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Clinical Laboratories and Pathology Groups

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Critical Shortages of Supplies and Qualified Personnel During the COVID-19 Pandemic is Taking a Toll on the Nation’s Clinical Laboratories says CAP

As demand for SARS-CoV-2 coronavirus testing increases, leaders of the College of American Pathologists meet online to brainstorm possible solutions to the crisis

In September, the College of American Pathologists (CAP) began its series of “virtual media briefings” given by leading pathologists and physicians at the forefront of COVID-19 testing which are designed to “offer insights and straight talk” on the crisis confronting today’s clinical laboratories.

During the third virtual meeting on December 9, presenters discussed how the ever-increasing demand for COVID-19 testing has placed an enormous amount of stress on clinical laboratories, medical technologists (MTs), and clinical laboratory scientists (CLSs) responsible for processing the high volume of SARS-CoV-2 tests, and on the supply chains medical laboratories depend on to receive and maintain adequate supplies of testing materials.

The CAP virtual meetings, collectively titled, “The Rapidly Changing COVID-19 Testing Landscape: Where We Are/Where We Are Going,” are available for viewing on YouTube and Facebook.

Critical Supply Chain Deficiencies Hamstring Nation’s Clinical Laboratories

“As soon as we get one set of supplies, then it’s another set of supplies that we can’t get our hands on,” said Christine Wojewoda, MD, Clinical Pathologist and Associate Professor at the University of Vermont Medical Center, during the third CAP virtual briefing. “Right now, we’re very concerned that our lab can’t get pipette tips that have a certain filter in them to transfer patient samples into the tubes that we need, or the plates that we need to do the testing. If we can’t get the patient sample into where it needs to go, safely, without contaminating other patient samples, that’s a big issue.” 

Other members of the CAP panel concurred with Wojewoda and indicated that their clinical labs also are encountering supply chain challenges.

“It’s a daily battle,” said Amy Karger, MD, PhD, Clinical Pathologist and Associate Professor at University of Minnesota Physicians. “One of our managers spends hours a day making sure our lab has enough supplies, plastics, and chemicals to do the testing that we want to do. And he is often having to look for alternative solutions for COVID-19 testing, making phone calls, trying to find alternative products, and so we have a consistent worry about that.”

A June survey of CAP-accredited laboratories for COVID-19 testing found that more than 60% of lab directors reported difficulties in procuring critical supplies needed to conduct COVID-19 testing. The respondents indicated they encountered substantial barriers to obtaining equipment needed for SARS-CoV-2 testing—particularly test kits (69%), swabs (66%), and transport media (62%).

Staff Burnout and Shortages at Many Medical Laboratories

Karger also indicated that she is concerned about staff burnout and the toll the workload is taking on medical technologists at her laboratory. 

“Lab staff have been working full throttle since March. I think that is often lost on people. They kind of assumed that when cases were low with COVID-19, that maybe the lab staff got a break. Well, that wasn’t the case,” she stated, adding, “They [the medical technologists] were planning for this surge that we’re experiencing now and have been working often seven days a week, double shifts to get us to this point of high testing capacity [to respond to the demand for COVID-19 testing].” 

Another member of the CAP panel echoed Karger’s concerns.

“We worry about that as well,” said Patrick Godbey, MD, Founder and Laboratory Director at Southeastern Pathology Associates and current CAP President. “This demand for COVID-19 testing has made an already bad situation worse because there’s an absolute shortage of medical laboratory personnel and the increased demands on clinical labs have made this shortage even more acute.” 

Almost all of the surveyed CAP-accredited laboratories reported losses in revenue and financial stress since the pandemic started. But few had applied for any of the available funds offered through federal assistance programs. The survey found that the top issues among pathologists reported by laboratory directors were:

  • reduced work hours (72%),
  • reductions in pay (41%),
  • increased burnout (21%), and
  • increased work hours (20%).

According to the survey, the top stresses affecting non-pathologist professionals working in clinical labs were:

  • reduced work hours (69%),
  • reduced staff capacity (36%),
  • temporary furloughs (34%), and
  • increased burnout (31%).

