NORTH CAROLINA
REGISTER
Volume 20, Issue 23
Pages 2007 - 2152
June 1, 2006
This issue contains documents officially filed
through May 10, 2006.
Office of Administrative Hearings
Rules Division
424 North Blount Street (27601)
6714 Mail Service Center
Raleigh, NC 27699-6714
(919) 733-2678
FAX (919) 733-3462
Julian Mann III, Director
Camille Winston, Deputy Director
Molly Masich, Director of APA Services
Dana Sholes, Publications Coordinator
Julie Brincefield, Editorial Assistant
Felicia Williams, Editorial Assistant
Lisa Johnson, RRC Administrative Assistant
IN THIS ISSUE
I. IN ADDITION
Secretary of State – Notice.............................................. 2007
Brownfields Property – Imperial Partners....................... 2008
Brownfields Property – Town of Forest City.................. 2009
II. PROPOSED RULES
Health and Human Services
Facility Services .......................................................... 2010 - 2034
Medical Care Commission .......................................... 2034 – 2035
Labor
Mine and Quarry Bureau............................................. 2036 - 2037
III. APPROVED RULES.................................................... 2038 – 2102
Community Colleges
Community Colleges, Board of
Environment and Natural Resources
Radiation Protection Commission
Water Treatment Facility Operators Certification Board
Wildlife Resources Commission
Health and Human Services
Child Care Commission
Medical Assistance
Medical Care Commission
Social Services Commission
Labor
Elevator & Amusement Device Bureau
Licensing Boards and Commissions
Auctioneer Licensing Board
General Contractors, Board of
Medical Board
Nursing Board
Plumbing, Heating & Fire Sprinkler Contractors
Veterinary Medical Board
Revenue
The Department
IV. RULES REVIEW COMMISSION.............................. 2103 - 2123
V. CONTESTED CASE DECISIONS
Index to ALJ Decisions................................................... 2124 - 2133
Text of Selected Decisions
05 DHR 1077 .............................................................. 2134 - 2141
05 DHR 1392 .............................................................. 2142 - 2152
For the CUMULATIVE INDEX to the NC Register go to:
http://reports.oah.state.nc.us/cumulativeIndex.pl
North Carolina Register is published semi-monthly for $195 per year by the Office of Administrative Hearings, 424 North Blount Street, Raleigh, NC
27601. North Carolina Register (ISSN 15200604) to mail at Periodicals Rates is paid at Raleigh, NC. POSTMASTER: Send Address changes to
the North Carolina Register, 6714 Mail Service Center, Raleigh, NC 27699-6714.
NORTH CAROLINA ADMINISTRATIVE CODE CLASSIFICATION SYSTEM
The North Carolina Administrative Code (NCAC) has four major classifications of rules. Three of these, titles, chapters, and sections are
mandatory. The major classification of the NCAC is the title. Each major department in the North Carolina executive branch of
government has been assigned a title number. Titles are further broken down into chapters which shall be numerical in order.
Subchapters are optional classifications to be used by agencies when appropriate.
NCAC TITLES TITLE 21
LICENSING BOARDS
TITLE 24
INDEPENDENT AGENCIES
1 ADMINISTRATION
2 AGRICULTURE & CONSUMER SERVICES
3 AUDITOR
4 COMMERCE
5 CORRECTION
6 COUNCIL OF STATE
7 CULTURAL RESOURCES
8 ELECTIONS
9 GOVERNOR
10A HEALTH AND HUMAN SERVICES
11 INSURANCE
12 JUSTICE
13 LABOR
14A CRIME CONTROL & PUBLIC SAFETY
15A ENVIRONMENT &NATURAL RESOURCES
16 PUBLIC EDUCATION
17 REVENUE
18 SECRETARY OF STATE
19A TRANSPORTATION
20 TREASURER
21* OCCUPATIONAL LICENSING BOARDS
22 ADMINISTRATIVE PROCEDURES
(REPEALED)
23 COMMUNITY COLLEGES
24* INDEPENDENT AGENCIES
25 STATE PERSONNEL
26 ADMINISTRATIVE HEARINGS
27 NC STATE BAR
28 JUVENILE JUSTICE AND DELINQUENCY
PREVENTION
1 Acupuncture
2 Architecture
3 Athletic Trainer Examiners
4 Auctioneers
6 Barber Examiners
8 Certified Public Accountant Examiners
10 Chiropractic Examiners
11 Employee Assistance Professionals
12 General Contractors
14 Cosmetic Art Examiners
16 Dental Examiners
17 Dietetics/Nutrition
18 Electrical Contractors
19 Electrolysis
20 Foresters
21 Geologists
22 Hearing Aid Dealers and Fitters
25 Interpreter/Transliterator
26 Landscape Architects
28 Landscape Contractors
29 Locksmith Licensing
30 Massage & Bodywork Therapy
31 Marital and Family Therapy
32 Medical Examiners
33 Midwifery Joint Committee
34 Funeral Service
36 Nursing
37 Nursing Home Administrators
38 Occupational Therapists
40 Opticians
42 Optometry
44 Osteopathic Examination (Repealed)
45 Pastoral Counselors, Fee-Based Practicing
46 Pharmacy
48 Physical Therapy Examiners
50 Plumbing, Heating & Fire Sprinkler
Contractors
52 Podiatry Examiners
53 Professional Counselors
54 Psychology
56 Professional Engineers & Land Surveyors
57 Real Estate Appraisal
58 Real Estate Commission
60 Refrigeration Examiners
61 Respiratory Care
62 Sanitarian Examiners
63 Social Work Certification
64 Speech & Language Pathologists &
Audiologists
65 Therapeutic Recreation Certification
66 Veterinary Medical
68 Substance Abuse Professionals
69 Soil Scientists
1 Housing Finance
2 Agricultural Finance Authority
3 Safety & Health Review
Board
4 Reserved
5 State Health Plan Purchasing
Alliance Board
Note: Title 21 contains the chapters of the various occupational licensing boards and Title 24 contains the chapters of independent agencies.
NORTH CAROLINA REGISTER
Publication Schedule for January 2006 – December 2006
FILING DEADLINES NOTICE OF TEXT PERMANENT RULE TEMPORARY
RULES
Volume &
issue
number
Issue date Last day
for filing
Earliest date for
public hearing
End of required
comment
period
Deadline to submit
to RRC
for review at
next meeting
Earliest Eff.
