Clinical laboratories nationwide could follow Yale’s example and enact programs to bring much needed lab services to traditionally underserved communities
Ever since the COVID-19 pandemic drove up demand for telehealth medical services, mobile clinical laboratories have grown in popularity as well, especially among residents of remote and traditionally underserved communities. Now, several divisions of Yale University are getting in on the trend.
“Using a van retrofitted with laboratory-grade diagnostic equipment, the mobile clinic will employ SalivaDirect—a saliva-based COVID-19 PCR test developed at YSPH—to facilitate on-site testing with a turnaround time of two to three hours,” Yale Daily News reported.
Funded by a federal grant, the initial goal was to provide 400 free COVID-19 tests, but the program has exceeded that number. By April 10, the mobile lab had been deployed more than 60 times, appearing at events and pop-up sites throughout various communities in Connecticut, including regular stops at the WHEAT Food Pantry of West Haven.
“[The clinical laboratory-in-a-van] is a brilliant way to reduce the barriers to testing, instead taking the lab to communities who may be less likely—or unable—to access the necessary clinic or labs,” microbiologist Anne Wyllie, PhD, a research scientist who helped develop the PCR test deployed by the mobile lab told Yale Daily News. Wyllie works in the Department of Epidemiology of Microbial Diseases at Yale School of Public Health. “We are actively working with our community partners to identify how we can best serve their communities,” she added. (Photo copyright: Yale School of Medicine.)
Mobile Lab’s Capabilities
Collecting samples, processing, and delivering same-day COVID-19 results was the initial goal but that plan has expanded, Yale School of Medicine noted in a news release.
“Same-day onsite delivery of test results is an added benefit for communities and individuals without access to Wi-Fi or the ability to receive private health information electronically,” Yale added.
The mobile van is staffed with trained clinical laboratory technicians as well as community health navigators who provide both healthcare information and proper follow-up connections as needed for patients who receive positive COVID-19 results. The van runs off power from outdoor electrical outlets at each location and currently serves historically underserved populations in Hartford, Middlesex, Fairfield, New Haven, and New London counties, Yale noted.
“The van allows us to bring our services, as well as healthcare information, directly to communities where they are needed,” said Angelique Levi, MD, Associate Professor, Vice Chair and Director of Pathology Reference Services, and CLIA Laboratory Medical Director in the Department of Pathology at Yale University School of Medicine in a news release.
Launch of a High Complexity Molecular Lab on Wheels
YPL and YSPH collaborated to make the mobile lab a reality. YSPH created the saliva-based COVID-19 test and YPL “provided clinical validation necessary to get the testing method ready for emergency use authorization by the US Food and Drug Administration,” Yale noted.
“YPL recognized the need to be closer to the front lines of patient care and that retrofitting a fully licensed, high complexity molecular laboratory into a consumer-sized van was the right next step,” Chen Liu, MD, PhD, Chair of the Department of Pathology at Yale School of Medicine, noted in a Yale news release. This “gives us options to efficiently deliver accurate diagnostic information when and where it’s needed,” he added.
Throughout the COVID-19 pandemic, the Connecticut Department of Public Health, the City of New Haven, and various community organizations partnered with YPL, YSPH, and the SalivaDirect team to offer free SARS-CoV-2 testing to the public at two different sites in New Haven.
Principal investigators Levi and microbiologist Anne Wyllie, PhD, who helped develop the PCR test deployed by the mobile, lab led the Yale lab-in-a-van research project.
Flambeau Diagnostics, a biomedical company that specializing in mobile lab testing, worked with the Yale team to design and implement the mobile lab van.
“According to Wyllie, the new YSPH and YPL initiative utilizes one of the former Flambeau vans that had been retrofitted for clinical testing,” a Yale news release noted.
Kat Fajardo, Laboratory Manager at Yale University, added custom pieces of equipment to ensure seamless PCR testing. One was a Magnetic Induction Cycler (Mic) measuring only six by six inches. The Mic allowed for measurement of 46 biological specimens, while it’s diminutive size freed up space on the van’s countertop. This allowed lab techs to process specimens concurrently while also providing COVID-19 testing, according to a Yale news release.
