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

(a)  The North Carolina State Medical Facilities Plan contains the following information:

(1)           inventory of certain categories of inpatient and outpatient health care facilities, including number of beds and utilization of beds;

(2)           type of services provided by each category of health care facility;

(3)           projections of need for acute care hospitals (including rehabilitation services), long‑term care facilities (including nursing homes, home health agencies, and hospice inpatient facilities), mental health facilities and end stage renal dialysis services for various geographical areas of the state;

(4)           statement of policies related to acute care facilities, rehabilitation services, long‑term care, psychiatric facilities, chemical dependency facilities, and facilities for intermediate care for the mentally retarded, which are used with other criteria contained in this Subchapter and in G.S. 131E‑183 and need projections to determine whether applications proposing additional beds and services of these types may be approved under the certificate of need program; and

(5)           the certificate of need review schedule and description of review categories.

(b)  The annually published State Medical Facilities Plan approved by the Governor, and any duly adopted amendments or additions thereto, is hereby adopted by reference pursuant to G.S. 150B‑14(c) as a rule for the calendar year during which it is in effect.

(c)  This plan may be purchased from the Division of Health Service Regulation, 701 Barbour Drive, Raleigh, North Carolina.  This plan is also available for inspection at the Division of Health Service Regulation.

 

History Note:        Filed as a Temporary Amendment Eff. January 1, 1983 for a Period of 120 Days to Expire on May 1, 1983;

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

Eff. June 19, 1979;

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

 

section .0200 – application and review process

 

10A NCAC 14C .0201       LETTER OF INTENT

(a)  Potential applicants may contact the agency as soon as possible after determining the scope or possible scope of the project to determine on a preliminary basis whether a certificate of need is required, which review schedule or schedules might be applicable, and to address any other questions that may arise.

(b)  An applicant shall file a letter of intent with the agency no later than the date the application is required to be submitted to the agency in 10A NCAC 14C .0203.  A conference with the agency may be substituted for the letter of intent.  The conference may be held at the agency or by telephone.

(c)  The letter of intent or conference shall describe the:

(1)           project;

(2)           estimated total capital cost of the project; and

(3)           proposed filing date of the application.

(d)  If more than six months have passed since the filing of the letter of intent or the conference and an application has not been filed with the agency, a new letter of intent must be filed or another conference must be held before an application or applications are filed.

 

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

Eff. October 1, 1981;

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

 

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;

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;

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

Amended Eff. December 1, 1994; 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;

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

(a)  The CON Section will not issue a certificate of need to an applicant so long as any affected person has filed a petition for a contested case challenging the agency decision to award a certificate to that applicant and has posted a bond pursuant to N.C.G.S. 131E‑188.

(b)  A contested case hearing is available to any affected person on an agency decision to withdraw or not to withdraw a certificate of need.  The reasonableness of the approved timetable shall not be an issue at such a hearing.  That issue may only be addressed in a contested case hearing on the agency's decision to issue a certificate following the review of an application.

 

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

Eff. October 1, 1981;

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

 

10A NCAC 14C .0402       ISSUES

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

 

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

Contested case hearings shall be conducted in accordance with Article 3 of Chapter 150B of the General Statutes except for the timetables set forth in G.S. 131E‑188.

 

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

Eff. January 1, 1990.

 

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

(a)  An applicant proposing to establish new nursing facility or adult care home beds shall project an occupancy level for the entire facility for each of the first eight calendar quarters following the completion of the proposed project.  All assumptions, including the specific methodologies by which occupancies are projected, shall be stated.

(b)  An applicant proposing to establish new nursing facility or adult care home beds shall project patient origin by percentage by county of residence.  All assumptions, including the specific methodology by which patient origin is projected, shall be stated.

(c)  An applicant proposing to establish new nursing facility or adult care home beds shall show that at least 85 percent of the anticipated patient population in the entire facility lives within a 45 mile radius of the facility, with the exception that this standard shall be waived for applicants proposing to transfer existing certified nursing facility beds from a State Psychiatric Hospital to a community facility, facilities that are fraternal or religious facilities, or facilities that are part of licensed continuing care facilities which make services available to large or geographically diverse populations.

(d)  An applicant proposing to establish a new nursing facility or adult care home shall specify the site on which the facility will be located.  If the proposed site is not owned by or under the control of the applicant, the applicant shall specify at least one alternate site on which the services could be operated should acquisition efforts relative to the proposed site ultimately fail, and shall demonstrate that the proposed and alternate sites are available for acquisition.

(e)  An applicant proposing to establish a new nursing facility or adult care home shall document that the proposed site and alternate sites are suitable for development of the facility with regard to water, sewage disposal, site development and zoning including the required procedures for obtaining zoning changes and a special use permit after a certificate of need is obtained.

(f)  An applicant proposing to establish new nursing facility or adult care home beds shall provide documentation to demonstrate that the physical plant will conform with all requirements as stated in 10A NCAC 13D or 10A NCAC 13F, whichever is applicable.

 

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.

 

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

(a)  An applicant that proposes new or expanded intensive care services shall use the Acute Care Facility/Medical Equipment application form.

(b)  An applicant proposing new or expanded intensive care services shall submit the following information:

(1)           the number of intensive care beds currently operated by the applicant and the number of intensive care beds to be operated following completion of the proposed project;

(2)           documentation of the applicant's experience in treating patients at the facility during the past twelve months, including:

(A)          the number of inpatient days of care provided to intensive care patients;

(B)          the number of patients initially treated at the facility and referred to other facilities for intensive care services; and

(C)          the number of patients initially treated at other facilities and referred to the applicant's facility for intensive care services.

(3)           the projected number of patients to be served and inpatient days of care to be provided by county of residence by specialized type of intensive care for each of the first twelve calendar quarters following completion of the proposed project, including all assumptions and methodologies;

(4)           data from actual referral sources or correspondence from the proposed referral sources documenting their intent to refer patients to the applicant's facility;

(5)           documentation which demonstrates the applicant's capability to communicate effectively with emergency transportation agencies;

(6)           documentation of written policies and procedures regarding the provision of care within the intensive care unit, which includes the following:

(A)          the admission and discharge of patients;

(B)          infection control;

(C)          safety procedures; and

(D)          scope of services.

(7)           documentation that the proposed service shall be operated in an area organized as a physically and functionally distinct entity, separate from the rest of the facility, with controlled access;

(8)           documentation to show that the services shall be offered in a physical environment that conforms to the requirements of federal, state, and local regulatory bodies;

(9)           a floor plan of the proposed area drawn to scale; and

(10)         documentation of a means for observation by unit staff of all patients in the unit from at least one vantage point.

 

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.

 

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

(a)  An applicant proposing new or additional intensive care services shall document the extent to which the following items are available:

(1)           twenty-four hour on-call laboratory services including microspecimen chemistry techniques and blood gas determinations;

(2)           twenty-four hour on-call radiology services, including portable radiological equipment;

(3)           twenty-four hour blood bank services;

(4)           twenty-four hour on-call pharmacy services;

(5)           twenty-four hour on-call coverage by respiratory therapy;

(6)           oxygen and air and suction capability;

(7)           electronic physiological monitoring capability;

(8)           mechanical ventilatory assistance equipment including airways, manual breathing bag and ventila­tor/respirator;

(9)           endotracheal intubation capability;

(10)         cardiac pacemaker insertion capability;

(11)         cardiac arrest management plan;

(12)         patient weighing device for bed patients; and

(13)         isolation capability.

(b)  If any item in Subparagraphs (a)(1) - (13) of this Rule will not be available, the applicant shall document the reason why the item is not needed for the provision of the proposed services.

 

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

Eff. January 4, 1994;

Amended Eff. November 1, 1996.

 

10A NCAC 14C .1205       STAFFING AND STAFF TRAINING

The applicant shall demonstrate the ability to meet the following staffing requirements:

(1)           nursing care shall be supervised by a qualified registered nurse with specialized training in the care of critically ill patients, cardiovascular monitoring, and life support;

(2)           direction of the unit shall be provided by a physician with training, experience and expertise in critical care;

(3)           assurance from the medical staff that twenty-four hour medical and surgical on-call coverage is available; and

(4)           inservice training or continuing education programs shall be provided for the intensive care staff.

 

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

Eff. January 4, 1994.

 

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

(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 use the Acute Care Facility/Medical Equipment application form.

(b)  The applicant shall also submit the following additional information:

(1)           the number of designated pediatric intensive care beds currently operated by the applicant and the number of designated pediatric intensive care beds to be operated following completion of the proposed project;

(2)           documentation of the applicant's experience in treating pediatric patients at its facility during the past twelve months, including:

(A)          the number of pediatric trauma patients provided emergency room services;

(B)          the number of pediatric patients provided surgical and emergency surgical services;

(C)          the number of inpatient days of care provided to pediatric patients; and

(D)          the number of pediatric patients treated and referred to a pediatric intensive care unit in another facility;

(3)           the number of patients, by county of residence, in the proposed pediatric intensive care service area that are projected to need pediatric intensive care services in each of the first twelve quarters of operation following the completion of the project; also, all assumptions and methodologies for projecting need shall be stated;

(4)           the projected number, by county of residence, of those patients identified in response to Item (3) of this Rule that are projected to be served in the applicant's facility in each of the first twelve calendar quarters following completion of the proposed project; also, all assumptions and methodologies for projecting utilization shall be stated;

(5)           documentation that at least 90 percent of the anticipated patient population is within 90-minute automobile driving time one-way from the facility, unless the applicant demonstrates that its facility provides:

(A)          specialized levels of pediatric intensive care services to a large and geographically diverse population, or

(B)          air ambulance services;

(6)           documentation that the existing and approved pediatric intensive care units in the same service area and adjacent service areas are unable to accommodate the projected need for pediatric intensive care services;

(7)           documentation that the services shall be offered in conformance with the requirements of federal, state, and local regulatory bodies;

(8)           correspondence from physicians, hospitals, or other health care facilities documenting their intent to refer patient's to the applicant's pediatric intensive care unit;

(9)           evidence of the applicant's capability to communicate effectively with emergency transportation agencies;

(10)         copies of written policies that provide for parental participation in the care of the child, as the child's condition permits, in order to facilitate family adjustment and continuity of care following discharge;

(11)         copies of written policies and procedures regarding the operation of the pediatric intensive care unit, including but not limited to the following:

(A)          the admission and discharge of patients;

(B)          infection control;

(C)          safety procedures;

(D)          the triaging of patients requiring consultations, including the transfer of patients to another facility; and

(E)           the protocol for obtaining emergency physician care for a critically ill child;

(12)         documentation that the proposed service shall be operated in an area of the facility that is organized as a physically and functionally distinct entity and that has controlled access;

(13)         a detailed floor plan of the proposed area drawn to scale; and

(14)         documentation that unit staff shall be able to observe all patients from at least one vantage point.

 

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

Eff. January 4, 1994;

Amended Eff. November 1, 1996.

 

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

(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 document that the following items shall be available; except that if an item shall not be available, then documentation shall be provided obviating the need for that item:

(1)           twenty-four hour laboratory services including microspecimen chemistry techniques and blood gas determinations;

(2)           twenty-four hour radiology services, including portable radiological equipment;

(3)           twenty-four hour blood bank services;

(4)           twenty-four hour pharmacy services with pediatric dosage expertise;

(5)           twenty-four hour respiratory therapy services with pediatric expertise;

(6)           twenty-four hour CT scanning services;

(7)           EEG testing capability;

(8)           oxygen and air and suction capability;

(9)           pediatric specific cardiovascular monitoring capability with alarm capacity;

(10)         mechanical ventilatory assistance equipment including airways, manual breathing bag, ventilator and respirator of pediatric patient size;

(11)         endotracheal intubation capability;

(12)         a cardiac arrest management plan;

(13)         a patient weighing device for bed patients;

(14)         isolation capability;

(15)         a designated social worker;

(16)         consultation with the following medical subspecialties:

(A)          Pediatric Cardiology and cardiology diagnostic services;

(B)          Pediatric Surgery or surgeons with training or interest in pediatrics, including neurosurgery, otolaryngology and cardiothoracic surgery;

(C)          Pediatric Neurology; and

(D)          other pediatric subspecialties as required; and

(17)         pediatric expertise in the following areas:

(A)          physical therapy;

(B)          occupational therapy;

(C)          speech therapy; and

(D)          dietary support.

(b)  An applicant shall describe the types of patient care monitoring that shall be available to meet the specific needs of each type of patient that the applicant proposes to serve.

 

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

Eff. January 4, 1994;

Amended Eff. November 1, 1996.

 

10A NCAC 14C .1305       STAFFING AND STAFF TRAINING

(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 staffing requirements listed in this Rule shall be met or shall provide documentation obviating the need for an item:

(1)           nursing care shall be supervised by a registered nurse with training in the following:

(A)          patient care monitoring;

(B)          drug administration;

(C)          fluid and electrolyte administration;

(D)          respiratory care;

(E)           pediatric advanced life support certification;

(F)           pediatric growth and development; and

(G)          pediatric nursing skills;

(2)           direction of the unit shall be provided by a physician with training, experience and expertise in critical care; and

(3)           documentation from the medical staff confirming that pediatricians and surgeons of at least the resident or staff level shall be in the facility twenty-four hours per day.

(b)  An applicant shall document that inservice training or continuing education programs specific to pediatric intensive care services shall be provided to the pediatric intensive care staff and shall describe the inservice training and continuing care programs which shall be offered.

 

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

Eff. January 4, 1994;

Amended Eff. November 1, 1996.

 

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

(a)  An applicant proposing to develop a Level I nursery in the facility for the first time or new or additional Level II, III or IV neonatal beds shall use the Acute Care Facility/Medical Equipment application form.

(b)  An applicant proposing to develop a Level I nursery in the facility for the first time or new or additional Level II, III or IV neonatal beds shall provide the following information:

(1)           the current number of Level I nursery bassinets, Level II beds, Level III beds and Level IV beds operated by the applicant;

(2)           the proposed number of Level I nursery bassinets, Level II beds, Level III beds and Level IV beds to be operated following completion of the proposed project;

(3)           evidence of the applicant's experience in treating the following patients at the facility during the past twelve months, including:

(A)          the number of obstetrical patients treated at the acute care facility;

(B)          the number of neonatal patients treated in Level I nursery bassinets, Level II beds, Level III beds and Level IV beds, respectively;

(C)          the number of inpatient days at the facility provided to obstetrical patients;

(D)          the number of inpatient days provided in Level II beds, Level III beds and Level IV beds, respectively;

(E)           the number of high-risk obstetrical patients treated at the applicant's facility and the number of high-risk obstetrical patients referred from the applicant's facility to other facilities or programs; and

(F)           the number of neonatal patients referred to other facilities for services, identified by required level of neonatal service (i.e. Level II, Level III or Level IV);

(4)           the projected number of neonatal patients to be served identified by Level I, Level II, Level III and Level IV neonatal services for each of the first three years of operation following the completion of the project, including the methodology and assumptions used for the projections;

(5)           the projected number of patient days of care to be provided in Level I bassinets, Level II beds, Level III beds, and Level IV beds, respectively, for each of the first three years of operation following completion of the project, including the methodology and assumptions used for the projections;

(6)           if proposing to provide Level I or Level II neonatal services in the facility for the first time, documentation that at least 90 percent of the anticipated patient population is within 30 minutes driving time one-way from the facility;

(7)           if proposing to provide Level I or Level II neonatal services in the facility for the first time, documentation of a written plan to transport infants to Level III or Level IV neonatal services as the infant's care requires;

(8)           evidence that the applicant shall have access to a transport service with at least the following components:

(A)          trained personnel;

(B)          transport incubator;

(C)          emergency resuscitation equipment;

(D)          oxygen supply, monitoring equipment and the means of administration;

(E)           portable cardiac and temperature monitors; and

(F)           a mechanical ventilator;

(9)           documentation that the proposed service shall be operated in an area organized as a physically and functionally distinct entity with controlled access;

(10)         documentation to show that the new or additional Level I, Level II, Level III or Level IV neonatal services shall be offered in a physical environment that conforms to the requirements of federal, state, and local regulatory bodies;

(11)         a floor plan of the proposed area drawn to scale;

(12)         documentation of visual observation by unit staff of all patients from one or more vantage points; and

(13)         documentation that the floor space allocated to each bed and bassinet shall accommodate equipment and personnel to meet anticipated contingencies.

(c)  If proposing to provide Level III or Level IV neonatal services in the facility for the first time, the applicant shall also provide the following information:

(1)           documentation that at least 90 percent of the anticipated patient population is within 90 minutes driving time one-way from the facility, with the exception that there shall be a variance from the 90 percent standard for facilities which demonstrate that they provide specialized levels of neonatal care to a large and geographically diverse population, or facilities which demonstrate the availability of air ambulance services for neonatal patients;

(2)           evidence that existing and approved neonatal services in the applicant's defined neonatal service area are unable to accommodate the applicant's projected need for additional Level III and Level IV services;

(3)           an analysis of the proposal's impact on existing Level III and Level IV neonatal services which currently serve patients from the applicant's primary service area;

(4)           the availability of high risk OB services at the site of the applicant's planned neonatal service;

(5)           copies of written policies which provide for parental participation in the care of their infant, as the infant's condition permits, in order to facilitate family adjustment and continuity of care following discharge; and

(6)           copies of written policies and procedures regarding the scope and provision of care within the neonatal service, including the following:

(A)          the admission and discharge of patients;

(B)          infection control;

(C)          safety practices;

(D)          the triaging of patients requiring consultations, including the transfer of patients to another facility; and

(E)           the protocols for obtaining emergency physician care for a sick infant.

 

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.

 

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

(a)  An applicant proposing to provide new Level I, Level II, Level III or Level IV services shall document that the following items shall be available, unless an item shall not be available, then documentation shall be provided obviating the need for that item:

(1)           competence to manage uncomplicated labor and delivery of normal term newborn;

(2)           capability for continuous fetal monitoring;

(3)           a continuing education program on resuscitation to enhance competence among all delivery room personnel in the immediate evaluation and resuscitation of the newborn and of the mother;

(4)           obstetric services;

(5)           anesthesia services;

(6)           capability of cesarean section within 30 minutes at any hour of the day; and

(7)           twenty-four hour on-call blood bank, radiology, and clinical laboratory services.

(b)  An applicant proposing to provide new Level III Level IV services shall document that the following items shall be available, unless any item shall not be available, then documentation shall be provided obviating the need for that item:

(1)           competence to manage labor and delivery of premature newborns and newborns with complications;

(2)           twenty-four hour availability of microchemistry hematology and blood gases;

(3)           twenty-four hour coverage by respiratory therapy;

(4)           twenty-four hour radiology coverage with portable radiographic capability;

(5)           oxygen and air and suction capability;

(6)           electronic cardiovascular and respiration monitoring capability;

(7)           vital sign monitoring equipment which has an alarm system that is operative at all times;

(8)           capabilities for endotracheal intubation and mechanical ventilatory assistance;

(9)           cardio-respiratory arrest management plan;

(10)         isolation capabilities;

(11)         social services staff;

(12)         occupational or physical therapies with neonatal expertise; and

(13)         a registered dietician or nutritionist with training to meet the special needs of neonates.

