Laboratory tests largely fall under two categories: waived and nonwaived.
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 dipstick 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 that require collection and shipment of specimens 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.
Waived tests are simple exams and procedures that have an insignificant risk of erroneous result
Nonwaived tests can also be considered “moderate” or “high complexity”
Many rapid tests are categorized as waived
Moderate- and high-complexity tests require
technical knowledge and training and are
more difficult to perform or interpret
Examples include pregnancy dipstick tests
and blood glucose tests
Examples include cytology testing (e.g., pap
smears) and immunohistochemistry
California’s Laboratory Field Services Department not only processes state lab license and registration applications but also serves as the intermediary for federal CLIA applications that are filed within the state. Follow the instructions below when completing both applications and submitting to LFS.
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.
CLIA Certificates of Waiver are renewed biennially. Initial filing fees for most dentists are approximately $180 (plus the $113 state filing fee for $293 total) and will be billed directly to dentists after the LFS processes the application. Laboratories with a Certificate of Waiver are not subject to routine inspections or surveys but may be surveyed in response to a complaint.
When applying 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:
Save a copy of your application and submit the original application and LFS filing fee through certified mail. The average processing times for these applications are approximately four to six weeks.
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 if you received your laboratory license and it contains an error, email [email protected].
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