News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

Hosted by Robert Michel

News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

Hosted by Robert Michel
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Three Prominent Clinical Laboratory Leaders Make the Same Prediction: COVID-19 Testing Will Be Significant Through 2020 and Throughout 2021

CEOs of NorDx Laboratories, Sonora Quest Laboratories, and HealthPartners/Park Nicollet Laboratories expect demand for SARS-CoV-2 tests to only increase in coming months

AUSTIN, TEXAS—For clinical laboratories and anatomic pathology groups in the United States, the single most urgent question is this: how long will the need for substantial volumes of COVID-19 testing continue? Last Wednesday, that question was answered in a most definitive way by CEOs of three nationally-prominent clinical laboratory organizations during a general session of the virtual Executive War College on Clinical Laboratory and Pathology Management.

The short answer is that large volumes of COVID-19 testing will be needed for the remaining weeks of 2020 and substantial COVID-19 testing will occur throughout 2021 and even into 2022. This has major implications for all clinical laboratories in the United States as they plan budgets for 2021 and attempt to manage their supply chain in coming weeks. The additional challenge in coming months is the surge in respiratory virus testing that is typical of an average influenza season.

The title of this information-filled general session was “Coming Next to Clinical Laboratory and Pathology: A Robust Panel Discussion of How Labs Can Prosper Clinically and Financially Going Forward.” Chair and Moderator for the panel was Robert L. Michel, Publisher and Editor-in-Chief of The Dark Report and Dark Daily.

Panel is David Dexter and Stan Schofield and Rick L. Panning

The panelists were:

Each panelist was asked how his parent health system and clinical laboratory was preparing to respond to the COVID-19 pandemic through the end of 2020 and into 2021.

First to answer was Panning, whose laboratory serves the Minneapolis-Saint Paul market.

A distinguishing feature of healthcare in the Twin Cities is that it is at the forefront of operational and clinical integration. Competition among health networks is intense and consumer-focused services are essential if a hospital or physician office is to retain its patients and expand market share.

Panning first explained how the pandemic is intensifying in Minnesota. “Our state has been on a two-week path of rising COVID-19 case numbers,” he said. “That rise is mirrored by increased hospitalizations for COVID-19 and ICU bed utilization is going up dramatically. The number of hospitalized COVID-19 patients has doubled during this time and Minnesota is surrounded by states that are even in worse shape than us.”

These trends are matched by the outpatient/outreach experience. “We are also seeing more patients use virtual visits to our clinics, compared to recent months,” noted Panning. “About 35% of clinical visits are virtual because people do not want to physically go into a clinic or doctor’s office.

“Given these recent developments, we’ve had to expand our network of specimen collection sites because of social distancing requirements,” explained Panning. “Each patient collection requires more space, along with more time to clean and sterilize that space before it can be used for the next patient. Our lab and our parent health system are focused on what we call crisis standards of care.

“For all these reasons, our planning points to an ongoing demand for COVID-19 testing,” he added. “Influenza season is arriving, and the pandemic is accelerating. Given that evidence, and the guidance from state and federal officials, we expect our clinical laboratory will be providing significant numbers of COVID-19 tests for the balance of this year and probably far into 2021.”

 COVID-19 Vaccine Could Increase Antibody and Rapid Molecular Testing

Arizona is seeing comparable increases in new daily COVID-19 cases. “There’s been a strong uptick that coincides with the governor’s decision to loosen restrictions that allowed bars and exercise clubs to open,” stated Dexter. “We’ve gone from a 3.8% positivity rate up to 7% as of last night. By the end of this week, we could be a 10% positivity rate.”

Looking at the balance of 2020 and into 2021, Dexter said, “Our lab is in the midst of budget planning. We are budgeting to support an increase in COVID-19 PCR testing in both November and December. Arizona state officials believe that COVID-19 cases will peak at the end of January and we’ll start seeing the downside in February of 2021.”

The possible availability of a SARS-CoV-2 vaccine is another factor in planning at Dexter’s clinical laboratory. “If such a vaccine becomes available, we think there will be a significant increase in antibody testing, probably starting in second quarter and continuing for the balance of 2021. There will also be a need for rapid COVID-19 molecular tests. Today, such tests are simply unavailable. Because of supply chain difficulties, we predict that they won’t be available in sufficient quantities until probably late 2021.”