(c)  An applicant proposing to provide new Level IV services shall document that the following items shall be available, unless any item shall not be available, then documentation shall be provided obviating the need for that item:

(1)           pediatric surgery services;

(2)           ophthalmology services;

(3)           pediatric neurology services;

(4)           pediatric cardiology services;

(5)           on-site laboratory facilities;

(6)           computed tomography and pediatric cardiac catheterization services;

(7)           emergency diagnostic studies available 24 hours per day;

(8)           designated social services staff; and

(9)           serve as a resource center for the statewide perinatal network.

 

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.

 

10A NCAC 14C .1405       STAFFING AND STAFF TRAINING

An applicant shall demonstrate that the following staffing requirements for hospital care of newborn infants shall be met:

(1)           If proposing to provide new Level I or II services the applicant shall provide documentation to demonstrate that:

(a)           the nursing care shall be supervised by a registered nurse in charge of perinatal facilities;

(b)           a physician is designated to be responsible for neonatal care; and

(c)           the medical staff will provide physician coverage to meet the specific needs of patients on a 24 hour basis.

(2)           If proposing to provide new Level III services the applicant shall provide documentation to demonstrate that:

(a)           the nursing care shall be supervised by a registered nurse;

(b)           the service shall be staffed by a pediatrician certified by the American Board of Pediatrics; and

(c)           the medical staff will provide physician coverage to meet the specific needs of patients on a 24 hour basis.

(3)           If proposing to provide new Level IV services the applicant shall provide documentation to demonstrate that:

(a)           the nursing care shall be supervised by a registered nurse with educational preparation and advanced skills for maternal-fetal and neonatal services;

(b)           the service shall be staffed by a full-time board certified pediatrician with certification in neonatal medicine; and

(c)           the medical staff will provide physician coverage to meet the specific needs of patients on a 24 hour basis.

(4)           All applicants shall submit documentation which demonstrates the availability of appropriate inservice training or continuing education programs for neonatal staff.

(5)           All applicants shall submit documentation which demonstrates the proficiency and ability of the nursing staff in teaching parents how to care for neonatal patients following discharge to home.

(6)           All applicants shall submit documentation to show that the proposed neonatal services will be provided in conformance with the requirements of federal, state and local regulatory bodies.

 

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.

 

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

(a)  An applicant proposing to develop a hospice shall complete the application form for Hospice Services. 

(b)  An applicant proposing to develop a hospice shall provide the following information:

(1)           the annual unduplicated number of hospice patients projected to be served in each of the first two years following completion of the project and the methodology and assumptions used to make the projections;

(2)           the projected number of duplicated hospice patients to be served by quarter for the first 24 months following completion of the project and the methodology and assumptions used to make the projections;

(3)           the projected number of patient care days, by level of care (i.e., routine home care, respite care, and inpatient care), by quarter, to be provided in each of the first two years of operation following completion of the project and the methodology and assumptions used to make the projections shall be stated;

(4)           the projected number of hours of continuous care to be provided in each of the first two years of operation following completion of the project and the methodology and assumptions used to make these projections;

(5)           the projected average annual cost per hour of continuous care for each of the first two operating years following completion of the project and the methodology and assumptions used to make the projections;

(6)           the projected average annual cost per patient care day, by level of care (i.e., routine home care, respite care, and inpatient care), for each of the first two operating years following completion of the project and the methodology and assumptions used to project the average annual cost; and

(7)           documentation of attempts made to establish working relationships with sources of referrals to the hospice services and copies of proposed agreements for the provision of inpatient care.

(c)  An applicant proposing to develop a hospice shall commit that it shall comply with all certification requirements for participation in the Medicare program within one year after issuance of the certificate of need.

 

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.

 

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

(a)  An applicant proposing to develop a hospice shall demonstrate that the following core services will be provided directly by the applicant to the patient and the patient's family or significant others:

(1)           nursing services;

(2)           social work services;

(3)           counseling services including dietary, spiritual, and family counseling;

(4)           bereavement counseling services;

(5)           volunteer services;

(6)           physician services; and

(7)           medical supplies.

(b)  An applicant shall demonstrate that the nursing services listed in Paragraph (a) of this Rule will be available 24 hours a day, seven days a week.

(c)  An applicant proposing to develop a hospice shall provide documentation that the following services, when ordered by the attending physician and specified in the care plan, shall either be provided directly by the hospice or provided through a contract arranged by the hospice:

(1)           hospice inpatient care provided in a licensed hospice inpatient facility bed, licensed acute care bed or licensed nursing facility bed,

(2)           physical therapy,

(3)           occupational therapy,

(4)           speech therapy,

(5)           home health aide services,

(6)           medical equipment,

(7)           respite care,

(8)           homemaker services, and

(9)           continuous care.

(d)  For each of the services listed in Paragraph (c) of this Rule which are proposed to be provided by contract, the applicant shall provide a copy of a letter from the proposed provider which expresses their interest in working with the proposed facility.

 

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.

 

10A NCAC 14C .1505       STAFFING AND STAFF TRAINING

(a)  An applicant proposing to develop a hospice shall document that staffing for hospice services will be provided in a manner consistent with G.S. 131E, Article 10.

(b)  The applicant shall demonstrate that:

(1)           the staffing pattern will be consistent with licensure requirements as specified in 10A NCAC 13K, Hospice Licensing Rules;

(2)           training for all hospice staff and volunteers will meet the requirements as specified in 10A NCAC 13K .0400, Hospice Licensing Rules;

(3)           a volunteer program will be established and operated in accordance with 10A NCAC 13K .0400 and .0500 and 42 CFR 418.70;

(4)           an interdisciplinary team will be established which includes, a physician, a licensed nurse, a social worker, a clergy member, and a trained hospice volunteer, as specified in G.S. 131E-201;

(5)           a coordinator as set forth in 42 CFR 418.68 will coordinate the hospice interdisciplinary team to assure implementation of an integrated care plan and the continuous assessment of the needs of the patient and the patient's family or significant others;

(6)           a written care plan will be developed by the attending physician, the medical director or medical director's physician designee, and the interdisciplinary team before care is provided to a patient and the patient's family or significant others;

(7)           meetings of the interdisciplinary care team and other invited personnel will be held on a frequent and regular basis, at least once every two weeks, for the purpose of care plan review and staff support; and

(8)           each interdisciplinary team member will be provided orientation, training, and continuing education programs appropriate to their responsibilities and to the maintenance of skills necessary for the physical care of the patient and the psychosocial and spiritual care of the patient and the patient's family or significant others.

 

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

Eff. July 1, 1994;

Temporary Amendment Eff. February 1, 2006;

Amended Eff. November 1, 2006.

 

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

(a)  An applicant that proposes to acquire cardiac catheterization or cardiac angioplasty equipment shall use the acute care facility/medical equipment application form.

(b)  The applicant shall provide the following additional information based on the population residing within the applicant's proposed cardiac catheterization service area:

(1)           the projected annual number of cardiac catheterization procedures, by CPT or ICD‑9‑CM codes, classified by adult diagnostic, adult therapeutic and pediatric cardiac catheterization procedure, to be performed in the facility during each of the first three years of operation following completion of the proposed project, including the methodology and assumptions used for these projections;

(2)           documentation of the applicant's experience in treating cardiovascular patients at the facility during the past 12 months, including:

(A)          the number of patients receiving stress tests;

(B)          the number of patients receiving intravenous thrombolytic therapies;

(C)          the number of patients presenting in the Emergency Room or admitted to the hospital with suspected or diagnosed acute myocardial infarction;

(D)          the number of patients referred to other facilities for cardiac catheterization procedures or open heart surgery procedures, by type of procedure; and

(E)           the number of diagnostic and therapeutic cardiac catheterization procedures performed during the twelve month period reflected in the most recent licensure form on file with the Division of Health Service Regulation;

(3)           the number of cardiac catheterization  patients, classified by adult diagnostic, adult therapeutic and pediatric, from the proposed cardiac catheterization service area that the applicant proposes to serve by patient's county of residence in each of the first three years of operation, including the methodology and assumptions used for these projections;

(4)           documentation of the applicant's projected sources of patient referrals that are located in the proposed cardiac catheterization service area, including letters from the referral sources that demonstrate their intent to refer patients to the applicant for cardiac catheterization procedures;

(5)           evidence of the applicant's capability to communicate with emergency transportation agencies and with an established comprehensive cardiac services program;

(6)           the number and composition of cardiac catheterization teams available to the applicant;

(7)           documentation of the applicant's in‑service training or continuing education programs for cardiac catheterization team members;

(8)           a written agreement with a comprehensive cardiac services program that specifies the arrangements for referral and transfer of patients seen by the applicant and that includes a process to alleviate the need for duplication in cardiac catheterization procedures;

(9)           a written description of patient selection criteria including referral arrangements for high‑risk patients;

(10)         a copy of the contractual arrangements for the acquisition of the proposed cardiac catheterization equipment including itemization of the cost of the equipment; and

(11)         documentation that the cardiac catheterization equipment and the procedures for operation of the equipment are designed and developed based on the American College of Cardiology/ Society for Cardiac Angiography and Interventions Clinical Expert Consensus Document on Cardiac Catheterization Laboratory Standards (June 2001) report.

 

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.

 

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

(a)  If the applicant proposes to perform therapeutic cardiac catheterization procedures, the applicant shall demonstrate that open heart surgery services are provided within the same facility.

(b)  If the applicant proposes to perform diagnostic cardiac catheterization procedures, the applicant shall document that its patients will have access to a facility which provides open heart surgery services, and that the patients can be transported to that facility within 30 minutes and with no greater risk than if the procedure had been performed in a hospital which provides open heart surgery services; with the exception that the 30 minute transport requirement shall be waived for equipment that was identified as needed in the State Medical Facilities Plan based on an adjusted need determination or the determination of a need for shared-fixed cardiac catheterization equipment.

(c)  The applicant shall provide documentation to demonstrate that the following services shall be available in the facility:

(1)           electrocardiography laboratory and testing services including stress testing and continuous cardiogram monitoring;

(2)           echocardiography service;

(3)           blood gas laboratory;

(4)           pulmonary function unit;

(5)           staffed blood bank;

(6)           hematology laboratory/coagulation laboratory;

(7)           microbiology laboratory;

(8)           clinical pathology laboratory with facilities for blood chemistry;

(9)           immediate endocardiac catheter pacemaking in case of cardiac arrest; and

(10)         nuclear medicine services including nuclear cardiology.

 

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.

 

10A NCAC 14C .1605       STAFFING AND STAFF TRAINING

(a)  An applicant proposing to acquire cardiac catheterization equipment shall provide documentation to demonstrate that the following staffing requirements shall be met:

(1)           one physician licensed to practice medicine in North Carolina who has been designated to serve as director of the cardiac catheterization service and who has all of the following credentials:

(A)          board‑certified in internal medicine by American Board of Internal Medicine, pediatrics by American Board of Pediatrics, or radiology by American Board of Radiologists;

(B)          subspecialty training in cardiology, pediatric cardiology, or cardiovascular radiology; and

(C)          clinical experience in performing physiologic procedures, angiographic procedures, or both;

(2)           at least one team to perform cardiac catheterizations, composed of at least the following professional and technical personnel:

(A)          one physician licensed to practice medicine in North Carolina with evidence of training and experience specifically in cardiovascular disease and radiation sciences;

(B)          one nurse with training and experience specifically in critical care of cardiac patients, cardiovascular medication, and catheterization equipment; and

(C)          at least two technicians with training specifically in cardiac care who are capable of performing the duties of a radiologic technologist, cardiopulmonary technician, monitoring and recording technician, and darkroom technician.

(b)  An applicant proposing to acquire cardiac catheterization equipment shall provide documentation to demonstrate that the following staff training shall be provided for members of cardiac catheterization teams:

(1)           American Red Cross or American Heart Association certification in cardiopulmonary resuscitation and advanced cardiac life support; and

(2)           an organized program of staff education and training which is integral to the cardiac services program and ensures improvements in technique and the proper training of new personnel.

 

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

Eff. January 1, 1987;

Amended Eff. February 1, 1994;

Temporary Amendment Eff. February 1, 2006;

Amended Eff. November 1, 2006.

 

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

(a)  An applicant that proposes to add an open heart surgery room or to acquire a heart-lung bypass machine shall use the acute care facility/medical equipment application form.

(b)  An applicant shall define the service area for the proposed project which shall be like the applicant's service area for other health services, unless the applicant documents that other providers are expected to refer patients to the applicant, including the methodology and assumptions used to define the service area.

(c)  An applicant shall provide the following information:

(1)           the number of procedures performed on each heart-lung bypass machine owned by or operated in the facility during the 12-month period prior to the submission of the application, identified by ICD-9, ICD-10, or CPT code;

(2)           a projection of the number of procedures using the applicant's existing, approved and proposed heart-lung bypass machines in each of the first three years following completion of the proposed project identified by ICD-9, ICD-10, or CPT code, including the methodology and assumptions used to make the projections;

(3)           the number of patients from the proposed service area who are projected to receive procedures using the applicant's existing, approved, and proposed heart-lung bypass equipment by patient's county of residence in each of the first three years following completion of the proposed project, including the methodology and assumptions used to make these projections;

(4)           the projected patient referral sources;

(5)           evidence of the applicant's capability to communicate efficiently with emergency transportation agencies and with all hospitals serving the proposed service area;

(6)           the number and composition of open heart surgical teams available to the applicant; and

(7)           evidence of the applicant's capability to perform both cardiac catheterization and open heart surgical procedures 24 hours per day, 7 days per week.

 

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.

 

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

(a)  An applicant that proposes to acquire a heart-lung bypass machine shall demonstrate that the following services will be available in the facility 24 hours per day, 7 days per week:

(1)           electrocardiography laboratory and testing services, including stress testing and continuous cardiogram monitoring;

(2)           echocardiography service;

(3)           blood gas laboratory;

(4)           nuclear medicine laboratory;

(5)           pulmonary function unit;

(6)           staffed blood bank;

(7)           hematology laboratory or coagulation laboratory;

(8)           microbiology laboratory; and

(9)           clinical pathology laboratory with facilities for blood chemistry.

(b)  An applicant that proposes to develop open-heart surgery services shall demonstrate that the following services will be available in the facility 24 hours per day, 7 days per week:

(1)           a dedicated cardiac surgical intensive care unit;

(2)           for facilities performing pediatric open heart surgery services, a pediatric intensive care unit that will be a distinct intensive care unit and will meet the requirements of 10A NCAC 14C .1300;

(3)           an emergency department with full-time director, staffed for cardiac emergencies with acute coronary suspect surveillance area and voice communication linkage to the ambulance service and the coronary care unit; and

(4)           cardiac catheterization services including both diagnostic and interventional cardiac catheterization capabilities.

 

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.

 

10A NCAC 14C .1705       STAFFING AND STAFF TRAINING

(a)  An applicant that proposes to acquire a heart-lung bypass machine shall demonstrate that it can meet the following staffing requirements:

(1)           at least two cardiovascular surgeons on the medical staff, at least one of whom is certified by the American Board of Thoracic Surgery; and

(2)           one perfusionist certified by the American Board of Cardiovascular Perfusion and licensed by the Perfusionist Advisory Committee of the North Carolina Medical Board per operational heart lung bypass machine and an additional licensed, certified perfusionist on standby.

(b)  An applicant that proposes to develop open-heart surgery services shall demonstrate that it can meet the following staffing requirements:

(1)           one cardiovascular surgeon who has been designated to serve as director of the open heart surgery program and who has the following special qualifications:

(A)          certification by the American Board of Thoracic Surgery; and

(B)          licensed by the North Carolina Medical Board to practice medicine; and

(2)           at least one open heart surgical team comprised of at least the following professional and technical personnel:

(A)          one cardiovascular surgeon board certified by the American Board of Thoracic Surgery;

(B)          one assistant surgeon;

(C)          one anesthesiologist certified by The American Board of Anesthesiology and trained in open heart surgical procedures;

(D)          one certified registered nurse anesthetist;

(E)           one circulating nurse or scrub nurse, with training in open heart surgical procedures;

(F)           one operating room technician or nurse with training in open heart surgical procedures;

(G)          one licensed, certified perfusionist;

(H)          staff for the dedicated cardiac surgical intensive care unit to ensure the availability of 1 registered nurse for every 2 patients during the first 48 hours of post-operative care; and

(I)            if pediatric open heart surgical procedures are performed, at least one cardiac surgeon trained to perform pediatric open heart surgical procedures.

(c)  An applicant that proposes to acquire a heart-lung bypass machine or to develop open-heart surgery services shall demonstrate that it can provide the following:

(1)           staff training for certification in cardiopulmonary resuscitation and advanced cardiac life support; and

(2)           a program of staff education and training that ensures improvements in technique and the training of new personnel.

 

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.

 

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

(a)  An applicant proposing to establish a new diagnostic center or to expand an existing diagnostic center shall use the Acute Care Facility/Medical Equipment application form.

(b)  An applicant shall also provide the following additional information:

(1)           the number, type, cost, condition, useful life and depreciation schedule of all medical diagnostic equipment that either is proposed to be acquired or is currently owned or operated by the applicant, and will be part of the diagnostic center following completion of the project;

(2)           other than the equipment listed in Subparagraph (b)(1) of this Rule, a list of all equipment and related components which are necessary to perform the proposed procedures and services;

(3)           the maximum number of procedures that each piece of medical diagnostic equipment in the diagnostic center is capable of performing and the assumptions used to project capacity;

(4)           a list of all existing and approved health service facilities that operate or have been approved to operate medical diagnostic equipment and diagnostic suites by type and location in the proposed medical diagnostic equipment service area;

(5)           the hours of operation of the proposed diagnostic center and each proposed diagnostic service;

(6)           the patient origin by percentage by county of residence for each diagnostic service provided by the applicant in the 12 month period immediately preceding the submittal of the application;

(7)           the projected patient origin by percentage by county of residence for each service proposed, and all the assumptions and data supporting the methodology used for the projections;

(8)           drawings or schematics of the proposed diagnostic center that identifies a distinct, identifiable area for each of the proposed services; and

(9)           a three year capital budget.

(c)  An applicant proposing to establish a new mobile diagnostic program shall also provide the following information:

(1)           the number, type and cost of all proposed mobile medical diagnostic equipment including the cost of the transporting equipment;

(2)           other than the equipment listed in Subparagraph (b)(1) of this Rule, a list of all equipment and related components which are necessary to perform the proposed procedures and services;

(3)           the number and type of all existing and approved mobile diagnostic equipment in the proposed mobile diagnostic center service area;

(4)           the maximum number of procedures that each proposed piece of medical diagnostic equipment is capable of performing and the assumptions used to project capacity;

(5)           the name, address and hours of service at each host facility that is proposed to be served by the mobile diagnostic program; and

(6)           copies of letters of intent from, and proposed contracts with, all of the proposed host facilities of the mobile diagnostic program.

