10A NCAC 14C .0301. RESEARCH ACTIVITY

(a)  Under G.S. 131E‑179 a health care facility may apply to the agency for an exemption from obtaining a certificate of need for any of the following if they are to be used solely for research:

(1)           acquisition of major medical equipment;

(2)           the offering of institutional health services; or

(3)           the incurring of the obligation of a capital expenditure.

If any of the foregoing is used to provide patient care on an occasional and irregular basis and not as a part of the research program, the agency will not deny any request for an exemption solely on that basis.

(b)  The exemption shall be granted if notice is filed in accordance with this Rule and if the notice shows that the proposed new institutional health service will not:

(1)           affect the charges of the health care facility for the provision of medical or other patient care services other than the services which are included in research;

(2)           substantially change the bed capacity of the facility; or

(3)           substantially change the medical or other patient care services of the facility.

(c)  The notice required by G.S. 131E‑179 shall be given on a form "Notice of Proposed Research Activity."  This form may be obtained by contacting the agency at the address and telephone number stated in 10A NCAC 14C .0102.

(d)  The notice must be completed and delivered to the agency before the new institutional health service is offered or developed.  The notice is not filed in accordance with this Rule until the notice is deemed complete.

(e)  The agency shall promptly acknowledge in writing receipt of the notice.  The notice shall be deemed complete unless the agency, within seven days after receipt, mails a letter to the person submitting the notice which states that the notice was incomplete and specifies what information is necessary to make it complete.  As soon as the requested information is delivered to the agency, the notice shall be deemed complete and filed in accordance with this Rule.

(f)  Within 30 days after receipt of a completed notice, the agency shall notify the health care facility submitting the notice whether the agency has granted the exemption.  If the exemption has been granted, the health care facility may proceed to offer and develop the new institutional health service.  If a certificate of need is required, the notice and review under this Rule shall be deemed to be in compliance with 10A NCAC 14C .0201.

(g)  Any affected person, as defined in G.S. 131E‑188(c), may obtain a contested case hearing on a decision of the agency under this Rule by following procedures set forth in G.S. 150B and G.S. 131E-188.

 

History Note:        Authority G.S. 131E‑177; 131E‑179;

Eff. January 1, 1982;

Amended Eff. February 1, 2000; January 1, 1990; November 1, 1989; February 1, 1986.