LigoLab and Northwest Laboratory Featured on the June 11 COVID-19 Stat Intelligence Briefing

Below is a recording of an episode of the COVID-19 Stat Intelligence Briefing that originally aired on June 11, 2020. The briefing featured LigoLab CEO Suren Avunjian, Northwest Laboratory COO Jennifer Bull, and Robert Michel, Founder and President of the Dark Intelligence Group. The recording is followed by a transcript of the discussion. 

Welcome everyone to call six and our COVID-19 live stat intelligent briefings calls. All attendees are in listen only mode. If you're having trouble with your computer audio, please dial in from your phone. Using the numbers found in the audio box on the control panel on the right side of your screen. Feel free to request additional technical assistance or ask the presenters for more information in the questions box on your control panel on the right. This event will be recorded and an on-demand link will be emailed out to everyone following the event once spinal edits are complete. our moderator for today's call is Robert Michelle, founder and president of the dark intelligence group home with a dark report. So Robert, take it away with some breaking news. 

Okay, thank you, Shelly. Good morning, everyone. Good afternoon, wherever you may be. And I want to point out that the anchor to our service is this website with our COVID-19 step intelligence briefings for you. And so there's information in many different forms. And our call today, I'll give you a quick hit on some breaking news relating to lamps and COVID-19. And then I'm going to pass it off to our two speakers. So, if you'll advance the slide, please. And the interesting news for everybody on this call. This is a letter that a 30 representatives from the house have sent to Alex a czar at the Department of Health and Human Services. The letters dated June 8. And the context for this is when Congress passed the second COVID-19 funding bill, it included 25 billion for what's always referenced in the statute as quote testing, unquote. And so the question is, where is that funds? Where are those funds going? Who's going to get them? Well, there's no language in the statute that says clinical labs should get any part of that 25 billion. So these 30 folks have written this letter, and I'm going to read you these two paragraphs. And this is the context for the bill that sets aside $25 billion for testing. 

While laboratories are eligible along with other providers for these funds. There have been no federal funds specifically designated for the clinical laboratories that have stepped up in this public health crisis, and have made significant investments to expand access to COVID-19 testing, despite having a 40 to 60% reduction in their regular commercial volume due to the economic lockdowns and then the second paragraph, as clinical laboratories work to maintain their investments in critical resources for testing platforms for reagents, slobs, and personal protection equipment, as well as hiring, training and overtime pay for the lab workforce. 

We urge HHS to direct a portion of funding that has not already been allocated towards these efforts. These funds will ensure that labs can continue to rapidly scale up diagnostic and antibody testing, particularly for health care workers, first responders and other Americans on the frontlines of this pandemic. And ultimately, for all citizens to be able to return to school work and the activities they enjoy. And you can find this letter on the website of the American clinical lab Association, there'll be a link to it, there's 30 different representatives, I would suggest you access the letter. And if one of your representatives have signed the letter, contact them and affirm that this is a positive thing and let them know that in their congressional district, your lab is working to do this, and it would be important for you to have these funds. 

So that's a little quick hit on breaking news. And let's go to our next slide, please. And I'd like to introduce today's COVID called topic, which is how Florida has turned to Northwest laboratory and the test directly direct to consumer web portal of legal lamps for statewide testing of all their long-term care residents and staff for COVID-19. And your two speakers today. 

Next slide please will be Suren Avunjian CEO of LigoLab and he's got a little bio there. And Jennifer Bull, who's the Chief Operating Officer at Northwest Pathology and Northwest Labs up in Bellingham. And so, one is providing the information technology platform and the others providing the diagnostic testing. So let's go to the next slide. And I'd like to welcome Suren and Jennifer to our COVID live call and I'll send it over to you two.

Thank you, dear colleagues for joining us today. And thank you, Robert, and the rest of the Dark Report Group for the opportunity to allow us to share the story.

LigoLab has been around for the last 14 years helping over 100 plus laboratories facilities nationwide to grow and thrive their operation.

