10a NCAC 14C .2903       PERFORMANCE STANDARDS

(a)  An applicant that proposes to provide new or expanded autologous or allogeneic bone marrow transplantation services shall demonstrate that:

(1)           all existing facilities within the applicant's bone marrow transplantation service area which have been offering bone marrow transplantation services for at least two years shall have performed at least 20 transplants during the most recent 12 month period;

(2)           all existing and approved facilities within the applicant's bone marrow transplantation service area will provide at least 20 transplants during the second year of operation following completion of the project; and

(3)           the projected utilization for the new or expanded bone marrow transplantation program shall perform at least 20 transplants during the second year of operation following completion of the project.

(b)  An applicant that proposes to provide new or expanded autologous or allogeneic bone marrow transplantation services shall describe all of the assumptions and methodologies used to calculate the projections requested in Subparagraphs (a)(2) and (3) of this Rule.

(c)  An applicant that proposes the use of bone marrow transplantation services for clinical use shall demonstrate 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 will be operated under an institutional review board whose membership is consistent with U.S. Department of Health and Human Services' regulations.

 

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.