Prior to that, however, the FDA had already announced its intention to issue a proposed rule giving the agency regulatory oversight of LDTs.
“The FDA has continually supported the passage of the VALID Act by Congress,” attorney Charles Dunham IV, a Shareholder at Greenberg Traurig LLP in Houston, told Dark Daily. “In fact, there is speculation that the VALID Act will be attached to the Pandemic and All Hazards Preparedness Act as it moves through Congress.”
“The FDA may not actually proceed with promulgating rules to regulate LDTs if it is concerned it will not be successful in court if the rules are challenged, which would happen,” said attorney Charles Dunham IV (above), a Shareholder at Greenberg Traurig, LLP. Clinical laboratory leaders can learn more from Dunham during a panel discussion at next week’s 2023 Executive War College on Diagnostics, Clinical Laboratory, and Pathology Management in New Orleans. (Photo copyright: Greenberg Traurig LLP.)
Arguments For and Against FDA LDT Regulation of LDTs
Supporters of the VALID Act contend that putting LDTs under FDA regulation will lead to improved patient safety and less review for low-risk tests. Their argument is that LDTs should undergo the same FDA review and approval process as other medical devices.
Hospital laboratory managers and pathologists—particularly in academic medical center laboratories—have largely opposed FDA regulation of LDTs. They prefer to keep the current setup under which lab-developed tests are validated under the Clinical Laboratory Improvement Amendments of 1988 (CLIA). They argue that FDA intervention will slow down development of new tests.
In response, an FDA official indicated during the American Clinical Laboratory Association’s (ACLA) annual meeting on March 1 that the federal agency plans to issue a proposed rule to regulate LDTs, BioWorld reported. That rulemaking has not yet emerged. It’s possible the FDA will wait and see what happens in Congress with the VALID Act.
“Some legal experts have suggested that one significant new legal challenge FDA may face is the Supreme Court’s West Virginia v. EPA decision last summer that limited the ability of the EPA to cap power plant emissions by regulation due to the EPA’s lack of explicit congressional authority to do so,” said Gee, who also will appear on the Executive War College legal panel next week.
“The West Virginia v. EPA ruling provides support for those in the clinical lab industry who point to the FDA’s lack of clear statutory authority to regulate LDTs and therefore fundamentally disagree with FDA’s longstanding position that LDTs are medical devices subject to FDA’s authority to regulate,” he added.
Actions Clinical Laboratory Managers Can Take
Clinical laboratory managers who want to share their thoughts about the future of LDT regulation may want to take one or both of the following actions:
Contact their representatives in Congress.
Find out whether any trade associations they belong to have taken a position on the VALID Act.
Clinical laboratory professionals should monitor the VALID Act’s progress while also paying attention to industry groups and manufacturers that support or oppose the bill.
Doing so will provide a clearer indication of who has the most to gain or lose should the legislation be passed. Pathologists and medical laboratory managers should also remain alert for further efforts by the FDA to issue proposed rulemaking to regulate LDTs.
As a deployable medical laboratory, the 1st AML is designed to run field-based clinical laboratory diagnostics and conduct health threat assessments
Clinical laboratory professionals may be surprised to learn that the US Army has a deployable medical laboratory that is equipped to perform the same menu of basic lab tests as their labs here in the United States, but in support of army units deployed in the field. At the same time, the Army’s deployable medical lab has the added responsibility of testing for infectious diseases and chemicals/agents that could be used by terrorists or enemy forces.
“The 1st Area Medical Laboratory identifies and evaluates health hazards through unique medical laboratory analyses and rapid health hazard assessments of nuclear, biological, chemical, endemic disease, occupational, and environmental health threats,” according to an Army new release.
A recent visit by the leaders of this lab unit to meet with their counterparts in Poland highlights the important diagnostic work the military prepares for by using this one-of-a-kind clinical laboratory model.