Date of
Permanent Rule
Delayed Eff. Date of
Permanent Rule
(first legislative
day of the next
regular session)
270th day from publication
in the Register
20:13 01/03/06 12/08/05 01/18/06 03/06/06 03/20/06 05/01/06 05/09/06 09/30/06
20:14 01/17/06 12/21/05 02/01/06 03/20/06 04/20/06 06/01/06 01/07 10/14/06
20:15 02/01/06 01/10/06 02/16/06 04/03/06 04/20/06 06/01/06 01/07 10/29/06
20:16 02/15/06 01/25/06 03/02/06 04/17/06 04/20/06 06/01/06 01/07 11/12/06
20:17 03/01/06 02/08/06 03/16/06 05/01/06 05/22/06 07/01/06 01/07 11/26/06
20:18 03/15/06 02/22/06 03/30/06 05/15/06 05/22/06 07/01/06 01/07 12/10/06
20:19 04/03/06 03/13/06 04/18/06 06/02/06 06/20/06 08/01/06 01/07 12/29/06
20:20 04/17/06 03/24/06 05/02/06 06/16/06 06/20/06 08/01/06 01/07 01/12/07
20:21 05/01/06 04/07/06 05/16/06 06/30/06 07/20/06 09/01/06 01/07 01/26/07
20:22 05/15/06 04/24/06 05/30/06 07/14/06 07/20/06 09/01/06 01/07 02/09/07
20:23 06/01/06 05/10/06 06/16/06 07/31/06 08/21/06 10/01/06 01/07 02/26/07
20:24 06/15/06 05/24/06 06/30/06 08/14/06 08/21/06 10/01/06 01/07 03/12/07
21:01 07/03/06 06/12/06 07/18/06 09/01/06 09/20/06 11/01/06 01/07 03/30/07
21:02 07/17/06 06/23/06 08/01/06 09/15/06 09/20/06 11/01/06 01/07 04/13/07
21:03 08/01/06 07/11/06 08/16/06 10/02/06 10/20/06 12/01/06 01/07 04/28/07
21:04 08/15/06 07/25/06 08/30/06 10/16/06 10/20/06 12/01/06 01/07 05/12/07
21:05 09/01/06 08/11/06 09/16/06 10/31/06 11/20/06 01/01/07 01/07 05/29/07
21:06 09/15/06 08/24/06 09/30/06 11/14/06 11/20/06 01/01/07 01/07 06/12/07
21:07 10/02/06 09/11/06 10/17/06 12/01/06 12/20/06 02/01/07 05/08 06/29/07
21:08 10/16/06 09/25/06 10/31/06 12/15/06 12/20/06 02/01/07 05/08 07/13/07
21:09 11/01/06 10/11/06 11/16/06 01/01/07 01/22/07 03/01/07 05/08 07/29/07
21:10 11/15/06 10/24/06 11/30/06 01/15/07 01/22/07 03/01/07 05/08 08/12/07
21:11 12/01/06 11/07/06 12/16/06 01/30/07 02/20/07 04/01/07 05/08 08/28/07
21:12 12/15/06 11/22/06 12/30/06 02/13/07 02/20/07 04/01/07 05/08 09/11/07
EXPLANATION OF THE PUBLICATION SCHEDULE
This Publication Schedule is prepared by the Office of Administrative Hearings as a public service and the computation of time periods are not to be deemed binding or controlling.
Time is computed according to 26 NCAC 2C .0302 and the Rules of Civil Procedure, Rule 6.
GENERAL
The North Carolina Register shall be published twice
a month and contains the following information
submitted for publication by a state agency:
(1) temporary rules;
(2) notices of rule-making proceedings;
(3) text of proposed rules;
(4) text of permanent rules approved by the Rules
Review Commission;
(5) notices of receipt of a petition for municipal
incorporation, as required by G.S. 120-165;
(6) Executive Orders of the Governor;
(7) final decision letters from the U.S. Attorney
General concerning changes in laws affecting
voting in a jurisdiction subject of Section 5 of
the Voting Rights Act of 1965, as required by
G.S. 120-30.9H;
(8) orders of the Tax Review Board issued under
G.S. 105-241.2; and
(9) other information the Codifier of Rules
determines to be helpful to the public.
COMPUTING TIME: In computing time in the
schedule, the day of publication of the North Carolina
Register is not included. The last day of the period so
computed is included, unless it is a Saturday, Sunday,
or State holiday, in which event the period runs until
the preceding day which is not a Saturday, Sunday, or
State holiday.
FILING DEADLINES
ISSUE DATE: The Register is published on the first
and fifteen of each month if the first or fifteenth of
the month is not a Saturday, Sunday, or State holiday
for employees mandated by the State Personnel
Commission. If the first or fifteenth of any month is
a Saturday, Sunday, or a holiday for State employees,
the North Carolina Register issue for that day will be
published on the day of that month after the first or
fifteenth that is not a Saturday, Sunday, or holiday for
State employees.
LAST DAY FOR FILING: The last day for filing for any
issue is 15 days before the issue date excluding
Saturdays, Sundays, and holidays for State
employees.
NOTICE OF TEXT
EARLIEST DATE FOR PUBLIC HEARING: The hearing
date shall be at least 15 days after the date a notice of
the hearing is published.
END OF REQUIRED COMMENT PERIOD
An agency shall accept comments on the text of a
proposed rule for at least 60 days after the text is
published or until the date of any public hearings held
on the proposed rule, whichever is longer.
DEADLINE TO SUBMIT TO THE RULES REVIEW
COMMISSION: The Commission shall review a rule
submitted to it on or before the twentieth of a month
by the last day of the next month.
FIRST LEGISLATIVE DAY OF THE NEXT REGULAR
SESSION OF THE GENERAL ASSEMBLY: This date is
the first legislative day of the next regular session of
the General Assembly following approval of the rule
by the Rules Review Commission. See G.S. 150B-
21.3, Effective date of rules.
IN ADDITION
20:23 NORTH CAROLINA REGISTER JUNE 1, 2006
2007
Note from the Codifier: This Section contains public notices that are required to be published in the Register or have been
approved by the Codifier of Rules for publication.
DEPARTMENT OF THE SECRETARY OF STATE
NOTICE OF PUBLIC HEARING
Pursuant to G.S. 150B-21.2(e), the Department will conduct a public hearing regarding proposed administrative rules concerning
regulation of lobbying filed with the Office of Administrative Hearings on April 24, 2006, cited as 18 NCAC 12 .0101-.0117 and 18
NCAC 13 .0101-.0116. The public hearing will be held as follows:
Date: Monday, June 19, 2006
Time: 9:00 a.m.
Location: Department of Commerce's Utilities Commission Hearing Room (#2115), Dobbs Building
(enter on Mall side of Dobbs Building)
Comments may be submitted to: Joal Broun, Secretary of State's Office, 2 South Salisbury Street, Raleigh, NC 27601-2903 or P.O.
