The Urgent Need for Professional Advocacy in Laboratory Medicine

Volume 39 Number 4 | August 2025

Summary

Medical laboratory professionals face growing challenges including workforce shortages, regulatory uncertainty, and cuts to public health infrastructure. Author Nicholas Moore urges the profession to engage in advocacy through education, mentorship, and empowerment of early-career professionals. By raising their collective voice, laboratorians can safeguard the profession’s future and ensure science-based policymaking endures.

Safeguarding the Future through Engagement, Education, and Empowerment

Nicholas Moore, PhD, D(ABMM), MLS(ASCP)^CM, ASCLS Director

Medical laboratory professionals serve as the diagnostic backbone of modern medicine, generating results that inform most decisions made by our clinical colleagues. Yet despite our indispensable role, laboratory professionals remain largely invisible to the public and policymakers. Today, our profession is under multiple pressures that constitute a threat not only to ourselves but also to the public that we serve. These threats include: a growing workforce shortage, disruptive regulatory debates, and recent federal actions that threaten to erode scientific expertise in national health policymaking. In this volatile landscape, professional advocacy is not optional, it is essential. And to sustain momentum, we must actively cultivate the next generation of laboratory leaders and advocates.

A Profession in Crisis: Vacancies and Visibility

Across the country, clinical laboratories are facing unprecedented workforce shortages. According to the U.S. Bureau of Labor Statistics, between 2023-2033, they expect to see an additional 18,200 jobs added, roughly a 5 percent increase. The increase is similar to other health professions and is being driven by the increasing population of older adults and the need for testing and monitoring for a greater number of chronic conditions among healthcare recipients.

Unfortunately, vacancy rates already exceed 10 percent in many clinical laboratory specialties, with persistent challenges in recruitment, retention, and succession planning. Laboratory training programs cannot keep pace with demand, and many are reaching retirement age. Burnout, stagnant wages, and limited public recognition compound the problem.

In metropolitan areas like Chicago, open positions for certified MLS professionals may remain unfilled for several months. This has several negative repercussions for laboratories and health systems, including increasing costs and decreasing employee satisfaction and engagement. Laboratories with multiple vacancies may see impacts in test result turnaround times, test availability, and ultimately, patient care. While the need for laboratory testing has grown—spurred by COVID-19, emerging pathogens, and precision medicine—the workforce crisis has left laboratories stretched thin.

If we are to reverse this trend, professional advocacy must extend beyond seasoned leaders to include early-career professionals who are empowered to speak, act, and lead on behalf of the field.

“If we fail to act, decisions will continue to be made without us—by individuals who may not understand the science, the stakes, or the realities of our work.”

Regulatory Turbulence: The LDT Debate

On March 31, 2025, the U.S. District Court for the Eastern District of Texas ruled that the Food and Drug Administration lacked the statutory authority to regulate laboratory-developed tests (LDTs). The FDA’s published final rule promulgated that they always had the authority to regulate LDTs but opted for enforcement discretion. The rule further aimed to classify and regulate LDTs as medical devices, which would have burdened laboratories performing LDTs to submit applications like commercial in vitro device manufacturers. Following the initial announcement by the FDA, lab directors faced confusion and uncertainty over how to comply with these sweeping changes.

The court’s ruling reaffirmed that LDTs fall under CLIA oversight, not FDA jurisdiction. Laboratories that develop and use LDTs for patient care will continue to be required to establish performance specifications for the tests consistent with CLIA requirements. Because LDTs are considered high-complexity tests, after validating the test, laboratories must ensure that they comply with all CLIA regulations applicable to high-complexity laboratories. While this outcome protects access to specialized testing, it highlights the fragile and contested regulatory environment laboratories must navigate.

Medical laboratory professionals must be at the table during these regulatory discussions. Not just scientists and administrators, but also bench-level staff who understand how these decisions translate into daily practice. Without strong professional advocacy, we risk having rules written for us, not with us.

A Blow to Science-Based Policy: Disbanding of Federal Advisory Committees

Despite numerous pledges to work to ensure the health and safety of the American public, in a deeply concerning move, Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. has disbanded several federal health advisory bodies, including the Healthcare Infection Control Practices Advisory Committee (HICPAC), the Advisory Committee on Heritable Disorders in Newborns and Children (ACHDNC), the Clinical Laboratory Improvement Advisory Committee (CLIAC), and others. These expert groups, which are nonpartisan, have long provided scientific guidance to the Centers for Disease Control and Prevention (CDC), the Centers for Medicare & Medicaid Services (CMS), and other HHS agencies and departments in shaping policy on laboratory quality, infection prevention, and public health preparedness.

