SUBCHAPTER 14C – CERTIFICATE OF NEED REGULATIONS

 

SECTION .0100 - GENERAL

 

10a NCAC 14C .0101       DEFINITIONS

(a)  The definitions in G.S. 131E-176 shall apply to all the rules of this Subchapter.

(b)  "Home health agency office", as that phrase is used in G.S. 131E-176(9b) and G.S. 131E-176(16)o, means:

(1)           any site that is marketed or advertised as a place from which home health services are provided or for which a physical address or phone number for home health services is listed in the yellow or white pages of any telephone directory, any directory of home health agencies, any inventory of home health services, any promotional material, any agency letterhead, or any other documents distributed to the public; or

(2)           any site at which patients are accepted for home health services and regulatory responsibility and authority are assumed for organizing, implementing and evaluating a plan of care to meet the medical, nursing and social needs of the patient; or

(3)           any site at which staff are based to serve home health patients, excluding sites of a third party with which the home health agency subcontracts or private residences of employees; or

(4)           any site at which original client service records or patient medical records of current clients are maintained or stored.

(c)  "In use", as that phrase is used in G.S. 131E-176(16)s, means frequent, regular, periodic, or recurrent use of equipment and not occasional, sporadic, isolated, or incidental use of equipment.

 

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

Eff. January 1, 1990;

Amended Eff. November 1, 1996.

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.

 

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.

 

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

(a)  An applicant which desires an expedited review shall submit a petition for an expedited review with the Certificate of Need Section when the application is submitted.

(b)  The Certificate of Need Section shall review the petition within 15 days from the beginning of the review and shall notify the applicant if the Agency has determined that a public hearing is in the public interest.

(c)  If the Certificate of Need Section decides that it is not in the public interest to hold a public hearing, a final determination on the request for an expedited review shall not be issued until after the thirty day written comment period has expired.

(d)  If a request for a public hearing is received by the Agency during the 30 day written comment period, which is defined in G.S. 131E-185, the request for an expedited review shall be denied.

(e)  After the thirty day written comment period, the Certificate of Need Section shall notify the applicant that its petition for an expedited review is approved or denied.

 

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);

Eff. January 4, 1994.

 

10A NCAC 14C .0207       AGENCY DECISION

(a)  The agency shall determine whether a proposal is consistent with the review criteria set forth in G.S. 131E‑183 and the standards, plans, and criteria promulgated thereunder in effect at the time the review commences.  The agency shall determine which standards, plans, and criteria are applicable to the proposal.  If a proposal is consistent with all applicable standards, plans, and criteria, the agency decision shall be to issue the certificate of need.  If a proposal is not consistent with all applicable standards, plans, and criteria, the agency decision shall be to either not issue the certificate of need or issue one subject to those conditions necessary to insure that the proposal is consistent with applicable standards, plans, and criteria.  The agency may only impose conditions which relate directly to applicable standards, plans, and criteria.

(b)  The written agency decision shall include the following:

(1)           the basis for the decision;

(2)           the findings regarding the extent to which the proposal meets the criteria set forth in G.S. 131E‑183;

(3)           the time when the service or equipment is to be available or the project completed and the timetable to be followed; and

(4)           the approved capital expenditure for the project.

(c)  The agency decision and findings shall be sent to the applicant. The agency decision shall be sent to aggrieved persons as required under N.C.G.S. 150B‑23.  Any other person may obtain a copy of an agency decision and findings by requesting them from the agency, for which there will be a charge to cover the cost of reproducing the document.

 

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

Eff. October 1, 1981;

Amended Eff. January 1, 1990.

 

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

(a)  A certificate shall not be issued until 30 days after the date of the final decision under 10A NCAC 14C .0207.  If no request for a contested case hearing is received by the agency within that time, the agency shall issue the certificate.  If a request for a contested case hearing is received within that time, the certificate shall not be issued until the final agency decision from the contested case hearing has been issued.

(b)  The certificate, or attachments, shall specify:

(1)           the scope of the project;

(2)           the physical location of the project;

(3)           the person to whom the certificate was issued;

(4)           the maximum capital expenditure, if any, which may be obligated under the certificate;

(5)           the timetable to be followed in making the service or equipment available or in completing the project; and

(6)           when the first progress report under 10A NCAC 14C .0209 is due.