Box 29622, Raleigh, NC, telephone (919) 807-2005, fax (919) 807-2010, e-mail jbroun@sosnc.com
Comment period ends: July 14, 2006
IN ADDITION
20:23 NORTH CAROLINA REGISTER JUNE 1, 2006
2008
SUMMARY OF NOTICE OF
INTENT TO REDEVELOP A BROWNFIELDS PROPERTY
Imperial Centre Partners, LP
Pursuant to N.C.G.S. § 130A-310.34, Imperial Centre Partners, LP has filed with the North Carolina Department of
Environment and Natural Resources ("DENR") a Notice of Intent to Redevelop a Brownfields Property ("Property") in Rocky Mount,
Nash County, North Carolina. The Property consists of the former sites of the Imperial Tobacco Plant at 270 Gay Street and the
former Braswell Memorial Library at 344 Falls Road and comprises approximately 3.6 acres. Environmental contamination exists on
the Property in the soil and groundwater. Imperial Centre Partners, LP has committed itself to redevelopment of the Property for no
use other than as a cultural arts center for the City of Rocky Mount. The Notice of Intent to Redevelop a Brownfields Property
includes: (1) a proposed Brownfields Agreement between DENR and Imperial Centre Partners, LP, which in turn includes (a) a map
showing the location of the Property, (b) a description of the contaminants involved and their concentrations in the media of the
Property, (c) the above-stated description of the intended future use of the Property, and (d) proposed investigation and remediation;
and (2) a proposed Notice of Brownfields Property prepared in accordance with G.S. 130A-310.35.
The full Notice of Intent to Redevelop a Brownfields Property may be reviewed at the Braswell Library, 727 North Grace
Street, Rocky Mount by contacting Phillip Whitford at (252) 442-1951, extension 255 or by email at PWhitford@Braswell-
Library.org; or at NC Brownfields Program, 401 Oberlin Rd., Suite 150, Raleigh, NC 27605 by contacting Shirley Liggins at that
address, at shirley.liggins@ncmail.net, or at (919) 508-8411, where DENR will provide auxiliary aids and services for persons with
disabilities who wish to review the documents.
Written public comments may be submitted to DENR within 60 days after the date this Notice is published in a newspaper of
general circulation serving the area in which the brownfields property is located, or in the North Carolina Register, whichever is later.
Written requests for a public meeting may be submitted to DENR within 30 days after the period for written public comments begins.
Thus, if Imperial Centre Partners, LP, as it plans, publishes this Summary in the North Carolina Register after it publishes the
Summary in a newspaper of general circulation serving the area in which the brownfields property is located, and if it effects
publication of this Summary in the North Carolina Register on the date it expects to do so, the periods for submitting written requests
for a public meeting regarding this project and for submitting written public comments will commence on June 2, 2006. All such
comments and requests should be addressed as follows:
Mr. Bruce Nicholson
Brownfields Program Manager
Division of Waste Management
NC Department of Environment and Natural Resources
401 Oberlin Road, Suite 150
Raleigh, North Carolina 27605
IN ADDITION
20:23 NORTH CAROLINA REGISTER JUNE 1, 2006
2009
SUMMARY OF NOTICE OF
INTENT TO REDEVELOP A BROWNFIELDS PROPERTY
Town of Forest City
Pursuant to N.C.G.S. § 130A-310.34, the Town of Forest City has filed with the North Carolina Department of Environment
and Natural Resources ("DENR") a Notice of Intent to Redevelop a Brownfields Property ("Property") in Forest City, Rutherford
County, North Carolina. The Property, known as the former Cone Mill site, consists of 9.2 acres and is located at 186 Mill Street;
108, 110 and 112 East Main Street; 125 Depot Street and 139 Depot Street. Environmental contamination exists on the Property in the
soil and groundwater. The Town of Forest City has committed itself to limit redevelopment of the Property to commercial, retail,
office, residential, storage, hotel, public gathering and open space uses. The Notice of Intent to Redevelop a Brownfields Property
includes: (1) a proposed Brownfields Agreement between DENR and RiverLink, Incorporated, which in turn includes (a) a map
showing the location of the Property, (b) a description of the contaminants involved and their concentrations in the media of the
Property, (c) the above-stated description of the intended future use of the Property, and (d) proposed investigation and remediation;
and (2) a proposed Notice of Brownfields Property prepared in accordance with G.S. 130A-310.35.
During the 60-day public comment period, the full Notice of Intent to Redevelop a Brownfields Property may be reviewed at
Forest City's utility bill payments desk, 128 North Powell Street, Forest City, NC 28043 by contacting Danielle Withrow at that
address or at (828) 248-5200; at Forest City's public library, 240 East Main Street, Forest City, NC 28043 by contacting Mary Sandra
Costner at that address or at (828) 248-5224; or at the offices of the N.C. Brownfields Program, 401 Oberlin Rd., Suite 150, Raleigh,
NC 27605 by contacting Shirley Liggins at that address (where DENR will provide auxiliary aids and services for persons with
disabilities who wish to review the documents), at shirley.liggins@ncmail.net, or at (919) 508-8411.
Written public comments may be submitted to DENR within 60 days after the date this Notice is published in a newspaper of
general circulation serving the area in which the brownfields property is located, or in the North Carolina Register, whichever is later.
Written requests for a public meeting may be submitted to DENR within 30 days after the period for written public comments begins.
Thus, if the Town of Forest City, as it plans, publishes this Summary in the North Carolina Register after it publishes the Summary in
a newspaper of general circulation serving the area in which the brownfields property is located, and if it effects publication of this
Summary in the North Carolina Register on the date it expects to do so, the periods for submitting written requests for a public
meeting regarding this project and for submitting written public comments will commence on June 2, 2006. All such comments and
requests should be addressed as follows:
Mr. Bruce Nicholson
Brownfields Program Manager
Division of Waste Management
NC Department of Environment and Natural Resources
401 Oberlin Road, Suite 150
Raleigh, North Carolina 27605
PROPOSED RULES
20:23 NORTH CAROLINA REGISTER JUNE 1, 2006
2010
Note from the Codifier: The notices published in this Section of the NC Register include the text of proposed rules. The agency
must accept comments on the proposed rule(s) for at least 60 days from the publication date, or until the public hearing, or a
later date if specified in the notice by the agency. If the agency adopts a rule that differs substantially from a prior published
notice, the agency must publish the text of the proposed different rule and accept comment on the proposed different rule for 60
days.
Statutory reference: G.S. 150B-21.2.
TITLE 10A – DEPARTMENT OF HEALTH AND HUMAN
SERVICES
Notice is hereby given in accordance with G.S. 150B-21.2 that
the Division of Facility Services intends to adopt the rules cited
as 10A NCAC 14C .3901-.3906, .4001-.4005; amend the rules
cited as 10A NCAC 14C .0203, .1501-.1505, .1601-.1603, .1605,
.1901, .2101, .2103, .2203, .2502-.2503, .2505, .2602, .2701-
.2705, .2801, .3702-.3704; and repeal the rules cited as 10A
NCAC 14C .2806, .3501-.3502, .3504-.3505.
Proposed Effective Date: October 1, 2006
Public Hearing:
Date: July 27, 2006
Time: 10:00 a.m.
Location: Room 201, Council Building, 701 Barbour Drive,
Dorothea Dix Campus, Raleigh, North Carolina, 27603
Reason for Proposed Action: Several subject matters are
addressed in the State Medical Facilities Plan (SMFP). Changes
to existing Certificate of Need rules are required to ensure
consistency with the SMFP that became effective January 1,
2006.
