Transcript: Clinical Lab 2.0: Lab Leadership's Link to Patient Outcomes

Transcript

Triona Henderson: All right, so good afternoon. My name is Triona Henderson, and I am a clinical pathologist and the facilitator of this ECHO Model™ pilot project. And we extend a warm welcome to you from the Division of Laboratory Systems at the Centers for Disease Control and Prevention in Atlanta, Georgia. Thank you for joining.

The topic for today is Clinical Lab 2.0, Lab Leadership's Link to Patient Outcomes. Our subject matter expert today is James Crawford, the senior vice president for Laboratory Services, and chair of the Department of Pathology and Laboratory Medicine Donald and Barbara Zucker School of Medicine at Hofstra/Northwell Health in Lake Success, New York.

Before introductions and presentations, I want to briefly mention some technical details related to our ECHO sessions. Please use the video capabilities of whatever device you're using for this session. All audience microphones are now muted. During the discussion section, please unmute yourself to speak. If you are experiencing technical difficulties during the session, please send a private chat message to Johanzynn Gatewood, labeled as DLS ECHO tech. She will do her best to respond to your issue, and she's waving to you now.

If you are connecting by phone only, at the time of discussion, please announce yourself by name and state when beginning to speak. Finally, part of designing relevant sessions is looking at your evaluation responses. We would like to encourage everyone to complete the post-session evaluation. P.A.C.E.® credits are being offered for this session, either certificate of participation or a P.A.C.E.® certificate will be issued upon completion, depending on your selection. If you have any additional comments, please send a private chat message directly to Johanzynn or email directly to dlsecho@cdc.gov.

How are these ECHO sessions different? These sessions are different from expert lecture teleconferences or webinars in that discussion of cases or clinical laboratory challenges, or in this session today, prime time updates of what's going on in Jim's lab, is the main feature. Subject matter experts hope to share some solutions that will be translatable to all of you in your individual laboratories. These ECHO sessions will focus exclusively on clinical laboratories in the United States and US territories.

Once again, we value the discussion amongst all of you that ensues and want to encourage you to share your own experiences and challenges on this topic. We thank you for your interest and participation.

Here is an overview of the process. Jim will go through a quick case presentation as a subject matter expert, and then a summary. And then we will open up to discussion, as we're sure this will be a robust discussion today. Then we'll have closing comments and reminders and then adjourn.

Today's session is being recorded. If you do not wish to be recorded, please disconnect now. Closed captioning will be provided for this session. Find a link in the chat box. A transcript of the session and the slide deck will be provided via email to registered participants.

Dr. James Crawford currently oversees the integrated laboratories of the Northwell health system as a system chair and as a senior vice president of the laboratory services. He formerly served as faculty and staff pathologist at Harvard Medical School and Brigham and Women's Hospital and the Yale University School of Medicine. Immediately prior to his current position, he was a professor and chair of the Department of Pathology, Immunology, and Laboratory Medicine at the University of Florida College of Medicine in Gainesville.

Dr. Crawford is a leading proponent of the role of pathology in the clinical laboratory industry in patient-centered care and value-based care. As a founding member of the Project Santa Fe Foundation and the chair of the board of directors, He is a leader in the effort to develop the value statements for laboratory diagnostic services in the next era of health care.

He is editor in chief of Academic Pathology, the official journal of the Association of Pathology Chairs, APC, and has served as president of the APC, as Chair of the Council of Academic Societies of the Association of American Medical Colleges, and on the AAMC board of directors.

Dr. Crawford received his MD and Ph.D. degrees from Duke University's School of Medicine, and his postgraduate training in anatomic pathology and gastrointestinal pathology at Brigham and Women's Hospital, followed by a fellowship in hepatic pathology at the Royal Free Hospital in London.

Now we'll invite Dr. Crawford to describe his experience. Please be thinking about similar situations that you've encountered. We expect this to be a robust discussion. Please offer your questions in the discussion period. At this time, CDC will not make any official comments around this discussion. Dr. Crawford.

James Crawford: Thank, you Triona. And this webinar was scheduled in December of 2019, and who could have thought that it would be given during this particular week? When I've told my immediate colleagues that I'm giving a CDC webinar at midday today, the relevance and impact is for me quite humbling, because– next slide, Triona– we do have a case to discuss, which is what's happening everywhere in the country now.

This was yesterday morning. I did not download from the New York Times this morning's map. I now understand that all 50 states have positive patients. But if you look at the New York region, you can see we've been a little busy. And quite honestly, I have never been more pressed for time in my career. It's both exhilarating and a unique experience. And I think for all of us this is going to be a career experience.

For me, first and foremost is taking care of our workforce, because it's only with our workforce that we can meet the challenge that is now before us. So I'm going to fit the initial inspiration for this talk, which is the value of the laboratory in the next era of health care, and really zero in on what's happening right now. I will use one other example just to broaden the scope, but the talk will be in two portions. One is the general principles of what Project Santa Fe has been advancing, and then, of course, looking at the immediate present.

Next slide, please. So it's been quite a time here in New York. This is our own laboratory. Governor Cuomo held his press conference here last week, took a tour of the lab. It is a unique feeling, as a laboratory, to be resulting positives for COVID-19, and within minutes to the following hours, our result rippled through the community and become part of the news cycle.

We know that we issue, on both the clinical laboratory and anatomic pathology side, information of great importance. And we know it's of great importance to our patients. It is a unique experience when you're in the middle of an epidemic and now pandemic when your lab results affect civic decisions, public discourse, and obviously the lives of people in your communities.

Governor Cuomo said something which I think is incredibly meaningful when he was here. Quote, "you have been training for this all your careers. This is your time to lead." And that is what we've been advancing. It's this idea. And it really has come to extremely sharp focus in this particular moment.

Next slide, please. And one of the comments that was made amongst the listserves, reverberating around amongst the laboratory community, is that the clinical laboratory is being recognized as necessary and foundational to patient care and public health. We've always known this, but it is the key to getting the COVID-19 pandemic in check. And really, the whole country and the whole world is watching the laboratory.

Next slide, please. So some comments about Project Santa Fe. The founding members are the four organizations shown. We met in March of 2016 in Santa Fe, New Mexico, which is where the name came from. Next slide. And the idea– it was basically a two and a half-day think tank of what the issues were in pathology and laboratory medicine, and how we needed to adapt to the next era of health care.

And the thoughts of this meeting were published about 11 months later in Academic Pathology. There's advantage to being editor of a journal sometimes. And in the next slide are articulated the unifying concepts of what we call Clinical Lab 2.0. To me, Clinical Lab 2.0 is simply shorthand for communicating a whole set of concepts. And these concepts are the following.

