Strategic Rebuild and Post-COVID Planning for a Diagnostic Laboratory
The Challenge
A CLIA-certified lab acquired for COVID testing faced a critical setback: license revocation due to non-compliance. With declining pandemic volumes and regulatory challenges, the lab risked becoming a stranded asset.
License Revocation
Non-compliance issues resulted in revoked CLIA certification
Declining Volumes
COVID testing demand decreased significantly post-pandemic
Compliance Gaps
Operational deficiencies in location and systems
Business Model Risk
Needed clear path to sustainable, diversified testing services
Our Solution
We provided comprehensive operational and strategic support spanning regulatory recovery, infrastructure buildout, and business model development to transform the lab into a compliance-ready, diversified diagnostic business.
Regulatory Recovery
Resubmitted licensing with site identification and compliance readiness
Buildout Management
Oversaw lab construction aligned with CLIA and state requirements
Strategic Pivot Planning
Designed roadmap for diversified diagnostic services beyond COVID
Client Development
Co-designed service menu with institutional clients and physician groups
Key Deliverables
Licensure Recovery Plan
Lab Buildout Strategy
Diversified Service Roadmap
Billing Infrastructure
Measurable Results
De-risked Acquisition
Transformed non-compliant lab into license-ready facility
Compliance Rebuilt
Identified and remediated operational and system gaps
Future-Proofed Business
Positioned for success beyond pandemic with aligned services
Launch Ready
Enabled partner onboarding with operational momentum