Procedure by which a person can object to the agency on a
proposed rule: An individual may object to the agency on the
proposed rule by submitting written comments on the proposed
rule. They may also object by attending the public hearing and
personally voice their objections during that time.
Comments may be submitted to: Elizabeth K. Brown, NC
Division of Facility Services, 2701 Mail Service Center, Raleigh,
North Carolina, 27699-2701, phone (919) 855-3751; fax (919)
733-2757; email elizabeth.brown@ncmail.net
Comment period ends: July 31, 2006
Procedure for Subjecting a Proposed Rule to Legislative
Review: If an objection is not resolved prior to the adoption of
the rule, a person may also submit written objections to the
Rules Review Commission. If the Rules Review Commission
receives written and signed objections in accordance with G.S.
150B-21.3(b2) from 10 or more persons clearly requesting
review by the legislature and the Rules Review Commission
approves the rule, the rule will become effective as provided in
G.S. 150B-21.3(b1). The Commission will receive written
objections until 5:00 p.m. on the day following the day the
Commission approves the rule. The Commission will receive
those objections by mail, delivery service, hand delivery, or
facsimile transmission. If you have any further questions
concerning the submission of objections to the Commission,
please call a Commission staff attorney at 919-733-2721.
Fiscal Impact:
State
Local
Substantive (>$3,000,000)
None
CHAPTER 14 – DIRECTOR, DIVISION OF FACILITY
SERVICES
SUBCHAPTER 14C – CERTIFICATE OF NEED
REGULATIONS
SECTION .2000 – CRITERIA AND STANDARDS FOR
HOME HEALTH SERVICES
10A NCAC 14C .0203 FILING APPLICATIONS
(a) An application shall not be reviewed by the agency 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 following formula:
(1) With each application proposing the addition
of a sixth bed to an existing or approved five
bed intermediate care facility for the mentally
retarded, the proponent shall transmit a fee in
the amount of two thousand dollars ($2,000).
(2) With each application, other than those
referenced in Subparagraph (b)(1) of this Rule,
proposing no capital expenditure or a capital
expenditure of up to, but not including, one
million dollars ($1,000,000), the proponent
shall transmit a fee in the amount of three
thousand five hundred dollars ($3,500).
(3) With each application, other than those
referenced in Subparagraph (b)(1) of this Rule,
proposing a capital expenditure of one million
dollars ($1,000,000) or greater, the proponent
shall transmit a fee in the amount of three
thousand five hundred dollars ($3,500), plus
an additional fee equal to .003 of the amount
of the proposed capital expenditure in excess
of one million dollars ($1,000,000). The
additional fee shall be rounded to the nearest
PROPOSED RULES
20:23 NORTH CAROLINA REGISTER JUNE 1, 2006
2011
whole dollar. In no case shall the total fee
exceed seventeen thousand five hundred
dollars ($17,500).
(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.
Authority G.S. 131E-177; 131E-182.
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) "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.
(6)(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.
(7)(6) "Hospice" means any coordinated program of
home care as defined in G.S. 131E-176(13a).
(8)(7) "Hospice inpatient facility" means a facility as
defined in G.S. 131E-176(13b).
(9) "Hospice residential care facility" means a
facility as defined in G.S. 131E-176(13c).
(10) "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.
(11)(8) "Hospice services" means services as defined
in G.S. 131E-201(5b).
(12)(9) "Hospice staff" means personnel as defined in
10A NCAC 13K .0102 of the Hospice
Licensing Rules.
(13)(10) "Interdisciplinary team" means personnel as
defined in G.S. 131E-201(6).
(14)(11) "Palliative care" means treatment as defined in
G.S. 131E-201(8).
(15)(12) "Respite care" means care provided as defined
in 42 CFR 418.98.
Authority G.S. 131E-177(1).
10A NCAC 14C .1502 INFORMATION REQUIRED OF
APPLICANT
(a) An applicant proposing to develop a hospice shall complete
the application form for Hospice Services. 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 a hospice, hospice
inpatient facility beds, or hospice residential care facility beds
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 clearly 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
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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.
(d) An applicant proposing to develop hospice inpatient or
hospice residential care facility beds shall also provide the
following information:
(1) a description of the means by which hospice
services shall be provided in the patient's own
home;
(2) copies of the proposed contractual agreements,
with a licensed hospice or a licensed home
care agency with a hospice designation on its
license, for the provision of hospice services in
the patient's own home;
(3) a copy of the admission policies, including the
criteria that shall be used to select persons for
admission and to assure that terminally ill
patients are served in their own homes as long
as possible; and
(4) documentation that a home-like setting shall
be provided in the facility.
Authority G.S. 131E-177(1); 131E-183.
10A NCAC 14C .1503 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 in the facility is projected to be at
least 50% 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 in the facility is projected to be at
least 65% for the second operating year
following completion of the project; and
(3) if the application is submitted to address the
need for a hospice residential care facility,
each existing facility which is located in the
hospice service area and which has licensed
hospice beds of the type proposed by the
applicant attained an occupancy rate of at least
65% for the 12 month period reported on that
facility's most recent Licensure Renewal
Application Form.
(b) An applicant proposing to add beds to an existing hospice
inpatient facility or hospice residential care facility shall
document that the average occupancy of the licensed hospice
inpatient and hospice residential care facility beds in its existing
facility was at least 65% for the nine months immediately
preceding the submittal of the proposal.
(c) An applicant proposing to develop a hospice shall
demonstrate that no less than 80% 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).
Authority G.S. 131E-177(1).
10A NCAC 14C .1504 SUPPORT SERVICES
(a) An applicant proposing to develop a hospice, hospice
inpatient facility beds, or hospice residential care facility beds
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, hospice
inpatient facility beds, or hospice residential care facility beds
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) 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.
(e)(d) For each of the services listed in Paragraphs Paragraph (c)
and (d) 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.
Authority G.S. 131E-177(1); 131E-183.
10A NCAC 14C .1505 STAFFING AND STAFF
TRAINING
(a) An applicant proposing to develop a hospice, hospice
inpatient facility beds, or hospice residential care facility beds
shall document that staffing for hospice services will be
provided in a manner consistent with G.S. 131E, Article 10.
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(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, at a minimum, 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 qualified health care professional 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
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 appropriate 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.
Authority G.S. 131E-177(1).
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 or cardiac
angioplasty 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 angioplasty equipment" shall have
the same meaning as defined in G.S.
131E-176(2e).
(4)(3) "Cardiac catheterization equipment" shall have
the same meaning as defined in G.S.
131E-176(2f).
(5)(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.
(6)(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.
(7)(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.
(8)(7) "Cardiac catheterization services" means the
provision of diagnostic cardiac catheterization
procedures or therapeutic cardiac
catheterization procedures performed utilizing
cardiac catheterization equipment or cardiac
angioplasty equipment in a cardiac
catheterization room.
(9)(8) "Comprehensive cardiac services program"
means a cardiac services program which
provides the full range of clinical services
associated with the treatment of cardiovascular
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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.
(10)(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.
(11)(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.
