about 3 million plus people should be tested a week in the US and continuous screening will be needed for the foreseeable future.

And our country's testing availability for our population is well below where it needs to be for us to better understand the virus and stop continuing the spread by quickly isolating those who turn out positive.

While the demand for Coronavirus testing has soared volume for non-COVID-19 testing has plummeted. As patients are putting off elective procedures and routine doctor visits. We've seen pathology group routine volumes go down but if 40 to 60%.

And this brings us to today's virtual fireside chat that we're hosting on exchanging ideas and winning strategies during the pandemic. Typically, labs have the luxury to develop their own tests have plenty of reagents, plenty of samples that they can test to ensure the quality and the accuracy of the assay. Or they choose to go with a commercial vendor with plenty of data to speak to its performance. commercial vendors usually go through the 510k process for FDA approval or clearance of the assay. With COVID-19 testing, we do not have the breadth of data available for each of the assays at this point. There has not been a parallel study, if you will, comparing assay to assay really understanding things like sensitivity, specificity, we know limits of detection, and so forth from the QA process. And there are standards for figuring out that are for each assay whether it's an in-house lab develop test or commercial assay.

Today we'll cover how wrapping up COVID-19 testing can help the community and the country help offset the loss of normal lab revenue and gain new customers. Increased testing capacity with streamlined and scalable workflow that you can continue on for your molecular department. How pathology labs are bringing up the molecular tests selection of the right platform and automation, sourcing and making your own supplies equipment and setting up instruments and

Pulling methodology. We'll also talk about the legal lab network for load balancing and routing, routing of cases. And also, we will unveil, test directly a direct-to-consumer portal that will help streamline the entire process.

So with that, I'd like to ask Jenny ball and Dr. Rossi to join us in talking about safety and supplies. So Jenny, if you could please talk a little bit about how your lab a little bit about, you know, the supplies and how you guys have been able to build your own supplies. Within Northwest pathology, I think that'd be really helpful for everyone.

Yeah, and I think we experienced a lot of the same issues that all labs are and that there's just a shortage and lack of availability of supplies. And if they are, you can't get any quantity, and you definitely can't get them in a complete kit. So we addressed this pretty early on by essentially setting up a manufacturing or production line within our laboratory. So, we are making our own kits with sterile, conical tubes, sterile saline.

We've sourced swabs from a variety of different sources. And at any given point, I think we had standing orders out for close to 800,000 swabs for about five different vendors, just in hopes that the allocation would keep, you know, consistent in what we were getting weekly or bi weekly. So we've been working, we've probably sent out about 20,000 kits that have been made in house and we continue to keep about eight to 10,000 on hand at any given point. Great and then maybe if we can discuss the need for the BSL two hoods. I know there's a shortage of those. That seems to be one of the also key areas that are that's important for the safety. Yeah, I don't know that we've actually experienced a shortage in BSL hoods. There's definitely a timeframe and there's a delay, you can't obviously overnight them but we've been order, we've been able to order BSL, two hoods from our vendors, they take a couple of weeks to get here, we purchased a couple used ones, eBay, Allison has been our friend for used equipment, and a few other surplus vendors that we have relationships and have reputable product lines. So aside from just the time and the finances involved in getting BSL two hoods, and we've actually been able to procure those pretty availably. Yeah, and they do need to be checked. So, you can't in one of the things we do, all we need to do is we've been bringing in our biosafety technicians to do checks on them too. So that that tends to add a few days to up to a week to coordinate.

Great.
Thank you, Jenny.

And then the next slide, if we can go over the workflow overall, every laboratory, depending on the platform you select, the workflow can be quite different than certain steps. But maybe, Jenny, if you could describe the platform that you have selected, that are that are working at Northwest and how you guys are going through the workflow, I think that would be helpful to the attendees too.

