The federal government shutdown has suspended key scientific operations—including FDA application processing, EPA inspections, NIH and NSF grant reviews, CDC reporting, and OSHA enforcement—resulting in significant delays for laboratories.
As of October 1, 2025, a lapse in federal funding has forced many U.S. science-relevant agencies to curtail nonessential operations, leaving laboratory leaders to manage uncertainty, delays, and compliance risks.
What’s Happening Across Agencies
Lab Manager reported that the FDA warned that “new drug, biologics, and device applications that require user fees are not being accepted during the shutdown.”
In an official message, FDA Commissioner Marty Makary, MD, MPH, stated that while “many employees will be furloughed during the lapse period,” the agency will “continue to fully execute our public health mission to the extent permitted by law.”
FDA Commissioner Marty Makary, MD, MPH, noted in the FDA’s official message, “I am disappointed that Congress failed to reach a budget agreement. As a result, the FDA is now faced with a lapse in appropriations and will be forced to shut down certain operations of the agency.” (Photo credit: FDA)
The Los Angeles Times reported that EPA will see a sweeping reduction in capacity, with nearly 90 % of its workforce being furloughed.
Lab Manager also reported that new permits, inspections, and compliance enforcement are largely frozen.
HHS Contingency Plan
Under the HHS contingency plan, which covers NIH, CDC, and other health agencies:
Out of ~79,717 employees, 32,460 are estimated to be furloughed under the plan.
HHS will continue only “exempt or excepted” activities, such as outbreak monitoring by CDC and “core functions” at the FDA.
All non-exempt NIH extramural research, grant oversight, and data collection will be suspended.
The Occupational Safety and Health Administration (OSHA) has largely ceased routine enforcement and consultation activities during the shutdown, with only emergency inspections continuing. According to Lab Manager, the agency has suspended “most programmed inspections and compliance assistance,” retaining only personnel necessary to respond to “imminent danger situations” and fatalities. This means laboratory safety programs will receive no regular oversight until funding is restored, placing greater responsibility on lab leaders to maintain compliance and documentation internally.
Key Impacts for Laboratory Leaders
While grant proposals may still be submitted in some cases, their review and processing are stalled, according to Lab Manager. Further, labs awaiting FDA approvals or oversight (e.g. for devices, reagents, protocols) may see deliverables and timelines move unpredictably.
Without regular EPA permitting, inspections, or enforcement, labs that rely on environmental permits must sustain internal compliance vigilance in the absence of federal oversight.
Agencies that supply routine safety, epidemiological, or environmental data are scaling back to minimal essential operations, potentially leaving labs with delayed access to critical datasets.
In many agencies, core capabilities are cut to only those functions required to protect human life or property.
What Lab Leaders Should Do Now
Revisit project timelines: Recognize that regulatory submission dates, funding disbursements, and permit cycles may shift.
Document internal compliance: Maintain logs, audits, and safety checks independent of federal interaction.
Communicate with stakeholders: Funders, collaborators, and regulatory bodies should be notified of possible delays.
Prioritize essential operations: Identify which experiments, sample storage, or assays must continue even under constrained oversight.
Monitor agency updates: Shutdowns evolve, and agencies may alter which functions are considered “essential” or “excepted.”
30th edition of the conference returns to New Orleans this week, bringing together diagnostic lab executives and innovators
Medical laboratory leaders and executives, along with diagnostic innovators from across the country, are convening in New Orleans this week for the 30th annual Executive War College on Diagnostics, Clinical Laboratory, and Pathology Management.
Given the political, regulatory, and financial upheaval occurring in the US, this year’s Executive War College gathering offers a timely opportunity for lab leaders to discuss important strategies and network with sellers.
Featuring 85 sessions across two days, attendees will delve into key topics such as revenue growth strategies, regulatory updates, AI integration, workforce development, and evolving payer dynamics.
With clinical laboratories playing an increasingly pivotal role in value-based care and patient outcomes, the 2025 conference agenda reflects a growing need for labs to operate not just as diagnostic services but as critical business units driving healthcare innovation.
Robert Michel (above), founder of the Executive War College and outgoing editor-in-chief of Dark Daily, will lead a closing session on Wednesday looking at common themes that emerged during the Executive War College. “It’s important that lab leaders take note of what they learned—whether it was during a session, networking reception, or chance meeting with a peer—before heading back to their organizations,” he said. (Photo copyright: LabX.)
Event Will Illustrate Paths Forward for Lab Industry
Robert Michel, founder of the Executive War College and outgoing editor-in-chief of Dark Daily, previously noted that smart laboratory leaders are viewing financial, staffing, and operational pressures as opportunities to move ahead.
