subchapter 14c certificate of need regulations …reports.oah.state.nc.us/ncac/title 10a - health...

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.


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Repealed Eff.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


Eff. October 1, 1981;

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



The following definitions shall apply throughout this Subchapter:

(1) "Applicant" means each person identified in Section A of the application forms listed in 10A

NCAC 14C .0203(a).

(2) "Application deadline" means no later than 5:00 p.m. on the 15th day of the month preceding the

month that the review period begins. If the 15th day of the month falls on a weekend or a State

holiday as set forth in 25 NCAC 01E .0901, which is hereby incorporated by reference including

subsequent amendments, the application deadline is the next business day.

(3) "Competitive review" means two or more applications submitted to begin review in the same

review period proposing the same new institutional health service in the same service area and the

CON Section determines that approval of one application may require denial of another

application included in the same review period.

(4) "CON Section" means the Healthcare Planning and Certificate of Need Section of the Division of

Health Service Regulation.

(5) "Full fiscal year" means the 12-month period used by the applicant to track and report revenues

and operating expenses for the services proposed in the application.

(6) "Health service" shall have the same meaning as defined in G.S. 131E-176(9a).

(7) "New institutional health service" shall have same meaning as defined in G.S. 131E-176(16).

(8) "Person" shall have the same meaning as defined in G.S. 131E-176(19).

(9) "Proposal" means a new institutional health service that requires a certificate of need.

(10) "Related entity" means a person that:

(a) shares the same parent corporation or holding company with the applicant;

(b) is a subsidiary of the same parent corporation or holding company as the applicant; or

(c) participates with the applicant in a joint venture that provides the same type of health

services proposed in the application.

(11) "Review category" means the categories described in Chapter 3 of the annual State Medical

Facilities Plan.

(12) "Review period" means the 90 to 150 days that the CON Section has to review a certificate of

need application and issue a decision pursuant to G.S. 131E-185 and G.S. 131E-186. There are

eleven review periods each calendar year. Each review period starts on the first day of the month

and the first review period starts on February 1. There is no review period beginning January 1.

(13) "State Medical Facilities Plan" shall have the same meaning as defined in G.S. 131E-176(25). For

purposes of this Subchapter, the annual State Medical Facilities Plan is hereby incorporated by

reference, including subsequent amendments and editions. This document is available at no cost at

https://info.ncdhhs.gov/dhsr/ncsmfp/index.html.

(14) "USB flash drive" means a device used for data storage that includes a flash memory and an

integrated universal serial bus interface.



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

Temporary Amendment Eff. January 1, 2000;

Amended Eff. April 1, 2001;

Readopted Eff. January 1, 2021.

10A NCAC 14C .0203 FILING APPLICATIONS

(a) "Application form" refers to one of the following:

(1) the Certificate of Need Application form; or

(2) the Dialysis or End Stage Renal Disease Services Application form.

(b) An application form may be obtained from the CON Section by:

(1) sending an email to [email protected]; or

(2) calling (919) 855-3873.

(c) An email request for an application form shall:

(1) describe the proposal;

(2) identify the city or county where the proposal would be located; and

(3) include the estimated capital cost for the proposal.

(d) For each proposal, the CON Section shall determine based on Chapter 3 of the annual State Medical Facilities

Plan in effect at the time the review begins the:

(1) review category; and

(2) review period.

(e) An application is complete for inclusion in the review period if the CON Section determines that all of the

following are true:

(1) the original application is printed, placed between a front and back cover, and bound using metal

paper fasteners;

(2) the original and one copy of the application were received by the CON Section on or before the

application deadline for the review period;

(3) the entire application fee required by G.S. 131E-182(c) was received by the CON Section; and

(4) each applicant identified in Section A of the application form signed the certification page that

asks the applicant to certify that the information in the application is correct and they intend to

develop and offer the project as described in the application.

(f) The copy of the application shall be printed and bound consistent with Subparagraph (e)(1) of this Rule or in an

electronic format saved on a USB flash drive. The files on the USB flash drive shall not be encrypted or password

protected.

(g) No later than the fifth business day following the application deadline, the CON Section shall notify the contact

individual identified in Section A of the application if the application is complete.

(h) If the application is not complete pursuant to Paragraph (e) of this Rule, the CON Section shall notify the

contact individual identified in Section A of the application of what is missing or incorrect. The applicant shall only

provide the items listed below in order to complete the application after the application deadline:

(1) a signed certification page; or

(2) the copy of the application.

(i) Signed certification pages or the copy of the application shall be received by the CON Section no later than 5:00

p.m. on the last business day of the month preceding the first day of the review period.

(j) The CON Section shall not include the application in the review period if it is not complete pursuant to

Paragraph (e) of this Rule by 5:00 p.m. on the last business day of the month preceding the first day of the review

period.