Towards the end of last year, Jenny and I started talking about creating a platform for direct to consumers test ordering. And we had been cooking this up towards the quarantine. And as that was coming to fruition, we really decided to come together and put this platform, build it very quickly. So I put a few of our top developers on it. And right as this started happening, one of my main guys actually ended up getting hit with the COVID-19 virus. So, he ended up being down for almost a month and a half. So that prompted me to continue to throw more resources on this project as it was becoming more and more evidence that it was much needed. So, we were able to deploy this already in April of this year. And now we have it currently running for Florida, Illinois, Colorado, Washington, and some more states are coming. Today's story will focus on our Northwest Pathology and the Florida Department of Health.

This project started early May 19 when the Trump administration put together set a challenge for all of the states to test all long-term care, and nursing home staff and residents for COVID-19. The very next day, we were approached by the public health department of Florida.

And their objective was to be the first state to complete this challenge. Even though they have one of the highest senior populations in the country. Within a week we had the platform configured based on their workflow and ready to test half a million people, employees and residents across 4000 facilities and 67 counties.

Our team worked around the clock in different shifts for months, really to prepare for and everyone had a lot of passion. Because it can it was directly it could directly save lives. The nursing home population is one of the most high-risk populations that could be infected by and die from the Coronavirus. According to the CDC, COVID-19 is known to be particularly lethal to older adults with underlying health conditions, and can spread more easily through the congregate facilities, or many people live in confined environments. And workers move from room to room, while just 11% of the country's cases have occurred in long term care facilities that are related to COVID-19 and these facilities accounted for more than 75% of country's pandemic fatalities. Next slide.

The state relies on staff of 100 people who travel from facility to facility in groups of five to seven people in specialized RV and they collect 10,000 nasal pharyngeal swab samples every day and ship them diagonally across the country to Northwest pathology and laboratory.

In the first phase Florida health objective was to get a baseline test to identify asymptomatic patients while protecting one of the largest senior populations in the US. Then the collection responsibility shifts to individual facilities after the completion of this baseline test, Florida Department of Health has their own portal where they monitor the results and the prevalence in real time and is in touch with the county health departments to isolate those who test positive and initiate contact tracing. Next slide.

The Test Directly platform assists the state of Florida by enabling nursing staff to self-register online and facility administrators to order for all residents through the portal. This streamlines the process of collection eliminating additional paperwork, data entry errors and contact with Florida Department of Health facility administrators and staff are notified as soon as the results are available as the instrument transmits the results to the LMS. The reports are available in test directly within 10 minutes.

Plus the Test Directly platform can integrate bi-directionally with any LIS to maximize efficiency and testing capacity by connecting the patient government agencies, collection centers, laboratories and physician eliminating the risk of human error and delays providing a platform that manages the entire workflow from self-registration, to report delivery and follow ups.

The easy-to-use portal also provides business b2b testing, and to support organizational testing for employees, and deployment of testing protocols.

Okay, so let's check and see if Devin may have any questions from the audience. 

Yes, we have one question from the audience.

We know that you started this with COVID-19. Are there any plans to expand this to other testing?

Yeah, absolutely. The platform is designed from the ground up to support any kind of laboratory testing for all of the in within all the states where direct to consumer testing is allowed. And in addition, it is designed to also support b2b testing as well. So, it has multiple portals, depending on the use cases. 

So Suren, on the b2b part, are you referring to employer testing where the employer wants to do COVID testing on the employer?

That's correct. And so yes, for those that are the listening audience that are interested in the employer testing program.

There are different requirements to minimize your risk and liability as a lab when you're working with an employer to test employees. So, we did an earlier comment call on that topic. But it's useful to know that there's a platform here that can turn-key that for any labs that would like to get into the employer COVID testing. So back to you, sir.