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

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

(1)           the projected number of patients to be served, classified by diagnosis for each of the first twelve calendar quarters following completion of the project; and

(2)           the projected number of patients to be served by county of residence for each of the first twelve calendar quarters following completion of the project; and

(3)           the projected number and type of diagnostic procedures proposed to be provided by CPT code or ICD-9-CM procedure code for each of the first twelve calendar quarters following completion of the project.

 

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 .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

An applicant shall provide documentation showing the proximity of the proposed diagnostic center to the following services:

(1)           emergency services;

(2)           support services;

(3)           ancillary services; and

(4)           public transportation.

 

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 .1806       STAFFING AND STAFF TRAINING

(a)  An applicant proposing to establish a new diagnostic center or to expand an existing diagnostic center shall identify the number of radiologists, radiation physicists, other physicians, laboratory staff, radiologic technologists and support staff that are projected to be involved in providing each of the proposed diagnostic services.

(b)  An applicant proposing to provide ionizing and nonionizing radiation procedures shall demonstrate that a physician, licensed to practice medicine in North Carolina shall be available to perform and supervise all radiation procedures and shall document the qualifications of this physician to perform radiation procedures.

(c)  An applicant proposing to establish a new diagnostic center or to expand an existing diagnostic center shall document that a program of continuing education shall be available for technologists and medical staff.

 

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.

 

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

(a)  An applicant proposing to acquire radiation therapy equipment shall use the Acute Care Facility/Medical Equipment application form.

(b)  An applicant proposing to acquire radiation therapy equipment shall provide the following information:

(1)           a list of all the radiation therapy equipment to be acquired and documentation of the capabilities and capacities of each item of equipment;

(2)           documentation of the purchase price and fair market value of each piece of radiation therapy equipment, each simulator, and any other related equipment proposed to be acquired;

(3)           the projected number of patient treatments by intensity modulated radiation treatment (IMRT); stereotactic radiosurgery; simple, intermediate and complex radiation treatments to be performed on each piece of radiation therapy equipment for each of the first three years of operation following the completion of the proposed project and documentation of all assumptions by which utilization is projected;

(4)           documentation that the proposed radiation therapy equipment shall be operational at least seven hours per day, five days a week;

(5)           documentation that no more than one simulator is available for every two linear accelerators in the applicant's facility, except that an applicant that has only one linear accelerator may have one simulator;

(6)           documentation that the services shall be offered in a physical environment that conforms to the requirements of federal, state, and local regulatory bodies;

(7)           the projected total number of radiation treatment patients by county that will be treated in the facility in each of the first three years of operation following completion of the proposed project;

(8)           the projected number of radiation treatment patients that will be treated for palliation in each of the first three years of operation following completion of the proposed project; and

(9)           the projected number of radiation treatment patients that will be treated for cure in each of the first three years of operation following completion of the proposed project.

(c)  An applicant proposing to acquire a linear accelerator for development of a multidisciplinary prostate health center pursuant to a need determination for a demonstration project in the State Medical Facilities Plan shall provide the following information:

(1)           description of all services to be provided by the proposed multidisciplinary prostate health center, including a description of each of the following services:

(A)          urology services,

(B)          medical oncology services,

(C)          biofeedback therapy,

(D)          chemotherapy,

(E)           brachytherapy, and

(F)           living skills counseling and therapy;

(2)           documentation that urology services, medical and radiation oncology services, biofeedback therapy, brachytherapy and post-treatment living skills counseling and therapy will be provided in the same building;

(3)           description of any services that will be provided by other facilities or in different buildings;

(4)           demographics of the population in the county in which the proposed multidisciplinary prostate health center will be located, including:

(A)          percentage of the population in the county that is African American,

(B)          the percentage of the population in the county that is male,

(C)          the percentage of the population in the county that is African American male,

(D)          the incidence of prostate cancer for the African American male population in the county, and

(E)           the mortality rate from prostate cancer for the African American male population in the county;

(5)           documentation that the proposed center is located within walking distance of an established bus route and within five miles of a minority community;

(6)           documentation that the multiple medical disciplines in the center will collaborate to create and maintain a single or common medical record for each patient and conduct multidisciplinary conferences regarding each patient's treatment and follow-up care;

(7)           documentation that the center will establish its own prostate/urological cancer tumor board for review of cases;

(8)           copy of the center's written policies that prohibit the exclusion of services to any patient on the basis of age, race, religion, disability or the patient's ability to pay;

(9)           copy of written strategies and activities the center will follow to assure its services will be accessible by patients without regard to their ability to pay;

(10)         description of the center's outreach activities and the manner in which they complement existing outreach initiatives;

(11)         documentation of number and type of clinics to be conducted to screen patients at risk for prostate cancer;

(12)         written description of patient selection criteria, including referral arrangements for high-risk patients;

(13)         commitment to prepare an annual report at the end of each of the first three operating years, to be submitted to the Medical Facilities Planning Section and the Certificate of Need Section, that shall include:

(A)          the total number of patients treated;

(B)          the number of African American persons treated;

(C)          the number of persons in other minority populations treated; and

(D)          the number of insured, underinsured and uninsured patients served by type of payment category;

(14)         documentation of arrangements made with a third party researcher to evaluate, during the fourth operating year of the center, the efficacy of the clinical and outreach initiatives on prostate and urological cancer treatment, and develop recommendations regarding the advantages and disadvantages of replicating the project in other areas of the State.  The results of the evaluation and recommendations shall be submitted in a report to the Medical Facilities Planning Section and Certificate of Need Section in the first quarter of the fifth operating year of the demonstration project; and

(15)         if the third party researcher is not a historically black university, document the reasons for using a different researcher for the project.

 

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.

 

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

(a)  An applicant proposing to acquire radiation therapy equipment shall document that the following items will be available; and if any item will not be available, the applicant shall provide information obviating the need for that item:

(1)           a program of radiation therapy continuing education for radiation therapists, technologists and medical staff;

(2)           a program for the collection of utilization data relative to the applicant's provision of radiation therapy services;

(3)           medical laboratory services;

(4)           pathology services; and

(5)           pharmaceutical support services.

(b)  An applicant proposing to acquire a linear accelerator for development of a multidisciplinary prostate health center pursuant to a need determination for a demonstration project in the State Medical Facilities Plan shall provide a written description of the center's plans and strategies to establish:

(1)           an African American Prostate Cancer Education/Outreach Program that will partner with and complement existing support groups, such as the N.C. Minority Prostate Cancer Awareness Action Team; and

(2)           an Advisory Board composed of representatives of prostate cancer advocacy groups, prostate cancer patients and survivors that will meet to provide feedback to the center regarding outreach practices which are effective or which need to be changed.

 

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. February 1, 2009;

Amended Eff. November 1, 2009.

 

10A NCAC 14C .1905       STAFFING AND STAFF TRAINING

(a)  An applicant proposing to acquire radiation therapy equipment shall document the number and availability of staff or provide evidence that obviates the need for staff in the following areas:

(1)           Radiation Oncologist;

(2)           Radiation Physicist;

(3)           Dosimetrist or Physics Assistant;

(4)           Radiation Therapist;

(5)           Radiation-Oncology Administrator;

(6)           Registered Nurse or LPN;

(7)           Physical Therapist;

(8)           Dietician;

(9)           Pharmacist;

(10)         Social Worker; and

(11)         Maintenance Engineer.

(b)  An applicant proposing to acquire a linear accelerator for development of a multidisciplinary prostate health center pursuant to a need determination for a demonstration project in the State Medical Facilities Plan shall document that the center will have:

(1)           a medical director who is either a urologist certified by the American Board of Urology, a medical oncologist certified by the American Board of Internal Medicine, or a radiation oncologist certified by the American Board of Radiology; and

(2)           a multidisciplinary team consisting of medical oncologists, radiation oncologists, urologists, urologic pharmacologists, pathologists and therapy specialists.

 

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. February 1, 2009;

Amended Eff. November 1, 2009.

 

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

(a)  An applicant shall identify:

(1)           the counties that are proposed to be served by the new office;

(2)           the proposed types of services to be provided, including a description of each discipline;

(3)           the projected total unduplicated patient count of the new office for each of the first two years of operation;

(4)           the projected number of patients to be served per service discipline for each of the first two years of operation;

(5)           the projected number of visits by service discipline for each of the first two years of operation;

(6)           within each service discipline, the average number of patient visits per day that are anticipated to be performed by each staff person;

(7)           the projected average annual cost per visit for each service discipline;

(8)           the projected charge by payor source for each service discipline;

(9)           the names of the anticipated sources of referrals; and

(10)         documentation of attempts made to establish working relationships with the sources of referrals.

All assumptions, including the specific methodology by which patient utilization and costs are projected, shall be stated.

(b)  An applicant shall specify the proposed site on which the office is proposed to be located.  If the proposed site is not owned by or under the control of the applicant, the applicant shall specify an alternate site.  The applicant shall provide documentation from the owner of the sites or a realtor that the proposed and alternate site(s) are available for acquisition.

(c)  An applicant proposing to establish a new home health agency pursuant to a need determination in the State Medical Facilities Plan to meet the special needs of the non-English speaking, non-Hispanic population shall provide the following additional information:

(1)           for each staff person in the proposed home health agency, the foreign language in which the person is fluent to document the home health agency will have employees fluent in multiple foreign languages other than Spanish, including Russian;

(2)           description of the manner in which the proposed home health agency will market and provide its services to non-English speaking, non-Hispanic persons; and

(3)           documentation that the proposed home health agency will accept referrals of non-English speaking, non-Hispanic persons from other home health agencies and entities within Medicare Conditions of Participation and North Carolina licensure rules.

 

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.

 

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

(a)  An applicant shall demonstrate that proposed staffing for the home health agency office will meet the staffing requirements as contained in 10A NCAC 13J which is incorporated by reference including all subsequent amendments.  A copy of 10A NCAC 13J may be obtained from the Division of Health Service Regulation, Medical Facilities Licensure Section at a cost of two dollars and sixty cents ($2.60).

(b)  An applicant shall provide copies of letters of interest, preliminary agreements, or executed contractual arrangements between the proposed home health agency office and each health care provider with which the home health agency office plans to contract for the provision of home health services in each of the counties proposed to be served by the new office.

 

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

Eff. March 1, 1996.

 

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

(a)  An applicant proposing to establish a new ambulatory surgical facility, to establish a new campus of an existing facility, to establish a new hospital, 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 identify each of the following specialty areas that will be provided in the facility:

(1)           gynecology;

(2)           otolaryngology;

(3)           plastic surgery;

(4)           general surgery;

(5)           ophthalmology;

(6)           orthopedic;

(7)           oral surgery; and

(8)           other specialty area identified by the applicant.

(b)  An applicant proposing to increase the number of operating rooms in a service area, 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 provide the following information:

(1)           the number and type of operating rooms in each facility which the applicant or a related entity owns a controlling interest in and is located in the service area, (separately identifying the number of dedicated open heart and dedicated C-Section rooms);

(2)           the number and type of operating rooms to be located in each facility which the applicant or a related entity owns a controlling interest in and is located in the service area after completion of the proposed project and all previously approved projects related to these facilities (separately identifying the number of dedicated open heart and dedicated C-Section rooms);

(3)           the number of inpatient surgical cases, excluding trauma cases reported by Level I, II, or III trauma centers, cases reported by designated burn intensive care units, and cases performed in dedicated open heart and dedicated C-section rooms, and the number of outpatient surgical cases performed in the most recent 12 month period for which data is available, in the operating rooms in each facility listed in response to Subparagraphs (b)(1) and (b)(2) of this Rule;

(4)           the number of inpatient surgical cases, excluding trauma cases reported by level I, II, or III trauma centers, cases reported by designated burn intensive care units and cases performed in dedicated open heart and dedicated C-section rooms, and the number of outpatient surgical cases projected to be performed in each of the first three operating years of the proposed project, in each facility listed in response to Subparagraphs (b)(1) and (b)(2) of this Rule;

(5)           a description of and documentation to support the assumptions and methodology used in the development of the projections required by this Rule;

(6)           the hours of operation of the proposed new operating rooms;

(7)           if the applicant is an existing facility, the average reimbursement received per procedure for the 20 surgical procedures most commonly performed in the facility during the preceding 12 months and a list of all services and items included in the reimbursement;

(8)           the projected average reimbursement to be received per procedure for the 20 surgical procedures which the applicant projects will be performed most often in the facility and a list of all services and items included in the reimbursement; and

(9)           identification of providers of pre-operative services and procedures which will not be included in the facility's charge.

(c)  An applicant proposing to relocate existing or approved operating rooms within the same service area shall provide the following information:

(1)           the number and type of existing and approved operating rooms in each facility in which the number of operating rooms will increase or decrease (separately identifying the number of dedicated open heart and dedicated C-Section rooms);

(2)           the number and type of operating rooms to be located in each affected facility after completion of the proposed project and all previously approved projects related to these facilities (separately identifying the number of dedicated open heart and dedicated C-Section rooms);

(3)           the number of inpatient surgical cases, excluding trauma cases reported by Level I, II, or III trauma centers, cases reported by designated burn intensive care units, and cases performed in dedicated open heart and dedicated C-section rooms, and the number of outpatient surgical cases performed in the most recent 12 month period for which data is available, in the operating rooms in each facility listed in response to Subparagraphs (c)(1) and (c)(2) of this Rule;

(4)           the number of inpatient surgical cases, excluding trauma cases reported by level I, II, or III trauma centers, cases reported by designated burn intensive care units and cases performed in dedicated open heart and dedicated C-section rooms, and the number of outpatient surgical cases projected to be performed in each of the first three operating years of the proposed project, in each facility listed in response to Subparagraphs (c)(1) and (c)(2) of this Rule;

(5)           a detailed description of and documentation to support the assumptions and methodology used in the development of the projections required by this Rule;

(6)           the hours of operation of the facility to be expanded;

(7)           the average reimbursement received per procedure for the 20 surgical procedures most commonly performed in each affected facility during the preceding 12 months and a list of all services and items included in the reimbursement;

(8)           the projected average reimbursement to be received per procedure for the 20 surgical procedures which the applicant projects will be performed most often in the facility to be expanded and a list of all services and items included in the reimbursement; and

(9)           identification of providers of pre-operative services and procedures which will not be included in the facility's charge.

(d)  An applicant proposing to establish a new single specialty separately licensed ambulatory surgical facility pursuant to the demonstration project in the 2010 State Medical Facilities Plan shall provide:

(1)           the single surgical specialty area in which procedures will be performed in the proposed ambulatory surgical facility;

(2)           a description of the ownership interests of physicians in the proposed ambulatory surgical facility;

(3)           a commitment that the Medicare allowable amount for self-pay and Medicaid surgical cases minus all revenue collected from self-pay and Medicaid surgical cases shall be at least seven percent of the total revenue collected for all surgical cases performed in the proposed facility;

(4)           for each of the first three full fiscal years of operation, the projected number of self-pay surgical cases;

(5)           for each of the first three full fiscal years of operation, the projected number of Medicaid surgical cases;

(6)           for each of the first three full fiscal years of operation, the total projected Medicare allowable amount for the self-pay surgical cases to be served in the proposed facility, i.e. provide the projected Medicare allowable amount per self-pay surgical case and multiply that amount by the projected number of self-pay surgical cases;

(7)           for each of the first three full fiscal years of operation, the total projected Medicare allowable amount for the Medicaid surgical cases to be served in the facility, i.e. provide the projected Medicare allowable amount per Medicaid surgical case and multiply that amount by the projected number of Medicaid surgical cases;

(8)           for each of the first three full fiscal years of operation, the projected revenue to be collected from the projected number of self-pay surgical cases;

(9)           for each of the first three full fiscal years of operation, the projected revenue to be collected from the projected number of Medicaid surgical cases;

(10)         for each of the first three full fiscal years of operation, the projected total revenue to be collected for all surgical cases performed in the proposed facility;

(11)         a commitment to report utilization and payment data for services provided in the proposed ambulatory surgical facility to the statewide data processor, as required by G.S. 131E-214.2;

(12)         a description of the system the proposed ambulatory surgical facility will use to measure and report patient outcomes for the purpose of monitoring the quality of care provided in the facility;

(13)         descriptions of currently available patient outcome measures for the surgical specialty to be provided in the proposed facility, if any exist;

(14)         if patient outcome measures are not currently available for the surgical specialty area, the applicant shall develop its own patient outcome measures to be used for monitoring and reporting the quality of care provided in the proposed facility, and shall provide in its application a description of the measures it developed;

(15)         a description of the system the proposed ambulatory surgical facility will use to enhance communication and ease data collection, e.g. electronic medical records;

(16)         a description of the proposed ambulatory surgical facility’s open access policy for physicians, if one is proposed;

(17)         a commitment to provide to the Agency annual reports at the end of each of the first five full years of operation regarding:

(A)          patient payment data submitted to the statewide data processor as required by G.S. 131E-214.2;

(B)          patient outcome results for each of the applicant’s patient outcome measures;

(C)          the extent to which the physicians owning the proposed facility maintained their hospital staff privileges and provided Emergency Department coverage, e.g. number of nights each physician is on call at a hospital; and

(D)          the extent to which the facility is operating in compliance with the representations the applicant made in its application relative to the single specialty ambulatory surgical facility demonstration project in the 2010 State Medical Facilities Plan.

 

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.

 

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

(a)  An applicant proposing to establish a new ambulatory surgical facility, a new campus of an existing facility, or a new hospital shall provide copies of the written policies and procedures that will be used by the proposed facility for patient referral, transfer, and follow-up.

(b)  An applicant proposing to establish a new ambulatory surgical facility, a new campus of an existing facility, or a new hospital shall provide documentation showing the proximity of the proposed facility to the following services:

(1)           emergency services;

(2)           support services;

(3)           ancillary services; and

(4)           public transportation.

 

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, 2010;

Amended Eff. November 1, 2010.

 

10A ncac 14C .2105       STAFFING and staff training

(a)  An applicant proposing 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 a facility, 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 identify, justify and document the availability of the number of current and proposed staff to be utilized in the following areas in the facility to be developed or expanded:

(1)           administration;

(2)           pre-operative;

(3)           post-operative;

(4)           operating room; and

(5)           other.

(b)  The applicant shall identify the number of physicians who currently utilize the facility and estimate the number of physicians expected to utilize the facility and the criteria to be used by the facility in extending surgical and anesthesia privileges to medical personnel.