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


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;


Temporary Amendment Eff. August 12, 1994, for a period of 180 days or until the permanent rule


Amended Eff. December 1, 1994;



Temporary Amendment Eff. February 16, 2004;

Amended Eff. August 1, 2004;




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.





19, 2019.

10A NCAC 14C .0205 EXTENSION OF REVIEW PERIOD

(a) If the review is not expedited, the review may be extended for the following reasons:

(1) the total number of applications, including those in other review periods, prevents the CON

Section from completing the review in 90 days;

(2) the applicant has not submitted a response to a request from the CON Section for clarifying

information; or

(3) the CON Section received clarifying information from the applicant but is not able to complete the

review in 90 days.

(b) The CON Section shall notify the contact individual identified in Section A of the application if the review

period is extended. Failure to receive such notice prior to the last day of the review period does not entitle the

applicant to a certificate of need nor authorize the applicant to proceed with the proposal in the application without a

certificate of need.








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




10A NCAC 14C .0207 AGENCY DECISION

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

10A NCAC 14C .0209 PROGRESS REPORTS



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


SECTION .0300 - EXEMPTIONS

10A NCAC 14C .0301 RESEARCH ACTIVITY



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


10A NCAC 14C .0302 HEALTH MAINTENANCE ORGANIZATIONS



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



Repealed Eff. January 1, 2013.

10A NCAC 14C .0303 REPLACEMENT EQUIPMENT

(a) This Rule defines the terms used in the definition of "replacement equipment" set forth in G.S. 131E-176(22a).

(b) "Currently in use" means that the equipment to be replaced has been used by the person requesting the

exemption at least 10 times to provide a health service during the 12 months prior to the date the written notice

required by G.S. 131E-184(a) is submitted to the CON Section.

(c) Replacement equipment is not "comparable" if:

(1) the replacement equipment to be acquired is capable of providing a health service that the

equipment to be replaced cannot provide; or

(2) the equipment to be replaced was acquired less than 12 months prior to the date the written notice

required by G.S. 131E-184(a) is submitted to the CON Section and it was refurbished or

reconditioned when it was acquired by the person requesting the exemption.





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

Temporary Amendment Eff. June 3, 2002;



10A NCAC 14C .0304 PSYCHIATRIC BED CONVERSIONS




SECTION .0400 – CERTIFICATE OF NEED APPEAL PROCESS

10A NCAC 14C .0401 PETITION FOR A HEARING



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


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.



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


19, 2019.

10A NCAC 14C .0403 CONTESTED CASE HEARINGS




SECTION .0500 – ENFORCEMENT AND SANCTIONS

10A NCAC 14C .0501 ASSESSMENT OF CIVIL PENALTY

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



10A NCAC 14C .0502 WITHDRAWAL OF A CERTIFICATE




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;


SECTION .0600 – 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;


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;



Amended Eff. April 1, 2003.

SECTION .1200 – CRITERIA AND STANDARDS FOR INTENSIVE CARE SERVICES


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




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










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);




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





















SECTION .1400 – CRITERIA AND STANDARDS FOR NEONATAL SERVICES


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.






Temporary Amendment Eff. March 15, 2002;














(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.










Amended Eff. November 1, 2010.










SECTION .1500 - CRITERIA AND STANDARDS FOR HOSPICES



Eff. July 1, 1994;








Eff. July 1, 1994;









Eff. July 1, 1994;


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


Temporary Amendment effective January 1, 2000 amends and replaces a permanent rulemaking

originally proposed to be effective August 2000;










Eff. July 1, 1994;





SECTION .1600 – CRITERIA AND STANDARDS FOR CARDIAC CATHETERIZATION EQUIPMENT

AND CARDIAC ANGIOPLASTY EQUIPMENT


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.





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





originally proposed to be effective August 1, 2000;



originally proposed to be effective April 1, 2001;
















(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


(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



(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



(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.
















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

effective August 1, 2002;










Amended Eff. February 1, 1994;





effective

August 1, 2002;





SECTION .1700 - CRITERIA AND STANDARDS FOR OPEN-HEART SURGERY SERVICES AND

HEART-LUNG BYPASS MACHINES


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


(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.









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. January 1, 2013; November 1, 2010.








Temporary Amendment January 1, 1999;





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



(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.








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. January 1, 2013; November 1, 2010.










SECTION .1800 - CRITERIA AND STANDARDS FOR DIAGNOSTIC CENTERS

10A NCAC 14C .1801 PURPOSE AND SCOPE





Repealed Eff. March 16, 2017.







Repealed Eff. December 1, 2016.



















SECTION .1900 – CRITERIA AND STANDARDS FOR RADIATION THERAPY EQUIPMENT


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


(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.







