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.

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

Not Sure How to Start Up a CLIA Laboratory?

Reach out to us for a FREE 1-HR lab startup evaluation, where we will discuss your testing needs, projected specimen volume, and other key factors!

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Our CLIA Laboratory Startup Strategy:

Test Menu Determination. We take the time to understand your clinical needs and create a customized test menu designed to support them.
Laboratory Staffing and Director Assignment. We help design your lab with the right team and structure in place to meet CLIA, COLA, and CAP requirements, ensuring a highly compliant and efficient operation.
Instrumentation Determination. We connect you with trusted instrument vendors and negotiate on your behalf to secure the most practical and cost-effective solutions for your laboratory.
Lab Design and Outfitting. We evaluate your space and design an efficient layout to maximize your laboratory’s workflow and functionality.
Regulatory Application Completion. We handle all CLIA application requirements and state licensing documentation to ensure your lab is set up for full compliance.
Standard Operating Procedure (SOP) Creation. We create comprehensive SOPs tailored to your laboratory’s custom test menu, ensuring full compliance with CLIA regulations.
Quality Assurance Policies and Procedures. We develop CLIA-compliant QA policies and procedures tailored to your lab’s unique needs.
Method Development. Certain highly-customizable systems, such as confirmatory LCMS instruments, require method setup before use. We develop specialized methods to ensure accurate and reliable detection of the analytes on your test menu.
Method Validation. We conduct thorough CLIA-compliant method validations to ensure every method delivers accurate and reliable results.
Staff Training. We provide comprehensive training for all testing personnel on workflow, instrument operation, and data review analysis.
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.
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.
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.

CLIA Laboratory Startup Services

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

Not Sure How to Start Up a CLIA Laboratory?

Our CLIA Laboratory Startup Strategy:

Test Menu Determination. We take the time to understand your clinical needs and create a customized test menu designed to support them.

Laboratory Staffing and Director Assignment. We help design your lab with the right team and structure in place to meet CLIA, COLA, and CAP requirements, ensuring a highly compliant and efficient operation.

Instrumentation Determination. We connect you with trusted instrument vendors and negotiate on your behalf to secure the most practical and cost-effective solutions for your laboratory.

Lab Design and Outfitting. We evaluate your space and design an efficient layout to maximize your laboratory’s workflow and functionality.

Regulatory Application Completion. We handle all CLIA application requirements and state licensing documentation to ensure your lab is set up for full compliance.

Standard Operating Procedure (SOP) Creation. We create comprehensive SOPs tailored to your laboratory’s custom test menu, ensuring full compliance with CLIA regulations.

Quality Assurance Policies and Procedures. We develop CLIA-compliant QA policies and procedures tailored to your lab’s unique needs.

Method Development. Certain highly-customizable systems, such as confirmatory LCMS instruments, require method setup before use. We develop specialized methods to ensure accurate and reliable detection of the analytes on your test menu.

Method Validation. We conduct thorough CLIA-compliant method validations to ensure every method delivers accurate and reliable results.

Staff Training. We provide comprehensive training for all testing personnel on workflow, instrument operation, and data review analysis.

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.

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.

GO LIVE!

Why Choose Us?

QUALITY We place an unparalleled emphasis on quality—setting a standard that stands out in the clinical laboratory industry. ​

PASSION We’re not driven by private equity ownership—we’re guided by science and a passion for helping laboratories succeed. ​​

CUSTOM SOLUTIONS We offer fully customizable test menus tailored to each laboratory’s unique needs.

Improve Patient Care
with Trusted Results

QUALITY
We place an unparalleled emphasis on quality—setting a standard that stands out in the clinical laboratory industry.

PASSION
We’re not driven by private equity ownership—we’re guided by science and a passion for helping laboratories succeed.

CUSTOM SOLUTIONS
We offer fully customizable test menus tailored to each laboratory’s unique needs.