Clinical laboratories continue to test sample delivery by drone as a viable alternative to ground transport
In Switzerland, another clinical laboratory drone delivery service recently launched and it has several unique capabilities. This new pilot project to test the delivery of medical laboratory samples by UAV (unmanned aerial vehicle, aka drone) is being conducted by the Dr. Risch laboratory group and start-up drone company Jedsy.
What makes the Risch/Jedsy drone delivery service unique when compared to other drone delivery services is their drone’s capability to deliver directly to windows, regardless of where that window is. This, according to a Jedsy news release, “makes the transport of samples faster and more environmentally friendly.”
Dr. Risch group has 14 clinical laboratories and eight sample collection locations throughout Switzerland. The Swiss Federal Office of Civil Aviation (FOCA) approved Dr. Risch’s first flight between its lab in Vaduz, the capital of Liechtenstein, to its lab in Buchs St. Gallen, sUAS News reported. Risch began transporting lab samples between those locations on an experimental basis in December of 2022.
The Jedsy glider, as the drone is called, has a distinctive vertical takeoff, hover, and landing capability. Once it achieves a safe altitude, it transitions to forward flight and can travel at speeds up to 150 kilometers per hour or about 93 miles per hour.
All systems on the Jedsy drone are redundant and developed to be fail-safe. A human drone operator follows the flight visually via a livestream connection. Once the drone approaches a building for landing, with the exception of the docking station the entire surrounding area is blurred to ensure the privacy of nearby individuals.
The Jedsy Glider (above) is quieter than other multicopters, according to Jedsy, and is able to dock outside a window or balcony. This enables the convenient loading and unloading of clinical laboratory specimens in any type of weather. The docking station also serves as a charger for the drone’s battery to ensure the craft is available for use at any time. Similar medical laboratory sample drone delivery services have been tested in Switzerland but none with Dr. Risch Labs’ unique window delivery option. (Photo copyright: Jedsy.)
Why Transport Clinical Laboratory Samples by Drone?
“The last two years during the COVID-19 pandemic have shown convincingly how important this service is for the healthcare sector,” explained the medical laboratory group’s founder and CEO, Martin Risch, MD, in the Jedsy press release.
Risch envisions a need for drones in certain medical situations. Dr. Risch currently employs about 50 courier drivers who transport by ground medical samples to regional medical laboratories throughout Switzerland every day.
“If, however, the courier vehicles are stuck in traffic or if they are driving during rush hour, the planned daily routine regarding the analysis and the medical diagnosis is delayed. We hope that this will allow us to offer an even better service, which will ultimately benefit the patients,” Risch stated.
Jedsy has already utilized its glider drone successfully in Africa to deliver laboratory specimens and medicines to remote locations and looks forward to its continued benefits.
“With the new drone, we have already gained important flying experience in Malawi, where over 5,000 flights have been performed as part of the UNICEF drone corridor,” said aerospace engineer Herbert Weirather, founder and CEO of Jedsy, in the press release. “Health centers have already been supplied with critical medicines by Jedsy and the service is being expanded continuously,” he added.
Use of Drones to Deliver Clinical Laboratory Samples Growing Worldwide
Utilizing drones to deliver medical supplies and laboratory specimens is not a new concept and has been tested several times in the past. Dark Daily has previously reported on some of the projects that have been attempted.
The use of drones to deliver clinical laboratory specimens is a rising trend that could be extremely beneficial for healthcare systems, medical professionals, and patients. A number of clinical laboratories in the US and around the world have initiated drone pilot programs, however, there has been little follow-up press coverage about either the success of these efforts or whether they continue to operate.
Nevertheless, faster delivery of laboratory specimens can lead to more timely diagnoses which can potentially lead to better patient outcomes. In the future, it’s likely more clinical laboratories will receive specimens via drones.
NIH program could lead to new diagnostic biomarkers for clinical laboratory tests across a more diverse segment of US population
In another milestone in the US National Institutes of Health’s (NIH) plan to gather diverse genetic information from one million US citizens and then use that data to inform clinical care in ways consistent with Precision Medicine, the NIH’s All-of-Us Research Program announced in a news release it has “begun returning personalized health-related DNA results” to more than 155,000 study participants.
In addition, those participants who request them will receive genetic reports that detail whether they “have an increased risk for specific health conditions and how their body might process certain medications.”
The All-of-Us program, which began enrolling people in 2018, is one of the world’s largest—if not the largest—project of its kind. It could result in more than a million human whole genome sequences to drive medical research and speed discoveries. Study findings, for example, may produce new biomarkers for clinical laboratory tests and diagnostics.
