CAP president maintains medical laboratory staff are ‘indispensable’ in pandemic fight and should be in ‘top tier’ for vaccination
As COVID-19 vaccinations continue to roll out, the College of American Pathologists (CAP) is lobbying for clinical pathologists and medical laboratory staff to be moved up the priority list for vaccinations, stating they are “indispensable” in the pandemic fight.
In a news release, CAP’s President Patrick Godbey, MD, FCAP argued for the early vaccination of laboratory workers, “It is essential that early access to the vaccine be provided to all pathologists and laboratory personnel,” he said. “Pathologists have led throughout this pandemic by bringing tests for the coronavirus online in communities across the country and we must ensure that patient access to testing continues. We must also serve as a resource to discuss the facts about the vaccine and answer questions patients, family members, and friends have about why they should get the vaccine when it is available to them.”
Who Does CDC Think Should Be First to Be Vaccinated?
According toThe New York Times (NYT), there are an estimated 21 million healthcare workers in the United States, making it basically “impossible,” the NYT wrote, for them all to get vaccinated in the first wave of COVID-19 vaccinations.
A December 11, 2020, CDC Morbidity and Mortality Weekly Report, titled, “ACIP Interim Recommendation for Allocating Initial Supplies of COVID-19 Vaccine—United States, 2020,” notes that “The [federal] Advisory Committee on Immunization Practices (ACIP) recommended, as interim guidance, that both 1) healthcare personnel and 2) residents of long-term care facilities be offered COVID-19 vaccine in the initial phase of the vaccination program.”
The ACIP report defines healthcare personnel as “paid and unpaid persons serving in healthcare settings who have the potential for direct or indirect exposure to patients or infectious materials.”
However, a CDC terminology guidance document listed at the bottom of the ACIP report states, “For this update, HCP [Healthcare Personnel] does not include dental healthcare personnel, autopsy personnel, and laboratory personnel, as recommendations to address occupational infection prevention and control (IPC) services for these personnel are posted elsewhere.”
In part, the letter stated, “We are convinced that ACIP did not intend to exclude any healthcare workers from its recommendation to offer vaccinations to healthcare personnel in the initial phase of the COVID-19 vaccination program (Phase 1a). However, we would hate for jurisdictions to overlook dental, autopsy, and laboratory personnel because of a minor footnote in [CDC] guidance that was developed for an entirely different purpose (i.e., infection control).
“We respectfully ask CDC to clarify,” the letter continues, “… that all healthcare workers—including dental, autopsy, and laboratory personnel—are among those who should be given priority access to vaccine during the initial phase of the COVID-19 vaccination program.”
“In the laboratory, they are encountering and handling thousands of samples that have active live virus in them,” said Karger, who called clinical laboratory staff and phlebotomists the “forgotten” frontline healthcare workers. “We’re getting 10,000 samples a day. That’s a lot of handling of infectious specimens, and we do want [staff] to be prioritized for vaccination.”
Karger continued to stress the vital role clinical laboratories play not only in COVID-19 testing but also in the functioning of the overall health system. She added that staff burnout is a concern since laboratory staff have been working “full throttle” since March.
“From an operational standpoint, we do need to keep our lab up and running,” she said. “We don’t want to have staff out such that we would have to decrease our testing capacity, which would have widespread impacts for our health system and state.”
Testing for Post-Vaccine Immunity
The CAP panelists also highlighted the need to prepare for the aftermath of widespread COVID-19 vaccinations—the need to test for post-vaccine immunity.
“It’s not routine practice to check antibody levels after getting a vaccine but given the heightened interest in COVID testing, we are anticipating there is going to be some increased in demand for post-vaccine antibody testing,” Karger said. “We’re at least preparing for that and preparing to educate our providers.”
Karger pointed out that clinical pathologists will play an important role in educating providers about the type of antibody tests necessary to test for COVID-19 immunity, because, she says, only the SARS-CoV-2 spike protein antibody test will check for an immune response.
