§ 44–202. License requirements for clinical laboratories.

(a) Except as provided in subsection (b) of this section, it shall be unlawful to operate a clinical laboratory in the District of Columbia, whether public or private, for profit or not-for-profit, unless licensed by the Mayor.

(a-1) Except as provided in subsection (c) of this section, it shall be unlawful to engage in any of the following activities unless licensed to engage in that activity by the Mayor, whether the activity is public or private, for profit or not for profit:

(1) Performing or offering to perform clinical laboratory tests or examinations in the District of Columbia; or

(2) Performing or offering to perform clinical laboratory tests or examinations on specimens acquired in the District of Columbia, regardless of the location of the clinical laboratory at which the tests or examinations are performed.

(b) Clinical laboratory licenses shall not be required of:

(1) Clinical laboratories operated by the federal government;

(2) Any laboratory maintained and operated purely for nonclinical research purposes, the results of which are not used for clinical application;

(3) Any laboratory operated solely for teaching and conducting analyses, the results of which are not used for clinical application; or

(4) Repealed.

(c) Clinical laboratories that, prior to March 16, 1989, were not or would not have been subject to licensure in the District of Columbia may operate without a license until one year after the issuance of rules pursuant to § 44-213.

(d) An application for a clinical laboratory license shall be made by the owner of the clinical laboratory on forms provided by the Mayor. The application shall contain the name of the owner, the name of the laboratory director, the categories of laboratory tests for which the clinical laboratory license is sought, an approved proficiency testing program in which the clinical laboratory plans to participate, the location and physical description of the facility at which tests are to be performed, and other information as the Mayor may require.

(e) A license shall be valid only for the premises stated on the application.

(f) A license shall automatically become void 30 days following a change in the laboratory director, or 30 days following a change in ownership or location of the clinical laboratory. A new application for a license may be made prior to a change in the laboratory director, ownership, or location of the clinical laboratory, or prior to the expiration of the 30-day period, in order to permit the uninterrupted operation of the clinical laboratory.

(g) Unless already terminated or renewed, a clinical laboratory license shall expire 2 years from the date of initial issuance or the date of last renewal. An application for a license shall be accompanied by a license fee determined by the Mayor that is commensurate to the cost of inspection.

(h) A clinical laboratory license shall specify on its face the names of the owner and the director of the laboratory, the categories of laboratory tests authorized, and the location at which the tests may be performed. Each clinical laboratory licensed under this chapter shall post its license in a conspicuous place on the premises, and have its license readily available for inspection by the public.

(i) A license shall not be issued or renewed unless:

(1) A valid certificate of qualification in the procedures for which the license is sought has been issued to the laboratory director by a recognized personnel certifying agency as approved by the Mayor;

(2) The clinical laboratory is appropriately staffed with qualified personnel and properly equipped;

(3) The clinical laboratory has participated to the satisfaction of the Mayor in an approved proficiency testing program, pursuant to § 44-209; and

(4) The clinical laboratory is operated in the manner required by this chapter and rules issued pursuant to this chapter.

(j) Any license issued pursuant to this section shall be issued as a Public Health: Laboratory endorsement to a basic business license under the basic business license system as set forth in subchapter I-A of Chapter 28 of Title 47.