CLIA Certification / Laboratory Director

In order to assist you in obtaining a Moderately Complex CLIA certificate, TearLab has developed a simple step-by-step process as follows:

1. CLIA Application: TearLab will assist you in the submission of a CLIA application (CMS 116 form and in certain States, State forms), after which a certificate of registration and a CLIA number is received, CLIA fees must be paid and patient testing can begin, including 3rd party billing (CPT 83861).
2. Laboratory Director: Identify an MD or OD in your practice to serve as Laboratory Director (based on your State regulations, an on-line certification course may be required). California, Florida and Nevada ODs please contact TearLab directly for additional information.
3. Lab Audit: Once over the next 11 months, participate in an audit of your laboratory at your facility to review your CLIA Manual, TearLab test data and answer any questions regarding CLIA compliance, which will then qualify you for your CLIA certification.

The fee for the CLIA application and the biennial CLIA certification fee is borne by the practice, as required by law. TearLab will cover the cost of the Lab Director course, should it be required, along with providing all materials necessary to meet the quality testing required under CLIA.  This includes the laboratory manual, test cards and the control solutions used to populate the manual, plus support in completing the required testing, all at no additional charge.  

Please notify TearLab Customer Service at 1-855-TEARLAB (1-855-832-7522) when you receive your CLIA number and we will ship you our appreciation gift of complimentary test cards.

We at TearLab are excited to offer you this avenue to comply with the CLIA regulations, allowing you to accomplish both your clinical and financial goals by integrating the TearLab Osmolarity System into your practice. We will be involved throughout the entire process and are available to answer any questions that you have regarding this program and our technology.

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