Col. Matthew Grieser (left), Commander of the 1st Area Medical Laboratory (AML) is shown above meeting with Col. Przemysław Makowski, MD, (right), Deputy Commander of the Military Preventive Medicine Center in Wrocław, Poland. Leaders from the US Army’s 1st AML visited military and medical officials in Poland. “It was a great opportunity to meet our Polish counterparts and to learn from one another,” said Grieser in an Army news release. “We intend to continue to strengthen this relationship … Poland is a great ally, and it was an honor to visit our counterpart organizations.” (Photo copyright: US Army.)
Role and Makeup of the 1st Area Medical Laboratory
The 1st AML traces its roots back to World War II, where it was one of 19 field laboratories spun up in 1944. It was deactivated after the Vietnam War and then reactivated in 2004. It is currently the Army’s only deployable field laboratory, according to the National Library of Medicine.
This specialized unit deploys worldwide to conduct threat detection and medical surveillance, according to the Army. For example, the military can send the 1st AML to locations where samples cannot quickly be transported to a fixed facility, or where there is a need for immediate hazard identification due to chemical or biological contamination or epidemic disease.
During the Ebola outbreak in Liberia in 2014-2015, the 1st AML operated four blood-testing laboratories and helped oversee two others manned by Navy personnel. The goal was to perform quick turnaround times to identify local residents who carried the disease, all while operating with extensive safety measures. More than 4,500 samples were tested during a six-month stay, Army Times reported.
Commanders from the 1st AML recently met with medical officials and chemical, biological, radiological, and nuclear experts from the Polish Armed Forces in the Warsaw area of Poland, the Army news release noted.
“It was a great opportunity to meet our Polish counterparts and to learn from one another,” said Col. Matthew Grieser, Commander of the 1st AML.
Maj. Suzanne Mate, the Chief of chemical threat assessment for the 1st AML, said meeting with allies helps to keep NATO ready for any contingency.
“It’s better to know your partners before you have to work together in a high-consequence situation,” said Mate in the Army news release. “We learned the strengths in different mobility platforms for laboratories and the capabilities within fixed scientific institutions to maintain standards and currency in chemical, biological, and radiological [CBR] investigations.
“This knowledge is invaluable when determining how to move a sample quickly and efficiently to characterize a suspected CBR threat when airlift resources are constrained or country treaties prevent movement activities,” she added.
Observant clinical laboratory managers will note similarities between their own jobs and those of the 1st AML. The military needs lab-based capabilities to perform a menu of diagnostic tests in support of Army units in the field and traditional clinical laboratories do the same in support of the healthcare providers they service.
Should this AI-driven technology prove viable in clinical settings, it could contribute to easing the shortage of qualitied phlebotomists for medical laboratories worldwide
Could phlebotomists one day be out of a job? If European medical technology company Vitestro has its way, that could someday become a reality in European hospitals and in clinical laboratories worldwide. Headquartered in the Netherlands, the company has raised EUR 12.7 million ($14,057,947.50 US) in Series A financing to bring to market “the world’s first autonomous blood drawing device,” BioWorld Med Tech reported.
According to Vitestro’s website, the “device combines AI-based, ultrasound-guided 3D reconstruction with robotic needle insertion, ensuring accurate and secure blood collection. The procedure is performed fully automatically, from tourniquet to bandage application.”
This is another example of how artificial intelligence companies are finding opportunities in staffing shortages the healthcare industry is experiencing globally. In this case, the novel technology could help address the lack of qualified phlebotomists. And clinical laboratories around the world could become the proving grounds for new AI-driven devices that end up replacing human healthcare workers.
“This financing round marks a new phase of growth for Vitestro which brings the company closer to its mission of improving the venipuncture procedure for hundreds of millions of patients per year,” said Vitestro CEO and co-founder Toon Overbeeke (above), in a press release. “We look forward to growing the business and transforming patient care with Sonder Capital, leveraging their expertise in successfully commercializing medical robotic technologies.” If proven viable, clinical laboratories around the world suffering from shortages of phlebotomists could benefit from AI-driven autonomous blood draw stations. (Photo copyright: LinkedIn.)
