SUBCHAPTER 14C – CERTIFICATE OF NEED REGULATIONS

 

SECTION .0100 - GENERAL

 

10a NCAC 14C .0101      DEFINITIONS

 

History Note:        Authority G.S. 131E-177;

Eff. January 1, 1990;

Amended Eff. November 1, 1996;

Expired Eff. February 1, 2019 pursuant to G.S. 150B-21.3A.

 

10A NCAC 14C .0102      LOCATION OF THE AGENCY

As used in this Subchapter, the agency is the Certificate of Need Section in the Division of Health Service Regulation, North Carolina Department of Health and Human Services. The location of the agency is 809 Ruggles Drive, Raleigh, North Carolina, 27603. The mailing address of the agency is Certificate of Need Section, Division of Health Service Regulation, 2704 Mail Service Center, Raleigh, NC 27699-2704. The telephone number of the agency is 919‑855-3873.

 

History Note:        Authority G.S. 131E‑177;

Eff. November 1, 1996;

Amended Eff. January 1, 2013; January 1, 2000.

Pursuant to G.S. 150B-21.3A, rule is necessary without substantive public interest Eff. January 19, 2019.

 

10A NCAC 14C .0103      STATE MEDICAL FACILITIES PLAN

 

History Note:        Authority G.S. 131E‑176(25); 131E‑177(1); 131E‑183(1); 42 U.S.C. 300K‑2;

Eff. June 19, 1979;

Temporary Amendment Eff. January 1, 1983 for a Period of 120 Days to Expire on May 1, 1983;

Amended Eff. November 1, 1989; January 1, 1989; February 1, 1988; January 1, 1987;

Repealed Eff. October 1, 2016.

 

SECTION .0200 – APPLICATION AND REVIEW PROCESS

 

10A NCAC 14C .0201      LETTER OF INTENT

 

History Note:        Authority G.S. 131E‑177;

Eff. October 1, 1981;

Amended Eff. November 1, 1996; January 1, 1990; November 1, 1989;

Repealed Eff. October 1, 2016.

 

10A NCAC 14C .0202      DETERMINATION OF REVIEW

(a)  After receipt of a letter of intent, the agency shall determine whether the proposed project requires a certificate of need.

(b)  When any of the equipment listed in G.S. 131E-176(16)(f1) or (p) is acquired in parts or piecemeal fashion, the acquisition shall be determined to require a certificate of need on the date that the components are assembled.

(c)  If the agency determines that the project requires a certificate of need, the agency shall determine the appropriate review category or categories for the proposed project, the type or types of application forms to be submitted, the number of separate applications to be submitted, the applicable review period for each application, and the deadline date for submitting each application, as contained in this Subchapter.

(d)  Copies of the application forms may be obtained from the agency.

(e)  Proposals requiring review shall be reviewed according to the categories and schedule set forth in the duly adopted State Medical Facilities Plan in effect at the time the scheduled review period commences, as contained in this Subchapter.

(f)  Applications are competitive if they, in whole or in part, are for the same or similar services and the agency determines that the approval of one or more of the applications may result in the denial of another application reviewed in the same review period.

 

History Note:        Filed as a Temporary Amendment 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;

Eff. October 1, 1981;

Amended Eff. November 1, 1996; January 4, 1994; January 1, 1990; January 1, 1987;

Temporary Amendment Eff. January 1, 2000;

Amended Eff. April 1, 2001.

 

10A NCAC 14C .0203      FILING APPLICATIONS

(a)  A certificate of need application shall not be reviewed by the Certificate of Need Section until it is filed in accordance with this Rule.

(b)  An original and a copy of the application shall be file-stamped as received by the agency no later than 5:30 p.m. on the 15th day of the month preceding the scheduled review period.  In instances when the 15th of the month falls on a weekend or holiday, the filing deadline is 5:30 p.m. on the next business day.  An application shall not be included in a scheduled review if it is not received by the agency by this deadline.  Each applicant shall transmit, with the application, a fee to be determined according to the formula as stated in G.S. 131E-182(c).

(c)  After an application is filed, the agency shall determine whether it is complete for review.  An application shall not be considered complete if:

(1)           the requisite fee has not been received by the agency; or

(2)           a signed original and copy of the application have not been submitted to the agency on the appropriate application form.

(d)  If the agency determines the application is not complete for review, it shall mail notice of such determination to the applicant within five business days after the application is filed and shall specify what is necessary to complete the application.  If the agency determines the application is complete, it shall mail notice of such determination to the applicant prior to the beginning of the applicable review period.

(e)  Information requested by the agency to complete the application must be received by the agency no later than 5:30 p.m. on the last working day before the first day of the scheduled review period.  The review of an application shall commence in the next applicable review period that commences after the application has been determined to be complete.

 

History Note:        Authority G.S. 131E‑177; 131E‑182;

Eff. October 1, 1981;

Amended Eff. January 1, 1982;

Temporary Amendment Eff. July 15, 1983, for a Period of 118 Days, to Expire on November 10, 1983;

Amended Eff. November 1, 1990: January 1, 1990; December 1, 1989; January 1, 1987; October 1, 1984; November 10, 1983;

Temporary Amendment Eff. August 11, 1993, for a period of 180 days or until the permanent rule becomes effective, whichever is sooner;

Amended Eff. January 4, 1994;

Temporary Amendment Eff. August 12, 1994, for a period of 180 days or until the permanent rule becomes effective, whichever is sooner;

Amended Eff. December 1, 1994;

Temporary Amendment Eff. January 1, 2000;

Amended Eff. April 1, 2001;

Temporary Amendment Eff. February 16, 2004;

Amended Eff. August 1, 2004;

Temporary Amendment Eff. February 1, 2006;

Amended Eff. November 1, 2006;

Temporary Amendment Eff. January 1, 2008;

Amended Eff. July 1, 2008.

 

10A NCAC 14C .0204      AMENDMENTS TO APPLICATIONS

An applicant may not amend an application. Responding to a request for additional information made by the agency after the review has commenced is not an amendment.

 

History Note:        Authority G.S. 131E‑177; 131E‑182;

Eff. October 1, 1981;

Amended Eff. January 1, 1990; January 1, 1987;

Pursuant to G.S. 150B-21.3A, rule is necessary without substantive public interest Eff. January 19, 2019.

 

10A NCAC 14C .0205      REVIEW PERIOD

(a)  The review of an application for a certificate of need shall be completed within 90 days from the beginning date of the review period for the application, except as provided in Paragraph (b) of this Rule.

(b)  Except in the case of an expedited review, the period for review may be extended for up to 60 days by the agency if it determines that, for one or more of the following reasons, it cannot complete the review within 90 days:

(1)           the extension is necessary to consider conflicting, contradictory, or otherwise relevant matters;

(2)           the total number of applications assigned to the project analyst for review, including those in other review periods, preclude the project analyst from completing the review within 90 days;

(3)           the complexity of the application or applications to be reviewed make it necessary to extend the review period;

(4)           the review of an applicant's response to the agency's request for additional information has not been completed;

(5)           the timing of the public hearing which was held for the application or applications under review does not allow sufficient time to consider the information presented;

(6)           extension of previous reviews necessitated that the project analyst delay the commencement of the review; or

(7)           the unavailability of the project analyst due to illness, annual leave, litigation associated with other reviews, or other duties and responsibilities.

(c)  In the case of an expedited review, the review period may be extended only if the Agency has requested additional substantive information from the applicant in accordance with G.S. 131E-185(c).

(d)  Applicants will be provided written notice of the extension of the review period after the agency determines that an extension is necessary.  Failure to receive such notice prior to the last day of the scheduled review period, however, does not entitle an applicant to a certificate of need nor authorize an applicant to proceed with a project without one.

 

History Note:        Filed as a Temporary Amendment 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; 131E‑185;

Eff. October 1, 1981;

Amended Eff. January 4, 1994; January 1, 1990; January 1, 1982.

 

10A NCAC 14C .0206      EXPEDITED REVIEW

 

History Note:        Authority G.S. 131E-177(1);

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

Eff. January 4, 1994;

Expired Eff. February 1, 2019 pursuant to G.S. 150B-21.3A.

 

10A NCAC 14C .0207      AGENCY DECISION

10A NCAC 14C .0208      ISSUANCE OF A CERTIFICATE OF NEED

10A NCAC 14C .0209      PROGRESS REPORTS

 

History Note:        Authority G.S. 131E‑177; 131E‑189;

Eff. October 1, 1981;

Amended Eff. January 1, 1990; February 1, 1986;

Expired Eff. February 1, 2019 pursuant to G.S. 150B-21.3A.

 

section .0300 - exemptions

 

10A NCAC 14c .0301      RESEARCH ACTIVITY

 

History Note:        Authority G.S. 131E‑177; 131E‑179;

Eff. January 1, 1982;

Amended Eff. February 1, 2000; January 1, 1990; November 1, 1989; February 1, 1986;

Expired Eff. February 1, 2019 pursuant to G.S. 150B-21.3A.

 

10A ncac 14c .0302      HEALTH MAINTENANCE ORGANIZATIONS

 

History Note:        Authority G.S. 131E‑177; 131E‑180;

Eff. January 1, 1982;

Amended Eff. November 1, 1996; January 1, 1990; November 1, 1989; February 1, 1986;

Temporary Amendment Eff. January 1, 2000;

Amended Eff. April 1, 2001;

Repealed Eff. January 1, 2013.

 

10A NCAC 14C .0303      REPLACEMENT EQUIPMENT

(a)  The purpose of this Rule is to define the terms used in the definition of "replacement equipment" set forth in G.S. 131E-176(22a).

(b)  "Activities essential to acquiring and making operational the replacement equipment" means those activities which are indispensable and requisite, absent which the replacement equipment could not be acquired or made operational.

(c)  "Comparable medical equipment" means equipment which is functionally similar and which is used for the same diagnostic or treatment purposes.

(d)  Replacement equipment is comparable to the equipment being replaced if:

(1)           it has the same technology as the equipment currently in use, although it may possess expanded capabilities due to technological improvements; and

(2)           it is functionally similar and is used for the same diagnostic or treatment purposes as the equipment currently in use and is not used to provide a new health service; and

(3)           the acquisition of the equipment does not result in more than a 10% increase in patient charges or per procedure operating expenses within the first twelve months after the replacement equipment is acquired.

(e)  Replacement equipment is not comparable to the equipment being replaced if:

(1)           the replacement equipment is new or reconditioned, the existing equipment was purchased second-hand, and the replacement equipment is purchased less than three years after the acquisition of the existing equipment; or

(2)           the replacement equipment is new, the existing equipment was reconditioned when purchased, and the replacement equipment is purchased less than three years after the acquisition of the existing equipment; or

(3)           the replacement equipment is capable of performing procedures that could result in the provision of a new health service or type of procedure that has not been provided with the existing equipment; or

(4)                the replacement equipment is purchased and the existing equipment is leased, unless the lease is a capital lease; or

(5)                the replacement equipment is a dedicated PET scanner and the existing equipment is:

(A)          a gamma camera with coincidence capability; or

(B)          nuclear medicine equipment that was designed, built, or modified to detect only the single photon emitted from nuclear events other than positron annihilation.

 

History Note:        Authority G.S. 131E-177(1);

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

Eff. January 4, 1994;

Amended Eff. April 1, 1999; November 1, 1996;

Temporary Amendment Eff. June 3, 2002;

Amended Eff. April 1, 2003.

 

10A NCAC 14C .0304      PSYCHIATRIC BED CONVERSIONS

 

History Note:        Authority G.S. 131E-177;

Eff. November 1, 1996;

Expired Eff. February 1, 2019 pursuant to G.S. 150B-21.3A.

 

SECTION .0400 – CERTIFICATE OF NEED APPEAL PROCESS

 

10A NCAC 14C .0401      PETITION FOR A HEARING

 

History Note:        Authority G.S. 131E‑177; 131E‑188;

Eff. October 1, 1981;

Amended Eff. January 1, 1990; November 1, 1989; February 1, 1986;

Repealed Eff. October 1, 2016.

 

10A NCAC 14C .0402      ISSUES

The correctness, adequacy, or appropriateness of criteria, plans, and standards shall not be an issue in a contested case hearing.

 

History Note:        Authority G.S. 131E‑177; 131E‑188;

Eff. October 1, 1981;

Amended Eff. February 1, 1986; October 1, 1984;

Pursuant to G.S. 150B-21.3A, rule is necessary without substantive public interest Eff. January 19, 2019.

 

10A NCAC 14C .0403      CONTESTED CASE HEARINGS

 

History Note:        Authority G.S. 131E‑177; 131E‑188;

Eff. January 1, 1990;

Repealed Eff. October 1, 2016.

 

section .0500 – enforcement and sanctions

 

10A NCAC 14C .0501      ASSESSMENT OF CIVIL PENALTY

 

History Note:        Authority G.S. 131E-177(1); 131E-190(f);

Eff. November 1, 1996;

Expired Eff. February 1, 2019 pursuant to G.S. 150B-21.3A.

 

10A NCAC 14C .0502      WITHDRAWAL OF A CERTIFICATE

 

History Note:        Authority G.S. 131E-177; 131E-189;

Eff. October 1, 1981;

Amended Eff. January 1, 1990;

Temporary Amendment Eff. October 10, 1990, for a Period of 142 Days to Expire on February 28, 1991;

Amended Eff. November 1, 1996; March 1, 1991;

Expired Eff. February 1, 2019 pursuant to G.S. 150B-21.3A.

 

section .0600 – reserved for future codification

 

section .0700 – reserved for future codification

 

Section .0800 – reserved for future codification

 

section .0900 – reserved for future codification

 

section .1000 – reserved for future codification

 

SECTION .1100 – CRITERIA AND STANDARDS FOR NURSING FACILITY OR ADULT CARE HOME SERVICES

 

10A NCAC 14C .1101      INFORMATION REQUIRED OF APPLICANT

 

History Note:        Authority G.S. 131E-175; 131E-176; 131E‑177(1); 131E-183(b); S.L. 2001, c. 234;

Eff. November 1, 1996;

Temporary Amendment Eff. January 1, 2003; January 1, 2002;

Amended Eff. August 1, 2004; April 1, 2003;

Repealed Eff. February 1, 2016.