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












History Note: Authority G.S. 131E-177; 131E-183; NC 2009 State Medical Facilities Plan, Chapter 9:

Radiation Therapy Services – Linear Accelerator;






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













(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.





Amended Eff. November 1, 1996


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

Temporary Amended Eff. January 1, 2000;






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















SECTION .2000 – CRITERIA AND STANDARDS FOR HOME HEALTH SERVICES


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).


Eff. September 1, 1980;

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



Eff. March 1, 1996;





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.


Eff. March 1, 1996;



10A NCAC 14C .2004 RESERVED FOR FUTURE CODIFICATION



Eff. March 1, 1996;


SECTION .2100 – CRITERIA AND STANDARDS FOR SURGICAL SERVICES AND OPERATING

ROOMS



(1) "Approved operating rooms" means those operating rooms that were approved for a certificate of

need by the CON Section prior to the date on which the applicant's proposed project was

submitted to the CON Section, but that have not been licensed.

(2) "Dedicated C-section operating room" means an operating room as defined in Chapter 6 in the

annual State Medical Facilities Plan.

(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 annual 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 annual State Medical Facilities Plan.

(7) "Service area" means the Operating Room Service Area as defined in Chapter 6 in the annual State

Medical Facilities Plan.



Amended Eff. March 1, 1993;










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







Temporary Rule Eff. February 1, 2006;








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





Temporary Amendment Eff. July 1, 2001;












(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

annual State Medical Facilities Plan in effect at the time the review began. The applicant is not required to use the

population growth factor.

(b) The applicant shall provide the assumptions and methodology used for the projected utilization required by this

Rule.



Amended Eff. March 1, 1993;




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







Temporary Rule Eff. February 1, 2006;













10A NCAC 14C .2106 FACILITY






Temporary Amendment Eff. July 1, 2001;











SECTION .2200 – CRITERIA AND STANDARDS FOR END-STAGE RENAL DISEASE SERVICES


The following definitions shall apply to this Section:

(1) "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.

(2) "Dialysis facility" means a kidney disease treatment center as defined in G.S. 131E-176(14e).

(3) "Dialysis station" means the treatment area in a dialysis facility used to accommodate the

equipment and supplies needed to perform hemodialysis on a single patient.

(4) "Hemodialysis" means the form of dialysis in which the blood is circulated outside the body

through equipment that permits transfer of waste through synthetic membranes.

(5) "Home hemodialysis" means hemodialysis performed in a location other than a dialysis facility by

the patient after the patient is trained in a dialysis facility to perform the hemodialysis.

(6) "In-center hemodialysis" means hemodialysis performed in a dialysis facility.

(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. This form of dialysis is performed in a

location other than a dialysis facility by the patient after the patient is trained in a dialysis facility

to perform the peritoneal dialysis.


Eff. September 1, 1980;

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




Eff. March 1, 1989;









(a) An applicant proposing to establish a new dialysis facility for in-center hemodialysis services shall document the

need for at least 10 dialysis stations based on utilization of 2.8 in-center patients per station per week as of the end of

the first full fiscal year of operation following certification of the facility. An applicant may document the need for

fewer than 10 stations if the application is submitted in response to an adjusted need determination in the State

Medical Facilities Plan for fewer than 10 stations.

(b) An applicant proposing to increase the number of in-center dialysis stations in:

(1) an existing dialysis facility; or

(2) a dialysis facility that is not operational as of the date the certificate of need application is

submitted but has been issued a certificate of need

shall document the need for the total number of dialysis stations in the facility based on 2.8 in-center patients per

station per week as of the end of the first full fiscal year of operation following certification of the additional

stations.

(c) An applicant proposing to establish a new dialysis facility dedicated to home hemodialysis or peritoneal dialysis

training shall document the need for the total number of home hemodialysis stations in the facility based on training

six home hemodialysis patients per station per year as of the end of the first full fiscal year of operation following

certification of the facility.

(d) An applicant proposing to increase the number of home hemodialysis stations in a dialysis facility dedicated to

home hemodialysis or peritoneal dialysis training shall document the need for the total number of home

hemodialysis stations in the facility based on training six home hemodialysis patients per station per year as of the

end of the first full fiscal year of operation following certification of the additional stations.

(e) The applicant shall provide the assumptions and methodology used for the projected utilization required by this

Rule.


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

Eff. April 1, 2003;










10A NCAC 14C .2204 SCOPE OF SERVICES



Eff. March 1, 1989;


SECTION .2300 – CRITERIA AND STANDARDS FOR COMPUTED TOMOGRAPHY EQUIPMENT



(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).




Eff. February 1, 1994;

Amended Eff. February 1, 2008.









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.





Amended Eff. February 1, 2008.