Yeah, absolutely. I'll start and then I'll probably pass it to Dr. Horton, on to talk a little bit about the asset itself. But

I would say one of the things I talked to you about certain staffing is definitely consideration. So as sessioning, we've upped we have 16, dedicated sessioning stations, functioning 24 seven, and obviously remote orders coming through legal lab have made that process our staff on a remote order can a session about three a minute. And so you can kind of do the math and see what your capacity is to maintain the sessioning portion data entry of insurance and other information obviously takes a little longer, but we've been working to find efficiencies in that regards as well. So we're looking at about 75 people do effectively staff, enough especially to accommodate 20,000 specimens and a 20.

So about 75 people on a 24 hour period, we're about 25 per shift for per eight hour shift.And with that we can do roughly give or take 20,000 sessions.

So that's a big consideration. I think for most labs, and it's one we've had to kind of find some innovative solutions to racking we've got a pretty good flow chart on that we've revised over time we we essentially have four four buckets that our vials go into ultimately when they come into the lab based on priority if there's problems meaning the swabs jammed in and you know it needs to be removed

prior to processing efficiently, it leaks during transport and there's inadequate volume of media and to those kinds of things versus tubes that come in, they're ready to go. They can be done with automation, and they can actually be pulled with other specimens. So we've got a kind of a triage unit at a sessioning. That's kind of got really four clearly defined buckets of specimens go into prior to going into the pipetting and extraction process. I'm going to hand it to Dr. Fortner to talk a little bit about what the pipetting and extraction looks like. So yes, so I think certain you asked about which assay we're doing. So, we are doing primarily the Thermo Fisher tech path essay. And we also have validated the quite Dell, Lyra St.

Both of them are ones that are fairly manual processes. So I think the experience of a lab bringing this test on will be very different depending on which essay you use. So, if a lab brings on, for example, the [inaudible], we actually also have the [inaudible] test too, but that's a much more automated one that's lower, I mean, you can get to relatively high volume in a day, I think the max for us would be like 700 in a day. But we're using that one primarily for stack cases. So if you were to mostly bring on something like sephia, or Panther that are mostly automated, your experience is going to be very different than if you're bringing on one of these other ones that there are primary assets.

So, these other ones that I mentioned in tech path and Lyra, they take a lot more manual work, pipetting work etc. But they also have the capability of potentially being ramped up to much higher volumes than the more automated instruments.

So, what we have done is really break down each step of the process and train different people to do them, so that everything can be done simultaneously. So, you know, the two main processes for those acids are extraction, and then PCR.

But within that you need to, you need to get lots and lots of plates ready. So we have people who are trained to label plates for the extraction, you need to fill the extraction with reagents. So we have people trained to do that simultaneously. The pipetting under the hood is obviously a big part of the whole process. So I think the main workarounds for making that faster, are whatever the workarounds but just you know processes for making that faster are a just scaling up your BSL to goods and your staffing that are trained for pipetting. 

Then the other thing we've done that we're just starting to implement now is there are robotic pipetting instruments that can help with that, you do have to be a little careful because some samples can be problematic, for example, if they're really mucoid. So, what we've found is that if you're using robotic pipe betters, you kind of have to watch them as they're going to keep track of any samples that don't get picked up properly. But our experience so far is that that does speed up the process overall.

And then the PCR plate loading is another process we have different people trained for. And then finally reporting. So, for our essays, depending on the sex of the tech path sa comes with an interpretive software. So,our process at that point is a person needs to be trained to move it from that software to legal lab, to a place that legal and grab it. And then the other essay, the Lyra takes a little bit more manual work, we have to copy and paste from the instrument that we're using. But in any case, different people are trained to do those. So. I'd say the main overall point is if you're using one of these types of essays, you really need to break it down into the different groups of people are doing everything at the same time. Because what we found is when we first trained the same people to do everything in series rather than in, it's just, you know, exponentially slower than, than if different groups of people are doing each of those processes. Thank you so much. One more thing, I wanted to note that there was a study in the Journal of Clinical microbiology.