If we think of 1.0 as our incredible obligation and privilege to provide information in the form of results from every portion of our laboratory to patients and their providers for patient care, Lab 2.0 is, in essence, developing the evidence base for the value of what we do. And it needs to be examined from the standpoint of how does the laboratory provide leadership, not just in being reactive, but in optimizing time to diagnosis, time to effective care?

Since we have data streams across the longitudinal breadth of a patient's life and populations to provide leadership in helping to affect transitions in care and care coordination, and increasingly so to specifically guide in the personalized medicine era actual selection of effective care. That's the optimization part.

I think all of us in our experiences can speak to the issue of gaps in care. And to the extent that we have laboratory data, which indicates a need for addressing an evolving condition. Chronic kidney disease is a perfect example. But also if a patient is diabetic and has had HbA1cs measured and then they drop off the map, that is also a gap in care. Support, and to me, lead wellness care programming, which includes screening, in essence, chronic disease management, monitoring of patients who are post-illnesses, cancer being an example.

And for all of these things, and this is the heart of Clinical Lab 2.0 is to translate our efforts into quantifiable measures of population outcomes and economic outcomes. We must examine the economic value of what we do. And the concept is if lab is 3% to 4% of the US health care dollar spent, we influence the vast majority of the remainder. And in my personal opinion, it is our responsibility to examine the total impact of what we do, not just try to provide a cheaper lab test along the way.

Maybe we will be doing utilization management along the way. That's always going to be part of our lives. But how do we know that downstream, and quite honestly upstream, from our efforts that our laboratories are providing value to the communities we serve? It's really a unique time. And this is true for every laboratory practice setting, is that health systems are undergoing consolidation.

The smaller sites are becoming part of larger health systems. There is laboratory integration across health systems. Northwell is very far advanced in this space, but it's something that is really occurring across the country. And very important, there's payer interest in innovative managed care programming, which can benefit from laboratory leadership. And to the extent that the laboratory is part of the negotiations with payers to come up with innovative program designs, that's a very specific opportunity to link both health outcomes as well as economic outcomes.

Next slide, please. So if we ask the question, in value-based health, where is the lab? This is how I articulate it. If you're going to say, what is your value as a lab in the inpatient and outpatient setting and everywhere in between, you need to have quantitative information on how your laboratory effort hopefully affects better patient outcomes. You have to roll that up to population, which means you have to have a grasp of your own data streams, and those of your health system.

And again, you must address cost, the total cost of care. And the challenge I ask every laboratory professional, not just the pathologists and clinical scientists, but the managerial leaders and all the way down to the professionals who are part of the technical workforce, how does the laboratory provide leadership in doing this? How do you get into the rooms where leadership can occur? And how do you, through your own initiative, create those leadership opportunities?

Next slide, please. It was a patient with chronic kidney disease, a patient advocate, who really jolted me a year ago when he described his own journey through and beyond chronic kidney disease into renal failure. Ultimately he got a renal transplant, but it had basically upended his life. And he said to me, the lab is a first responder. You carry not just opportunity, but moral obligation to respond to the data that you are generating. And to me, it was a very profound statement.

And this slide, which was put together by my fellow co-founder of Project Santa Fe, are four areas where being that first responder comes to bear. I've already spoken to the first one. The second, I think, is a key point. We live and breathe in a structured data space. And even anatomic pathology has structure.

Each touch point of the laboratory is measured scientifically as structured data. It's our job to attach value to it. And it is also our job to take what is often latent data in the clinical health record and make it actionable. To the extent that we represent more than 70% of the actual structured clinical data on the electronic health record, the urban myth, which is actually reasonably well supported that we also affect 70% of clinical decisions, it means that we rule in or rule out physicians' hypotheses for a health condition and we directly inform pharmacy and therapeutics.

Next slide. So if we take these ideas and roll them up to population health, it is the aggregated longitudinal data which enables us to risk stratify populations for chronic conditions and therefore guide the clinical care programs for the patients who need the greatest attention. That includes identifying care gaps and helping to close them, and identifying high risk patients early before their lives fall apart, including hospitalization and ED visits.

And the fact that we are embedded in the clinical workflow, the data is generated as the patient is being cared for, we're a pivot point for point-of-care intervention. And recognizing that I'm speaking to laboratorians, I think the argument can still be made that we provide the highest yield for the return on investment. We have clinically-actionable data for a fraction of the US health care data. And to the extent that we start pivoting from sick care to wellness care, hopefully we can be in the room, not just as a commodity but actually as leaders in value-based care.

So next slide, please. The question is, is the headwinds are pretty strong. And absent the current event, how good are we and what does that our public think of [? us? ?] Talking to ourselves, at least, we are subject matter experts [? in ?] the meaning of the data that we generate. As I mentioned, we're embedded in the patient care workflow.

But the next two points are really quite important. The simple fact that we need to take care of basically all the patients in the health ecosystem, it also means that we touch virtually every part of the health system. And when we do something, we can propagate it rapidly through a health system very economically. It is our way of life and our professional skill set to manage systems to be efficient and to propagate good ideas across the breadth of our service. And so we actually have a very broad impact in a health system.

Ergo, we should be part of virtually every programmatic team for clinical care. This is actually hard-won territory. And even better, we should initiate and lead those teams. The very top line, I actually last year, went on to the US Bureau of Labor Statistics and documented. It is true that while we are 3% or 4% of the US health care spend, we're also about 3 and 1/2% of the US health care workforce, as shown in the numbers at the bottom.

We are a really good bargain for delivering good health care. So next slide. It's really funny because with all these bell curves we're seeing recently, we have to back up a second and say, how do we bell curve a population? And to the extent that we identify people, persons, before they become patients, through wellness care, through chronic disease management when they do start progressing into conditions, chronic kidney disease is the best example, but it's certainly not the only one, and help people live with their comorbidity without going into the red zone, we can do good.

And the argument can also be made if we fail to act on the information in front of us, we failed that person. So we should be looking at helping people before they become patients and before they need the intensive care. And ideally, we're working with people who could be called consumers on their wellness. Next slide, please.

So if we were to contrast Clinical Lab 1.0, which must be done. Don't ever misinterpret me. Clinical Lab 1.0 must be done. We must do all these things. We must be accurate, and reliable and safe, and timely. We must have the expertise to do all these things. We need to innovate by bringing the science of medicine to our local practice sites. And absolutely, and I'm sure you all know this, we have to be financially disciplined and accountable to our various stakeholders.

So this all is true. It also means we're a commodity. And if someone can do it cheaper without additional value statements to differentiate us from someone else, our stakeholders, particularly health system leadership and managed care, will choose the more cost-effective commodity.

So if we go to the next slide and say, OK, well, how does a clinical laboratory act as an asset? These are principles. Your lab, not just any lab, your lab should be valued as an essential component of a high performance integrated delivery network. Your consumers, hopefully, will value your lab, this is hard to do, as a key partner in their journey through wellness and illness. And especially your providers, who do have some say in this decision-making, will feel that your lab is a key partner for their ability to care for their patients.