 

10A ncac 14C .1102      PERFORMANCE STANDARDS

(a)  An applicant proposing to add nursing facility beds to an existing facility, except an applicant proposing to transfer existing certified nursing facility beds from a State Psychiatric Hospital to a community facility, shall not be approved unless the average occupancy, over the nine months immediately preceding the submittal of the application, of the total number of licensed nursing facility beds within the facility in which the new beds are to be operated was at least 90 percent.

(b)  An applicant proposing to establish a new nursing facility or add nursing facility beds to an existing facility, except an applicant proposing to transfer existing certified nursing facility beds from a State Psychiatric Hospital to a community facility, shall not be approved unless occupancy is projected to be at least 90 percent for the total number of nursing facility beds proposed to be operated, no later than two years following the completion of the proposed project.  All assumptions, including the specific methodologies by which occupancies are projected, shall be clearly stated.

(c)  An applicant proposing to add adult care home beds to an existing facility shall not be approved unless the average occupancy, over the nine months immediately preceding the submittal of the application, of the total number of licensed adult care home beds within the facility in which the new beds are to be operated was at least 85 percent.

(d)  An applicant proposing to establish a new adult care home facility or add adult care home beds to an existing facility shall not be approved unless occupancy is projected to be at least 85 percent for the total number of adult care home beds proposed to be operated, no later than two years following the completion of the proposed project. All assumptions, including the specific methodologies by which occupancies are projected, shall be stated.

 

History Note:        Authority G.S. 131E-175; 131E-176; 131E-177(1); 131E-183(b); S.L. 2001, c. 234;

Eff. November 1, 1996;

Temporary Amendment Eff. January 1, 2002;

Amended Eff. April 1, 2003.

 

section .1200 – criteria and standards for intensive care services

 

10A NCAC 14C .1201      DEFINITIONS

 

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

Eff. January 4, 1994;

Expired Eff. February 1, 2019 pursuant to G.S. 150B-21.3A.

 

10A NCAC 14C .1202      INFORMATION REQUIRED OF APPLICANT

 

History Note:        Authority G.S. 131E-177(1); 131E-183;

Eff. January 4, 1994;

Amended Eff. November 1, 1996;

Temporary Amendment Eff. February 1, 2010;

Amended Eff. November 1, 2010;

Repealed Eff. February 1, 2016.

 

10A NCAC 14C .1203      PERFORMANCE STANDARDS

 

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

Eff. January 4, 1994;

Expired Eff. February 1, 2019 pursuant to G.S. 150B-21.3A.

 

10A NCAC 14C .1204      Support Services

10A NCAC 14C .1205      STAFFING AND STAFF TRAINING

 

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

Eff. January 4, 1994;

Amended Eff. November 1, 1996;

Repealed Eff. February 1, 2016.

 

SECTION .1300 - CRITERIA AND STANDARDS FOR PEDIATRIC INTENSIVE CARE SERVICES

 

10A NCAC 14C .1301      DEFINITIONS

 

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

Eff. January 4, 1994;

Expired Eff. February 1, 2019 pursuant to G.S. 150B-21.3A.

 

10A NCAC 14C .1302      INFORMATION REQUIRED OF APPLICANT

 

History Note:        Authority G.S. 131E-177(1); 131E-183;

Eff. January 4, 1994;

Amended Eff. November 1, 1996;

Repealed Eff. February 1, 2016.

 

10A NCAC 14C .1303      PERFORMANCE STANDARDS

 

History Note:        Authority G.S. 131E-177(1); 131E-183;

Eff. January 4, 1994;

Amended Eff. November 1, 1996;

Expired Eff. February 1, 2019 pursuant to G.S. 150B-21.3A.

 

10A NCAC 14C .1304      Support Services

10A NCAC 14C .1305      STAFFING AND STAFF TRAINING

 

History Note:        Authority G.S. 131E-177(1); 131E-183;

Eff. January 4, 1994;

Amended Eff. November 1, 1996;

Repealed Eff. February 1, 2016.

 

section .1400 – criteria and standards for neonatal services

 

10A NCAC 14C .1401      DEFINITIONS

The definitions in this Rule shall apply to all rules in this Section:

(1)           "Approved neonatal service" means a neonatal service that was not operational prior to the beginning of the review period.

(2)           "Existing neonatal service" means a neonatal service in operation prior to the beginning of the review period.

(3)           "High-risk obstetric patients" means those patients requiring specialized services provided by an acute care hospital to the mother and fetus during pregnancy, labor, delivery and to the mother after delivery. The services are characterized by specialized facilities and staff for the intensive care and management of high-risk maternal and fetal patients before, during, and after delivery.

(4)           "Level I neonatal services" means services provided by an acute care hospital to full term and pre-term neonates that are stable, without complications, and may include neonates that are small for gestational age or large for gestational age.

(5)           "Level II neonatal service" means services provided by an acute care hospital in a licensed acute care bed to neonates and infants that are stable without complications but require special care and frequent feedings; infants of any weight who no longer require Level III or Level IV neonatal services, but still require more nursing hours than normal infants; and infants who require close observation in a licensed acute care bed.

(6)           "Level III neonatal service" means services provided by an acute care hospital in a licensed acute care bed to neonates or infants that are high-risk, small (approximately 32 and less than 36 completed weeks of gestational age) but otherwise healthy, or sick with a moderate degree of illness that are admitted from within the hospital or transferred from another facility requiring intermediate care services for sick infants, but not intensive care.  Level III neonates or infants require less constant nursing care than Level IV services, but care does not exclude respiratory support.

(7)           "Level IV neonatal service" means neonatal intensive care services provided by an acute care hospital in a licensed acute care bed to high-risk medically unstable or critically ill neonates (approximately under 32 weeks of gestational age) or infants requiring constant nursing care or supervision not limited to continuous cardiopulmonary or respiratory support, complicated surgical procedures, or other intensive supportive interventions.

(8)           "Neonatal bed" means a licensed acute care bed used to provide Level II, III or IV neonatal services.

(9)           "Neonatal intensive care services" shall have the same meaning as defined in G.S. 131E-176(15b).

(10)         "Neonatal service area" means a geographic area defined by the applicant from which the patients to be admitted to the service will originate.

(11)         "Neonatal services" means any of the Level I, Level II, Level III or Level IV services defined in this Rule.

(12)         "Obstetric services" means any normal or high-risk services provided by an acute care hospital to the mother and fetus during pregnancy, labor, delivery and to the mother after delivery.

(13)         "Perinatal services" means services provided during the period shortly before and after birth.

 

History Note:        Authority G.S. 131E-177(1); 131E-183;

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

Eff. January 4, 1994;

Amended Eff. November 1, 1996;

Temporary Amendment Eff. March 15, 2002;

Amended Eff. April 1, 2003.

 

10A NCAC 14C .1402      INFORMATION REQUIRED OF APPLICANT

 

History Note:        Authority G.S. 131E-177(1); 131E-183;

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

Eff. January 4, 1994;

Amended Eff. November 1, 1996;

Temporary Amendment Eff. March 15, 2002;

Amended Eff. April 1, 2003;

Temporary Amendment Eff. February 1, 2010;

Amended Eff. November 1, 2010;

Repealed Eff. February 1, 2016.

 

10A NCAC 14C .1403      PERFORMANCE STANDARDS

(a)  An applicant shall demonstrate that the proposed project is capable of meeting the following standards:

(1)           if an applicant is proposing to increase the total number of neonatal beds (i.e., the sum of Level II, Level III and Level IV beds), the overall average annual occupancy of the combined number of existing Level II, Level III and Level IV beds in the facility is at least 75 percent, over the 12 months immediately preceding the submittal of the proposal;

(2)           if an applicant is proposing to increase the total number of neonatal beds (i.e., the sum of Level II, Level III and Level IV beds), the projected overall average annual occupancy of the combined number of Level II, Level III and Level IV beds proposed to be operated during the third year of operation of the proposed project shall be at least 75 percent; and

(3)           The applicant shall document the assumptions and provide data supporting the methodology used for each projection in this rule.

(b)  If an applicant proposes to develop a new Level III or Level IV service, the applicant shall document that an unmet need exists in the applicant's defined neonatal service area, unless the State Medical Facilities Plan includes a need determination for neonatal beds in the service area.  The need for Level III and Level IV beds shall be computed for the applicant's neonatal service area by:

(1)           identifying the annual number of live births occurring at all hospitals within the proposed neonatal service area, using the latest available data compiled by the State Center for Health Statistics;

(2)           identifying the low birth weight rate (percent of live births below 2,500 grams) for the births identified in (1) of this Paragraph, using the latest available data compiled by the State Center for Health Statistics;

(3)           dividing the low birth weight rate identified in (2) of this Paragraph by .08 and subsequently multiplying the resulting quotient by four; and

(4)           determining the need for Level III and Level IV beds in the proposed neonatal service area as the product of:

(A)          the product derived in (3) of this Paragraph, and

(B)          the quotient resulting from the division of the number of live births in the initial year of the determination identified in (1) of this Paragraph by the number 1000.

 

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

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

Eff. January 4, 1994;

Temporary Amendment Eff. March 15, 2002;

Amended Eff. April 1, 2003;

Temporary Amendment Eff. February 1, 2009;

Amended Eff. November 1, 2009;

Temporary Amendment Eff. February 1, 2010;

Amended Eff. November 1, 2010.

 

10A NCAC 14C .1404      Support Services

10A NCAC 14C .1405      STAFFING AND STAFF TRAINING

 

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

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

Eff. January 4, 1994;

Temporary Amendment Eff. March 15, 2002;

Amended Eff. April 1, 2003;

Repealed Eff. February 1, 2016.

 

section .1500 - CRITERIA AND STANDARDS FOR HOSPICES

 

10A NCAC 14C .1501      DEFINITIONS

 

History Note:        Authority G.S. 131E-177(1);

Eff. July 1, 1994;

Temporary Amendment Eff. January 1, 2003;

Amended Eff. August 1, 2004;

Temporary Amendment Eff. February 1, 2006;

Amended Eff. November 1, 2006;

Expired Eff. February 1, 2019 pursuant to G.S. 150B-21.3A.

 

10A NCAC 14C .1502      INFORMATION REQUIRED OF APPLICANT

 

History Note:        Authority G.S. 131E-177(1); 131E-183;

Eff. July 1, 1994;

Amended Eff. November 1, 1996;

Temporary Amendment Eff. January 1, 2003;

Amended Eff. August 1, 2004;

Temporary Amendment Eff. February 1, 2006;

Amended Eff. November 1, 2006;

Repealed Eff. February 1, 2016.

 

10A NCAC 14C .1503      PERFORMANCE STANDARDS

 

History Note:        Authority G.S. 131E-177(1);

Eff. July 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 and replaces a permanent rulemaking originally proposed to be effective August 2000;

Amended Eff. April 1, 2001;

Temporary Amendment Eff. January 1, 2003;

Amended Eff. August 1, 2004;

Temporary Amendment Eff. February 1, 2006;

Amended Eff. November 1, 2006;

Expired Eff. February 1, 2019 pursuant to G.S. 150B-21.3A.

 

10A NCAC 14C .1504      Support Services

10A NCAC 14C .1505      STAFFING AND STAFF TRAINING

 

History Note:        Authority G.S. 131E-177(1); 131E-183;

Eff. July 1, 1994;

Amended Eff. November 1, 1996;

Temporary Amendment Eff. February 1, 2006;

Amended Eff. November 1, 2006;

Repealed Eff. February 1, 2016.

 

section .1600 – criteria and standards for cardiac catheterization equipment and cardiac angioplasty equipment

 

10A ncac 14c .1601      DEFINITIONS

The following definitions shall apply to all rules in this Section:

(1)           "Approved" means the equipment was not in operation prior to the beginning of the review period and had been issued a certificate of need.

(2)           "Capacity" of an item of cardiac catheterization equipment means 1500 diagnostic‑equivalent procedures per year.  One therapeutic cardiac catheterization procedure is valued at 1.75 diagnostic‑equivalent procedures.  One cardiac catheterization procedure performed on a patient age 14 or under is valued at two diagnostic‑equivalent procedures.  All other procedures are valued at one diagnostic‑equivalent procedure.

(3)           "Cardiac catheterization equipment" shall have the same meaning as defined in G.S. 131E‑176(2f).

(4)           "Cardiac catheterization procedure," for the purpose of determining utilization in a certificate of need review, means a single episode of diagnostic or therapeutic catheterization which occurs during one visit to a cardiac catheterization room, whereby a flexible tube is inserted into the patient's body and advanced into the heart chambers to perform a hemodynamic or angiographic examination or therapeutic intervention of the left or right heart chamber, or coronary arteries.  A cardiac catheterization procedure does not include a simple right heart catheterization for monitoring purposes as might be done in an electrophysiology laboratory, pulmonary angiography procedure, cardiac pacing through a right electrode catheter, temporary pacemaker insertion, or procedures performed in dedicated angiography or electrophysiology rooms.

(5)           "Cardiac catheterization room" means a room or a mobile unit in which there is cardiac catheterization or cardiac angioplasty equipment for the performance of cardiac catheterization procedures.  Dedicated angiography rooms and electrophysiology rooms are not cardiac catheterization rooms.

(6)           "Cardiac catheterization service area" means a geographical area defined by the applicant, which has boundaries that are not farther than 90 road miles from the facility, if the facility has a comprehensive cardiac services program; and not farther than 45 road miles from the facility if the facility performs only diagnostic cardiac catheterization procedures; except that the cardiac catheterization service area of an academic medical center teaching hospital designated in 10A NCAC 14B shall not be limited to 90 road miles.

(7)           "Cardiac catheterization services" means the provision of diagnostic cardiac catheterization procedures or therapeutic cardiac catheterization procedures performed utilizing cardiac catheterization equipment in a cardiac catheterization room.

(8)           "Comprehensive cardiac services program" means a cardiac services program which provides the full range of clinical services associated with the treatment of cardiovascular disease including community outreach, emergency treatment of cardiovascular illnesses, non‑invasive diagnostic imaging modalities, diagnostic and therapeutic cardiac catheterization procedures, open heart surgery and cardiac rehabilitation services. Community outreach and cardiac rehabilitation services shall be provided by the applicant or through arrangements with other agencies and facilities located in the same city.  All other components of a comprehensive cardiac services program shall be provided within a single facility.