From the Mayo Clinic comparing whether four kinds of virtual transport media worked equally on their laboratory developed tests. And the commercial vendors molecular tests and that should study showed that a facility runs on a specific viral transport media, there are options that can be deployed. So they had a very, they were they correlated fairly well for different transport media. So that was a study in Journal of Clinical microbiology. So, in case there are some shortages that can be switched around. So what are some immediate adjustments that can be made in the clinical lab to reduce the turnaround as you heard earlier, really, staffing is very critical. So increasing the ratio of non-technical to technical staff to increase the capacity, utilizing administrative staff maybe to for inventory and order supplies, pre-emptive ordering, monitor the volume changes in other testings, reallocate staff.

Research, availability and relocation of supplies within the within your health systems may be the most readily available to improve turnaround times. And, of course, evaluate the systems in place for your workflow to make sure your instruments are all integrated. You have front-end and back-end optimization for all of your processes.

I'd like to ask Dr. Fortna to discuss the polling methodologies that they are that have been approved in the Senate. So, this is state by state basis and needs to be considered and validated.

And this will of course, help increase the capacity and lower the region's costs.

So, just a little bit of background, what pooling is, is simply when you test multiple specimens at the same time in a single well. And this is actually done pretty commonly in some areas. For example, in blood banking, it's typical to pull multiple specimens together, for example, to do PCR for HIV or hepatitis, viruses. And then if any of So, for example, those are low prevalence viruses, so it works well, if it's unlikely to be positive, because then most of those cases, you don't have to reflex tests.

If you were talking about a high prevalence virus, it works less well. So, in those cases, like in the blood banking example, typically what's done is like 10, different samples of different donated blood pools are pulled together.

In this in this world of COVID, that would probably not be a smart move, because the prevalence is higher. So, what we've calculated is that if your prevalence is something like 8% or less, then in your particular population that you're testing, then pulling two or three specimens at the same time works well. If it's much higher than that, then probably only pulling two works well. And going up to numbers, like five to 10 really doesn't work well. Unless you're having to be testing a population that's really low prevalence.

So of course, what happens then is that if you find a positive, well, then you have to go back and retest each of those samples individually as neat samples, and figure out which one of those is positive.

So, you can see that there is extra work to do with it, because any pauses will need to be reflexed. But it does, overall, it does decrease reagent use. So, our motivation for doing it was sort of twofold. The main one primarily was because the reagents are in short supply, and we want to make sure that we don't run out of them. So far, our vendors have not had significant problems with that, at least for us. But it is a concern. And then of course the other one is it reduces costs.

So, our process, you mentioned the state-by-state element of this CERN. And that is true, at least in our context. So, our state has been overseeing our testing. So we're in Washington State. And Washington State Department of Health is one of a handful at least last time I checked, it was like five or six states that the FDA has granted the authority to oversee any testing within labs within their state. So, our approvals have all been through our state health department, not directly with the FDA. And so there are I can't remember which other states are have that status. But last time I checked, it was maybe five or six other ones. And so we worked closely with our state health department. And basically we did separate validations of a polling process for Thermo Fisher and are quite Dell essays. And found, I think we did 45 positive and 45, negative those for each of those essays, found a really good correlation. I think of those 90, only one that didn't show positivity after cooling. And then that was in the CODEL essay and then we change to a protocol where we're running it to 45 cycles instead of 40. We can increase sensitivity a little bit by taking it out to 45. So that's now our protocol with the quite LSA with the Thermo Fisher essay, it's a little bit different because that x is three genes that it's looking at. So the likelihood of picking up the really, really weak positives is higher. And so, we haven't seen any discordances at all with the Thermo Fisher essay. And so that process showed that the sensitivity is essentially the same.

And that that data to the state health department, they were very happy with it and, and that's what we're planning on doing now right now our volumes aren't high enough to really do it on a routine basis, but starting soon they will be so it's just nice to have it in our back pocket, so that we don't experience reagent shortages.