‘An Overwhelming Sense of Doom’

Of course, clinical laboratory managers have been dealing with dwindling availability of qualified personnel for years, as one medical technologist training program after another closed and the supply of MTs and CLSs tightened. Dark Daily’s sister publication The Dark Report covered this trend as far back as 2012. (See, “GHSU Graduates Med Techs Using Distance Training: Medical Laboratory Scientist training program helps laboratories to recruit and to train MLSs.)

The diminishing labor pool trained for COVID-19 testing—coupled with high stress/burnout among existing staff—is a major impediment to ongoing expansion in the daily number of molecular COVID-19 tests that can be performed by the nation’s labs.

Also, the already-tight supply of med techs means many metropolitan area labs—particularly hospital labs—are operating with just 75% of the number of staff they are authorized to hire, because there are no techs available. Thus, existing staff are working lots of overtime, and vacant FTE positions are being temporarily filled by MTs placed by employment agencies.

A New York Times (NYT) article in December, titled, “‘Nobody Sees Us’: Testing-Lab Workers Strain Under Demand,” revealed that testing teams across the country are dealing with “burnout, repetitive-stress injuries, and an overwhelming sense of doom.” The article reported on the shortages of supplies needed to perform testing and states there is a “dearth of human power” in the field of pathology as well.

The supply of MTs and CLSs, molecular PhDs, clinical pathologists, MLTs, and other laboratory scientists available to work in the nation’s labs is finite and training programs take years to produce qualified workers to perform laboratory testing. 

Karissa Culbreath, PhD, Scientific Director, Infectious Diseases at TriCore Reference Laboratories
In the NYT article, microbiologist Karissa Culbreath, PhD (above), Scientific Director, Infectious Diseases at TriCore Reference Laboratories, and Assistant Professor of Pathology at the University of New Mexico, said that when shortages arise, “there are workarounds for almost everything else, but people are irreplaceable.” In addition to the large volume of COVID-19 tests that labs are expected to perform, they also must keep up with the other tests that are sent to them for analysis. Some facilities are even transitioning to 24/7 testing to keep up with the demand. “Labs are trying to maintain our standard of operation with everything else, with a pandemic on top of it,” said Culbreath. (Photo copyright: KOB 4/NBC.)

Should Clinical Lab Workers Be First to Receive the COVID-19 Vaccine?

In the third CAP virtual media briefing, the panel suggested that medical laboratory workers should be among the first to receive the COVID-19 vaccine.

“They are encountering and handling thousands of samples that have active live virus in them,” Karger said. “We are getting 10,000 samples a day [for SARS-CoV-2 testing]. That’s a lot of handling of infectious specimens and we do want them to be prioritized for vaccination.”

She added, “From an operational standpoint, we need to keep our lab up and running. We don’t want to have staff out such that we would have to decrease our SARS-CoV-2 testing capacity, which would have widespread impact on our health system and our state.”

Since the pandemic began nearly a year ago, there have been more than 18 million cases of COVID-19 confirmed in the US and more than 300,000 people have died from the virus, according to data from the federal Centers for Disease Control and Prevention (CDC).

And, as we move into flu season, the number of new COVID-19 cases is reportedly increasing, which adds more stress to clinical laboratories and their supply chains. As this is unlikely to end anytime soon, clinical lab managers must find new ways to do more with less.  

—JP Schlingman

Related Information:

The Rapidly Changing COVID-19 Testing Landscape: Where We Are/Where We Are Going

‘Nobody Sees Us’: Testing-Lab Workers Strain Under Demand

Clinical Laboratory COVID-19 Response Call

Pathologists Explore COVID-19 Testing Challenges, Breakthroughs

Labs Brace for Impact of Infection, COVID-19 Testing Surge as Thanksgiving Looms

Help Wanted at COVID-19 Testing Labs

Pathologists Want First Crack at COVID Vaccines

Clinical Laboratories Need Creative Staffing Strategies to Keep and Attract Hard-to-Find Medical Technologists, as Demand for COVID-19 Testing Increases

Clinical Laboratories Need Creative Staffing Strategies to Keep and Attract Hard-to-Find Medical Technologists, as Demand for COVID-19 Testing Increases

Critical shortages in medical laboratory workers and supplies are yet to be offset by new applicants and improved supply chains. But there is cause for hope.