COVID-19 Testing Supply Shortages Predicted as Demand Increases

At NorDx Laboratories in Portland, Maine, the expectation is that the COVID-19 pandemic will continue even into 2022. “Our team believes that people will be wearing masks for 18 more months and that COVID-19 testing with influenza is going to be the big demand this winter,” observed Schofield. “The demand for both COVID-19 and influenza testing will press all of us up against the wall because there are not enough reagents, plastics, and plates to handle the demand that we see building even now. 

“Our hospitals are already preparing for a second surge of COVID-19 cases,” he said.

COVID-19 patients will be concentrated in only three or four hospitals. The other hospitals will handle routine work. Administration does not want to have COVID-19 patients spread out over 12 or 14 hospitals, as happened last March and April.

“Administration of the health system and our clinical laboratory think that the COVID-19 test volume and demand for these tests will be tough on our lab for another 12 months. This will be particularly true for COVID-19 molecular tests.”

As described above, the CEOs of these three major clinical laboratories believe that the demand for COVID-19 testing will continue well into 2021, and possibly also into 2022. A recording of the full session was captured by the virtual Executive War College and, as a public service to the medical laboratory and pathology profession, access to this recording will be provided to any lab professional who contacts and provides their email address, name, title, and organization.

Executive War College Closing Session

This week’s closing general session of the virtual Executive War College also will deal with the current state of the clinical laboratory industry and bring together three notable lab industry leaders and thinkers. The session, titled “What Comes Next in Healthcare and Laboratory Medicine: Essential Insights to Position Your Clinical Lab and Pathology Group for Clinical and Financial Success, Whether COVID or No COVID,” takes place Thursday, Oct. 29, 2020, from 2:00 PM to 3:00 PM Eastern.

Your presenters will be:

Given the importance of sound strategic planning for all clinical laboratories and pathology groups during their fall budget process, the virtual Executive War College is opening this session to all professionals in laboratory medicine, in vitro diagnostics, and lab informatics.

To register for access, visit: Enter the code: COURTESYCAPTDR. Next, select “apply code” and complete the registration.

—Michael McBride

Related Information:

Coming Next to Clinical Laboratory and Pathology: A Robust Discussion of How Labs Can Prosper Clinically and Financially Going Forward

Expert Panel—What Comes Next in Healthcare and Laboratory Medicine: Essential Insights to Position your Clinical Lab and Pathology Group for Clinical and Financial Success, COVID or No COVID

Clinical Lab 2.0 Advances as Project Santa Fe Foundation Secures Nonprofit Status, Prepares to Share Case Studies of Medical Laboratories Getting Paid for Adding Value

Clinical laboratory leaders interested in positioning their labs to be paid for added-value services will get knowledge, insights, and more at upcoming third annual Clinical Lab 2.0 Workshop in November

It’s a critical time for medical laboratories. Healthcare is transitioning from a fee-for-service payment system to new value-based payment models, creating disruption and instability in the clinical lab test market. In addition, payers are cutting reimbursement for many lab tests.

These are among the market factors leading some pathologists and clinical lab leaders to seek new or alternative sources of revenue to keep the lights on and the machines running in their laboratories. Some might say, it’s a dark time for the lab industry.

However, in an exclusive interview with Dark Daily, Khosrow Shotorbani, President and Executive Director of the Project Santa Fe Foundation (PSFF) and founder of the Clinical 2.0 movement, said clinical laboratories should not fear the future. 

“This is not the time to be shy or timid,” he declared. “The quantitative value of medical laboratory domain is significant and will be lost if not exploited or leveraged.”

Shotorbani has reason to be positive. In recent years the Project Santa Fe Foundation (PSFF) has emerged to advocate for, and teach, the Clinical Lab 2.0 model. Clinical Lab 2.0 is an approach which focuses on longitudinal clinical laboratory data to augment population health in new payment arrangements.

Earlier this year, PSFF filed for 501(c) status, according to a news release. It is now positioned as a nonprofit organization, guided by a board of directors whose mission is “to create a disruptive value paradigm and alternative payment model that defines placement of diagnostic services in healthcare.”

Progressing Toward Clinical Lab 2.0

At the 24th Annual Executive War College on Lab and Pathology Management held in New Orleans last May, the nation’s first ever Clinical Lab 2.0 “Shark Tank” competition was won by Aspenti Health, a full-service diagnostic laboratory specializing in toxicology screening.