(c)  The applicant shall provide documentation that physicians with privileges to practice in the facility will be active members in good standing at a general acute care hospital within the service area in which the facility is, or will be, located or documentation of contacts the applicant made with hospitals in the service area in an effort to establish staff privileges.

(d)  The applicant shall provide documentation that physicians owning the proposed single specialty demonstration facility will meet Emergency Department coverage responsibilities in at least one hospital within the service area, or documentation of contacts the applicant made with hospitals in the service area in an effort to commit its physicians to assume Emergency Department coverage responsibilities.

 

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, 2010;

Amended Eff. November 1, 2010.

 

10A ncac 14C .2106       FACILITY

(a)  An applicant proposing to establish a licensed ambulatory surgical facility that will be physically located in a physician's or dentist's office or within a general acute care hospital shall demonstrate that reporting and accounting mechanisms exist and can be used to confirm that 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 licensed ambulatory surgical facility or a new hospital shall receive accreditation from the Joint Commission for the Accreditation of Healthcare Organizations, the Accreditation Association for Ambulatory Health Care or a comparable accreditation authority within two years of completion of the facility.

(c)  All applicants shall document that the physical environment of the facility to be developed or expanded conforms to the requirements of federal, state, and local regulatory bodies.

(d)  An applicant proposing to establish a new ambulatory surgical facility, a new campus of an existing facility or a new hospital shall provide a floor plan of the proposed facility identifying the following areas:

(1)           receiving/registering area;

(2)           waiting area;

(3)           pre-operative area;

(4)           operating room by type;

(5)           recovery area; and

(6)           observation area.

(e)  An applicant proposing to expand by converting a specialty ambulatory surgical program to a multispecialty ambulatory surgical program or by adding a specialty to a specialty ambulatory surgical program that does not propose to add physical space to the existing ambulatory surgical facility shall demonstrate the capability of the existing ambulatory surgical program to provide the following for each additional specialty area:

(1)           physicians;

(2)           ancillary services;

(3)           support services;

(4)           medical equipment;

(5)           surgical equipment;

(6)           receiving/registering area;

(7)           clinical support areas;

(8)           medical records;

(9)           waiting area;

(10)         pre-operative area;

(11)         operating rooms by type;

(12)         recovery area; and

(13)         observation area.

 

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.

 

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

(a)  An applicant that proposes to increase dialysis stations in an existing certified facility or relocate stations must provide the following information:

(1)           Utilization rates;

(2)           Mortality rates;

(3)           The number of patients that are home trained and the number of patients on home dialysis;

(4)           The number of transplants performed or referred;

(5)           The number of patients currently on the transplant waiting list;

(6)           Hospital admission rates, by admission diagnosis, i.e., dialysis related versus non-dialysis related;

(7)           The number of patients with infectious disease, e.g., hepatitis, and the number converted to infectious status during last calendar year.

(b)  An applicant that proposes to develop a new facility, increase the number of dialysis stations in an existing facility, establish a new dialysis station, or relocate existing dialysis stations shall provide the following information requested on the End Stage Renal Disease (ESRD) Treatment application form:

(1)           For new facilities, a letter of intent to sign a written agreement or a signed written agreement with an acute care hospital that specifies the relationship with the dialysis facility and describes the services that the hospital will provide to patients of the dialysis facility.  The agreement must comply with 42 C.F.R., Section 405.2100.

(2)           For new facilities, a letter of intent to sign a written agreement or a written agreement with a transplantation center describing the relationship with the dialysis facility and the specific services that the transplantation center will provide to patients of the dialysis facility.  The agreements must include the following:

(A)          timeframe for initial assessment and evaluation of patients for transplantation,

(B)          composition of the assessment/evaluation team at the transplant center,

(C)          method for periodic re-evaluation,

(D)          criteria by which a patient will be evaluated and periodically re-evaluated for transplantation, and

(E)           signatures of the duly authorized persons representing the facilities and the agency providing the services.

(3)           For new or replacement facilities, documentation that power and water will be available at the proposed site.

(4)           Copies of written policies and procedures for back up for electrical service in the event of a power outage.

(5)           For new facilities, the location of the site on which the services are to be operated.  If such site is neither owned by nor under option to the applicant, the applicant must provide a written commitment to pursue acquiring the site if and when the approval is granted, must specify a secondary site on which the services could be operated should acquisition efforts relative to the primary site ultimately fail, and must demonstrate that the primary and secondary sites are available for acquisition.

(6)           Documentation that the services will be provided in conformity with applicable laws and regulations pertaining to staffing, fire safety equipment, physical environment, water supply, and other relevant health and safety requirements.

(7)           The projected patient origin for the services.  All assumptions, including the methodology by which patient origin is projected, must be stated.

(8)           For new facilities, documentation that at least 80 percent of the anticipated patient population resides within 30 miles of the proposed facility.

(9)           A commitment that the applicant shall admit and provide dialysis services to patients who have no insurance or other source of payment, but for whom payment for dialysis services will be made by another healthcare provider in an amount equal to the Medicare reimbursement rate for such services.

 

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.

 

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

To be approved, the applicant must demonstrate that the following services will be available:

(1)           diagnostic and evaluation services;

(2)           maintenance dialysis;

(3)           accessible self‑care training;

(4)           accessible follow‑up program for support of patients dialyzing at home;

(5)           x‑ray services;

(6)           laboratory services;

(7)           blood bank services;

(8)           emergency care;

(9)           acute dialysis in an acute care setting;

(10)         vascular surgery for dialysis treatment patients;

(11)         transplantation services;

(12)         vocational rehabilitation counseling and services; and

(13)         transportation.

 

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

Eff. March 1, 1989.

 

10A NCAC 14C .2205       STAFFING AND STAFF TRAINING

(a)  To be approved, the state agency must determine that the proponent can meet all staffing requirements as stated in 42 C.F.R., Section 405.2100.

(b)  To be approved, the state agency must determine that the proponent will provide an ongoing program of training for nurses and technicians in dialysis techniques at the facility.

 

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

Eff. March 1, 1989.

 

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

(a)  An applicant proposing to acquire a CT scanner shall use the acute care facility/medical equipment application form.

(b)  An applicant proposing to acquire a CT scanner shall provide the number of CT scans that have been performed on each existing CT scanner which the applicant or a related entity owns a controlling interest in and is located in the proposed CT service area for each type of CT scan listed in this Paragraph for the previous 12 month period:

(1)           head scan without contrast;

(2)           head scan with contrast;

(3)           head scan without and with contrast;

(4)           body scan without contrast;

(5)           body scan with contrast;

(6)           body scan without contrast and with contrast;

(7)           biopsy in addition to body scan with or without contrast; and

(8)           abscess drainage in addition to body scan with or without contrast.

(c)  The applicant shall project the number of CT scans to be performed on the proposed CT scanner for each type of CT scan listed in this Paragraph for each of the first three years the new CT scanner is proposed to be operated:

(1)           head scan without contrast;

(2)           head scan with contrast;

(3)           head scan without and with contrast;

(4)           body scan without contrast;

(5)           body scan with contrast;

(6)           body scan without contrast and with contrast;

(7)           biopsy in addition to body scan with or without contrast; and

(8)           abscess drainage in addition to body scan with or without contrast.

(d)  The applicant shall convert the historical and projected number of CT scans to HECT units as follows:

 

Type of CT Scan

No. of

Scans

 

Conversion Factor

 

HECT Units

1

Head without contrast

 

X

1.00

=

 

2

Head with contrast

 

X

1.25

=

 

3

Head without and with contrast

 

X

1.75

=

 

4

Body without contrast

 

X

1.50

=

 

5

Body with contrast

 

X

1.75

=

 

6

Body without contrast and with contrast

 

X

2.75

=

 

7

Biopsy in addition to body scan with or without contrast

 

X

2.75

=

 

8

Abscess drainage in addition to body scan with or without contrast

 

X

4.00

=

 

(e)  An applicant proposing to acquire a mobile CT scanner shall provide the information requested in Paragraphs (b), (c), and (d) of this Rule for each proposed host facility.

(f)  The applicant shall provide projected charges for each of the 20 most frequent CT scans to be performed for each of the first three years the new CT scanner is proposed to be operated.

(g)  If an applicant that has been utilizing a mobile CT scanner proposes to acquire a fixed CT scanner for its facility, the applicant shall demonstrate that its projected charge per CPT code shall not increase more than 10 percent over its current charge per CPT code on the mobile CT scanner.

(h)  An applicant proposing to acquire a mobile CT scanner shall provide copies of letters of intent from and proposed contracts with all of the proposed host facilities of the new CT scanner.

(i)  An applicant proposing to acquire a CT scanner shall demonstrate that it has a written commitment from a radiologist, licensed to practice medicine in North Carolina, to provide professional interpretation services for the applicant.

(j)  An applicant proposing to acquire a CT scanner shall demonstrate that the CT scanner shall be available and staffed for performing CT scan procedures at least 66 hours per week.

 

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 .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

(a)  With the exception of applicants that currently provide CT services, an applicant proposing to acquire a CT scanner shall document the availability of the following diagnostic services:

(1)           diagnostic radiology services;

(2)           therapeutic radiology services;

(3)           nuclear medicine services; and

(4)           diagnostic ultrasound services.

(b)  An applicant proposing to acquire a mobile CT scanner shall provide:

(1)           referral agreements between each host site and at least one other provider of CT services in the proposed CT service area to document the availability of CT services if patients require them when the mobile unit is not in service at that host site; and

(2)           documentation that each of the services listed in Paragraphs (a) and (b) of this Rule shall be available at each host facility or shall be available through written affiliation or referral agreements.

 

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 .2305       STAFFING AND STAFF TRAINING

(a)  With the exception of applicants that currently provide CT services, an applicant proposing to acquire a CT scanner shall demonstrate that it can meet the following staffing requirements:

(1)           one radiologist who is certified by the American Board of Radiologists and has had:

(A)          training in computed tomography as an integral part of his or her residency training program; or

(B)          six months of supervised CT experience under the direction of a diagnostic radiologist who is certified by the American Board of Radiologists; or

(C)          at least six months of fellowship training, or its equivalent, in CT; or

(D)          a combination of CT experience and fellowship training equivalent to Parts (a)(1) (A), (B), or (C) of this Rule;

(2)           at least one radiology technologist registered by the American Registry of Radiologic Technologists shall be present during the hours of operation of the CT unit; and

(3)           a radiation physicist with training in medical physics shall be available for consultation for the calibration and maintenance of the equipment.  The radiation physicist may be an employee or an independent contractor.

(b)  With the exception of applicants that currently provide CT services, an applicant proposing to acquire a CT scanner shall demonstrate that the following staff training is provided to clinical personnel:

(1)           certification in cardiopulmonary resuscitation (CPR) and basic cardiac life support; and

(2)           an organized program of staff education and training which is integral to the services program and ensures improvements in technique and the proper training of new personnel.

(c)  An applicant proposing to acquire a mobile CT scanner shall document that the requirements in Paragraphs (a) and (b) of this Rule shall be met at each host facility.

 

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.

 

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

(a)  An applicant proposing to establish new ICF/MR beds shall project an occupancy level for the entire facility for the first eight calendar quarters following the completion of the proposed project. The application shall contain all assumptions and the methodology for projecting occupancy.

(b)  An applicant proposing to establish new ICF/MR beds shall project resident origin by percentage by county of residence.

(c)  An applicant proposing to establish new ICF/MR shall specify the primary site on which the facility will be located. If such site is neither owned by nor under option by the applicant, the applicant shall provide a written commitment to diligently pursue acquiring the site if and when a certificate of need application is approved, shall specify at least one alternate site on which the facility could be located should acquisition efforts relative to the primary site ultimately fail, and shall demonstrate that the primary site and alternate sites are available for acquisition.

(d)  An applicant proposing to establish new ICF/MR beds shall document that the services will be provided in a physical environment that conforms with the requirements in 10A NCAC 27G .0300.

(e)  An applicant proposing to establish new ICF/MR beds shall document that the existing or proposed facility is located within 45 minutes normal automobile driving time (one‑way) of the resident's developmental day programs.

(f)  An applicant proposing to establish new ICF/MR beds shall document that provisions for recreation areas and activities are appropriate to the developmental level of the proposed residents.

(g)  The applicant shall identify the Area Authority that will serve as the Single Portal of Entry/Exit for the facility.

 

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

Eff. December 1, 1996.

 

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

(a)  An application for new ICF/MR beds shall document that the staffing pattern for the ICF/MR will comply with staffing requirements as contained in 10A NCAC 27G .2102 and 42 CFR 483.430 which are incorporated by reference including all subsequent amendments.

(b)  An application for new ICF/MR beds shall document that the ICF/MR will be administered by a qualified developmental disabilities professional.

 

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

Eff. December 1, 1996.

 

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

(a)  An applicant proposing to establish new intensive treatment beds shall project resident origin by percentage by county of residence. All assumptions and the methodology for projecting occupancy shall be stated.

(b)  An applicant proposing to establish new intensive treatment beds shall project an occupancy level for the entire facility for the first eight calendar quarters following the completion of the proposed project, including the average length of stay. All assumptions and the methodology for projecting occupancy shall be clearly stated.

(c)  If the applicant is an existing chemical dependency treatment facility, the applicant shall document the percentage of patients discharged from the facility that are readmitted to the facility at a later date.

(d)  An applicant shall document that the following items are currently available or will be made available following completion of the project:

(1)           admission criteria for clinical admissions to the facility or unit, including procedure for accepting emergency admissions;

(2)           client evaluation procedures, including preliminary evaluation and establishment of an individual treatment plan;

(3)           procedures for referral and follow‑up of clients to necessary outside services;

(4)           procedures for involvement of family in counseling process;

(5)           provision of an aftercare plan; and

(6)           quality assurance/utilization review plan.

(e)  An applicant shall document the attempts made to establish working relationships with the health care providers and others that are anticipated to refer clients to the proposed intensive treatment beds.

(f)  An applicant shall provide copies of any current or proposed contracts or agreements or letters of intent to develop contracts or agreements for the provision of any services to the clients served in the chemical dependency treatment facility.

(g)  An applicant shall document the provisions that will be made to obtain services for patients with a dual diagnosis of chemical dependency and psychiatric problems.

(h)  An applicant proposing to establish new intensive treatment beds shall specify the primary site on which the facility will be located. If such site is neither owned by nor under option by the applicant, the applicant shall provide a written commitment to pursue acquiring the site if and when a certificate of need application is approved, shall specify at least one alternate site on which the facility could be located should acquisition efforts relative to the primary site ultimately fail, and shall demonstrate that the primary site and alternate sites are available for acquisition.

(i)  An applicant proposing to establish new intensive treatment beds shall document that the services will be provided in a physical environment that conforms with the requirements in 10A NCAC 27G .0300 which are incorporated by reference including all subsequent amendments.

 

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.

 

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

(a)  An applicant proposing to establish new intensive treatment beds shall document that clinical staff members will be:

(1)           currently licensed or certified by the appropriate state licensure or certification boards; or

(2)           supervised by staff who are licensed or certified by the appropriate state licensure or certification boards.

(b)  An applicant proposing to establish new intensive treatment beds shall document that the staffing pattern in the facility is consistent with the staffing requirements contained in 10A NCAC 27G which are incorporated by reference including all subsequent amendments.

 

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.

 

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

(a)  An applicant proposing to establish new psychiatric beds shall project resident origin by percentage by county of residence.  All assumptions and the methodology for projecting occupancy shall be stated.

(b)  An applicant proposing to establish new psychiatric beds shall project an occupancy level for the entire facility for the first eight calendar quarters following the completion of the proposed project, including average length of stay.  All assumptions and the methodology for projecting occupancy shall be stated.

(c)  The applicant shall provide documentation of the percentage of patients discharged from the facility that are readmitted to the facility at a later date.

(d)  An applicant proposing to establish new psychiatric beds shall describe the general treatment plan that is anticipated to be used by the facility and the support services to be provided, including provisions that will be made to obtain services for patients with a dual diagnosis of psychiatric and chemical dependency problems.

(e)  The applicant shall document the attempts made to establish working relationships with the health care providers and others that are anticipated to refer clients to the proposed psychiatric beds.

(f)  The applicant shall provide copies of any current or proposed contracts or agreements or letters of intent to develop contracts or agreements for the provision of any services to the clients served in the psychiatric facility.

(g)  The applicant shall document that the following items are currently available or will be made available following completion of the project:

(1)           admission criteria for clinical admissions to the facility or unit;

(2)           emergency screening services for the targeted population which shall include services for handling emergencies on a 24-hour basis or through formalized transfer agreements;

(3)           client evaluation procedures, including preliminary evaluation and establishment of an individual treatment plan;

(4)           procedures for referral and follow-up of clients to necessary outside services;

(5)           procedures for involvement of family in counseling process;

(6)           comprehensive services which shall include individual, group and family therapy; medication therapy; and activities therapy including recreation;

(7)           educational components if the application is for child or adolescent beds;

(8)           provision of an aftercare plan; and

(9)           quality assurance/utilization review plan.

(h)  An applicant proposing to establish new psychiatric beds shall specify the primary site on which the facility will be located.  If such site is neither owned by nor under option by the applicant, the applicant shall provide a written commitment to pursue acquiring the site if and when a certificate of need application is approved, shall specify at least one alternate site on which the facility could be located should acquisition efforts relative to the primary site ultimately fail, and shall demonstrate that the primary site and alternate sites are available for acquisition.

(i)  An applicant proposing to establish new psychiatric beds shall provide documentation to show that the services will be provided in a physical environment that conforms with the requirements in 10A NCAC 27G .0300.

(j)  An applicant proposing to establish new adult or child/adolescent psychiatric beds shall provide:

(1)           documentation that adult or child/adolescent inpatient psychiatric beds designated for involuntary admissions in the licensed hospitals that serve the proposed mental health planning area were utilized at less than 70 percent for facilities with 20 or more beds, less than 65 percent for facilities with 10 to 19 beds, and less than 60 percent for facilities with one to nine beds in the most recent 12 month period prior to submittal of the application; or

(2)           a written commitment that the applicant will accept involuntary admissions and will meet the requirements of 10A NCAC 26C .0103 for designation of the facility, in which the new psychiatric beds will be located, for the custody and treatment of involuntary clients, pursuant to G.S. 122C-252.

 

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.

 

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

(a)  A proposal to provide new or expanded psychiatric beds must provide a listing of disciplines and a staffing pattern covering seven days per week and 24 hours per day.

(b)  A proposal to provide new psychiatric beds must identify the number of physicians licensed to practice medicine in North Carolina with a specialty in psychiatry who practice in the primary service area.  Proposals specifically for or including child or adolescent psychiatric beds must provide documentation to show the availability of a psychiatrist specializing in the treatment of children or adolescents.

(c)  A proposal to provide additional psychiatric beds in an existing facility shall indicate the number of psychiatrists who have privileges and practice at the facility proposing expansion.  Proposals specifically for or including child or adolescent psychiatric beds must provide documentation to show the availability of a psychiatrist specializing in the treatment of children or adolescents.