Medical laboratory scientists (aka, medical technologists) can be hard to find and retain under normal circumstances. During the current coronavirus pandemic, that’s becoming even more challenging. As demand for COVID-19 tests increases, clinical laboratories need more technologists and lab scientists with certifications, skills, and experience to perform these complex assays. But how can lab managers find, attract, and retain them?

The Johns Hopkins Coronavirus Resource Center reports that as of mid-October more than one million tests for SARS-CoV-2 were being performed daily in the US. And as flu season approaches, the pandemic appears to be intensifying. However, supply of lab technologists remains severely constrained, as it has been for a long time.

An article in the Wall Street Journal (WSJ), titled, “Help Wanted at COVID-19 Testing Labs: Coronavirus Pandemic Has Heightened Longstanding Labor Shortages in America’s Clinical Laboratories,” reported that to address staff shortages “labs are grappling at solutions,” such as:

  • using traveling lab workers,
  • automation,
  • flexible scheduling, and
  • salary increases.

Still, qualified medical technologists (MT) and clinical laboratory scientists (CLS) are hard to find.

Demand for COVID Tests Exceeds Available Clinical Lab Applicants

“I can replace hardware and I can manage not having enough reagents, but I can’t easily replace a qualified [medical] technologist,” said David Grenache, PhD, Chief Scientific Officer at TriCore Reference Laboratories, Albuquerque, N.M., in the WSJ.

Another area where demand outstrips supply is California. Megan Crumpler, PhD, Laboratory Director, Orange County Public Health Laboratory, told the WSJ, “We are constantly scrambling for personnel, and right now we don’t have a good feel about being able to fill these vacancies, because we know there’s not a pool of applicants.”

In fact, according to an American Association for Clinical Chemistry (AACC) Coronavirus Testing Survey, 56% of labs surveyed in September said staffing the lab is one of the greatest challenges. That is up from 35% in May.

Are Reductions in Academic Programs Responsible for Lack of Available Lab Workers?

Recent data from the US Bureau of Labor Statistics (BLS) show 337,800 clinical laboratory technologists and technicians employed by hospitals, public health, and commercial labs, with Job Outlook (projected percent change in employment) growing at 7% from 2019 to 2029. This, according to the BLS’ Occupational Outlook Handbook on Clinical Laboratory Technologists and Technicians, is “faster than average.”

“The average growth rate for all occupations is 4%,” the BLS notes.

Medical laboratories have the most staff vacancies in phlebotomy (13%) and the least openings in point-of-care (4%), according to an American Society for Clinical Pathology 2018 Vacancy Survey published in the American Journal of Clinical Pathology (AJCP).

Becker’s Hospital Review reported that “Labor shortages in [clinical] testing labs have existed for years due to factors including low recruitment, an aging workforce, and relatively low pay for [medical] lab technicians and technologists compared to that of other healthcare workers with similar education requirements.

“In 2019, the median annual salary for clinical laboratory technologists and technicians was $53,000, according to the US Bureau of Labor Statistics. The skills required for lab workers also are often specialized and not easily transferred from other fields.”

At the “root” of the problem, according to an article in Medical Technology Schools, is a decrease in available academic programs. Laboratory technologists require a Bachelor of Science (BS) degree and technicians need an associate degree or post-secondary certificate.

Lisa Cremeans, MMDS, CLS(NCA), MLS(ASCP), Clinical Assistant Professor at University of North Carolina
“(The programs) are expensive to offer, so when it comes to cuts and budgets, some of those cuts have been based on how much it costs to run them. That, and they may not have high enough enrollments,” said Lisa Cremeans, MMDS, CLS(NCA), MLS(ASCP), Clinical Assistant Professor at University of North Carolina at Chapel Hill, in the Medical Technology Schools article. (Photo copyright: University of North Carolina.)

AACC has called for federal funding of these programs, which now number 608, down from 720 programs for medical laboratory scientists in 1990.