(c)  The effective date of the issuance of a certificate shall be the first day after the 30 day appeal period expires, the date the agency receives notice of withdrawal of the request for a contested case hearing, the date of the Department's final decision made in accordance with G.S. 131E‑188(a), or the date the agency determines that the conditions of approval are satisfied, whichever is latest.

 

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

Eff. October 1, 1981;

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

 

10A NCAC 14C .0209       PROGRESS REPORTS

(a)  The holder of a certificate of need shall submit a report on the progress made in making the service or equipment available or in completing the project.  These reports shall also include information as to the total dollar amount of capital expenditures which have been obligated under the certificate, and any changes in amounts of proposed or previously obligated capital expenditures.  These reports will be made on a form provided by the agency and will be due on the date or dates indicated by the agency on the Certificate of Need and in subsequent correspondence.

(b)  The agency may also request additional reports as often as necessary in order to determine:

(1)           if the timetable specified in the certificate is being met;

(2)           if the scope of the project is being completed as described on the certificate and in the application for the certificate of need;

(3)           if the amount of the capital expenditure or expenditures obligated under the certificate has exceeded or can be expected to exceed the maximum under the certificate; and

(4)           if the condition(s) of approval have been satisfactorily met.

 

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

Eff. October 1, 1981;

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

 

section .0300 - exemptions

 

10A NCAC 14c .0301       RESEARCH ACTIVITY

(a)  Under G.S. 131E‑179 a health care facility may apply to the agency for an exemption from obtaining a certificate of need for any of the following if they are to be used solely for research:

(1)           acquisition of major medical equipment;

(2)           the offering of institutional health services; or

(3)           the incurring of the obligation of a capital expenditure.

If any of the foregoing is used to provide patient care on an occasional and irregular basis and not as a part of the research program, the agency will not deny any request for an exemption solely on that basis.

(b)  The exemption shall be granted if notice is filed in accordance with this Rule and if the notice shows that the proposed new institutional health service will not:

(1)           affect the charges of the health care facility for the provision of medical or other patient care services other than the services which are included in research;

(2)           substantially change the bed capacity of the facility; or

(3)           substantially change the medical or other patient care services of the facility.

(c)  The notice required by G.S. 131E‑179 shall be given on a form "Notice of Proposed Research Activity."  This form may be obtained by contacting the agency at the address and telephone number stated in 10A NCAC 14C .0102.

(d)  The notice must be completed and delivered to the agency before the new institutional health service is offered or developed.  The notice is not filed in accordance with this Rule until the notice is deemed complete.

(e)  The agency shall promptly acknowledge in writing receipt of the notice.  The notice shall be deemed complete unless the agency, within seven days after receipt, mails a letter to the person submitting the notice which states that the notice was incomplete and specifies what information is necessary to make it complete.  As soon as the requested information is delivered to the agency, the notice shall be deemed complete and filed in accordance with this Rule.

(f)  Within 30 days after receipt of a completed notice, the agency shall notify the health care facility submitting the notice whether the agency has granted the exemption.  If the exemption has been granted, the health care facility may proceed to offer and develop the new institutional health service.  If a certificate of need is required, the notice and review under this Rule shall be deemed to be in compliance with 10A NCAC 14C .0201.

(g)  Any affected person, as defined in G.S. 131E‑188(c), may obtain a contested case hearing on a decision of the agency under this Rule by following procedures set forth in G.S. 150B and G.S. 131E-188.

 

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.

 

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

If psychiatric beds are established pursuant to G.S. 131E-184(c), those beds shall remain psychiatric beds only as long as the contract required in G.S. 131E-184(c) remains in effect. If that contract is terminated, then the facility shall:

(1)           obtain a certificate of need to convert the psychiatric beds back to acute care beds prior to termination of the contract, or

(2)           terminate the provision of psychiatric services in the beds.

 

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

Eff. November 1, 1996.

 

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.