Hey, that's important. Are you guys having anyone [inaudible] your, your runs off of the quants studio or the Thermo Fisher asset? If you get a bother engine and the other two genes are not positive, and you're getting an end determinant? Are you rerouting those? Are you doing any QC for that? Or what are you guys doing for that? So, if we were doing in the context of pooling, then any indeterminate on the Thermo Fisher so for those who don't know, the Thermo Fisher essay has three different genes, it's looking at it in a way it's interpreted as two or three of the genes are detected. If one of the genes is detected, and then reflex it through our protocol is a neat sample, not cool. And if it's simplistic reflex it, just repeating it. And if it's once again, really one gene found, then we call it's been the second zero genes is fairly, we call it negative and then positive, we do have somebody QC and visually, we have to look extra first to make sure that they agree because actually sometimes interpreted software and looks at curves and misinterpret things. And so, we're pretty careful.

Then in the context of a customer, basically, whether a call is called positive or inclusive results in the same thing, we just go back and rerun each of those samples. 

I actually wanted to go back to the back to the safety and supplies really, because it's really all testing solutions should eliminate the risk of exposure for all involved, both patients and healthcare providers. So, you know, I want to go back and give Dr. Rossi the opportunity to talk a little bit about what he's doing it within his lab. So everyone knows that, you know, it's not just simply purchasing an instrument for COVID-19. And you're ready to go. There's a large number of shortage of reagents. And so maybe if you could talk a little bit about

Dr. Rossi, your approach to all these supply issues?

Yeah, so we also did the same thing that Northwest Assad described, and call on making it catching those mobs and putting their media together and everything else talks a lot more cost effective to do that. Well, I know that some individuals like Fisher Scientific are charging $3.50 for just a small tube is failing. So we're doing the same thing that they're doing, we have AI engines in here doing them in production line as well. We also started to manufacture our own PP equipment on a different side of our business. In fact, your face shields, and we're able to source quite a bit a large supply of the three-ply mass. I know that from our guidelines, face shield, and a three-ply mat, take the place and then 95 mass, I think when you started to bring this stuff up within your lavatory. It's something that's new, the number one thing is concerned to have your employees have, you know, worried that they're going to contract the virus by working around specimens that could potentially have positive, positive positivity to him from an actual patient. So, we, you know, looked into this as well, we had the same concerns. The herds, obviously, that were discussed were one thing, and definitely their rate limiting staff within within the operation. 

So having more of them is better than not having enough. I don't think it's a good idea to go around the DSL to hood. Even though I think there's somewhere in that somewhere that says that you can set up a similar workflow that gets routed having the hood I think the hood is often something that employees appreciate. And also, just to re-emphasize what Jenny said, for sure that they have an untested is a big deal, which also adds time to those as well. So just a real quick snippet on what we're doing. So, we have manufactured on pp. We have Face shields. everybody wears a disposable gown, were able to source quite a bit of those. And then gloves, obviously So, but getting your own workflow together, I can just tell you is going to be something that you guys work through internally, what we thought we would do right away, not exactly what we're doing now. So, everybody gets a lot more comfortable with it as days go on. And he needs to figure it out that way, basically.

And what assays are you using? Are you using thermo there, right?

Yeah, sure. So, we're doing the using the Thermo Fisher as a as well, we did an LD t test using the quants to do 12. k flags.

I know Northwest has allergies, their numbers are huge. We're not doing that amount of testing. And we're doing we're up to about 4200 tests a day. It's a lot of tests, I don't know how many people are in your lab. But on a smaller scale. That's what we're doing. We're very, very particular about how we're reviewing all of our runs, were to be seen, and we had somebody around the clock doing that our operation is 24 seven as well. The biggest, the biggest upfront headache is accessioning. So, utilizing a platform that has everything, so you can have the patients in the wherever you're getting your tests from do that for you with us directly, or, you know, legal pad system, we're able to put them on the lab Connect, if it's an office and into us, we do a lot of state-run drive throughs. So those are coming in on paper, and we're getting ready to eliminate that. But you can imagine it when you have 4000 samples coming in your door a day.

