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Step 2: Applying for Laboratory Testing Licensure

October 12, 2021 1391

Before dentists can administer waived rapid COVID-19 tests, they must first obtain the requisite licensing including a Clinical Laboratory Improvement Amendments Certificate of Waiver from the Centers for Medicare & Medicaid Services. Additionally, health care providers who administer lab tests must obtain the appropriate licensure from the CLIA state counterpart, Laboratory Field Services, a program within the California Department of Public Health.

Waived Versus Nonwaived Tests

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*

Nonwaived Tests

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

 

Lab Licensure Application Process

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 Certificate of Waiver

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. 

LFS Laboratory Registration

When applying for a lab registration (labs limited to waived testing only), applications must complete the following:

✔︎ CLIA Application (CMS 116)

  • See section above for step-by-step instructions.

✔︎ Application for Clinical Laboratory Registration (LAB 155)

  • Section 1: Opt to register for state oversight.
  • Section 3: Type “pending” for CLIA number.
  • Section 4: Check “Certificate of Waiver.”
  • Section 7: List at least one dentist within the dental office to serve as laboratory director.
  • Signature: Must contain original signatures (no photocopies); owner and lab director can be the same individual but must sign both signature boxes. All lab directors listed in Section 7 must also sign in the signatory area (either by signing at the bottom of the page or reprinting the form to attach individual signatures of all lab directors).

✔︎ Director Attestation (LAB 183)

  • List CLIA and State ID number as “pending.”
  • Check “yes” for CLIA Director.
  • Laboratory director signatory information should match information listed on BreEZe for dental board license.

✔︎ LFS Filing Fee

  • $113 check made payable to California Department of Public Health.

*Please note: You will be billed separately from CLIA after submission of your application (CLIA filing fee is usually $180).

Submitting Your Application

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 Health
Laboratory Field Services
850 Marina Bay Pkwy, Bldg. P-1st Floor
Richmond, CA 94804-6403

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].