(9)           "Diagnostic cardiac catheterization procedure," for the purpose of determining utilization in a certificate of need review, means a cardiac catheterization procedure performed for the purpose of detecting and identifying defects or diseases in the coronary arteries or veins of the heart, or abnormalities in the heart structure, but not the pulmonary artery.

(10)         "Electrophysiology procedure" means a diagnostic or therapeutic procedure performed to study the electrical conduction activity of the heart and characterization of atrial ventricular arrhythmias.

(11)         "Existing" means the equipment was in operation prior to the beginning of the review period.

(12)         "High‑risk patient" means a person with reduced life expectancy because of left main or multi‑vessel coronary artery disease, often with impaired left ventricular function and with other characteristics as referenced in the American College of Cardiology/ Society for Cardiac Angiography and Interventions Clinical Expert Consensus Document on Cardiac Catheterization Laboratory Standards (June 2001) report.

(13)         "Mobile equipment" means cardiac catheterization equipment and transporting equipment which is moved to provide services at two or more host facilities.

(14)         "Percutaneous transluminal coronary angioplasty (PTCA)" is one type of therapeutic cardiac catheterization procedure used to treat coronary artery disease in which a balloon‑tipped catheter is placed in the diseased artery and then inflated to compress the plaque blocking the artery.

(15)         "Primary cardiac catheterization service area" means a geographical area defined by the applicant, which has boundaries that are not farther than 45 road miles from the facility, if the facility has a comprehensive cardiac services program; and not farther than 23 road miles from the facility if the facility performs only diagnostic cardiac catheterization procedures; except that the primary cardiac catheterization service area of an academic medical center teaching hospital designated in 10A NCAC 14B shall not be limited to 45 road miles.

(16)         "Therapeutic cardiac catheterization procedure," for the purpose of determining utilization in a certificate of need review, means a cardiac catheterization procedure performed for the purpose of treating or resolving anatomical or physiological conditions which have been determined to exist in the heart or coronary arteries or veins of the heart, but not the pulmonary artery.

 

History Note:        Authority G.S. 131E‑177(1); 131E‑183;

Eff. January 1, 1987;

Temporary Amendment Eff. September 1, 1993 for a period of 180 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 and replaces a permanent rulemaking originally proposed to be effective August 1, 2000;

Temporary Amendment Eff. January 1, 2001;

Temporary Amendment effective January 1, 2001 amends and replaces a permanent rulemaking originally proposed to be effective April 1, 2001;

Amended Eff. August 1, 2002;

Temporary Amendment Eff. February 1, 2006;

Amended Eff. November 1, 2006.

 

10A NCAC 14C .1602      INFORMATION REQUIRED OF APPLICANT

 

History Note:        Authority G.S. 131E‑177(1); 131E‑183;

Eff. January 1, 1987;

Temporary Amendment Eff. September 1, 1993 for a period of 180 days or until the permanent rule becomes effective, whichever is sooner;

Amended Eff. November 1, 1996; February 1, 1994;

Temporary Amendment Eff. January 1, 2005;

Amended Eff. November 1, 2005;

Temporary Amendment Eff. February 1, 2006;

Amended Eff. November 1, 2006;

Repealed Eff. February 1, 2016.

 

10A ncac 14C .1603      PERFORMANCE STANDARDS

(a)  An applicant proposing to acquire cardiac catheterization equipment shall demonstrate that the project is capable of meeting the following standards:

(1)           each proposed item of cardiac catheterization equipment, including mobile equipment but excluding shared fixed cardiac catheterization equipment, shall be utilized at an annual rate of at least 60 percent of capacity excluding procedures not defined as cardiac catheterization procedures in 10A NCAC 14C .1601(5), measured during the fourth quarter of the third year following completion of the project;

(2)           if the applicant proposes to perform therapeutic cardiac catheterization procedures, each of the applicant's therapeutic cardiac catheterization teams shall be performing at an annual rate of at least 100 therapeutic cardiac catheterization procedures, during the third year of operation following completion of the project;

(3)           if the applicant proposes to perform diagnostic cardiac catheterization procedures, each diagnostic cardiac catheterization team shall be performing at an annual rate of at least 200 diagnostic‑equivalent cardiac catheterization procedures by the end of the third year following completion of the project;

(4)           at least 50 percent of the projected cardiac catheterization procedures shall be performed on patients residing within the primary cardiac catheterization service area;

(b)  An applicant proposing to acquire mobile cardiac catheterization equipment shall:

(1)           demonstrate that each existing item of cardiac catheterization equipment, excluding mobile equipment, located in the proposed primary cardiac catheterization service area of each host facility shall have been operated at a level of at least 80 percent of capacity during the 12 month period reflected in the most recent licensure form on file with the Division of Health Service Regulation;

(2)           demonstrate that the utilization of each existing or approved item of cardiac catheterization equipment, excluding mobile equipment, located in the proposed primary cardiac catheterization service area of each host facility shall not be expected to fall below 60 percent of capacity due to the acquisition of the proposed mobile cardiac catheterization equipment;

(3)           demonstrate that each item of existing mobile equipment operating in the proposed primary cardiac catheterization service area of each host facility shall have been performing at least an average of four diagnostic‑equivalent cardiac catheterization procedures per day per site in the proposed cardiac catheterization service area in the 12 month period preceding the submittal of the application;

(4)           demonstrate that each item of existing or approved mobile equipment to be operating in the proposed primary cardiac catheterization service area of each host facility shall be performing at least an average of four diagnostic‑equivalent cardiac catheterization procedures per day per site in the proposed cardiac catheterization service area in the applicant's third year of operation; and

(5)           provide documentation of all assumptions and data used in the development of the projections required in this Rule.

(c)  An applicant proposing to acquire cardiac catheterization equipment excluding shared fixed and mobile cardiac catheterization shall:

(1)           demonstrate that its existing items of cardiac catheterization equipment, except mobile equipment, located in the proposed cardiac catheterization service area operated at an average of at least 80 percent of capacity during the twelve month period reflected in the most recent licensure renewal application form on file with the Division of Health Service Regulation;

(2)           demonstrate that its existing items of cardiac catheterization equipment, except mobile equipment, shall be utilized at an average annual rate of at least 60 percent of capacity, measured during the fourth quarter of the third year following completion of the project; and

(3)           provide documentation of all assumptions and data used in the development of the projections required in this Rule.

(d)  An applicant proposing to acquire shared fixed cardiac catheterization equipment as defined in the applicable State Medical Facilities Plan shall:

(1)           demonstrate that each proposed item of shared fixed cardiac catheterization equipment shall perform a combined total of at least 225 cardiac catheterization and angiography procedures during the fourth quarter of the third year following completion of the project; and

(2)           provide documentation of all assumptions and data used in the development of the projections required in this Rule.

(e)  If the applicant proposes to perform cardiac catheterization procedures on patients age 14 and under, the applicant shall demonstrate that it meets the following additional criteria:

(1)           the facility has the capability to perform diagnostic and therapeutic cardiac catheterization procedures and open heart surgery services on patients age 14 and under; and

(2)           the proposed project shall be performing at an annual rate of at least 100 cardiac catheterization procedures on patients age 14 or under during the fourth quarter of the third year following initiation of the proposed cardiac catheterization procedures for patients age 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 of 180 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 and replaces a permanent rulemaking originally proposed to be effective August 2000;

Temporary Amendment Eff. January 1, 2001;

Temporary Amendment effective January 1, 2001 amends and replaces a permanent rulemaking originally proposed to be effective April 1, 2001;

Temporary Amendment Eff. January 1, 2002;

Amended Eff. August 1, 2002;

Temporary Amendment effective January 1, 2002 amends and replaces the permanent rule effective August 1, 2002;

Amended Eff. April 1, 2003;

Temporary Amendment Eff. February 1, 2006;

Amended Eff. November 1, 2006.

 

10A NCAC 14C .1604      Support Services

10A NCAC 14C .1605      STAFFING AND STAFF TRAINING

 

History Note:        Authority G.S. 131E‑177(1); 131E‑183(b);

Eff. January 1, 1987;

Temporary Amendment Eff. September 1, 1993 for a period of 180 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;

Amended Eff. August 1, 2002;

Temporary Amendment effective January 1, 2002 amends and replaces the permanent rule effective

August 1, 2002;

Amended Eff. April 1, 2003;

Temporary Amendment Eff. February 1, 2006;

Amended Eff. November 1, 2006;

Repealed Eff. February 1, 2016.

 

SECTION .1700 - criteria and standards for open-heart surgery services and heart-lung bypass machines

 

10A NCAC 14C .1701      DEFINITIONS

The following definitions apply to all rules in this Section:

(1)           "Approved heart-lung bypass machine" means a heart-lung bypass machine that was not operational prior to the beginning of the review period.

(2)           "Capacity" of a heart-lung bypass machine means 400 adult-equivalent open heart surgical procedures per year.  One open heart surgical procedure on persons age 14 and under is valued at two adult open heart surgical procedures.  For purposes of determining capacity, one open heart surgical procedure is defined to be one visit or trip by a patient to an operating room for an open heart operation.

(3)           "Cardiac Surgical Intensive Care Unit" means an intensive care unit as defined in 10A NCAC 14C .1201(2) and that is for exclusive use by post-surgical open heart patients.

(4)           "Existing heart-lung bypass machine" means a heart-lung bypass machine in operation prior to the beginning of the review period.

(5)           "Heart-lung bypass machine" has the same meaning as defined in G.S. 131E-176(10a).

(6)           "Open heart surgery services" has the same meaning as defined in G.S. 131E-176(18b).

(7)           "Open heart surgical procedures" means specialized surgical procedures that:

(a)           utilize a heart-lung bypass machine (the "pump"); and

(b)           are designed to correct congenital or acquired cardiac and coronary disease by opening the chest for surgery on the heart muscle, valves, arteries, or other parts of the heart.

 

History Note:        Authority G.S. 131E-177(1); 131E-183;

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. November 1, 1996; January 4, 1994;

Temporary Amendment Eff. January 1, 1999;

Temporary Eff. January 1, 1999 Expired on October 12, 1999;

Temporary Amendment Eff. January 1, 2000 and shall expire on the date on which 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. March 1, 2010;

Amended Eff. January 1, 2013; November 1, 2010.

 

10A NCAC 14C .1702      INFORMATION REQUIRED OF APPLICANT

 

History Note:        Authority G.S. 131E‑177(1); 131E-183;

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. November 1, 1996; January 4, 1994;

Temporary Amendment 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 and replaces a permanent rulemaking originally proposed to be effective August 2000;

Amended Eff. January 1, 2013; April 1, 2001;

Repealed Eff. February 1, 2016.

 

10A ncac 14C .1703      PERFORMANCE STANDARDS

(a)  An applicant that proposes to develop open-heart surgery services shall:

(1)           demonstrate that the projected utilization and proposed staffing patterns are such that each open heart surgical team shall perform at least 150 open heart surgical procedures in the third year following completion of the project; and

(2)           document the assumptions and provide data supporting the methodology used to make these projections.

(b)  An applicant that proposes to acquire a heart-lung bypass machine shall demonstrate either:

(1)           that the applicant's projected annual utilization of its existing, approved, and proposed heart-lung bypass machines (other than a machine acquired pursuant to 10A NCAC 14C .1703(b)(3)) will be at least 200 open heart surgical procedures per machine during the third year following completion of the project;

(2)           that the projected annual utilization of its existing, approved, and proposed heart-lung bypass machines (other than a machine acquired pursuant to 10A NCAC 14C .1703(b)(3)), will be at least 900 hours per year during the third year following completion of the project, as measured in minutes used or staffed on standby for all procedures; or

(3)           that the proposed machine is needed to provide coverage for open-heart surgery emergencies and will not be scheduled for use at the same time as the applicant's equipment used to support scheduled open heart surgical 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.

 

10A NCAC 14C .1704      Support Services

10A NCAC 14C .1705      STAFFING AND STAFF TRAINING

 

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 1, 2013; January 4, 1994;

Repealed Eff. February 1, 2016.

 

SECTION .1800 - CRITERIA AND STANDARDS FOR DIAGNOSTIC CENTERS

 

10A NCAC 14C .1801      PURPOSE AND SCOPE

 

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

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

Eff. January 4, 1994;

Repealed Eff. March 16, 2017.

 

10A NCAC 14C .1802      DEFINITIONS

 

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

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

Eff. January 4, 1994;

Amended Eff. November 1, 1996;

Repealed Eff. December 1, 2016.

 

10A NCAC 14C .1803      INFORMATION REQUIRED OF APPLICANT

 

History Note:        Authority G.S. 131E-177(1); 131E-183;

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

Eff. January 4, 1994;

Amended Eff. November 1, 1996;

Repealed Eff. February 1, 2016.

 

10A NCAC 14C .1804      PERFORMANCE STANDARDS

 

History Note:        Authority G.S. 131E-177(1); 131E-183;

Eff. November 1, 1996;

Repealed Eff. March 16, 2017.

 

10A NCAC 14C .1805      Support Services

10A NCAC 14C .1806      STAFFING AND STAFF TRAINING

 

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

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

Eff. January 4, 1994;

Repealed Eff. February 1, 2016.

 

section .1900 – criteria and standards for radiation therapy equipment

 

10A ncac 14C .1901      DEFINITIONS

These definitions shall apply to all rules in this Section:

(1)           "Approved linear accelerator" means a linear accelerator which was not operational prior to the beginning of the review period.

(2)           "Complex Radiation treatment" is equal to 1.0 ESTV and means: treatment on three or more sites on the body; use of techniques such as tangential fields with wedges, rotational or arc techniques; or use of custom blocking.

(3)           "Equivalent Simple Treatment Visit [ESTV]" means one basic unit of radiation therapy which normally requires up to fifteen (15) minutes for the uncomplicated set-up and treatment of a patient on a megavoltage teletherapy unit including the time necessary for portal filming.

(4)           "Existing linear accelerator" means a linear accelerator in operation prior to the beginning of the review period.

(5)           "Intermediate Radiation treatment" means treatment on two separate sites on the body, three or more fields to a single treatment site or use of multiple blocking and is equal to 1.0 ESTV.