With the pandemic expected to stretch far into 2021, clinical laboratories will continue to play a crucial role in the nation’s healthcare response to COVID-19. As essential workers in the fight against infectious disease, clinical pathologists, clinical chemists, and all medical laboratory staff should be prioritized as frontline healthcare workers.
As coronavirus pandemic emerged, the Minnesota reference laboratory surged its testing capacity from 2,600 to 20,000 samples per day in an effort to meet ever-increasing demand
Over the past several years, medical laboratory workforce shortages worldwide have challenged clinical laboratory managers to process increasing numbers of clinical laboratory tests with fewer staff. But that did not prepare them for the Herculean task of processing millions of tests each week! According to the CDC’s COVID Data Tracker, as of January 11, 2021, labs nationwide have processed 264,642,631 PCR tests since the start of the SARS-CoV-2 pandemic.
How were medical laboratories able to ramp up their processing capability so quickly? Here’s one example.
A Massive Undertaking at Mayo Clinic Laboratories
On March 12, 2020, Mayo Clinic Laboratories (Mayo) of Rochester, Minn., became one of the first hospital-affiliated reference labs in the country to develop a test for the SARS-CoV-2 coronavirus. At that time, the Minneapolis Star Tribune reported, Mayo was processing 200 to 300 COVID-19 tests/day. By late March through early April, 5,000 to 6,000 COVID-testing samples were arriving daily, but the lab’s capacity topped out at 2,600 samples/day. Today, however, Mayo Clinic Laboratories processes 20,000 samples each day.
How did the Mayo increase its capacity to meet unprecedented demand for COVID-19 testing? According to the Rochester Post Bulletin (Post Bulletin) the laboratory’s tenfold increase in testing capacity “required a massive undertaking of planning, hiring, construction, acquisition of equipment, and a lot of imagination and adaptation.”
The Post Bulletin reported that Mayo Clinic Laboratories started with one advantage—it already owned two automated Roche cobas SARS-CoV-2 systems that had received emergency-use authorization (EUA) from the FDA in March to test for the novel coronavirus.
But as demand for processing kits rose worldwide, the clinical laboratory could obtain only enough kits to process 4,500 tests per day, effectively limiting testing capacity to half, the Post Bulletin reported.
Mayo responded to the supply-chain disruptions by adding less-automated platforms to their testing arsenal. But using systems that required more manpower and took longer to process tests meant lab managers needed to hire even more staff.
During a two-week span in November, the laboratory added 180 new staff, four times the number of new hires in a typical year. To get new hires on the lab floor faster, a two-week orientation course was transformed into a condensed one-day training session. Other spots were filled by employees transferring in from other departments.
“It was kind of crazy. The size of the lab area just kept growing and growing,” said Ben Larson—who volunteered to move from his job as a lab processing assistant to a crew that processed COVID-19 samples in the Hepatitis/HIV Molecular Laboratory—in a Mayo Clinic Laboratories Insights blog post. “I thought it was cool, seeing all the COVID news and being able to say, ‘I’m actually working in the lab that’s doing the testing.’ It’s something I’ll tell my kids and grandkids. When there was the huge pandemic, I was working at Mayo Clinic as one of the people on the frontlines.”
Linda Spiten, Operations Administrator, Mayo Clinic Department of Laboratory Medicine and Pathology (DLMP), credits much of the lab’s success to the 400 DLMP staffers who shifted to different roles for the COVID transformation.
“We were definitely building the car as it was rolling down the street, because so much was hitting us so fast. But our staff is resilient and gracious. Knowing we didn’t have all the answers, but trusting, they took a leap of faith that we could work it out,” she said in the Insights blog post. “Many people made many sacrifices to work nights and weekends. We had people in labs working for weeks on end training in new folks, so we could make sure we had people ready to go. It was incredible.”
