In many laboratories, decisions about safety, quality, and internal policies now rely less on prescriptive rules and more on leadership judgment. As federal agencies revisit oversight approaches across multiple regulated sectors—reflected in recent shifts at the Occupational Safety and Health Administration and the Environmental Protection Agency—external expectations are becoming less uniform and, in some cases, less predictable.
For lab managers, this does not reduce responsibility or risk. Instead, it places greater emphasis on internal governance, professional standards, and risk-based decision-making. The challenge is compounded by the fact that regulatory change does not affect all laboratories equally.
Why less prescription means more responsibility in a deregulated climate
“While regulations can provide structure and accountability, our lab policies should be guided by science, evidence-based medicine, and continuous quality improvement.”
Regulations often serve as a shared baseline for laboratories. They establish minimum expectations, standardize controls, and reduce ambiguity about acceptable practice. When those baselines become less prescriptive, laboratories lose a common external reference point. That loss of clarity forces internal decisions that were previously settled by regulation. Questions about documentation practices, training frequency, quality checks, environmental controls, or maintenance intervals no longer have a single external answer. Instead, they require deliberate judgment grounded in risk and mission.
Isabel Gonzalez, PhD, HCLD, regional IVF lab director for IVI RMA North America’s West Region, sees this dynamic across clinical laboratories operating under different oversight models. “While regulations can provide structure and accountability, our lab policies should be guided by science, evidence-based medicine, and continuous quality improvement,” she says. For Gonzalez, regulatory change does not define laboratory performance. “For me, shifts in regulatory expectations don’t drive the quality of care we deliver. In actuality, it is the opposite.”
A deregulated climate does not change the underlying hazards of laboratory work. Chemicals remain hazardous. Instruments still drift. Biological samples still carry risk. What changes is who decides how much control is enough—and how consistently it is applied. In that environment, laboratory leadership becomes the primary stabilizing force.
Why regulatory change affects laboratories differently
One reason regulatory change creates uncertainty is that it does not affect laboratories uniformly. Some operate in environments where federal oversight is only one layer among many, while others rely more heavily on external rules to structure daily operations. Clinical laboratories, for example, continue to face detailed oversight through accreditation and Clinical Laboratory Improvement Amendments requirements, even as expectations shift elsewhere. Academic, industrial, environmental, and government laboratories often operate under institutional, contractual, or mission-specific frameworks that remain largely stable regardless of broader regulatory trends.
Even within a single sector, variability can be significant. “IVF laboratories operate in a uniquely high-risk environment—high stakes, high stress, and high reward,” Gonzalez says. “Interestingly, despite this, IVF labs are less regulated than most people realize. In fact, andrology or endocrinology labs face more regulations than embryology labs do.”
Oversight often comes through accreditation rather than direct regulation, which creates room for interpretation in how standards are applied. “Most IVF labs are accredited by organizations such as CAP or the Joint Commission and undergo inspections at defined intervals,” Gonzalez explains. “While the inspection criteria are clear, the manner in which laboratories meet those requirements is often open to interpretation.” That flexibility can also lead to uneven practice. “As a result, there can be significant variability in laboratory practices and quality of care across centers,” she says.
This uneven impact underscores a key point: laboratory decision-making in a deregulated climate must be localized. Effective leaders evaluate how external shifts intersect with their specific hazards, workflows, and obligations rather than assuming deregulation has the same meaning everywhere.
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A decision-making framework for laboratory leadership
When external requirements become less clear, laboratories benefit from a repeatable framework for internal decision-making. Rather than reacting to regulatory signals, lab managers can anchor decisions to a consistent set of questions.
Does the regulatory change actually apply to the laboratory’s activities? Has the underlying hazard changed? What non-regulatory obligations still apply through accreditation, institutional policy, or customer expectations?
High-performing laboratories tend to exceed minimum expectations regardless of the regulatory climate. “High-performing IVF laboratories design internal quality systems that organically exceed regulatory requirements as they are grounded in data, validated processes, and boots on the ground experience,” Gonzalez says. “Regulations establish boundaries and accountability, but they do not teach you how to run a good and safe IVF laboratory.”
Consistency across sites requires intentional governance. “Maintaining consistency, quality, and safety across different labs and operating under different regulations requires an informed and centralized approach,” Gonzalez says. “The most effective strategy is to identify the most stringent applicable regulatory standard and apply it uniformly across all laboratories, regardless of location.”
Holding the line on laboratory safety and quality
“The real risk arises if deregulation is viewed as an opportunity to prioritize convenience, cost, or efficiency over quality.”
One of the most common missteps in a deregulated climate is equating flexibility with permission to do less. In practice, laboratories that perform well tend to maintain—or strengthen—their internal standards even when external oversight becomes less prescriptive.
“The real risk arises if deregulation is viewed as an opportunity to prioritize convenience, cost, or efficiency over quality,” Gonzalez warns. “In a field where small changes can have big consequences, relaxing standards is rarely the right answer.”
Laboratory safety and quality systems are difficult to rebuild once they erode. Expectations around incident reporting, maintenance, training, and documentation require consistency to remain effective. When standards are treated as organizational values rather than compliance obligations, they remain stable even as oversight fluctuates.
Leadership defines standards when regulation shifts
Ultimately, regulations do not define laboratory excellence—leaders do. In periods of regulatory change, staff look to management for clarity about what matters and what will not change.
“When external oversight becomes less prescriptive, leadership plays an even more critical role in sustaining a strong laboratory culture,” Gonzalez says. “Active leadership stays the course by setting clear expectations and a road map of where we are and where we are going.”
Leadership also extends beyond individual labs. “Surround yourself with a strong community of trusted colleagues and mentors you can rely on for thoughtful discussion and perspective. No one should navigate change in isolation,” Gonzalez says.
Laboratory leadership in a deregulated climate requires confidence in professional judgment and a willingness to uphold standards even when they are not explicitly mandated. The laboratories that navigate deregulation most successfully are not those that remove the most requirements, but those that remain anchored in science, ethics, and a clear commitment to safety and quality.
