5 Signs Your Compliance Monitoring Process is Outdated

In December 2025, the most significant update to CLIA regulations in over 20 years will go into effect. These long-anticipated revisions aim to modernize the Clinical Laboratory Improvement Amendments (CLIA) program in response to advances in laboratory medicine—especially in molecular diagnostics and decentralized testing.

For labs, pharmacies, and healthcare organizations, these changes will require significant operational updates—from re-evaluating personnel qualifications to revising SOPs for test complexity, quality systems, and training. The stakes are high: compliance failures can result in survey deficiencies, suspended reimbursements, and even operational shutdowns.