The role of these panels was at the core of the HHS mission “to enhance the health and well-being of all Americans.” The elimination of HICPAC, for example, which provided guidance on preventing and controlling healthcare-associated infections, could leave healthcare facilities without timely and evidence-based recommendations. This could negatively impact national preparedness and response capacity, especially with emerging pathogens and antimicrobial resistance. CLIAC, which was formed in 1992 in conjunction with the passage of CLIA, has been the principle federal advisory committee responsible for advising the federal government on public policy, safety, and workforce issues related to anatomic pathology and clinical laboratory testing. Its relevance to quality patient care and laboratory testing cannot be overstated. The Trump Administration’s Executive Order 14217, “Commencing the Reduction of the Federal Bureaucracy,” ordered the termination of “unnecessary” federal advisory committees that are not mandated by statute.

Disbanding these committees, silences subject matter experts and further distances frontline professionals from federal decision-making. It represents a devaluation of scientific input at the highest level and an urgent call to action for all medical laboratory professionals to stand up, speak out, and advocate for the integrity of their field.

Deep Cuts to Public Health and Research: A System Under Siege

The profession now faces an even more alarming threat: the dismantling of the federal health infrastructure that supports laboratory science, public health, and biomedical innovation.

In early 2025, the Trump administration and HHS Secretary Kennedy initiated a sweeping reorganization of HHS, resulting in the elimination of 20,000 jobs—nearly a quarter of the department’s workforce. This includes significant layoffs at the CDC, the National Institutes of Health (NIH), and the FDA. Entire programs, such as the National Institute for Occupational Safety and Health (NIOSH), have been gutted, with over 90 percent of staff terminated, effectively halting critical research on worker safety, respirator approval, and firefighter cancer registries.

The NIH has canceled over 230 grants related to HIV research, including a $258 million program focused on vaccine development, setting the field back by a decade or more. Additionally, the administration has proposed a 43 percent cut to the NIH budget, equivalent to $20 billion per year.

Public health departments across the nation are reeling from the withdrawal of $11 billion in federal support, leading to the elimination of 20,000 jobs and the scaling back of essential services, such as vaccination programs, disease surveillance, and outbreak response. The CDC, which allocates 80 percent of its budget to states, is facing proposed cuts that could halve its funding, further weakening the national health infrastructure.

These cuts have also impacted academic public health systems, with grant freezes and budget reductions leading to shuttered clinics, canceled research projects, and lost student opportunities.

The dismantling of these programs not only undermines decades of progress in public health and biomedical research but also jeopardizes the nation’s ability to respond to current and future health crises.

Cultivating Advocacy Among Emerging Professionals

The future hinges on empowering the next generation of laboratory professionals to become advocates—not only for their own career advancement but for the visibility and viability of the entire profession. To build a culture of advocacy, we must:

1. Integrate Advocacy into Education

• Embed advocacy training in all laboratory professional curricula—include modules on health policy, regulatory systems, and communication with lawmakers.
• Encourage student participation in state and national professional organizations, such as ASCLS, with opportunities for advocacy days and legislative internships.

2. Mentorship and Modeling

• Pair early-career laboratorians with experienced mentors who model professional advocacy.
• Highlight role models who have successfully influenced policy, led initiatives, or expanded the visibility of the profession.

3. Create Accessible Advocacy Pathways

• Provide templates, toolkits, and scripts for engaging with legislators, writing op-eds, or giving community presentations.
• Use social media platforms to amplify voices and share stories about the value of laboratory medicine.

4. Foster Local Engagement

• Encourage participation in local hospital or health system committees.
• Promote volunteerism within local public health departments or emergency response teams to build interdisciplinary relationships.

5. Celebrate Advocacy Achievements

• Recognize and reward advocacy efforts in annual awards, conferences, and employee recognition events to reinforce the value of speaking out.

A Call to Action

As laboratory professionals and concerned citizens, we cannot afford to be passive. As the political and regulatory environment continues to shift, laboratory professionals must be vigilant and vocal. The dissolution of advisory committees, drastic funding cuts, and the persistent workforce crisis all demand a unified, strategic response.

If we fail to act, decisions will continue to be made without us—by individuals who may not understand the science, the stakes, or the realities of our work.

But if we succeed in nurturing a culture of advocacy—one that spans generations, specialties, and institutions—we can elevate the visibility, influence, and impact of medical laboratory science for decades to come.

The microscope may be our tool, but our voice is our power. It’s time we used both.

Nicholas Moore is Associate Director of Clinical Microbiology & Associate Professor at Rush University Medical Center in Chicago, Illinois.