Taft Foley, III, says he got the idea for the mobile lab after waiting on a COVID-19 testing line that went ‘around the entire building’
In a remarkable example of ingenuity and observation, Texas high school student Taft Foley, III, is bringing COVID-19 testing to underserved patients, wherever they may be. He launched a medical lab company, then developed a mobile clinical laboratory which performs rapid antigen tests that can detect the presence of antigen in about 15 minutes.
Foley—who recently became an EMT after graduating from the Texas EMS Academy—designed his mobile medical lab to use Quidel Sofia SARS Antigen FIA tests (nasal swabs). Results are sent to patients by text or e-mail. Foley also works with CLIA-certified Baylor Genetics Laboratories on COVID-19 (SARS-CoV-2) RT-PCR molecular testing, which gives his customers results in 24 to 48 hours, Forbes reported.
Foley, who is 18-years-old and an Eagle Scout, said he got the idea to launch the mobile COVID-19 testing business after he went for a coronavirus test and had to wait on a line that “wrapped around the entire building,” ABC13 reported. “I said to myself, ‘There needs to be a better way,’” Foley told ABC13.
Forbes reported that Texas Mobile Medical Labs allocates a portion of test fees paid ($100 to $150/test) to help provide tests to the homeless and others who need them, such as veterans and senior citizens.
“The (majority of) tests have been done at businesses who appreciate our mobile capabilities. We arrive and test all employees onsite and have their results back in 15 minutes,” Foley told Forbes.
After raising $60,000 through events and sale of personal items, Taft Foley, III (above), purchased a van and rapid antigen tests, reported The Kinkaid Falcon. “I think that that idea is hopefully going to galvanize a lot of good things, because we as humans, we’re good at learning from one another. If my idea is good enough to inspire others to create their own businesses and ideas for the betterment of the community, then I’m all for it,” Foley told the Falcon. (Photo copyright: Texas Mobile Medical Labs.)
Other States with Mobile COVID-19 Testing
Texas is not the only state where savvy entrepreneurs like Foley and health agencies are offering mobile COVID-19 testing.
In May, Florida Gov. Ron DeSantis announced Statlab Mobile, a COVID-19 mobile laboratory out of Miami that tests people in skilled nursing and long-term care facilities and other areas of the Sunshine State.
“We believe this will be a game-changer (in long-term care),” DeSantis told the Miami Herald.
“The idea was to bring help to those who are vulnerable, those who can’t otherwise get the kind of medical information they would otherwise love to have,” Bryan Wilson, Statlab Chief Executive Officer, told Patch, which noted the tests are free.
Mobile medical laboratories are being deployed to help handle surges of COVID-19 cases in Massachusetts, New Jersey, and Arizona, as well.
In Massachusetts, testing vans operated by American Family Care (AFC), an urgent care provider, started heading out in November to schools and businesses state-wide with a goal to test at least 100 to 150 people daily for COVID-19, according to The Reminder.
The vans are staffed by medical providers who test people with Abbott’s BinaxNOW COVID-19 Ag Card, AFC told The Reminder. The rapid antigen test offers results in 15 minutes.
In September, Dark Daily reported that the US federal Department of Health and Human Services (HHS) awarded a $760 million contract to Abbott for 150 million rapid antigen tests to aid in detection of COVID-19 as workplaces and schools reopen.
“We’ve had several companies who would like to schedule their employees to be tested on a regular basis. But they also want to be able to make sure that if there is a potential contamination within their businesses, they have a resource to utilize to make sure they can test people right away,” Jim Brennan, Owner/CEO of Medvest, LLC, AFC urgent care’s parent company, told The Reminder.
And in Phoenix, a COVID-19 mobile medical van provides testing to underserved communities. The City of Phoenix, along with staff from the Vincere Cancer Center, use Quidel’s Sofia SARS Antigen FIA test at public and private locations and at family services centers, AZ Central reported.
Clearly, mobile COVID-19 testing labs are here to stay. They serve seniors and vulnerable populations challenged to access clinical laboratory testing at traditional locations and at COVID-19 drive-through sites. And on larger scales, mobile medical laboratories have become key resources to address coronavirus case surges and to conveniently test people at businesses and schools to help identify symptomatic individuals who should be quarantined.