At the level of a health system, whatever your business model is, you are part of some health ecosystem, and to the extent, given everything I've said, that your contribution helps the financial and quality performance of the health system. And you have quantitative evidence to support the premise that your lab is enhancing patient outcomes and the patient experience. And I don't think you should be shy that your lab helps enhance your health system's or your ecosystem's brand value and strategic clinical program growth. You are bringing value as an asset, and you are more than a commodity.

And for payers, again, these are times when payers are much more interested in innovation than they them before. You are a partner. They're already getting your data. But if you can help your payers design managed care products, including wellness programming, if you can help their patients navigate their chronic conditions for lower cost, and especially if they can be better off medically, and patient experience, then you are bringing value to your payers. Next slide.

So changing the algebra is really again a quantitative game. For the payer, their metrics are per members per month and quality. For your health system leadership, patient outcomes, financial benefit, and quality. For your providers, at the very least, you're a collaborator, but potentially you can be a champion. And one of your fundamental values as an asset is you're available. You're accessible to them.

And for patients, I didn't highlight access, but I don't think you should overlook the fact that especially given the current times, patient access to your diagnostic services is a pivot point. Under most ordinary times, where a patient's pain points are are in benefits design and copays, and increasingly their access to precision medicine. And yes, you're helping close their gaps in care as a value generator for patients. Next slide, please.

And I will actually skip over this next slide to close the opening section with– what I say is Clinical Lab 2.0 is about leadership, not followship. OK, I'm going to give you two examples, and the second one is COVID-19. But the first one I think is worth touching base on as well.

This is an image of the hospitals and the ambulatory practice sites, those orange circles. At Northwell it's a 23 hospital system and the largest not-for-profit organization in New York. We deliver about 20% of the babies in New York, take care of about 1% of all cancer patients in the United States. We're a large health system. Next slide.

To support this health system, we have a highly integrated laboratory network. The hospital-based clinical labs are in green at the bottom. We also support six affiliated hospitals through our own laboratory network. And since 2014, we are in a joint venture affiliated network with health and hospitals of New York City with their 13– actually, 11 hospitals is shown. And all of this is supported by a reference laboratory, which is where I am right now.

So we serve a substantial portion of the greater New York Metropolitan Market. Next slide. There is deja vu right now, because Queens was the epicenter of the 2009 novel H1N1 influenza epidemic, which became a pandemic. And I was here. It was baptism by fire as the new chair. And we actually had 1,000 positives at our core lab before the CDC did.

And I don't know whether it shows on your screen, but when we submitted diagnostics on those first 1,000 on June 3, it was accepted in 48 hours, this being less than two months after the first patient– only six weeks after the first patient had shown up on April 24. And I actually– next slide– I actually wrote this up as an addition to the medical science that came out of it, which was the diagnostics and the biology of this virus.

But this article was published in early 2010 in Emerging Infectious Diseases, which is, how do you respond to something like this? When a pandemic sweeps through your community. And the next slide shows what honestly we're experiencing right now with COVID-19, which is the effort it takes of your workforce to respond to the incoming. And in the current environment here in New York, we've been in touch with our laboratory colleagues in Seattle and in California. They're basically saying you've got about two weeks, maybe less, for all of you and your various locations. I don't know how many weeks it will be before you will find yourselves rather busy, but you need to prepare for this kind of work effort to respond. And I'll be commenting on that towards the end of the talk.

If we go to– next slide, please– a second example, and I'm going to go through this fairly quickly. Blood culture bottle fill volume. This is the Becton Dickinson product, which says that ideal is 8 to 10 mLs, minimum of 3 to 10 mLs filled inoculum if you want to get an accurate measurement of bacteremia.

I went back to the original literature from the 1970s and '80s as regards glass bottles back then, and the original literature didn't even look at inoculums less than three mLs. But down to 3 mLs, the false negative rate for detecting bacteremia was greater than 30%. So the basic idea is if someone filled a blood bottle and just gets a blush and doesn't get even the 3 mLs, their false negative rate will exceed 30%. Next slide.

So we started measuring spectroscopically the hemoglobin absorbance. How much blood was in our bottles back May of 2015? And I'm showing you what we were finding coming out of emergency departments at two different parts of one of our medical centers. And you can see the vast majority of blood bottles were filled with just a pink blush, 0 to 1 or 1 to 2 mLs of blood. And blood bottles filled with an adequate amount were basically almost nonexistent. So we can do all the wonderful diagnostics we want in our clinical microbiology labs, but if inoculum is not sufficient, we're going to have a very high false negative rate.

And so in June of 2015, we started a campaign to educate the entire health system. And 70% of bloods are drawn by non-phlebotomists in our health system. To try to improve this– next slide please. A two-year effort, which involved nursing and emergency departments and physicians and medical students for the assembled hospitals of our health system, shows that a laboratory-led program can effect hand system improvement. This became one of the primary quality indicators within our system.

These charts are on every wall in EDs around the health system, as well as in the central administration. There was some pretty decent friendly competition amongst the hospitals as well, and this has been sustained since. So how does that translate into improved outcomes? Next slide.

Shown top left is the mean plus or minus standard error for the assembled hospitals over this period of time. The middle top is the percentage of bottles that turned positive as the inoculum went up. And this is also shown in the histogram's top right. But it's the middle bottom that's the most important to me. Based on prior benchmarking, the maroon numbers in those different histograms representing different hospitals, [INAUDIBLE] be detected on the basis of increased inoculum.

Next slide. We published this just last year in Clinical Infectious Diseases. And Triona, if you hit the next button, you will see perhaps the most important part of this, which is that on the basis of our delta, there were 300 additional patients per month who were diagnosed with bacteremia when they came into the ER rather than after they got more sick and septic up on the floors.

So you could call it simple, but this was a pan system leadership effort led by a laboratory. It provided quantitative evidence of better and more timely health care. And from a quality standpoint, which really meant a lot to our quality officers, the difference between a hospital acquired-infection or not. OK, next slide.

This is a program of the CDC to speak to clinical practice sites across our entire country. And I myself, by circumstance, actually found myself as the local medical director of two of our system hospitals, Northern Westchester Hospital and Phelps Memorial Hospital, both in Westchester County, for a year last year. And what I told my clinical colleagues at the end of that year, when we were able to hire sufficient that I could go back to my usual job, I knew this in my head. After 2019, I knew it in my heart. And that's really true. And I believe all of you listening to this already know this in your heart and have for the duration of your career.

These are my thoughts about what it means to be a pathologist and member of a community hospital lab. For the medical community of which you're part, you are part of a global health care team. You're part of the team. And to me, that is the most meaningful thing that I could possibly have taken away from serving in these two community hospitals.

