Lab Consulting

Service

Expert Support for Compliant and Sustainable
Laboratory Operations

Lab Consulting Services

Heart to Heart International (HHI) is an independent, non-governmental global humanitarian organization dedicated to serving communities in need. We can empower you with the knowledge, skills, and resources needed to manage and operate your own sustainable laboratory operation.

Why HHI’s Lab Consulting Services?

Our lab team is composed of laboratory professionals who are subject matter experts with decades of experience in the clinical laboratory field. We are committed to empowering partners with knowledge, skills, and resources to manage and operate their own sustainable laboratory operation, enhancing positive patient outcomes and experiences while ensuring regulatory compliance.

What We Offer

CLIA Application Processing Assistance with proper level of certification.
Test Menu Recommendations for your clinic’s patient population needs.
Laboratory Design Support for adequate space for the lab’s needs.
Documentation Provision of SOPs, policies, logs, forms, checklists, and other.
On-Site Installation with calibration, and validation of lab analyzers and testing kits.
Staff Training & Assessment with orientation and initial training of clinic personnel.
Inspection Preparation for potential audit or perform a mock audit.
Mobile Laboratory Implementation and regulatory considerations, if needed.
Varying Ongoing Technical Consulting as determined.

Laboratory Consulting Services

In-house testing is crucial in assessing the potential for specific diseases. Together, we can enhance positive patient outcomes and experiences while ensuring regulatory compliance.

Do you need?

Expanded or improved in-house laboratory testing?
Help with regulatory compliance?
Defined training on laboratory testing procedures and operations?
Guidance in managing your laboratory testing supplies and inventory?
Proper maintenance procedures to optimize your laboratory analyzers?
Annual competency program for your staff and volunteers?
Stronger quality control with more accurate and reliable patient results?

Lab Consulting Testimonial

Download Lab Consultation Flyer

“As a free and charitable clinic serving the uninsured and underinsured, we recognized a growing need for more comprehensive point-of-care (POC) testing.

At first, we believed we could expand to a moderately complex CLIA-certified lab in-house, but soon we realized we needed expert assistance. We turned to Heart to Heart International (HHI) and began a collaborative partnership focused on building strong, compliant lab protocols.

With HHI’s guidance, we developed comprehensive P&Ps, strengthened our quality assurance processes, and became confident in our path forward. We faced challenges, as any clinic upgrading to a moderately complex lab would, but HHI’s support helped us navigate each one effectively.

Thanks to this transformation, we now operate a fully CLIA-compliant in-house lab offering timely, cost-effective, and high-quality diagnostics. From early detection of prostate cancer to better thyroid management and addressing vitamin D deficiencies in our community, the impact is both tangible and profound.

This journey has not only elevated our clinical capabilities but deepened our commitment to compliance, quality, and the life-changing power of accessible healthcare.”

– Ann Quillen
Executive Director, Ohio Valley Health Center

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