(d)  A proposal to provide new or expanded psychiatric beds must demonstrate that it will be able to retain the services of a psychiatrist who is eligible to be certified or is certified by the American Board of Psychiatry and Neurology to serve as medical director of the facility or department chairman of the unit of a general hospital.

(e)  A proposal to provide new or expanded psychiatric beds must provide documentation to show the availability of staff to serve involuntary admissions, if applicable.

(f)  A proposal to provide new or expanded psychiatric beds must describe the procedures which have been developed to admit and treat patients not referred by private physicians.

(g)  A proposal to provide new or expanded psychiatric beds shall indicate the availability of training or continuing education opportunities for the professional staff.

 

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

Eff. May 1, 1983;

Amended Eff. November 1, 1989.

 

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

(a)  An applicant proposing to acquire an MRI scanner, including a mobile MRI scanner, shall use the Acute Care Facility/Medical Equipment application form.

(b)  Except for proposals to acquire mobile MRI scanners that serve two or more host facilities, both the applicant and the person billing the patients for the MRI service shall be named as co-applicants in the application form.

(c)  An applicant proposing to acquire a magnetic resonance imaging scanner, including a mobile MRI scanner, shall provide the following information:

(1)           documentation that the proposed fixed MRI scanner, excluding fixed extremity and breast MRI scanners, will be available and staffed for use at least 66 hours per week;

(2)           documentation that the proposed mobile MRI scanner will be available and staffed for use at least 40 hours per week;

(3)           documentation that the proposed fixed extremity or dedicated breast MRI scanner shall be available and staffed for use at least 40 hours per week;

(4)           the average charge to the patient, regardless of who bills the patient, for each of the 20 most frequent MRI procedures to be performed for each of the first three years of operation after completion of the project and a description of items included in the charge; if the professional fee is included in the charge, provide the dollar amount for the professional fee;

(5)           if the proposed MRI service will be provided pursuant to a service agreement, the dollar amount of the service contract fee billed by the applicant to the contracting party for each of the first three years of operation;

(6)           letters from physicians indicating their intent to refer patients to the proposed magnetic resonance imaging scanner and their estimate of the number of patients proposed to be referred per year, which is based on the physicians' historical number of referrals;

(7)           for each location in the MRI service area at which the applicant or a related entity will provide MRI services, utilizing existing, approved, or proposed fixed MRI scanners, the number of fixed MRI scanners operated or to be operated at each location;

(8)           for each location in the MRI service area at which the applicant or a related entity will provide MRI services, utilizing existing, approved, or proposed fixed MRI scanners, projections of the annual number of unweighted MRI procedures to be performed for each of the four types of MRI procedures, as identified in the SMFP, for each of the first three years of operation after completion of the project;

(9)           for each location in the MRI service area at which the applicant or a related entity will provide services, utilizing existing, approved, or proposed fixed MRI scanners, projections of the annual number of weighted MRI procedures to be performed for each of the four types of MRI procedures, as identified in the SMFP, for each of the first three years of operation after completion of the project;

(10)         a detailed description of the methodology and assumptions used to project the number of unweighted MRI procedures to be performed at each location, including the number of contrast versus non-contrast procedures, sedation versus non-sedation procedures, and inpatient versus outpatient procedures;

(11)         a detailed description of the methodology and assumptions used to project the number of weighted MRI procedures to be performed at each location;

(12)         for each existing, approved or proposed mobile MRI scanner owned by the applicant or a related entity and operated in North Carolina in the month the application is submitted, the vendor, tesla strength, serial number or vehicle identification number, CON project identification number, and host sites;

(13)         for each host site in the mobile MRI region in which the applicant or a related entity will provide the proposed mobile MRI services, utilizing existing, approved, or proposed mobile MRI scanners, projections of the annual number of unweighted and weighted MRI procedures to be performed for each of the four types of MRI procedures, as identified in the SMFP, for each of the first three years of operation after completion of the project;

(14)         if proposing to acquire a mobile MRI scanner, an explanation of the basis for selection of the proposed host sites if the host sites are not located in MRI service areas that lack a fixed MRI scanner; and

(15)         identity of the accreditation authority the applicant proposes to use.

(d)  An applicant proposing to acquire a mobile MRI scanner shall provide copies of letters of intent from, and proposed contracts with, all of the proposed host facilities of the new MRI scanner.

(e)  An applicant proposing to acquire a dedicated fixed breast MRI scanner shall demonstrate that:

(1)           it has an existing and ongoing working relationship with a breast–imaging radiologist or radiology practice group that has experience interpreting breast images provided by mammography, ultrasound, and MRI scanner equipment, and that is trained to interpret images produced by a MRI scanner configured exclusively for mammographic studies;

(2)           for the last 12 months it has performed the following services, without interruption in the provision of these services: breast MRI procedures on a fixed MRI scanner with a breast coil, mammograms, breast ultrasound procedures, breast needle core biopsies, breast cyst aspirations, and pre-surgical breast needle localizations;

(3)           its existing mammography equipment, breast ultrasound equipment, and the proposed dedicated breast MRI scanner is in compliance with the federal Mammography Quality Standards Act;

(4)           it is part of an existing healthcare system that provides comprehensive cancer care, including radiation oncology, medical oncology, surgical oncology and an established breast cancer treatment program that is based in the geographic area proposed to be served by the applicant; and,

(5)           it has an existing relationship with an established collaborative team for the treatment of breast cancer that includes, radiologists, pathologists, radiation oncologists, hematologists/oncologists, surgeons, obstetricians/gynecologists, and primary care providers.

(f)  An applicant proposing to acquire an extremity MRI scanner, pursuant to a need determination in the State Medical Facilities Plan for a demonstration project, shall:

(1)           provide a detailed description of the scope of the research studies that will be conducted to demonstrate the convenience, cost effectiveness and improved access resulting from utilization of extremity MRI scanning;

(2)           provide projections of estimated cost savings from utilization of an extremity MRI scanner based on comparison of "total dollars received per procedure" performed on the proposed scanner in comparison to "total dollars received per procedure" performed on whole body scanners;

(3)           provide projections of estimated cost savings to the patient from utilization of an extremity MRI scanner;

(4)           commit to prepare an annual report at the end of each of the first three operating years, to be submitted to the Medical Facilities Planning Section and the Certificate of Need Section, that will include:

(A)          a detailed description of the research studies completed;

(B)          a description of the results of the studies;

(C)          the cost per procedure to the patient and billing entity;

(D)          the cost savings to the patient attributed to utilization of an extremity MRI scanner;

(E)           an analysis of "total dollars received per procedure" performed on the extremity MRI scanner in comparison to "total dollars received per procedure" performed on whole body scanners; and

(F)           the annual volume of unweighted and weighted MRI procedures performed, by CPT code;

(5)           identify the operating hours of the proposed scanner;

(6)           provide a description of the capabilities of the proposed scanner;

(7)           provide documentation of the capacity of the proposed scanner based on the number of days to be operated each week, the number of days to be operated each year, the number of hours to be operated each day, and the average number of unweighted MRI procedures the scanner is capable of performing each hour;

(8)           identify the types of MRI procedures by CPT code that are appropriate to be performed on an extremity MRI scanner as opposed to a whole body MRI scanner;

(9)           provide copies of the operational and safety requirements set by the manufacturer; and

(10)         describe the criteria and methodology to be implemented for utilization review to ensure the medical necessity of the procedures performed.

(g)  An applicant proposing to acquire a multi-position MRI scanner, pursuant to a need determination in the State Medical Facilities Plan for a demonstration project, shall:

(1)           commit to prepare an annual report at the end of each of the first three operating years, to be submitted to the Medical Facilities Planning Section and the Certificate of Need Section, that will include:

(A)          the number of exams by CPT code performed on the multi-position MRI scanner in an upright or nonstandard position;

(B)          the total number of examinations by CPT code performed on the multi-position MRI scanner in any position;

(C)          the number of doctors by specialty that referred patients for an MRI scan in an upright or nonstandard position;

(D)          documentation to demonstrate compliance with the Basic Principles policy included in the State Medical Facilities Plan;

(E)           a detailed description of the unique information that was acquired only by use of the multi-position capability of the multi-position MRI scanner; and

(F)           the number of insured, underinsured, and uninsured patients served by type of payment category;

(2)           provide the specific criteria that will be used to determine which patients will be examined in other than routine supine or prone imaging positions;

(3)           project the number of exams by CPT code performed on the multi-position MRI scanner in an upright or nonstandard position;

(4)           project the total number of examinations by CPT code performed on the multi-position MRI scanner in any position;

(5)           demonstrate that access to the multi-position MRI scanner will be made available to all spine surgeons in the proposed service area, regardless of ownership in the applicant's facility;

(6)           demonstrate that at least 50 percent of the patients to be served on the multi-position MRI scanner will be spine patients who are examined in an upright or nonstandard position; and

(7)           provide documentation of the capacity of the proposed fixed multi-position MRI scanner based on the number of days to be operated each week, the number of days to be operated each year, the number of hours to be operated each day, and the average number of unweighted MRI procedures the scanner is capable of performing each hour.

 

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.

 

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

(a)  An applicant proposing to acquire a mobile MRI scanner shall provide referral agreements between each host site and at least one other provider of MRI services in the geographic area to be served by the host site, to document the availability of MRI services if patients require them when the mobile unit is not in service at that host site.

(b)  An applicant proposing to acquire a fixed or mobile MRI scanner shall obtain accreditation from the Joint Commission for the Accreditation of Healthcare Organizations, the American College of Radiology or a comparable accreditation authority, as determined by the Certificate of Need Section, for magnetic resonance imaging within two years following operation of the proposed MRI scanner.

 

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, 2005;

Amended Eff. November 1 2005;

Temporary Amendment Eff. February 1, 2006;

Amended Eff. November 1, 2006.

 

10A ncac 14C .2705       STAFFING AND STAFF TRAINING

(a)  An applicant proposing to acquire an MRI scanner, including extremity and breast MRI scanners, shall demonstrate that one diagnostic radiologist certified by the American Board of Radiologists shall be available to interpret the images who has had:

(1)           training in magnetic resonance imaging as an integral part of his or her residency training program; or

(2)           six months of supervised MRI experience under the direction of a certified diagnostic radiologist; or

(3)           at least six months of fellowship training, or its equivalent, in MRI; or

(4)           a combination of MRI experience and fellowship training equivalent to Subparagraph (a)(1), (2) or (3) of this Rule.

(b)  An applicant proposing to acquire a dedicated breast MRI scanner shall provide documentation that:

(1)           the radiologist is trained and has expertise in breast imaging, including mammography, breast ultrasound and breast MRI procedures; and

(2)           two full time MRI technologists or two mammography technologists are available with training in breast MRI imaging and that one of these technologists shall be present during the hours operation of the dedicated breast MRI scanner.

(c)  An applicant proposing to acquire a MRI scanner, including extremity but excluding dedicated breast MRI scanners, shall provide evidence of the availability of two full‑time MRI technologist‑radiographers and that one of these technologists shall be present during the hours of operation of the MRI scanner.

(d)  An applicant proposing to acquire an MRI scanner, including extremity and breast MRI scanners, shall demonstrate that the following staff training is provided:

(1)           American Red Cross or American Heart Association certification in cardiopulmonary resuscitation (CPR) and basic cardiac life support; and

(2)           the availability of an organized program of staff education and training which is integral to the services program and ensures improvement in technique and the proper training of new personnel.

(e)  An applicant proposing to acquire a mobile MRI scanner shall document that the requirements in Paragraph (a) of this Rule shall be met at each host facility, and that one full time MRI technologist-radiographer shall be present at each host facility during all hours of operation of the proposed mobile MRI scanner.

(f)  An applicant proposing to acquire an extremity MRI scanner, pursuant to a need determination in the State Medical Facilities Plan for a demonstration project, also shall provide:

(1)           evidence that at least one licensed physician shall be on-site during the hours of operation of the proposed MRI scanner;

(2)           a description of a research group for the project including a radiologist, orthopaedic surgeon, and research coordinator; and

(3)           letters from the proposed members of the research group indicating their qualifications, experience and willingness to participate on the research team.

(g)  An applicant proposing to perform cardiac MRI procedures shall provide documentation of the availability of a radiologist, certified by the American Board of Radiology, with training and experience in interpreting images produced by an MRI scanner configured to perform cardiac MRI studies.

 

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.

 

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

(a)  An applicant proposing to establish new rehabilitation beds shall specify the total number of rehabilitation beds in the facility or unit to be operated following completion of the proposed project.

(b)  An applicant proposing to establish new rehabilitation beds shall demonstrate that:

(1)           The target population for the program is specifically defined;

(2)           Arrangements and responsibilities for administration and medical direction are specified;

(3)           A plan exists that describes how clinical personnel (e.g., rehabilitative nurses and therapists) and ancillary services will be allocated if personnel or services for the rehabilitation beds will be shared with other units or facilities; and

(4)           Referral and transfer agreements exist or shall be arranged for between the proposed rehabilitation program or unit and all units within the program, the facility in which the proposed rehabilitation program or unit will be situated, and the agencies that are involved in the provision of rehabilitation or related support services and are located in the proposed service area.

(c)  An applicant proposing to establish new rehabilitation beds shall document the proximity of the proposed facility or unit to the following services:

(1)           support services;

(2)           ancillary services;

(3)           public transportation;

(4)           outpatient rehabilitation clinics;

(5)           home health agencies;

(6)           group homes for disabled persons.

(d)  An applicant proposing to add rehabilitation beds to an existing facility shall show the current rehabilitation patient origin by percentage by county of residence for the 12 month period immediately preceding the submittal of the application.  All assumptions, including the specific methodology by which patient origin is projected shall be clearly stated.

(e)  An applicant proposing to establish new rehabilitation beds shall project patient origin by percentage by county of residence.  All assumptions, including the specific methodology by which patient origin is projected shall be clearly stated.

(f)  An applicant proposing to establish new rehabilitation beds shall project the average length of stay (ALOS) for each for the following categories of patients:

(1)           spinal cord;

(2)           traumatic brain injury;

(3)           stroke;

(4)           pediatric.

(g)  An applicant proposing to establish new rehabilitation beds shall project an occupancy level for all rehabilitation beds in the facility for each of the first eight calendar quarters following completion of the proposed project.  The applicant shall clearly document all assumptions, including the specific methodologies by which occupancies are projected.

 

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

Eff. May 1, 1991;

Amended Eff. November 1, 1996.

 

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

An applicant proposing to establish new rehabilitation beds shall identify which of the following rehabilitation services shall be provided in the facility upon licensure and operation of the new rehabilitation beds:

(1)           Program Manager;

(2)           Occupational Therapy;

(3)           Physical Therapy;

(4)           Physiatrist or a physician who has training and experience in providing rehabilitation care;

(5)           Psychology;

(6)           Rehabilitation Nursing;

(7)           Respiratory Therapy;

(8)           Social Work;

(9)           Speech‑Language Pathology and Audiology;

(10)         Vocational Rehabilitation;

(11)         Orthotics;

(12)         Prosthetics.

 

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

Eff. May 1, 1991;

Amended Eff. November 1, 1996.

 

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

(a)  An applicant proposing new or expanded autologous or allogeneic bone marrow transplantation services shall use the Acute Care Facility/Medical Equipment application form.

(b)  An applicant proposing new or expanded autologous or allogeneic bone marrow transplantation services shall also provide the following additional information:

(1)           the projected number of autologous and allogeneic transplant patients by disease type (e.g. Hodgkin's lymphoma Stage III) to be performed in each of the first 12 calendar quarters following completion of the proposed project, including the methodology and assumptions used for these projections; and

(2)           a copy of the applicant's proposed policy and guidelines for participation in peer-reviewed clinical trials or research protocols.

(c)  An applicant that proposes new autologous or allogeneic bone marrow transplantation services shall provide documentation that the applicant will participate in approved clinical trials or research protocols and also participate in a National Cancer Institute approved cooperative research group.

(d)  An applicant that proposes expanded autologous or allogeneic bone marrow transplantation services shall provide documentation that the applicant is participating in approved clinical trials or research protocols, and is participating in a National Cancer Institute approved cooperative research group.

(e)  An applicant that proposes to provide new or expanded autologous or allogeneic bone marrow transplantation services for clinical purposes shall:

(1)           provide documentation of existing referral networks and other referral sources for patients to be treated with bone marrow transplantation, and

(2)           identify the sources of reimbursement for the procedures and demonstrate the availability of these sources for treatment of the specific diseases proposed to be treated with bone marrow transplantation.

(f)  An applicant that proposes to provide new or expanded autologous or allogeneic bone marrow transplantation services for research purposes shall demonstrate how capital costs and service operations for the research will be funded and shall provide documentation of the commitment of the funding agency.

 

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 .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

(a)  An applicant that proposes to provide new or expanded autologous or allogeneic bone marrow transplantation services shall demonstrate that the following will be available in the facility upon initiation of bone marrow transplantation services:

(1)           accommodations which offer 24 hour critical support and which are appropriate for patients whose immune systems are depressed from the effects of the treatment;

(2)           air handling systems which are appropriate for patients whose immune systems are depressed from the effects of the treatment;

(3)           if processing autologous bone marrow transplantation services, cryopreservation equipment for the storage of bone marrow;

(4)           laboratory services which are available to the bone marrow transplant patient on a twenty-four hour basis;

(5)           radiology services, including CT scanning and nuclear medicine, which are available to the bone marrow transplant patient on a twenty-four hour basis;

(6)           total body radiotherapy for patients whose treatment protocols require total body irradiation;

(7)           irradiated red cells, platelets and other blood products available on a twenty-four hour basis;

(8)           access to blood bank services which are accredited by the American Association of Blood Banks;

(9)           operating and recovery room resources;

(10)         microbiology and virology laboratories;

(11)         a multidisciplinary plan for providing rehabilitative services;

(12)         basic and clinical laboratory research;

(13)         an active, formal research program related to the proposed bone marrow transplantation program; and

(b)  An applicant that proposes to provide new or expanded allogeneic bone marrow transplantation services shall also demonstrate that the following will be available in the facility upon initiation of allogeneic bone marrow transplantation services:

(1)           if proposing allogeneic bone marrow transplantation services, laboratory facilities for histocompati­bility testing which are certified by the American Society for Histocompatibility and Immunogenet­ics; and

(2)           if proposing allogeneic bone marrow transplantation services, an established on-site program to promote bone marrow donation.

(c)  A proposal to provide new or expanded bone marrow transplantation services shall provide evidence that, prior to the operation of the service, the applicant will develop a clinical oversight committee for bone marrow transplant services. The clinical oversight committee shall be responsible for the following activities:

(1)           developing screening criteria for appropriate bone marrow transplantation utilization;

(2)           reviewing clinical protocols;

(3)           reviewing appropriateness and quality of clinical procedures;

(4)           developing educational programs; and

(5)           overseeing the data collection, evaluation, and reporting activities of the bone marrow transplanta­tion service.