 

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

(a)  In determining the amount of a penalty assessed for a violation in accordance with G.S. 131E-190(f), the Agency may consider, but is not limited to, the following factors in evaluating the degree and extent of harm and the cost of rectifying the damage caused by the violation:

(1)           the amount of revenues derived as a consequence of offering the service; and

(2)           the amount of the unauthorized capital expenditure; and

(3)           the amount expended in excess of 115 percent of the approved capital expenditure of a certificate of need; and

(4)           the person's record of compliance with the Certificate of Need Law and with the terms and conditions of any other certificate of need issued to that person; and

(5)           the degree of completion of the project; and

(6)           the number of patients served as a consequence of the violation; and

(7)           the number of procedures performed or treatments offered as a consequence of the violation; and

(8)           the number of days a service is offered as a consequence of the violation; and

(9)           whether the violation duplicates an existing or approved health service capability or facility; and

(10)         whether the conduct violated any judicial or administrative order, injunction, decree, or decision; and

(11)         whether the person impeded or attempted to obstruct the Department's investigation of the current violation; and

(12)         whether the development ceased prior to the offering of a new institutional health service; and

(13)         whether the person voluntarily terminated the project prior to the Department's investigation of the violation; and

(14)         whether the person voluntarily and truthfully cooperated with the Department's investigation of the violation.

(b)  Payment of the penalty shall be due within 60 days from the date of notification of the penalty.

 

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

Eff. November 1, 1996.

 

10A NCAC 14C .0502       WITHDRAWAL OF A CERTIFICATE

(a)  Before the agency withdraws a certificate of need, pursuant to G.S. 131E-189, it shall give the holder an opportunity to demonstrate why the certificate of need should not be withdrawn.

(b)  Ownership of a certificate of need is transferred when any person acquires a certificate from the holder by purchase, donation, lease, trade, or any comparable arrangement, except that ownership of a certificate of need is not transferred when:

(1)           the holder of the certificate is a corporation and the identity of the holder changes because of a corporate reorganization; or

(2)           the holder of the certificate is a partnership and the identity of the holder changes because the same partners reorganize as a new partnership.

(c)  Control of a certificate of need is transferred when any person acquires a majority interest in the facility, project or holder or any parent entity of the facility, project or holder.

(d)  "Parent entity" means any person that directly or indirectly controls the facility, project or holder of a certificate.

(e)  A transfer of ownership or control of a facility, project, or certificate shall not be grounds for the withdrawal of the certificate of need, pursuant to G.S. 131E-189, if the transfer occurs after the completion of the project or the operation of the facility.

 

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

Authority G.S. 131E-177; 131E-189;

Eff. October 1, 1981;

Amended Eff. November 1, 1996; March 1, 1991; January 1, 1990.

 

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

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

(1)           "Intensive care services" means those services provided by an acute care hospital to patients with a wide variety of illnesses of a life-threatening nature, including patients with highly unstable conditions which require sophisticated medical and surgical intervention and a high level of nursing care and those patients which require continuous, comprehensive observation.

(2)           "Intensive care unit" means a separate self-sufficient entity which has all supplies, equipment, and staff necessary to offer intensive care services twenty-four hours a day, seven days a week.  The term does not include post-operative recovery rooms, post-delivery rooms, or emergency observation units.

 

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

Eff. January 4, 1994.

 

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

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

(1)           the overall average annual occupancy rate of all intensive care beds in the facility, excluding neonatal and pediatric intensive care beds, over the 12 months immediately preceding the submittal of the proposal, shall have been at least 70 percent for facilities with 20 or more intensive care beds, 65 percent for facilities with 10-19 intensive care beds, and 60 percent for facilities with 1-9 intensive care beds; and

(2)           the projected occupancy rate for all intensive care beds in the applicant's facility, exclusive of neonatal and pediatric intensive care beds, shall be at least 70 percent for facilities with 20 or more intensive care beds, 65 percent for facilities with 10-19 intensive care beds, and 60 percent for facilities with 1-9 intensive care beds, in the third operating year following the completion of the proposed project.

(b)  All assumptions and data supporting the methodology by which the occupancy rates are projected shall be provided.

 

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

Eff. January 4, 1994.

 

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

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

(1)           "Pediatric intensive care service area" means a geographic area defined by the applicant from which the patients to be admitted to the unit will originate.

(2)           "Pediatric intensive care services" means those services provided by an acute care hospital to children with a wide variety of illnesses of a life-threatening nature, including children with highly unstable conditions requiring sophisticated medical and surgical intervention, children requiring a high level of nursing care and those children requiring continuous, comprehensive observation.

(3)           "Pediatric intensive care unit" means a separate self-sufficient entity that contains supplies and equipment essential to provide treatment on a 24-hour basis to children who need pediatric intensive care services.  It does not include post-operative recovery rooms, post-delivery rooms, or emergency observation units.

 

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

Eff. January 4, 1994.