Thank you. Yeah. And just to add to that, the HR department can upload their list of employees and the system can reach out to them to schedule the testing and get any kind of releases, as well as it can ask them on a daily basis have to have any of the symptoms and as well as get their temperature checks. 

But back to our Florida, some of the key benefits that they have experienced has been that they've tested over 100,000 people in under two weeks after going live. As of today, we're about 130,000 orders through the platform. The test results are available electronically within two to three days after the collection.

And they have the ability to mine and visualize their data based on age, sex, race, ethnicity, geographic location, facilities, and prevalence between staff and residents. Next slide please.

We are especially proud of our partnership with Northwest pathology and laboratories and the state of Florida as our solution addresses the most vulnerable population and one third of all US Coronavirus deaths are nursing home and residents of residence or workers.

Testing and protection protecting this population is a crucial component of getting control over this pandemic. In fact, scaling up testing is part of the reason we're social distancing. Now, the idea is that shutting down large part of us is effectively a pause button, one that buys the country time while flattening the curve to build up testing capacity. Therefore, lab workers are the unseen warriors fighting Coronavirus. Thank you, Jenny for the countless of hours, you and your staff have been putting in the last few months. It's a privilege and an honor to be part of the journey with you.

Please, - yeah, yeah, thank you. Same thing goes to your team. They've definitely been working around the clock with us. So, I appreciate that. Thank you, Robert, for having us on today and hearing our story.

While we'd already started working with Florida, testing their individual county populations, the scope of testing changes to a certain note, as noted in May 19, with the White House initiative.

And it became really clear that some collaborative and creative work with legal was going to be necessary to meet those needs. Testing that number of patients and especially with Florida's motivation to be the first to the finish line with that, um, as you can imagine, it was a little overwhelming. The first day the two FedEx trucks delivered 329 boxes of COVID specimens from Florida and it became very quickly apparent that even with workflow efficiencies and staffing adjustments, if we were going to be successful meeting Florida's testing needs, we were going to need to think outside the box despite Ligo’s speedy response to get Florida set up with Tests Directly. They were pretty motivated to start testing early on, which meant starting on paper. And you know, on average, especially in one case takes manually takes about 60 to 90 seconds. And was even more than 20 people on each shift assigned to a succession - a moving assessment. And that was a lot slower process than what we needed.

Ligo worked with us to build out some batch scanning capabilities allowing us to print batches of barcodes linking facility and collection date to individual specimen record revision and PCR plates. And this facilitated really quick movement from a session into PCR and converted the session work to really data entry that could be completed off site. And via the scan requisition that's attached to the case. That was what allowed us essentially to barcode our specimens and get them straight to PCR. I think we can go to the next slide.

It was a pretty awesome day for the staff and for all of us the first day we received specimens with paperwork with barcode on them. And it's great, the workflow itself directly couldn't be easier. The bundling that comes into the lab is unpackaged. It is a verified specimen and that and the rec go together. They go to a specialty station, the barcode is scanned, which generates the label that goes on the specimen and it goes straight to PCR. When PCR is complete, and results have been verified and released, it goes directly out to the patient into the facility, like Darren said about 10 minutes to cross over that interface. We never touched the cases. Out of most of those that have come through, we haven't even opened them up other than to do to see so it seems a little lackluster to talk about it because it's such a simple workflow. But it's been instrumental in getting that volume through our lab. So we're very excited about those pieces.

Um, let me let me interrupt here for a minute. We got questions coming in. 

Can you do an overview of the process and who puts in the requisitions in the beginning? 

And then, how do you label and track the samples? And then, you know, how is the specimen labeled and bagged with a requisition - just kind of go through that workflow? If you can, again, Jennifer, that would be great. 

Yeah, so what the tests are actually. So, there's two methods of workflow and I'll go quickly over them:

One is a paper requisition that is standardized, that Florida has asked us to manually print and write on. And the other is the Test Directly - that when they complete their registration in the system, it generates it so save and print, and it prints a requisition that they can take to the test site or they can also store it on their phone. And that has a barcode on it. 

