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Step 6: Maintaining Regulatory Compliance

October 12, 2021 861

Dentists must adhere to the following requirements related to renewals, record retention and other regulatory compliance requirements.

Renewals

Laboratory licensure renewal occurs on a biannual basis (every two years).

✔︎ CMS 116 (PDF) — CLIA application for new locations or for changes in your testing site (dental office) such as change in laboratory director, ownership, change in certificate type, address, etc. This form is not necessary if there are no changes in your site since the last renewal.

✔︎ LAB 155R (PDF) — Renewal Application for Clinical Laboratory Registration

✔︎ LAB 183 (PDF) — Director Attestation (each director or co-director must file a separate attestation)

Renewal fee – This is usually $113; refer to the LFS fee schedule for any changes. Write your state LAB ID (e.g., XXX 123456) on your check or money order and make it payable to: 

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

Please note: Lab renewal forms may provide a different address for submitting renewal applications and fees; however, the Richmond address is the most current address.

CMS will mail a renewal-fee coupon and instructions approximately six months before expiration of the CLIA Certificate of Waiver. The renewal fee is typically $180 every two years. Click here to view the CLIA fee schedule.

Records Retention

Clinical laboratories, including those that have ceased operations, must retain medical and laboratory records for three years from the date of testing. 

  • Medical records are defined as test requisition or test authorization, or the patient’s health record if used as the test requisition, the final and preliminary test or examination result and the name of the person contacted if the laboratory test result indicated an imminent life-threatening result or was of panic value, such as a positive COVID-19 test.
     
  • Laboratory records are defined as records showing compliance with CLIA and LFS, including records for patient test management, quality control, quality assurance and all invoices documenting the purchase or lease of laboratory equipment and test kits, reagents or media.
    See Cal. Bus. & Prof. Code Section 1265.

Change-Triggering Filings

If any of the following changes occur to your practice, you must submit a filing to LFS within 30 calendar days:

  • Change of laboratory director - If the lab site continues to process tests during the 30-day filing period, written notice must be provided to LFS of the appointment of an interim laboratory director within five business days.
     
  • Change of owner - This will usually occur if there is a lab director change for most dental practices, especially if it is the same person.
     
  • Various other changes - Such as change of lab name or closure.

None of these filings require a filing fee, but application forms must include original signatures and be mailed to:

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