In 2020, the All-of-Us program “had begun releasing genetic results for ancestry and a small number of nonclinical genetic traits,” according to GenomeWeb. Now, the program is taking on the greater challenge of sharing health-related genetic test results directly with its participants.
“We really wanted to make sure that we are providing a responsible return to our participants,” Anastasia Wise, PhD, All-of-Us Program Director for the Genetic Counseling Resource, told GenomeWeb. “They might get information that’s unexpected,” she explained.
So far, about 10,000 people received the NIH’s invitation and 56% have shown interest in receiving their genetic test results, GenomeWeb noted.
“Knowledge is powerful,” said Josh Denny, MD (above), Chief Executive Officer, NIH All-of-Us Research Program, in an NIH news release. “By returning health-related DNA information to participants, we are changing the research paradigm, turning it into a two-way street—fueling both scientific and personal discovery that could help individuals navigate their own health,” he added. The NIH’s research could lead to new clinical laboratory precision medicine diagnostics for chronic diseases across a more diverse segment of the US population. (Photo copyright: National Institutes of Health.)
Two Types of Genetic Health Reports
Study participants who provided a blood sample and gave their consent to receiving genomic information may also receive a Hereditary Disease Risk report that includes 59 genes and genetic variants linked to serious and “medically actionable” health conditions.
About 3% to 5% of participants will have findings suggesting a high risk for a genetic disease such as breast and ovarian cancers as indicated by BRCA1 and BRCA2 genes, Medical Xpress reported.
“I kind of shudder to think about what could happen if I hadn’t known this [finding that she has the BRCA2 gene],” said Rachele Peterson, All-of-Us Chief of Staff, who spoke to the Associated Press about her receiving own Hereditary Disease Risk report.
Participants can also choose to receive an All-of-Us Medicine and Your DNA report with insights on seven genes that affect how specific medications are metabolized. This pharmacogenetics report is important for those who could learn, for example, that they have a 50% to 60% greater risk of a second heart attack when they continue to take the standard medication, as opposed to a different medication, Medical Xpress noted.
“The information on metabolizing medication can be particularly important for people who need treatment after a heart attack,” Josh Denny, MD, Chief Executive Officer, NIH All-of-Us Research Program, told Medical Xpress.
“Such transparency of genetic information about a massive group—as well as the genetic information on individuals—can be used to improve patient care and clinical outcomes,” said Robert Michel, Editor-in-Chief of Dark Daily and its sister publication The Dark Report.
“The program provides a roadmap for other healthcare organizations to follow. And this is useful strategic knowledge for clinical laboratory leaders to understand and incorporate into their plans to support precision medicine with genetic testing and whole human genome sequencing,” Michel added.
Rich Genetic Data Across a More Diverse Population
As to its goal to reflect national diversity, NIH reported about 80% of All-of-Us participants reside in communities that have been unrepresented in medical research, and that 50% are part of a racial or ethnic minority group.
By combining this information into a single database, the MVP promises to advance knowledge about the complex links between genes and health, according to an MVP news release.
Researchers tapping All-of-Us and MVP data may ultimately produce enlightening and impactful study findings, which could enable clinical laboratories to perform new diagnostic precision medicine tests that identify diseases early and save lives.
It’s not only medical laboratory technicians, healthcare workers across the board continue to deal with extreme pressures that preceded the pandemic
Burnout in healthcare is a constant problem, especially in overstressed clinical laboratories and anatomic pathology groups. To raise awareness about the plight of medical laboratory technicians (MLTs) and other frontline workers in the healthcare industry, a former lab tech recounted her experience during the COVID-19 pandemic that led to burnout and her departure from the lab profession during 2020-2021.
Suzanna Bator was formerly a laboratory technician with the Cleveland Clinic and with MetroHealth System in Cleveland, Ohio. Her essay in Daily Nurse, titled, “The Hidden Healthcare Heroes: A Lab Techs Journey Through the Pandemic,” is a personalized, human look at the strain clinical laboratory technicians were put under during the pandemic. Her story presents the quandary of how to keep these critical frontline healthcare workers from experiencing burnout and leaving the field.
“We techs were left unsupported and unmentored throughout the pandemic. No one cared if we were learning or growing in our job, and there was little encouragement for us to enter training or residency programs. We were just expendable foot soldiers: this is not a policy that leads to long-term job retention,” she wrote.
Clinical laboratory leaders and pathology group managers may find valuable insights in Bator’s essay that they can use when developing worker support programs for their own clinical laboratories and practices.