So when it arrives in the lab, we open a box and it's from each facility has its own syntax that shows up and in that is the specimen in the requisition individually packaged like any other lab specimen you would receive. The difference in those is that the requisition filled out via the computer and the barcode is on there. There's a reference ID I think it's a five-digit code that that correlates that patient samples to the remote order that was saved in Ligo when they completed their registration.

All right, um, and then just one additional question is what is the method you're using per year PCR?

The PCR, we're using a Thermo Fisher Taphouse PCR. So, we're using King Fisher extraction and the 7500 DX for the piece of thermal cycling. So, let me jump in really quick. When you started working with the Florida Department of Health, one of yours was Fisher. Is Thermo Fisher, one of your existing vendors? And if not, what happened when you went back to your existing vendors and said, “Can we get some of these kits for COVID-19?”  How did you end up with Thermo Fisher just because I know everybody's got supply chain issues. And that's the point of this question. What was your existing chain and how did you get an expanded supply chain?

Well, we did work with Fisher when we opened our clinical lab a couple years ago. They were one of our vendors we worked pretty closely with them. They were the only ones that were really responsive to my needs.

Then messaging, emailing and calling. So, I think we're very fortunate that we were able to partner with both of them with Ligo early on.  I think it's what determines success. Truly,

Fisher was a push. We worked really hard, collaboratively for about two weeks to really secure all of the reagents and instrumentation we needed. And then we built on that. So, once we felt comfortable enough, we could get some sort of a start that we could build off of, you know, initially, we were just hoping to do 1000 tests a day. So, we've definitely built off of that, as, as we've grown that relationship.

First, very helpful. So continue on.

So, I think that the biggest piece that I think it's important to note and to kind of sum up is to give credit back to Ligo, from a lab perspective. Aside from the workflow in the lab, and the efficiencies that the partnering has brought, we continue daily to work with the Ligo team to just identify individual pieces of the process that can be streamlined and quicker, more efficient, more quality driven. The nice thing for us as a lab and working with somebody like the state of Florida, is there's full transparency in what Florida sees. And what we see they actually have a desktop installation of RL is specific to their patient population. So, the minute an order is received and resulted, they can see it even before the report goes out. They can see if we're pending, or if we're repeating….

They see everything we see. So, we have full collaboration and transparency with Florida, which I think is really notable. I don't know that there's a lot of LIS partners out there that give that to their customers. There's an easy follow-up with patients and facilities. So, Florida has been really thankful and we've actually implemented and are beginning to implement Tests Directly with some of our other clients and some health departments here in Washington State. And even some universities, it's a huge burden relieved when patients and administrators can log in and get their own results.

Most of these health departments we're finding are not staffed as well as Florida is and just following up with patients. You know, we might know their negative, but they don't know until somebody calls and tells them to get in touch directly with the health department.

Add to a little bit. Okay, I was going to add a little bit while the next slide loads. Just a little bit follow up on the question. 

So when the Test Directly requisitions come in on that scan, it automatically generates bar-coded labels for the specimens, and a specimen is ready to go right away to the instrument. So, it removes the entire order-entry bottleneck. So that was important to note. And as soon as the results generator is generated from the instrument, then it automatically creates the record, and it's sent back. So, nobody has to do anything at that point.

Any questions coming in?

I think one of the questions maybe for Suren is

Who's paying for this test? And if you can,  the cost per test  - if that's something you can talk about?

I'll defer that to Jennifer.

We actually have an agreement with LigoLab on that, so that that fee is not transferred on to the customer.

Great, thanks.

Why don't we go next slide. We've got a few minutes left and it's lessons learned. And I think you have some interesting comments on that.

Yeah, it's a really actually good question that quite frankly, until yesterday when you asked me that,  we  haven't really had time to stop and pause and think about  - it's been a constant Go go go and you know, every day we're seeing efficiencies,  and so that reflective time is good. 

