Can Clinical Laboratory Improvement Amendments (CLIA) certified labs test for animal infections?

CLIA-Certified Labs Cannot Test for Animal Infections

CLIA-certified laboratories are specifically authorized to perform testing on human specimens for disease diagnosis, prevention, treatment, or health assessment purposes, and are not permitted to test for animal infections. 1

Regulatory Framework for CLIA Labs

CLIA (Clinical Laboratory Improvement Amendments) regulations were established to ensure the quality and reliability of laboratory testing on human specimens. The regulatory scope is explicitly defined:

• CLIA was enacted through Public Law 100-578, amending the Clinical Laboratory Improvement Act of 1967, requiring HHS to establish regulations for laboratory testing on human specimens 1
• The regulatory authority is specifically limited to "laboratory testing on human specimens for disease diagnosis, prevention or treatment, or health assessment purposes" 1
• CMS administers the CLIA laboratory certification program in collaboration with FDA and CDC 1

Limitations on Animal Testing

CLIA certification applies exclusively to human testing for several key reasons:

• CLIA regulations are designed to ensure quality and reliability specifically for human diagnostic testing 1
• For referral testing under research protocols, CAP standard GEN.41350 requires that if such testing is used for patient management decisions, the referral laboratory must be CLIA-certified or appropriately licensed to perform clinical testing according to CMS 1
• The regulatory oversight is structured around human clinical applications, with no provisions for veterinary or animal testing 1

Alternative Testing Options for Animal Specimens

When animal testing is required, appropriate alternatives include:

• Veterinary diagnostic laboratories that operate under separate regulatory frameworks
• Research laboratories with appropriate animal testing capabilities
• Public health laboratories that may have specialized divisions for zoonotic disease surveillance

Potential Consequences of Misuse

Using CLIA-certified labs for animal testing could result in:

• Regulatory violations that may jeopardize the lab's CLIA certification
• Potential billing and reimbursement issues as CLIA labs are structured for human clinical testing
• Quality concerns as validation protocols and reference ranges are established for human specimens

Exceptions and Special Considerations

While CLIA labs cannot routinely test animal specimens, there are limited circumstances where testing related to animals might occur:

• Testing human specimens for zoonotic diseases (diseases transmitted from animals to humans) is permitted as this involves human specimens 1
• Public health laboratories may conduct specialized testing for organisms of public health concern, including those with animal origins, but this is still focused on human health impacts 1

CLIA-certified laboratories must adhere strictly to their regulatory scope of human specimen testing to maintain compliance with federal regulations and ensure the quality and reliability of clinical laboratory services.