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.
“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:
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.
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.
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.
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.”
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.
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
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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.
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
“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.
Healthcare System Disruption Impacts Providers, Including
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
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.”
“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 firstname.lastname@example.org.
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.
“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.”
“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.
“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
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
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:
C-suite Drivers: moderated by Mark Dixon, President of The Mark Dixon Group;
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.
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.
Changes That Will Impact All Clinical Laboratories
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
continued shift away from pure fee-for-service payment (volume) to value-based
reimbursement that rewards improved patient outcomes;
discussion regarding prevention of illnesses, chronic diseases, and personal
focus on primary care and proactive care;
advances in science and technology that will spark development of new healthcare
trend toward consumerism, as more patients pay a larger portion of their
healthcare expenses and shop for hospitals, doctors, and labs; and
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.
“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:
of clinical laboratories navigating the transition from volume to value-based
and update on fundamental changes coming to the US healthcare industry that
impact clinical laboratories;
case for demonstrating the value of clinical labs to healthcare organizations;
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.)