“This project, as well as all of the other cases that were presented, were quite strong and all were aligned with the mission of the Clinical Lab 2.0 movement,” said Shotorbani, in a news release. “This movement transforms the analytic results from a laboratory into actionable intelligence at the patient visit in partnership with front-liners and clinicians—allowing for identification of patient risks—and arming providers with insights to guide therapeutic interventions.

“Further, it reduces the administrative burden on providers by collecting SDH [social determinants of health] predictors in advance and tying them to outcomes of interest,” he continued. “By bringing SDH predictors to the office visit, it enables providers to engage in SDH without relying on their own data collection—a current care gap in many practices. The lab becomes a catalyst helping to manage the population we serve.”

Aspenti Health’s Shark Tank entry, “Integration of the Clinical Laboratory and Social Determinants of Health in the Management of Substance Use,” focused on the social factors tied to the co-use of opioids and benzodiazepines, a combination that puts patients at higher risk of drug-related overdose or death.

The project revealed that the top-two predictors of co-use were the prescribing provider practice and the patient’s age.

“They did an interesting thing—what clinical laboratories alone cannot do—the predictive value of lab test data mapped by zip code for patients admitted in partnership with social determinants of health. This helps to create delivery models to potentially help prevent opioid overdose,” said Shotorbani, who sees economic implications for chronic conditions.

“If clinical laboratories have that ability to do that in acute conditions such as opioid overdose, what is our opportunity to use lab test data in chronic conditions, such as diabetes? The cost of healthcare is in chronic conditions, and that is where clinical lab data has an essential role—to support early detection and early prevention,” he added.

“This is often described as the transition from volume to value because this trend will fundamentally change how all clinical laboratories and anatomic pathology groups are paid,” said Khosrow Shotorbani (above), MBA, MT(ASCP), Executive Director of the Project Santa Fe Foundation (PSFF), during his presentation at the 22nd annual Executive War College in New Orleans. “This shift from volume to value also will create new winners and losers in the clinical lab industry,” he declared. “Not every lab organization will take the timely action required to introduce the value-based laboratory testing services that hospitals, physicians, and payers will need. (Photo copyright: Albuquerque Business First.)

Clinical Laboratory Data is Health Business Data

One clinical laboratory working toward that opportunity is TriCore Reference Laboratories in Albuquerque, N.M. It recently launched Diagnostic Optimization with the goal of improving the health of their communities.

“TriCore turned to this business model,” Shotorbani explained. “It is actively pursuing the strategy of intervention, prevention, and cost avoidance. TriCore is in conversation with health plans on how its lab test data and other data sets can be combined and analyzed to risk-stratify a population and to identify care gaps and assist in closing gaps.

“Further, TriCore is identifying high-risk patients early before they are admitted to hospitals and ERs—the whole notion of facilitating intervention between the healthcare provider and the potential person who may get sick,” he added. “These are no longer theoretical goals. They are realizations. Now the challenge is for Project Santa Fe to help other lab organizations develop similar value-added collaborations in their communities.”

Renee Ennis, TriCore’s Chief Financial Officer, told American Healthcare Leader, “Women go in (to an ER) for some condition, and the lab finds out they are pregnant before anyone else,” she said, adding that TriCore reaches out to insurers who can offer care coordinators for prenatal services.

“There is definitely a movement within the industry in this direction [of Clinical Lab 2.0],” she added. “But others might not be moving as quickly as we are. As a leader in this transition, I think a lot of eyes are on what we are doing and how we are doing it.”

Why Don’t More Lab Leaders Move Their Labs to Clinical Lab 2.0?

So, what holds labs back from pursing Clinical Lab 2.0? Shotorbani pointed to a couple of possibilities:

  • A lab’s traditional focus on volume while not developing partnerships (such as with pharmacy colleagues) inside the organization; and
  • Limited longitudinal data due to a provider’s sale of lab outreach services or outsourcing the lab.

“The whole notion of Clinical Lab 2.0 is basically connecting the longitudinal data—the Holy Grail of lab medicine. That is the business model. Without the longitudinal view, the ability to become a Clinical Lab 2.0 is extremely limited,” added Shotorbani.