I think one of the things that we learned and we did well was getting in with vendors early. I think identifying partnerships with Fischer and having strong relationships and securing our supply chain was huge. And then selecting the right partners for technology. I will stand behind that I know any other LIS I've worked with, we would not have been able to accomplish this. I called Suren’s team, pretty much 24/7 and they pick up their phone and talk to me – I think I've gotten a few out of bed. So, knowing and being able to rely on that is huge when you have a commitment as large as the one we have with Florida with that. That I think is a really important. And planning two steps ahead and being able to take the financial risk associated with.

That's just one thing, you know, when we were trying to figure out how we were going to do this, we spent a lot of time

Thinking ahead. What's gonna go wrong? Where are we going to run out or be short? You know, we're gonna run into shortages, with supplies with equipment, we purchased a lot of things that we ended up not needing just, you know, worried that we were better to have them not then not have them. And then really just breaking down our entire process. And I say that from a testing, running parallel processes, so that we can be efficient, moving specimens to the lab when they're here and getting accurate results out. But also in technology, I mean, we've considerably broken down every single process through receiving assessment, printing barcodes, verifying the results, getting them out to the client… You know, every single process has been broken down and made efficient. And I think that's been a huge piece of the success. One of our biggest lessons learned is you cannot possibly staff for this appropriately in the timeframe that we've had to bring it up. So, we're learning, you know, daily, the ins and outs of bringing on staff. We brought on over 150 new employees in the last six weeks to just touch. I mean, you got to get these out of boxes. We've got 10,000 or more pieces of paper coming in with these specimens. We've got recycling and disposal names we never anticipated. So, the staffing and all that comes with that has definitely been eye opening for us. So, whenever I have a question, that's a very good list of lessons learned. 

You've talked repeatedly about process, did your lab work with Lean and Six Sigma kinds of methodologies?

I would have told you Yes. But I'm finding that, you know, when you throw volume at things, you definitely realize your deficiencies. So, I think that's one area we will focus on.

Yep. And another question: Is auto verification part of your process for the COVID-19 tests? 

Absolutely. Yeah. 

That was something we had to bring on pretty early with Lego. They've worked with that on our clinical website, and then COVID there, you just can't run the volume through without auto verifying.

Yes, and Deb, any questions from the audience? 

Yeah, some final questions. 

Are you running 24/7, and how many instruments do you use to meet this capacity that you plan for?

Great question! 

We are running 24 seven. We are running three Kingfisher extraction instruments, we run 570 500. And we've also implemented some automation in our hoods. As far as automated pipettors. We're working towards bringing in some cappers and uncap, ORS and standardizing our supplies that we're sending out so that we can be more efficient in the actual processing of assessments.

Great. Thanks, Jennifer.

Okay, well, I want to thank our two presenters; Suren  - And they're in sunny Southern California where it never rains. And it's always t-shirt weather. And to Jennifer up there in Bellingham, Washington, where the clouds are finally starting to disperse I suspect.  And I want to also thank Deborah Hewitt Smith. And of course, Shelly hatch here with the Dark Report. 

Our call for Tuesday is going to be about auto verification. And its use of auto verification to standard eyes COVID-19 test result review criteria, eliminate input errors, shorten turnaround time and produce analytics to support patient outcomes. And we have Angela Martin of Norton Health Care and Joshua Hayden of Northern Health, Norton Healthcare, to do that presentation. And so we encourage you to call in and dial in and listen to that one. And we have a call happening in 30 minutes with Dr. Westguard and Stan, Westguard. And then we're going to be talking about your serology test programs. And once you've decided which serology tests you want to purchase, validate and bring into production. How do you have confidence that the results that your serology tests are producing are with a high degree of confidence, accurate and reproducible. So, with that, I want to thank everybody and thank Jennifer and Suren once more. Everybody travel safe, and we'll close the call right now. 

And thank you very much on this Thursday. Goodbye.