Clinical laboratory managers may be impressed by how quickly mobile testing companies and entrepreneurs form partnerships with public health agencies toward making COVID-19 tests available to all at places where people live and work.
While working to increase turn-around-times for STAT tests, Florida’s first coronavirus patient arrived, requiring SMH’s clinical laboratory team to adapt its plans
Despite the COVID-19 pandemic, the clinical laboratory team at 839-bed Sarasota Memorial Hospital, part of the Sarasota Memorial Health Care System (SMH) in Sarasota, Fla., not only implemented a new automated microbiology system, it also installed a new mass spectrometry analyzer, along with new instruments to support large volumes of SARS-CoV-2 testing.
How SMH’s microbiology laboratory team accomplished this while shelter-in-place directives in Florida caused many patients to stop visiting emergency departments and physicians’ offices—and as hospitals and medical laboratory facilities restricted access to staff and essential personnel—provides useful lessons for pathologists and clinical laboratory managers.
“Florida reported its first positive SARS-CoV-2 infection on March 2, marking the beginning of an outbreak that continues today,” he noted, adding, “This created the need to support the hospital in identifying infected patients in Sarasota County by having the microbiology lab acquire and set up more instruments. Also, the micro lab needed space for a new mass spectrometry analyzer to speed up pathogen identification this year.
In the same TDR interview, Olevia Fulkert, Microbiology Technical Supervisor at SMH said the microbiology lab had to reconfigure its layout to be prepared for the new COPAN system. “Our team had to arrange space for these new instruments, while protecting the space needed for the microbiology automation.”
“The WASPLab (above) literally went right into the middle of the busiest area of our lab,” said SMH’s Director of Laboratory Services, Harold Vore, MS, MT. “That’s the room we call COVID central, because that’s where we process all SARS-CoV-2 specimens.” SMH’s medical laboratory team began this implementation in the early months of the COVID-19 pandemic and relied on Lean processes to accomplish its goals. (Photo copyright: Sarasota Memorial Health Care System.)
Return of the ‘Snowbirds’
In August, SMH’s microbiology laboratory staff was busy validating the WASPLab instruments so the lab would be ready to process patient specimens when Florida’s snowbirds—out-of-state residents who arrive for the winter—return to Sarasota.
Vore knew several elements would be required for SMH’s microbiology automation project to succeed:
He had to assure the microbiology lab’s staff that adding automation would not cause any loss of jobs.
Timing of the implementation was critical, because lab test volume rises in the winter when tourists and part-time residents return.
Lean methods would be important because lab staff was familiar with them and they would help the vendor to arrange the physical layout and workflow to optimize productivity, reduce errors, and decrease turnaround times.
Vore needed documentation that showed automating the microbiology lab met and exceeded the return-on-investment projections he and his lab team used to persuade health system administrators of its value.
According to Vore, to date the installation has gone smoothly. “The staff in the microbiology lab has been phenomenal,” he commented. “They have continued to do what they always do, while at the same time we’re installing this large new system right in their midst.
“And they did not complain. In fact, they were eager to make progress in improving production,” he continued. “That attitude is common among our laboratory staff, because we saw the same thing happen when we automated our core lab.”
Increasing Microbiology Lab Capacity without Increasing Staff
Vore estimates automation will expand SMH’s microbiology laboratory capacity by up to 40%. “We measure that 40% in terms of the number of plates our techs can read per day with the WASPLab versus how we did it manually with our existing staff,” he explained. “We may still need to increase some staff. But even without adding staff, we thought we could move the peg further down the road in terms of throughput and improve our turnaround time too.
“We cannot make bacteria grow any faster and yet our specimen volume continues to increase,” he noted. “That makes automating microbiology the right strategy. Also, if we hadn’t automated the core lab starting in 2015, we might not have been able to handle the increased volume that we saw last year and this year’s additional surge in COVID-19 tests.”
How Lean Helped with the Implementation
Workflow in microbiology has traditionally been mostly manual. Therefore, combining Lean and automation can generate substantial benefits for a lab. “By definition, the design of the WASPLab is Lean,” Vore explained. “By that I mean the person who touches each specimen the least wins. That’s why the WASPLab is designed the way it is. Once we load a specimen in the front end, theoretically, no one needs to touch those plates until the testing is complete.”
