District of Columbia CLIA and State Lab Requirements

Verified October 10, 2026 against the statutes, regulations and sources cited below. The state decides every application. All states

What testing sites miss in District of Columbia

A DC license becomes void 30 days after a change of director, owner or location unless a new application is filed first.
The license is issued as a Public Health: Laboratory endorsement to a DC basic business license.
No one may direct more than five DC-licensed labs, and that cap is in the DC code, not only in CLIA.
An out-of-state lab running temporary screenings or health fairs in DC notifies DC Health on its Health Awareness Screening form.

Does District of Columbia require a state lab license on top of CLIA?

Operating a clinical laboratory in the District requires a license from the Mayor (DC Health), public or private, for profit or not. The law sets staffing rules for labs performing only waived tests, and its separate physician office lab section was repealed, leaving no office exemption. The owner applies.

Clinical laboratory license
Issued by DC Health
Reaches labs doing only waived tests

Citation: D.C. Code 44-202, 44-204(a), 44-205 (repealed)

Who is exempt in District of Columbia?

Only federal labs and labs doing nonclinical research or teaching whose results are not used clinically.

Citation: D.C. Code 44-202(b)

What does District of Columbia charge?

A license fee set by the Mayor to match the cost of inspection; the amount was not confirmed.

Citation: D.C. Code 44-202(g)

How often does a District of Columbia lab registration renew?

Renews every two years
Due Two years from issue or last renewal

Do labs in other states need a District of Columbia license to test its specimens?

A license is required to perform clinical lab tests on specimens acquired in the District, wherever the lab is located.

Citation: D.C. Code 44-202(a-1)(2)

Does District of Columbia add a form to the CMS-116?

DC Health asks for a copy of the director's DC medical license, PhD or highest degree with every CMS-116, including waiver applications and later changes.

Where does a District of Columbia CMS-116 go?

DC Health, Health Care Facilities Division, Laboratory Programs
Email: DCHealth.CLIA@dc.gov
Phone: (202) 727-1740

Opening a testing site in District of Columbia?

We prepare the CMS-116 and any District of Columbia filing for your owner or director to sign, and track both to approval. You pay CMS and the state directly. A Certificate of Waiver application is $399 per site.