10A NCAC 14C .3602. INFORMATION REQUIRED OF APPLICANT

(a)  An applicant proposing the acquisition of a gamma knife shall use the Acute Care Facility/Medical Equipment application form.

(b)  The applicant shall also provide the following additional information:

(1)           copies of written policies that establish the gamma knife as a regional resource having no administrative, clinical or charge requirements which would impede physician referrals of patients for whom gamma knife procedures would be appropriate;

(2)           documentation that the following diagnostic modalities have been operational in the facility in which the gamma knife will be used for at least 12 months prior to the submittal of the application:

(A)          magnetic resonance imaging (MRI);

(B)          angiography, including digital;

(C)          neuroangiography and CT services; and

(D)          linear accelerator;

(3)           if the proposed gamma knife will be used for clinical use or for clinical trials, documentation that all equipment, supplies and pharmaceuticals proposed for the service have been certified for clinical use by the U.S. Food and Drug Administration or that the gamma knife shall be operated under an institutional review board whose membership is consistent with U.S. Department of Health and Human Services' regulations;

(4)           if the proposed gamma knife will be used for experimental or research activities, documentation of the sources of funds to be used to finance the capital cost and operational costs of the gamma knife;

(5)           documentation of the projected number of procedures, by type, to be  performed in each of the first 12 calendar quarters following completion of the proposed project, including the methodology and assumptions used for these projections;

(6)           documentation of the type and estimated number of procedures performed in the facility that the gamma knife will replace or complement;

(7)           evidence that protocols will be established to assure that all clinical gamma knife procedures performed are medically necessary and that alternative treatment modalities have been considered; and

(8)           evidence of cooperative agreements with facilities and appropriate individuals to assure efficient equipment utilization and availability of the gamma knife, including:

(A)          letters from qualified physicians indicating their intent to use the gamma knife proposed by the applicant and to comply with all relevant gamma knife criteria and guidelines; and

(B)          the provisions that have been established to accommodate referrals from other facilities in the gamma knife service area.

 

History Note:        Filed as a Temporary Adoption Eff. September 1, 1993 for a period of 180 days or until the permanent rule becomes effective, whichever is sooner;

Authority G.S. 131E-177(1); 131E-183(b);

Eff. January 4, 1994.