Clinical Laboratory Staff Shortages a Widespread Problem
Mayo Clinic Laboratories is not alone in facing supply-chain interruptions and staffing shortages during the pandemic. An Association for Molecular Pathology (AMP) survey in August of 2020 revealed the extent of the problem. More than 85% of respondents reported supply chain interruptions had delayed and/or decreased testing. The shortages most often cited were:
swabs (60%),
transport media (53%),
testing kits (34%),
reagents (33%),
testing platforms (32%).
Eighty-five percent of those surveyed said they have staffing shortages as well:
more than half (53%) reported not having enough medical technicians.
To manage these shortages, Mayo Clinic Laboratories found innovative ways to transform its operations. The Post Bulletin noted the lab implemented an employee’s suggestion to mark lab coats with color-coded duct tape, so that new hires could more easily identify supervisors’ roles and departments.
The need for added refrigeration was solved by parking 53-foot refrigerated trucks at the lab for storage of up to 15,000 pounds of dry ice each week, a changed that necessitated installing new doors on the building.
And according to the American Association of Clinical Chemistry (AACC), Mayo Clinic Laboratories also added a third shift to the workday to increase capacity and enable lab technologists to work spaced six feet apart.
“This management team has taught us to think on our feet,” lab worker Jane Masching told the Post Bulletin.
Infectious Disease Specialist Joseph Yao, MD, was tasked with coordinating the surge in Mayo Clinic’s testing capacity to 20,000 samples a day, an amount that still falls short of demand.
“I said we had better be prepared for the worst,” Yao told the Post Bulletin, noting the lab has received up to as many as 50,000 COVID test samples in a single day. “We’re still 15, 20 thousand behind. We’re always behind by about 24 hours.”
But some say there is reason to remain positive. Though the COVID-19 pandemic has clearly stretched clinical laboratories’ ingenuity, staffing, and workflow, Christopher Doern, PhD (above), Director of Clinical Microbiology at Virginia Commonwealth University School of Medicine in Richmond, Va., believes there is a silver lining for the clinical laboratory profession. He says the general public now has firsthand knowledge of the value of clinical laboratory medicine and its important role in patient care.
Nevertheless, while Mayo Clinic Laboratories is a prime example of how an organization can bring together the resources needed to meet the demand for COVID-19 tests, many clinical laboratories in the United States still struggle to hire more staff for the lab, as well as to obtain the needed volume of SARS-CoV-2 test kits and supplies.
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.”
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.
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 hospitals where results of molecular COVID-19 testing can take up to several days to return, this new method for identifying potentially infected patients could improve triage
Frustrated by shortages of essential COVID-19 tests and supplies—as well by lengthy coronavirus test turn-around times—researchers at Weill Cornell Medicine have created an Artificial Intelligence (AI) algorithm that can use routine clinical laboratory test data to determine if a patient is infected with SARS-CoV-2, the coronavirus that causes the COVID-19 disease.
This is an important development because the turn-around-time (TAT) for common lab tests is generally much shorter than COVID-19 molecular diagnostics—such as real-time reverse transcription polymerase chain reaction (RT-PCR), currently the most popular coronavirus test—and certainly serological (antibody) diagnostics, which require an infection incubation time of as much as 10-14 days before testing.
Some RT-PCR diagnostic tests for COVID-19, which detect viral RNA on nasopharyngeal swab specimens, can take up to several days to return depending on the test and on the lab’s location. But routine medical laboratory tests generally return much sooner, often within minutes or hours, making this a potential game-changer for triaging infected patients.
Machine Learning Brings AI to COVID-19 Diagnostics
Advances in the use of AI in healthcare have led to the development of machine-learning algorithms that are being utilized as diagnostic tools for anatomic pathology, radiology, and for specific complex diseases, such as cancer. The Weill Cornell scientists wanted to see if alternative lab test results could be used by an algorithmic model to identify people infected with the SARS-CoV-2 coronavirus.