(12)(11) "Existing" means the equipment was in
operation prior to the beginning of the review
period.
(13)(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/American
Heart Association Guidelines for Cardiac
Catheterization and Cardiac Catheterization
Laboratories (1991) American College of
Cardiology/ Society for Cardiac Angiography
and Interventions Clinical Expert Consensus
Document on Cardiac Catheterization
Laboratory Standards (June 2001) report.
(14)(13) "Mobile equipment" means cardiac
angioplasty equipment or cardiac
catheterization equipment and transporting
equipment which is moved to provide services
at two or more host facilities.
(15)(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.
(16)(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.
(17)(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.
Authority G.S. 131E-177(1); 131E-183.
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
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most recent licensure form on file
with the Division of Facility Services;
(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 or cardiac
angioplasty equipment including itemization
of the cost of the equipment; and
(11) documentation that the cardiac catheterization
equipment and cardiac angioplasty equipment
and the procedures for operation of the
equipment are designed and developed based
on the American College of
Cardiology/American Heart Association
Guidelines for Cardiac Catheterization
Laboratories (1991) American College of
Cardiology/ Society for Cardiac Angiography
and Interventions Clinical Expert Consensus
Document on Cardiac Catheterization
Laboratory Standards (June 2001) report.
Authority G.S. 131E-177(1); 131E-183.
10A NCAC 14C .1603 PERFORMANCE STANDARDS
(a) An applicant shall demonstrate that the project is capable of
meeting the following standards:
(1) each proposed item of cardiac catheterization
equipment or cardiac angioplasty equipment,
including mobile equipment but excluding
shared fixed cardiac catheterization or
angioplasty 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 or mobile cardiac angioplasty equipment shall:
(1) demonstrate that each existing item of cardiac
catheterization equipment and cardiac
angioplasty 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
Facility Services;
(2) demonstrate that the utilization of each
existing or approved item of cardiac
catheterization equipment and cardiac
angioplasty 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 cardiac catheterization, cardiac
angioplasty, or 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
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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 or
cardiac angioplasty equipment excluding shared fixed and
mobile cardiac catheterization or cardiac angioplasty equipment
shall:
(1) demonstrate that its existing items of cardiac
catheterization and cardiac angioplasty
equipment, except mobile equipment, located
in the proposed cardiac catheterization service
area operated at an average of at least 80% of
capacity during the twelve month period
reflected in the most recent licensure renewal
application form on file with the Division of
Facility Services;
(2) demonstrate that its existing items of cardiac
catheterization equipment or cardiac
angioplasty 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 or cardiac angioplasty equipment as defined in
the applicable State Medical Facilities Plan shall:
(1) demonstrate that each proposed item of shared
fixed cardiac catheterization or cardiac
angioplasty 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.
Authority G.S. 131E-177(1); 131E-183(b).
10A NCAC 14C .1605 STAFFING AND STAFF
TRAINING
(a) The applicant 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
special credentials:
(A) board-certified in internal medicine,
pediatrics or radiology;
(B) subspecialty training in cardiology,
pediatric cardiology, or
cardiovascular radiology; and
(C) current clinical experience in
performing physiologic procedures,
angiographic procedures, or both;
(2) at least one specialized 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 current
experience specifically in
cardiovascular disease and radiation
sciences;
(B) one nurse with training and current
experience specifically in critical care
of cardiac patients, cardiovascular
medication, and catheterization
equipment; and
(C) at least three 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) The applicant shall provide documentation to demonstrate
that the following staff training shall be provided for members of
cardiac catheterization teams:
(1) 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.
Authority G.S. 131E-177(1); 131E-183(b).
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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 special 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" means MRT equipment
which is used to deliver a beam of electrons or
photons in the treatment of cancer patients.
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" means a machine that reproduces
the geometric relationships of the MRT
equipment to the patient. 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 2.0
ESTVs; 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.
Authority G.S. 131E-177(1); 131E-183(b).
SECTION .2100 – CRITERIA AND STANDARDS FOR
SURGICAL SERVICES AND OPERATING ROOMS
10A NCAC 14C .2101 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) "Operating room" means an inpatient
operating room, an outpatient or ambulatory
surgical operating room, or a shared operating
room, or an endoscopy procedure room in a
licensed health service facility. room.
(3) "Ambulatory surgical program" means a
program as defined in G.S. 131E-176(1c).
(4) "Existing operating rooms" means those
operating rooms in ambulatory surgical
facilities and hospitals which were reported in
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the License Application for Ambulatory
Surgical Facilities and Programs and in Part III
of Hospital Licensure Renewal Application
Form submitted to the Licensure Section of the
Division of Facility Services and which were
licensed and certified prior to the beginning of
the review period.
(5) "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.
and certified. licensed.
(6) "Multispecialty ambulatory surgical program"
means a program as defined in G.S. 131E-
176(15a).
(7) "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.
(8) "Service area" means the Operating Room
Service Area as defined in the applicable State
Medical Facilities Plan.
(9) "Shared operating room" means an operating
room that is used for the performance of both
ambulatory and inpatient surgical procedures.
(10) "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, but is not limited to the
following: gynecology, otolaryngology, plastic
surgery, general surgery, ophthalmology,
urology, orthopedics, and oral surgery.
(11) "Specialty ambulatory surgical program"
means a program as defined in G.S. 131E-
176(24c).
(12) "Surgical case" means an individual who
receives one or more surgical procedures in an
operating room during a single operative
encounter.
Authority G.S. 131E-177(1); 131E-183(b).
10A NCAC 14C .2103 PERFORMANCE STANDARDS
(a) In projecting utilization, the existing, approved and proposed
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
increase the number of operating rooms (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 not be approved unless the applicant documents
that the average number of surgical cases per operating room to
be performed in each facility owned by the applicant in the
proposed service area, is reasonably projected to be at least 2.4
surgical cases per day for each inpatient operating room, room
(excluding dedicated open-heart and dedicated C-Section
operating rooms), 4.8 surgical cases per day for each outpatient
or ambulatory surgical operating room, 7.2 cases per day for
each endoscopy procedure room, and 3.2 surgical cases per day
for each shared operating room during the third year of operation
following completion of the project.
(c) A proposal to develop an additional operating room to be
used as a dedicated C-section operating room shall not be
approved unless the applicant documents that the average
number of surgical cases per operating room to be performed in
each facility owned by the applicant in the proposed service
area, is reasonably projected to be at least 2.4 surgical cases per
day for each inpatient operating room (excluding dedicated
open-heart and dedicated C-section operating rooms), 4.8
surgical cases per day for each outpatient or ambulatory surgical
operating room and 3.2 surgical cases per day for each shared
operating room during the third year of operation following
completion of the project.
(d) 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 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 operating at 4.8 surgical cases per day
for each outpatient or ambulatory surgical operating room, 7.2
gastrointestinal endoscopy cases per day for each gastrointestinal
endoscopy procedure room, and 3.2 surgical cases per day for
each shared operating room.