“That’s the ideal we’re trying to reach,” he added. “At the moment, we still need to pull the plates to, as we say, ‘pick them.’ But we just introduced a way to improve that part of the process.
Adding Mass Spectrometry
“Along with the microbiology automation, we now read specimens digitally and we tell the machine to take a certain plate off so we can spot it,” Vore continued. “To speed up that process, we got some additional funding and bought a mass spec analyzer that uses MALDI-TOF to identify pathogens. Now we get the boost from the WASPLab, and we also use mass spec to cut six hours off our first read,” Vore added.
“The WASPLab and the mass spec give us higher quality incubation and better harvest of pathogens. Once we spot the plate, the mass spec can identify the pathogen in about two minutes,” he said.
“After going live with the mass spectrometry in August, we’ve made huge progress versus the normal process, where we would plate the specimen manually under a hood and then put the specimen in the incubator and pull it out to read 24 hours later,” he said.
“That whole step-by-step process to identify the pathogen could take 48 hours,” he continued. “But now we can move to a 24-hour, seven-day-a-week operation, where we can do first-in-first-out of pathogens in about 18 hours. That cuts six hours off the time to do the first plate read. Then we can spot it and get a result from the mass spec in two minutes. The impact for patient care can be tremendous.
“In a recent case, for example, we had to identify a specimen from an infant and used the mass spec to identify salmonella in two minutes,” Vore noted. “Normally that would take at least a day or more. That’s what I mean about making tremendous impact on patient care by using automation in microbiology.”
Clearly, this would be a challenging project for any medical laboratory to complete during the best of times, let alone during the early months of the COVID-19 pandemic. But through determination, the use of Lean, and a positive approach, SMH’s microbiology lab team implemented the first WASPLab in the state of Florida. And it will improve SMH’s ability to care for patients for years to come.
Sophisticated cyberattacks have already hit hospitals and healthcare networks in Oregon, California, New York, Vermont, and other states
Attention medical laboratory managers and pathology group administrators: It’s time to ramp up your cyberdefenses. The FBI, the federal Department of Health and Human Services (HHS), and the federal Cybersecurity and Infrastructure Security Agency (CISA) issued a joint advisory (AA20-302A) warning US hospitals, clinical laboratories, and other healthcare providers to prepare for impending ransomware attacks, in which cybercriminals use malware, known as ransomware, to encrypt files on victims’ computers and demand payment to restore access.
The joint advisory, titled, “Ransomware Activity Targeting the Healthcare and Public Health Sector,” states, “CISA, FBI, and HHS have credible information of an increased and imminent cybercrime threat to US hospitals and healthcare providers.” It includes technical details about the threat—which uses a type of ransomware known as Ryuk—and suggests best practices for preventing and handling attacks.
In his KrebsOnSecurity blog post, titled, “FBI, DHS, HHS Warn of Imminent, Credible Ransomware Threat Against U.S. Hospitals,” former Washington Post reporter, Brian Krebs, wrote, “On Monday, Oct. 26, KrebsOnSecurity began following up on a tip from a reliable source that an aggressive Russian cybercriminal gang known for deploying ransomware was preparing to disrupt information technology systems at hundreds of hospitals, clinics, and medical care facilities across the United States. Today, officials from the FBI and the US Department of Homeland Security hastily assembled a conference call with healthcare industry executives warning about an ‘imminent cybercrime threat to US hospitals and healthcare providers.’”
Krebs went on to reported that the threat is linked to a notorious cybercriminal gang known as UNC1878, which planned to launch the attacks against 400 healthcare facilities.
Clinical Labs, Pathology Groups at Risk Because of the Patient Data They Keep
Hackers initially gain access to organizations’ computer systems through phishing campaigns, in which users receive emails “that contain either links to malicious websites that host the malware or attachments with the malware,” the advisory states. Krebs noted that the attacks are “often unique to each victim, including everything from the Microsoft Windows executable files that get dropped on the infected hosts to the so-called ‘command and control’ servers used to transmit data between and among compromised systems.”
