1. The name and location of the clinical laboratory




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3646336-463.  Licensure of laboratories located outside of a health care institution; application; issuance; display; expiration; renewal

A.  Except as otherwise provided pursuant to this article and rules adopted pursuant to this article, a person who desires to operate a clinical laboratory outside of a licensed health care institution shall file with the department an application accompanied by a license application fee prescribed by the director by rule pursuant to section 36 464.

B.  The application shall be on a form prescribed and furnished by the department.  The application shall be under oath and shall contain:

1.  The name and location of the clinical laboratory.

2.  The name of the person owning the facility and the name of the person directing the facility.

3.  A description of the services provided by the clinical laboratory.

4.  Other information as the department determines necessary or expedient in carrying out its powers and duties under this article.

C.  The department may issue a provisional license to the applicant to operate a clinical laboratory to provide the services described in the application if the department is satisfied that the applicant substantially complies with the provisions of this article and the rules adopted pursuant to this article.

D.  A provisional license is valid for no more than six months and may not be renewed.

E.  If the owner of a clinical laboratory located outside of a licensed health care institution is not the director of that laboratory the director of the department of health services shall issue a joint license.  The owner and the director of the laboratory are severally and jointly responsible to the department for the maintenance and conduct of the laboratory and for any violations of the provisions of this article and rules adopted pursuant to this article.  A separate license shall be obtained for each clinical laboratory.  A license is valid only for the persons to whom it is issued and shall not be sold or transferred.  A license is not valid for any premises other than those for which it is issued.

F.  A person may apply for and shall be granted a new license without charge if the licensed laboratory is undergoing a change in location and the director or owner, 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.

G.  A regular license is valid for two years and may be renewed on payment of an application for 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.

H.  A person who maintains, conducts or operates a clinical laboratory shall display in a prominent place in the clinical laboratory the license issued to him by the department.

I.  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. 36463





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