(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 provide documentation to show that each existing
and approved ambulatory surgery program in the service area
that performs ambulatory surgery in the same specialty areas as
proposed in the application is reasonably projected to be
operating at 4.8 surgical cases per day for each outpatient or
ambulatory surgical operating room, 7.2 gastrointestinal
endoscopy cases per day for each gastrointestinal endoscopy
procedure room, and 3.2 surgical cases per day for each shared
surgical operating room prior to the completion of the proposed
project.
(f) The applicant shall document the assumptions and provide
data supporting the methodology used for each projection in this
Rule.
Authority G.S. 131E-177; 131E-183(b).
SECTION .2200 – CRITERIA AND STANDARDS FOR
END-STAGE RENAL DISEASE SERVICES
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. 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.
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2019
(b) An applicant proposing to increase the number of dialysis
stations in an existing End Stage Renal Disease facility 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 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. stations.
(c) An applicant shall provide all assumptions, including the
specific methodology by which patient utilization is projected.
Authority G.S. 131E-177(1); 131E-183(b).
SECTION .2500 – CRITERIA AND STANDARDS FOR
SUBSTANCE ABUSE/CHEMICAL DEPENDENCY
TREATMENT BEDS
10A NCAC 14C .2502 INFORMATION REQUIRED OF
APPLICANT
(a) An applicant proposing to establish new intensive treatment
beds or detoxification beds shall project resident origin by
percentage by county of residence. All assumptions and the
methodology for projecting occupancy shall be clearly stated.
(b) An applicant proposing to establish new intensive treatment
beds or detoxification 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 proposing to establish new detoxification beds
shall identify the location of each referral source for follow-up
outpatient, residential and rehabilitation services located in the
proposed service area for clients who have completed
detoxification.
(f)(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 and detoxification beds.
(g)(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.
(h) An applicant shall identify the Area Authority that will serve
as the Single Portal of Entry/Exit for the facility.
(i)(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.
(j)(h) An applicant proposing to establish new intensive
treatment beds or detoxification 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 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.
(k)(i) An applicant proposing to establish new intensive
treatment beds or detoxification 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.
Authority G.S. 131E-177(1); 131E-183.
10A NCAC 14C .2503 PERFORMANCE STANDARDS
(a) An applicant 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 and detoxification beds within the facility in
which the beds are to be located, located except in facilities with
only detoxification beds, has been:
(1) 75 percent for facilities with a total of 1-15
intensive treatment beds and detoxification
beds; or
(2) 85 percent for facilities with a total of 16 or
more intensive treatment beds and
detoxification beds.
(b) An applicant shall not be approved unless the overall
occupancy of the total number of intensive treatment beds and
detoxification beds to be operated in the facility is projected,
projected except in facilities with only detoxification beds, 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 1-15
intensive treatment beds and detoxification
beds; or
(2) 85 percent for facilities with a total of 16 or
more intensive treatment beds and
detoxification beds.
(c) An applicant proposing to add detoxification beds to an
existing facility that includes only detoxification beds shall not
be approved unless the overall occupancy of the total number of
detoxification beds in the facility has been at least 75 percent for
the nine months immediately preceding the submittal of the
application.
(d) An applicant proposing to establish a new detoxification
facility or add detoxification beds to an existing facility that
includes only detoxification beds shall demonstrate that the
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2020
overall occupancy of the total number of detoxification beds in
the facility is reasonably projected to be 75 percent by the fourth
quarter of the third year of operation following completion of the
project.
(e)(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.
Authority G.S. 131E-177(1); 131E-183(b).
10A NCAC 14C .2505 STAFFING AND STAFF
TRAINING
(a) An applicant proposing to establish new intensive treatment
beds or detoxification 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 or detoxification beds shall document that the staffing
pattern in the facility is consistent with the staffing requirements
contained in 10A NCAC 27G .3102, .3202, or .3402, which are
incorporated by reference including all subsequent amendments.
Authority G.S. 131E-177(1); 131E-183.
SECTION .2600 – CRITERIA AND STANDARDS FOR
PSYCHIATRIC BEDS
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 clearly 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 clearly
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 application shall identify the Area Authority that will
serve as the Single Portal of Entry/Exit for the facility.
(h)(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.
(i)(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
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.
(j)(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.
Authority G.S. 131E-177(1); 131E-183.
SECTION .2700 - CRITERIA AND STANDARDS FOR
MAGNETIC RESONANCE IMAGING SCANNER
10A NCAC 14C .2701 DEFINITIONS
The following definitions shall 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%
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
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2021
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% 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.
(4)(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.
(5)(7) "Fixed MRI scanner" means an MRI scanner
that is not a mobile MRI scanner.
(6)(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.
(7)(9) "Magnetic resonance imaging scanner" (MRI
Scanner) is defined in G.S. 131E-176(14e).
(8)(10) "Mobile MRI region" means either the eastern
part of the State which includes the counties in
Health Service Areas IV, V and VI, VI
(Eastern Mobile MRI Region), or the western
part of the State which includes the counties in
Health Service Areas I, II, and III. III (Western
Mobile MRI Region). The counties in each
Health Service Area are identified in Appendix
A of the State Medical Facilities Plan.
(9)(11) "Mobile MRI scanner" means an MRI scanner
and transporting equipment which is moved at
least weekly to provide services at two or more
host facilities.
(10)(12) "MRI procedure" means a single discrete MRI
study of one patient.
(11)(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.
(12)(14) "MRI study" means one or more scans relative
to a single diagnosis or symptom.
(13) "Pediatric MRI patient" means a patient
requiring an MRI scan who is under the age of
12 years or who is a special needs patient and
is under the age of 21 years.
(14)(15) "Related entity" means the parent company of
the applicant, a subsidiary company of the
applicant (i.e., the applicant owns 50% 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).
(15) "Special Needs patient" means a patient who
has cerebral palsy, encephalomyelopathy,
central nervous system injuries, genetic and
metabolic disorders, autism, and mental
retardation.
(16) "Temporary MRI scanner" means a 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.
(17) "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.
(18) "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
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2022
biopsy procedure is valued at 1.6 weighted
MRI procedures (based on an average of 96
minutes per procedure).
Authority G.S. 131E-177(1); 131E-183(b).