“The pandemic has shone a spotlight on how crucial testing is to patient care. It also has revealed the weak points in our country’s [clinical laboratory] testing infrastructure, such as the fact that the US has allowed the number of laboratory training programs to diminish for years now,” said Grenache, who is also AACC President, in a news release.

Creative Staffing Strategies Clinical Labs Can Take Now

Clinical laboratory managers need staffing and related solutions now. As Dark Daily recently reported in, “Three Prominent Clinical Laboratory Leaders Make the Same Prediction: COVID-19 Testing Will Be Significant Through 2020 and Throughout 2021,” prominent clinical labs are gearing up for dramatic increases in COVID-19 testing. This e-briefing was based on a 2020 Executive War College virtual session that covered how labs should prepare now so they can prosper clinically and financially going forward. That session can be download by registering here.

The final session of the 2020 Virtual Executive War College, 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,” took place on Thursday, Oct. 29, 2020. Given the importance of sound strategic planning for all clinical laboratories and pathology groups during their fall budget process, this session is being provided free to download for all professionals in laboratory medicine, in vitro diagnostics, and lab informatics.

To register for free access:

How Some Clinical Labs are Coping with Staff and Recruitment Challenges

The Arizona Chamber Business News reported that Sonora Quest Laboratories in Tempe earlier this year launched “Operation Catapult” to help with a 60,000 COVID-19 test increase in daily test orders. The strategy involved hiring 215 employees and securing tests with the help of partners:

Meanwhile, students in the UMass Lowell (UML) medical laboratory science (MLS) program, see brighter skies ahead.

“The job outlook even before COVID-19 was so amazing,” said Dannalee Watson, a UML MLS student, in a news release. “It’s like you’re figuring out a puzzle with your patient. Then, we help the doctor make decisions.”

Such enthusiasm is refreshing and reassuring. In the end, the SARS-CoV-2 pandemic and the resultant demand for clinical laboratory testing may call more students’ attention to careers in medical laboratories and actually help to solve the lab technologist/technician shortage. We can hope.

—Donna Marie Pocius

Related Information:

Help Wanted at COVID-19 Testing Labs

AACC COVID-19 Testing Survey: Full Survey Results

The American Society for Clinical Pathology’s 2018 Vacancy Survey of Medical Laboratories in the United States

Labs Squeezed for Staff to Meet COVID-19 Testing Demand

Medical Lab Scientist: Interview Clinical Worker Shortage

AACC Urges Congress to Fund Lab Training Programs to Prepare U.S. for Future Pandemics

Sonora Quest Pulls Out All Stops to Put Arizona in Front of COVID-19 Testing

Diagnostic Labs Eager to Hire UML Medical Lab Science Majors

Three Prominent Clinical Laboratory Leaders Make the Same Prediction: COVID-19 Testing Will be Significant Through 2020 and Throughout 2021

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

Federal Advisory Committee Seeks Public Comments on Revising CLIA Regulations, says Keynote Speaker at 13th Annual Lab Quality Confab in Atlanta

At The Dark Report’s annual Lab Quality Confab for clinical laboratory administrators, managers, and quality team members, experts outline how disruption in healthcare requires labs to improve processes and cut costs

ATLANTA, Oct. 15, 2019—Clinical laboratory professionals have a chance to advise the federal Centers for Disease Control and Prevention (CDC) on how the federal government could revise the regulations under the Clinical Laboratory Improvement Amendments of 1988 (CLIA). That’s according to one of the keynote speakers on Wednesday at The Dark Report’s 13th Annual Lab Quality Confab (LQC), which began here on Tuesday.

Reynolds M. Salerno, PhD, Director of the Division of Laboratory Systems (DLS) for the CDC in Atlanta, explained that the agency is collecting comments from the public and from its Clinical Laboratory Improvement Advisory Committee (CLIAC) on how to revise the CLIA regulations.

This is an opportunity for clinical laboratory directors, pathologists, and other lab professionals, to comment on the proposed revisions to CLIA before or during the upcoming CLIAC meeting on Nov. 6.

The agenda for the meeting is posted on the CDC’s website.