 

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

(a)  An applicant proposing to develop a new pediatric intensive care unit or to add a bed to an existing pediatric intensive care unit shall demonstrate that the following standards are met:

(1)           the overall average annual occupancy rate of the number of beds in the applicant's existing pediatric intensive care unit for the twelve months immediately preceding the submittal of the application shall have been at least 70 percent in units with 20 or more pediatric intensive care beds, 65 percent in units with 10-19 pediatric intensive care beds, and 60 percent in units with 1-9 pediatric intensive care beds; and

(2)           the projected annual occupancy rate of the applicant's new or expanded pediatric intensive care unit in the third year of operation following completion of the proposed project shall be at least 70 percent in units with 20 or more pediatric intensive care beds, 65 percent in units with 10-19 pediatric intensive care beds, and 60 percent in units with 1-9 pediatric intensive care beds.

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

 

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

Eff. January 4, 1994;

Amended Eff. November 1, 1996.

 

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

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)           "Continuous care" means care as defined in 42 CFR 418.204, the Hospice Medicare Regulations.

(5)           "Homemaker services" means services provided to assist the patient with personal care, maintenance of a safe and healthy environment and implementation of the patient's care plan.

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

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

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

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

(10)         "Interdisciplinary team" means personnel as defined in G.S. 131E-201(6).

(11)         "Palliative care" means treatment as defined in G.S. 131E-201(8).

(12)         "Respite care" means care provided as defined in 42 CFR 418.98.

 

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.

 

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

An applicant proposing to develop a hospice shall demonstrate that no less than 80 percent of the total combined number of days of hospice care furnished to Medicaid and Medicare patients will be provided in the patients' residences in accordance with 42 CFR 418.302(f)(2).

 

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.

 

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

The rules set forth in this Section shall apply to applications for diagnostic centers for which specific criteria and standards have not otherwise been promulgated in 10A NCAC 14C.

 

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.

 

10A NCAC 14C .1802       DEFINITIONS

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

(1)           "Approved diagnostic center" means a diagnostic center that was not operational prior to the beginning of the review period but that had been issued a certificate of need or had been developed prior to March 18, 1993 in accordance with 1993 N.C. Sess. Laws c. 7, s. 12.

(2)           "Diagnostic center" shall have the same meaning as defined in G.S. 131E-176(7a).

(3)           "Diagnostic center service area" means the geographic area, as defined by the applicant, for which the proposed diagnostic center will provide services.

(4)           "Diagnostic procedure" means a discrete diagnostic procedure with a distinct CPT code or ICD-9-CM procedure code performed on one patient during one visit to a diagnostic suite.

(5)           "Diagnostic suite" means a single room or group of rooms in a diagnostic center which is used for the purpose of conducting diagnostic procedures.

(6)           "Essential" means those items which are indispensable, the absence of which renders the equipment useless.

(7)           "Existing diagnostic center" means a diagnostic center in operation prior to the beginning of the review period.

(8)           "Freestanding diagnostic center" means a diagnostic center that is not operated as a part of another health service facility but rather as a discrete business entity.  A freestanding diagnostic center may be owned by another health service facility and may be located on the campus of another health service facility.

(9)           "Medical diagnostic equipment" means a single piece of diagnostic equipment or a single component of a multi-component diagnostic system which costs ten thousand dollars ($10,000) or more, or whose fair market value is ten thousand dollars ($10,000) or more.

(10)         "Mobile medical diagnostic equipment" means medical diagnostic equipment and transporting equipment which is moved to provide services at two or more host facilities.

(11)         "Mobile diagnostic program" means the provision of diagnostic services using mobile medical diagnostic equipment and transporting equipment at two or more host facilities.

(12)         "Radiologic technologist or X-Ray technician" means a person who, under the supervision of a physician radiologist, operates radiologic equipment and assists radiologists and other health professionals, and whose competence has been tested and approved by the American Registry of Radiologic Technologists.

 

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;

Eff. January 4, 1994;

Amended Eff. November 1, 1996.

 

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

An applicant proposing to establish a new diagnostic center or to expand an existing diagnostic center shall provide:

(1)           documentation that all existing health service facilities providing similar medical diagnostic equipment and services as proposed in the CON application in the defined diagnostic center service area were operating at 80% of the maximum number of procedures that the equipment is capable of performing for the twelve month period immediately preceding the submittal of the application;

(2)           documentation that all existing and approved medical diagnostic equipment and services of the type proposed in the CON application are projected to be utilized at 80% of the maximum number of procedures that the equipment is capable of performing by the fourth quarter of the third year of operation following initiation of diagnostic services;

(3)           documentation that the applicant's utilization projections are based on the experience of the provider and on epidemiological studies; and

(4)           all the assumptions and data supporting the methodologies used for the projections in this Rule.