To perform the research, the team incorporated patients’ age, sex, and race, into a machine learning model that was based on results from 27 routine lab tests chosen from a total of 685 different tests ordered for the patients. The study included 3,356 patients who were tested for SARS-CoV-2 at New York-Presbyterian Hospital/Weill Cornell Medical Center between March 11 and April 29 of this year. The patients ranged in ages from 18 to 101 with the mean age being 56.4 years. Of those patients, 1,402 were RT-PCR positive and the remaining 1,954 were RT-PCR negative.
Using a machine-learning technique known as a gradient-boosting decision tree, the algorithm identified SARS-CoV-2 infections with 76% sensitivity and 81% specificity. When looking at only emergency department (ED) patients, the model performed even better with 80% sensitivity and 83% specificity. ED patients comprised just over half (54%) of the patients used for the study.
Weill Cornell Medicine Algorithm Could Lower False Negative Test Results
The algorithm also correctly identified patients who originally tested negative for COVID-19, but who tested positive for the coronavirus upon retesting within two days. According to the researchers, these results indicated their model could potentially decrease the amount of incorrect test results.
“We are thinking that those potentially false negative patients may demonstrate a different routine lab test profile that might be more similar to those that test positive,” Fei Wang, PhD, Assistant Professor of Healthcare Policy and Research at Weill Cornell Medicine and the study’s senior author, told Modern Healthcare. “So, it offers us a chance to capture those patients who are false negatives.”
The researchers validated their model by comparing the results with patients seen at New York Presbyterian Hospital/Lower Manhattan Hospital during the same time period. Among those patients, 496 were RT-PCR positive and 968 were negative and the algorithmic model performed with 74% specificity and 76% sensitivity.
preliminarily identify high-risk SARS-CoV-2 infected patients before RT-PCR results are available,
risk stratify patients in the ED,
select patients who need relatively urgent retesting if initial RT-PCR results are negative,
help isolate infected patients earlier, and
assist in the identification of SARS-CoV-2 infected patients in areas where RT-PCR testing is unavailable due to financial or supply constraints.
Early Results of Study Promising, But More Research is Needed
Wang noted that more research is needed on the algorithm and that he and his colleagues are currently working on ways to improve the model. They are hoping to test it with different conditions and geographies.
“Our model in the paper was built on data from when New York was at its COVID peak,” he told Modern Healthcare. “At that time, we were not doing wide PCR testing, and the patients who were getting tested were pretty sick.”
At the time of the study, the positivity rate for COVID-19 at New York-Presbyterian Hospital was in the 40% to 50% range. That was substantially higher than the current positivity rate, which is in the 2% to 3% range, Modern Healthcare reported.
“This model we built in a population in New York in a certain time period, so we can’t guarantee that it will work well universally,” Wang told Modern Healthcare.
It’s exciting to think that advances in software algorithms may one day make it possible to combine routine clinical laboratory testing and create diagnostics that identify diseases in ways the individual tests were not originally designed to do.
This study is an example that researchers in AI and informatics are working to bring new tools and diagnostic capabilities to clinical laboratories. Also, this is a demonstration of how a patient’s results from multiple other types of lab tests can by analyzed using AI and similar analytical algorithms to diagnose a health condition unrelated to the original reasons for performing those tests.
If this can be demonstrated with other diseases and health conditions, it would open up one more way that pathologists and clinical laboratory scientists can contribute to more accurate diagnoses and improved selection of the most appropriate therapies for individual patients.
New value-based healthcare payment models could have far-reaching effects on medical laboratories and the testing they provide
Hospitals, physicians, and medical laboratories recognize the transition from “volume to value” that’s underway in the American healthcare system. Fee-for-service payments for clinical services (regardless of whether they are needed or effective) will soon cease and providers will be increasingly paid on how much value they deliver to patient care. This will fundamentally alter the complete care continuum, from hospital stays to pathology consults to clinical laboratory testing services.