New Clinical Lab 2.0 Workshop Focuses on Critical ‘Pillars’

Project Santa Fe Foundation will host the Third Annual Clinical Lab. 2.0 Workshop in Chicago on November 3-5. New this year are sessions aligned with Clinical Lab 2.0 “pillars” of leadership, standards, and evidence. The conference will feature panels addressing:

Click here to register online for this informative workshop, or place this URL in your browser

—Donna Marie Pocius

Related Information:

Project Santa Fe Foundation Files for 501( c) Status, Expands Board of Directors

Aspenti Health Wins Clinical Lab 2.0 Innovation Award Demonstrating the Clinical Laboratory as a First Responder to the Opioid Crisis

Renee Ennis Wants Lab to A Have a Seat at the Table

Aspenti Health Takes Home Grand Prize in Nation’s First Clinical Lab 2.0 Shark Tank Competition Showcasing Added Value, Clinical Success Stories

New At-Home CBC Device Enables Complete Blood Testing for Cancer Treatments and Biological/Viral Monitoring

Chronic disease monitoring at home has become a boon to patients as well as hospitals that are finding cost savings in programs designed to monitor/treat patients at external locations

Many clinical pathologists and medical laboratory scientists will be wary about the news that a California company wants to have cancer patients do their own CBCs at home, and  that a device to enable such testing is being prepped to go through the FDA clearance process.

Home-based medicine care and chronic disease therapy treatments are gaining in popularity. Patients, understandably, would prefer to stay in the comfort of their homes then be exposed to stressful, germ-laden healthcare environments. And healthcare providers are finding cost savings in home-healthcare programs, which Dark Daily recently reported.

However, each new breakthrough in home medical care impacts clinical laboratories when specimen collection, near-patient medical laboratory testing, and therapy administration/monitoring shifts from traditional healthcare environments to home settings.

Nevertheless, new devices that enable chronic disease patients to monitor and report findings to care providers continue to be developed and embraced by healthcare consumers.

Complete Blood Count at Home

One such device from Athelas, a diagnostic test developer based in Mountain View, Calif., makes it easier and less expensive for patients undergoing cancer therapy to monitor their complete blood counts (CBC) at home without the need to travel to a doctor or medical laboratory to have the blood work performed, Medgadget reported. The device, which is undergoing the FDA Class 2 clearance process, enables patients to test their complete blood count (CBC) in the privacy of their own homes and report the results to their oncologists.

Athelas co-founders Tanay Tandon (left) and Deepika Bodapati (right) secured $3.7 million in funding from Sequoia Capital, Y Combinator, and NVIDIA, to produce their blood analysis device. (Photo copyright: Sina.)

To use the Athelas device, patients perform a simple finger prick and place a drop of blood on a proprietary testing strip. The strip is then inserted into the device where the blood is analyzed. Patients can view their lab-grade blood test results in about a minute.

Information gathered by the device can be sent to Android or iOS devices/apps and also to the patient’s doctor. The process allows patients and their doctors to receive frequent updates for monitoring treatments and disease progression and precisely observe changes in immune health.

According to Athelas, in about 60 seconds the blood analyzer provides accurate reading for:

“Athelas is bringing cancer patients a quick and reliable way to test their blood levels from within their home,” noted Alfred Lin, partner at Sequoia, in a statement. “Their new platform empowers patients to confidently monitor their condition and will cut down on unnecessary urgent care visits. We believe in Tanay and Deepika’s bold vision to transform at-home blood tests into an easy and accurate diagnostics tool that’s as trusted as a thermometer.”

The home-testing platform will cost consumers $20 per month, which Athelas hopes will eventually be covered by insurance companies.

Additional Benefits to At-Home Monitoring

The Athelas device also has functions beyond chronic disease monitoring. It can be used to determine if a viral or bacterial infection is present in an individual. In addition, the company is currently testing the machine with 100 patients at risk for a cardiac event to evaluate whether or not it can predict such an event days before it occurs.

“There’s a lot of research out there that shows inflammatory markers inside your own body will spike a couple days in advance,” Tandon told TechCrunch.

In the video above, Deepika Bodapati, co-founder of Athelas, describes how the diagnostic device operates. Click on the image above to view the video. (Video copyright: TechCrunch.)

