Expert Lab Oversight for Clinician-Run Labs — Without the Full-Time Cost
CLIA requires a qualified consultant to oversee your testing. It doesn't require you to hire one full-time.
I serve as Technical Consultant or Technical Supervisor for physician office labs, dialysis centers, urgent care clinics, and multi-site clinic chains — remotely or in a hybrid model, scaled to your test menu. You work with me directly. Not a staffing agency, not a rotating contractor.
What I Do For Your Lab
CLIA Technical Consultant & Technical Supervisor services
Test validation and verification
Inspection readiness for CLIA, CAP, COLA, and TJC
Competency assessments, on-site or remote
Multi-site standardization
Ongoing quality oversight
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Yes. We support setup, verification, training, and ongoing CLIA-compliant oversight for i-STAT and other moderate-complexity point-of-care platforms.
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Yes. We provide CLIA laboratory oversight and ongoing compliance support for labs performing waived testing only, as well as those offering a mix of waived and moderate-complexity tests.
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Yes — multi-site compliance standardization is a core part of what I do. I build a unified oversight program that covers all your locations under one consistent compliance framework. Whether you have two clinic locations or twenty, your testing program runs the same way everywhere.
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I offer predictable monthly pricing based on your test menu, complexity, and number of locations — so you always know what compliance costs. No hourly billing surprises, no agency markups. Most clients find the monthly retainer pays for itself quickly compared to the cost of a compliance failure, a failed inspection, or sending testing out to a reference lab.
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You work directly with me — a credentialed laboratory director with 20+ years of hands-on compliance experience. No layers, no handoffs, no junior staff filling in. When you have a compliance question at 4pm before an inspection, you reach me. That direct access is the core of how this model works.
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Start with a free 20-minute consultation. I'll assess your current setup, walk you through what expansion requires under CLIA, and give you a clear picture of what's involved — before you commit to any equipment or contracts. There's no obligation and no sales pitch.
Frequently Asked Questions
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I'm Michelle Spinosa, MPH, CLS, MLS(ASCP), Lean Six Sigma Green Belt — a clinical laboratory leader with 20+ years of experience building compliant, high-performing labs in complex, resource-constrained environments.
I've built two hospital laboratories from the ground up, earned ASCP’s 40 Under Forty recognition, and served as Lab Director for California’s statewide COVID-19 and flu testing program — supporting more than 6,000 testing sites and 20,000 testers while achieving near-100% compliance using a machine learning–assisted oversight model.
Over two decades, I’ve seen the same pattern: physician office labs, dialysis centers, and multi-site clinics are leaving significant value on the table. They rely on costly send-outs for testing that could be performed in-house, delay care while waiting for results, and operate without the level of laboratory oversight required to stay consistently inspection-ready — increasing both risk and missed revenue opportunities.
Lab Compliance Simplified exists to close that gap.
I provide fractional laboratory leadership — including regulatory oversight, test implementation, validation, and inspection readiness — so you can confidently expand in-house testing without the cost or burden of a full-time lab director.
Professional Recognition:
Let’s work together.
Interested in working together? Fill out some info and I will be in touch shortly! I can't wait to hear from you!