Public to be Heard on CLIA Regulations

“For the first time in its 26-year history, the council has called for three workgroups to address how to revise CLIA,” Salerno said. The workgroups will address these topics:

“It’s a dramatic step for the government to ask the laboratory community how to revise the CLIA regulations,” Salerno commented. Chartered in 1992, the advisory council meets twice a year, once in April and once in November.

CLIAC issued a summary report of its April 10-11 meeting. It also published an agenda for its upcoming meeting in Nov. 6.

In the coming weeks, Dark Daily will publish more information on how clinical laboratory professionals can comment on the important issue of CLIA revisions.

Digital slides from Salerno’s keynote address are posted on LQC’s presentations website.

Clinical Laboratory Testing is Increasing in Value, Keynote Speaker Says

As a service to clinical laboratories, Salerno outlined many of the services the CDC’s Division of Laboratory Systems provides for free to clinical labs, including information on such topics as:

During his remarks at the 13th Annual Lab Quality Confab in Atlanta, Salerno had good news for the clinical laboratory professionals in attendance. He said that lab testing was becoming a more valued commodity in healthcare because physicians and other providers were growing increasingly confident in lab test results. [Photo copyright: The Dark Report.]

Healthcare System Disruption Impacts Providers, Including Clinical Laboratories

Other keynote speakers addressed how disruption in the US healthcare systems affects provider organizations in significant ways. For clinical laboratories, such disruption has resulted in reduced payment and demands for quality improvement and shorter turnaround times.

For all these reasons, quality management systems may be every clinical laboratory’s best strategy to survive and thrive, the keynote speakers said.

The first keynoter was Robert L. Michel, Editor-in-Chief and Publisher of The Dark Report. Michel’s remarks focused on how price cuts from Medicare, Medicaid, private payers, and the drive for value-based payment, are requiring labs to do more with less. For this reason, quality management systems are necessary for all labs seeking to improve results, eliminate errors, and cut costs, he said.

“The people closest to the work know how to fix these problems,” he added. “That’s why labs know they must train their staff to identify problems and then report them up the chain so they can be fixed,” Michel commented. “Labs that are best at listening to their employees are getting very good at identifying problems by measuring results and monitoring and reporting on their own performance.”

Michel identified three principle factors that are disrupting healthcare:

  • The shift from reactive care in which the health system cares for sick patients to proactive care in which the health system aims to keep patients healthy and out of the hospital and other costly sites of care.
  • The transition away from fee-for-service payment that encourages providers to do more for patients, whether more care is needed or not, to value-based payment that aims to reward providers for keeping patients healthy.
  • The consolidation among hospitals, health systems, physicians, and other providers. A trend that requires clinical laboratories to find new partners and new ways to improve lab services and reduce costs.

Informatics Performance Data Help Clinical Laboratories Respond to Change

“The attributes of new and successful labs are that they will have faster workflow and shorter cycle times for clinical lab tests and anatomic pathology specimen results,” Michel explained. “That means that labs will attack non-value-added processes by implementing continuous improvement strategies [such as Lean and Six Sigma] and by the sophisticated use of informatics.”

Making use of performance data enables clinical laboratory directors to make changes in response to disruptions that affect healthcare. “If you have good informatics, then seven or eight of every 10 decisions you make will be good decisions, and with the other two and three decisions, you’ll have time to pull back and adjust,” Michel commented.

The second keynote speaker, Jeremy Schubert, MBA, MPH, Division Vice President of Abbott, reiterated what Michel said about how the health system is moving away from fee-for-service payment. Instead of focusing on caring for sick patients exclusively, he said, health insurers are paying all healthcare providers to keep patients healthy.

“Healthcare today is about the whole life course of the individual,” Schubert explained. “Patients no longer want healthcare only when they’re sick. Instead, they want to be healthy. And health creation is not just about a person’s physical health. It’s about their mental health, their emotional health, and their social wellbeing.

“In fact,” he continued, “you can learn more about a person’s health from their Zip code than from their genetic code.”

That is essentially what TriCore Reference Laboratories (TriCore) has been doing in New Mexico, Schubert added. During his presentation, Michel mentioned TriCore as being one of four clinical laboratories participating in Project Santa Fe, a non-profit organization that promotes the movement from Clinical Lab 1.0 to Clinical Lab 2.0. (See “TriCore Forges Ahead to Help Payers Manage Population Health,” The Dark Report, May 20, 2019.)