You are the local experts in all matters pertaining to laboratory testing, which means you own everything about lab testing. It doesn't matter what lab delivered the testing. It could be send-outs, it could be precision medicine, it could be reference labs. You are the ones who own that information and interact with your local practitioners, and you're part of the local teams that guide patient care and management.

And I'm sure all of you can agree with this. You are a local resource for problem-solving everything pertaining to lab, whether it's hospital administrators, providers, the patients themselves. You're the local problem-solver. And I think very importantly, including [INAUDIBLE] the webinar [INAUDIBLE] you're an expert who brings innovation and new programs from the broader world to the local practice area.

I am sure you would agree. To hospital leadership, hopefully you are a problem-solver, but to me this was another takeaway lesson. And it dovetails with everything I've been saying about Clinic Lab 2.0. You are a key partner in addressing their total cost of care. This is not just about the lab. You're key problem-solvers for their vexing pain points.

For hospital administration, you are a key colleague in working with their local doctors and local health care team. You can help solve their problems. And again, you are key experts in bringing the outside world to the local care environment. So next slide.

Let's now look at what's happening. I've got two more slides to go. This is what we've been experiencing over the last two weeks. Yes, there were some initial indicators that in our service area, which is all of the New York metropolitan area, that there were initial positives.

But the action really began the weekend of March 7 and 8. And we went live with a CDC assay, you can see it on the far left, we went live with a CDC assay at 5:00 PM on Sunday evening, March 8. And shown on the far left are the first three or four patients that we detected as COVID positive, those who were not detected, and the tests that we did not get run that night.

And over the following week, you can see the numbers slowly increase. This is all on the CDC assay. And in essence, we were able to keep up with incoming demand. We turned on a semi-automated platform. And we actually have this platform throughout the health system. So quite honestly, if we were able to get all of the kits from our commercial manufacturer, we could have taken these numbers well north of 600 or 700. But as it was, the supply chain issues that are affecting all of the country affect us.

We turned on our semi-automated platform on Wednesday, March 11 at 7:00 PM. And for the ensuing seven days up till this morning, we've been constrained by the supply chain. Interestingly enough, I prepared this slide at 1:30 AM this morning. The 24-hour report at 5:00 AM is not on here, but we actually went up to 250 tests resulted in the past 24 hours. And that's going to go up again, because the supply chain is easing.

And we're also in the process, literally as I speak, of bringing one of the fully-automated platforms onboard. So these numbers should continue to change. The gray shows the incoming specimens from our health system. We cannot help our service area except at the request of the New York State Department of Health. So there are prioritized specimens from the New York State Department of Health, including the New Rochelle drive-through screening area, which we're staffing, actually.

But you can see that there's an unmet need. And fortunately, regional commercial laboratories have been coming online. Through yesterday morning, LabCorp was the first one to come online and help us, and Quest came online to support our needs just three days ago. And yesterday BioReference came on. Again, I didn't report these at 1:30 this morning when I finished up this slide, but you can see this is all hands on deck.

And in your practice environments, you will be going through a similar exercise of specimens coming in. And whether you are doing the testing yourself, including especially on semi-automated platforms, and/or working with reference laboratories, non-profit or commercial labs, this is a team sport. And the goal is regional testing to serve your communities. And you figure out as you go along.

Next slide. It is interesting to see that what has come to our Northwell health laboratories, and this is inclusive– on the right are shown all of the positives, all of the detected, by whatever platform, from March 8 to March 16 of COVID-19. And 272 of these positives had been resulted out of our own Northwell health labs. 79 have been resulted out of LabCorp.

And in the first two days of operation, Quest has not resulted any positives. I'm sure this is going to change by the day. And actually, the numbers I saw this morning is that with BioReference coming online, they actually resulted a whole bunch of positives through the hours of yesterday as well.

So the speed with which this is occurring is breathtaking. As I commented at the top of this conversation, your data is out there in minutes and covered by the news services. And for the State of New York, certainly for the New York region, we've been a major player in generating these results.

So the last slide. This is a quote from Tolkien, or taking off from Tolkien. COVID-19 is coming. It is here. And these are my comments to you. Right now, verify the status of your existing platforms. You are doing routine RVP, respiratory virus panels, and you are doing rapid flu A/B with RSV. So you're doing stuff.

Get your arms around those, because number one, that will continue. And number two, depending on how the commercial chips are integrated, it's still a do an RVP first, and then if it's negative on a high index patient, you'll be running a COVID-19 19. Number two, right now verify your supply chains and stay in touch with your vendors. You're going to be spending a lot of time talking with your manufacturing vendors.

Number three, I consider it your responsibility to be the experts in tracking availability of regional COVID-19 testing and keeping your leadership informed. Your health system leadership, your medical colleagues, your incident command, you should be the expert on what's out there, what's available. And that changes by the day, if not by the hour.

And something also important is you should carry responsibility for paying attention to your regional blood supply. For us, it continues to be sustained, donations are sustained, but be aware that your blood supply may be OK today, but may not be tomorrow. There is going to be money. There's going to be cost. And plan for the spend. You went to the next slide. I don't know if that's cutting me off. OK. Anticipate the costs.

Stay in touch with your regional laboratory colleagues. All hands on deck. I've mentioned at the beginning, protect your workforce. COVID will enter into your laboratory, it has into ours, and you will have to furlough people. Plan for an infield shift. As you have to furlough, people you will have to bring other people into work areas. And especially, even before that happens, do an infield shift of other personnel to help your clinical microbiology people deal with the increasing volume.

Stand up your data reporting. You're going to be responsible to incident command. Your workforce, as may be, may engage in remote work. And plan for interruptions that may compromise your ability to provide services.

The last comment is prepare for incident command. Whether you or your designate, you need a laboratory commander. And both for distraction, and there are distractions everywhere, but also potentially that commander may be compromised. You should have a lieutenant commander who tracks everything alongside your commander and can pick up mid-sentence if your commander is pulled away.

These are the lessons I bring to you from our experience at Northwell Health in the New York area. And I think it's going to be an interesting time for all of us as we move through the coming weeks. I believe that's my last slide, Triona.

Triona Henderson: Yes.

James Crawford: Right, OK. So let's open up for conversation.

Triona Henderson: So please remember that we're going to open up to the audience for conversation and discussion and questions right now. Please either remember to raise your hand if you want to speak across the microphone, and/or you can enter your questions through the chat box. So I know there are some questions coming through the chat box, so let us see.

There is a question from Anna Murphy. So she said she has several questions. Since this is [? her ?] first time, she'll share them and we'll use them as fit. OK. To provide leadership in the laboratory, to provide leadership, how will the workforce shortage of MLS be addressed? Allowing nursing to serve as laboratory director is a harmonization of laboratory's reimbursement. LabCorp, Quest, chronic problem. No or improper use of PPE in accredited health system. So I guess it's a statement with a question.