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, shall be available and staffed
for use at least 66 hours per week;
(2) documentation that the proposed mobile MRI
scanner shall 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;
(3)(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;
(4)(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;
(5)(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; year, which is based on the
physicians' historical number of referrals;
(7) for each location at which the applicant or a
related entity will provide MRI services,
utilizing existing, approved, or proposed 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;
(6)(8) for each location at which the service will be
provided, applicant or a related entity will
provide services, utilizing existing, approved,
or proposed MRI scanners, projections of the
annual number of weighted MRI procedures to
be performed for each of the four types of
weighted MRI procedures, as identified in the
SMFP, for each of the first three years of
operation after completion of the project;
(7)(9) a detailed description of the methodology and
assumptions used to project the number of
unweighted weighted MRI procedures to be
performed; performed at each location,
including the number of contrast versus non-contrast
procedures, sedation versus non-sedation
procedures, and inpatient versus
outpatient procedures;
(8)(10) documentation to support each assumption
used in projecting the number of procedures to
be performed; a detailed description of the
methodology and assumptions used to project
the number of weighted MRI procedures to be
performed at each location;
(9)(11) for each existing fixed or 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, physical location for
fixed MRI scanners, and host sites for mobile
MRI scanners;
(10)(12) for each approved fixed or mobile MRI
scanner to be owned by the applicant or a
related entity and approved to be operated in
North Carolina, the proposed vendor, proposed
tesla strength, CON project identification
number, physical location for fixed MRI
scanners, and host sites for mobile MRI
scanners;
(11)(13) 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
(14) 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: shall demonstrate that:
(1) provide a copy of a contract or working
agreement with a radiologist or practice group
that has experience interpreting images and is
trained to interpret images produced by an
MRI scanner configured exclusively for
mammographic studies;
(2) document that the applicant performed
mammograms without interruption in the
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20:23 NORTH CAROLINA REGISTER JUNE 1, 2006
2023
provision of the service during the last year;
and
(3) document that the applicant's existing
mammography equipment is in compliance
with the U.S. Food and Drug Administration
Mammography Quality Standards Act.
(1) it has an existing and ongoing working
relationship with a specialized 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 a dedicated fixed pediatric
an extremity MRI scanner, pursuant to a need determination in
the State Medical Facilities Plan for a demonstration project,
shall:
(1) provide a copy of a contract or working
agreement with two pediatric radiologists
qualified as described in 10A NCAC 14C
.2705(f)(1);
(2) provide a copy of the facility's emergency plan
for pediatric and special needs patients that
outline all emergency procedures including
acute care transfers and a copy of a contract
with an ambulance service for transportation
during any emergencies;
(3) commit that the proposed MRI scanner shall
be used exclusively to perform procedures on
pediatric MRI patients;
(4) provide a description of the scope of the
research studies that shall be conducted to
develop protocols related to MRI scanning of
pediatric MRI patients; which includes special
needs patients, and
(5) commit to prepare an annual report, to be
submitted to the Medical Facilities Planning
Section and the Certificate of Need Section,
which shall include the protocols for scanning
pediatric MRI patients and the annual volume
of weighted MRI procedures performed, by
type.
(1) provide a detailed description of the scope of
the research studies that shall 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 shall 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
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20:23 NORTH CAROLINA REGISTER JUNE 1, 2006
2024
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 specific criteria and methodology
to be implemented for utilization review to
ensure the medical necessity of the procedures
performed.
Authority G.S. 131E-177(1); 131E-183(b).
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. 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.];
(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 mobile MRI region, 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
MI 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,
PROPOSED RULES
20:23 NORTH CAROLINA REGISTER JUNE 1, 2006
2025
(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)(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.];
(5)(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 1,716 1,664
weighted MRI procedures per year; which is
.80 X 1 procedure per hour X 40 hours per
week X 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 dedicated fixed
pediatric 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 2746
weighted MRI procedures (i.e., 80 percent of
one procedure per hour, 66 hours per week, 52
weeks per year); 80 percent of the capacity
defined by the applicant in response to 10A
NCAC 14C .2702(f)(6), and
(2) document the assumptions and provide data
supporting the methodology used for each
projection required in this Rule.
Authority G.S. 131E-177(1); 131E-183(b).
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 proposed MRI
service area 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 dedicated fixed
pediatric MRI scanner shall provide a written policy regarding
pediatric sedation which outlines the criteria for sedating a
pediatric patient, including the special needs patients, and
identifies the staff that will administer and supervise the sedation
process.
(c) An applicant proposing to acquire a dedicated fixed pediatric
MRI scanner shall provide evidence of the availability of a
pediatric code cart at the facility where the proposed pediatric
MRI scanner will be located and a plan for emergency situations
as described in 10A NCAC 14C .2702(f)(2).
(d)(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.
Authority G.S. 131E-177(1); 131E-183(b).
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 provide the proposed
services 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 fixed breast
MRI scanner shall provide documentation that that: the
radiologist is trained and has experience in interpreting images
produced by an MRI scanner configured exclusively to perform
mammographic studies.
(1) the radiologist is trained and has specific
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 specialized training in breast MRI
imaging and that one of these technologists
shall be present during the hours operation of
the dedicated breast MRI scanner.
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2026
(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 Paragraphs Paragraph
(a) and (c) of this Rule shall be met at each host facility. 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 a dedicated fixed pediatric
an extremity MRI scanner scanner, pursuant to a need
determination in the State Medical Facilities Plan for a
demonstration project, also shall provide:
(1) provide documentation of the availability of at
least two radiologists, certified by the
American Board of Radiology, with a pediatric
fellowship or two years of specialized training
in pediatrics;
(2)(1) provide evidence that the applicant will have
at least one licensed physician shall be on-site
during the hours of operation of the proposed
MRI scanner;
(3) provide documentation that the applicant will
employ at least two licensed registered nurses
and that one of these nurses shall be present
during the hours of operation of the proposed
MRI scanner;
(4)(2) provide a description of a research group for
the project including a radiologist, neurologist,
pediatric sedation specialist orthopaedic
surgeon, and research coordinator; and
(5) provide documentation of the availability of
the research group to conduct research studies
on the proposed MRI scanner; and
(6)(3) provide 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.
Authority G.S. 131E-177(1); 131E-183(b).
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 10
NCAC 14B the current State Medical
Facilities Plan and which are located in a
hospital licensed pursuant to G.S. 131E-77 or
a nursing facility licensed pursuant to G.S.
131E-102. 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.
Authority G.S. 131E-177; 131E-183(b).
10A NCAC 14C .2806 QUALITY OF SERVICES
A proposal to add rehabilitation beds to an existing facility shall
document that the facility has not operated on a provisional
license beyond the effective date of the initial provisional license
issued for a new operator, received an administrative penalty or
had its admissions suspended within the 18 month period
immediately preceding the submittal of the certificate of need
application.
Authority G.S. 131E-177; 131E-183(b).
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20:23 NORTH CAROLINA REGISTER JUNE 1, 2006
2027
SECTION .3500 - CRITERIA AND STANDARDS FOR
ONCOLOGY TREATMENT CENTERS
10A NCAC 14C .3501 DEFINITIONS
The following definitions shall apply to all rules in this section:
(1) "Major medical equipment" is defined in G.S.
131E-176(14f).
(2) "Medical equipment" means equipment used
by the oncology treatment center to diagnose
or treat disease or injury in patients, including
major medical equipment.
(3) "Medical oncologist" is a physician with a
special interest in and competence in
managing patients with cancer.
(4) "Medicine-Oncology" means a clinical
medical specialty with a specific involvement
with the treatment of tumors.
(5) "Oncology diagnostic services" means those
services which include, but are not limited to,
procedures using diagnostic radiology and
imaging techniques, clinical and pathological
laboratory tests, or physical examination to
obtain information from which a diagnosis is
established.
