NC Register Volume 16 Issue 15 - Office of Administrative Hearings

(3) provide documentation of all assumptions anddata used in the development of theprojections required in this Rule.(d) An applicant proposing to acquire shared fixed cardiaccatheterization or cardiac angioplasty equipment as defined inthe applicable State Medical Facilities Plan shall:(1) demonstrate that each proposed item of sharedfixed cardiac catheterization or cardiacangioplasty equipment shall perform acombined total of at least 225 cardiaccatheterization and angiography proceduresduring the fourth quarter of the third yearfollowing completion of the project; and(2) provide documentation of all assumptions anddata used in the development of theprojections required in this Rule.(e) If the applicant proposes to perform cardiac catheterizationprocedures on patients age 14 and under, the applicant shalldemonstrate that it meets the following additional criteria:(1) the facility has the capability to performdiagnostic and therapeutic cardiaccatheterization procedures and open heartsurgery services on patients age 14 and under;(2) the proposed project shall be performing at anannual rate of at least 100 cardiaccatheterization procedures on patients age 14or under during the fourth quarter of the thirdyear following initiation of the proposedcardiac catheterization procedures for patientsage 14 and under.History Note: Authority G.S. 131E-177(1); 131E-183(b);Eff. January 1, 1987;Temporary Amendment Eff. September 1, 1993 for a period of180 days or until the permanent rule becomes effective,whichever is sooner;Amended Eff. November 1, 1996; February 1, 1994;Temporary Amendment Eff. January 1, 1999;Temporary Eff. January 1, 1999 Expired on October 12, 1999;Temporary Amendment Eff. January 1, 2000;Temporary Amendment effective January 1, 2000 amends andreplaces a permanent rulemaking originally proposed to beeffective August 2000;Temporary Amendment Eff. January 1, 2001;Temporary Amendment effective January 1, 2001 amends andreplaces a permanent rulemaking originally proposed to beeffective April 1, 2001;Temporary Amendment Eff. January 1, 2002;Temporary Amendment effective January 1, 2002 amends andreplaces a permanent rulemaking originally proposed to beeffective August 1, 2002.10 NCAC 03R .1616 REQUIRED SUPPORTSERVICES(a) If the applicant proposes to perform therapeutic cardiaccatheterization procedures, the applicant shall demonstrate thatopen heart surgery services are provided within the samefacility.(b) If the applicant proposes to perform diagnostic cardiaccatheterization procedures, the applicant shall document that itspatients will have access to a facility which provides open heartTEMPORARY RULES16:15 NORTH CAROLINA REGISTER February 1, 20021678surgery services, and that the patients can be transported to thatfacility within 30 minutes and with no greater risk than if theprocedure had been performed in a hospital which provides openheart surgery services; with the exception that the 30 minutetransport requirement shall be waived for equipment that wasidentified as needed in the State Medical Facilities Plan basedon an adjusted need determination or the determination of a needfor shared-fixed cardiac catheterization equipment.(c) The applicant shall provide documentation to demonstratethat the following services shall be available in the facility:(1) electrocardiography laboratory and testingservices including stress testing andcontinuous cardiogram monitoring;(2) echocardiography service;(3) blood gas laboratory;(4) pulmonary function unit;(5) staffed blood bank;(6) hematology laboratory/coagulation laboratory;(7) microbiology laboratory;(8) clinical pathology laboratory with facilities forblood chemistry;(9) immediate endocardiac catheter pacemaking incase of cardiac arrest; and(10) nuclear medicine services including nuclearcardiology.History Note: Authority G.S. 131E-177(1); 131E-183(b);Eff. January 1, 1987;Temporary Amendment Eff. September 1, 1993 for a period of180 days or until the permanent rule becomes effective,whichever is sooner;Amended Eff. February 1, 1994;Temporary Amendment Eff. February 2, 2001;Temporary Amendment Eff. January 1, 2002;Temporary Amendment effective January 1, 2002 amends andreplaces a permanent rulemaking originally proposed to beeffective August 1, 2002.SECTION .1700 - CRITERIA AND STANDARDS FOROPEN-HEART SURGERY SERVICES ANDHEART-LUNG BYPASS MACHINES10 NCAC 03R .1715 REQUIRED PERFORMANCESTANDARDSThe applicant shall demonstrate that the proposed project iscapable of meeting the following standards:(1) the applicant shall perform at least 4diagnostic catheterizations per open heartsurgical procedure during each quarter;(2) an applicant's existing and new or additionalheart-lung bypass machines shall be utilized atan annual rate of 200 open heart surgicalprocedures per machine, measured during thetwelfth quarter following completion of theproject;(3) at least 50 percent of the projected open heartsurgical procedures shall be performed onpatients residing within the primary open heartsurgery service area;(4) the applicant's projected utilization andproposed staffing patterns are such that each