“This path forward is informed by two longstanding precepts recognized by innovative managers,” Michel said. “One precept is ‘Change creates new winners and losers.’ The other precept is ‘Change creates opportunity.’ Savvy lab leaders recognize the powerful truths in each precept.”
The general sessions kick off Tuesday morning with a keynote address from Michel titled, “Healthcare at a Tipping Point: Why Lab Opportunities and Challenges in Coming Years Will Be Different than Those of the Past 30 Years.” The keynote will synthesize nationwide trends, setting the stage for two days of in-depth discussion.
Other general sessions on Tuesday will explore the continued move towards precision medicine, how to take innovative steps to improve lab operations, and ways to elevate the value of laboratory services.
Agenda Features More than One Dozen AI-Themed Sessions
Artificial intelligence (AI) will be another hot topic this year, particularly as labs grapple with how to harness a technology that just in the past year seems to have proliferated exponentially.
This year’s Executive War College will devote more than a dozen sessions to AI discussions, as experts from both the technology and pathology sectors dissect AI’s current capabilities, legal aspects, and financial implications.
Another major focus for 2025 is the regulatory environment. Several sessions will provide updates on the latest CLIA inspection deficiencies, where regulators stand on current concerns, and the future of laboratory developed test oversight given a federal court’s recent decision to vacate the Food and Drug Administration’s final rule on LDTs.
Wide Swath of Laboratory Influencers Expected
Nearly 1,000 attendees, speakers, and vendor representatives are expected at the Executive War College, including C-level executives, pathologists, lab directors, and business development leaders.
Watch Dark Daily this week for further updates from New Orleans, including coverage of the opening day’s general sessions and a wrap-up of what lab leaders learned during the event.
Big question for medical laboratory managers is whether Medicare, private health insurers, and medical claims clearinghouses can make a smooth changeover when processing lab test claims using ICD-10 codes
Conversion to ICD-10 is now only 56 days away! Physicians are not the only ones with a large stake in the conversion from ICD-9 to ICD-10 that takes place October 1, 2015. Clinical laboratories and anatomic pathology groups will be watching to see whether physicians include appropriate ICD-10 codes on lab test forms for Medicare patients.
The Medicare program requires appropriate ICD codes on medical laboratory test claims for Medicare patients. That is one reason why clinical laboratories and anatomic pathology are financially vested in a smooth conversion process. All Medicare Part B claims for medical laboratory tests must be submitted with an appropriate International Classification of Diseases (ICD) code provided by the physician who ordered the lab tests. The Medicare program will not reimburse lab test claims without an appropriate ICD code. No code, no payment to the lab, even though it did the test.
“People really need to plan ahead for [reduced] cash flows in October and November,” Roth told Dark Daily. “If your Medicare denials go through the roof, all your commercial payer denials are probably going to go through the roof as well. Extending your DSO (Days Sales Outstanding) from 45 to 55 days has a material financial impact.” (more…)
Wyss Institute develops prototype Ebola test in less than 12 hours with $20 in materials, perhaps paving the way for inexpensive paper-based diagnostic tests with a wide range of applications outside the medical laboratory
One goal of many synthetic biology researchers is to create in vitro diagnostic testing systems that produce results that are as accurate as those produced in today’s state-of-the-art clinical laboratories, yet are much cheaper to run because they incorporate low-cost materials, such as paper.
Recently, two teams of researchers worked to demonstrate how several synthetic biology methods, when combined with programmable paper-based diagnostic platform, could detect antibiotic-resistant bacteria and strain-specific Ebola virus. These findings were published in a peer-reviewed medical journal last fall.
Such cell-free circuits embedded in paper could be the breakthrough in synthetic biology that leads to pocketsize blotter tests that can detect such diseases as Ebola in the field. Should this line of research be applied to clinical settings, pathologists and medical laboratory scientists could soon be processing bandages that change colors in the presence of certain bacteria, or examining paper-based clothing infused with diagnostic laboratory tests that react to bio-markers specific to a chronic disease patient’s condition. (more…)
It’s the second acquisition of a hospital lab outreach program in past six days
Several days ago, a two-part deal was announced between Quest Diagnostics Incorporated (NYSE:DGX) and Caritas Christi Health Care of Boston, Massachusetts. Caritas sold its clinical laboratory outreach business to Quest Diagnostics and both parties formed a “strategic alliance” going forward that centers upon laboratory testing and informatics integration. Caritas will continue to own and manage the laboratories in its six hospitals.