Additionally, the van has a Myra portable robotic liquid handler which is “designed to automate the process of moving clinical specimens between vials,” the news release notes.
“What we wanted to do is run high complexity testing in the van, with a reduced timeframe, and then be able to get the results out to the patients as soon as we possibly could,” Fajardo stated.
Exploring the Mobile Laboratory’s Potential
According to a news release, YPL and YSPH consult with community partners to select locations for the mobile lab to visit. These partners include:
APT Foundation (New Haven County, in addition to others.
Although the van was initially used to provide SalivaDirect COVID-19 testing to vulnerable populations, YPL is working with its partners in those communities to identify other testing needs beyond COVID.
The Yale team is considering additional offerings and support such as the addition of a social worker as well as expanding lung health awareness beyond COVID-19 to other respiratory diseases. Also under consideration:
Vaccinations including for COVID-19 and Hepatitis B, and
Health education and materials for harm reduction and STI prevention, a Yale news release noted.
Yale’s Laboratory-in-a-Van program is a consumer-facing effort that is bringing much needed clinical lab services to traditionally underserved communities in Connecticut. Clinical laboratories throughout the nation could do the same with remote or homebound patients who cannot reach critical care.
Some experts in medical community question value of health screenings of older patients with shortened life expectancies, though many aging adults are skeptical of calls to skip tests
What does it mean when a credible health organization makes the assertion that there is an “epidemic” of clinical laboratory testing being ordered on the nation’s elderly? Clinical laboratory leaders and anatomic pathologists know that lab tests are a critical part of screening patients.
Health screenings, particularly those for chronic diseases, such as cancer, can save lives by detecting diseases in their early stages. However, as consumers become more engaged with the quality of their care, one trend is for healthcare policymakers to point out that many medical procedures and care protocols may not bring benefit—and may, instead, bring harm.
No less an authority than Kaiser Health News (KHN) also is questioning what it calls an “epidemic” of testing in geriatric patients. Since medical laboratory tests are part of many screening programs, a rethinking of what tests are necessary in older patients would likely impact clinical laboratories and pathology groups going forward.
Treatment Overkill or Necessary Clinical Laboratory Tests?
That opinion is supported by a 2014 study published in the Journal of the American Medical Association (JAMA) Internal Medicine. The researchers concluded, “A substantial proportion of the US population with limited life expectancy received prostate, breast, cervical, and colorectal cancer screening that is unlikely to provide net benefit. These results raise concerns about over screening in these individuals, which not only increases healthcare expenditure but can lead to patient harm.”
Yet, seniors and their family members often request health screenings for themselves or their elderly parents, even those with dementia, if they perceive doing so will improve their quality of life, KHN noted.
Cary Gross, MD, Professor of Medicine and Director of the National Clinician Scholars Program at Yale University, told Kaiser Health News patients “well into their 80s, with other health conditions” are unlikely candidates for the many routine health screening tests administered to elderly patients. Were this to become a trend, medical laboratories could see a drop in physician-ordered screening tests. (Photo copyright: Yale University.)
Meanwhile, an earlier study in JAMA Internal Medicine found older adults perceived screening tests as “morally obligatory” and were skeptical of stopping routine screenings.
In its series, KHN noted two studies that outlined the frequency of screening tests in seniors with limited life expectancies due to dementia or other diseases:
According to the American Journal of Public Health, nearly one in five women with severe cognitive impairment are still getting regular mammograms;
Likewise, 55% of older men with a high risk of death over the next decade still receive PSA tests for prostate cancer, the 2014 JAMA Internal Medicine study found.
“Screening tests are often done in elderly patients as a knee-jerk reaction,” Damon Raskin, MD, a board-certified internist in Pacific Palisades, Calif., who also serves as Medical Director for two skilled nursing facilities, told AgingCare.com.
