top of page
CLIA Laboratory Startup Services
We offer full-service laboratory start-up assistance. Whether you’re building a lab from the ground up or adding a new test platform, we take a hands-on approach to guide you through every step of the process. This is ideal for organizations looking to start up a physician office laboratory or an independent reference laboratory. With years of experience, our staff has the expertise to get your laboratory up and running in a cost-effective and efficient way.
ToxLab Consulting's CLIA Lab Startup Service Overview
Why Start Up a CLIA Lab?
Improve Patient Care
with Trusted Results
Faster Turnaround Times for Providers and Patients
Revenue Stream
Custom Test Menus and Physician Control of Testing
Why Start Up A CLIA Lab? Lab Startup Consultants
Ready to Start a CLIA Laboratory?
Ready to Start up A CLIA Lab? CLIA Lab Consultants
Starting up a laboratory can be an overwhelming and costly endeavor without the proper expertise. At ToxLab Consulting, we deliver comprehensive guidance throughout the entire setup to ensure efficiency, compliance, and long-term success.
Contact us for a complimentary 1-hour lab startup evaluation. We’ll review your testing needs, projected specimen volume, and other critical factors to help you prepare for a successful lab setup.
What Should I Know Before Starting Up a CLIA Laboratory?
At ToxLab Consulting, our top priority is your lab's long-term success. Here are some factors that we recommend evaluating prior to setting up your lab.
Sample Volume
You'll want to ensure that you have sufficient specimen volume to successfully operate a laboratory.
Consulting Group Choice
Not All Consulting Groups Are Created Equally.
Before choosing a partner for your laboratory, it’s important to understand how they operate. Understand these topics to ensure you select a group that truly supports your long-term success:
1. Contract Flexibility
Can you easily exit the contract if you’re not satisfied or if it’s not financially sustainable? This single factor can make or break a lab’s success.
2. "Comprehensive Service" Consulting Contracts – Who Really Benefits?
Many consulting groups lock clients into “comprehensive service” agreements that drive up costs across all facets of the laboratory—staffing, reagents, consumables, and more. This model is rarely sustainable for small to medium-sized laboratories.
At Toxlab Consulting, we take a transparent approach: we charge only for direct consulting services and connect you straight to trusted vendors, ensuring your lab gets the best possible service and pricing without unnecessary markups.
3. Fee-Per-Sample vs. Flat Fee Approach
Many toxicology consulting groups charge a hefty fee-per-specimen. That means that as you earn more business, they take more of your revenue.
At Toxlab Consulting, we charge a transparent, flat fee for our consulting services. That means that as your revenue grows along with your business.
4. Proprietary Software – A Hidden Trap
Some consulting groups push their own proprietary Laboratory Information Systems (LIS) to maximize their profit and minimize your control over your own lab. This happens a lot! The problem? Switching away from these systems later is costly and disruptive—often keeping you tied to their services. Avoid LISs that are not mainstream.
At ToxLab Consulting, we recommend proven, mainstream LIS platforms that protect your lab’s flexibility, reduce risk, and give you long-term stability.
Controlled Growth
When launching your lab, it’s best to start with a focused test menu tailored to your anticipated sample volume. As your lab grows, you can expand your offerings strategically. Taking on too many platforms too soon often leads to unnecessary strain and is rarely sustainable.
ToxLab Consulting's CLIA Laboratory Startup Strategy:
ToxLab Consulting's CLIA Lab Startup Strategy. CLIA Lab Consultants
1. Test Menu Determination
We take the time to understand your clinical needs and create a customized test menu designed to support them. This will determine the foundation for your instrumentation needs and how your lab will be established.
2. Laboratory Staffing and Director Assignment
We design laboratories with the right team and structure to meet CLIA, COLA, and CAP requirements, ensuring compliance and operational efficiency. Our experts review your test menu and establish a qualified leadership team—because experienced leadership is essential to every laboratory’s success.
3. Instrumentation Determination
We connect you with trusted instrument vendors and negotiate on your behalf to secure the most practical, cost-effective solutions for your laboratory. Because instrumentation should align with your test menu, ToxLab Consulting helps you select the optimal setup to meet your specific needs.
4. Lab Design and Outfitting
We evaluate your space and design an efficient layout to maximize workflow and functionality. Our team collaborates directly with your contractors and guides you through every step to ensure a smooth, successful lab setup.
5. Regulatory Application Completion
We handle all CLIA and COLA regulatory application requirements and state licensing documentation to ensure your lab is set up for full compliance.
6. Standard Operating Procedure (SOP) Creation
We create comprehensive SOPs tailored to your laboratory’s custom test menu, ensuring full compliance with CLIA regulations.
7. Quality Assurance Policies and Procedures
We develop CLIA-compliant Quality Assurance (QA) policies and procedures tailored to your lab’s unique needs.
8. Method Development
Certain highly customizable systems, such as confirmatory LCMS instruments, require method setup before use. At ToxLab Consulting, we develop specialized methods to ensure accurate and reliable detection of the analytes on your test menu. This critical step establishes the foundation for precise data generation and long-term reliability of your LCMS system.
9. Method Validation
We conduct comprehensive CLIA-compliant method validations to ensure every test produces accurate and reliable results. This process gives you full confidence in the quality of your lab’s data. In fact, COLA surveyors consistently praise our validations for their clarity, precision, and outstanding documentation.
10. Staff Training
At ToxLab Consulting, we provide comprehensive training for laboratory staff across all testing platforms. Our training covers regulatory compliance, quality assessment protocols, SOPs, specimen preparation, analyzer or LCMS operation, instrument maintenance, troubleshooting, calibration curve and quality control review, as well as patient data review. Training is typically a blend of on-site and remote support. And our assistance doesn’t end there—we remain just a phone call or text away whenever additional guidance is needed.
11. Proficiency Testing and Split Sample Testing Setup
We ensure that your lab is enrolled with a properly credentialed proficiency testing organization. We provide split sample testing services for all LCMS analytes.
12. Final Workflow Optimization
We guide your lab through a full beta test of its workflow prior to Go Live, addressing and resolving any issues to ensure a smooth launch.
13. GO LIVE!
Why Choose Us?
QUALITY
We place an unparalleled emphasis on quality—setting a standard that stands out in the clinical laboratory industry.
NO EXPENSIVE PER-SAMPLE FEES
We provide a clean laboratory setup that gives owners full control over every aspect of their operation. Unlike many consultants, we don’t charge hefty per-sample management fees. Instead, we connect you directly with vendors—without hidden markups—so you get the best possible pricing. An expensive per sample lab management fee is unsustainable financially for most labs. Our goal is your lab’s long-term success, and that starts with transparency, affordability, and trusted support.
PASSION
We’re not driven by private equity ownership—we’re guided by science and a passion for helping laboratories succeed.
VENDOR DIRECT PRICING
We connect laboratories directly with a variety of trusted vendors—without adding hidden markups or inflated costs. We provide flexible options for directly connecting you to essential laboratory software platforms, such as the Laboratory Information System (LIS). Unlike some consultants who bundle proprietary LIS systems into costly per-sample fees to lock clients into long-term contracts, we recommend widely available, industry-standard LIS solutions that prioritize your independence and long-term success.
CUSTOM SOLUTIONS
We offer fully customizable test menus tailored to each laboratory’s unique needs.
Why Choose ToxLab Consulting? CLIA Consultants?
Testimonials
bottom of page