Understanding CLIA Certification: 42 CFR §493.20 - Moving Beyond Waived Testing and PPM

In my two previous posts, I discussed CLIA-waived testing and Provider-Performed Microscopy (PPM). As we move into the next level of laboratory testing, I want to step back and review some key definitions that will help put the regulatory requirements into context.

There are five types of CLIA certificates:

• Certificate of Waiver: For laboratories performing only waived testing.

• Certificate for Provider-Performed Microscopy (PPM): For laboratories performing only PPM and, potentially, waived testing.

• Certificate of Registration: Allows a laboratory to perform moderate- or high-complexity testing while awaiting its initial inspection by CMS, its agent, or an approved accreditation organization.

• Certificate of Compliance: Issued following a successful CLIA inspection demonstrating compliance with applicable requirements.

• Certificate of Accreditation: Issued to laboratories deemed compliant with CLIA requirements by a CMS-approved accreditation organization, such as the College of American Pathologists (CAP), COLA, or The Joint Commission (TJC).

  
  

If your office performs—or plans to perform—moderate- or high-complexity testing, you are moving beyond the Waiver/PPM framework and into substantially more detailed CLIA requirements.

For a resource to help determine the complexity of the testing and platforms you perform or are considering, see my previous post from September 15, 2026.

For the remainder of this series, “laboratory” refers to a laboratory performing, or preparing to perform, moderate- or high-complexity testing.

What happens next?

CLIA addresses many aspects of operating these laboratories, including:

• Location and certification: Separate laboratory locations may require separate CLIA certificates and applications.

• Registration and inspection: The process generally begins with a Certificate of Registration, allowing testing while the laboratory awaits its initial inspection.

• Accreditation: Laboratories may choose a CMS-approved accrediting organization such as CAP, COLA, or TJC. Their standards must meet or exceed applicable CLIA requirements.

• Proficiency testing: Laboratories performing applicable testing must participate in an approved proficiency testing program.

• Physical and administrative requirements: CLIA establishes requirements for the laboratory environment, documentation, record retention, and other administrative functions.

• Quality systems: Laboratories must establish policies and procedures covering all phases of testing: pre-analytical, analytical, and post-analytical.

• Personnel: Specific education and experience requirements apply to roles including laboratory director, technical consultant, clinical consultant, technical supervisor, general supervisor, and testing personnel. One individual may fulfill multiple roles when permitted by the applicable requirements.

• Inspections and compliance: CLIA establishes processes for inspections conducted by CMS, its agent, or an approved accreditation organization.

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Moving into moderate- or high-complexity testing means taking on more than a new test platform. It means establishing a regulatory framework, quality system, personnel structure, documentation, proficiency testing, and ongoing oversight.

In future posts, I’ll examine these requirements in greater detail and discuss what they mean for practices performing—or considering—moderate- or high-complexity testing.

A laboratory consultant can also be a valuable resource, helping practices interpret requirements, identify compliance gaps, develop policies and procedures, and prepare for inspection and ongoing compliance.

Understanding the framework first makes the individual requirements much easier to understand.