Clinical labs cannot afford to treat regulatory changes as background noise. Rules shift, inspections arrive, and new accreditation standards drop with little warning. As Kelly VanBemmel, laboratory operations supervisor at Divisor Genomic Laboratories, told attendees at the 2025 Lab Manager Leadership Summit: “Success in this space isn’t just about compliance, it’s about being adaptable, having clear communication, and keeping people grounded when everything else feels like it’s moving.”
Today’s regulatory environment is particularly volatile. As VanBemmel explained, the US Food and Drug Administration (FDA) has vacated major rulings, global efforts are underway to align standards, and financial penalties for noncompliance continue to rise. At the same time, lab leaders are under pressure to balance faster turnaround times, new technologies, and commercial growth with uncompromising compliance. VanBemmel’s message is clear: surviving this landscape requires more than checklists—it demands leadership.
Lead with structure, not reaction
VanBemmel has led labs through acquisitions, start-ups, and inspections. Her advice for leaders facing regulatory changes is blunt: do not cherry-pick what to focus on. “Business logistics and regulations, policies and documentation, procurement and verification, hiring, personnel, and training. In my mind, these are four pillars that represent the foundational categories that every clinical lab leader has to navigate.”
Her point is simple: leadership collapses if one of those pillars is ignored. “Your lab isn’t registered with your state? It doesn’t exist,” she said, underscoring how even basic operational details can derail ambitious plans.
Even the physical lab must measure up to scrutiny. “It needs to function like a lab, not just look like one on paper. Can it support the loads of heavy instruments? Is there plumbing for an eyewash station? How’s your climate control? Because temperature swings and humidity down in Atlanta aren’t just bad for your hair, but they can be really bad for your equipment and your instruments.”
Make policy your operating system
VanBemmel rejected the idea that policies are merely paperwork. “If you are writing your policies after you need them, you’re already behind.” For her, documentation is the lifeline of a compliant lab: “Your lab policies aren't just another regulatory check box. They’re your business continuity plan, your quality management system, your HR handbook, your safety manual, your training curriculum, your [corrective and preventive action] (CAPA) plans, your entire how-to guide to run the lab on a rainy day or in the middle of an audit.”
Meeting the Clinical Laboratory Improvement Amendments (CLIA) standards is only the beginning. Labs must also be prepared for visits from the FDA, state health departments, the Occupational Safety and Health Administration (OSHA), the fire marshal, and other authorities. Regulatory compliance in labs extends across all local, state, and federal requirements—whether or not those agencies are the ones granting accreditation.
Policies, then, are not red tape. They are resilience—amid regulatory changes, leaders cannot afford to let that resilience slip.
Buy with compliance in mind
Procurement often slips into routine—buy the familiar or grab the latest tool. VanBemmel pushed back on both instincts. “Buying stuff sounds easy, except until you realize that every purchase is a commitment to quality, compliance, and performance.”
She pressed leaders to weigh regulatory fit, not just cost or convenience. “Don’t fall into the trap of centralizing your experience when evaluating products, both physical equipment and software, especially now that we have AI coming into play.”
Lab Quality Management Certificate
The Lab Quality Management certificate is more than training—it’s a professional advantage.
Gain critical skills and IACET-approved CEUs that make a measurable difference.
Procurement, she argued, is also about relationships. “These relationships you form will impact everything from your product support to emergency response when—not if—something breaks or the supply chain is affected.” In other words, every decision leaders make in this area either strengthens or weakens their ability to withstand regulatory changes.
Shape culture, not just compliance
Even with strong policies and technology, VanBemmel said leadership success ultimately comes down to people. “It matters who’s at the helm. You need people who understand not just the science but also the business, and who can scale with you as you grow. If you hire with blinders on, you’ll end up backfilling gaps in a panic six months later.”
She dismissed the idea that accreditation marks the end of the journey. “It’s important to remember that accreditation isn’t just about getting the stamp of approval and putting that shiny logo on your website. One of the real values of this entire process is the opportunity to learn from our peers, to hear different perspectives, catch blind spots, and constantly push for better.”
And she reminded leaders that compliance is collective, not top-down. “Every team member plays a crucial role in maintaining compliance and ensuring safety, but it’s the leadership’s responsibility to invoke this mindset.”
Guard against burnout in regulatory times
Regulation is stressful, and unchecked, that stress burns out teams. “Burnout doesn’t affect just one person. It spreads slowly until there’s dysfunction across the entire team.”
VanBemmel works to stay ahead of fatigue with small but consistent gestures. “To keep spirits high, I like to sprinkle in a surprise appreciation once in a while, bagel breakfast, lunch and learn, small moments for bonding and creativity. It does show them that they’re valued and keeps motivation alive when the work gets tough.”
In a regulatory environment that demands constant vigilance, these cultural investments are not luxuries—they are safeguards against compliance breakdowns.
Regulations as guardrails, not barriers
VanBemmel closed with a reminder that leaders must change the way they view compliance and regulations. “They’re not here to slow us down. They’re here to help keep us up. And remember, the rules don’t build a great lab. Our people do. Compliance just gives them the foundation to do their best work safely, consistently, and proudly.”
Her challenge to the field is straightforward: regulation will remain unpredictable, but leadership can transform compliance from a box-checking burden into the framework that keeps labs steady through change.