 

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

Eff. November 1, 1996.

 

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

(2)           "Operating room" means a room as defined in G.S. 131E-176(18c), which includes an inpatient operating room, an outpatient or ambulatory surgical operating room, or a shared operating room.

(3)           "Ambulatory surgical program" means a program as defined in G.S. 131E-176(1c).

(4)           "Dedicated cesarean section operating room" means an operating room as defined in the applicable State Medical Facilities Plan.

(5)           "Existing operating rooms" means those operating rooms in ambulatory surgical facilities and hospitals which were reported in the License Application for Ambulatory Surgical Facilities and Programs and in Part III of Hospital Licensure Renewal Application Form submitted to the Acute and Home Care Licensure and Certification Section of the Division of Health Service Regulation and which were licensed and certified prior to the beginning of the review period.

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

(7)           "Multispecialty ambulatory surgical program" means a program as defined in G.S. 131E-176(15a).

(8)           "Outpatient or ambulatory surgical operating room" means an operating room used solely for the performance of surgical procedures which require local, regional or general anesthesia and a period of post-operative observation of less than 24 hours.

(9)           "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).

(10)         "Service area" means the Operating Room Service Area as defined in the applicable State Medical Facilities Plan.

(11)         "Shared operating room" means an operating room that is used for the performance of both ambulatory and inpatient surgical procedures.

(12)         "Specialty area" means an area of medical practice in which there is an approved medical specialty certificate issued by a member board of the American Board of Medical Specialties and includes the following: gynecology, otolaryngology, plastic surgery, general surgery, ophthalmology, urology, orthopedics, and oral surgery.

(13)         "Specialty ambulatory surgical program" means a program as defined in G.S. 131E-176(24c).

(14)         "Surgical case" means an individual who receives one or more surgical procedures in an operating room during a single operative encounter.

 

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.

 

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)  In projecting utilization, the operating rooms shall be considered to be available for use five days per week and 52 weeks a year.

(b)  A proposal to establish a new ambulatory surgical facility, to establish a new campus of an existing facility, to establish a new hospital, to increase the number of operating rooms in an existing facility (excluding dedicated C-section operating rooms), to convert a specialty ambulatory surgical program to a multispecialty ambulatory surgical program or to add a specialty to a specialty ambulatory surgical program shall:

(1)           demonstrate the need for the number of proposed operating rooms in the facility which is proposed to be developed or expanded in the third operating year of the project based on the following formula: {[(Number of facility's projected inpatient cases, excluding trauma cases reported by Level I or II trauma centers, cases reported by designated burn intensive care units and cases performed in dedicated open heart and C-section rooms, times 3.0 hours) plus (Number of facility's projected outpatient cases times 1.5 hours)] divided by 1872 hours} minus the facility's total number of existing and approved operating rooms and operating rooms proposed in another pending application, excluding one operating room for Level I or II trauma centers, one operating room for facilities with designated burn intensive care units, and all dedicated open heart and C-section operating rooms or demonstrate conformance of the proposed project to Policy AC-3 in the State Medical Facilities Plan titled "Exemption From Plan Provisions for Certain Academic Medical Center Teaching Hospital Projects;" and

(2)           The number of rooms needed is determined as follows:

(A)          in a service area which has more than 10 operating rooms, if the difference is a positive number greater than or equal to 0.5, then the need is the next highest whole number for fractions of 0.5 or greater and the next lowest whole number for fractions less than 0.5; and if the difference is a negative number or a positive number less than 0.5, then the need is zero;

(B)          in a service area which has 6 to 10 operating rooms, if the difference is a positive number greater than or equal to 0.3, then the need is the next highest whole number for fractions of 0.3 or greater and the next lowest whole number for fractions less than 0.3, and if the difference is a negative number or a positive number less than 0.3, then the need is zero; and

(C)          in a service area which has five or fewer operating rooms, if the difference is a positive number greater than or equal to 0.2, then the need is the next highest whole number for fractions of 0.2 or greater and the next lowest whole number for fractions less than 0.2; and if the difference is a negative number or a positive number less than 0.2, then the need is zero.

