North Carolina Administrative Code (Last Updated: November 13, 2014) |
TITLE 10A. HEALTH AND HUMAN SERVICES |
CHAPTER 14. DIRECTOR, DIVISION OF HEALTH SERVICE REGULATION |
SUBCHAPTER C. CERTIFICATE OF NEED REGULATIONS |
10A NCAC 14C .3102. DEFINITIONS
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The following definitions shall apply to all rules in this Section:
(1) "Essential" means those items which are indispensable, the absence of which renders the equipment useless.
(2) "Major Medical Equipment" is defined in G.S. 131E-176(14f).
(3) "Mobile Major Medical Equipment" means major medical equipment and transporting equipment which is moved to provide services at two or more host facilities.
(4) "New Major Medical Technology" means major medical equipment that:
(a) has been approved for clinical use by the U.S. Food and Drug Administration or shall be operated in accordance with protocols approved by an institutional review board whose membership is consistent with the U.S. Department of Health and Human Services' regulations;
(b) is intended for use in the diagnosis or treatment of medical conditions;
(c) meets the definition of major medical equipment in G.S. 131E-176(14f); and
(d) is so new that no state or national utilization data is readily available to the Agency for the development of specific criteria and standards.
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.