Next Evolution for Clinical Laboratories
According to the Centers for Disease Control and Prevention (CDC), there are 14 billion clinical laboratory tests ordered annually in the US and 70% of medical decisions depend on laboratory results. One of the more common clinical laboratory procedures—venous blood draws—is pivotal in clinical diagnostics, but a worldwide shortage of skilled phlebotomists is having an impact on this critical testing method.
With the announcement of its completion of a EUR 12.7-million Series A financing round to bring the “world’s first” autonomous blood draw device to market, Vitestro seems poised to impact both the shortage and the job prospects of existing phlebotomists. This financing round was led by San Carlos, California-based Sonder Capital and included investors with experience in the clinical laboratory and medical technology industries.
“Automating this ubiquitous procedure is the next evolution for clinical laboratories, allowing them to improve quality of care for patients while building a more sustainable operation,” stated Andy McGibbon, Managing Partner at Sonder Capital in a March press release.
According to Investopedia, Series A financing refers to “an investment in a privately-held start-up company after it has shown progress in building its business model and demonstrates the potential to grow and generate revenue. It often refers to the first round of venture money a firm raises after seed and angel investors.”
Vitestro says it will utilize the capital from this financing round to accelerate production development, prepare market authorization in the European Union, and initiate production.
Vitestro’s autonomous blood drawing device prototype (above) has been tested on more than 1,000 volunteers and patients. Vitestro plans to continue its studies on the device this year and anticipates entering the European market with the device sometime in 2024. Development of this technology is something that phlebotomists and clinical laboratory managers will want to track. (Photo copyright: Vitestro.)
Coming to a Clinical Laboratory Near You
“Medical robotics will make optimal outcomes available to everyone. I strongly believe Vitestro will set the world standard in autonomous blood drawing,” said Fred Moll, MD, Managing Partner of Sonder Capital in the press release. Moll, who has been heralded as the “father of robotic surgery,” was also appointed as a non-executive board member of Vitestro. Moll co-founded Intuitive Surgical, Inc., Hansen Medical, Restoration Robotics, and Auris Health (acquired by Ethicon, a Johnson and Johnson company).
On April 12, Vitestro announced that leading Dutch clinical laboratory OLVG Lab will be the first healthcare provider to begin using their blood-drawing device. A number of hospitals, clinical laboratories, and blood drawing departments are preparing to use the device and OLVG Lab plans to have the system fully operational by late next year, according to a press release. OLVG lab provides laboratory services to hospitals, clinics, and care providers in the greater Amsterdam area.
“Robotization has become an important topic in diagnostics. Vitestro’s technology will improve the standardization and optimization of the sampling procedure. And it helps solve staff shortages in our blood drawing department,” said Anja Leyte, director of OLVG Lab, in the press release. “But more importantly, the patients are also very positive. Our staff are really enthusiastic as well and can’t wait to start using this breakthrough technology in our healthcare.”
Vitestro’s device is still in the testing phase but could prove to be very beneficial to clinical laboratories and help alleviate the shortage of trained phlebotomists. An automated blood draw machine might also improve the consistency of the blood draw experience for both patients and healthcare professionals.
Proposed regulation to limit rate increases during health crises gets pushback from staffing agencies and travel nurses who disagree with salary restrictions
Hospitals across the nation are seeking relief from skyrocketing costs due to increased demand for temporary workers—especially travel nurses. This has led organizations like the American Hospital Association (AHA) to step in and call for legislators to cap spiking salary rates. Many clinical laboratories report similar increases in salaries following the outbreak of SARS-CoV-2 for medical technologists (MTs), clinical laboratory scientists (CLSs), histologists, and other skilled positions. This increase in salaries of lab scientists was mirrored by an even greater increase in the cost of travel MTs.
According to analysis conducted by Becker’s Hospital Review of hiring data from Vivian Health, an online job placement website for healthcare professionals, “Average weekly travel nurse pay climbed from $1,896 in January 2020 to $3,782 in December 2021, a 99.47% increase.”
