36-463.01. Licensure of laboratories located in a health care institution

A. A person who wishes to operate a laboratory in a health care institution which is covered by a single license issued pursuant to chapter 4 of this title shall submit an application for licensure on a form prescribed and furnished by the department. The application shall be under oath and shall contain the following:

1. The name and location of the health care institution.

2. A copy of the license of the health care institution.

3. The name of the governing authority.

4. A description of clinical laboratory services to be provided, including those to be provided in special function laboratories and ancillary test sites covered by the single license of the health care institution.

5. The name of the chief administrative officer directing the health care institution.

6. Other information required by the department.

B. The application shall be signed by the owner of the health care institution. If the application is submitted by a partnership or a corporation it shall be signed by two of the partners or officers. If the application is submitted by a governmental unit it shall be signed by the head of the appropriate department.

C. The department shall issue the license to the governing authority of the health care institution, and the license shall show the name of the chief administrative officer. The licensee is responsible for the maintenance and conduct of the laboratory and for violations of this article. The department shall issue a single license for all clinical laboratory services provided by the health care institution including those provided in special function laboratories and ancillary test sites covered by the single health care license. A license is valid only for the person to whom it is issued and may not be sold or transferred.

D. The department may issue a provisional license if it is satisfied that the applicant substantially complies with the provisions of this article. A provisional license is valid for no more than six months and may not be renewed.

E. A licensee may apply for and shall be granted a new license without charge if the licensed laboratory is undergoing a change in location and the administrator of the health care institution, prior to the actual change, proves to the satisfaction of the department that the change is in compliance with the provisions of this article and rules adopted pursuant to this article. The department must receive the application at least thirty days before the proposed change in location.

F. A license is valid for two years and may be renewed on payment of a renewal fee prescribed by the director by rule pursuant to section 36-464 if the laboratory is in substantial compliance with this article and rules adopted pursuant to this article.

G. The department shall maintain a list of laboratories that meet the licensure requirements of this section. The department shall make this list available on request to licensed laboratories, physicians and the public.