Client Snapshot
Organization Type
CLIA-certified laboratory with a focus on COVID-19 PCR testing, acquired by a new investor during the late-stage pandemic.
Scope of Services
• Regulatory and site compliance oversight
• Relicensure planning and execution
• Lab buildout management and equipment strategy
• Post-COVID business model planning
• Contract development and client engagement
• Billing system implementation and payer readiness
The Challenge
A healthcare investor purchased a lab primarily focused on COVID-19 testing. However, with declining pandemic volumes and regulatory challenges, including a revoked license due to non-compliance. The lab was at risk of becoming a stranded asset.
The investor engaged Kaizenleap to:
• Oversee the operational rebuild
• Regain licensure
• Identify a compliant and scalable lab location
• Develop a forward-looking business strategy beyond COVID testing
Our Role: From Emergency Stabilization to Future Positioning
Kaizenleap was brought in to stabilize operations and design a long-term strategy. Our work spanned regulatory recovery, infrastructure buildout, client development, and billing enablement to ensure the lab could operate as a diversified, compliant, and revenue-ready diagnostic business.
Key Areas of Focus
Regulatory Recovery
• Collaborated with the Medical Director to resubmit licensure application
• Researched and conducted site visits to identify a new, compliance-ready lab location
Buildout and Equipment Strategy
• Oversaw the lab construction process and ensured alignment with CLIA and state requirements
• Structured lease and purchase agreements with testing equipment vendors for COVID and future testing modalities
Post-COVID Strategic Planning
• Built a roadmap to pivot the lab toward broader diagnostic services (toxicology, respiratory panels, wellness testing)
• Identified potential customer segments and validated product-market fit through direct outreach
Client Development and Readiness
• Met with potential institutional clients and physician groups to co-design the menu of services
• Ensured the lab could meet volume, turnaround time, and interface requirements
Billing and Reimbursement Enablement
• Structured foundational billing workflows, including clearinghouse relationships, code setup, and payer outreach
• Developed SOPs to align lab operations with insurance and compliance requirements
What We Delivered
| Deliverable | Impact |
|---|---|
| Licensure Recovery | Achieved reapplication readiness and selected a site that ensured long-term compliance |
| Equipment and Vendor Management | Secured cost-effective COVID testing infrastructure while future-proofing equipment strategy |
| Strategic Pivot Plan | Developed a business model for diversified testing services post-COVID |
| Client Engagement | Built early commitments with potential lab partners, validating service menu and delivery model |
| Billing Infrastructure | Established processes for compliant, scalable reimbursement |
Results
• De-risked the Acquisition: Transformed a non-compliant lab into a license-ready facility with growth potential
• Compliance Rebuilt: Identified and remediated prior operational gaps in location, leadership, and systems
• Future-Proofed the Business: Positioned the lab for success beyond the pandemic by aligning services with client needs and reimbursement models
• Operational Momentum: Enabled onboarding of early lab partners and created a launch-ready foundation
Why It Worked
Kaizenleap’s cross-functional expertise spanning regulatory, operational, clinical, and financial strategy allowed us to act as a turnkey operator during a high-risk transition. We didn’t just restore the lab; we built a future-ready blueprint grounded in compliance, capability, and commercial viability.