(c)  A proposal to increase the number of operating rooms (excluding dedicated C-section operating rooms) in a service area shall:

(1)           demonstrate the need for the number of proposed operating rooms in addition to the rooms in all of the licensed facilities identified in response to 10A NCAC 14C .2102(b)(2) in the third operating year of the proposed project based on the following formula:  {[(Number of projected inpatient cases for all the applicant's or related entities' facilities, excluding trauma cases reported by Level I or II trauma centers, cases reported by designated burn intensive care units and cases performed in dedicated open heart and C-section rooms, times 3.0 hours) plus (Number of projected outpatient cases for all the applicant's or related entities' facilities times 1.5 hours)] divided by 1872 hours} minus the total number of existing and approved operating rooms and operating rooms proposed in another pending application, excluding one operating room for Level I or II trauma centers, one operating room for facilities with designated burn intensive care units, and all dedicated open heart and C-Section operating rooms in all of the applicant's or related entities' licensed facilities in the service area; and

(2)           The number of rooms needed is determined as follows:

(A)          in a service area which has more than 10 operating rooms, if the difference is a positive number greater than or equal to 0.5, then the need is the next highest whole number for fractions of 0.5 or greater and the next lowest whole number for fractions less than 0.5; and if the difference is a negative number or a positive number less than 0.5, then the need is zero;

(B)          in a service area which has 6 to 10 operating rooms, if the difference is a positive number greater than or equal to 0.3, then the need is the next highest whole number for fractions of 0.3 or greater and the next lowest whole number for fractions less than 0.3, and if the difference is a negative number or a positive number less than 0.3, then the need is zero; and

(C)          in a service area which has five or fewer operating rooms, if the difference is a positive number greater than or equal to 0.2, then the need is the next highest whole number for fractions of 0.2 or greater and the next lowest whole number for fractions less than 0.2; and if the difference is a negative number or a positive number less than 0.2, then the need is zero.

(d)  An applicant that has one or more existing or approved dedicated C-section operating rooms and is proposing to develop an additional dedicated C-section operating room in the same facility shall demonstrate that an average of at least 365 C-sections per room were performed in the facility's existing dedicated C-section operating rooms in the previous 12 months and are projected to be performed in the facility's existing, approved and proposed dedicated C-section rooms during the third year of operation following completion of the project.

(e)  An applicant proposing to convert a specialty ambulatory surgical program to a multispecialty ambulatory surgical program or to add a specialty to a specialty ambulatory surgical program shall:

(1)           provide documentation to show that each existing ambulatory surgery program in the service area that performs ambulatory surgery in the same specialty area as proposed in the application is currently utilized an average of at least 1,872 hours per operating room per year, excluding dedicated open heart and C-Section operating rooms. The hours utilized per operating room shall be calculated as follows:  [(Number of projected inpatient cases, excluding open heart and C-sections performed in dedicated rooms, times 3.0 hours) plus (Number of projected outpatient cases times 1.5 hours)] divided by the number of operating rooms, excluding dedicated open heart and C-Section operating rooms; and

(2)           demonstrate the need in the third operating year of the project based on the following formula:  [(Total number of projected outpatient cases for all ambulatory surgery programs in the service area times 1.5 hours) divided by 1872 hours] minus the total number of existing, approved and proposed outpatient or ambulatory surgical operating rooms and shared operating rooms in the service area.  The need is demonstrated if the difference is a positive number greater than or equal to one, after the number is rounded to the next highest number for fractions of 0.50 or greater.

(f)  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.

 

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

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

(1)           "Allogeneic bone marrow transplantation services" means the procedure by which the bone marrow of a person other than the patient is infused after treating the patient for disease.

(2)           "Approved bone marrow transplantation service" means an allogeneic or an autologous bone marrow transplantation service which was not operational prior to the beginning of the review period but which had been issued a certificate of need or had been developed and offered prior to March 18, 1993 in accordance with 1993 N.C. Sess. Laws c. 7, s. 12.

(3)           "Autologous bone marrow transplantation services" means the process of reinfusing the patient's own bone marrow after treating the patient for disease.

(4)           "Bone marrow transplantation service area" means a geographic area defined by the applicant from which patients to be admitted to the service will originate.

(5)           "Bone marrow transplantation services" is defined in G.S. 131E-176(2a).

(6)           "Cryopreservation" means the process of preserving tissue by freezing at very low temperatures.

(7)           "Existing bone marrow transplantation service" means an allogeneic or an autologous bone marrow transplantation service in operation prior to the beginning of the review period.

