Navigating the New York State CLEP Program to Achieve Approvals

The Clinical Laboratory Evaluation Program (CLEP), overseen by the New York State Department of Health’s Wadsworth Center, is a well-established program that ensures all laboratories testing patient specimens from New York deliver accurate, reliable, and high-quality results. New York is the only state with a formal program requiring review and approval of lab-developed tests (LDTs) before they can be offered to patients in the state. Other states (such as California, Maryland, and Washington) require labs to hold Clinical Laboratory Improvement Amendments (CLIA) certification and may add state-level licensure/inspection requirements for labs, but they do not review and approve LDTs. The CLEP is a regulatory framework that evaluates and monitors more than 1,000 labs nationwide that test specimens originating in New York. Compared to CLIA, CLEP has more rigorous requirements, covering test validation, proficiency testing, staff qualifications, and on-site inspections. Under CLIA, a laboratory can offer the test to patients after internal CLIA validation, which is reviewed during accreditation audits such as College of American Pathologists (CAP) inspections. As of March 2024, according to U.S. Centers for Medicare and Medicaid Services (CMS) reports, there were 317,545 registered labs, of which 244,971 were laboratories performing waived tests. A total of 15,894 labs hold a Certificate of Accreditation (COA) from accreditation bodies such as CAP, COLA, and others. New York State Department of Health (NYSDOH) records show approximately 10,977 approved LDTs from 1,146 facilities.    

Why CLEP Approval? 

• Credibility and Differentiation: CLEP approvals provide credibility and confidence that the LDT has gone through a rigorous review process to ensure the quality of the test. Combining a CLEP approval with accreditation, such as CAP, provides stronger differentiation compared to labs that have not gone through the CLEP process. This is especially the case for commercial and reference labs providing new and innovative LDTs in high- and moderate-complexity areas.  

• Market Access and Reimbursement: CLEP approval is required for testing NYS patient samples, which expands the market size. Payers are more likely to reimburse for tests that have gone through the CLEP process.

Achieving CLEP Approval 

• Step 0: Before submitting the CLEP application, a lab must ensure the laboratory director and any assistant directors hold a Certificate of Qualification for applicable categories.  

  
  

• Step 1: Submit application materials with fees, director qualifications, disclosures, etc. Clearly identify categories or subcategories in the permit application.  

  
  

• Step 2: Provide a test validation data package and SOPs covering quality control and reporting for review.  

  
  

• Step 3: Participate in proficiency testing through CMS-approved providers. 

  
  

• Step 4: Complete an on-site inspection to confirm compliance in the areas of personnel, equipment, and the quality management system.  

  
  

• Step 5: Once requirements have been completed, the lab is registered and receives a one-year renewable permit. The permit will show the location and category. The laboratory is only allowed to offer the approved test in the listed categories (e.g., Genetic – Molecular, Oncology – Molecular and Cellular Tumor Markers, Hematology, Histopathology, etc.). Any change or modification to the test requires submission of validation data.  

Final Note

CLEP approval is both a challenge and an opportunity. Achieving CLEP approval helps labs gain not only regulatory clearance but also market credibility, payer confidence, and a competitive edge. For laboratories developing LDTs, CLEP approval signals that a test has been thoroughly validated for accuracy, reproducibility, and clinical relevance. A critical part of achieving successful results is effective, thoughtful planning to gather required validation data and SOPs. This data can also be used for reimbursement and future submissions.