The Athelas device is not yet cleared to market by the Food and Drug Administration (FDA) and more clinical research may be needed to validate the efficacy of the product. Athelas is currently loaning the device to cancer patients for the purpose of monitoring their chemotherapy progress, and is conversing with healthcare professionals, hospitals, and pharmaceutical companies regarding the benefits of the device.

Other CBC Devices

In 2017, Sysmex America announced it had received clearance from the FDA for the Sysmex XW-100 hematology analyzer, the first CBC system that allows in-house staff to perform CBC tests at Clinical Laboratory Improvement Amendments (CLIA)-waived locations. The Dark Report reported on this last year. (See TDR, “FDA Clears Waived CBC For Near-Patient Testing,” November 20, 2017.”

The XW-100 device enables physicians to perform in-office blood tests and receive results in as little as three minutes. This allows treatment plans to be initiated without interacting with clinical laboratories, which clearly impacts test ordering and lab revenue.

At-home and onsite blood testing devices serve an important role in patient care and provide healthcare professionals with expeditious and convenient test results. However, with the arrival of these new technologies, clinical laboratories will need to find new ways to bring value to physicians who employ them in their offices.

—JP Schlingman

Related Information:

Athelas Device Provides Accurate CBC Testing—From Home

Athelas Launches a New Type of Blood Testing Device for the Home

Precise Blood Testing from a Fingerprick? Tanay Tandon and Deepika Bodapati Think It’s Possible

Athelas Releases Automated Blood Testing Kit for Home Use

Athelas Announces $3.7m Funding Led by Sequoia Capital

Primary Care Doctors Can Provide Blood Test Results in Minutes, Onsite, With New Sysmex XW-100

Is Your Laboratory Performing at “World Class” Quality, as Measured by Emerging Benchmarks?

Is your laboratory a “world class” performer? You will soon have an objective and universal benchmark to gauge your laboratory’s performance against peers and competitors.  Dark Daily predicts it will be a measure of laboratory performance defined in Six Sigma terms.

This insight emerged during The Dark Report’s participation at the DIAmante Laboratory Conference in Cartagena, Colombia earlier this month. DIAmante featured speakers from Spain, the United States, and Colombia discussing ways that laboratories could add value to clinicians and the health systems they serve. The meeting was produced by Roche Diagnostics and Sysmex America and was attended by laboratory administrators from 13 nations in Central America and the Caribbean.

Many of you understand the key principle of a Six Sigma quality management system. It is to re-engineer and improve work processes that generate a statistically-predictable level of outcomes. The outcomes are measured by looking at the number of errors or non-conforming events per one million events. Thus, a work process producing 66,807 defects per million is performing at three sigma. A work process producing just 3.4 defects per million is performing at six sigma.

When Dr. Alba Garzón of Laboratorio Medico Echavarria in Bogota, Colombia presented the successes of Six Sigma projects in her laboratory, she made a profound statement. “Six Sigma measurements now give me an objective way to measure the performance of my clinical laboratory against any other clinical laboratory in the world,” she told the audience. “If the rate of bar code errors at reception (accessioning) is 5.5 sigma in my laboratory, for example, that gives me a common way to evaluate that performance against any other clinical laboratory which also measures the rate of bar code errors at reception in parts per million.”

Dr. Garzón’s insight shows that the measurement of laboratory work processes in terms of defects per million, using a sigma scale, is already on its way to becoming a method for laboratories to compare their operational performance and quality with that of other laboratories. This is a development of major significance. Use of sigma measurement systems to evaluate work process and quality outcomes in the laboratory is likely to supplant some existing methodologies. As laboratory directors and pathologists know, many peer comparison programs fall short of creating the common performance benchmarks that laboratory leaders sought as a way to judge their laboratory’s quality and productivity against peer laboratories.

Finally, Dark Daily offers another insight. The fact that a clinical laboratory in Bogota, Colombia is ready to use errors per million to evaluate its performance against other laboratories in the world shows how laboratory operations are likely to converge across the globe. This convergence will be the subject of an intelligence briefing in the December 18 issue of The Dark Report.

Acknowledgements: Several individuals with foresight and hard work collaborated to make the DIAmante meeting in Cartagena, Colombia a success.  Recognition should go to Frank Mrongowius, Roche Diagnostic’s General Manager for Central America and the Caribbean, Patricia Monzo, Product Manager for the same region, and Ricardo del Valle of the Marketing Group.

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