I mean, it's a lot, we're pulling the papers out, we're putting stuff into computer. And we're just doing some client bills. So we're not entering insurance information. But still, that's a huge rate limiting rate limiting step. I know Jamie mentioned it as well. So, figuring that that workflow out huge. But again, we're using the quantity of 12 k flex, by the way, at Thermo Fisher in there as an attack path essay. We have a Kingfisher as well, but we're running 384 samples in the time. And we have to complete setups right now. So, we're not doing any automation yet, we're looking into it heavily. But at this point in time, we haven't made a decision on what we want to utilize with the Hamilton or today we're looking at how much capacity you have on the PCR to max capacity.

What's your max capacity on the PCR”?

So, the rate limiting step is really the exact affordance I was talking about, you have the individuals doing the pipetting under the hood. So, it's the preparation step. And then the Kingfisher does the extraction and then it goes over to the PCR on the quantum studio to run our runs taken our run, it's just a matter of being able to utilize a Kingfisher, which is off to the side that does the extraction step. So, the tap step and adding the Kingfisher into it, before it gets on to the actual 12 k flux is is our rate limiting step. But the mass capacities are basically takes an hour and 10 minutes or an hour and five minutes to do an actual run on the PCR machine. And it's 378 samples because we have six controls in there. But that's, we can run that, you know, 20 times a day, if we had, we had all the preparation done, but for us, and that's why I was saying that your workflow, it'll be much different depending on what kind of app what kind of setup you're using the platform you're using. Because the key Fisher with the Thermo Fisher platform, there's some manual processes and a lot of pipetting. Then there's an extraction step that goes to the Kingfisher, which is extremely hard to get right now that everybody's racing to them and go to the Kingfisher and then you go to the PCR the PCR machine is it running 24 seven, you know, it's running once you get the sample there. So, it's about a four hour prep time, if you want in your lab and started, you know opened up a bag of samples up about four hours before you get your first spread out of your mind. And then you can condense it down to just about every two and a half hours after that. To get up on the king up on the quad studio.

Yeah.

Please, please talk to us a little bit about workflow and the platform's you're leveraging.

Yeah, we are we using our two tests that we developed in developing the one is that thermal tack that you're also mentioned that we took off label and we put on our automated PCR line. And that's full automation that from sample prep to extraction.

Um, and also, that's I'll do production right now. We are submitted for UAE last week, last Tuesday. And the other one we are in the process of developing right now.

Which is our own ldg. from scratch, that one is, should be, we should be submitting for you a two-weeks from now.

That gives us evermore automation and, and, and a lot more flexibility particularly on the supply side.

So that's kind of where we are with a PCR test. And we are up capacity wise right now today, what a 500 a day.

By the end of next week, we should be at 1000 a day, I will just add a second a second extraction robot

and then expect to be in June by you know, mean early June the June 2000 per day, and that we need to get one more extractions last sample prep robot. So that's kind of where we are without our validated this off of all the typical transport media and all the various collectors out there, including on the transfer media, we also have our own proprietary medium that's that does not does not require refrigeration.

Great, thank you. Next, I'd like to go with the invite Adam from our billing team, to talk about the latest updates on COVID-19.

Thank you, sir. I'd like to thank our esteemed guests for joining us today. I'll be quickly addressing a few of the topic relevant changes in coding and billing due to the global pandemic of COVID-19. Since we're not diving deep into the subject, it is recommended that your billing staff stay briefed regularly with sources such as cms.gov, for updates to patient billing policies that have been changing weekly.

Now, as of April 14, CMS released and made effective immediately to type codes for laboratories testing making use of what they're defining as high throughput technology. rates for reimbursement with these tests have increased to $100 due to the public health, emergency and sophistication of technology as well as the process involved. These codes are use 0003 and use 000 for when these tests are performed, instead of slower tests, you would not be using 87635 but instead should identify as one of these two codes.

As mentioned earlier, the AMA also came out with the new code for streamlining COVID-19 testing, which is eight 765. Effective March 13.

To us as the industry standard for reporting of COVID-19 tests across the nation's healthcare system.