James Crawford: Well, I mean it's– you packed a lot of things into one question. On the one hand, there's our laboratory work force. On the second, there is the current event. And I'll sort of take those two apart. I agree with you. The ability to fill open positions in the laboratory is, I think, a problem of our time long before COVID arrived on our shores. And it is a stress point across our health system.

In this era of resilience and burnout and that sort of stuff, it's an active topic where we are. And my feeling is that staff shortages will kill any strategy for resilience. And so I don't think there is one easy answer. I most certainly feel that being an employer of choice is important. v

In the competitive New York area, laboratory technologists frequently work multiple jobs. I'm staggered and awed by the work effort they put in. And they will move from you if you are not a good employer. So for you as a laboratory leader, you must fight and advocate for the quality of their workplace. That includes technologies. That includes the physical plant of their workplace.

It includes your presence and engagement in the operations of the laboratory. You cannot be a distant medical director, for example. You've got to truly be part of the team. And I think there's a lot of communication back to the workforce about what's going on. The data charts that I showed at the end in terms of laboratory testing are just a scratch on the surface of what I'm taking as my responsibility to bring information about the COVID crisis back to our laboratory front lines.

It takes hours per day for me to do this, but it's worth doing, because I want our people to know what's going on, not just be working three shifts and getting ground up by the stress. I really do think you've got to be a very strong advocate for your workforce, and that is the starting point for recruitment, the word on the street as to what kind of place you are to work. v

There is also advocacy, in our case at the state level, for having regulations that actually align with people's ability to do work. And we have been successful at the state level in correcting some rather appalling issues. Unfortunately, they were. So I'm thankful to the State Department of Health, and the legislature and governor in one instance, for taking care of the lab.

Right now, I think we're seeing a unique time in our careers, because as we move through and beyond the current pandemic, I think this is unprecedented opportunity to have discussions about what it means to provide laboratory services to a population. So I encourage you strongly to be engaged and active in the advocacy efforts for what it means to be providers of health care.

In terms of the specific events going on right now, despite the fact that we deal with infectious specimens as a way of life, and universal precautions are part of what we do in HIV, and hep C and B, and herpes come through, our workforce is disquieted. COVID-19 patients are in our MICUs. COVID-19 patients are in our EDs. And quite honestly, you don't know who's COVID-19 positive when you receive a specimen.

And we've had to spend time, literally this morning, with one of our site workforces, just walking them through the principles of what we do as a way of life, and to provide reassurance that we're not going to compromise them or our workplace by these vestments coming through. Come through they will. Patients will need care. They will be in your facilities. So I think your involvement with your workforce is going to be hugely important. You cannot be a distant medical director or administrative director as we move through this. Next question.

Triona Henderson: Perfect so I'm going to start alternating between microphone questions and chat box questions. So Elle, if you unmute yourself, then you can go ahead with your question. Can we?

James Crawford: Or send a chat.

Triona Henderson: Well, she asked if she could get on her microphone, which is why I gave her the opportunity. I'm going to go ahead with the next question, and then we'll come back to her. So this is a question from Ren.

Elle: Hi, sorry.

Triona Henderson: OK, go ahead.

Elle: Did it not work?

Triona Henderson: No, it didn't. Now we can hear you.

Elle: OK, I apologize.

Triona Henderson: That's OK.

Elle: Let me just hang up my phone, because I was on the phone and computer. Can you hear me?

Triona Henderson: We can.

Elle: I apologize. I wanted to first thank you for your incredible generosity in this time of crisis and leadership. It says so much about the way you run the system that despite obviously having the oversight, and we're all running at full capacity trying to stay ahead of things here, but the fact that you have sort of pivoted so quickly and were able to share best practices with us in order to help us, is just so– I'm at least very grateful for that.

And compared to first Seattle, then New York, and I think Boston is not far behind. We as of yesterday morning had 78 people in the hospital and 17 in our MICU. So we're very busy, and we're out of PPE and everything that everyone else is experiencing. Reagents are a limiting step for our testing, et cetera. So I wanted to thank you for your generosity.

But my question actually is with regards to your blood culture.

James Crawford: Oh, yes.

Elle: So, you know, it's a universal problem. Certainly we have pediatric settings that we oversee as well, and that's always an issue. I was wondering deal with an issue in education in general is sort of [INAUDIBLE]. As much as I'm very impressed by your improved performance, it tends to be a sort of weak quality improvement intervention that sort of tails off after a period of time.

I was wondering if you had any success or any template for partnering with the manufacturers and/or the FDA to do things, for example like a hard stop on the side of the bottle that has a line, instead of saying fill line, it says like, below this rate of 30% false negative. Or something that would prompt nurses or front line providers rather than sort of a separate education QI initiative.

James Crawford: This is a battle in detail, and it has to be detail. I smile, because we've talked– we're one of, if not the largest, consumer of Beckman products. And we went to them and said, you know, couldn't you just put something on the bottle that says–

Elle: We did the same.

James Crawford: –fill to here. But the problem is you have to have– you're drawing blood in very variable care settings. And in order to see what you're doing, you have to have the bottle on a table next to the patient, vertical. And you may be tilting the bottle, in which case you can't tell.

And so what we wound up doing, the reason I smiled, we wound up having Sharpie parties. Every crate of bottle that was delivered to an ED, people would get their sharpies out. And they'd open it up, and they'd just mark. They do exactly that. They put the fill line target. And that continues.

Visuals, very dramatically bright visuals went up in every single emergency department, every single MICU, throughout the health system. But to me the heart of it is leadership across the disciplines and professions of your health system. When we first presented these data, we had all of our hospitals, and all of our EDs, and all of our PICUs on our charts at the monthly meeting of the chief medical officers of the health system. And I gave them this 30% false negative rate. Their jaws dropped. In that moment, this was a system event.

And nursing, emergency department, and with all of their CNOs and CQOs for every site. And CMOs, they were the ones who led this charge. And it went through the entire health system. And it is a metric that is public and on our website. It was that important, especially–

Elle: laboratorians are having a seat at the table at the highest level.

James Crawford: And so in the interest of not taking up all the time, one of my slides is if what you are doing does not matter to the CEO, you're not thinking big enough. You should be doing stuff that matters to your health system's leadership at that level. And if your creativity and leadership is not that important, then I say re-prioritize. Right now, the priority is easy. But it should be a way of life.

Now granted, there are a lot of details. You don't want your CEO and chief medical officer to be bothered with 99% of the problems you deal with. But you need to be working on the big stuff, and they need to appreciate it. It's sort of a guide– now again, there are many, many different pathology practice settings, which is why I think your relationship with your medical staff is so critical. Because you need– it doesn't matter what your practice model is. You need to be part of the local medical practice community. And together, you identify the things that need to be done for your communities and your patients.