SECTION .2400 – CRITERIA AND STANDARDS FOR INTERMEDIATE CARE FACILITIES FOR

INDIVIDUALS WITH INTELLECTUAL DISABILITIES


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.






(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.




Amended Eff. August 1, 2004.






SECTION .2500 – CRITERIA AND STANDARDS FOR SUBSTANCE USE DISORDER (CHEMICAL

DEPENDENCY TREATMENT) BEDS



(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.


Eff. March 1, 1983;

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


Amended Eff. August 1, 2002.








(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.






Amended Eff. January 1, 2007.








SECTION .2600 – CRITERIA AND STANDARDS FOR PSYCHIATRIC BEDS


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.


Eff. May 1, 1983;

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





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



(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.


Eff. November 1, 1996.




Eff. May 1, 1983;



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



(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).












































(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


(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



(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



(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



(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
















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

August 1, 2002;






















SECTION .2800 - CRITERIA AND STANDARDS FOR REHABILITATION SERVICES


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.


Eff. May 1, 1991;




10A NCAC 14C .2802 INFORMATION REQUIRED BY APPLICANT


Eff. May 1, 1991;




(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.






Eff. May 1, 1991;



10A NCAC 14C .2806 QUALITY OF SERVICES


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


























SECTION .3000 - CRITERIA AND STANDARDS FOR SOLID ORGAN TRANSPLANTATION

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 .3009 ACCESSIBILITY







SECTION .3100 - CRITERIA AND STANDARDS FOR MAJOR MEDICAL EQUIPMENT

10A NCAC 14C .3101 PURPOSE AND SCOPE












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


10A NCAC 14C .3104 NEED FOR SERVICES













SECTION .3200 - CRITERIA AND STANDARDS FOR LITHOTRIPTOR EQUIPMENT



























SECTION .3300 - CRITERIA AND STANDARDS FOR AIR AMBULANCE








Temporary Amendment Eff. May 15, 2002;

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








Temporary Amendment Eff. May 15, 2002;



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



























SECTION .3500 - CRITERIA AND STANDARDS FOR ONCOLOGY TREATMENT CENTERS



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);







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);




SECTION .3600 - CRITERIA AND STANDARDS FOR GAMMA KNIFE




























SECTION .3700 - CRITERIA AND STANDARDS FOR POSITRON EMISSION TOMOGRAPHY

SCANNER



(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.











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








originally proposed to be effective August 1, 2002;








(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


(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.


























SECTION .3800 - CRITERIA AND STANDARDS FOR ACUTE CARE BEDS


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.


Temporary Adoption Eff. January 1, 2004;

Eff. August 1, 2004.




Eff. August 1, 2004;





(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.



Eff. August 1, 2004.





Eff. August 1, 2004;


SECTION .3900 - CRITERIA AND STANDARDS FOR GASTROINTESTINAL ENDOSCOPY

PROCEDURE ROOMS IN LICENSED HEALTH SERVICE FACILTIES



(1) "Approved gastrointestinal (GI) endoscopy rooms" means GI endoscopy rooms that were

approved for a certificate of need by the CON Section prior to the date the application was

submitted but that are not licensed as of the date the application is submitted.

(2) "Existing GI endoscopy rooms" means GI endoscopy rooms that were licensed prior to the


(3) "GI endoscopy procedure" means each upper endoscopy, esophagoscopy, or colonoscopy

procedure performed on a patient during a single visit to the licensed health service facility.

(4) "Licensed health service facility" means either a hospital as defined in G.S. 131E-176(13) or an

ambulatory surgical facility as defined in G.S. 131E-176(1b).

(5) "New GI endoscopy room" means a GI endoscopy room that is not included in the inventory of GI

endoscopy rooms in the State Medical Facilities Plan as of the date the application is submitted.

(6) "Service area" means the county where the proposed GI endoscopy room will be developed.


Temporary Adoption Eff. February 1, 2006;









An applicant proposing to develop a new GI endoscopy room in a licensed health service facility shall:

(1) identify the proposed service area;

(2) identify all existing and approved GI endoscopy rooms owned or operated by the applicant or a

related entity located in the proposed service area;

(3) provide projected utilization for each of the first three full fiscal years of operation following

completion of the project for all GI endoscopy rooms identified in Item (2) of this Rule;

(4) project to perform an average of at least 1,500 GI endoscopy procedures per GI endoscopy room

during the third full fiscal year of operation following completion of the project in the GI

endoscopy rooms identified in Item (2) of this Rule; and

(5) provide the assumptions and methodology used to project the utilization required by this Rule.












SECTION .4000 - CRITERIA AND STANDARDS FOR HOSPICE INPATIENT FACILITIES AND

HOSPICE RESIDENTIAL CARE FACILITIES



(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.












(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


(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.










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