 

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.

 

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

(a)  An applicant that proposes to provide new or expanded autologous or allogeneic bone marrow transplantation services shall demonstrate that:

(1)           all existing facilities within the applicant's bone marrow transplantation service area which have been offering bone marrow transplantation services for at least two years shall have performed at least 20 transplants during the most recent 12 month period;

(2)           all existing and approved facilities within the applicant's bone marrow transplantation service area will provide at least 20 transplants during the second year of operation following completion of the project; and

(3)           the projected utilization for the new or expanded bone marrow transplantation program shall perform at least 20 transplants during the second year of operation following completion of the project.

(b)  An applicant that proposes to provide new or expanded autologous or allogeneic bone marrow transplantation services shall describe all of the assumptions and methodologies used to calculate the projections requested in Subparagraphs (a)(2) and (3) of this Rule.

(c)  An applicant that proposes the use of bone marrow transplantation services for clinical use shall demonstrate that all equipment, supplies and pharmaceuticals proposed for the service have been certified for clinical use by the U.S. Food and Drug Administration or will be operated under an institutional review board whose membership is consistent with U.S. Department of Health and Human Services' regulations.

 

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.

 

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

The rules set forth in this Section shall apply to applications for major medical equipment, including new major medical technology, for which specific criteria and standards have not otherwise been promulgated in 10A NCAC 14C.

 

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.

 

10A NCAC 14C .3102       DEFINITIONS

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

(1)           "Essential" means those items which are indispensable, the absence of which renders the equipment useless.

(2)           "Major Medical Equipment" is defined in G.S. 131E-176(14f).

(3)           "Mobile Major Medical Equipment" means major medical equipment and transporting equipment which is moved to provide services at two or more host facilities.

(4)           "New Major Medical Technology" means major medical equipment that:

(a)           has been approved for clinical use by the U.S. Food and Drug Administration or shall be operated in accordance with protocols approved by an institutional review board whose membership is consistent with the U.S. Department of Health and Human Services' regulations;

(b)           is intended for use in the diagnosis or treatment of medical conditions;

(c)           meets the definition of major medical equipment in G.S. 131E-176(14f); and

(d)           is so new that no state or national utilization data is readily available to the Agency for the development of specific criteria and standards.

 

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

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

Eff. January 4, 1994.

 

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

(a)  An applicant proposing to acquire major medical equipment shall provide the following information:

(1)           the number of patients who will use the service, classified by diagnosis;

(2)           the number of patients who will use the service, classified by county of residence;

(3)           documentation of the maximum number of procedures that existing equipment that is used for similar procedures in the facility is capable of performing;

(4)           quarterly projected utilization of the applicant's existing and proposed equipment three years after the completion of the project; and

(5)           all the assumptions and data supporting the methodology used for the projections in this Rule.

(b)  An applicant proposing to acquire new major medical technology shall provide the following information:

(1)           the number of patients who will use the service, classified by diagnosis;

(2)           the number of patients who will use the service, classified by county of residence;

(3)           quarterly projected utilization of the applicant's  proposed new major medical technology three years after the completion of the project;

(4)           documentation that the applicant's utilization projections are based on the experience of the provider and on epidemiological studies;

(5)           documentation of the effect the new major medical technology may have on existing major medical technology and procedures offered at its facility and other facilities in the proposed service area; and

(6)           all the assumptions and data supporting the methodology used for the projections in this Rule.

 

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.

 

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, 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

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

(1)           "Approved burn intensive care unit" means a burn intensive care unit which was not operational prior to the beginning of the review period but which had been issued a certificate of need or had been developed prior to March 18, 1993 in accordance with 1993 N.C. Sess. Laws c. 7, s. 12.

(2)           "Burn care technician" means:

(a)           a licensed practical nurse;

(b)           an operating room technician;

(c)           an operating room corpsman; or

(d)           a high school graduate with basic nurse aide training who has received special education or experience in burn treatment care.

(3)           "Burn intensive care services" as defined in G.S. 131E-176(2b).

(4)           "Burn intensive care service area" means a geographic area defined by the applicant from which the patients to be admitted to the unit will originate.

(5)           "Burn intensive care unit" means a designated area within a hospital dedicated to the provision of burn intensive care services to severely burned patients.

(6)           "Burn specialist" means a registered nurse who possesses experience in general nursing and experience in or knowledge of intensive nursing care and burn treatment care.