Triona Henderson: Perfect. Next question. And this is coming from Vinita from Yale New Haven. Your 2009 chart showed increased work from additional workload. What was the resource allocation for this effort? What were the balancing measures? How do you ensure that performance does not fall in another typically not measured area?

James Crawford: By the way, hello, Vinita. I saw your chats in prior sessions. At a time like this, you're not thinking about money. You're thinking about patient care. You're thinking about the community. You obviously stay in touch with your administration, but your responsibility is to meet the needs of your community through your abilities as a health care provider.

I built that chart prospectively, because you can't collect that data after the fact. You can't go back to people two weeks later and say, how hard did you work? So as soon as this one started, I asked people to start keeping track of their time, because it's pretty impressive when you come back on the tail end. And this is going to be a long time before we see the tail end, so I think there's going to be a lot of interim metrics and retuning as we go along. But I think, again, as a leader, you need to be proactive in documenting the effort you put in and hopefully the quantitative outcomes.

And so I lost part of the thread of your question. Could you read the question again, Triona? Because I was [INAUDIBLE].

Triona Henderson: Sure. The tail end, how do you ensure that performance does not fall?

James Crawford: Yes. A funny thing happens at times like this. Performance actually goes up. And the paper that we published in Academic Pathology in 2016 about threatened interruptions in service, and it's quite a grab bag. Two floods, two fires, one laboratory floor subsidence where we ended to vacate the lab, and a variety of other adventures. They seem to happen on a daily basis across our health system.

The performance of the lab actually goes up, because people are zeroed in. They are locked in, and it's all hands on deck. It's exhilarating. It is exhausting. You cannot keep it up. But in the moment, it is absolutely amazing how the laboratory performs. This one's different, because your workforce is going to get compromised. We just had to furlough 14 people in our department this morning. And granted, it's a large department, but one of our practice sites just got 14 people furloughed.

And so the idea of all hands on deck in this episode is different. And it's not a matter of, OK, let's just run a COVID-19 tests and if they're negative we're fine, because people are transmissible before they become symptomatic, which means you really do have to wait for a while. Which means you have to plan for a compromise of your workforce. And it means reaching collaterally within your practice environment, but it also means preparing for a collateral practice elsewhere.

We're cross-credentialed at the 23 hospitals of our health system. While I'm doing this talk, our anatomic pathology group is doing their disaster planning for basically up and move. If one of our sites is compromised, workforce can't support it, at the very least the caseload, but also an uncompromised pathologists move and pathologist assistants. And we're doing that right now, because it just happened at one of our sites.

Now, the elective surgeries are going down. So on the AP side, and we're about midweek, and this is anticipated. So our local hope is that the decrement in elective procedures will match the compromise of our workforce, but that's not true for the clinical lab. The clinical lab is running at full tilt. And so protecting the integrity of the clinical lab is absolutely critical. But we have to plan for that as well, which if a local lab is compromised, we have to be able to divert lab specimens. You've got to think about that beforehand.

Triona Henderson: So the next question is from Dr. Salerno from DLS. For COVID-19 testing, could you comment on the adequacy of supplies, materials, reagents necessary to respond to the testing demand? How do you keep track of availability of regional testing capacity, assuming that it involves understanding what is going on outside of your own company?

James Crawford: It's a long answer, but I'll start with your command architecture. I spoke about the commander and lieutenant commander. There is a host of people who are staffing our incident commanders. I'm one of them. I may be chair, but I'm staffing right now. My primary staffing responsibility is information management, but it's also a lot of personnel.

Basically, we've tapped every senior manager available to provide staffing support for the many, many, many moving parts. And we all report up to our incident commander and our lieutenant commander. And quite honestly, they're the ones who are on the phone with the governor's office, and the National Guard, and the New York City and New York State Departments of Health.

And I can assure you with our vendors, because it takes that level of seniority to talk to your vendors and make sure that you're staying in touch with your supply chain. You must be an advocate. If you're quiet, you're not going to get supplies. Now, maybe two, four, six weeks from now that will change, but my feeling is the industry is in a full sprint.

And the virus is in an upswing. I won't call it a full sprint. The virus is going to do what it's going to do. But I think we're going to be at the very least working to keep up and hopefully not falling behind the need for diagnostics.

I retain optimism, because in point of fact, the pain, the excruciating process of not being able to provide adequate testing, is beginning to ease a little bit. Cases are increasing, but our supply chain is increasing as well. And so I'm hoping that as the virus spreads to other communities around the country, and it will, that the supply chain will be more sturdy than it was during the initial weeks.

Triona Henderson: Perfect. Vinita is thanking you, and Ren is also thanking you. Ren also had a similar question, but I think you answered it with Elle's question about blood culture. What did you change? So I think you answered that adequately.

James Crawford: I'll add one thing. I didn't show our needles initiative. The chief quality officer of the health system in 2012 asked me to improve phlebotomy practices across the health system. And we formed a huge task force. Actually, it was a small task force, but it had a lot of tentacles, primarily with nursing but also with ED. And the first thing we did was sort of collect the devices, kits, needles, you name it, that people were using around the health system to draw blood in EDs and MICUs and on the ward in physician offices.

It was like a needle exchange clinic for four drug addicts. I mean, the variety of what people were using to, now we know, provide inadequate blood cultures as well as other inadequate samples, was entertaining at least. And this was also concordant with our looking at canceled tests in our hospital laboratories for QNS, which to me was an entire– I mean, yes, there will be patients, small kids and elderly frail, for whom QNS is an issue. But the rates were far higher than I would have expected.

We could not find national benchmarks on what should be an appropriate QNS for inpatients, so we made up our own. And our goal was to decrease those numbers by 10% every year. And we declared victory each year if we had decreased by 10%. The education involved standardizing phlebotomy practices, the butterflies, the gauge of needles, obviously the order of tubes.

We standardized the fact that you need to order the times frequency by which tubes are obtained, rather than just getting a bunch of tubes in the ED and sticking them in your pocket and pulling them out if the patient needed to be admitted. And through these things– again, mind you, this was pre-blood-filled bottom, but we got our community talking. And we established the working relationships. And yes, we reduced QNS by 10% per year over a sequence of years, which to me is time spent in a hospital, too many needle sticks, and potentially delay in diagnosis and treatment.

Triona Henderson: Perfect, thank you. We are going to alternate. If there is anyone during the session who would like to speak up now, please unmute yourself and identify yourself, and ask your question.

Without hearing anything, I'm going to go back to the chat box. So we have another question. Regarding the Clinical Lab 2.0, what is your take on the doctorate in clinical lab science DCLS? And do you think this is something that will be embraced?

James Crawford: We have a DCLS doctoral student in our lab. And number one, I commend her. The gumption it takes, the initiative, to in the midst of your current working job spend time away to take on a thesis project to educate yourself, to me is tremendous. And what I told her is that it's our responsibility as an employer to create the opportunity for her to be the professional that she is transforming herself into.

