CLIA Application Form (CLIA Form 116)
The ATD System is classified as a Class II (Moderate Complexity) Diagnostic Device and, as such, requires all persons involved in the taking, processing or reading of lab samples be properly licensed. Upon receipt of the proper license, each laboratory will be issued a CLIA number that must accompany any and all requests for reimbursement.
ATD is well versed on all regulatory issues associated with applying for and receiving the appropriate license, and offers individualized regulatory support to assist each customer through this process. The regulatory burden associated with applying for, receiving and maintaining a CLIA Class I (waived) or II license is not onerous; in fact is pretty simple and straight forward.
While CLIA regulations cover specific educational, training and experience requirements needed for proper CLIA licensure by the Federal government, States have varying requirements. With few exceptions, ophthalmologists and optometrists meet the regulatory requirements to serve as Lab Director.