(7)           "Existing burn intensive care unit" means a burn intensive care unit in operation prior to the beginning of the review period.

(8)           "Severely burned patient" means a patient that has burns covering more than 20 percent of the body area or that has burns which require intensive treatment, such as, but not limited to: inhalation injuries; chemical and electrical burns; burns with complications, such as fractures; burns to the face; full thickness burns to the hands and feet; burns on patients whose pre-burned health was known to be poor, such as patients with diabetes or heart disease; and, burns on patients who are under 5 and over 60 years of age.

 

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;

Eff. January 4, 1994;

Amended Eff. November 1, 1996.

 

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

(a)  An applicant proposing to develop a new burn intensive care unit or to add a bed to an existing or approved burn intensive care unit shall demonstrate that:

(1)           the existing burn intensive care units in the state had an overall average occupancy rate of at least 80 percent for the last year, which shall be calculated by dividing the total number of bed days utilized in the last year by severely burned patients in all facilities in the state that have burn intensive care units, by the total number of burn intensive care unit beds in all facilities in the state that have burn intensive care units multiplied by 365 days;

(2)           the average occupancy rate of the applicant's existing unit for the last year was at least 70% in units with 20 or more beds, 65% in units with 10 to 19 beds, and 60% in units with 1 to 9 beds;

(3)           the applicant's unit shall be utilized at an annual occupancy rate of at least 70% in units with 20 or more beds, 65% in units with 10 to 19 beds, and 60% in units with 1 to 9 beds, no later than 2 years following completion of the proposed project; and

(4)           each existing or approved burn intensive care unit shall be projected to be utilized at an annual occupancy rate of at least 70% in units with 20 or more beds, 65% in units with 10 to 19 beds, and 60% in units with 1 to 9 beds, no later than 2 years following completion of the applicant's proposed project.

(b)  The calculation of occupancy rates in this Rule shall be based only on severely burned patients.

(c)  The applicant shall document all assumptions and data supporting the methodology used for all occupancy rates projected in this Rule.

 

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.

 

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

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

(1)           "Approved gamma knife" means a gamma knife which was not operational prior to the beginning of the review period but which had been issued a certificate of need or had been acquired prior to March 18, 1993 in accordance with 1993 N.C. Sess. Laws c. 7, s. 12.

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

(3)           "Gamma knife" is defined in G.S. 131E-176(7c).

(4)           "Gamma knife procedure" means a radiation dosage delivered in one treatment session.

(5)           "Gamma knife service area" means the geographic area defined by the 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.

 

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

An applicant proposing to acquire a gamma knife shall:

 (1)          demonstrate that the gamma knife shall be utilized at an annual rate of at least 250 procedures per machine based on utilization in the fourth quarter of the third year of operation following completion of the project, multiplied by four, and shall provide all assumptions and data supporting the methodology used for the projections;

(2)           provide the number of procedures projected to be performed for clinical purposes and the number of procedures projected to be performed for research purposes in each of the first operating years of the proposed gamma knife.

 

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.

 

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.

 

10A ncac 14C .3906       FACILITY

(a)  An applicant proposing to establish a licensed ambulatory surgical facility that will be physically located in a physician's office or within a general acute care hospital shall demonstrate reporting and accounting mechanisms exist that confirm the licensed ambulatory surgery facility is a separately identifiable entity physically and administratively, and is financially independent and distinct from other operations of the facility in which it is located.

(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 commit to obtain accreditation and to submit documentation of accreditation of the facility by The Accreditation Association for Ambulatory Health Care, The Joint Commission on Accreditation of Healthcare Organizations, or The American Association for Accreditation of Ambulatory Surgical Facilities within one year of completion of the proposed project.

(c)  If the facility is not accredited at the time the application is submitted, 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:

(1)           document that the physical environment of the facility conforms to the requirements of federal, state, and local regulatory bodies.

(2)           provide a floor plan of the proposed facility identifying the following areas:

(A)          receiving/registering area;

(B)          waiting area;

(C)          pre-operative area;

(D)          procedure room by type; and

(E)           recovery area.

(3)           demonstrate that the procedure room suite is separate and physically segregated from the general office area; and

(4)           document that the applicant owns or otherwise has control of the site on which the proposed facility or GI endoscopy rooms will be located.

 

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

Temporary Adoption Eff. February 1, 2006;

Eff. November 1, 2006.

 

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.