Last updated on November 24, 2020
Laboratory tests largely fall under two categories: waived and nonwaived tests.
Waived tests are described as simple tests with a very low risk for incorrect results and often can generate results quickly. Common waived tests in medical settings include dip stick pregnancy tests or A1C glucose tests.
Nonwaived tests can vary in their level of complexity (moderate, high) and often require laboratory equipment such as centrifuges to process results. An example of a high-complexity test is the COVID-19 nasopharyngeal swab tests where specimens are collected and shipped off to a lab facility for processing. A dental practice would have difficulty obtaining a license to perform medium- or high-complexity tests because of the necessary laboratory equipment to process tests and the personnel certification and lab director requirements.
For purposes of this toolkit, these resources are for implementing a waived rapid test to detect SARS-CoV-2 in patients and dental team members.
Before dentists can administer waived rapid COVID-19 tests, they must first obtain the requisite licensing including a Clinical Laboratory Improvement Amendments (CLIA) Certificate of Waiver from the Centers for Medicare & Medicaid Services (CMS). Additionally, health care providers who administer lab tests must also obtain the appropriate licensure from the CLIA state counterpart, Laboratory Field Services (LFS), a program within the California Department of Public Health (CDPH).
CLIA applications are initially processed through LFS. CDA will continue to keep dentists updated on this page once they are eligible to apply for LFS testing licensure and at the COVID-19 Newsroom.
CLIA applications are initially processed through the appropriate state licensing agency, meaning that applicants will bundle CLIA and LFS forms together into one application and submit to LFS. See complete instructions in the LFS section below.
For step-by-step directions on how to complete a CLIA Certificate of Waiver application (FORM CMS 116), please refer to pages 6-7 of the ADA Testing Toolkit. Please note that CLIA Certificates of Waiver are renewed biennially. Initial filing fees will cost approximately $180 for most dentists and will be billed directly to dentists after the application is processed by LFS. Laboratories with a Certificate of Waiver are not subject to routine inspections or surveys but may be surveyed in response to a complaint.
In order to apply for a Lab Registration (labs limited to waived testing only), applications must complete the following:
*Please note: You will be billed separately from CLIA after submission of your application (CLIA filing fee is usually $180)
State testing agencies process both federal and state laboratory licensing applications. In California, applicants must submit both CLIA and LFS applications with original signatures to the following address:
California Department of Public HealthLaboratory Field Services850 Marina Bay Pkwy, Bldg. P-1st FloorRichmond, CA 94804-6403
It is recommended to save a copy of your application and submit the original application and LFS filing fee through certified mail. If you have not received any correspondence from LFS within 60 days of receipt of your application, if your filing fee was not cashed within 30 days of receipt of application or you received your laboratory license and it contains an error, email [email protected].