Correct Age or Correct Test?
While a movement may be afoot to reduce screening tests in older patients, a one-size-fits-all answer to who should continue to be tested may not be possible.
“You can have an 80-year-old who’s really like a 60-year-old in terms of [his or her] health,” Raskin noted. “In these instances, screening tests such as mammograms and colonoscopies, can be extremely valuable. However, I’ve seen 55-year-olds who have end-stage Parkinson’s or Alzheimer’s disease. For those individuals, I probably wouldn’t recommend screenings, for quality of life reasons.”
However, for the general population, researchers have emphasized that the focus should not be on whether physicians are ordering “unnecessary” lab tests, but whether they are ordering the “correct” tests.
A 2013 study published in the online journal PLOS ONE analyzed 1.6 million results from 46 of medicine’s 50 most commonly ordered lab tests. Researchers found, on average, the number of unnecessary tests ordered (30%) was offset by an equal number of necessary tests that went unordered.
“It’s not ordering more tests or fewer tests that we should be aiming for. It’s ordering the right tests, however few or many that is,” senior author Ramy Arnaout, MD, Harvard Medical School, Assistant Professor of Pathology and Associate Director of the Clinical Microbiology Laboratories at Beth Israel Deaconess Medical Center in Boston, stated in a news release. “Remember, lab tests are inexpensive. Ordering one more test or one less test isn’t going to ‘bend the curve,’ even if we do it across the board. It’s everything that happens next—the downstream visits, the surgeries, the hospital stays—that matters to patients and to the economy and should matter to us.”
Since the elderly are the fastest growing population in America, and since diagnosing and treating chronic diseases is a multi-billion-dollar industry, it seems unlikely that such a trend to move away from medical laboratory health screenings for the very old will gain much traction. Still, with increasing focus on healthcare costs, the federal government may pressure doctors to do just that.
Antibody validation standards would help ensure reproducibility of research studies and improve the consistency medical laboratory test results
As science and industry gets better at measuring things and assessing quality, the acceptable standard often comes into question. This seems to be happening with antibodies, the most common reagents used in diagnostics, clinical laboratory diagnostic tests, and medical research. In many cases, the end result is that companies and their suppliers must use new technologies and quality methods to revise the “old way” and create products that have measurable better quality.
The techniques currently used to validate antibodies is the topic of a recently-published scientific paper. The authors of a paper published in the March, 2010, issue of Biotechniques pointed out, antibody validation and standardization ensure study reproducibility, which is critical to accuracy. And yet, no standard guidelines define how these important biological tools should be validated prior to use.
Thus, researchers participating in a recent webinar, presented by The Scientist expressed concern that—without improved antibody validation and standardization—the accuracy of published research is in question and diagnostic test results, such as those produced by medical laboratories, will continue to be inconsistent. (more…)
Innovative use of crowdsourcing allows pathologists and genetic scientists to create a sizeable database of BRCA mutations that is accessible to clinicians and patients
There’s a new development in the longstanding battle over proprietary healthcare data versus public sharing of such information. Pathologists and clinical laboratory managers will be interested to learn that, when it comes to genetic testing of the BRCA mutation involved in breast cancer, a public data base of mutations is growing so rapidly that it may become the world’s largest repository of such information.
Smaller, more affordable sequencers and genome sequence interpretation computers are catching the interest of pathologists and medical laboratory scientists
In the field of whole human genome sequencing, the technology continues to improve at a remarkable pace. Products now entering the research and clinical marketplace offer speedier, more accurate gene sequencing capabilities at prices that are within the budget reach of many clinical laboratories and anatomic pathology group practices.
Miniaturization and lower cost is driving genomic medicine ever closer to the routine clinical setting. The combination of next generation gene sequencers with a smaller footprint and advances in genomic data analysis technology mean that genomic testing will increasingly migrate to smaller lab settings. Dark Daily offers its readers a look at some of the latest gene sequencing products and what their manufacturers say about the capabilities of these gene-sequencing systems. (more…)