(6)           "Linear accelerator" shall have the same meaning as defined in G.S. 131E‑176(14g).

(7)           "Linear accelerator service area" means a single or multi-county area as used in the development of the need determination in the applicable State Medical Facilities Plan.

(8)           "Megavoltage unit" means MRT equipment which provides a form of teletherapy that involves the delivery of energy greater than, or equivalent to, one million volts by the emission of x-rays, gamma rays, electrons, or other radiation.

(9)           "Megavoltage radiation therapy (MRT)" means the use of ionizing radiation in excess of one million electron volts in the treatment of cancer.

(10)         "MRT equipment" means a machine or energy source used to provide megavoltage radiation therapy including linear accelerators and other particle accelerators.

(11)         "Radiation therapy equipment" means medical equipment which is used to provide radiation therapy services.

(12)         "Radiation therapy services" means those services which involve the delivery of controlled and monitored doses of radiation to a defined volume of tumor bearing tissue within a patient. Radiation may be delivered to the tumor region by the use of radioactive implants or by beams of ionizing radiation or it may be delivered to the tumor region systemically.

(13)         "Radiation therapy service area" means a single or multi-county area as used in the development of the need determination in the applicable State Medical Facilities Plan.

(14)         "Simple Radiation treatment" means treatment on a single site on the body, single treatment field or parallel opposed fields with no more than simple blocks and is equal to 1 ESTV.

(15)         "Simulator" shall have the same meaning as defined in G.S. 131E‑176(24b).

(16)         "Special technique" means radiation therapy treatments that may require increased time for each patient visit including:

(a)           total body irradiation (photons or electrons) which equals 2.5 ESTVs;

(b)           hemi-body irradiation which equals 2.0 ESTVs;

(c)           intraoperative radiation therapy which equals 10.0 ESTVs;

(d)           neutron and proton radiation therapy which equals 2.0 ESTVs;

(e)           intensity modulated radiation treatment (IMRT) which equals  1.0 ESTV;

(f)            limb salvage irradiation at lengthened SSD which equals 1.0 ESTV;

(g)           additional field check radiographs which equals .50 ESTV;

(h)           stereotactic radiosurgery treatment management with linear accelerator or gamma knife which equals 3.0. ESTVs; and

(i)            pediatric patient under anesthesia which equals  1.5 ESTVs.

 

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

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

Eff. January 4, 1994;

Amended Eff. November 1, 1996;

Temporary Amendment January 1, 1999;

Temporary Amendment Eff. January 1, 1999 expired October 12, 1999;

Temporary Amendment Eff. January 1, 2000;

Temporary Amendment effective January 1, 2000 amends and replaces a permanent rulemaking originally proposed to be effective August 2000;

Amended Eff. April 1, 2001;

Temporary Amendment Eff. January 1, 2002;

Amended Eff. April 1, 2003;

Temporary Amendment Eff. January 1, 2005;

Amended Eff. November 1, 2005;

Temporary Amendment Eff. February 1, 2006;

Amended Eff. November 1, 2006.

 

10A NCAC 14C .1902      INFORMATION REQUIRED OF APPLICANT

 

History Note:        Authority G.S. 131E-177; 131E-183; NC 2009 State Medical Facilities Plan, Chapter 9: Radiation Therapy Services – Linear Accelerator;

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

Eff. January 4, 1994;

Amended Eff. November 1, 1996;

Temporary Amendment Eff. January 1, 1999;

Temporary Amendment Eff. January 1, 1999 Expired on October 12, 1999;

Temporary Amendment Eff. January 1, 2000;

Temporary Amendment effective January 1, 2000 amends and replaces a permanent rulemaking originally proposed to be effective August 2000;

Amended Eff. April 1, 2001;

Temporary Amendment Eff. January 1, 2005;

Amended Eff. November 1, 2005;

Temporary Amendment Eff. February 1, 2009;

Amended Eff. November 1, 2009;

Temporary Amendment Eff. February 1, 2010;

Amended Eff. November 1, 2010;

Repealed Eff. February 1, 2016.

 

10A NCAC 14C .1903      PERFORMANCE STANDARDS

(a)  An applicant proposing to acquire a linear accelerator shall demonstrate that each of the following standards will be met:

(1)           an applicant's existing linear accelerators located in the proposed radiation therapy service area performed at least 6,750 ESTV treatments per machine or served at least 250 patients per machine in the twelve months prior to the date the application was submitted;

(2)           each proposed new linear accelerator will be utilized at an annual rate of 250 patients or 6,750 ESTV treatments during the third year of operation of the new equipment; and

(3)           an applicant's existing linear accelerators located in the proposed radiation therapy service area are projected to be utilized at an annual rate of 6,750 ESTV treatments or 250 patients per machine during the third year of operation of the new equipment.

(b)  A linear accelerator shall not be held to the standards in Paragraph (a) of this Rule if the applicant provides documentation that the linear accelerator has been or will be used exclusively for clinical research and teaching.

(c)  An applicant proposing to acquire radiation therapy equipment other than a linear accelerator shall provide the following information:

(1)           the number of patients who are projected to receive treatment from the proposed radiation therapy equipment, classified by type of equipment, diagnosis, treatment procedure, and county of residence; and

(2)           the maximum number and type of procedures that the proposed equipment is capable of performing.

(d)  The applicant shall document all assumptions and provide data supporting the methodology used to determine projected utilization as required in this Rule.

 

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

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

Eff. January 4, 1994;

Amended Eff. November 1, 1996

Temporary Amendment Eff. January 1, 1999;

Temporary Amendment effective January 1, 1999 expired October 12, 1999;

Temporary Amended Eff. January 1, 2000;

Temporary Amendment Eff. February 1, 2006;

Amended Eff. November 1, 2006.

Temporary Amendment effective January 1, 2000 amends and replaces a permanent rulemaking originally proposed to be effective August 2000;

Amended Eff. April 1, 2001;

Temporary Amendment Eff. March 15, 2002; January 1, 2002; Amended Eff. April 1, 2003;

Temporary Amendment Eff. February 1, 2008;

Amended Eff. November 1, 2008;

Temporary Amendment Eff. February 1, 2009;

Amended Eff. November 1, 2009.

 

10A NCAC 14C .1904      Support Services

10A NCAC 14C .1905      STAFFING AND STAFF TRAINING

 

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

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

Eff. January 4, 1994;

Amended Eff. November 1, 1996;

Temporary Amendment Eff. February 1, 2009;

Amended Eff. November 1, 2009;

Repealed Eff. February 1, 2016.

 

section .2000 – criteria and standards for home health services

 

10A NCAC 14C .2001      DEFINITIONS

The following definitions in this Rule shall apply to all rules in this Section:

(1)           "Home Health Agency" shall have the same meaning as defined in G.S. 131E‑176(12).

(2)           "Home Health Services" shall have the same meaning as defined in G.S. 131E‑176(12).

 

History Note:        Authority G.S. 131E‑177(1); 131E‑183(b);

Eff. September 1, 1980;

Amended Eff. March 1, 1996; July 1, 1995; July 1, 1991; February 1, 1985; May 1, 1983.

 

10A NCAC 14C .2002      INFORMATION REQUIRED OF APPLICANT

 

History Note:        Authority G.S. 131E-177(1); 131E-183;

Eff. March 1, 1996;

Temporary Amendment Eff. February 1, 2009;

Amended Eff. November 1, 2009;

Repealed Eff. February 1, 2016.

 

10A ncac 14C .2003      PERFORMANCE STANDARDS

An applicant shall project, in the third year of operation, an annual unduplicated patient caseload for the county in which the facility will be located that meets or exceeds the minimum need used in the applicable State Medical Facilities Plan to justify the establishment of a new home health agency office in that county.  An applicant shall not be required to meet this performance standard if the home health agency office need determination in the applicable State Medical Facilities Plan was not based on application of the standard methodology for a Medicare-certified home health agency office.

 

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

Eff. March 1, 1996;

Temporary Amendment Eff. January 1, 2002;

Amended Eff. April 1, 2003.

 

10A NCAC 14C .2004      reserved for future codification

 

10A NCAC 14C .2005      STAFFING AND STAFF TRAINING

 

History Note:        Authority G.S. 131E‑177(1); 131E-183;

Eff. March 1, 1996;

Repealed Eff. February 1, 2016.

 

section .2100 – criteria and standards for surgical services and operating rooms

 

10A ncac 14C .2101      DEFINITIONS

The following definitions apply to all rules in this Section:

(1)           "Approved operating rooms" means those operating rooms that were approved for a certificate of need by the Healthcare Planning and Certificate of Need Section (Agency) prior to the date on which the applicant's proposed project was submitted to the Agency, but that have not been licensed.

(2)           "Dedicated C-section operating room" means an operating room as defined in Chapter 6 in the 2018 State Medical Facilities Plan. For purposes of this Section, Chapter 6 in the 2018 State Medical Facilities Plan is hereby incorporated by reference including subsequent amendments and editions. This document is available at no cost at https://www.ncdhhs.gov/dhsr/ncsmfp/index.html.

(3)           "Existing operating rooms" means those operating rooms in ambulatory surgical facilities and hospitals that were reported in the Ambulatory Surgical Facility License Renewal Application Form or in the Hospital License Renewal Application Form submitted to the Acute and Home Care Licensure and Certification Section of the Division of Health Service Regulation, and that were licensed prior to the beginning of the review period.

(4)           "Health System" shall have the same meaning as defined in Chapter 6 in the 2018 State Medical Facilities Plan.

(5)           "Operating room" means a room as defined in G.S. 131E-176(18c).

(6)           "Operating Room Need Methodology" means the Methodology for Projecting Operating Room Need in Chapter 6 in the 2018 State Medical Facilities Plan.

(7)           "Service area" means the Operating Room Service Area as defined in Chapter 6 in the 2018 State Medical Facilities Plan.

 

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

Eff. November 1, 1990;

Amended Eff. March 1, 1993;

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 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 and replaces a permanent rulemaking originally proposed to be effective August 2000;

Amended Eff. April 1, 2001;

Temporary Amendment Eff. January 1, 2002; July 1, 2001;

Amended Eff. August 1, 2002;

Temporary Amendment effective January 1, 2002 amends and replaces the permanent rule effective August 1, 2002;

Amended Eff. April 1, 2003;

Temporary Amendment Eff. January 1, 2005;

Amended Eff. November 1, 2005;

Temporary Rule Eff. February 1, 2006;

Amended Eff. November 1, 2006;

Temporary Amendment Eff. February 1, 2008;

Amended Eff. November 1, 2008.

Temporary Amendment Eff. February 1, 2018;

Amended Eff. December 1, 2018.

 

10A NCAC 14C .2102      INFORMATION REQUIRED OF APPLICANT

 

History Note:        Authority G.S. 131E-177; 131E-183(b);

Eff. November 1, 1990;

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 Eff. July 1, 2001;

Temporary Amendment Eff. January 1, 2002;

Amended Eff. August 1, 2002;

Temporary Amendment effective January 1, 2002 amends and replaces the permanent rule effective August 1, 2002;

Amended Eff. April 1, 2003;

Temporary Amendment Eff. February 1, 2008;

Amended Eff. November 1, 2008;

Temporary Amendment Eff. February 1, 2010;

Amended Eff. November 1, 2010;

Repealed Eff. February 1, 2016.

 

10A ncac 14C .2103      performance standards

(a)  An applicant proposing to increase the number of operating rooms (excluding dedicated C-section operating rooms) in a service area shall demonstrate the need for the number of proposed operating rooms in addition to the existing and approved operating rooms in the applicant's health system in the applicant's third full fiscal year following completion of the proposed project based on the Operating Room Need Methodology set forth in the 2018 State Medical Facilities Plan. The applicant is not required to use the population growth factor.

(b)  The applicant shall document the assumptions and provide data supporting the methodology used for each projection in this Rule.

 

History Note:        Authority G.S. 131E-177; 131E-183(b);

Eff. November 1, 1990;

Amended Eff. March 1, 1993;

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 Eff. January 1, 2002; July 1, 2001;

Amended Eff. August 1, 2002;

Temporary Amendment effective January 1, 2002 amends and replaces the permanent rule effective August 1, 2002;

Amended Eff. April 1, 2003;

Temporary Amendment Eff. January 1, 2005;

Amended Eff. November 1, 2005;

Temporary Rule Eff. February 1, 2006;

Amended Eff. November 1, 2006;

Temporary Amendment Eff. February 1, 2008;

Amended Eff. November 1, 2008;

Temporary Amendment Eff. February 1, 2009;

Amended Eff. November 1, 2009;

Temporary Amendment Eff. February 1, 2010;

Amended Eff. November 1, 2010;

Temporary Amendment Eff. February 1, 2018;

Amended Eff. December 1, 2018.

 

10A NCAC 14C .2104      Support Services

10A NCAC 14C .2105      STAFFING AND STAFF TRAINING

10A ncac 14C .2106      FACILITY

 

History Note:        Authority G.S. 131E-177; 131E-183(b);

Eff. November 1, 1990;

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 Eff. July 1, 2001;

Temporary Amendment Eff. January 1, 2002;

Amended Eff. August 1, 2002;

Temporary Amendment effective January 1, 2002 amends and replaces the permanent rule effective August 1, 2002;

Amended Eff. April 1, 2003;

Temporary Amendment Eff. February 1, 2008;

Amended Eff. November 1, 2008;

Temporary Amendment Eff. February 1, 2010;

Amended Eff. November 1, 2010;

Repealed Eff. February 1, 2016.

 

section .2200 – criteria and standards for end-stage renal disease services

 

10A NCAC 14C .2201      DEFINITIONS

The definitions in this Rule will apply to all rules in this Section:

(1)           "End stage renal disease (ESRD) services" means those dialysis or transplantation services necessary for the treatment of patients with end stage renal disease provided by transplantation centers, dialysis centers or dialysis facilities.

(2)           "Renal transplantation center" means a hospital unit which furnishes directly rental transplantation and other medical and surgical specialty services required for transplant candidates or patients.

(3)           "Renal dialysis center" is a hospital unit which furnishes the full spectrum of diagnostic, therapeutic, and rehabilitative services.

