1. (a) A health service facility that proposes to develop a new open-heart surgery service shall:

   1. (1) provide the projected number of open-heart surgical procedures to be performed during each of the first three full fiscal years of operation following completion of the project;
   2. (2) provide the assumptions and methodology used to project the utilization required by Subparagraph (a)(1) of this Paragraph; and
   3. (3) project to perform 150 or more open-heart surgical procedures in the third full fiscal year of operation following completion of the project.

2. (b) A health service facility that proposes to acquire a heart-lung bypass machine, excluding a heart-lung bypass machine proposed to be acquired pursuant to Policy AC-6 in the annual State Medical Facilities Plan in effect as of the first day of the review period, shall:

   1. (1) provide the number of existing heart-lung bypass machines owned or operated by the health service facility;
   2. (2) provide the number of approved heart-lung bypass machines that will be owned or operated by the health service facility;
   3. (3) provide projected utilization of the existing and approved heart-lung bypass machines identified in Subparagraphs (b)(1) and (b)(2) of this Paragraph and the proposed heart-lung bypass machine during each of the first three full fiscal years of operation following completion of the project;
   4. (4) provide the assumptions and methodology used to project the utilization required by Subparagraph (b)(3) of this Paragraph; and

   5. (5) project that the existing and approved heart-lung bypass machines identified in Subparagraphs (b)(1) and (b)(2) of this Paragraph and the proposed heart-lung bypass machine will be used during the third full fiscal year of operation following completion of the project:

      1. (A) to perform 200 or more open-heart surgical procedures per heart-lung bypass machine; or
      2. (B) for 900 hours or more per heart-lung bypass machine, including time in use and time spent on standby, for all types of procedures.

History Note: Authority G.S. 131E-177(1); 131E-183(b);
Eff. January 1, 1987;
Amended Eff. November 1, 1989;
Temporary Amendment Eff. September 1, 1993 for a period of 180 days or until the permanent rule becomes effective, whichever is sooner;
Amended Eff. January 4, 1994;
Temporary Amendment January 1, 1999;
Temporary Eff. January 1, 1999 expired October 12, 1999;
Temporary Amendment Eff. January 1, 2000 and shall expire on the date the permanent amendment to this rule, approved by the Rules Review Commission on November 17, 1999, becomes effective;
Amended Eff. July 1, 2000;
Temporary Amendment Eff. January 1, 2002;
Amended Eff. April 1, 2003;
Temporary Amendment Eff. February 1, 2010;
Amended Eff. January 1, 2013; November 1, 2010;
Readopted Eff. February 1, 2022.