There are also two other codes I would like to mention that have been effective as of April the 10th.

Code 86328 was established for using antibodies single step method and you know, I say typically including a strip with all critical components for the essay and is appropriate for point of care testing.

Now code 86769 was established for antibody testing using a multi-step method.

Continuing one of the dramatic changes released recently is the diagnostic testing and reporting for physicians and practitioners. E&M code 99211 can now be used to report assessment and specimen collection for COVID-19.

Due to the public health emergency Medicare will recognize this code to be billed for all patients not just established patients. Also, importantly, Medicare will not require any order for testing physician or non-physician practitioner as a condition for Medicare coverage for COVID-19 testing during this public health emergency.

IDs requirements were also removed for other laboratory diagnostic tests necessary to establish or rule out a COVID-19 diagnosis.

However, FDA prescription and state requirements for ordering diagnostic tests will still apply.

CMS will also expect labs to furnish results for COVID-19 tests to beneficiaries in addition to regular and prompt reporting of all test results to local officials consistent to the state and local health requirements within 24 hours.

Now, laboratories can use two new hicks-picks level two codes to identify and receive reimbursement for specimen collection of COVID-19 testing.

codes can only be billed by clinical diagnostic laboratories or on or after the effective lin- item date of service Of March 1 2020.

These codes are a G 2023 and G 2024. With both codes applying to collection of any specimen source that should be used no matter how the specimen is collected, the key difference in the two codes is that g 2024 is collected in a field nursing facility or excuse me, or on behalf of a home health agency.  Now, CMS did clarify for tests that allow patients to collect the specimen would not be eligible for the specimen collection fee.

Lastly, let's move on to the new ICD 10 code for diagnosis COVID. diagnosing COVID-19 uS 07 point one.

This code was released on April the first by the World Health Organization it's this code is an unprecedented upcycle release set up as an exception to the obvious urgency simply could not wait until October when new ICD 10 codes are usually released.

With these sweeping changes, COVID-19 is now one of the easiest lab procedures to build for. Because CMS and all the government agencies revoked many of the regulations at least temporarily, to ease this process. It's understandable that people have questions because this is something new. But in reality, there is really nothing unique about the billing process for COVID-19.

With the advantage of an integrated billing system, and automated CPT coding, legal lab can make this process even simpler for our partners and just business as usual. Yeah, I have a couple questions on here. What's the difference between the oh three and the Oh, four up and up on top? For the that's actually on the diagnostic test? right?

Correct. If you'd like I can send you the full write ups for both of those codes.

Okay, would that be acceptable? Yeah, please do. And then the second question I have is done and you know, if that request follow-up, please do but if you um, you know, for some we operate a drive thru centers with in partnership with some physicians in those that data collection. So, in those scenarios, actually do assessments last election in those scenarios still do not need they do not necessarily mean and a provider order correct.

I would have to look into that a little bit further. But I will take that into account as well for your questions. And I'll just give you the follow up for both of those. Okay, so but but in those scenarios that are appropriate court since the physician personnel is conducting the specimen collection, that should be the 99211 code for the collection, correct?

Yes, yes. Correct. However, if we were to do it in our own facility, under our control that to be the there's two codes at the bottom, the G 2023. And two to three right, I suppose not the two fours for level two codes. Yeah, yeah. Okay. Great. Thank you, Adam.

Yeah, so the question is a CPT code you were asking, what's the difference between use 003 and use 00403? They're mostly using for amplified protecting and use for for multiple types of different types of technique, anything. Okay. Okay. Thank you. Thank you.

So, really looking at a little bit of cost, the on average, running these volumes, we're seeing average reagent costs $20. Labor coming to about $3, supplies at two and miscellaneous fees at five.Dr. Rossi I think you have done some more studies here and do you have other feedback on this particular slide?