So number one, I think the DCLS is a professional opportunity that we should be taking advantage of. And we should be not only making room in our workforce, but giving them meaningful responsibilities. Nisha is in the Galveston DCLS program that's directed by Mike Laposata, and that's heavily oriented to diagnostic management teams. Since DMT is already an initial acronym taken up here as disease management teams, we call it something else, but in essence, we have a consultation service.

You know, the doctor is in. We are the doctors. And Nisha is lieutenant to the senior clinical pathologists who established this five years ago and the heir apparent. And so the primary focus of this diagnostic management group is antibiotic stewardship. It's amazing the questions that come in from the ambulatory and nursing home side as well as the inpatient side.

We are looking forward to addressing such issues as precision medicine, cancer therapeutics, and pharmacogenomics, and we are– the two of them are actually mentoring a work group of about 30 different people of very different talents, including a doctoral pharmacist that is part of our laboratory workforce.

And what we've found is the world is rushing our stage. There is tremendous need in our health system for conversation, problem solving, and leadership in these interdisciplinary spaces, lab pharmacy being one that has resonated very strongly. And so this DCLS professional growth is syncing up very nicely with where our laboratory is going. And yes, we're quantitatively tracking the benefits and the cost, and putting it into the CL2 ledger.

Triona Henderson: Awesome. There is another question in the chat box from Nathan Cuka. He said it looks like the part of the challenge is identifying which metrics, example, blood culture results, are worth looking at. How do you identify these key metrics?

James Crawford: You start with the pain points of your stakeholders. What are the pain points of your hospital leadership? What are the pain points of your health system leadership? What are the pain points of your clinical leadership? How can you help them? And I've actually developed a reputation on the health system. At system meetings, I say, lab can help.

And it's a great way to basically get on every committee you can think of. And obviously you have to delegate, but that's a career development opportunity for other people. And so it's volunteering every which way to help solve problems. And doing that, then you prioritize. You know, to be the top priority is do the top people in your organization care? CEO, CMO, CNO, nursing, CQO, CFO.

Do those people care about what you're doing? And you can take it down from there, because obviously it's a very target-rich area. But volunteering and then placing your delegates, if not yourself, into these working groups. And then you've got to have moxie. You actually have to contribute. You can't just sort of sit there.

You can also found programs. The blood bottle fill volume was founded and led by lab. The needle exchange was founded and led by lab. Precision medicine, obviously, is a team sport, heavily weighted towards laboratory leadership. And it goes on. But you have to be solving local problems.

Triona Henderson: Last call for questions, either via microphone or in the chat box. Please remember to unmute yourself if you would like to ask a question.

Anna Murphy: Hi, my name is Anna Murphy, and I'm sorry about the first question. I had not participated before, and I wasn't sure how much would be directed to the COVID discussion or the Laboratory 2.0 discussion. I'd like to take us back to the Laboratory 2.0 discussion, because these are the problems that are facing US laboratories before this COVID has hit.

And until now, we've been putting Band-Aids on, such as, like you said, the workforce shortage. Or how about having nursing become laboratory directors? How are we going to fulfill the advisory services required in interpreting PCR testing? Or making sure that testing names are standardized so physicians throughout different services, hospital services, can understand what they're looking at?

Also, reimbursement. You can't keep running if you don't have money. But many of the reimbursement as we go forward is based on LabCorp and Quest, and not the individual hospitals in rural or urban areas. And then lastly, we are still talking about PPE not being used or used incorrectly in the United States. If we take out the first line defenders, then we're going to have much more problems than just trying to put on Band-Aids.

So your discussion started out with Laboratory 2.0. If we can't have a solid foundation, how will we go forward? And these are some of my concerns that I have. So thank you again for a wonderful presentation and for your response to this.

James Crawford: So you've lined up the whole deck. These are the problems. And the Lab 1.0 issue, we can't withdraw services. We must, must provide outstanding services in the Lab 1.0 realm. And the reimbursables are going down. That's what some people, a lot of people, are talking about as the tipping point in our industry.

And so in the interest of time, I did not go into revenue diversification, which is the fact that we can't win this game, if you want to call it that, we cannot be the providers that we hope to be, if it's simply on the basis of cost per test. Because it's a race to the bottom. It has been for most of my career. It's really racing to the bottom now.

And so the value statements, and quite honestly the money that comes to the laboratory, has to come by different routes. And that's where the payers come in, because the hospital is not giving you more money. And your fellow providers under bundled payments are not going to share money. And so it's really by whatever mechanism of access you have to the people to negotiate your contracts.

And again, if you're an independent laboratory serving some healthy ecosystem, you are the ones negotiating with your payers. If you are a laboratory that is embedded in a health system, it's your health system's managed care group that's negotiating. And then there are points in between where you may or may not have access to the contract negotiations.

It is still very early days to articulate the revenue streams from payers, including CMS, Medicare and Medicaid, that will bring money to the services you provide that are value added. But it is happening. And there are examples. My colleague Phil Chen of Sonic is succeeding. The TriCore laboratories in Albuquerque, New Mexico are having successful discussions with their regional payers and with their state. And so for two independent laboratories, one commercial and one nonprofit, there are successful discussions occurring in the managed care negotiation space.

For me, as an in-system laboratory, Northwell Health Laboratories is a wholly-owned business unit of Northwell Health, it is entirely about my local stakeholders. And it is our ability to articulate the financial benefit of our in-system laboratory to the total cost of care outcomes, and yes, to the revenues as well, that allows us to grow and be the employer of 2,200 laboratory professionals system-wide.

So what does that mean? It means that the quality indicators for the health system, that we help improve by closing care gaps, improve the quality metrics that have direct financial benefit to the health system. It means that our pathology informatics effort, myself included, have direct benefit of programmatic growth and programmatic patient outcome successes, and that is certainly something we're shooting for in the COVID-19 sequence.

It means that we can help our health systems stand up clinical programs of importance to them successfully without adverse events for their patients. You can look at a transplant or a stem cell transplantation. Wherever your health system wants to be going, if you as laboratory can develop the quantitative statements to show the reason they are successful is because of your participation. And the alternative, which quite honestly, is you not being the one who's participating, that's something I am shamelessly brazen about. I am constantly making that point and putting the numbers that I have in front of senior leadership.

I will also say that when it comes to budget time, when everything [? left ?] I have is on the chopping block, I have to be able to defend every one. Because to create this value, there are people who are not doing part B, and there are people who are not doing part A. There are people who are doing value, and I've got to defend every single one of those FTEs, which means I have to communicate with my senior leadership 365 days a year of not by name, but by group effort, what these value FTEs are doing. It's taken years to get to this point. It's not something you build in a day.

Triona Henderson: Perfect. We know you have to get back to the front line, so we are going to–

James Crawford: There's a sign on my door.

Triona Henderson: That's good. I'm going to project our final slide.