Charles Carmakal, SVP and Chief Technology Officer of cybersecurity firm Mandiant told Reuters, “UNC1878 is one of the most brazen, heartless, and disruptive threat actors I’ve observed over my career,” adding, “Multiple hospitals have already been significantly impacted by Ryuk ransomware and their networks have been taken offline.”
John Riggi (above), senior cybersecurity adviser to the American Hospital Association (AHA), told the AP, “We are most concerned with ransomware attacks which have the potential to disrupt patient care operations and risk patient safety. We believe any cyberattack against any hospital or health system is a threat-to-life crime and should be responded to and pursued as such by the government.” Hospital-based medical laboratories and independent clinical laboratories that interface with hospital networks should be assess their vulnerability to cyberattacks and take appropriate steps to protect their patients’ data. (Photo copyright: American Hospital Association.)
Multiple Healthcare Provider Networks Under Attack
Hospitals in Oregon, California, and New York have already been hit by the attacks, Reuters reported. “We can still watch vitals and getting imaging done, but all results are being communicated via paper only,” a doctor at one facility told Reuters, which reported that “staff could see historic records but not update those files.”
Some of the hospitals that have reportedly experienced cyberattacks include:
In October, the Associated Press (AP) reported that a recent cyberattack disrupted computer systems at six hospitals in the University of Vermont (UVM) Health Network. The FBI would not comment on whether that attack involved ransomware, however, it forced the UVM Medical Center to shut down its computer system and reschedule elective procedures.
Threat intelligence analyst Allan Liska of US cybersecurity firm Recorded Future told Reuters, “This appears to have been a coordinated attack designed to disrupt hospitals specifically all around the country.”
He added, “While multiple ransomware attacks against healthcare providers each week have been commonplace, this is the first time we have seen six hospitals targeted in the same day by the same ransomware actor.”
An earlier ransomware attack in September targeted 250 healthcare facilities operated by Universal Health Services Inc. (UHS). A clinician at one facility reported “a high-anxiety scramble” where “medical staff could not easily see clinical laboratory results, imaging scans, medication lists, and other critical pieces of information doctors rely on to make decisions,” AP reported.
Outside of the US, a similar ransomware attack in October at a hospital in Düsseldorf, Germany, prompted a homicide investigation by German authorities after the death of a patient being transferred to another facility was linked to the attack, the BBC reported.
CISA, FBI, HHS, Advise Against Paying Ransoms
To deal with the ransomware attacks, CISA, FBI, and HHS advise against paying ransoms. “Payment does not guarantee files will be recovered,” the advisory states. “It may also embolden adversaries to target additional organizations, encourage other criminal actors to engage in the distribution of ransomware, and/or fund illicit activities.” The federal agencies advise organizations to take preventive measures and adopt plans for coping with attacks.
The advisory suggests:
Training programs for employees, including raising awareness about ransomware and phishing scams. Organizations should “ensure that employees know who to contact when they see suspicious activity or when they believe they have been a victim of a cyberattack.”
Regular backups of data and software. These should be “maintained offline or in separated networks as many ransomware variants attempt to find and delete any accessible backups.” Personnel should also test the backups.
Continuity plans in case information systems are not accessible. For example, organizations should maintain “hard copies of digital information that would be required for critical patient healthcare.”
“Without planning, provision, and implementation of continuity principles, organizations may be unable to continue operations,” the advisory states. “Evaluating continuity and capability will help identify continuity gaps. Through identifying and addressing these gaps, organizations can establish a viable continuity program that will help keep them functioning during cyberattacks or other emergencies.”
Dark Daily Publisher and Editor-in-Chief, Robert Michel, suggests that clinical laboratories and anatomic pathology groups should have their cyberdefenses assessed by security experts. “This is particularly true because the technologies and methods used by hackers change rapidly,” he said, “and if their laboratory information systems have not been assessed in the past year, then this proactive assessment could be the best insurance against an expensive ransomware attack a lab can purchase.”