 

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 .2905       STAFFING AND STAFF TRAINING

(a)  An applicant shall demonstrate that it can meet each of the following staffing requirements:

(1)           a bone marrow transplant clinical coordinator;

(2)           a physician licensed to practice medicine in North Carolina who will be designated as the director of the program and who has documented experience within the past year in:

(A)          pretransplant evaluation;

(B)          bone marrow processing;

(C)          the provision of medical care services to hospitalized bone marrow transplant patients; and

(D)          post-transplant care;

(3)           availability of physicians in the following specialties to the bone marrow transplantation program on a 24 hour basis:

(A)          hematology or oncology;

(B)          gastroenterology;

(C)          nephrology;

(D)          infectious diseases;

(E)           pulmonary diseases; and

(F)           pediatrics (if pediatric patients will be treated);

(4)           laboratory staff who are trained in the processing of bone marrow;

(5)           a state certified social worker with a master's degree in social work who is available for inpatient and outpatient ongoing support of both the patient and family; and

(6)           a board-certified or equivalently qualified psychiatrist who is available for inpatient and outpatient ongoing support of both the patient and family.

(b)  An applicant shall demonstrate that a program of staff education and training which is integral to the bone marrow transplantation service and which ensures improvements in technique and the proper training of new personnel will be provided.

 

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.

 

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

 

10A NCAC 14C .3001       DEFINITIONS

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

(1)           "Solid organs" mean the heart, lung, liver, kidney, pancreas and islet cells and intestines.

(2)           "Pediatric Patient" means a patient under the age of 17.

(3)           "Solid Organ Transplantation Service Area" means a geographical area defined by the applicant from which patients projected to receive the services originate.

(4)           "Solid Organ Transplantation Services" is defined in G.S. 131E-176(16)(24b).

(5)           "UNOS" or the "United Network for Organ Sharing" means the organization contracted by the Department of Health and Human Services to operate both the organ procurement and transplantation network and the scientific registry of information on organ donors and recipients.

 

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 .3002       INFORMATION REQUIRED OF APPLICANT

(a)  An applicant proposing to establish a new solid organ transplantation service or to expand an existing solid organ transplantation service shall use the Acute Care Facility/Medical Equipment application form.

(b)  The applicant shall provide a copy of its procedures for selecting transplant candidates and for distributing organs which are consistent with UNOS guidelines.

(c)  The applicant shall provide letters of agreement or contracts with either an independent organ procurement organization or a hospital-based organ procurement organization. The letters shall demonstrate the capability to provide sufficient numbers of organs to support the minimum activity level for the applicable type of organ transplantation proposed in the application.

(d)  The applicant shall document collaboration with experts in the fields of hepatology, cardiology, pediatrics, infectious disease, nephrology, renal dialysis, pulmonary medicine, respiratory therapy, pathology, immunology, anesthesiology, physical therapy, and rehabilitation. The documentation shall include, but not be limited to, a plan of operation detailing the interaction of the transplant service and the stated specialty areas.

(e)  An applicant that proposes to establish a joint sharing arrangement for organ transplantation services which involves more than one hospital shall demonstrate all of the following:

(1)           all hospitals in the joint sharing arrangement are geographically proximate to permit cost-effective sharing of resources; and

(2)           a single hospital site has been designated where the organ transplant surgical procedures shall be performed which involves both adult and pediatric organ transplant procedures, except one hospital site may be designated where all adult organ transplant procedures will be performed and another hospital site may be designated where all pediatric organ transplant procedures will be performed if both hospital sites are part of the joint sharing arrangement.

(f)  The applicant shall demonstrate that transplantation services shall be offered in a physical environment that conforms to the requirements of federal, state and local bodies.

(g)  An applicant proposing to establish a new solid organ transplantation service or to expand an existing solid organ transplantation service shall include drawings or schematics of the proposed project that identify the location of the operating rooms in the hospital where transplantation procedures will be performed.

(h)  An applicant proposing to establish a new solid organ transplantation service or to expand an existing solid organ transplantation service shall project the number and type of transplantations by CPT code or ICD-9-CM procedure code by distinct transplantation service for each of the first twelve calendar quarters following completion of the proposed project.

(i)  An applicant proposing to establish a new solid organ transplantation service or to expand an existing solid organ transplantation service shall project patient origin by state and by county for North Carolina residents and shall indicate the percentage of total patients to originate from each State and county.

 

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 .3003       SUPPORT SERVICES

An applicant proposing to establish a new or to expand an existing solid organ transplantation service shall demonstrate that it offers the services listed in this Rule or shall provide documentation obviating the need for an item:

(1)           operating and recovery room resources;

(2)           intensive care facilities allowing reverse isolation;

(3)           microbiology and virology laboratory;

(4)           laboratory facilities for histocompatibility testing that are certified by the American Society for Histocompatibility and Immunogenetics;

(5)           a multidisciplinary plan for providing rehabilitation;

(6)           CT scanning;

(7)           nuclear medicine;

(8)           magnetic resonance imaging;

(9)           duplex ultrasound scanning for liver, pancreas and kidney transplantation;

(10)         pulmonary medicine;

(11)         cardiology;

(12)         an acute hemodialysis unit;

(13)         a state certified social worker with a master's degree in social work who is available for inpatient and outpatient ongoing support of both the patient and family;

(14)         a licensed practicing psychologist or licensed psychological associate who is available for inpatient and outpatient ongoing support of both the patient and family;

(15)         a psychiatrist who is available for inpatient and outpatient ongoing support of both the patient and family;

(16)         full-time organ transplant coordinator(s);

(17)         an on-going program of community-based post-transplantation care;

(18)         basic and clinical laboratory research;

(19)         an existing research program that is currently conducting research related to the proposed organ transplantation service;

(20)         a written organ donation protocol, with brain death protocol, consistent with North Carolina law;

(21)         an existing program to promote organ donation at the applicant's hospital; and

(22)         a nursing team trained in immunosuppression management including isolation techniques and infection control methods.

 

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 .3004       ADDITIONAL REQUIREMENTS FOR HEART, HEART/LUNG OR LUNG TRANSPLANTATION SERVICES

(a)  An applicant proposing to establish a new heart or heart/lung transplantation service shall project a cumulative minimum of 15 heart or heart/lung transplantation procedures by the end of the second full year of operation following the date on which the first heart or heart/lung transplant procedure is performed.

(b)  An applicant proposing to establish a new heart or heart/lung transplantation service or to expand an existing heart or heart/lung transplantation service shall demonstrate that it offers the services listed in this Rule or shall provide documentation obviating the need for an item:

(1)           a histocompatibility laboratory, or a written agreement with such a laboratory;

(2)           anatomic and clinical pathology with an approved residency program;

(3)           24-hour angiography;

(4)           an intensive care unit with 24-hour per day resident coverage;

(5)           a continuously available coagulation laboratory;

(6)           a blood bank capable of providing 20 units of blood, platelets, and fresh blood products on demand; and

(7)           availability of cardiopulmonary bypass on a 24 hour basis.

(c)  An applicant that proposes to establish a new lung transplantation service shall project a cumulative minimum of 15 lung transplantation procedures by the end of the second full year of operation following the date on which the first lung transplantation procedure is performed.

(d)  An applicant proposing to establish a new lung transplantation service shall demonstrate that it offers the services listed in this Rule or shall provide documentation obviating the need for an item:

(1)           a histocompatibility laboratory, or a written agreement with such a laboratory;

(2)           anatomic and clinical pathology with an approved residency program;

(3)           24-hour angiography;

(4)           an intensive care unit with 24-hour per day resident coverage;

(5)           a continuously available coagulation laboratory;

(6)           a blood bank capable of providing 20 units of blood, platelets, and fresh blood products on demand; and

(7)           availability of cardiopulmonary bypass on a 24-hour basis.

 

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 .3005       ADDITIONAL REQUIREMENTS FOR LIVER TRANSPLANTATION SERVICES

(a)  An applicant proposing to establish a new liver transplantation service shall project a cumulative minimum of 15 liver transplantation procedures by the end of the second full year of operation following the date on which the first liver transplant procedure is performed.

(b)  An applicant proposing to establish a new liver transplantation service or to expand an existing liver transplantation service shall demonstrate that it either:

(1)           operates an existing renal transplant service; or

(2)           has a written agreement with a renal transplant service that ensures that the professional expertise of the renal transplant service is readily available to the proposed liver transplantation service.

(c)  An applicant proposing to establish a new liver transplantation service or to expand an existing liver transplantation service shall demonstrate that it offers the services listed in this Rule or shall provide documentation obviating the need for an item:

(1)           a histocompatibility laboratory, or a written agreement with such a laboratory;

(2)           anatomic and clinical pathology with an approved residency program;

(3)           24-hour angiography;

(4)           an intensive care unit with 24-hour per day resident coverage;

(5)           veno-venous bypass equipment that does not require heparin;

(6)           adult and pediatric (as appropriate) gastroenterologists and hepatologists on the active medical staff who meet UNOS criteria for transplant physicians and surgeons;

(7)           endoscopic retrograde cholangiopancreatography (ERCP) availability;

(8)           percutaneous cholangiogram availability;

(9)           a rapid blood infusion system;

(10)         percutaneous liver biopsy capability;

(11)         hemoperfusion;

(12)         a rapid red blood cell (RBC) saver system; and

(13)         duplex ultrasound.

(d)  The applicant shall establish and maintain all of the following:

(1)           nuclear HID biliary scan availability;

(2)           continuously available coagulation laboratory; and

(3)           a blood bank system capable of providing 200 units of blood or packed cells, 100 units of plasma on demand, 24 units (or four adult doses) of platelet concentrates and 30 units of cryoprecipate on demand.

 

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 .3006       ADDITIONAL REQUIREMENTS FOR PANCREAS TRANSPLANTATION SERVICES

(a)  An applicant proposing to establish a new pancreas transplantation service or to expand an existing pancreas transplantation service shall project a cumulative minimum of 10 pancreas transplantation procedures by the end of the second full year of operation following the date on which the first pancreas transplant procedure is performed.

(b)  An applicant proposing to establish a new pancreas transplantation service or to expand an existing pancreas transplantation service shall demonstrate that it offers the services listed in this Rule or shall provide documentation obviating the need for an item:

(1)           a histocompatibility laboratory, or a written agreement with such a laboratory;

(2)           anatomic and clinical pathology;

(3)           24-hour angiography;

(4)           an intensive care unit with 24-hour per day resident coverage;

(5)           approved on-site renal transplant services;

(6)           physicians with rehabilitation expertise;

(7)           both adult and pediatric surgeons, as appropriate; and

(8)           both adult and pediatric diabetologists, as appropriate, on the active medical staff.

(c)  The applicant shall establish and maintain all of the following:

(1)           insulin,

(2)           C-peptide,

(3)           glycosylated hemoglobin assays, and

(4)           glucometer glucose assays.

 

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 .3007       ADDITIONAL REQUIREMENTS FOR KIDNEY TRANSPLANTATION SERVICES

(a)  An applicant proposing to establish a new kidney transplantation service shall project a cumulative minimum of 25 kidney transplantation procedures by the end of the second full year of operation following the date on which the first kidney transplant procedure is performed.

(b)  An applicant proposing to establish a new kidney transplantation service or to expand an existing kidney transplantation service shall demonstrate that it provides the services listed in this Rule or shall provide documentation obviating the need for an item:

(1)           a histocompatibility laboratory, or a written agreement with such a laboratory;

(2)           an intensive care unit with 24-hour per day resident coverage;

(3)           inpatient renal dialysis services;

(4)           available freestanding renal dialysis clinic services;

(5)           pre-dialysis, dialysis and post-transplantation nutritional services;

(6)           bacteriologic services;

(7)           biochemical services;

(8)           pathological services;

(9)           radiologic services; and

(10)         ophthalmology retinal eye services.

 

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 .3008       STAFFING AND STAFF TRAINING

(a)  An applicant proposing to establish a new heart or heart/lung transplantation service or to expand an existing heart or heart/lung transplantation service shall demonstrate that the following persons shall provide the proposed services:

(1)           anesthesiologists with expertise in transplantation anesthesia;

(2)           cardiologists and surgeons trained in endocardial biopsy and immunosuppression techniques;

(3)           cardiologists and surgeons for both adult and pediatric patients, as appropriate;

(4)           surgeons and physicians that meet UNOS criteria as transplant physicians and surgeons; and

(5)           a nursing team trained in immunosuppression management including isolation techniques and infection control methods.

(b)  An applicant proposing to establish a new lung transplantation service or to expand an existing lung transplantation service shall demonstrate that the following persons will provide the proposed services:

(1)           anesthesiologists with expertise in thoracic anesthesia;

(2)           pulmonologist(s) and surgeons trained in immunosuppression techiques;

(3)           pulmonologist(s) and surgeons for both adult and pediatric patients, as appropriate;

(4)           pulmonologist(s) and surgeons trained in transbronchial lung biopsy techniques;

(5)           surgeons and physicians that meet UNOS criteria as transplant physicians and surgeons; and

(6)           a nursing team trained in immunosuppression management including isolation techniques and infection control methods.

(c)  An applicant proposing to establish a new liver transplantation service or to expand an existing liver transplantation service shall demonstrate that the following persons shall provide the proposed services:

(1)           anesthesiologists with expertise in transplantation anesthesia;

(2)           surgeons and physicians who meet UNOS criteria as liver transplant surgeons and physicians;

(3)           a veno-venous bypass team immediately available for liver transplant recipient operation, a requirement which may be satisfied by a written agreement which ensures that a veno-venous bypass team will always be on site throughout the entire liver transplant recipient operation; and

(4)           a nursing team trained in immunosuppression management including isolation techniques and infection control methods.

(d)  An applicant proposing to establish a new pancreas transplantation service or to expand an existing pancreas transplantation service shall demonstrate that the following persons shall provide the proposed services:

(1)           anesthesiologists with expertise in transplantation anesthesia;

(2)           transplant surgeons and physicians experienced with renal transplantation in diabetics;

(3)           surgeons and physicians who meet UNOS criteria as pancreatic transplant surgeons and physicians;

(4)           adult and pediatric diabetologists, as appropriate, actively participating in the transplant service; and

(5)           a nursing team trained in immunosuppression management including isolation techniques and infection control methods.

(e)  An applicant proposing to establish a new kidney transplantation service or to expand an existing kidney transplantation service shall demonstrate that the following persons shall provide the proposed services:

(1)           surgeons and physicians that meet UNOS criteria as kidney transplant surgeons and physicians;

(2)           the transplant team performing kidney transplantation shall include physicians in the areas of anesthesiol­ogy, nephrology, psychiatry, vascular surgery and urology;

(3)           additional support personnel shall be available including but not limited to a nephrology nurse with experience in the nursing care of patients with permanent kidney failure and a renal dietician;

(4)           adult and pediatric diabetologists, as appropriate, actively participating in the transplant service;

(5)           a nursing team trained in immunosuppression management including isolation techniques and infection control methods.

(f)  An applicant proposing to establish a new intestine transplantation service or to expand an existing intestine transplantation service shall demonstrate that the following persons shall provide the proposed services:

(1)           anesthesiologists with expertise in transplantation anesthesia;

(2)           surgeons and physicians that meet UNOS criteria as transplant surgeons and physicians;

(3)           a physician who meets UNOS criteria in the sub-specialty of Gastroenterology;

(4)           a pathologist who is certified by the American Board of Pathology or who has equivalent qualifications; and

(5)           a nursing team trained in immunosuppression management including isolation techniques and infection control methods.

 

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 .3009       ACCESSIBILITY

An applicant proposing to establish a new solid organ transplantation service or expand an existing solid organ transplant service shall document the procedures that will be used to ensure that patient selection criteria is public and that screening is based on medical suitability which is designed to offer transplantation to those who can benefit the most from it in terms of probability of living for a significant period of time with a reasonable prospect of rehabilitation.

 

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;

Amended Eff. November 1, 1996.

 

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

(a)  An applicant proposing to acquire new major medical technology or major medical equipment shall use the Acute Care Facility/Medical Equipment application form.

(b)  An applicant shall define a proposed service area for the major medical equipment or new major medical technology which shall be similar to the applicant's existing service area for other health services, unless the applicant documents that other providers outside of the applicant's existing service area are expected to refer patients to the applicant.

(c)  An applicant shall document its current experience in providing care to the patients to be served by the proposed major medical equipment or new major medical technology.

(d)  An applicant shall document that the proposed new major medical technology or major medical equipment, its supplies, and its pharmaceuticals have been approved by the U.S. Food and Drug Administration for the clinical uses stated in the application, or that the equipment shall be operated under protocols of an institutional review board whose membership is consistent with the U. S. Department of Health and Human Services' regulations.

(e)  An applicant proposing to acquire new major medical equipment or new major medical technology shall provide a floor plan of the facility in which the equipment will be operated that identifies the following areas:

(1)           receiving/registering area;

(2)           waiting area;

(3)           pre-procedure area;

(4)           procedure area or rooms;

(5)           post-procedure areas, including observation areas; and

(6)           administrative and support areas.

(f)  An applicant proposing to acquire major medical equipment or new major medical technology shall document that the facility shall meet or exceed the appropriate building codes and federal, state, and local manufacture's standards for the type of major medical equipment to be installed.

 

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. January 1, 1997; November 1, 1996.

 

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

An applicant proposing to acquire major medical equipment or new major medical technology shall identify all ancillary and support services that are required to support the major medical equipment or new major medical technology and shall document that all of these services shall be available prior to the operation of the equipment.

 

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 .3106       STAFFING AND STAFF TRAINING

(a)  An applicant proposing to acquire major medical equipment or new major medical technology shall document that:

(1)           trained and qualified clinical staff shall be employed, and

(2)           trained technical staff and support personnel to work in conjunction with the operators of the equipment shall be employed.

(b)  An applicant proposing to acquire major medical equipment or new major medical technology shall provide documentation that physicians who will use the equipment have had relevant residency training, formal continuing medical education courses, and prior on-the-job experience with this or similar medical equipment.

(c)  An applicant shall demonstrate that the following staff training will be provided to the staff that operates the major medical equipment or new major medical technology:

(1)           certification in cardiopulmonary resuscitation and basic cardiac life support; and

(2)           an organized program of staff education and training which is integral to the operation of the major medical equipment and ensures improvements in technique and the proper training of new personnel.

 

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.

 

SECTION .3200 - CRITERIA AND STANDARDS FOR LITHOTRIPTOR EQUIPMENT

 

10A NCAC 14C .3201       DEFINITIONS

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

(1)           "Approved lithotriptor" means a lithotriptor 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)           "Complicated stone disease treatment capability" means the expertise necessary to manage all patients during the treatment of kidney stone disease.  This includes but is not limited to a urologist skilled and experienced in both percutaneous and retrograde endoscopic stone removal procedures, and experienced interventional radiologic support.