“If you want to be a quality engine in healthcare you have to be operating at Lab 2.0. Who is best qualified to interpret information? It’s the lab,” Schubert said. Then he challenged labs to begin pursuing the goal of achieving Lab 3.0, saying “Lab 3.0 is being able to interface with the patient to address each patient’s problems.”

The 13th Annual Lab Quality Confab (LQC) in Atlanta continues through the 17th with post-event workshops in Six Sigma and mastering quality management systems. In attendance are 300 clinical laboratory administrators, managers, and quality team members who are learning a complete array of professional training methods.

To register to attend, click here or enter https://www.labqualityconfab.com/register into your browser, or call 707-829-9485, or e-mail lqcreg@amcnetwork.com.

—Joseph Burns

Related Information:

Clinical Laboratory Improvement Advisory Committee Agenda for meeting Nov. 6

Clinical Laboratory Improvement Advisory Committee Summary Report

TriCore Forges Ahead to Help Payers Manage Population Health

Helping Medical Laboratories Add Value to Health Systems, Providers, and Payers by Moving from Clinical Lab 1.0 to Clinical Lab 2.0

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 https://dark.regfox.com/clinical-lab-20-workshop-by-project-santa-fe-foundation.

—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

Repositioning the Clinical Laboratory as a Strategic Pillar of the Value-Based Healthcare Organization, Consistent with Clinical Lab 2.0

Panel of experts in healthcare and the clinical laboratory market identify key trends and discuss how innovative medical laboratories are adding value—and getting paid for that value

Effective clinical laboratory leadership in today’s value-based healthcare system means demonstrating value within an integrated delivery network. After all, as fee-for-service payment for clinical lab tests gives way to value-added reimbursement arrangements, all medical laboratories will need to justify their share of a value-based payment.

But how can clinical laboratories alert physicians and their parent hospitals to the real value they offer to improve patient outcomes and reduce healthcare costs? Though lab leaders may understand their medical lab’s complexity, accessibility, and impact, the question is how to direct the effort. The answer lies in a risk that some laboratory directors may not have considered.

Value-based healthcare systems include hospital-based medical laboratories as an essential part of their integrated health system. And, to lower the cost of care, healthcare systems involved in value-based care know they must become better at coordinating care and offering precision medicine services to their patients.

Year-by-year, more integrated health systems are learning how to eliminate gaps in care and become more proactive in delivering care that helps keep patients healthy. However, the task of leveraging the clinical laboratory in a strategic approach to demonstrating value in those health systems remains daunting. One of the goals of the Clinical Lab 2.0 model developed by the Project Santa Fe Foundation clinical laboratory organization is to demonstrate how labs can achieve two goals:

  • Create added-value services that improve patient care; and
  • Have health insurers, accountable care organizations (ACOs), and health networks pay remuneration to the clinical labs for those added-value services.

Pathologists, Clinical Chemists, and MTs Leave Thy Medical Labs

Expert panelists of a recent webinar hosted by Dark Daily and sponsored by Sunquest Information Systems suggested ways that clinical laboratories could better position themselves to be an asset for their organizations. One way to do this is to get their clinical pathologists, PhDs, and medical technologists out of the lab and engaged with physicians, nurses, and other clinical staff in specific ways that influence the healthcare organization’s overall performance in delivering better patient outcomes at less cost.

“If your pathologists aren’t sitting on the medical informatics committee or the clinical quality-improvement committee or any one of the myriad things at the enterprise level, that’s going to be a risk for you,” said Michael J. Crossey, MD, PhD, CEO and Chief Medical Officer for TriCore Reference Laboratories, during the webinar “Listen, Learn, Lead: Uncover Ways You Can Position Your Lab as a Strategic Pillar of the Healthcare Organization.” 

“Our labs have to be equal partners instead of recipients of where things are going,” he stressed. “We need to be, if not in the driver’s seat, at least in the front seat.”

