About Us
Meet the Baker Lab Consulting Team
Hannah Baker is one of only 40 professionals in the United States currently pursuing a Doctorate in Clinical Laboratory Science (DCLS) at Rutgers University, positioning her among the next generation of advanced clinical laboratory science leaders.
With over 12 years of diverse experience in laboratory operations, regulatory compliance, quality management, and consulting, Hannah has worked across laboratories ranging from CLIA-waived to high-complexity testing environments. Her expertise spans both technical and administrative aspects of laboratory management, making her a trusted partner for organizations seeking to strengthen compliance and operational efficiency.
Before launching her consulting practice, Hannah served as a Department of Health Laboratory Surveyor, where she gained firsthand experience evaluating labs for CLIA and state compliance. This background gives her a unique perspective in survey preparation, remediation, and quality improvement—helping laboratories identify root causes, implement corrective actions, and achieve long-term regulatory success.
Armed with a Bachelor’s degree in Medical Laboratory Science and advanced doctoral training, Hannah brings the perfect balance of technical expertise and practical insight. Her mission is to help laboratories thrive by providing personalized guidance, strategic compliance solutions, and expert education designed to ensure inspection readiness, operational excellence, and sustainable success.
Partner with Us to Elevate Your Laboratory’s Quality, Compliance, and Performance
Experience comprehensive laboratory consulting, education, and support tailored to your organization’s unique needs. We help laboratories of all sizes achieve excellence in CLIA compliance, regulatory readiness, and quality management systems, empowering your team to operate with accuracy, efficiency, and confidence.
Comprehensive Laboratory Consulting Services
Our team provides end-to-end support for waived, moderate, and high-complexity laboratories, with both remote and on-site options available. Whether you’re establishing a new lab, expanding services, or strengthening compliance, we offer the expertise to guide you every step of the way.
Our services include:
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Laboratory Director Services – Oversight and guidance to meet all CLIA and state requirements while supporting strategic growth.
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Technical Supervisor and Technical Consultant Services – Expertise in test validation, method verification, quality control, and staff competency assessment.
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Customized Education and Training Programs – Targeted instruction on laboratory management, regulatory updates, and best practices in quality assurance and process improvement.
Specialized in Survey Remediation Services
Facing a survey deficiency or inspection citation can be stressful — we help turn it into an opportunity for improvement. Our survey remediation services provide the structure and expertise your lab needs to return to full compliance quickly and confidently.
We assist with:
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Thorough review and interpretation of survey findings.
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Development of Corrective Action Plans (CAPs) aligned with CLIA, COLA, or CAP standards.
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Implementation guidance to ensure corrective actions are practical, measurable, and sustainable.
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Follow-up documentation review and staff training to prevent future deficiencies.
Our approach goes beyond correction — we focus on building long-term quality systems and continuous improvement processes that keep your lab compliant and inspection-ready year-round.
Why Laboratories Choose Us
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Proven success in improving audit and inspection outcomes.
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Deep expertise in CLIA compliance, quality assurance, and laboratory management.
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Hands-on, collaborative approach that translates regulations into clear, actionable steps.
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Commitment to education, sustainability, and operational excellence.
Let us be your trusted partner in ensuring your laboratory meets the highest standards of quality, compliance, and performance. Together, we can strengthen your systems, empower your staff, and support your mission to deliver reliable, high-quality patient results.
Navigating the CLIA Application Process
Starting or expanding a laboratory can be complex — and navigating the CLIA application process is one of the most critical first steps. Whether you’re applying for a new CLIA certificate, updating your existing license, or changing your test complexity or ownership, expert guidance can make all the difference.
With hands-on experience in laboratory compliance, operations, and regulatory oversight, Hannah Baker provides step-by-step support through every stage of the CLIA application process, ensuring your lab starts on a strong, compliant foundation.
Our CLIA Application Support Includes:
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Determining the appropriate CLIA certificate type (Waived, Moderate, or High Complexity).
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Assistance with completing and submitting CMS Form 116 and other required documentation.
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Guidance on state-specific laboratory licensing requirements (if applicable).
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Review of personnel qualifications, testing menus, and organizational structure for compliance.
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Preparation for pre-inspection or validation visits to ensure readiness before CMS or accrediting agency review.
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Ongoing consultation after certification to maintain compliance and quality standards.
Our approach ensures accuracy, efficiency, and peace of mind — helping laboratories avoid delays, rejections, or compliance pitfalls during the CLIA certification process.
Let us guide you through your CLIA application with confidence, so you can focus on what matters most — providing accurate, reliable, and high-quality patient testing.