“The pressure never let up. No matter how mind-numbing and repetitive the work could get, we had to work with constant vigilance, as there was absolutely no room for error,” Suzanna Bator wrote in Daily Nurse. Burnout in clinical laboratories is an ongoing problem that increased during the COVID-19 pandemic. (Photo copyright: Daily Nurse.)
Hopeful Beginnings and Eager to Help
During the early days of the COVID-19 pandemic, folks in every industry stepped up. Fashion designers tasked their haute couture seamstresses with making personal protective equipment (PPE), neighbors brought food and supplies to their immunosuppressed or elderly neighbors, and healthcare workers took on enormous workloads outside of their own departments and traditional responsibilities, The New York Times reported.
When Bator joined the Cleveland Clinic’s COVID-19 team she had no clinical lab tech accreditations. Nevertheless, she and 12 other non-accredited hires were quickly put onto the second and third shifts to keep up with SARS-CoV-2 test demands.
“In the beginning, I was so happy to be helping and working during the pandemic. I felt proud to be on the front lines, honing my skills and discovering what it was like to work under intense pressure. My work was good even when the work was hard. There was no room for error and no time to waste.”
At the Cleveland Clinic, Bator and her colleagues did not experience the equipment and supply shortages other clinics faced, at least not in the beginning of the pandemic. That began to change in late 2020.
Unrelenting Pace and Supply Shortages as Pandemic Grew
Despite their state-of-the-art equipment at the Cleveland Clinic, problems began to arise as the pandemic wore on.
“The machines we worked on were never meant to be run at this intensity and would frequently break down during the second shift. Those of us on the third shift were then left to deal with these problems despite our lack of technical training. Even worse, there were no supervisors on staff to help us problem-solve or troubleshoot, which only added to the pressure,” Bator noted.
And the high demand for testing left little room for new lab techs to hone any other skills.
“The pressure never let up. No matter how mind-numbing and repetitive the work could get, we had to work with constant vigilance, as there was absolutely no room for error,” she added.
Eventually, Bator left the Cleveland Clinic for a county hospital to “get off the graveyard shift and begin working on more than just COVID testing,” she wrote. However, soon after her move the Omicron variant hit, and she was once again running COVID tests.
Six months later she had had enough. She burned out and “dropped out of the industry after only a few years,” she wrote. And she was not the only one.
“The [Cleveland] Clinic began to hemorrhage techs who left for better opportunities at different hospitals or in different fields. Of my original 15-or-so-member team two years ago, only four remain in the same department, and only about half remain in the clinical lab field at all,” Bator wrote.
Burnout in Clinical Laboratories
Worker burnout is a state of mental and/or physical exhaustion caused by a heavy workload. Those experiencing burnout may feel emotionally overwhelmed, anxious, and depressed. Burnout can manifest in physical, mental, and emotional symptoms.
Burnout in the wake of the COVID-19 pandemic is an issue affecting all facets of healthcare. According to Forbes, a 2022 report by Elsevier Health found that 47% of US healthcare workers plan to leave their current role in the next two to three years, in some measure due to the enormous pressures healthcare workers face.
And workers are not the only ones paying attention to burnout. On May 23, 2022, the United States Surgeon General, Vice Admiral Vivek Murthy, MD, issued a Surgeon General’s Advisory highlighting the need to address worker burnout.
“COVID-19 has been a uniquely traumatic experience for the health workforce and for their families, pushing them past their breaking point,” Murthy noted. “Now, we owe them a debt of gratitude and action. And if we fail to act, we will place our nation’s health at risk. This Surgeon General’s Advisory outlines how we can all help heal those who have sacrificed so much to help us heal.”
Healthcare workers were facing high levels of burnout before 2020, the COVID-19 pandemic only made the issue worse. The National Academies of Medicine (NAM) reported in 2019 that worker burnout had reached a “crisis level,” and that during the pandemic, half of all healthcare workers reported symptoms of at least one mental health condition.
Training Programs Needed to Offset Worker Shortages and Retain Staff
As Bator reported in Daily Nurse, “The American Society of Clinical Pathology (ASCP)—the largest association for [medical] laboratory professionals—has stressed the importance of promoting MLS/MLT programs to produce certified, well-trained lab professionals, to fill major staffing shortages. However, filling the positions is only one piece of the puzzle.”
Bator points out that there wasn’t space nor time for guidance or advancement with the sheer volume of SARS-CoV-2 testing they had to complete.