Breakthrough assay a ‘tenfold improvement over any prior assay for TERT mutations in the blood for brain tumors,’ MGH says in an affirmation of a diagnostic technology clinical labs might soon use
In recent years, investors have poured tens of millions of dollars into companies that promised to create non-invasive cancer tests which use liquid biopsy technology. Medical laboratory scientists even watched some of these companies hype their particular liquid biopsy tests before clinical studies generated data demonstrating that these tests produced accurate, reliable, and reproducible results.
For diagnosing cancer, a liquid biopsy test typically uses a blood sample with the goal of finding and identifying circulating tumor cells. Harvard Medical School researchers at Massachusetts General Hospital (MGH) believe they have developed just such a blood test. Their assay utilizes an enhanced form of liquid biopsy to detect and monitor one of the more prevalent types of brain tumor in adults—a glioma—and, according to a Harvard news release, can detect the presence of glioma at a significantly higher “overall sensitivity” than other similar liquid-biopsy tests.
Gliomas start in glia cells contained in the brain or spine. They account for about 30% of all brain and central nervous system tumors and 80% of all malignant brain tumors.
During their study, MGH researchers compared blood samples and tumor biopsy tissues from patients diagnosed with a glioma. They discovered that an assay they developed—a droplet digital polymerase chain reaction (ddPCR) blood test—could detect and monitor two types of telomerase reverse transcriptase (TERT) promoter gene mutations—C228T and C250T. These two gene mutations promote cancer growth and are present in more than 60% of all gliomas. The mutations are also present in 80% of all high-grade gliomas, which are the most aggressive and life-threatening types of the cancer.
In the press release, instructor in Neurosurgery at MGH and one of the study’s authors, Leonora Balaj, PhD, said, “By ‘supercharging’ our ddPCR assay with novel technical improvements, we showed for the first time that the most prevalent mutation in malignant gliomas can be detected in blood, opening a new landscape for detection and monitoring of the tumors.”
Bob Carter, MD, PhD (above), is neurosurgical oncologist and Chief of Neurosurgery at MGH, a Professor of Neurosurgery at Harvard Medical School, and one of the study’s authors. In the MGH press release he said, “We envision the future integration of tests like this one into the clinical care of our patients with brain tumors. For example, if a patient has a suspected mass on MRI scanning, we can take a blood sample before the surgery and assess the presence of the tumor signature in the blood and then use this signature as a baseline to monitor as the patient later receives treatment, both to gauge response to the treatment and gain early insight into any potential recurrence.” What Carter describes is precision medicine and could open new diagnostic opportunities for anatomic pathology groups and clinical laboratories. (Photo copyright: Massachusetts General Hospital.)
MGH’s Ten-Fold Improvement over Previous ddPCR Assays
A liquid biopsy is the sampling and analysis of non-solid tissue in the body—primarily blood. MGH’s liquid-biopsy method detects cancer by examining fragments of tumor DNA circulating in the bloodstream. Since the technique is mostly non-invasive, tests can be performed more frequently to track tumors and mutations and monitor treatment progression. Prior to this new method, brain tumors had been difficult to detect using liquid biopsies.
“Liquid biopsy is particularly challenging in brain tumors because mutant DNA is shed into the bloodstream at a much lower level than any other types of tumors,” Balaj said in the press release.
However, MGH’s new ddPCR assay has an overall sensitivity rate of 62.5% and a specificity of 90%, which represents a tenfold improvement over prior assays for TERT mutations in the blood.
And when testing the performance of the ddPCR assay in tumor tissue, the MGH researchers discovered their results were the same as results from a previous independently-performed clinical laboratory assessment of TERT mutations within collected tumor specimens. They also found that their assay could detect TERT mutations when looking at blood plasma samples collected at other facilities.
The researchers believe that their test could be performed in most clinical laboratories and can be utilized to follow the course of disease in cancer patients. The MGH researcher’s goal is to expand and adapt the blood test to diagnose, differentiate, and monitor other types of brain tumors in addition to gliomas.
Of course, more research will be needed before MGH’s new assay can become a vital tool in the fight against disease. However, this type of genetic analysis may soon provide pathologists with new techniques to more accurately diagnose and monitor cancers, and to provide healthcare providers with valuable data regarding which therapies would be the most beneficial for individual patients, a key element of precision medicine.
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.
“(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
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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.