(3)           "Existing lithotriptor" means a lithotriptor in operation prior to the beginning of the review period.

(4)           "Host facility" means the site at which a mobile lithotriptor is parked for the provision of SWL procedures.

(5)           "Lithotriptor" means equipment as defined in G.S. 131E-176(14d).

(6)           "Lithotriptor service area" means a geographical area defined by the applicant and which has boundaries that encompass at least 1,000,000 of the state's residents.

(7)           "Mobile lithotriptor" means a lithotriptor and transporting equipment that is moved to provide services at two or more host facilities.

(8)           "Shock wave lithotripsy (SWL) procedure" means a procedure for the removal of kidney stones which involves focusing shock waves on kidney stones so that they are pulverized into sand-like particles which may then be passed through the urinary tract.

 

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 .3202       INFORMATION REQUIRED OF APPLICANT

(a)  An applicant proposing to acquire a lithotriptor shall use the Acute Care Facility/Medical Equipment application form.

(b)  An applicant proposing to acquire a lithotriptor shall also provide the following additional information:

(1)           the boundaries of the proposed lithotriptor service area;

(2)           documentation that 1,000,000 persons reside in the proposed lithotriptor service area based on population data provided by the North Carolina State Office of Management and Budget;

(3)           documentation 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 and used under an institutional review board whose membership is consistent with U.S. Department of Health and Human Services' regulations;

(4)           the number of patients from the proposed lithotriptor service area who are projected to receive SWL procedures by patient's county of residence in each of the first 12 quarters after completion of the project.  This information shall be provided separately for each proposed host facility in those applications which propose the acquisition of a mobile lithotriptor;

(5)           documentation from the applicant's projected referral sources which indicates their intent to refer to the applicant's lithotriptor; and

(6)           the locations at which existing and approved lithotriptors, including mobile units, operate or have been approved to operate in the lithotriptor service area.

(c)  An applicant proposing to acquire a mobile lithotriptor shall also provide the following information:

(1)           copies of letters of intent from, and proposed contracts with, all of the proposed host facilities;

(2)           the proposed schedule for the provision of SWL procedures at each host facility;

(3)           the projected method for staffing the service, including whether personnel will travel with the lithotriptor or will be supplied at each host facility where services are provided and whether personnel will be dedicated to providing lithotriptor services; and

(4)           documentation of the means by which patients will receive follow-up care after the lithotriptor leaves the site where the services are provided.

 

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 .3203       PERFORMANCE STANDARDS

An applicant proposing to acquire a lithotriptor, including a mobile lithotriptor, shall demonstrate that the following standards are met:

(1)           each existing lithotriptor in the proposed lithotriptor service area, except mobile lithotriptors, performed 1,000 procedures in the last year;

(2)           each proposed lithotriptor shall be projected to perform 1,000 procedures per year in the third year of operation of the proposed lithotriptor;

(3)           each existing and approved lithotriptor, except mobile lithotriptors, in the proposed lithotriptor service area shall be projected to perform at least 1000 procedures per year in the third year of operation of the proposed lithotriptor;

(4)           each existing mobile lithotriptor providing services in the proposed lithotriptor service area performed an average of 4.0 procedures per day per site in the proposed lithotriptor service area;

(5)           each existing and approved mobile lithotriptor providing services in the proposed lithotriptor service area shall perform an average of 4.0 procedures per day per site in the proposed lithotriptor service area in the applicant's third year of operation.

 

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 .3204       SUPPORT SERVICES

(a)  An applicant proposing to acquire a lithotriptor shall document the availability of the following services:

(1)           Radiology services and an existing urological practice that will refer patients; and

(2)           the availability and accessibility of acute inpatient services for patients who experience complications.

(b)  An applicant proposing to acquire a mobile lithotriptor shall provide referral agreements between each host facility and at least one other provider of lithotriptor services in the proposed lithotriptor service area to document the availability of lithotriptor services if patients require them when the mobile lithotriptor is not in service at that host facility.

 

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 .3205       STAFFING AND STAFF TRAINING

(a)  The applicant shall demonstrate that the following staff shall be available at each location at which the lithotriptor will be operated:

(1)           one certified general surgeon;

(2)           one certified urologist skilled and experienced in complicated stone disease treatment capability; and

(3)           one certified radiologist with experience in X-ray, CT and Ultrasound Imaging.

(b)  All individuals using the lithotriptor equipment shall obtain Quality Assurance and Training Certification from the American Lithotripsy Society or shall meet the training and proficiency guidelines and standards in the American Urological Association Guidelines and Standards, which are hereby incorporated by reference, including all subsequent amendments and editions of the referenced materials.  A list of the American Urological Association's approved training sites may be obtained free of charge from American Urological Association, 1120 North Charles Street, Baltimore, Maryland, 21201.  The schedule for offering Quality Assurance and Training Certification by the American Lithotripsy Society may be obtained free of charge from the American Lithotripsy Society, Thirteen Elm Street, Manchester, MA  01944.

(c)  The applicant shall demonstrate that the following staff training shall be provided at each location where the lithotriptor will be operated:

(1)           certification in cardiopulmonary resuscitation and basic cardiac life support; and

(2)           an organized program of staff education and training specific to lithotriptor services that ensures improvements in technique and the proper training of new personnel.

 

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;

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

Eff. January 4, 1994.

 

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

(a)  An applicant proposing to develop a new burn intensive care unit or to add beds to an existing or approved burn intensive care unit shall use the Acute Care Facility/Medical Equipment application form.

(b)  An applicant proposing to develop a new burn intensive care unit or to add beds to an existing or approved burn intensive care unit shall also provide the following additional information:

(1)           the number of beds in the burn intensive care unit currently operated in the applicant's facility and the total to be operated following completion of the proposed project;

(2)           documentation of the applicant's experience in treating severely burned patients at its facility during the last year, including:

(A)          the number of severely burned patients treated through emergency room services;

(B)          the number of severely burned patients referred to the applicant's facility from other facilities;

(C)          the number of inpatient days of care provided to severely burned patients; and

(D)          the number of severely burned patients the applicant referred to other facilities for burn treatment;

(3)           the number of severely burned patients from the proposed burn intensive care service area that are projected to require burn intensive care services, by the patient's county of residence, in each of the first 12 quarters of operation following completion of the project.  The applicant shall state the methodology and assumptions used to make the projections;

(4)           the projected utilization of the beds in the applicant's burn intensive care unit for each of the first twelve calendar quarters following completion of the proposed project, including the methodology and assumptions used for these projections;

(5)           evidence that existing and approved burn intensive care units in the state are unable to accommodate the applicant's projected need for additional burn intensive care services;

(6)           letters from physicians or other evidence that document the referral sources of patients to the burn intensive care unit;

(7)           evidence of the applicant's capability to communicate with and access emergency transportation resources including, but not limited to air ambulance services;

(8)           evidence of the applicant's capability to provide burn treatment services in the burn intensive care service unit on a 24 hour per day, 7 day per week basis;

(9)           description of inservice training or continuing education programs specific to burn intensive care services that shall be provided to unit staff; and

(10)         copies of written policies and procedures for the operation of the burn intensive care unit that shall be in effect at the time the unit becomes operational, for at least the following:

(A)          arrangements for treatment of a patient when patient load exceeds optimal operational capacity;

(B)          patient admission and discharge policies that are developed with input from the medical staff and the nursing service;

(C)          infection control and prevention, including handling of contaminated items, decontamination, transportation of patients outside of the unit, housekeeping and cleaning schedule, solid and liquid waste systems, staff and visitor traffic control, and aseptic isolation;

(D)          the inclusion of the unit in the facility's external and internal disaster plans;

(E)           performance of special procedures; and

(F)           acquisition and storage of homograft and heterograft skin.

(c)  The applicant shall provide documentation, including a detailed floor plan of the proposed unit drawn to scale, to demonstrate that the proposed unit shall:

(1)           be organized as a physically and functionally distinct entity with controlled access;

(2)           provide an effective means of isolation for patients suffering from communicable or infectious disease, for patients requiring protective isolation, and for disoriented or emotionally disturbed patients who require the services of the unit until placement elsewhere becomes possible;

(3)           provide a means for observation by unit staff of all patients from at least one vantage point; and

(4)           contain no fewer than 6 licensed acute care beds.

 

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 .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

(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 the following services, equipment and supplies shall be available to the burn intensive care unit 24 hours per day, 7 days per week:

(1)           monitoring devices which allow nurses at a nursing station to monitor patients around-the-clock;

(2)           ventilator capability at each bed in the unit;

(3)           a tub, tank or table for the cleaning of burn wounds located in an area of the unit separate from the general patient care area;

(4)           temperature control equipment or capability which allows for independent temperature control for each patient area;

(5)           renal dialysis;

(6)           an operating room;

(7)           a clinical laboratory which is capable of performing tests and reporting the results on a timely basis, including blood chemistries, blood gas analyses, Ph levels, electrolyte determinations, and serum and urine osmolalities;

(8)           microbiology services;

(9)           blood bank services;

(10)         diagnostic radiologic services;

(11)         a direct intercommunication/alarm system between the nurses' station and the patient's bedside, with connections to treatment, work, lounge, or other areas from which additional personnel would be summoned;

(12)         oxygen and compressed air and the means of administration;

(13)         mechanical ventilatory assistance equipment;

(14)         cardiac defibrillator with synchronization capability;

(15)         respiratory and cardiac monitoring equipment;

(16)         thoracentesis and closed thoracostomy sets;

(17)         tracheostomy sets;

(18)         tourniquets;

(19)         vascular cutdown sets;

(20)         infusion pumps;

(21)         laryngoscopes and endotracheal tubes;

(22)         tracheobronchial and gastric suction equipment;

(23)         portable x-ray equipment; and

(24)         a patient weighing device for bed patients.

(b)  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 also demonstrate that the following services shall be available:

(1)           aftercare services to burn unit patients for post hospitalization including social services, vocational counseling and physical rehabilitation; and

(2)           a community outreach and prevention education program, which shall include, but not be limited to, coordination with emergency medical service authorities in training in the assessment, care, triage and transfer of severely burned patients.

 

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 .3405       STAFFING AND STAFF TRAINING

(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 the following staff shall be available to provide the proposed services:

(1)           a designated physician in charge of the unit with board certification in general or plastic surgery and at least one year of experience in a burn unit;

(2)           in-house physician coverage by either a staff physician or a member of the house staff assigned to the unit 24 hours per day, 7 days per week;

(3)           a registered nurse administratively responsible for the nursing service in the unit who has experience working with burn patients and at least two years of intensive care experience or experience which the applicant determines to be equivalent to the intensive care experience;

(4)           a burn specialist 24 hours per day, 7 days per week;

(5)           a burn care technician 24 hours per day, 7 days per week;

(6)           designated support staff available to the unit, including:

(A)          anesthetist,

(B)          chaplain,

(C)          dietician,

(D)          inhalation therapist,

(E)           microbiologist,

(F)           occupational therapist,

(G)          pharmacist,

(H)          physical therapist, and

(I)            social worker;

(7)           other non-surgical support services staff available for consultation, including:

(A)          anesthesiology,

(B)          cardiology,

(C)          gastroenterology,

(D)          hematology,

(E)           infectious disease,

(F)           internal medicine,

(G)          nephrology,

(H)          neurology,

(I)            nutrition,

(J)            ophthalmology,

(K)          pathology,

(L)           pediatrics,

(M)         psychiatry,

(N)          pulmonary,

(O)          radiology, and

(P)           special education; and

(8)           surgical support specialists available for consultation, including:

(A)          cardiothoracic,

(B)          neurologic,

(C)          OB-GYN,

(D)          ophthalmic,

(E)           oral and maxillofacial,

(F)           orthopaedic,

(G)          otorhinolaryngologic,

(H)          pediatric,

(I)            plastic (if not the director of the burn unit),

(J)            urologic, and

(K)          vascular.

(b)  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 an organized staff education and training program shall be provided which is integral to the burn intensive care service unit and which ensures improvements in technique and the proper training of new personnel.

 

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.

 

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

(a)  An applicant proposing the acquisition of a gamma knife shall use the Acute Care Facility/Medical Equipment application form.

(b)  The applicant shall also provide the following additional information:

(1)           copies of written policies that establish the gamma knife as a regional resource having no administrative, clinical or charge requirements which would impede physician referrals of patients for whom gamma knife procedures would be appropriate;

(2)           documentation that the following diagnostic modalities have been operational in the facility in which the gamma knife will be used for at least 12 months prior to the submittal of the application:

(A)          magnetic resonance imaging (MRI);

(B)          angiography, including digital;

(C)          neuroangiography and CT services; and

(D)          linear accelerator;

(3)           if the proposed gamma knife will be used for clinical use or for clinical trials, documentation 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 that the gamma knife shall be operated under an institutional review board whose membership is consistent with U.S. Department of Health and Human Services' regulations;

(4)           if the proposed gamma knife will be used for experimental or research activities, documentation of the sources of funds to be used to finance the capital cost and operational costs of the gamma knife;

(5)           documentation of the projected number of procedures, by type, to be  performed in each of the first 12 calendar quarters following completion of the proposed project, including the methodology and assumptions used for these projections;

(6)           documentation of the type and estimated number of procedures performed in the facility that the gamma knife will replace or complement;

(7)           evidence that protocols will be established to assure that all clinical gamma knife procedures performed are medically necessary and that alternative treatment modalities have been considered; and

(8)           evidence of cooperative agreements with facilities and appropriate individuals to assure efficient equipment utilization and availability of the gamma knife, including:

(A)          letters from qualified physicians indicating their intent to use the gamma knife proposed by the applicant and to comply with all relevant gamma knife criteria and guidelines; and

(B)          the provisions that have been established to accommodate referrals from other facilities in the gamma knife service area.

 

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 .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

(a)  An applicant proposing to acquire a gamma knife shall provide documentation, such as formal consultation agreements or letters of commitment, that physicians certified in the following specialty areas shall be available for consultation:

(1)           neurological surgery,

(2)           radiation oncology,

(3)           medical physicist,

(4)           diagnostic radiology,

(5)           anesthesiology,

(6)           otolaryngology, and

(7)           neurology.

(b)  An applicant proposing to acquire a gamma knife shall demonstrate how medical emergencies within the gamma knife unit will be managed in conformity with accepted medical practice.

 

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 .3605       STAFF AND STAFF TRAINING

(a)  The applicant shall demonstrate that the following persons shall be available to provide the proposed services:

(1)           a neurological surgeon who is familiar with the principles of craniospinal irradiation and has expertise in conventional stereotactic surgery, microsurgery, and selection of target volumes defined by neuroimaging;

(2)           a radiation oncologist who is familiar with the principles of stereotactic imaging and has experience with precise single fraction irradiation of small target volumes;

(3)           qualified radiophysicist with documented training in radiosurgery; and

(4)           qualified gamma knife nurse with documented training in radiosurgery.

(b)  The applicant shall provide documentation that each staff member as identified in Paragraph (a) of this Rule who will be initiating gamma knife procedures shall have specific, documented training in radiosurgery prior to the operation of the gamma knife, including attendance at specific courses or symposia and a site visit at a center that is currently performing radiosurgery.  The documentation shall confirm that each team member has had education that includes:

(1)           analysis of prior results,

(2)           patient selection,

(3)           stereotactic head frame application,

(4)           stereotactic neurodiagnostic imaging using all pertinent modalities,

(5)           target selection,

(6)           dose determination,

(7)           dose prescription,

(8)           treatment delivery, and

(9)           instructions regarding radiation effects and protection.

(c)  The applicant shall submit documentation which demonstrates the availability of inservice training or continuing education programs for its staff specific to the provision of gamma knife services.

(d)  The applicant shall submit documentation which demonstrates that at least one staff member who is certified in CPR and basic life support shall be present in the facility at all times.

 

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.

 

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

(a)  An applicant proposing to acquire a PET scanner, including a mobile PET scanner, shall use the Acute Care Facility/Medical Equipment application form.

(b)  An applicant proposing to acquire a PET scanner, including a mobile PET scanner, shall provide the following information for each facility where the PET scanner will be operated:

(1)           The projected number of procedures to be performed and the projected number of patients to be served for each of the first three years following completion of the proposed project. Projections shall be listed by clinical area (e.g., oncology, cardiology), and all methodologies and assumptions used in making the projections shall be provided.

(2)           Documentation of arrangements made between the applicant and other providers to assure patients of the facility will have access to all of the following services:

(A)          nuclear medicine imaging services;

(B)          single photon emission computed tomography (including brain, bone, liver, gallium and thallium stress);

(C)          magnetic resonance imaging scans;

(D)          computerized tomography scans;

(E)           cardiac angiography;

(F)           cardiac ultrasound;

(G)          neuroangiography;

(H)          radiation oncology;

(I)            medical oncology; and

(J)            surgical oncology.

(3)           Documentation that the facility will:

(A)          establish the clinical PET unit, and any accompanying equipment used in the manufacture of positron-emitting radioisotopes, as a regional resource that will have no administrative, clinical or charge requirements that would impede physician referrals of patients for whom PET testing would be appropriate; and

(B)          provide scheduled hours of operation for the PET scanner of a minimum of  60 hours per week, except for mobile scanners.

(c)  An applicant proposing to acquire a mobile PET scanner shall provide copies of letters of intent from and proposed contracts with all of the proposed host facilities at which the mobile PET scanner will be operated.

(d)  An applicant proposing to acquire a mobile PET scanner shall demonstrate that each host facility offers or contracts with a hospital that offers comprehensive cancer services including radiation oncology, medical oncology, and surgical oncology.

(e)  An applicant shall document that all equipment, supplies and pharmaceuticals proposed for the service have been certified for use by the U.S. Food and Drug Administration or will be used under an institutional review board whose membership is consistent with U.S. Department of Health and Human Services' regulations.

(f)  An applicant shall document that each PET scanner and cyclotron shall be operated in a physical environment that conforms to federal standards, manufacturer's specifications, and licensing requirements. The following shall be addressed:

(1)           quality control measures and assurance of radioisotope production of generator or cyclotron-produced agents;

(2)           quality control measures and assurance of PET tomography and associated instrumentation;

(3)           radiation protection and shielding;

(4)           radioactive emission to the environment; and

(5)           radioactive waste disposal.

 

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.

 

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

(a)  An applicant proposing to acquire a PET scanner, including a mobile PET scanner, shall document that radioisotopes shall be acquired from one or more of the following sources and shall identify the sources which will be utilized by the applicant:

(1)           an off-site medical cyclotron and radioisotope production facility that is located within two hours transport time to each facility where the PET scanner will be operated;

(2)           an on-site rubidium-82 generator; or

(3)           an on-site medical cyclotron for radio nuclide production and a chemistry unit for labeling radioisotopes.