A prior study by Kaufman Hall and Associates, LLC., found rates for temporary workers almost 500% higher than pre-pandemic times. While numbers are trending downward, it’s clear that rates are still high enough to cause alarm, KFF Health News reported.
“During the pandemic there were staffing companies who were making a lot of promises and not necessarily delivering,” Dave Dillon (above), VP of Public and Media Relations at Missouri Hospital Association, told KFF Health News. “It created an opportunity for both profiteering and for bad actors to be able to play in that space.” (Photo copyright: L.G. Patterson/Missouri Hospital Association.)
AHA Alleges Price Gouging
Demand for temporary healthcare workers surged during the COVID-19 pandemic, and, because supply was limited, salaries for temporary workers—such as travel nurses—soared as well. This dramatic increase in hospitals’ costs prompted the AHA in 2021 to send a letter to the Federal Trade Commission seeking relief for healthcare providers from what the organization called “anticompetitive pricing by nurse-staffing agencies.”
In January 2022, about 200 House members urged then White House COVID-19 Response Team Coordinator Jeffrey Zients “to investigate reports that nurse staffing agencies are taking advantage of the COVID-19 pandemic to increase their profits at the expense of patients and the hospitals that treat them,” an AHA new release noted.
In an AHA House Statement titled, “Pandemic Profiteers: Legislation to Stop Corporate Price Gouging,” the AHA wrote “Our concerns range from potential collusion to increased prices way beyond competitive levels and/or egregious price gouging and the impact these behaviors could have on efforts to care for patients and communities.”
Temporary nurses make up a large portion of staff nationwide with 1,760,111 employed nationally as of September, according to Zippia research. With some nurses commandeering $40,000 signing bonuses and pay rates up to $10,000 a week for ICU nurses during the height of the COVID-19 pandemic, the significant impact of these rate hikes cannot be ignored.
“We have received reports that the nurse staffing agencies are vastly inflating price by two, three, or more times pre-pandemic rates, and then taking 40% or more of the amount being charged to the hospitals for themselves as profits. This situation is urgent and reliance on temporary workers caused normal staffing costs to balloon in all areas of the country,” Representatives Peter Welch, D-VT, and Morgan Griffith, R-VA, wrote in the letter submitted by the AHA to House members.
States Take a Stand
But nothing was done at the federal level to cap rates for travel nurses, so hospital organizations in 14 states lobbied legislators to cap rates at the local level. However, this has proven to be problematic.
At this time, at least 14 states have proposed legislation that impose limits on what temp nursing services can charge and what stipulations they must follow during a crisis. Navigating this patchwork of state laws could be challenging for both hospitals and temporary nurses.
Some states are taking sterner measures, KFF Health News reported:
Missouri regulators proposed legislation that would allow felony charges to be brought against healthcare staffing agencies that raise prices during emergencies.
Texas lawmakers proposed legislation that would administer civil penalties against agency price-gouging—laws which the state does not have on the books at all—and also would allow fees up to $10,000 to be assessed per violation of the proposed law.
New York proposed amendments to legislation that would cap the amount temporary staffing agencies could charge.
Nurses, Staffing Agencies Tell Their Side
The implementation of new laws to protect hospitals from alleged temp agency price gouging presents new challenges. One issue is state-to-state competition.
“It might become difficult to hire travel nurses, and some states could face a lower-quality hiring pool during a national crises if the neighboring state doesn’t have strict measures,” Hannah Neprash, PhD, Assistant Professor, Division of Health Policy and Management at the University of Minnesota, told KFF Health News.
And financial handcuffs may not sit well with staffing agencies that feel misunderstood by hospital organizations pushing for regulation. According to KFF Health News, “Typically about 75% of the price charged by a staffing agency to a healthcare facility goes to costs such as salary, payroll taxes, workers’ compensation programs, unemployment insurance, recruiting, training, certification, and credential verification, said Toby Malara, a Vice President at the American Staffing Association trade group.”