(4)           "Renal dialysis facility" is a unit, usually freestanding, which furnishes dialysis service to ESRD patients.

(5)           "Dialysis" means the artificially aided process of transferring body wastes from a person's blood to a dialysis fluid to permit discharge of the wastes from the body.

(6)           "Hemodialysis" means the form of dialysis in which the blood is circulated outside the body through an apparatus which permits transfer of waste through synthetic membranes.

(7)           "Peritoneal dialysis" means the form of dialysis in which a dialysis fluid is introduced into the person's peritoneal cavity and is subsequently withdrawn.

(8)           "Maintenance dialysis" is the term used to describe routine repetitive dialysis treatments necessary to sustain life of patients with ESRD.

(9)           "Self‑care dialysis or home dialysis training" means the systematic training of patients and their helpers in the techniques of self‑care dialysis.

(10)         "Self‑care dialysis" means the self administration of maintenance dialysis treatments in ESRD facility or elsewhere and may be assisted by an aide who is either a family member or a non‑family member assistant.

(11)         "Dialysis station" means a unit in an ESRD facility equipped with the apparatus for performing hemodialysis or peritoneal dialysis on a single patient.  Stations may designated for maintenance dialysis, self‑care dialysis, self‑care training, or isolation.

(12)         "Isolation station" means a dialysis station located apart from other maintenance dialysis stations to serve patients who either have or are suspected to have an infectious disease, i.e., hepatitis.

(13)         "Shift" means the scheduled time when a group of patients are provided their dialysis treatment.

(14)         "Transplantation" means a surgical procedure in which a functioning kidney is removed from a donor and implanted in the patient with ESRD.

(15)         "Organ procurement" means the process of acquiring kidneys for transplantation from potential donors.

(16)         "Histocompatability testing" means laboratory testing procedures which determine compatability between a potential donor organ and a potential organ transplant recipient.

 

History Note:        Authority G.S. 131E‑177(1); 131E-183(b);

Eff. September 1, 1980;

Amended Eff. November 1, 1989; November 1, 1983.

 

10A NCAC 14C .2202      INFORMATION REQUIRED Of APPLICANT

 

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

Eff. March 1, 1989;

Temporary Amendment Eff. January 1, 2003;

Amended Eff. August 1, 2004;

Temporary Amendment Eff. January 1, 2005;

Amended Eff. November 1, 2005;

Temporary Amendment Eff. February 1, 2010;

Amended Eff. November 1, 2010;

Repealed Eff. February 1, 2016.

 

10A ncac 14C .2203      PERFORMANCE STANDARDS

(a)  An applicant proposing to establish a new End Stage Renal Disease facility shall document the need for at least 10 stations based on utilization of 3.2 patients per station per week as of the end of the first operating year of the facility, with the exception that the performance standard shall be waived for a need in the State Medical Facilities Plan that is based on an adjusted need determination.

(b)  An applicant proposing to increase the number of dialysis stations in an existing End Stage Renal Disease facility or one that was not operational prior to the beginning of the review period but which had been issued a certificate of need shall document the need for the additional stations based on utilization of 3.2 patients per station per week as of the end of the first operating year of the additional stations.

(c)  An applicant shall provide all assumptions, including the methodology by which patient utilization is projected.

 

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

Temporary Adoption Eff. January 1, 2003; January 1, 2002;

Eff. April 1, 2003;

Amended Eff. August 1, 2004;

Temporary Amendment Eff. January 1, 2005;

Amended Eff. November 1, 2005;

Temporary Amendment Eff. February 1, 2006;

Amended Eff. November 1, 2006;

Temporary Amendment Eff. February 1, 2010;

Amended Eff. November 1, 2010.

 

10A NCAC 14C .2204      Scope of Services

10A NCAC 14C .2205      STAFFING AND STAFF TRAINING

 

History Note:        Authority G.S. 131E‑177(1); 131E-183(b);

Eff. March 1, 1989;

Repealed Eff. February 1, 2016.

 

section .2300 – criteria and standards for computed tomography equipment

 

10A NCAC 14C .2301      DEFINITIONS

The following definitions shall apply to all rules in this Section:

(1)           "Approved computed tomography (CT) scanner" means a CT scanner which was not operational prior to the beginning of the review period but which had been issued a certificate of need.

(2)           "Computed tomography" means a technique whereby a sharply collimated X‑ray beam is passed through the human body from a source which rotates around the body in a specific arc.  As the beam passes through the body from its perimeter, its intensity is reduced.  The transmitted intensity of the beam varies in accordance with the density of the tissue it passes through and is measured by sensitive detectors and, from this information, two‑dimensional cross‑sectional pictures or other images may be generated.  A computer is used to generate the image from the measurements of X‑ray beam intensity.  Tissue images can be done with or without contrast agents.  Computed tomography services are rendered by CT scanners.

(3)           "Computed tomography (CT) scanner" means an imaging machine which combines the information generated by a scanning X‑ray source and detector system with a computer to reconstruct a cross‑sectional image of the full body, including the head.

(4)           "Computed tomography (CT) service area" means a geographical area defined by the applicant from which the applicant projects to serve patients.

(5)           "CT scan" means one discrete image of a patient produced by a CT scanner.

(6)           "Existing CT scanner" means a computed tomography scanner in operation prior to the beginning of the review period.

(7)           "Fixed CT scanner" means a CT scanner that is used at only one location or campus.

(8)           "HECT unit" means a unit that is equivalent to one CT scan which is derived by applying a weighted conversion factor to a CT scan in accordance with the Head Equivalent Computed Tomography studies formula developed by the National Electric Manufacturers, based on the "Leonard Methodology".

(9)           "Mobile CT scanner" means a CT scanner and transporting equipment which is moved to provide services at two or more host facilities.

(10)         "Related entity" means the parent company of the applicant, a subsidiary company of the applicant (i.e., the applicant owns 50 percent or more of another company), a joint venture in which the applicant is a member, or a company that shares common ownership with the applicant (i.e., the applicant and another company are owned by some of the same persons).

 

History Note:        Authority G.S. 131E‑177(1); 131E‑183(b);

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

Eff. February 1, 1994;

Amended Eff. February 1, 2008.

 

10A NCAC 14C .2302      INFORMATION REQUIRED OF APPLICANT

 

History Note:        Authority G.S. 131E‑177(1); 131E‑183(b);

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

Eff. February 1, 1994;

Amended Eff. February 1, 2008;

Repealed Eff. February 1, 2016.

 

10A NCAC 14C .2303      PERFORMANCE STANDARDS

An applicant proposing to acquire a CT scanner shall demonstrate each of the following:

(1)           each fixed or mobile CT scanner to be acquired shall be projected to perform 5,100 HECT units annually in the third year of operation of the proposed equipment;

(2)           each existing fixed or mobile CT scanner which the applicant or a related entity owns a controlling interest in and is located in the applicant's CT service area shall have performed at least 5,100 HECT units in the 12 month period prior to submittal of the application; and

(3)           each existing and approved fixed or mobile CT scanner which the applicant or a related entity owns a controlling interest in and is located in the applicant's CT service area shall be projected to perform 5,100 HECT units annually in the third year of operation of the proposed equipment.

 

History Note:        Authority G.S. 131E‑177(1); 131E‑183(b);

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

Eff. February 1, 1994;

Amended Eff. February 1, 2008.

 

10A NCAC 14C .2304      Support Services

10A NCAC 14C .2305      STAFFING AND STAFF TRAINING

 

History Note:        Authority G.S. 131E‑177(1); 131E‑183(b);

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

Eff. February 1, 1994;

Amended Eff. February 1, 2008;

Repealed Eff. February 1, 2016.

 

section .2400 – criteria and standards for intermediate care facility/mentally retarded (ICf/mr)

 

10A NCAC 14C .2401      DEFINITIONS

The definitions in this Rule shall apply to all rules in this Section:

(1)           "Intermediate care facility for the mentally retarded (ICF/MR)" shall have the same meaning as defined in G.S. 131E-176(14a).

(2)           "Active treatment" means:

(a)           regular participation in professionally developed and supervised activities, experiences, or therapies in accordance with an individual plan of care;

(b)           an individual plan of care which is a written plan that is based on individual choice and sets forth measurable goals or behaviorally stated objectives and prescribes an integrated program of individually designed activities, experiences or therapies necessary to achieve such goals or objectives;

(c)           an interdisciplinary professional evaluation consisting of complete medical, social, or psychological diagnosis and an evaluation of the individual's need for the facility's care, prior to admission but not to exceed three months before admission to the facility or, in the case of individuals who make application while in such facility, before requesting payment under the plan;

(d)           re‑evaluation medically, socially, and psychologically, at least annually by the staff involved in carrying out the resident's individual plan of care, including review of the individual's progress toward meeting the plan of care, assessment of continuing need for facility care, and consideration of alternate methods of care; and

(e)           an individual plan (as part of the individual's total plan of care) developed prior to discharge that is based on individual choice by a qualified developmental disabilities professional and other appropriate professionals, which includes the present residence, specifying the type of care and services that will be needed to enable the individual to function in a different environment and also includes provisions for protective supervision.

(3)           "Qualified Developmental Disabilities Professional" means a staff person in an ICF/MR facility designated to be responsible for supervising the implementation of each resident's individual plan of care, integrating the various aspects of the facility's program, recording each resident's progress and initiating periodic review of each individual plan of care. A Qualified Developmental Disabilities Professional shall meet the minimum qualifications for employment as defined in the 42 CFR 483.430 which is incorporated by reference including all subsequent amendments.

(4)           "Catchment area" means the geographic part of the State served by a specific area authority ("Area authority" means the Mental Health, Developmental Disabilities, and Substance Abuse Authority.)

 

History Note:        Authority G.S. 131E‑177(1), (5); 131E-183;

Eff. December 1, 1981;

Amended Eff. November 1, 1996; September 1, 1989.

 

10A NCAC 14C .2402      INFORMATION REQUIRED OF APPLICANT

 

History Note:        Authority G.S. 131E‑177(1), (5); 131E-183;

Eff. December 1, 1996;

Repealed Eff. February 1, 2016.

 

10A NCAC 14C .2403      PERFORMANCE STANDARDS

(a)  An applicant proposing to add ICF/MR beds to an existing facility shall not be approved unless the average occupancy, over the six months immediately preceding the submittal of the application, of the total number of ICF/MR beds within the facility in which the new beds are to be operated was at least 90 percent.

(b)  An applicant proposing to establish new ICF/MR beds shall not be approved unless occupancy is projected to be at least 90 percent for the total number of ICF/MR beds proposed to be operated in the entire facility, no later than one year following the completion of the proposed project.

(c)  An applicant proposing to establish new ICF/MR beds shall comply with one of the following models:

(1)           a residential community based freestanding facility with six beds or less, i.e., group home model;

(2)           a community‑based facility with 7 to 15 beds if documentation is provided that a facility of this size is necessary because adequate residential community based freestanding facilities are not available in the Area Authority catchment area to meet the needs of the population to be served; or

(3)           a facility with greater than 15 beds if the proposed new beds are to be established in response to an adjusted need determination contained in the 2003 State Medical Facilities Plan.

(d)  No more than three intermediate care facilities for the mentally retarded housing a combined total of 18 persons shall be developed on contiguous pieces of property, with the exception that this standard shall be waived for beds proposed to be established in response to an adjusted need determination contained in the 2003 State Medical Facilities Plan.

 

History Note:        Authority G.S. 131E-177(1), (5); 131E-183;

Eff. November 1, 1996;

Temporary Amendment Eff. January 1, 2003;

Amended Eff. August 1, 2004.

 

10A NCAC 14C .2404      reserved for future codification

 

10A NCAC 14C .2405      STAFFING AND STAFF TRAINING

 

History Note:        Authority G.S. 131E‑177(1), (5); 131E-183;

Eff. December 1, 1996;

Repealed Eff. February 1, 2016.

 

section .2500 – criteria and standards for substance abuse/chemical dependency treatment beds

 

10A ncac 14C .2501      DEFINITIONS

The following definitions shall apply to all rules in this Section:

(1)           "Chemical dependency treatment beds" shall have the same meaning as defined in G.S. 131E-176(5b).

(2)           "Detoxification beds" means chemical dependency treatment beds that are used during the period of time when the patient is withdrawing from psycho-active substances under medical direction.

(3)           "Intensive treatment beds" means chemical dependency treatment beds that are not detoxification beds.

(4)           "Clinical staff members" means the employees of a chemical dependency treatment program who provide treatment or rehabilitation services to a patient.

(5)           "Aftercare plan" means a component of a treatment plan which provides continued contact with the patient after completion of the structured treatment process in order to maintain or improve on the patient's recovery progress.

 

History Note:        Authority G.S. 131E‑177(1); 131E-183;

Eff. March 1, 1983;

Amended Eff. November 1, 1996; October 1, 1984.

Temporary Amendment Eff. January 1, 2001;

Amended Eff. August 1, 2002.

 

10A NCAC 14C .2502      INFORMATION REQUIRED OF APPLICANT

 

History Note:        Authority G.S. 131E‑177(1); 131E-183;

Eff. December 1, 1996;

Temporary Amendment Eff. February 1, 2006;

Amended Eff. November 1, 2006;

Repealed Eff. February 1, 2016.

 

10A NCAC 14C .2503      PERFORMANCE STANDARDS

(a)  An applicant proposing additional intensive treatment beds shall not be approved unless the overall occupancy, over the nine months immediately preceding the submittal of the application, of the total number of intensive treatment beds within the facility in which the beds are to be located has been:

(1)           75 percent for facilities with a total of 1 through 15 intensive treatment beds; or

(2)           85 percent for facilities with a total of 16 or more intensive treatment beds.

(b)  An applicant shall not be approved unless the overall occupancy of the total number of intensive treatment beds to be operated in the facility is projected by the fourth quarter of the third year of operation following completion of the project, to be:

(1)           75 percent for facilities with a total of 1 through 15 intensive treatment beds; or

(2)           85 percent for facilities with a total of 16 or more intensive treatment beds.

(c)  The applicant shall document the specific methodology and assumptions by which occupancies are projected, including the average length of stay and anticipated recidivism rate.