(b)  An applicant proposing to acquire an on-site cyclotron for radioisotope production shall document that these agents are not available or cannot be obtained in an economically cost effective manner from an off-site cyclotron located within 2 hours total transport time from the applicant's facility.

(c)  An applicant proposing to develop new PET scanner services, including mobile PET scanner services, shall establish a clinical oversight committee at each facility where the PET scanner will be operated before the proposed PET scanner is placed in service that shall:

(1)           develop screening criteria for appropriate PET scanner utilization;

(2)           review clinical protocols;

(3)           review appropriateness and quality of clinical procedures;

(4)           develop educational programs; and

(5)           oversee the data collection and evaluation activities of the PET scanning service.

 

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.

 

10A NCAC 14C .3705       STAFFING AND STAFF TRAINING

(a)  An applicant proposing to acquire a PET scanner, including a mobile PET scanner, shall document that the scanner will be staffed by the following personnel:

(1)           One or more full-time nuclear medicine imaging physicians who:

(A)          are licensed by the State to handle medical radioisotopes;

(B)          have specialized in the acquisition and interpretation of nuclear images, including tomographic studies, for at least one year;

(C)          have acquired knowledge about PET through experience or postdoctoral education; and

(D)          have had practical training with an operational PET scanner;

(2)           Engineering and physics personnel with training and experience in the operation and maintenance of PET scanning equipment;

(3)           Radiation safety personnel with training and experience in the handling of short-lived positron emitting nuclides; and

(4)           Nuclear medicine technologists certified in this field by the Nuclear Medicine Technology Certification Board or the American Registry of Radiologic Technologists with training and experience in positron emission computed tomographic nuclear medicine imaging procedures.

(b)  An applicant proposing to acquire a cyclotron shall document that the cyclotron shall be staffed by radiochemists or radiopharmacists who:

(1)           have at least one year of training and experience in the synthesis of short-lived positron emitting radioisotopes; and

(2)           have at least one year of training and experience in the testing of chemical, radiochemical, and radionuclidic purity of PET radiopharmaceutical synthesis.

(c)  An applicant proposing to acquire a PET scanner, a mobile PET scanner, or a cyclotron, shall document that the personnel described in Paragraphs (a) and (b) of this Rule shall be available at all times that the scanner or cyclotron are operating.

(d)  An applicant proposing to acquire a PET scanner, including a mobile PET scanner, shall document that a program of continuing staff education will be provided that will insure training of new personnel and the maintenance of staff competence as clinical PET applications, techniques and technology continue to develop and evolve.

 

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.

 

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

(a)  An applicant that proposes to develop new acute care beds shall complete the Acute Care Facility/Medical Equipment application form.

(b)  An applicant proposing to develop new acute care beds shall submit the following information:

(1)           the number of acute care beds proposed to be licensed and operated following completion of the proposed project;

(2)           documentation that the proposed services shall be provided in conformance with all applicable facility, programmatic, and service specific licensure, certification, and JCAHO accreditation standards;

(3)           documentation that the proposed services shall be offered in a physical environment that conforms to the requirements of federal, state, and local regulatory bodies;

(4)           if adding new acute care beds to an existing facility, documentation of the number of inpatient days of care provided in the last operating year in the existing licensed acute care beds by medical diagnostic category, as classified by the Centers for Medicare and Medicaid Services according to the list set forth in the applicable State Medical Facilities Plan;

(5)           the projected number of inpatient days of care to be provided in the total number of licensed acute care beds in the facility, by county of residence, for each of the first three years following completion of the proposed project, including all assumptions, data and methodologies;

(6)           documentation that the applicant shall be able to communicate with emergency transportation agencies 24 hours per day, 7 days per week;

(7)           documentation that services in the emergency care department shall be provided 24 hours per day, 7 days per week, including a description of the scope of services to be provided during each shift and the physician and professional staffing that will be responsible for provision of those services;

(8)           copy of written administrative policies that prohibit the exclusion of services to any patient on the basis of age, race, sex, creed, religion, disability or the patient’s ability to pay;

(9)           a written commitment to participate in and comply with conditions of participation in the Medicare and Medicaid programs;

(10)         documentation of the health care services provided by the applicant, and any facility in North Carolina owned or operated by the applicant’s parent organization, in each of the last two operating years to Medicare patients, Medicaid patients, and patients who are not able to pay for their care;

(11)         documentation of strategies to be used and activities undertaken by the applicant to attract physicians and medical staff who will provide care to patients without regard to their ability to pay; and

(12)         documentation that the proposed new acute care beds shall be operated in a hospital that provides inpatient medical services to both surgical and non-surgical patients.

(c)  An applicant proposing to develop new acute care beds in a new licensed hospital or on a new campus of an existing hospital shall also submit the following information:

(1)           the projected number of inpatient days of care to be provided in the licensed acute care beds in the new hospital or on the new campus, by major diagnostic category as recognized by the Centers for Medicare and Medicaid Services (CMS) according to the list set forth in the applicable State Medical Facilities Plan;

(2)           documentation that medical and surgical services shall be provided in the proposed acute care beds on a daily basis within at least five of the major diagnostic categories as recognized by the Centers for Medicare and Medicaid Services (CMS) according to the list set forth in the applicable State Medical Facilities Plan;

(3)           copies of written policies and procedures for the provision of care within the new acute care hospital or on the new campus, including but not limited to the following:

(A)          the admission and discharge of patients, including discharge planning,

(B)          transfer of patients to another hospital,

(C)          infection control, and

(D)          safety procedures;

(4)           documentation that the applicant owns or otherwise has control of the site on which the proposed acute care beds will be located; and

(5)           documentation that the proposed site is suitable for development of the facility with regard to water, sewage disposal, site development and zoning requirements; and provide the required procedures for obtaining zoning changes and a special use permit if site is currently not properly zoned; and

(6)           correspondence from physicians and other referral sources that documents their willingness to refer or admit patients to the proposed new hospital or new campus.

 

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.

 

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

(a)  An applicant proposing to develop new acute care beds shall document that each of the following items shall be available to the facility 24 hours per day, 7 days per week:

(1)           laboratory services including microspecimen chemistry techniques and blood gas  determinations;

(2)           radiology services;

(3)           blood bank services;

(4)           pharmacy services;

(5)           oxygen and air and suction capability;

(6)           electronic physiological monitoring capability;

(7)           mechanical ventilatory assistance equipment including airways, manual breathing bag and ventilator/respirator;

(8)           endotracheal intubation capability;

(9)           cardiac arrest management plan;

(10)         patient weighing device for a patient confined to their bed; and

(11)         isolation capability;

(b)  If any item in Paragraph (a) of this Rule will not be available in the facility 24 hours per day, 7 days per week, the applicant shall document the basis for determining the item is not needed in the facility.

(c)  If any item in Paragraph (a) of this Rule will be contracted, the applicant shall provide correspondence from the proposed provider of its intent to contract with the applicant.

 

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

Temporary Adoption Eff. January 1, 2004;

Eff. August 1, 2004.

 

10A NCAC 14C .3805       STAFFING AND STAFF TRAINING

(a)  An applicant proposing to develop new acute care beds shall demonstrate that the proposed staff for the new acute care beds shall comply with licensure requirements set forth in Title 10A NCAC 13B, Licensing of Hospitals.

(b)  An applicant proposing to develop new acute care beds shall provide correspondence from the persons who expressed interest in serving as Chief Executive Officer and Chief Nursing Executive of the facility in which the new acute care beds will be located, documenting their willingness to serve in this capacity.

(c)  An applicant proposing to develop new acute care beds in a new hospital or on a new campus of an existing hospital shall provide a job description and the educational and training requirements for the Chief Executive Officer, Chief Nursing Executive and each department head which is required by licensure rules to be employed in the facility in which the acute care beds will be located.

(d)  An applicant proposing to develop new acute care beds shall document the availability of admitting physicians who shall admit and care for patients in each of the major diagnostic categories to be served by the applicant.

(e)  An applicant proposing to develop new acute care beds shall provide documentation of the availability of support and clinical staff to provide care for patients in each of the major diagnostic categories to be served by the applicant.

 

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

Temporary Adoption Eff. January 1, 2004;

Eff. August 1, 2004.

 

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

(a)  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 provide the following information:

(1)           the counties included in the applicant's proposed service area, as defined in 10A NCAC 14C .3906;

(2)           with regard to services provided in the applicant's GI endoscopy rooms, identify:

(A)          the number of existing and proposed GI endoscopy rooms in the licensed health service facility in which the proposed rooms will be located;

(B)          the number of existing or approved GI endoscopy rooms in any other licensed health service facility in which the applicant or a related entity has a controlling interest that is located in the applicant's proposed service area;

(C)          the number of GI endoscopy procedures, identified by CPT code or ICD-9-CM procedure code, performed in the applicant's licensed or non-licensed GI endoscopy rooms in the last 12 months;

(D)          the number of GI endoscopy procedures, identified by CPT code or ICD-9-CM procedure code, projected to be performed in the GI endoscopy rooms in each of the first three operating years of the project

(E)           the number of procedures by type, other than GI endoscopy procedures, performed in the GI endoscopy rooms in the last 12 months;

(F)           the number of procedures by type, other than GI endoscopy procedures, projected to be performed in the GI endoscopy rooms in each of the first three operating years of the project;

(G)          the number of patients served in the licensed or non-licensed GI endoscopy rooms in the last 12 months; and,

(H)          the number of patients projected to be served in the GI endoscopy rooms in each of the first three operating years of the project;

(3)           with regard to services provided in the applicant's operating rooms identify:

(A)          the number of existing operating rooms in the facility;

(B)          the number of procedures by type performed in the operating rooms in the last 12 months; and

(C)          the number of procedures by type projected to be performed in the operating rooms in each of the first three operating years of the project;

(4)           the days and hours of operation of the facility in which the GI endoscopy rooms will be located;

(5)           if an applicant is an existing facility, the type and average facility charge for each of the 10 GI endoscopy procedures most commonly performed in the facility during the preceding 12 months;

(6)           the type and projected average facility charge for the 10 GI endoscopy procedures which the applicant projects will be performed most often in the facility;

(7)           a list of all services and items included in each charge, and a description of the bases on which these costs are included in the charge;

(8)           identification of all services and items (e.g., medications, anesthesia) that will not be included in the facility's charges;

(9)           if an applicant is an existing facility, the average reimbursement received per procedure for each of the ten GI endoscopy procedures most commonly performed in the facility during the preceding 12 months; and,

(10)         the average reimbursement projected to be received for each of the ten GI endoscopy procedures which the applicant projects will be performed most frequently in the facility.

(b)  An applicant proposing to establish a new licensed ambulatory surgical facility for provision of GI endoscopy procedures shall submit the following information:

(1)           a copy of written administrative policies that prohibit the exclusion of services to any patient on the basis of age, race, religion, disability or the patient's ability to pay;

(2)           a written commitment to participate in and comply with conditions of participation in the Medicare and Medicaid programs within three months after licensure of the facility;

(3)           a description of strategies to be used and activities to be undertaken by the applicant to assure the proposed services will be accessible by indigent patients without regard to their ability to pay;

(4)           a written description of patient selection criteria including referral arrangements for high-risk patients;

(5)           the number of GI endoscopy procedures performed by the applicant in any other existing licensed health service facility in each of the last 12 months, by facility;

(6)           if the applicant proposes reducing the number of GI endoscopy procedures it performs in existing licensed facilities, the rationale for its change in practice pattern.

 

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

Temporary Adoption Eff. February 1, 2006;

Eff. November 1, 2006.

 

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

(a)  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 provide a copy of an agreement between the applicant and a pathologist for provision of pathology services.

(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 provide a copy of the guidelines it shall follow in the administration of conscious sedation or any type of anesthetic to be used, including procedures for tracking and responding to adverse reactions and unexpected outcomes.

(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 provide a copy of the policies and procedures it shall utilize for cleaning and monitoring the cleanliness of scopes, other equipment, and the procedure room between cases.

(d)  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 provide:

(1)           evidence that physicians utilizing the proposed facility will have practice privileges at an existing hospital in the county in which the proposed facility will be located or in a contiguous county;

(2)           documentation of an agreement to transfer and accept referrals of GI endoscopy patients from a hospital where physicians utilizing the facility have practice privileges; and

(3)           documentation of a transfer agreement with a hospital in case of an emergency.

 

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

Temporary Adoption Eff. February 1, 2006;

Eff. November 1, 2006.

 

10A ncac 14C .3905       STAFFING and staff training

(a)  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 identify the number of staff to be utilized in the following areas:

(1)           administration;

(2)           pre-operative;

(3)           post-operative;

(4)           procedure rooms;

(5)           equipment cleaning, safety, and maintenance; and

(6)           other.

(b)  The 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 identify the number of physicians by specialty and board certification status that currently utilize the facility and that are projected to utilize the facility.

(c)  The 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 provide the criteria to be used by the facility in extending privileges to medical personnel that will provide services in the facility.

(d)  If the facility is not accredited by The Joint Commission on Accreditation of Healthcare Organizations, The Accreditation Association for Ambulatory Health Care, or The American Association for Accreditation of Ambulatory Surgical Facilities at the time the application is submitted, the applicant shall demonstrate that each of the following staff requirements will be met in the facility:

(1)           a Medical director who is a board certified gastroenterologist by American Board of Internal Medicine, colorectal surgeon by American Board of Colon and Rectal Surgery or general surgeon by American Board of Surgery is licensed to practice medicine in North Carolina and is directly involved in the routine direction and management of the facility;

(2)           all physicians performing GI endoscopy procedures in the facility shall be board eligible or board certified gastroenterologists by American Board of Internal Medicine, colorectal surgeons by American Board of Colon and Rectal Surgery or general surgeons by American Board of Surgery;

(3)           all physicians with privileges to practice in the facility will be active members in good standing at a general acute care hospital within the proposed service area;

(4)           at least one registered nurse shall be employed per procedure room;

(5)           additional staff or patient care technicians shall be employed to provide assistance in procedure rooms, as needed; and

(6)           a least one health care professional who is present during the period the procedure is performed and during postoperative recovery shall be ACLS certified; and, at least one other health care professional who is present in the facility shall be BCLS certified.

 

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

Temporary Adoption Eff. February 1, 2006;

Eff. November 1, 2006.

 

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

(a)  An applicant proposing to develop hospice inpatient facility beds or hospice residential care facility beds shall complete the application form for Hospice Inpatient and Hospice Residential Care Services.

(b) An applicant proposing to develop hospice inpatient facility beds or hospice residential care facility beds shall provide the following information:

(1)           the projected annual number of hospice patients, admissions, deaths, and other discharges, for each level of care (i.e., respite care, hospice residential care and hospice inpatient care), to be served in the facility in each of the first three years following completion of the project and the methodology and assumptions used to make the projections;

(2)           the projected annual number of hospice patients, admissions, deaths, and other discharges for each level of care to be served by the applicant's licensed hospice agency in each of the first three years following completion of the project and the methodology and assumptions used to make the projections;

(3)           the projected annual number of patient care days, for each level of care (i.e., respite care, hospice residential care and hospice inpatient care), to be provided in each of the first three years of operation following completion of the project and the methodology and assumptions used to make the projections;

(4)           the projected average length of stay (ALOS) based on admissions to the applicant's facility, for each level of care, (i.e., respite care, hospice residential care and hospice inpatient care) and the methodology and assumptions used to make the projections;

(5)           the projected readmission rate, for each level of care, (i.e., respite care, hospice residential care and hospice inpatient care) and the methodology and assumptions used to make the projections;

(6)           the projected average annual cost per patient care day, by level of care (i.e., respite care, hospice residential care and hospice inpatient care) for each of the first three operating years following completion of the project and the methodology and assumptions used to project the average annual cost;

(7)           documentation of attempts made to establish working relationships with sources of referrals to the hospice facility including copies of proposed agreements for the provision of inpatient care and residential care;

(8)           documentation of the projected number of referrals to be made by each referral source;

(9)           copies of the proposed contractual agreements, if the applicant is not a licensed hospice, with a licensed hospice or a licensed home care agency with a hospice designation on its license, for the provision of hospice services;

(10)         documentation of the projected number of patients to be referred for each payor type from the referring hospices, if the applicant is not a licensed hospice or if the applicant proposes to admit patients on a contractual basis; and

(11)         a copy of the admission policies, including the criteria that shall be used to select persons for admission to the hospice inpatient and residential care beds.

 

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.

 

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

(a)  An applicant proposing to develop a hospice inpatient facility beds or hospice residential care facility beds shall demonstrate that the following services will be provided directly by the applicant or by a contracted hospice to the patient and the patient's family or significant others:

(1)           nursing services;

(2)           social work services;

(3)           counseling services including dietary, spiritual, and family counseling;

(4)           bereavement counseling services;

(5)           volunteer services;

(6)           physician services; and

(7)           medical supplies.

(b)  An applicant shall demonstrate that the nursing services listed in Paragraph (a) of this Rule will be available 24 hours a day, seven days a week.

(c)  An applicant proposing to develop a hospice inpatient facility or a hospice residential care facility shall provide documentation that pharmaceutical services will be provided directly by the facility or by contract.

(d)  For each of the services listed in Paragraphs (a) and (c) of this Rule which are proposed to be provided by contract, the applicant shall provide a copy of a letter from the proposed provider which expresses its interest in working with the proposed facility.

 

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

Temporary Adoption Eff. February 1, 2006;

Eff. November 1, 2006;

 

10A NCAC 14C .4005       STAFFING AND STAFF TRAINING

(a)  An applicant proposing to develop a hospice inpatient facility beds or hospice residential care facility beds shall document that staffing will be provided in a manner consistent with G.S. 131E, Article 10.

(b)  The applicant shall demonstrate that:

(1)           the staffing pattern will be consistent with licensure requirements as specified in 10A NCAC 13K, Hospice Licensing Rules;

(2)           training for all staff will meet the requirements as specified in 10A NCAC 13K .0400, Hospice Licensing Rules.

 

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

Temporary Adoption Eff. February 1, 2006;

Eff. November 1, 2006.

 

10A NCAC 14C .4006       FACILITY

An applicant proposing to develop new hospice inpatient facility beds or new hospice residential care facility beds shall document:

(1)           that a home-like setting shall be provided in the facility;

(2)           that the services will be provided in conformity with applicable state and local laws and regulations pertaining to zoning, physical environment, water supply, waste disposal and other relevant health and safety requirements; and

(3)           for new facilities, the location of the site on which the services are to be operated. If the site is neither owned by nor under option to the applicant, the applicant must provide a written commitment to pursue acquiring the site if and when the approval is granted, must specify a secondary site on which the services could be operated if acquisition efforts relative to the primary site ultimately fail, and must demonstrate that the primary and secondary sites are available for acquisition.

 

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

Temporary Adoption Eff. February 1, 2008;

Eff. November 1, 2008.