Malara added, “hospital executives have, ‘without understanding how a staffing firm works,’ wrongly assumed price gouging has been occurring. In fact, he said many of his trade group’s members reported decreased profits during the pandemic because of the high compensation nurses were able to command,” KFF Health News reported.
Not surprisingly, many nurses have also come out against government regulation of their wages.
“Imagine the government attempting to dictate how much a lawyer, electrician, or plumber would make in Missouri. This would never be allowed, yet this is exactly what’s happening right now to nurses,” Theresa Newbanks, FNP, a nurse practitioner who is affiliated with several hospitals in multiple states.
Creative Responses Required
Increases in both rates and legislation continue to spur creativity among hospitals needing to fill shifts, support staff, and prevent worker burnout.
The American Hospital Association December 2022 Task Force noted this in their “Creative Staffing Models” paper. The AHA cited telehealth visits, technical support, and working with non-traditional partners as beneficial ideas. These were also noted as meaningful ways to recruit and retain staff.
Other hospital systems have even created their own staffing agencies. Allegheny Health Network (AHN) developed a variety of systems where nurses can work a single weeklong assignment, multiple-week assignments, or transfer to other facilities, Kaiser Health News reported. While these staffing scenarios make up a small percentage of the hospital staff, it’s a worthwhile addition to increase options for nurses.
Staff turnover for RNs increased from 8.4% to 27.1% last year, as reported by the 2022 NSI National Healthcare Retention and RN Staffing Report. Finding solutions to staffing shortages—and consequently increased temporary nursing cost—is crucial because burnout is still a problem, just as it is in clinical laboratories and pathology groups.
Understanding why some people display no symptoms during a COVID-19 infection could lead to new precision medicine genetic tests medical labs could use to identify people with the mutated gene
New research from the University of California San Francisco (UCSF) may explain why some people could get COVID-19 but never test positive on a clinical laboratory test or develop symptoms despite exposure to the SARS-CoV-2 coronavirus.
According to the UCSF study, variations in a specific gene in a system of genes responsible for regulating the human immune system appears to be the factor in why about 10% of those who become infected with the virus are asymptomatic.
These scientific insights did not receive widespread news coverage but will be of interest to clinical laboratory managers and pathologists who oversee SARS-CoV-2 testing in their labs.
“Some people just don’t have symptoms at all,” Jill Hollenbach, PhD (above), Professor of Neurology atUCSF’s Weill Institute for Neurosciences and lead researcher in the study, told NBC News. “There’s something happening at a really fundamental level in the immune response that is helping those people to just completely wipe out this infection.” Identifying a genetic reason why some people are asymptomatic could lead to new precision medicine clinical laboratory diagnostics for COVID-19. (Photo copyright: Elena Zhukova /University of California San Francisco.)
Fortunate Gene Mutation
According to the Centers for Disease Control and Prevention’s (CDC) COVID Data Tracker, as of April 5, 2023, a total of 104,242,889 COVID-19 cases have been reported in the United States. However, according to a CDC Morbidity and Mortality Weekly Report (MMWR), “Traditional methods of disease surveillance do not capture all COVID-19 cases because some are asymptomatic, not diagnosed, or not reported; therefore, [knowing the true] proportion of the population with SARS-CoV-2 antibodies (i.e., seroprevalence) can improve understanding of population-level incidence of COVID-19.”
She also participates in the COVID-19 HLA and Immunogenetics Consortium, a group of academic researchers, clinical laboratory directors, journal editors, and others who examine the role of HLA variations in determining COVID-19 risk.
Hollenbach’s research identified an HLA variant—known as HLA-B*15:01—that causes the human immune system to react quickly to SARS-CoV-2 and “basically nuke the infection before you even start to have symptoms,” she told NPR.
“It’s definitely luck,” she added. “But, you know, this [gene] mutation is quite common. We estimate that maybe one in 10 people have it. And in people who are asymptomatic, that rises to one in five.”