 

History Note:        Authority G.S. 131E‑177(1); 131E-183(b);

Eff. November 1, 1996;

Temporary Amendment Eff. January 1, 2002;

Amended Eff. April 1, 2003;

Temporary Amendment Eff. February 1, 2006;

Amended Eff. January 1, 2007.

 

10A NCAC 14C .2504      reserved for future codification

 

10A NCAC 14C .2505      STAFFING AND STAFF TRAINING

 

History Note:        Authority G.S. 131E‑177(1); 131E-183;

Eff. December 1, 1996;

Temporary Amendment Eff. February 1, 2006;

Amended Eff. November 1, 2006;

Repealed Eff. February 1, 2016.

 

section .2600 – criteria and standards for psychiatric beds

 

10A NCAC 14C .2601      DEFINITIONS

The definitions in this Rule apply to all rules in this Section:

(1)           "Psychiatric Beds" means beds in:

(a)           psychiatric units of general hospitals licensed under G.S. Chapter 131E-77, Article 5;

(b)           free-standing psychiatric hospitals licensed under G.S. Chapter 122C-23, Article 2.

(2)           "Involuntary Admissions" means those persons admitted under the involuntary commitment procedure defined in G.S. Chapter 122, Article 5, Part 7.

(3)           "Service Area" means the counties in the Mental Health Planning Area, as defined in the applicable State Medical Facilities Plan.

(4)           "Professional Staff" means any employee who provides treatment or habilitation services to a patient receiving psychiatric treatment in a general hospital, psychiatric hospital or inpatient unit of a community mental health center.  This includes, but is not necessarily limited to, physicians licensed to practice medicine in North Carolina, psychiatric nurses, practicing psychologists or psychiatric social workers.

 

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

Eff. May 1, 1983;

Amended Eff. August 1, 2009; November 1, 1989.

 

10A NCAC 14C .2602      INFORMATION REQUIRED OF APPLICANT

 

History Note:        Authority G.S. 131E-177(1); 131E-183;

Eff. December 1, 1996;

Temporary Amendment Eff. February 1, 2006;

Amended Eff. August 1, 2009; November 1, 2006;

Repealed Eff. February 1, 2016.

 

10A NCAC 14C .2603      PERFORMANCE STANDARDS

(a)  An applicant proposing to add psychiatric beds in an existing facility shall not be approved unless the average occupancy over the six months immediately preceding the submittal of the application of the total number of licensed psychiatric beds within the facility in which the beds are to be operated was at least 75 percent.

(b)  An applicant proposing to establish new psychiatric beds shall not be approved unless occupancy is projected to be 75% for the total number of licensed psychiatric beds proposed to be operated in the facility no later than the fourth quarter of the second operating year following completion of the project.

 

History Note:        Authority G.S. 131E‑177(1); 131E-183;

Eff. November 1, 1996.

 

10A NCAC 14C .2604      reserved for future codification

 

10A NCAC 14C .2605      STAFFING AND STAFF TRAINING

 

History Note:        Authority G.S. 131E‑177(1); 131E-183(b);

Eff. May 1, 1983;

Amended Eff. November 1, 1989;

Repealed Eff. February 1, 2016.

 

SECTION .2700 - CRITERIA AND STANDARDS FOR MAGNETIC RESONANCE IMAGING SCANNER

 

10A NCAC 14C .2701      DEFINITIONS

The following definitions apply to all rules in this Section:

(1)           "Approved MRI scanner" means an MRI scanner which was not operational prior to the beginning of the review period but which had been issued a certificate of need.

(2)           "Capacity of fixed MRI scanner" means 100 percent of the procedure volume that the MRI scanner is capable of completing in a year, given perfect scheduling, no machine or room downtime, no cancellations, no patient transportation problems, no staffing or physician delays and no MRI procedures outside the norm. Annual capacity of a fixed MRI scanner is 6,864 weighted MRI procedures, which assumes two weighted MRI procedures are performed per hour and the scanner is operated 66 hours per week, 52 weeks per year.

(3)           "Capacity of mobile MRI scanner" means 100 percent of the procedure volume that the MRI scanner is capable of completing in a year, given perfect scheduling, no machine or room downtime, no cancellations, no patient transportation problems, no staffing or physician delays and no MRI procedures outside the norm. Annual capacity of a mobile MRI scanner is 4,160 weighted MRI procedures, which assumes two weighted MRI procedures are performed per hour and the scanner is operated 40 hours per week, 52 weeks per year.

(4)           "Dedicated breast MRI scanner" means an MRI scanner that is configured to perform only breast MRI procedures and is not capable of performing other types of non-breast MRI procedures.

(5)           "Existing MRI scanner" means an MRI scanner in operation prior to the beginning of the review period.

(6)           "Extremity MRI scanner" means an MRI scanner that is utilized for the imaging of extremities and is of open design with a field of view no greater than 25 centimeters.

(7)           "Fixed MRI scanner" means an MRI scanner that is not a mobile MRI scanner.

(8)           "Magnetic Resonance Imaging" (MRI) means a non-invasive diagnostic modality in which electronic equipment is used to create tomographic images of body structure.  The MRI scanner exposes the target area to nonionizing magnetic energy and radio frequency fields, focusing on the nuclei of atoms such as hydrogen in the body tissue.  Response of selected nuclei to this stimulus is translated into images for evaluation by the physician.

(9)           "Magnetic resonance imaging scanner" (MRI Scanner) is defined in G.S. 131E-176(14m).

(10)         "Mobile MRI region" means either the eastern part of the State which includes the counties in Health Service Areas IV, V and VI (Eastern Mobile MRI Region), or the western part of the State which includes the counties in Health Service Areas I, II, and III (Western Mobile MRI Region).  The counties in each Health Service Area are identified in Appendix A of the State Medical Facilities Plan.

(11)         "Mobile MRI scanner" means an MRI scanner and transporting equipment which is moved at least weekly to provide services at two or more campuses or physical locations.

(12)         "MRI procedure" means a single discrete MRI study of one patient.

(13)         "MRI service area" means the Magnetic Resonance Imaging Planning Areas, as defined in the applicable State Medical Facilities Plan, except for proposed new mobile MRI scanners for which the service area is a mobile MRI region.

(14)         "MRI study" means one or more scans relative to a single diagnosis or symptom.

(15)         "Multi-position MRI scanner" means an MRI scanner as defined in the State Medical Facilities Plan, pursuant to a special need determination for a demonstration project.

(16)         "Related entity" means the parent company of the applicant, a subsidiary company of the applicant (i.e., the applicant owns 50 percent or more of another company), a joint venture in which the applicant is a member, or a company that shares common ownership with the applicant (i.e., the applicant and another company are owned by some of the same persons).

(17)         "Temporary MRI scanner" means an MRI scanner that the Certificate of Need Section has approved to be temporarily located in North Carolina at a facility that holds a certificate of need for a new fixed MRI scanner, but which is not operational because the project is not yet complete.

(18)         "Weighted MRI procedures" means MRI procedures which are adjusted to account for the length of time to complete the procedure, based on the following weights: one outpatient MRI procedure without contrast or sedation is valued at 1.0 weighted MRI procedure, one outpatient MRI procedure with contrast or sedation is valued at 1.4 weighted MRI procedures, one inpatient MRI procedure without contrast or sedation is valued at 1.4 weighted MRI procedures; and one inpatient MRI procedure with contrast or sedation is valued at 1.8 weighted MRI procedures.

(19)         "Weighted breast MRI procedures" means MRI procedures which are performed on a dedicated breast MRI scanner and are adjusted to account for the length of time to complete the procedure, based on the following weights: one diagnostic breast MRI procedure is valued at 1.0 weighted MRI procedure (based on an average of 60 minutes per procedure), one MRI-guided breast needle localization MRI procedure is valued at 1.1 weighted MRI procedure (based on an average of 66 minutes per procedure), and one MRI-guided breast biopsy procedure is valued at 1.6 weighted MRI procedures (based on an average of 96 minutes per procedure).

 

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

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

Eff. February 1, 1994;

Temporary Amendment Eff. January 1, 1999;

Temporary Amendment Eff. January 1, 1999 Expired on October 12, 1999;

Temporary Amendment Eff. January 1, 2000;

Temporary Amendment effective January 1, 2000 amends and replaces a permanent rulemaking originally proposed to be effective August 2000;

Temporary Amendment Eff. January 1, 2001;

Temporary Amendment effective January 1, 2001 amends and replaces a permanent rulemaking originally proposed to be effective April 1, 2001;

Temporary Amendment Eff. January 1, 2002;

Amended Eff. August 1, 2002;

Temporary Amendment effective January 1, 2002 amends and replaces the permanent rule effective August 1, 2002;

Temporary Amendment Eff. January 1, 2003;

Amended Eff. August 1, 2004; April 1, 2003;

Temporary Amendment Eff. January 1, 2005;

Amended Eff. November 1, 2005;

Temporary Amendment Eff. February 1, 2006;

Amended Eff. November 1, 2006;

Temporary Amendment Eff. February 1, 2008;

Amended Eff. November 1, 2008;

Temporary Amendment Eff. February 1, 2009;

Amended Eff. November 1, 2009;

Temporary Amendment Eff. February 1, 2010;

Amended Eff. November 1, 2010.

 

10A NCAC 14C .2702      INFORMATION REQUIRED OF APPLICANT

 

History Note:        Authority G.S. 131E‑177(1); 131E‑183(b);

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

Eff. February 1, 1994;

Temporary Amendment Eff. January 1, 2003; January 1, 2002;

Amended Eff. August 1, 2004; April 1, 2003;

Temporary Amendment Eff. January 1, 2005;

Amended Eff. November 1, 2005;

Temporary Amendment Eff. February 1, 2006;

Amended Eff. November 1, 2006;

Temporary Amendment Eff. February 1, 2008;

Amended Eff. November 1, 2008;

Repealed Eff. February 1, 2016.

 

10A NCAC 14C .2703      PERFORMANCE STANDARDS

(a)  An applicant proposing to acquire a mobile magnetic resonance imaging (MRI) scanner shall:

(1)           demonstrate that each existing mobile MRI scanner which the applicant or a related entity owns a controlling interest in and operates in the mobile MRI region in which the proposed equipment will be located, except temporary MRI scanners, performed 3,328 weighted MRI procedures in the most recent 12 month period for which the applicant has data [Note: This is not the average number of weighted MRI procedures performed on all of the applicant's mobile MRI scanners.]; with the exception that in the event an existing mobile MRI scanner has been in operation less than 12 months at the time the application is filed, the applicant shall demonstrate that this mobile MRI scanner performed an average of at least 277 weighted MRI procedures per month for the period in which it has been in operation;

(2)           demonstrate annual utilization in the third year of operation is reasonably projected to be at least 3328 weighted MRI procedures on each of the existing, approved and proposed mobile MRI scanners owned by the applicant or a related entity to be operated in the mobile MRI region in which the proposed equipment will be located [Note: This is not the average number of weighted MRI procedures performed on all of the applicant's mobile MRI scanners.]; and

(3)           document the assumptions and provide data supporting the methodology used for each projection required in this Rule.

(b)  An applicant proposing to acquire a fixed magnetic resonance imaging (MRI) scanner, except for fixed MRI scanners described in Paragraphs (c) and (d) of this Rule, shall:

(1)           demonstrate that the existing fixed MRI scanners which the applicant or a related entity owns a controlling interest in and locates in the proposed MRI service area performed an average of 3,328 weighted MRI procedures in the most recent 12 month period for which  the applicant has data;

(2)           demonstrate that each existing mobile MRI scanner which the applicant or a related entity owns a controlling interest in and operates in the proposed MRI service area except temporary MRI scanners, performed 3,328 weighted MRI procedures in the most recent 12 month period for which the applicant has data [Note: This is not the average number of weighted MRI procedures performed on all of the applicant's mobile MRI scanners.];

(3)           demonstrate that the average annual utilization of the existing, approved and proposed fixed MRI scanners which the applicant or a related entity owns a controlling interest in and locates in the proposed MRI service area are reasonably expected to perform the following number of weighted MRI procedures, whichever is applicable, in the third year of operation following completion of the proposed project:

(A)          1,716 weighted MRI procedures in MRI service areas in which the SMFP shows no fixed MRI scanners are located,

(B)          3,775 weighted MRI procedures in MRI service areas in which the SMFP shows one fixed MRI scanner is located,

(C)          4,118 weighted MRI procedures in MRI service areas in which the SMFP shows two fixed MRI scanners are located,

(D)          4,462 weighted MRI procedures in MRI service areas in which the SMFP shows three fixed MRI scanners are located, or

(E)           4,805 weighted MRI procedures in MRI service areas in which the SMFP shows four or more fixed MRI scanners are located;

(4)           if the proposed MRI scanner will be located at a different site from any of the existing or approved MRI scanners owned by the applicant or a related entity, demonstrate that the annual utilization of the proposed fixed MRI scanner is reasonably expected to perform the following number of weighted MRI procedures, whichever is applicable, in the third year of operation following completion of the proposed project:

(A)          1,716 weighted MRI procedures in MRI service areas in which the SMFP shows no fixed MRI scanners are located,

(B)          3,775 weighted MRI procedures in MRI service areas in which the SMFP shows one fixed MRI scanner is located,

(C)          4,118 weighted MRI procedures in MRI service areas in which the SMFP shows two fixed MRI scanners are located,

(D)          4,462 weighted MRI procedures in MRI service areas in which the SMFP shows three fixed MRI scanners are located, or

(E)           4,805 weighted MRI procedures in MRI service areas in which the SMFP shows four or more fixed MRI scanners are located;

(5)           demonstrate that annual utilization of each existing, approved and proposed mobile MRI scanner which the applicant or a related entity owns a controlling interest in and locates in the proposed MRI service area is reasonably expected to perform 3,328 weighted MRI procedures in the third year of operation following completion of the proposed project [Note: This is not the average number of weighted MRI procedures to be performed on all of the applicant's mobile MRI scanners.]; and

(6)           document the assumptions and provide data supporting the methodology used for each projection required in this Rule.