“Late last year, during the worst of the Omicron variant surge, the only people I could commiserate with were the nurses who thanked us for running their pediatric ICU tests first,” she said. “They understood what we meant when we said we were drowning and stopped calling the lab to pester us for results because they knew that the positivity rate in Cuyahoga County was the third highest in the country and that the entire system was overwhelmed.”
Suzanna Bator is just one early-career worker among many healthcare professionals who have experienced this type of burnout due to the COVID-19 pandemic. As made evident by her piece, the pathology and clinical laboratory professions are losing workers who otherwise might have entered training programs to further their careers in those fields.
The issue of worker burnout is not just a temporary stressor on the clinical laboratory industry. Both worker burnout and staffing shortages in labs preceded the pandemic and will have continuing long-term effects unless steps are taken to reverse it.
Clinical laboratory data was key in identifying antibiotic-resistant bacteria responsible for surge in BSIs in hospitals and other healthcare facilities in 2020 and 2021
Clinical laboratory data compiled by the European Antimicrobial Resistance Surveillance Network (EARS-Net) shows that a massive increase in bloodstream infections (BSIs) occurred among EU nations during the first two years of the COVID-19 pandemic. The study found that BSIs caused by certain antimicrobial-resistant (AMR) pathogens, known as superbugs, more than doubled in EU hospitals and healthcare facilities in 2020 and 2021.
Microbiologists and clinical laboratory managers in the US may find it valuable to examine this peer-reviewed study into AMR involved in blood stream infections. It could contain useful insights for diagnosing patients suspected of BSIs in US hospitals where sepsis prevention and antibiotic stewardship programs are major priorities.
“Antimicrobial resistance undermines modern medicine and puts millions of lives at risk,” said Tedros Adhanom Ghebreyesus, PhD, Director-General, World Health Organization, in a WHO press release. “To truly understand the extent of the global threat and mount an effective public health response to [antimicrobial resistance], we must scale up microbiology testing and provide quality-assured data across all countries, not just wealthier ones.” Clinical laboratories in the US may be called upon to submit data on bloodstream infections in this country. (Photo copyright: WHO.)
Clinical Laboratories in EU Report Huge Increase in Carbapenem Resistance
To perform their study, researchers measured the increase in Acinetobacter BSIs between 2020 and 2021, the first two years of the COVID-19 pandemic. Their data originated from qualitative regular antimicrobial susceptibility testing (AST) from blood samples collected by local clinical laboratories in the European Union/European economic area (EU/EEA) nations.
The researchers limited their dataset to Acinetobacter BSI information from the European medical laboratories that documented results of carbapenem susceptibility testing for the bacterial species.
Carbapenems are a class of very powerful antibiotics that are typically used to treat severe bacterial infections. A total of 255 EU/EEA clinical laboratories reported their data for the study. The scientists found that the percentages of Acinetobacter resistance varied considerably between EU/EEA nations, so they separated the countries into three different groups:
Nations in Group One—The Netherlands, Belgium, Austria, Estonia, Denmark, Germany, Iceland, Finland, Luxembourg, Ireland, Norway, Sweden, and Malta—experienced less than 10% resistance to carbapenems.
Nations in Group Two—Slovenia, Czech Republic, and Portugal—had carbapenem resistance between 10% and 50%.
Nations in Group Three—Croatia, Bulgaria, Greece, Cyprus, Italy, Hungary, Lithuania, Latvia, Romania, Poland, Spain, and Slovakia—demonstrated carbapenem resistance equal or greater than 50%.
The study also found that Acinetobacter BSIs rose by 57% and case counts increased by 114% in 2020 and 2021 when compared to 2018 and 2019. The percentage of resistance to carbapenems rose to 66% in 2020 and 2021, up from 48% in 2018 and 2019.
Antimicrobial Resistance Especially High in Hospital Settings
The researchers further arranged the data into three hospital ward types: intensive care unit (ICU), non-ICU, and unknown. The increase in BSIs caused by Acinetobacter species resistant to carbapenems was greater in ICU-admitted individuals (144%) than non-ICU-admitted individuals (41%).
There are more than 50 species of Acinetobacter bacteria and various strains are often resistant to many types of commonly-used antibiotics. Symptoms of an Acinetobacter infection usually appear within 12 days after a person comes into contact with the bacteria. These symptoms may include:
Blood infections,
Urinary tract infections,
Pneumonia, and
Wound infections.
Healthy people have a low risk of contracting an Acinetobacter infection with the highest number of these infections occurring in hospitals and other healthcare settings. Acinetobacter bacteria can survive for a long time on surfaces and equipment, and those working in healthcare or receiving treatment are in the highest risk category.