Yeah, I think just looking, and everybody wants to know their return on investment if they go out and buy equipment or put a bunch of money into this hire staff. And just looking at the big picture, the reagent costs from what I've seen, and then

In the little tweaks that they are continually continuously making continues to go down, I mean, for our primary, we're at about 16 to $15 per agent per, per run per specimen, then you add some, you know, labor into it a little bit of cost for, you know, other things you're using pipette tips. I mean, there's, there's also a lot of extra little costs. And, you know, as everybody knows, her business size is continued to flow in but you know, your return on investment is significant. And if you just look at it like that, and $50 reimbursement rate with what Medicare was paying way back when, you know, what we, what we calculated and gone back and forth multiple times to see is, is what that heavily loaded, you're looking at a 40% margin per test, you know, at $50. 

So, just to quickly touch on that, that, and what we've seen in, you know, the reimbursements and the revenue generated on it, it's been extremely beneficial, we're happy we did for sure. So, I know that there can be a little bit of hesitancy with looking at smaller margins, or you know, when you're seeing your billing one test, but it is a volume game, as well. And it's just key to get your agent costs down. And make sure you have some backup plans, on reagent if it's needed. So I think, you know, down the line, there could be some rage and shortages. But you know, nothing as of yet. And we've had no issue with reagents or anything from our end, more or less, it's just, you know, we've had some issues with the pipette tips and some plastic stuff. So we just pay attention to that. But big picture, I think it's extremely beneficial. And, you know, I think it's especially in the last phase right now with things the way they are, you can't just sit around and hold the volume picks up, I think things will get back to normal at some point. But it's not gonna be back to normal for a little while. I don't think this thing is going anywhere, anytime soon. So my recommendation is, it was a great investment on our end. So that's all I gotta say about it. Great, thank you.

So, we, as volume started picking up, we were, we saw that Dr. Rossi was able to bring on business from Walmart and state of Illinois, and very quickly reached his capacity. And we were in the northwest pathology was bringing up their capacity at a fairly high rate, we were able to build the first step of something we call Lego net. Really, this is a we built this testing capacity routing network. And the throughout the current healthcare crisis. Legal net addresses three critical areas of needed of needs. So identified by laboratories and government agencies, and as soon as soon by businesses as well. So similar to like Walmart, there will be other larger organizations that are looking to looking for this type of capacity, and the availability of a network to be able to process cases faster, be able to route to laboratories, so we can get good turnaround times and be able to match the demand. So we're really proud that as of today, our footprint is about 35,000 tests per day capacity. And we're planning to grow it to 250,000 daily tests in the next 60 days to combat the spread of the Coronavirus.

So another tool that innovation we've built very quickly in this short period of time is a platform. It's a direct-to-consumer platform, cutting edge to facilitate fast, easy and safe COVID-19 collection, testing and reporting. it maximizes efficiency and capacity by connecting patients, government agencies, collection centers, laboratories, and physicians eliminating the risk of human errors and delays. So, it's a completely touchless and automated system for handling everything from collection to reporting.

So, I'll would like to give you guys a quick overview of the system. Alright, so the platform starts off with the entry of a zip code, the local collection sites. So, this is a perspective, from a user there's a perspective from a laboratory from the collection center.

And also businesses will have their own portals where they can upload their employees and they will automatically route them to the site and take them through this process. Everything is completely integrated all the way from the platform talking to it's really Of course it connects with the LIS.

So, it's agnostic, and upon selection of a particular site, the system then displays the test menu to be ordered. And you can collect symptoms, whether they are checkboxes, or big yes or no boxes. These are controlled by the laboratory, every component is actually fully dynamic. And this is web based. And also, you can have your own FAQ built into it. Order the test upon ordering, if the patient is logging in for the first time, they create an account, verify it. Upon verification, the login, we asked for more information. And this can be also supplemented with further information like race, ethnicity, Social Security, depending on the state you're in and the requirements they have.

