Physician Office Laboratories and the Clinical Laboratory Improvement Act (CLIA)

All laboratory testing performed in physician offices and other health care facilities is subject to government regulations under the Clinical Laboratory Improvement Act (CLIA). The purpose of CLIA regulations is to establish quality standards for clinical laboratories and ensure the accuracy and reliability of all patient test results. According to these regulations, the Centers for Medicare & Medicaid Services (CMS) oversees all laboratory testing conducted on materials derived from the human body when the purpose is to provide information for the diagnosis, prevention, or treatment of disease or impairment, or for the assessment of human health. 

CLIA Certification Requirements

Health care facilities performing laboratory tests must have a CLIA certificate. While most clinical testing falls under CLIA oversight, certain exceptions apply:

• research testing that does not report patient-specific results for clinical use
• forensic testing
• employment-related drug testing performed by Substance Abuse and Mental Health Services Administration-certified laboratories. 

Additionally, laboratories operating in states with their own laboratory regulatory programs approved by the U.S. Department of Health and Human Services may not need a CLIA certificate.

Types of CLIA Certificates

The kind of CLIA certificate depends on the category of the tests performed (see here for a comprehensive database). The most common CLIA certificate among physician office laboratories is a Certificate of Waiver (CoW). A CoW allows laboratories to do tests categorized by the U.S. Food and Drug Administration (FDA) as waived tests. See the FDA database, CLIA - Clinical Laboratory Improvement Amendments - Currently Waived Analytes, for a list of CLIA-waived tests.

Laboratories who wish to perform non-waived tests must apply for a certificate of registration (COR), which permits the lab to perform moderate and/or high complexity tests until the laboratory can be surveyed. The results of a successful survey might result in a Certificate of Compliance (COC) or a Certificate of Accreditation (COA), depending on the agency who surveys the laboratory. The certificate may further authorize the lab to perform the following:

• Moderate complexity lab tests, which require minimal knowledge and training.  Commonly performed moderate complexity tests include CBCs, chemistries (BMP and CMP) and blood cultures.
• High complexity lab tests, which require specialized knowledge and training.  Commonly performed high complexity tests include genetic testing, blood group/antigen typing, and immunological testing. 

For specific guidance on getting CLIA certification and categorization of tests, access the CMS resource, “CLIA Program & Medicare Lab Services.” 

Laboratory Oversight

It is advisable that laboratories, even those in physician offices, have a qualified laboratory supervisor who is responsible for oversight of the laboratory, following manufacturer guidance on operations including quality control and quality assurance, and seeing that all staff performing tests are educated on laboratory procedures and receiving proper training and competency assessments. This is increasingly important in light of regulatory updates that clarify qualification standards for laboratory directors and personnel.

Staying Current with CLIA Regulations

CLIA regulations and test categorizations change frequently. Given the ongoing evolution of CLIA regulations, keeping abreast of these dynamic regulations is important to maintain compliance. 

Additional Resources

• See the CMS CLIA webpage for comprehensive guidance on CLIA regulations, certification types, and compliance requirements.