The expert webinar panelists included:

Mark Dixon (above), President of the Mark Dixon Group LLC, moderated the webinar, which was sponsored by Sunquest Information Systems  and The Dark Report, sister publication of Dark Daily. Dixon has more than 30-years’ experience as a health system CEO and COO. He said TriCore and other labs are succeeding at value-based healthcare using methods that are well-defined and available for all clinical laboratories to learn. For example: TriCore has found that certain health insurers are willing to not only pay their laboratory differently, but also meet with the lab’s pathologists and leaders to negotiate value-based care arrangements. (Photo copyright: Mark Dixon Group.)

Fundamental Changes That Will Impact All Clinical Laboratories

The panel speakers discussed how clinical laboratories can strategically position themselves to be successful in today’s evolving healthcare industry. They predicted several fundamental changes would take place or continue. These changes include:

  • A continued shift away from pure fee-for-service payment (volume) to value-based reimbursement that rewards improved patient outcomes;
  • More discussion regarding prevention of illnesses, chronic diseases, and personal responsibility;
  • More focus on primary care and proactive care;
  • Rapid advances in science and technology that will spark development of new healthcare applications;
  • Continued trend toward consumerism, as more patients pay a larger portion of their healthcare expenses and shop for hospitals, doctors, and labs; and
  • Intense cost pressure on healthcare organizations and their medical laboratories.

It was noted during the panel discussion that, even as the US spends more than any other country in the world on healthcare, it has some of the worst overall outcomes.

Customers Rapidly Becoming Stakeholders

“I always think in terms of stakeholders and the number one stakeholder for any clinical laboratory or healthcare system is always the customer,” said Peters. “The lab’s customer is the ordering physician. So, it’s important that labs ‘speak their language’ and understand that the physician’s customer is the patient.”

Clinical laboratories also must be aware of what a particular healthcare system is trying to accomplish. “Lab leaders should stay in constant touch with where the market is, where the system is, and where reform is,” said Oravetz. “And realize there are things that can be done today to set up for what’s coming tomorrow.”

Terese said that for a clinical laboratory to survive during this rapid transformation of the US healthcare system—or at least continue to thrive—it needs to engage with the strategic and clinical initiatives guiding every health system around the country. “There is tremendous opportunity for clinical laboratories to not only support that transition, but to actually help drive it,” he said. “There’s nothing wrong with thinking of your medical laboratory as a leader of these initiatives, versus just as a follower of what the organization is doing.”

Key elements of the webinar that will be of interest to clinical laboratories include:

  • Examples of clinical laboratories navigating the transition from volume to value-based care;
  • Discussion and update on fundamental changes coming to the US healthcare industry that impact clinical laboratories;
  • The case for demonstrating the value of clinical labs to healthcare organizations; and
  • Eight ways to elevate the value of clinical labs within an integrated healthcare network.

The experts on this special discussion panel agree that US healthcare and the clinical laboratory marketplace is in a time of transition. Pathologists and medical laboratory scientists have an opportunity to position themselves as leaders and changemakers to the benefit of patients, as well as their parent hospitals and health networks.

This free webinar can be a critical tool for leadership training within every clinical laboratory. It can be used to give lab managers and lab staff fresh insights into the changes happening in healthcare. Insights that can guide strategic planning and inspire laboratory-led projects to collaborate with physicians and improve patient care.

Download this webinar for free by clicking here. (Or, copy and paste this URL into your browser: https://darkintelligenceprogramsondemand.uscreen.io/programs/listen-learn-lead-uncover-ways-you-can-position-your-lab-as-a-strategic-pillar-of-the-healthcare-organization.)

—JP Schlingman

Related Information:

Free On-Demand Webinar: Listen, Learn, Lead: Uncover Ways You Can Position Your Lab as a Strategic Pillar of the Healthcare Organization

Ochsner Accountable Care Network Recognized Nationally for Quality and Efficiency

Defining Value—The Foundation of Outcomes-Based Risk-Sharing Agreements

Value-Based Contracts with Risk 3 to 5 Years Away for Providers

Humana’s New Oncology Value-Based Care Program Includes Quality and Cost Measurements of Provider Performance, Clinical Laboratories, and Pathology Groups

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