“HLA variants are among the strongest reported associations with viral infections,” the UCSF study notes. So, the researchers theorized that HLA variations play a role in asymptomatic SARS-CoV-2 infections as well.
To conduct their study, shortly after the SARS-CoV-2 outbreak in 2020, the researchers recruited approximately 30,000 volunteer bone marrow donors from the National Marrow Donor Program to respond to periodic questions via a smartphone app or website. Because HLA variations can determine appropriate matches between donors and recipients, the database includes information about their HLA types.
Each week, respondents were asked to report if they had been tested for SARS-CoV-2. Each day, they were asked to report whether they had symptoms associated with COVID-19. “We were pretty stringent in our definition of asymptomatic,” Hollenbach told NBC News. “[The respondents couldn’t] even have a scratchy throat.”
The researchers eventually identified a cohort of 1,428 people who had tested positive for SARS-CoV-2 between February 2020 and April 30, 2021, before vaccines were widely available. Among these individuals, 136 reported no symptoms for two weeks before or two weeks after a positive test.
“Overall, one in five individuals (20%) who remained asymptomatic after infection carried HLA-B*15:01, compared to 9% among patients reporting symptoms,” the researchers wrote in their medRxiv preprint. Study participants with two copies of the gene were more than eight times more likely to be asymptomatic.
The UCSF researchers also looked at four other HLA variants and found none to be “significantly associated” with lack of symptoms. They confirmed their findings by reproducing the HLA-B association in two additional independent cohorts, one from an earlier study in the UK and the other consisting of San Francisco-area residents.
Individuals in the latter group had either tested positive for SARS-CoV-2 or reported COVID symptoms, and their DNA was analyzed to determine their HLA types.
Pre-existing T-Cell Immunity May Reduce Severity of COVID-19 Infection
The UCSF researchers also attempted to determine how HLA-B*15:01 plays a role in knocking out SARS-CoV-2 infections. They noted previous research that indicated previous exposure to seasonal coronaviruses, such as common cold viruses, could limit the severity of COVID-19. The scientists hypothesized that pre-existing T-cell immunity in HLA-B carriers may be the key.
The COVID-19 HLA and Immunogenetics Consortium website describes how HLA and T-cells work together to ward off disease. HLA “proteins are found on the surface of all cells except red-blood cells.” They’re “like windows into the inner workings of a cell,” and T-cells use the molecules to determine the presence of foreign proteins that are likely signs of infection. “Activated T-cells can kill infected cells, or activate B-cells, which produce antibodies in response to an infection,” the website explains.
Hollenbach’s research team analyzed T-cells from pre-pandemic individuals and observed that in more than half of HLA-B carriers, the T-cells were reactive to a SARS-CoV-2 peptide. The scientists corroborated the hypothesis by examining crystal structures of the HLA-B*15:01 molecule in the presence of coronavirus spike peptides from SARS-CoV-2 and two other human coronaviruses: OC43-CoV and HKU1-CoV.
“Altogether, our results strongly support the hypothesis that HLA-B*15:01 mediates asymptomatic COVID-19 disease via pre-existing T-cell immunity due to previous exposure to HKU1-CoV and OC43-CoV,” the researchers wrote.
Can Genes Prevent COVID-19 Infections?
Meanwhile, researchers at The Rockefeller University in New York City are attempting to go further and see if there are mutations that prevent people from getting infected in the first place. NPR reported that they were seeking participants for a study seeking to identify so-called “superdodger” genes.
Study participants identified as possibly having superdodger genes receive a kit designed to collect saliva samples, after which the researchers sequence the respondents’ genomes. “We hope that in a group of 2,000 to 4,000 people, some people will have genetic mutations that tell us why they’re resistant to infection,” Casanova told NPR.
All this genetic research is in very early stages. But results are promising and may lead to new precision medicine clinical laboratory tests for identifying people who are predisposed to having an asymptomatic response to COVID-19 infection. That in turn could help scientists learn how to moderate or even eliminate symptoms in those unfortunate people who suffer the typical symptoms of the disease.