We can also capture either client pay here, if it's business, it will automatically set it up, they don't have to do anything. We can capture credit card and or insurance and do the charge directly off the site, if it's a credit card, display all kinds of release forms and terms and conditions. So, all of these are completely automated. And also there is a scheduler and it's you get to control the capacity within the collection centers or the collection centers can control that. So as soon as the patient selects a particular date and time, they are provided with a QR code that will be used to go to the drive thru station. And they can get checked in to make sure they're there on time. And also, the QR code can change colors. For example, these circles can turn red, if they're symptomatic, if they've marked that they're symptomatic, just to create some extra caution. And you can have unique instructions. Also, if they've provided their mobile number, the system will text this QR code to them, it will remind them of their appointment. And they will let them know when the report is ready.

So for that, let me go to the Reports section.And you're able to come in as a user, see if you have any scheduled visits and click to see particular report. Here's an example of legal app generated COVID-19 report.

So this is a little bit about test directly. We're really passionate about building software, as some of you that have been working with us know, you know, we're a group of dedicated software engineers, architects, product managers, Li s, and RCM implementation and support specialists who have really rallied together to bring this kind of innovation to market in record time. And really to arm our partner laboratories, providers, government agencies with the tools they need to serve the patients and those affected by the pandemic. So with that, I'd like to turn to everyone to see if we have any questions for our panel, and we'll be happy to answer them. Or for me, and you probably have to unmute yourself.

I had some questions on the pooling because I missed most of it as it joined late, but I don't want to belabor this at this call. So, if I would love to be able to follow up with

Dr. Rossi or Northwest pathology separately. That's okay.

Yes, I'll be happy to connect you.

Sure.

I had a question about the billing codes.

I know if you could go back to that slide or not. But it seems to me like there are what I'm hearing is that there are three different codes related to collection.

To be honest, I don't understand what E&M is. But I'm the one with numbers and the one that g codes. So what I know that we looked into  the G codes, and we thought that they were supposed to be used only if lab personnel were going to off-site places like to a nursing home etc. And so we haven't been using those at all. So, I'm curious of your opinion on that. And then the nine to one there. Is that is that something that labs are using and what type of personnel needs to do the collection if you're using it. So, from what my understanding the specimen collection codes are for labs.

They're using the G codes at the bottom of the screen the night for a situation where like we host a drive thru so we run them out 80 to 100 people a day through our drive thru.

Question 

Could you use one of those g codes for that situation? Because our understanding is that those are only applicable if we went to like a long-term care facility or we went to the patient that could not otherwise come to us?

Answer

We can have our billing team, maybe look into that and get you guys the answer. Okay, thanks. And then on the 99211, what can you explain what scenario you think that should be used in? I see that we have Farzad or Edward can chime in here is a map of providers, though. That's providers. Yeah, that's what I understand. That's a physician collected? Yes. Collect position collects a specimen. Okay, thank you.

Question

Let me what do we need to do is read as clarify on this. specimen collection codes for laboratories. What's the 23 versus 24?

Answer

Okay, that's excellent point. Yeah, all these are super new. So, we're still studying and looking at best practice. This is a specimen collection for active Respiratory Syndrome in specimen sub. 84, this is the again, but for me individual in a skilled facility. So, 9999 to 1199211 is a is is an E&M code. And it's the level one code and that's for the practitioner in the office, I'm assuming that is going to do the swabbing. So, the 99 to 119921299213 and 214, or like establish office patient visit. So those are the ones that you know, that's what I believe that code is sitting there for.

Question

That'd be a physician performing service within their office. Right.?

Answer

As a physician, yeah, I don't think the physician is actually doing the swabbing on that either because that's the level one code so that the patient comes in physician office and the nurse or somebody swabs them, if you're a physician, and you're you know, and they're coming to your office, and you're performing an office visit and swabbing them, you'd be better off to Bill your level three or level four office visit code, you know, and bill that To try and build a level one swab code for 20 bucks or 10 bucks. So that's what that code is sitting there for. Right now. I will say that, thanks for the clarification. It's, it's good. We one of our drive throughs. We operate them in partnership with actually a physician group. And it's really on their, their parking lot outside their office. So really, there are nurse practitioners from their office actually doing the collection. So, it's not our personnel doing anything.




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