(c)  An applicant proposing to acquire a fixed dedicated breast magnetic resonance imaging (MRI) scanner for which the need determination in the State Medical Facilities Plan was based on an approved petition for an adjustment to the need determination shall:

(1)           demonstrate annual utilization of the proposed MRI scanner in the third year of operation is reasonably projected to be at least 1,664 weighted MRI procedures which is .80 times 1 procedure per hour times 40 hours per week times 52 weeks per year; and

(2)           document the assumptions and provide data supporting the methodology used for each projection required in this Rule.

(d)  An applicant proposing to acquire a fixed extremity MRI scanner for which the need determination in the State Medical Facilities Plan was based on an approved petition for an adjustment to the need determination shall:

(1)           demonstrate annual utilization of the proposed MRI scanner in the third year of operation is reasonably projected to be at least 80 percent of the capacity defined by the applicant in response to 10A NCAC 14C .2702(f)(7); and

(2)           document the assumptions and provide data supporting the methodology used for each projection required in this Rule.

(e)  An applicant proposing to acquire a fixed multi-position MRI scanner for which the need determination in the State Medical Facilities Plan was based on an approved petition for a demonstration project shall:

(1)           demonstrate annual utilization of the proposed multi-position MRI scanner in the third year of operation is reasonably projected to be at least 80 percent of the capacity defined by the applicant in response to 10A NCAC 14C .2702(g)(7); and

(2)           document the assumptions and provide data supporting the methodology used for each projection required in this Rule.

 

History Note:        Authority G.S. 131E‑177(1); 131E‑183(b);

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

Eff. February 1, 1994;

Temporary Amendment Eff. January 1, 1999;

Temporary Amendment Eff. January 1, 1999 Expired on October 12, 1999;

Temporary Amendment Eff. January 1, 2000;

Temporary Amendment effective January 1, 2000 amends and replaces a permanent rulemaking originally proposed to be effective August 2000;

Temporary Amendment Eff. January 1, 2001;

Temporary Amendment effective January 1, 2001 amends and replaces a permanent rulemaking originally proposed to be effective April 1, 2001;

Temporary Amendment Eff. January 1, 2002;

Temporary Amendment Eff. January 1, 2002 amends and replaces the   permanent rule effective, August 1, 2002;

Temporary Amendment Eff. January 1, 2003;

Amended Eff. August 1, 2004; April 1, 2003;

Temporary Amendment Eff. January 1, 2005;

Amended Eff. November 1, 2005;

Temporary Amendment Eff. February 1, 2006;

Amended Eff. November 1, 2006;

Temporary Amendment Eff. February 1, 2008;

Amended Eff. November 1, 2008.

 

10A NCAC 14C .2704      Support Services

10A NCAC 14C .2705      STAFFING AND STAFF TRAINING

 

History Note:        Authority G.S. 131E‑177(1); 131E‑183(b);

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

Eff. February 1, 1994;

Temporary Amendment Eff. January 1, 2002;

Amended Eff. April 1, 2003;

Temporary Amendment Eff. January 1, 2005;

Amended Eff. November 1, 2005;

Temporary Amendment Eff. February 1, 2006;

Amended Eff. November 1, 2006;

Repealed Eff. February 1, 2016.

 

SECTION .2800 ‑ CRITERIA AND STANDARDS FOR REHABILITATION SERVICES

 

10A NCAC 14C .2801      DEFINITIONS

The definitions in this Rule will apply to all rules in this Section.

(1)           "Rehabilitation Facility" means a facility as defined in G.S. 131E‑176.

(2)           "Rehabilitation" means the process to maintain, restore or increase the function of disabled individuals so that an individual can live in the least restrictive environment, consistent with his or her objective.

(3)           "Outpatient Rehabilitation Clinic" is defined as a program of coordinated and integrated outpatient services, evaluation, or treatment with emphasis on improving the functional level of the person in coordination with the patient's family.

(4)           "Rehabilitation Beds" means inpatient beds for which a need determination is set forth in the current State Medical Facilities Plan and which are located in a hospital licensed pursuant to G.S. 131E‑77.

(5)           "Traumatic Brain Injury" is defined as an insult to the brain that may produce a diminished or altered state of consciousness which results in impairment of cognitive abilities or physical functioning.  It can also result in the disturbance of behavioral or emotional functioning.  These impairments may be either temporary or permanent and cause partial or total functional disability or psychological maladjustment.

(6)           "Stroke" (cerebral infarction, hemorrhage) is defined as the sudden onset of a focal neurologic deficit due to a local disturbance in the blood supply to the brain.

(7)           "Spinal Cord Injury" is defined as an injury to the spinal cord that results in the loss of motor or sensory function.

(8)           "Pediatric Rehabilitation" is defined as inpatient rehabilitation services provided to persons 14 years of age or younger.

 

History Note:        Authority G.S. 131E‑177; 131E‑183(b);

Eff. May 1, 1991;

Amended Eff. February 1, 1993;

Temporary Amendment Eff. February 1, 2006;

Amended Eff. November 1, 2006.

 

10A NCAC 14C .2802      INFORMATION REQUIRED By APPLICANT

 

History Note:        Authority G.S. 131E‑177; 131E‑183(b);

Eff. May 1, 1991;

Amended Eff. November 1, 1996;

Repealed Eff. February 1, 2016.

 

10A NCAC 14C .2803      PERFORMANCE STANDARDS

(a)  An applicant proposing to establish new rehabilitation beds shall not be approved unless the average occupancy, over the nine months immediately preceding the submittal of the application, of the total number of licensed rehabilitation beds within the facility in which the new beds are to be operated was at least 80 percent.

(b)  An applicant proposing to establish new rehabilitation beds shall not be approved unless occupancy is projected to be 80 percent for the total number of rehabilitation beds to be operated in the facility no later than two years following completion of the proposed project.

 

History Note:        Authority G.S. 131E‑177; 131E‑183;

Eff. November 1, 1996.

 

10A NCAC 14C .2804      reserved for future codification

 

10A NCAC 14C .2805      STAFFING AND STAFF TRAINING

 

History Note:        Authority G.S. 131E‑177(1); 131E-183;

Eff. May 1, 1991;

Amended Eff. November 1, 1996;

Repealed Eff. February 1, 2016.

 

10A NCAC 14C .2806      QUALITY OF SERVICES

History Note:        Authority G.S. 131E‑177; 131E‑183(b);

Eff. May 1, 1991;

Temporary Repeal Eff. February 1, 2006;

Repealed Eff. November 1, 2006.

 

SECTION .2900 - CRITERIA AND STANDARDS FOR BONE MARROW TRANSPLANTATION SERVICES

 

10A NCAC 14C .2901      DEFINITIONS

 

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

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

Eff. January 4, 1994;

Expired Eff. February 1, 2019 pursuant to G.S. 150B-21.3A.

 

10A NCAC 14C .2902      INFORMATION REQUIRED OF APPLICANT

 

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

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

Eff. January 4, 1994;

Repealed Eff. February 1, 2016.

 

10a NCAC 14C .2903      PERFORMANCE STANDARDS

 

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

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

Eff. January 4, 1994;

Expired Eff. February 1, 2019 pursuant to G.S. 150B-21.3A.

 

10A NCAC 14C .2904      Support Services

10A NCAC 14C .2905      STAFFING AND STAFF TRAINING

 

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

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

Eff. January 4, 1994;

Repealed Eff. February 1, 2016.

 

SECTION .3000 - CRITERIA AND STANDARDS FOR SOLID ORGAN TRANSPLANTATION SERVICES

 

10A NCAC 14C .3001      definitions

10A NCAC 14C .3002      INFORMATION REQUIRED OF APPLICANT

10A NCAC 14C .3003      SUPPORT SERVICES

10A NCAC 14C .3004      ADDITIONAL REQUIREMENTS FOR HEART, HEART/LUNG OR LUNG TRANSPLANTATION SERVICES

10A NCAC 14C .3005      ADDITIONAL REQUIREMENTS FOR LIVER TRANSPLANTATION SERVICES

10a NCAC 14C .3006      ADDITIONAL REQUIREMENTS FOR PANCREAS TRANSPLANTATION SERVICES

10A NCAC 14C .3007      ADDITIONAL REQUIREMENTS FOR KIDNEY TRANSPLANTATION SERVICES

10A NCAC 14C .3008      STAFFING AND STAFF TRAINING

10A NCAC 14C .3009      ACCESSIBILITY

 

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

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

Eff. January 4, 1994;

Amended Eff. November 1, 1996;

Repealed Eff. February 1, 2016.

 

SECTION .3100 - CRITERIA AND STANDARDS FOR MAJOR MEDICAL EQUIPMENT

 

10A NCAC 14C .3101      PURPOSE AND SCOPE

10A NCAC 14C .3102      DEFINITIONS

 

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

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

Eff. January 4, 1994;

Repealed Eff. March 16, 2017.

 

10A NCAC 14C .3103      INFORMATION REQUIRED OF APPLICANT

 

History Note:        Authority G.S. 131E-177(1); 131E-183;

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

Eff. January 4, 1994;

Amended Eff. January 1, 1997; November 1, 1996;

Repealed Eff. February 1, 2016.

 

10A NCAC 14C .3104      NEED FOR SERVICES

 

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

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

Eff. January 4, 1994;

Repealed Eff. March 16, 2017.

 

10A NCAC 14C .3105      Support Services

10A NCAC 14C .3106      STAFFING AND STAFF TRAINING

 

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

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

Eff. January 4, 1994;

Repealed Eff. February 1, 2016.

 

SECTION .3200 - CRITERIA AND STANDARDS FOR LITHOTRIPTOR EQUIPMENT

 

10A NCAC 14C .3201      DEFINITIONS

 

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

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

Eff. January 4, 1994;

Repealed Eff. October 1, 2016.

 

10A NCAC 14C .3202      INFORMATION REQUIRED OF APPLICANT

 

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

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

Eff. January 4, 1994;

Repealed Eff. February 1, 2016.

 

10A NCAC 14C .3203      PERFORMANCE STANDARDS

 

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

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

Eff. January 4, 1994;

Repealed Eff. October 1, 2016.

 

10A NCAC 14C .3204      Support Services

10A NCAC 14C .3205      STAFFING AND STAFF TRAINING

 

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

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

Eff. January 4, 1994;

Amended Eff. November 1, 1996;

Repealed Eff. February 1, 2016.

 

SECTION .3300 ‑ CRITERIA AND STANDARDS FOR AIR AMBULANCE

 

10A ncac 14C .3301      Definitions

10A NCAC 14C .3302      INFORMATION REQUIRED OF APPLICANT

10A NCAC 14C .3303      PERFORMANCE STANDARDS

 

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

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

Eff. February 1, 1994;

Temporary Amendment Eff. May 15, 2002;

Amended Eff. April 1, 2007; April 1, 2005; April 1, 2003;

Repealed Eff. January 1, 2013.

 

10A NCAC 14C .3304      reserved for future codification

 

10A NCAC 14C .3305      STAFFING AND STAFF TRAINING

 

History Note:        Authority G.S. 131E‑177(1); 131E‑183(b);

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

Eff. February 1, 1994;

Temporary Amendment Eff. May 15, 2002;

Amended Eff. April 1, 2003;

Repealed Eff. January 1, 2013.

 

SECTION .3400 - CRITERIA AND STANDARDS FOR BURN INTENSIVE CARE SERVICES

 

10A NCAC 14C .3401      DEFINITIONS

 

History Note:        Authority G.S. 131E-177(1); 131E-183;

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

Eff. January 4, 1994;

Amended Eff. November 1, 1996;

Expired Eff. February 1, 2019 pursuant to G.S. 150B-21.3A.

 

10A NCAC 14C .3402      INFORMATION REQUIRED OF APPLICANT

 

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

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

Eff. January 4, 1994;

Repealed Eff. February 1, 2016.

 

10A NCAC 14C .3403      PERFORMANCE STANDARDS

 

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

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

Eff. January 4, 1994;

Expired Eff. February 1, 2019 pursuant to G.S. 150B-21.3A.

 

10A NCAC 14C .3404      Support Services

10A NCAC 14C .3405      STAFFING AND STAFF TRAINING

 

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

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

Eff. January 4, 1994;

Repealed Eff. February 1, 2016.

 

SECTION .3500 - CRITERIA AND STANDARDS FOR ONCOLOGY TREATMENT CENTERS

 

10A NCAC 14C .3501      DEFINITIONS

10A NCAC 14C .3502      INFORMATION REQUIRED OF APPLICANT

 

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;

Temporary Repeal Eff. February 1, 2006;

Repealed Eff. November 1, 2006.

 

10A NCAC 14C .3503      reserved for future codification

 

10A NCAC 14C .3504      SUPPORT SERVICES

10A NCAC 14C .3505      STAFFING AND STAFF TRAINING

 

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;

Temporary Repeal Eff. February 1, 2006;

Repealed Eff. November 1, 2006.

 

SECTION .3600 - CRITERIA AND STANDARDS FOR GAMMA KNIFE

 

10A NCAC 14C .3601      DEFINITIONS

 

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

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

Eff. January 4, 1994;

Expired Eff. February 1, 2019 pursuant to G.S. 150B-21.3A.

 

10A NCAC 14C .3602      INFORMATION REQUIRED OF APPLICANT

 

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

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

Eff. January 4, 1994;

Repealed Eff. February 1, 2016.

 

10A NCAC 14C .3603      PERFORMANCE STANDARDS

 

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

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

Eff. January 4, 1994;

Temporary Amendment Eff. January 1, 2003;

Amended Eff. August 1, 2004;

Expired Eff. February 1, 2019 pursuant to G.S. 150B-21.3A.

 

10A NCAC 14C .3604      Support Services

10A NCAC 14C .3605      STAFFING AND STAFF TRAINING

 

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

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

Eff. January 4, 1994;

Repealed Eff. February 1, 2016.

 

section .3700 - CRITERIA AND STANDARDS FOR POSITRON EMISSION TOMOGRAPHY SCANNER

 

10A NCAC 14C .3701      DEFINITIONS

The following definitions shall apply to all rules in this Section:

(1)           "Approved positron emission tomography (PET) scanner" means a PET scanner which was not operational prior to the beginning of the review period but which had been issued a certificate of need.

(2)           "Cyclotron" means an apparatus for accelerating protons or neutrons to high energies by means of a constant magnet and an oscillating electric field.

(3)           "Dedicated PET Scanner" means PET Scanners as defined in the applicable State Medical Facilities Plan.

