5 Common Mistakes Startup Labs Make (and How to Avoid Them)

Starting your own clinical laboratory is an exciting venture—but it's not without its challenges. From regulatory hurdles to operational oversights, the early decisions you make can shape the success—or failure—of your lab. At Knox Diagnostics, we’ve seen firsthand how small missteps can lead to costly delays and compliance issues.

To help you avoid the most common pitfalls, here are five mistakes startup labs often make—and how you can steer clear of them.

1. Skipping the Planning Phase

Too often, new lab owners jump straight into purchasing equipment or leasing space without a clear roadmap. But a lab isn’t just a business—it’s a regulated healthcare environment that requires precision in every step.

What to do instead: Start with a comprehensive business and compliance plan that includes your budget, target market, services offered, regulatory requirements, and staffing needs. Having a solid foundation will guide every decision going forward.

2. Not Getting Professional Help

One of the biggest mistakes startups make is trying to do everything alone. While DIY can work in some industries, lab startups are heavily regulated and require specific technical and legal knowledge.

Why it matters: Without professional guidance, you risk overlooking key compliance steps, such as CLIA certification, quality management systems, or proper test validation. This can lead to failed inspections, delays in opening, or worse—legal consequences.

What to do instead: Invest in a qualified laboratory consultant or startup service early in the process. Their expertise will help you move faster, avoid costly errors, and start your lab on the right foot.

3. Choosing the Wrong Test Menu

Some labs choose their test offerings based on what sounds popular or easy, but neglect to consider what their market actually needs or what is realistic based on their licensure and staffing.

What to do instead: Research the demand in your community, align it with your laboratory license (waived vs. moderate complexity), and make sure you have the right personnel and equipment to perform those tests accurately and compliantly.

4. Underestimating Pre-Analytical Processes

Most lab owners focus on testing and results but ignore how samples are collected, labeled, and transported. Poor pre-analytical processes can compromise the entire testing workflow.

What to do instead: Train your staff thoroughly on specimen collection, handling, and data entry. Implement standard operating procedures (SOPs) that ensure accuracy from the moment the sample is drawn.

5. Neglecting Quality and Compliance Systems

Even if your lab is small or mobile, you still need a robust quality management system in place. Failing to implement one can lead to failed inspections and loss of your CLIA certificate.

What to do instead: Create and maintain a Quality Management System (QMS) that includes internal audits, incident tracking, personnel training records, and regular reviews of your SOPs. These systems aren’t just for compliance—they build trust with your clients.

Final Thoughts

Starting a lab is more than ordering test kits and opening your doors. It requires strategic planning, expert guidance, and a commitment to regulatory excellence. Avoiding these five mistakes can help you launch successfully, build a reputation for quality, and grow with confidence.

Need help getting your lab off the ground? At Knox Diagnostics, we specialize in helping mobile labs and startup facilities navigate CLIA certification, test menu selection, and operational setup. Let's build your lab the right way—together.