Implement a New Laboratory Test with Colaborate

CLIA is the set of federal regulations that governs every clinical lab in the U.S. If you’re performing diagnostic testing on human specimens, you need a CLIA certificate. It manages every aspect of laboratory operations, from analyzers and personnel to quality systems, proficiency testing, and patient result management.

CMS administers the program, covering roughly 260,000 laboratory entities nationwide. CLIA certification is required to bill Medicare, Medicaid, and most commercial payers. With the right guidance, getting certified and staying compliant is a manageable process, and it’s one of the first things we help labs work through.

A CLIA Certificate of Waiver lets you perform simple, low-risk tests without routine inspections. These must be tests the FDA has specifically designated as “waived” under CLIA: glucose meters, urine dipsticks, rapid strep, and many COVID tests are common examples.

You can only perform tests that are FDA-cleared as waived. You can look up any specific test in the FDA CLIA Database to confirm its waived status before adding it to your test menu.

For most physician office labs, this is the fastest path to testing. You can typically get your Certificate of Waiver in 2 to 4 weeks. You still need to follow manufacturer instructions, and you may get random compliance checks, but there’s no scheduled inspection requirement.

Here’s the typical timeline by certificate type:

States with additional requirements (e.g. California and New York) can add several months. The single biggest factor in timeline? Submitting a complete application with proper documentation on the first try. That’s where having experienced support makes a real difference.

Required CLIA roles change by test complexity:

2025 Update: CMS now requires Lab Directors of non-waived labs to visit onsite at least every 6 months. This affects labs using remote or consulting directors. Read the full guidance →

Each serves a different purpose in clinical laboratory compliance:

CLIA is mandatory for every lab. COLA and CAP are voluntary accreditation programs that give you “deemed status,” meaning their inspection satisfies your CLIA requirements. Many payers and health system partners require or prefer accreditation beyond basic CLIA.

Here’s how we help labs decide:

Both provide CMS-deemed status. We prepare labs for both programs and can help you choose the right fit.

COLA (Commission on Office Laboratory Accreditation) is a nonprofit accreditation organization and a popular alternative to state agency CLIA inspections, especially for physician office labs and smaller clinical labs.

COLA grants CMS “deemed status,” meaning their inspection satisfies your CLIA survey requirements. Labs are inspected every two years, and COLA is known for taking an educational approach: helping labs understand and meet requirements, not just citing deficiencies. We work with hundreds of COLA labs and help prepare for their inspection process. 

Every lab test falls into one of three CLIA complexity levels. Your level determines your certificate requirements, personnel needs, QC obligations, and other compliance requirements:

The FDA assigns complexity based on seven criteria. You can look up any specific test in the FDA CLIA Database to confirm its classification. Our Test Complexity Guide covers the implications for each level in detail.

Moderate complexity tests use automated instruments with built-in safeguards, but still require trained personnel and a quality control program. They’re the middle ground: more capability than waived testing, with less regulatory overhead than high complexity.

Common examples: automated chemistry panels, CBC, coagulation testing, automated urine microscopy, and many immunoassay platforms. You’ll need a Lab Director, Clinical Consultant, and Technical Consultant on your team.

High complexity testing involves the most demanding qualifications, quality control, and oversight. These tests require significant operator judgment and sophisticated instrumentation.

Examples: molecular diagnostics (PCR, sequencing), flow cytometry, manual differentials, microbiology cultures, cytology, histopathology, and laboratory-developed tests (LDTs). Testing personnel typically need bachelor’s degrees with relevant training and experience. If you’re building a high complexity lab, we should talk early in the process.