(4)           "Existing PET scanner" means a PET scanner in operation prior to the beginning of the review period.

(5)           "Mobile PET Scanner" means a PET scanner and transporting equipment that is moved, at least weekly, to provide services at two or more host facilities.

(6)           "PET procedure" means a single discrete study of one patient involving one or more PET scans.

(7)           "PET scan" means an image-scanning sequence derived from a single administration of a PET radiopharmaceutical, equated with a single injection of the tracer.  One or more PET scans comprise a PET procedure.

(8)           "PET scanner service area" means the PET Scanner Service Area as defined in the applicable State Medical Facilities Plan.

(9)           "Positron emission tomographic scanner" (PET) is defined in G.S. 131E-176(19a).

(10)         "Radioisotope" means a radiochemical which directly traces biological processes when introduced into the body.

 

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

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

Eff. January 4, 1994;

Temporary Amendment Eff. January 1, 2001;

Temporary Amendment Eff. January 1, 2002;

Amended Eff. August 1, 2002;

Temporary Amendment effective January 1, 2002 amends and replaces the permanent rule effective August 1, 2002;

Temporary Amendment Eff. January 1, 2003;

Amended Eff. August 1, 2004; April 1, 2003.

 

10A NCAC 14C .3702      INFORMATION REQUIRED OF APPLICANT

 

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

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

Eff. January 4, 1994;

Temporary Amendment Eff. January 1, 2002;

Temporary Amendment effective January 1, 2002 amends and replaces a permanent rulemaking originally proposed to be effective August 1, 2002;

Amended Eff. April 1, 2003;

Temporary Amendment Eff. February 1, 2006;

Amended Eff. November 1, 2006;

Temporary Amendment Eff. February 1, 2008;

Amended Eff. November 1, 2008;

Repealed Eff. February 1, 2016.

 

10A NCAC 14C .3703      PERFORMANCE STANDARDS

(a)  An applicant proposing to acquire a dedicated PET scanner, including a mobile dedicated PET scanner, shall demonstrate that:

(1)           the proposed dedicated PET scanner, including a proposed mobile dedicated PET scanner, shall be utilized at an annual rate of at least 2,080 PET procedures by the end of the third year following completion of the project;

(2)           if an applicant operates an existing dedicated PET scanner, its existing dedicated PET scanners, excluding those used exclusively for research, performed an average of at least 2,080 PET procedures per PET scanner in the last year; and

(3)           its existing and approved dedicated PET scanners shall perform an average of at least 2,080 PET procedures per PET scanner during the third year following completion of the project.

(b)  The applicant shall describe the assumptions and provide data to support and document the assumptions and methodology used for each projection required in this Rule.

 

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

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

Eff. January 4, 1994;

Temporary Amendment Eff. January 1, 2002; January 1, 2001;

Amended Eff. August 1, 2002;

Temporary Amendment effective January 1, 2002 amends and replaces the permanent rule effective August 1, 2002;

Temporary Amendment Eff. January 1, 2003;

Amended Eff. August 1, 2004; April 1, 2003;

Temporary Amendment Eff. January 1, 2005;

Amended Eff. November 1, 2005;

Temporary Amendment Eff. February 1, 2006;

Amended Eff. November 1, 2006.

 

10A NCAC 14C .3704      Support Services

10A NCAC 14C .3705      STAFFING AND STAFF TRAINING

 

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

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

Eff. January 4, 1994;

Temporary Amendment Eff. January 1, 2002;

Amended Eff. April 1, 2003;

Temporary Amendment Eff. February 1, 2006;

Amended Eff. November 1, 2006;

Repealed Eff. February 1, 2016.

 

section .3800 - criteria and standards for ACUTE CARE BEDS

 

10A NCAC 14C .3801      DEFINITIONS

The following definitions shall apply to all Rules in this Section:

(1)           "Acute care beds" means acute care beds licensed by the Division of Health Service Regulation in accordance with standards in 10A NCAC 13B .6200, and located in hospitals licensed pursuant to G.S. 131E-79.

(2)           "Average daily census" means the number of days of inpatient acute care provided in licensed acute care beds in a given year divided by 365 days.

(3)           "Campus" shall have the same meaning as defined in G.S. 131E-176(2c).

(4)           "Service Area" means the single or multi-county area as used in the development of the acute care bed need determination in the applicable State Medical Facilities Plan.

 

History Note:        Authority G.S. 131E‑177(1); 131E-183;

Temporary Adoption Eff. January 1, 2004;

Eff. August 1, 2004.

 

10A NCAC 14C .3802      INFORMATION REQUIRED OF APPLICANT

 

History Note:        Authority G.S. 131E‑177(1); 131E-183;

Temporary Adoption Eff. January 1, 2004;

Eff. August 1, 2004;

Temporary Amendment Eff. January 1, 2005;

Amended Eff. November 1, 2005;

Repealed Eff. February 1, 2016.

 

10A NCAC 14C .3803      PERFORMANCE STANDARDS

(a)  An applicant proposing to develop new acute care beds shall demonstrate that the projected average daily census (ADC) of the total number of licensed acute care beds proposed to be licensed within the service area, under common ownership with the applicant, divided by the total number of those licensed acute care beds is reasonably projected to be at least 66.7 percent when the projected ADC is less than 100 patients, 71.4 percent when the projected ADC is 100 to 200 patients, and 75.2 percent when the projected ADC is greater than 200 patients, in the third operating year following completion of the proposed project or in the year for which the need determination is identified in the State Medical Facilities Plan, whichever is later.

(b)  An applicant proposing to develop new acute care beds shall provide all assumptions and data used to develop the projections required in this rule and demonstrate that they support the projected inpatient utilization and average daily census.

 

History Note:        Authority G.S. 131E‑177(1); 131E-183;

Temporary Adoption Eff. January 1, 2004;

Eff. August 1, 2004.

 

10A NCAC 14C .3804      Support Services

10A NCAC 14C .3805      STAFFING AND STAFF TRAINING

 

History Note:        Authority G.S. 131E‑177(1); 131E-183;

Temporary Adoption Eff. January 1, 2004;

Eff. August 1, 2004;

Repealed Eff. February 1, 2016.

 

SECTION .3900 - CRITERIA AND STANDARDS FOR GASTROINTESTINAL ENDOSCOPY PROCEDURE ROOMS IN LICENSED HEALTH SERVICE FACILTIES

 

10A ncac 14C .3901      DEFINITIONS

The following definitions shall apply to all rules in this Section:

(1)           "Ambulatory surgical facility" means a facility as defined in G.S. 131E-176(1b).

(2)           "Gastrointestinal (GI) endoscopy room" means a room as defined in G.S. 131E-176(7d) that is used to perform one or more GI endoscopy procedures.

(3)           "Gastrointestinal (GI) endoscopy procedure" means a single procedure, identified by CPT code or ICD-9-CM procedure code, performed on a patient during a single visit to the facility for diagnostic or therapeutic purposes.

(4)           "Operating room" means a room as defined in G.S. 131E-176(18c). )

(5)           "Related entity" means the parent company of the applicant, a subsidiary company of the applicant (i.e., the applicant owns 50 percent or more of another company), a joint venture in which the applicant is a member, or a company that shares common ownership with the applicant (i.e., the applicant and another company are owned by some of the same persons).

(6)           "Service area" means the geographical area, as defined by the applicant using county lines, from which the applicant projects to serve patients.

 

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

Temporary Adoption Eff. February 1, 2006;

Eff. November 1, 2006.

 

10A NCAC 14C .3902      INFORMATION REQUIRED OF APPLICANT

 

History Note:        Authority G.S. 131E‑177; 131E-183(b);

Temporary Adoption Eff. February 1, 2006;

Eff. November 1, 2006;

Repealed Eff. February 1, 2016.

 

10A ncac 14C .3903      performance standards

(a)  In providing projections for operating rooms, as required in this rule, the operating rooms shall be considered to be available for use 250 days per year, which is five days per week, 52 weeks per year, excluding ten days for holidays.

(b)  An applicant proposing to establish a new licensed ambulatory surgical facility for performance of GI endoscopy procedures or develop a GI endoscopy room in an existing licensed health service facility shall reasonably project to perform an average of at least 1,500 GI endoscopy procedures only per GI endoscopy room in each licensed facility the applicant or a related entity owns in the proposed service area, during the second year of operation following completion of the project.

(c)  An applicant proposing to establish a new licensed ambulatory surgical facility for performance of GI endoscopy procedures or develop a GI endoscopy room in an existing licensed health service facility shall demonstrate that at least the following types of GI endoscopy procedures will be provided in the proposed facility or GI endoscopy room: upper endoscopy procedures, esophagoscopy procedures, and colonoscopy procedures.

(d)  If an applicant, which proposes to establish a new licensed ambulatory surgical facility for performance of GI endoscopy procedures or develop a GI endoscopy room in an existing licensed health service facility, or a related entity to the applicant owns operating rooms located in the proposed service area, the applicant shall meet one of the following criteria:

(1)           if the applicant or a related entity performs GI endoscopy procedures in any of its surgical operating rooms in the proposed service area, reasonably project that during the second operating year of the project the average number of surgical and GI endoscopy cases per operating room, for each category of operating room in which these cases will be performed, shall be at least: 4.8 cases per day for each facility for the outpatient or ambulatory surgical operating rooms and 3.2 cases per day for each facility for the shared operating rooms; or

(2)           demonstrate that GI endoscopy procedures were not performed in the applicant's or related entity's inpatient operating rooms, outpatient operating rooms, or shared operating rooms in the last 12 months and will not be performed in those rooms in the future.

(e)  An applicant proposing to establish a new licensed ambulatory surgical facility for performance of GI endoscopy procedures or develop an additional GI endoscopy room in an existing licensed health service facility shall describe all assumptions and the methodology used for each projection in this Rule.

 

History Note:        Authority G.S. 131E‑177; 131E-183(b);

Temporary Adoption Eff. February 1, 2006;

Eff. November 1, 2006.

 

10A NCAC 14C .3904      Support Services

10A NCAC 14C .3905      STAFFING AND STAFF TRAINING

10A ncac 14C .3906      FACILITY

 

History Note:        Authority G.S. 131E‑177; 131E-183(b);

Temporary Adoption Eff. February 1, 2006;

Eff. November 1, 2006;

Repealed Eff. February 1, 2016.

 

section .4000 - CRITERIA AND STANDARDS FOR HOSPICE INPATIENT FACILITIES AND HOSPICE RESIDENTIAL CARE FACILITIES

 

10A NCAC 14C .4001      DEFINITIONS

The following definitions shall apply to all rules in this Section:

(1)           "Bereavement counseling" means counseling provided to a hospice patient's family or significant others to assist them in dealing with issues of grief and loss.

(2)           "Caregiver" means the person whom the patient designates to provide the patient with emotional support, physical care, or both.

(3)           "Care plan" means a plan as defined in 10A NCAC 13K .0102 of the Hospice Licensing Rules.

(4)           "Home-like" means furnishings of a hospice inpatient facility or a hospice residential care facility as defined in 10A NCAC 13K .1110 or .1204 of the Hospice Licensing Rules.

(5)           "Hospice" means any coordinated program of home care as defined in G.S. 131E-176(13a).

(6)           "Hospice inpatient facility" means a facility as defined in G.S. 131E-176(13b).

(7)           "Hospice residential care facility" means a facility as defined in G.S. 131E-176(13c).

(8)           "Hospice service area" means for residential care facilities, the county in which the hospice residential care facility will be located and the contiguous counties for which the hospice residential care facility will provide services.

(9)           "Hospice services" means services as defined in G.S. 131E-201(5b).

(10)         "Hospice staff" means personnel as defined in 10A NCAC 13K .0102 of the Hospice Licensing Rules.

 

History Note:        Authority G.S. 131E-177(1);

Temporary Adoption Eff. February 1, 2006;

Eff. November 1, 2006.

 

10A NCAC 14C .4002      INFORMATION REQUIRED OF APPLICANT

 

History Note:        Authority G.S. 131E-177(1); 131E-183;

Temporary Adoption Eff. February 1, 2006;

Eff. November 1, 2006;

Temporary Amendment Eff. February 1, 2008;

Amended Eff. November 1, 2008;

Repealed Eff. February 1, 2016.

 

10A NCAC 14C .4003      PERFORMANCE STANDARDS

(a)  An applicant proposing to develop hospice inpatient facility beds or hospice residential care facility beds shall demonstrate that:

(1)           the average occupancy rate of the licensed hospice beds, for each level of care, in the facility is projected to be at least 50 percent for the last six months of the first operating year following completion of the project;

 (2)          the average occupancy rate for the licensed hospice beds, for each level of care, in the facility is projected to be at least 65 percent for the second operating year following completion of the project; and

(3)           if the application is submitted to address the need for hospice residential care beds, each existing hospice residential care facility which is located in the hospice service area operated at an occupancy rate of at least 65 percent for the 12 month period reported on that facility's most recent Licensure Renewal Application Form.

(b)  An applicant proposing to add hospice inpatient facility beds to an existing hospice inpatient facility shall document that the average occupancy of the licensed hospice inpatient facility beds in its existing facility was at least 65 percent for the nine months immediately preceding the submittal of the proposal.

(c)  An applicant proposing to add residential care beds to an existing hospice residential care facility shall document that the average occupancy of the licensed hospice residential care beds in its existing facility was at least 65 percent for the nine months immediately preceding the submittal of the proposal.

 

History Note:        Authority G.S. 131E-177(1);

Temporary Adoption Eff. February 1, 2006;

Eff. November 1, 2006;

Temporary Amendment Eff. February 1, 2008;

Amended Eff. November 1, 2008.

 

10A NCAC 14C .4004      Support Services

10A NCAC 14C .4005      STAFFING AND STAFF TRAINING

 

History Note:        Authority G.S. 131E-177(1); 131E-183;

Temporary Adoption Eff. February 1, 2006;

Eff. November 1, 2006;

Repealed Eff. February 1, 2016.

 

10A NCAC 14C .4006      facility

 

History Note:        Authority G.S. 131E-177(1); 131E-183;

Temporary Adoption Eff. February 1, 2008;

Eff. November 1, 2008;

Repealed Eff. February 1, 2016.