James Crawford: And I'm not sure– yeah. So this is the one that I had. There's the one you provided.

Triona Henderson: Yes. Oh, it's after this? No. It's this.

James Crawford: No, you've got the wrong slide there. You're missing your favorite slide.

Triona Henderson: Let's try that again.

James Crawford: We were doing swap outs mid-morning to make sure we got Triona's slide rather than my placeholder slide.

Triona Henderson: If anybody has any last-minute questions, you can go ahead and ask while I–

James Crawford: If you share my screen, I've got it.

Triona Henderson: Oh, you can go ahead, because I still have you as a co-presenter.

James Crawford: Right. I'm not sure I can share my screen. Can you?

Triona Henderson: You should be able to have access. Hold on. JZ can you troubleshoot?

James Crawford: I might have just killed it. I think I killed you.

Johanzynn Gatewood: Yeah. Hold on a second.

Heather Duncan: I have a question to ask.

Triona Henderson: There's a question. Go ahead.

Heather Duncan: Sorry, I didn't raise my hand.

Triona Henderson: That's OK.

Heather Duncan: So I know you mentioned having to shift around your work force to kind of triage when things got intense. Did you find any one approach more useful than the other as you've had to make adjustments minute to minute?

James Crawford: The most important one was protecting our technical workforce. You're still going to be doing local RVPs and flu A/Bs, and if you are standing up the local testing, you'll be doing COVID-19s as well. We shifted every single interruption out of that lab. We rerouted the phones. We put basically senior laboratory managers in our triage area. So we diverted everything from the lab and the lab personnel who are at the top of their license for resulting molecular virology results had no interruptions. That to me is the most important.

Now, meanwhile, you have to be fighting the battles to get your machines up and going, the validations done, the vendors supplying you with the supplies you need, talking with the governor and your health system incident command. You've got to be running interference, which means you also have to have people staffing you. Because if you are the commander, you're going to be distracted by hundreds of phone calls, including from providers that are saying, I've got a VIP patient. Can you make sure they get their test?

Heather Duncan: Absolutely. Can I interrupt with one more question? Do you see the algorithm changing with the flu RSV interrupting? Do you ever see– do you see that changing pretty soon as test might opens up a little bit more?

James Crawford: OK, so I'll rephrase that by saying is a flu A/B RSV negative sufficient for a COVID-19 test? And that's actually not the conversation I've been hearing. The conversation has been, if the RVP is negative, then you do a second test. It's not a reflex. You're not using the remnant. You're getting another nasopharyngeal swab to run the COVID-19.

My understanding is that, although not immediate, we will see integration of the Novel 2019 CoV into the standing RVP panel. It's not going to be for a while yet because of the validations that have to occur, but for the semi-automated platforms, I think before we're through with this multi-month event we're going to have another RVP, and that's going to include the novel 2019 coronavirus.

In the meantime, though, you basically have routine RVPs and the semi-automatic single analyte COVID PCR landing on the same machines. And so for us, as one of our technologists said, all the lights are on. If you're not running one cartridge, you're running another one.

And so that's, in essence, the bench of the lab. I've said a lot about your leadership command, staffing the leadership command, running a triage center so that you eliminate interruptions in the laboratory. And I should emphasize the fourth, which is it's going to take these same people to validate the new platforms, whether you're broadening your technologies across the semi-automated platforms or standing up. But we're one of the larger labs standing up one of the fully automated platforms. You're going to need to validate them.

If you are ambitious, you're not just validating the commercial cartridges, but you're also validating your own LDT where you draw up your own PCR primers. It's a multipronged approach to reduce your dependence on one supply chain, one point of failure. It's all happening simultaneously.

Triona Henderson: Thank you JZ is there a question in the chat? Because I am now sharing my screen and I cannot see it.

Johanzynn Gatewood: Yes. Well, it's not a question. It's just a comment from Bethany. She said that the FDA has given EUA to [INAUDIBLE], at least it's anticipated this week.

Triona Henderson: OK, thank you, Bethany. So Jim, we just want to really thank you again for shifting, and shifting, and shifting to accommodate us in this ECHO session. Our next scheduled ECHO session is on Wednesday April 22 at 1:00 PM Eastern Standard time. The discussion area is machine learning and hematopathology. This will be presented by Dr. Hooman Rashidi from the University of California Davis in Sacramento, California. Please visit the DLS ECHO website to register for this session and to view all future sessions.

We're also going to have the transcripts up for the last session and this session at the same ECHO website, so you'll have access to that. Thank you for taking part in our discussion today. We hope you found it valuable in the important work that you're engaged in with your individual laboratories. We look forward to your participation in future sessions, and we'll keep you posted on any changes that may occur due to the COVID-19 response. And now, we will adjourn. Thank you, and have a great day.

Additional resources and related publications

Laboratory 2.0/Project Santa Fe:

• Crawford JM, Shotorbani K, Sharma G et al. Improving American Healthcare Through "Clinical Lab 2.0": A Project Santa Fe Report. Academic pathology. 2017;4:2374289517701067.
• O'Reilly KB. Laboratory 2.0: Changing the conversation. CAP Today.
• Doering TA, Plapp F, Crawford JM. Establishing an evidence base for critical laboratory value thresholds. American journal of clinical pathology. 2014;142(5):617-28.

Laboratory Management/Testing in a Pandemic:

• Ginocchio CC, Zhang F, Manji R et al. Evaluation of multiple test methods for the detection of the novel 2009 influenza A (H1N1) during the New York City outbreak. Journal of clinical virology : the official publication of the Pan American Society for Clinical Virology. 2009;45(3):191-5.
• Crawford JM, Stallone R, Zhang F et al. Laboratory surge response to pandemic (H1N1) 2009 outbreak, New York City metropolitan area, USA. Emerging infectious diseases. 2010;16(1):8-13.

Blood Culture Practices:

• Khare R, Kothari T, Castagnaro J, Hemmings B, Tso M, Juretschko S. Active Monitoring and Feedback to Improve Blood Culture Fill Volumes and Positivity Across a Large Integrated Health System. Clinical infectious diseases: an official publication of the Infectious Diseases Society of America. 2020;70(2):262-268.
• Zaleski M, Erdman P, Adams J et al. Establishing a Long-Term Model for Analysis and Improvement of Underfilled Blood Culture Volumes. American journal of clinical pathology. 2019;151(2):164-170.
• Libertin CR, Sacco KA, Peterson JH. Education and coaching to optimise blood culture volumes: continuous quality improvement in microbiology. BMJ open quality. 2018;7(3):e000228.
• Coorevits L, Van den Abeele AM. Evaluation of the BD BACTEC FX blood volume monitoring system as a continuous quality improvement measure. European journal of clinical microbiology & infectious diseases: official publication of the European Society of Clinical Microbiology. 2015;34(7):1459-66.