The prevalence of this type of bacteria increases in relation to the use of medical equipment, such as ventilators and catheters, as well as antibiotic treatments.
WHO Report Validates EARS-Net Research
In December of 2022, the World Health Organization (WHO) issued a Global Antimicrobial Resistance and Use Surveillance System (GLASS) report that revealed the presence of an increasing resistance to antibiotics in some bacterial infections. That report showed high levels (above 50%) of resistance in bacteria that frequently caused bloodstream infections in hospitals, such as Klebsiella pneumonia and Acinetobacter.
The WHO report examined data collected during 2020 from 87 different countries and found that common bacterial infections are becoming increasingly resistant to treatments. Both Klebsiella pneumoniae and Acinetobacter can be life threatening and often require treatment with strong antibiotics, such as carbapenems.
More research is needed to determine the reasons behind increases in Acinetobacter infections as reported in European hospitals and other healthcare settings, and to ascertain the extent to which they are related to hospitalizations and the upsurge in antimicrobial resistance during the COVID-19 pandemic.
Microbiologists and clinical laboratory managers in the US may want to learn more about the fIndings of this European study involving AMR and use those insights to plan accordingly for any future increase in bloodstream infections in this country.
Clinical laboratories and point-of-care settings may have a new diagnostic test if this novel handheld device and related technology is validated by clinical trials
Efforts to develop breath analyzers that accurately identify viral infections, such as SARS-CoV-2 and Influenza, have been ongoing for years. The latest example is ViraWarn from Opteev Technologies in Baltimore, Maryland, and its success could lead to more follow-up PCR tests performed at clinical laboratories.
“Breath is one of the most appealing non-invasive sample types for diagnosis of infectious and non-infectious disease,” said Opteev in its FDA Pre-EUA application. “Exhaled breath is very easy to provide and is less prone to user errors. Breath contains a number of biomarkers associated with different ailments that include volatile organic compounds (VOCs), viruses, bacteria, antigens, and nucleic acid.”
Further clinical trials and the FDA Pre-EUA are needed before ViraWarn can be made available to consumers. In the meantime, Opteev announced that the CES (Consumer Electronic Show) had named ViraWarn as a 2023 Innovation Award Honoree in the digital health category.
“ViraWarn is designed to allow users an ultra-fast and convenient way to know if they are spreading a dangerous respiratory virus. With a continued increase in COVID-19 and a new surge in RSV and influenza cases, we’re eager to bring ViraWarn to market so consumers can easily blow into a personal device and find out if they are positive or negative,” said Conrad Bessemer (above), Opteev President and Co-Founder, in a news release.
Opteev is a subsidiary of Novatec, a supplier of machinery and sensor technology, and a sister company to Prophecy Sensorlytics, a wearable sensors company.
The ViraWarn breath analyzer uses a silk-based sensor that “traces the electric discharge of respiratory viruses coupled with an artificial intelligence (AI) processor to filter out any potential inaccuracies,” according to the news release.
Here is how the breath analyzer (mouthpiece, attached biosensor chamber, and attached printed circuit board chamber) is deployed by a user, according to the Opteev website:
The user turns on the device and an LED light indicates readiness.
The user blows twice into the mouthpiece.
A carbon filter stops bacteria and VOCs and allows virus particles to pass through.
As “charge carriers,” virus particles have a “cumulative charge.”
Electrical data are forwarded to the AI processor.
The AI processer delivers a result.
Within 60 seconds, a red signal indicates a positive presence of a virus and a green signal indicates negative one.
“The interaction of the virus with a specially designed liquid semiconductive medium, or a solid polymer semiconductor, generates changes in the conductivity of the electrical biosensor, which can then be picked up by electrodes. Such electrical data can be analyzed using algorithms and make a positive or negative call,” explains an Opteev white paper on the viral screening process.
While the ViraWarn breath analyzer can identify the presence of a virus, it cannot distinguish between specific viruses, the company noted. Therefore, a clinical laboratory PCR test is needed to confirm results.
Other Breath Tests
Opteev is not the only company developing diagnostic tests using breath samples.
For clinical laboratory managers and pathologists, Opteev’s ViraWarn is notable in breath diagnostics development because it is a personal hand-held tool. It empowers people to do self-tests and other disease screenings, all of which would need to be confirmed with medical laboratory testing in the case of positive results.
Further, it is important to understand that consumers are the primary target for this novel diagnostic device. This is consistent with investor-funding companies wanting to develop testing solutions that can be used by consumers. At the same time, a device like ViraWarn could be used by clinical laboratories in their patient service centers to provide rapid test results.
