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ACLA Comments on MCIT/Reasonable and Necessary Definition Proposed Rule
Rapid Change is the Name of the Game
This Laboratory Professionals Week, we honor the innovators, collaborators and colleagues who have gone above and beyond behind the scenes to meet patient need. Today, ACLA is celebrating Dave Majewski, a supervisor at Mayo Clinic Laboratories in Rochester, Minnesota, whose job dramatically changed over the last year as he went from overseeing 40 staff members to more than 240 in a 24/7 lab.
For more than 15 years, Dave Majewski has led his colleagues at Mayo Clinic Laboratories’ Department of Laboratory Medicine and Pathology to meet patients’ critical health care needs. 
Prior to the COVID-19 pandemic, Dave supervised 42 staff members within the HIV/Hepatitis Laboratory, which was divided into two work units: the molecular lab and the serology lab.
In the early days of the pandemic, Dave Majewski faced the challenge of a lifetime: developing and validating a new COVID-19 PCR test in a matter of days.
It began with a routine call with a vendor about a potential COVID-19 test they might have available. The next morning, Dave was tasked with bringing a COVID-19 test online within three to four weeks — a process that typically takes six to nine months. At the end of the day, that timeline shifted to two weeks and by the next morning, Dave and his colleagues were given only few days to develop and validate a COVID-19 test.
“Within 119 hours, our team was able to adjust staffing, add equipment, validate the test, train staff and go live,” says Dave on the rapid change in his lab.
Adapting to address the needs of patients during the COVID-19 pandemic meant that Dave had to make adjustments among his staff and it needed to be done quickly. In the HIV/Hepatitis Molecular Lab work unit, the number of lab professionals increased exponentially, growing from 21 to roughly 240 individuals. In addition to welcoming and training a more than elevenfold increase in new colleagues to meet the demands of COVID-19, Dave noted the around-the-clock effort that completely transformed the molecular lab division. “We went from two shifts Monday through Friday, with one Saturday shift, to 24/7 testing,” explains Dave.
Dave attributes teamwork as his personal source of inspiration and calls it a key success factor in Mayo Clinic Laboratories’ efforts to innovate and introduce a highly accurate and reliable COVID-19 test. “Facilities did a remarkable job to rearrange with short notice on multiple occasions,” describes Dave. “All the supervisors around us offered to help, knowing we’re completely swamped. If we needed something, someone was there to provide assistance.”
In the year since ACLA member laboratories led the way to validate and launch the first novel tests for SARS-CoV-2 virus, lab professionals like Dave have worked around the clock to collectively perform more than 118 million PCR tests for COVID-19 as of April 18, all while adapting platforms and workflows, navigating supply constraints and working creatively and collaboratively to meet patients’ evolving health needs. As new strains of the virus emerge and more Americans get vaccinated, Dave’s work remain critical to ensure robust access to accurate and reliable COVID-19 testing. ACLA member laboratories remain focused on those efforts, and increasing and maintaining access to all kinds of clinical lab tests – including the latest innovative diagnostic tools to drive forth the next generation of patient care.
ACLA Comments on United States Core Data for Interoperability (USCDI) Draft V2
ACLA Letter to New York State on Executive Order
Connecting Patients with The Treatment They Need
Kavita Bhat, PhD, is the Vice President of Lab Operations at Myriad Neuroscience, a subsidiary of Myriad Genetics. In her role, Dr. Bhat works closely with her colleagues to perform pharmacogenetic (PGx) testing – a type of genetic test that provides doctors and patients with vital clinical information to inform care.
Providers rely on PGx tests to identify genetic markers and clinically actionable information that can anticipate a patient’s response to drugs based on well-documented scientific evidence. By helping providers pinpoint potential adverse drug reactions and response markers, PGx testing helps limit the significant costs associated with trial and error and supports a more efficient, patient-centered approach to care. As Dr. Bhat notes, this is particularly important for patients managing mental health conditions – the focus of her lab – given the health complications that may arise if a patient isn’t prescribed a medication compatible with their genetic makeup.
Dr. Bhat also shares how ongoing genetic innovations can play a critical role in making health care delivery more efficient, lowering patients’ costs, and improving their access to appropriate treatments. Given the direct role and value that these tests provide, “We really need to continue investing in research and development in order to provide better quality and improved outcomes,” emphasizes Dr. Bhat. “We’re all trying to improve care.”
Watch below for highlights from the interview with Dr. Bhat and learn more about the critical work performed by laboratory professionals across the country.
ACLA Comment Letter on Reconsideration Request for New Therapeutic Drug and Molecular Pathology CPT Codes
Multiplex Testing: An Important Tool To Counter the Spread of Flu and COVID-19
A key part of the country’s ability to track and stop the spread of this virus and other infectious diseases is the continued development and evolution of novel testing methods that can address the diverse health needs of patients across the country. The recent introduction of multiplex testing is the latest example of the industry tackling two prominent public health threats: COVID-19 and influenza.
Influenza impacts millions of individuals annually in the United States. In fact, the Centers for Disease Control (CDC) estimates that as many as 9.3 to 45 million people are infected by influenza each year, resulting in 140,000 – 810,000 hospitalizations and 12,000 – 61,000 deaths. Among those most susceptible to complications from the flu are older Americans over 65 years old, individuals with chronic conditions, pregnant women, young children and marginalized racial groups.
Multiplex testing is used for targeted cases as determined by a clinician, and is not a replacement for standard COVID-19 testing. For certain patients, such as those presenting with multiple symptoms associated with respiratory viral infections, multiplex testing allows providers to test for multiple viruses at once and provide a more comprehensive clinical diagnosis.
According to the CDC, patients may experience concurrent respiratory infections, making accurate identification of these viruses through a single diagnostic test even more important as the country faces a new surge of COVID-19 cases on top of flu season. Distinguishing these viruses is significant as they do not share the same treatment or public health implications, further underscoring the important role of multiplex testing for our broader public health response to the pandemic.
Though multiplex testing has played a key role in past flu seasons, several ACLA member laboratories have pioneered new multiplex tests to help providers quickly differentiate between SARS-CoV-2, influenza A, influenza B, RSV and other respiratory viruses that may have similar or overlapping symptoms.
Multiplex testing also helps clinical labs conserve important testing supplies, such as pipettes, swabs and reagents, all of which remain in high demand. By reducing the need for single-use testing, multiplex testing also decreases the consumption of critical testing supplies while delivering accurate and comprehensive results to both patients and providers. During continued high demand for COVID-19 tests and supply chain constraints, multiplex testing is vital to creating workflow efficiencies for clinical labs and streamlining test orders for patients, providers and public health authorities.
As the COVID-19 pandemic continues alongside peak flu season, it is critical that Congress strengthen the federal protections that allow patients to access critical diagnostic tests without cost-sharing. Multiplex testing remains an essential tool for providers, patients and public health officials to help manage this challenging flu season and the continued spread of COVID-19.