One such change involves value-based drug contracts with pharmaceutical manufacturers. According to an article in The BostonGlobe, in an effort to reduce the ever-increasing cost of prescription drugs while still “giving patients access to costly treatments,” Harvard Pilgrim Health Care (Harvard Pilgrim)—one of Massachusetts’ largest health insurers with more than 1.3 million members—is negotiating value-based agreements with major pharmaceutical manufacturers. How much money Harvard Pilgrim pays for certain drugs will depend on how much the healthcare organization contributes to curing/improving their patients’ conditions.
Value-Based Pharmaceutical Agreements
Harvard Pilgrim first made news for their value-based drug contracts in 2015 when they contracted with three companies:
Harvard Pilgrim currently has 12 value-based pricing contracts with pharmaceutical companies. According to a news release, the contracts enable Harvard Pilgrim to monitor “specific criteria in patients following discharge” for the effectiveness of medication. “If the medicines fail to meet the agreed upon outcomes criteria in real patients, Harvard Pilgrim will be charged a lower amount,” the news release states.
The graph above is from an analysis by Avalere Health, a strategic advisory company in Washington, DC, that develops solutions for healthcare. It shows how, according to Avalere, “a majority of health plans are interested in forming outcomes-based contracts with biopharmaceutical manufacturers that tie product reimbursement to patient outcomes.” (Image copyright: Avalere Health.)
These contracts link a drug’s cost to its overall effectiveness in ways that make companies accountable for results in terms of real-world patient outcomes, rather than controlled trial results. Michael Sherman, MD, Harvard Pilgrim’s Chief Medical Officer and SVP of Health Services, stated in the news release that they put drug companies “at risk for delivering” on their promises.
Can Medical Laboratories Participate in Value-based Models?
The rise of value-based healthcare models affects more than just pharmaceutical companies; medical laboratories nationwide are considering how value-based systems might affect their work and mission as well. In an Orchard Software whitepaper titled, “The Value of the Laboratory in the New Healthcare Model,” Daniel J. Scully, CEO of New York’s Buffalo Medical Group, stated that the “50-million dollar” question for laboratories is “does the laboratory offer enough value in service and speed of results” for the new value-based healthcare models?
Clinical laboratories play such a vital role in healthcare quality—providing accurate diagnosing and crucial monitoring, as well as data collection and risk assessment—they may find themselves affected by value-based healthcare changes. Because of the high costs of equipment and testing, laboratories may also find themselves scrambling to eliminate costs and improve on efficiency, by monitoring resources and testing outcomes in connection to patient needs.
Clinical pathologists may also find themselves more frequently called upon to assist in guiding clinicians to more “effectively utilize lab services to achieve better care,” according to the Orchard Software white paper.
Clinical Associations Say Medical Laboratories Crucial to Success of Value-based Healthcare
An ASCP white paper states that clinical pathology data has become increasingly important as “clinical laboratory data are now used to measure provider performance, both individual and organizational, as well as to inform value-based purchasing that optimizes healthcare resources and decreases costs.”
In a position statement, the AACC noted that laboratory testing was crucial to this new model, and that “laboratory professionals are uniquely positioned” to help increase value within healthcare by helping “clinicians identify the most effective testing protocol and interpret the results accurately. Clinical laboratorians can further reduce healthcare costs by developing new, more precise tests to personalize patient care and creating computerized clinical decision support interventions to aid test selection.” Some types of testing, however, particularly expensive molecular and genetic testing, may end up a target of similar value-based agreements between the labs that perform these tests and the provider organizations that use the tests.
Much of the focus on value-based healthcare is currently on value-based pharmaceutical contracts, such as those from Harvard Pilgrim. Nevertheless, clinical laboratories will likely play vital roles in providing care, guiding testing, and evaluating care outcomes under these new payment models. They also could find themselves part of a larger debate concerning overuse of testing or data collection.
Changes to healthcare from pay-for-service to pay-for-value will undoubtedly have far-reaching effects as healthcare fields attempt to cut costs while providing better services. Every clinical laboratory must be proactive in finding its place in these new models.