(6) "Oncology evaluation services" means the
compilation of all diagnostic test results and
consultation reports for the development of a
patient specific treatment plan to provide
curative or palliative cancer treatment.
(7) "Oncology treatment center" is defined in G.S.
131E-176(18a).
(8) "Oncology treatment center service area"
means the geographic area defined by the
applicant from which patients will originate
who will receive the health services proposed.
(9) "Oncology treatment services" means curative
or palliative services provided to cancer
patients which involve the use of radiation
therapy, chemotherapy or other treatment
techniques.
(10) "Radiation oncologist" means a medical
physician with a special interest, training and
competence in managing patients with cancer
who is certified by the American Board of
Radiology or its equivalent.
(11) "Radiology-Oncology" means a clinical
medical specialty involving the treatment of
tumors, particularly as they relate to treatment
with ionizing radiation.
Authority G.S. 131E-177(1); 131E-183(b).
10A NCAC 14C .3502 INFORMATION REQUIRED OF
APPLICANT
(a) An applicant proposing to develop a new oncology treatment
center shall use the Acute Care Facility/Medical Equipment
application form.
(b) An applicant shall also submit the following additional
information:
(1) documentation of the number of existing
oncology treatment centers and other health
service facilities which provide similar
services in the proposed oncology treatment
center's service area;
(2) a list of the medical/surgical specialties in the
existing oncology treatment centers and other
health service facilities which provide similar
services in the proposed oncology treatment
center service area, such as Radiation-
Oncology, Medicine-Oncology, and surgical
specialties;
(3) a list of the medical equipment that is
proposed to be acquired;
(4) documentation verifying the actual cost or
market value of each item of medical
equipment, whichever is greater;
(5) documentation that the proposed services shall
result in an integrated multidisciplinary effort
to diagnose and treat patients' clinical and
psychosocial needs;
(6) a list of all oncology diagnostic, oncology
evaluation, and oncology treatment services
that shall be available, and documentation
demonstrating the means by which these
services shall be provided;
(7) documentation that coordination and referral
agreements exist with a hospital, referring
physicians, and surgical and medical
specialists and subspecialists; and
(8) documentation that the services shall be
offered in a physical environment that
conforms to the requirements of federal, state,
and local regulatory bodies.
(c) An applicant proposing to acquire radiation therapy
equipment shall document compliance with 10A NCAC 14C
.1900, Criteria and Standards for Radiation Therapy Equipment.
(d) An applicant proposing to develop a new oncology
treatment center shall provide:
(1) the number of patients that are projected to use
the service, by diagnosis;
(2) the number of patients that are projected to use
the service, by county of residence;
(3) documentation of the maximum number of
procedures that the equipment in the facility is
capable of performing and the assumptions
used to determine the maximum number of
procedures;
(4) quarterly projected utilization of the
applicant's new equipment for each of the first
three years after the completion of the project;
(5) documentation of the effect the new oncology
treatment center may have on existing
oncology treatment centers and other health
service facilities which provide similar
services in the proposed oncology treatment
center service area; and
(6) all the assumptions and data supporting the
methodology used to make the above
projections.
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2028
Authority G.S. 131E-177(1); 131E-183.
10A NCAC 14C .3504 SUPPORT SERVICES
(a) An applicant proposing to develop an oncology treatment
center shall document that the following services will be
available to the center:
(1) medical oncology services;
(2) radiation oncology services;
(3) diagnostic radiology services;
(4) nuclear medicine services;
(5) hospice and home health services;
(6) psychology and social services;
(7) pharmaceutical services;
(8) pathology services;
(9) transportation services; and
(10) tumor registry services.
(b) An applicant proposing to develop an oncology treatment
center shall specify whether any services other than those listed
in Paragraph (a) of this Rule will be available to the center and
shall list those additional services.
(c) An applicant proposing to develop an oncology treatment
center shall list the types of surgical specialties which will be
available to the center.
(d) An applicant proposing to develop an oncology treatment
center for the provision of medical-oncology services shall
document that the following services will be available in the
center:
(1) pharmaceutical services; and
(2) pathology services.
(e) An applicant proposing to develop an oncology treatment
center for the provision of radiation-oncology services shall
document that diagnostic radiology services will be available in
the center.
Authority G.S. 131E-177(1); 131E-183(b).
10A NCAC 14C .3505 STAFFING AND STAFF
TRAINING
An applicant proposing to establish a new oncology treatment
center shall provide the following information:
(1) the medical specialties and board certification
status of each physician who will provide
services in the proposed center. An applicant
shall also provide documentation of at least the
following types of physicians:
(a) if proposing radiation-therapy
services, a radiation oncologist;
(b) if proposing radiation-therapy
services, access to a medical
oncologist;
(2) a description of the special training and
specialty certification which will be required
of all registered nurses who will be employed
by the center;
(3) documentation to show the types and numbers
of staff, particularly qualified medical
technologists and medical staff, that shall be
available to support the services and an
explanation as to why these staff are adequate
to provide the proposed services; and
(4) documentation to demonstrate that a formal
training program exists to ensure the continued
proficiency of the professional and technical
staff.
Authority G.S. 131E-177(1); 131E-183(b).
SECTION .3700 - CRITERIA AND STANDARDS FOR
POSITRON EMISSION TOMOGRAPHY SCANNER
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 that all of the following
services were provided, at each facility where
the PET scanner will be operated,
continuously throughout the 12 months
immediately prior to the date on which the
application is filed:
(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; and
(G) neuroangiography.
(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
12 hours per day, six days a week,
except for mobile scanners; and
scanners.
(C) implement a referral system which
shall include a feedback mechanism
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20:23 NORTH CAROLINA REGISTER JUNE 1, 2006
2029
of providing patient information to
the referring physician and facility.
(4) A description of the protocols that will be
established to assure that all clinical PET
procedures performed are medically necessary
and cannot be performed using other, less
expensive, established modalities.
(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, manufacturers 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
tomograph tomography and associated
instrumentation;
(3) radiation protection and shielding;
(4) radioactive emission to the environment; and
(5) radioactive waste disposal.
Authority G.S. 131E-177(1); 131E-183(b).
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
3,200 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
3,200 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
3,200 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.
Authority G.S. 131E-177(1); 131E-183(b).
10A NCAC 14C .3704 SUPPORT SERVICES
(a) An applicant proposing to acquire a PET scanner, including
a mobile PET scanner, shall document how medical emergencies
within the PET scanner unit will be managed at each facility
where the PET scanner will be operated.
(b)(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.
(c)(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.
(d)(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.
Authority G.S. 131E-177(1); 131E-183(b).
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
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2030
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.
Authority G.S. 131E-177(1); 131E-183(b).
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 ten
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
PROPOSED RULES
20:23 NORTH CAROLINA REGISTER JUNE 1, 2006
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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 specific
rationale for its change in practice pattern.
Authority G.S. 131E-177; 131E-183(b).
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