Ga. Comp. R. & Regs. R. 111-2-2-.42 - Specific Review Considerations for MegaVoltage Radiation Therapy Services/Units
(1)
Applicability.
(a) A Certificate of Need will be required
for the establishment of any new or expanded MegaVoltage Radiation Therapy
Service.
(b) MegaVoltage Radiation
Therapy, including Stereotactic Radiosurgery (SRS) and Stereotactic Body
Radiation Therapy (SBRT) may be conducted on non-special units or on special
purpose units.
(c) A Certificate of
Need will be required for the addition of a non-special MRT unit. An
application for the addition of a non-special MRT unit shall address the
standards contained in Ga. Comp. R. & Regs. r.
111-2-2-.42(3) in
addition to the general review considerations of Ga. Comp. R. & Regs. r.
111-2-2-.09(1). A
certificate holder who has been authorized to provide MRT service solely on a
non-special unit may not provide service on a special purpose unit without
obtaining a special purpose MRT Certificate of Need.
(d) A Certificate of Need will be required
for the addition of a special purpose MRT unit. An application for the addition
of a special purpose MRT unit shall address the standards contained in Ga.
Comp. R. & Regs. r.
111-2-2-.42(4) in
addition to the general review considerations of Ga. Comp. R. & Regs. r.
111-2-2-.09(1). A
certificate holder who has been authorized to provide MRT service solely on a
special purpose unit may not provide service on a non-special unit without
obtaining a non-special MRT Certificate of Need.
(e) An application for the establishment of a
new or expanded MegaVoltage Radiation Therapy Service with the addition of both
non-special and special purpose MRT units shall address the standards of Ga.
Comp. R. & Regs. r.
111-2-2-.42(3),
111-2-2-.42(4) and
the general review considerations of Ga. Comp. R. & Regs. r.
111-2-2-.09(1).
(2)
Definitions.
(a) "Brachytherapy" means the administration
of radiation therapy by applying a radioactive material inside or in close
proximity to the patient. The material may be contained in various types of
apparatus; may be on the surface of plaques; or may be enclosed in tubes,
needles, wire, seeds, or other small containers. Common materials that are or
have been used for the administration of brachytherapy include but are not
limited to radium, Cobalt-60, Cesium-137, Iodine-125, Palladium-103 and
Iridium-192.
(b) "Complex treatment
visit" means a treatment visit involving three or more treatment sites,
tangential fields with wedges, rotational or arc techniques or other special
arrangements, or custom blocking.
(c) "Course of treatment" means the planned
series of visits that compose a plan for treatment of one or more cancer sites
for a single patient.
(d) "Gamma
knife" means a special stereotactic radiosurgery unit consisting of multiple
cobalt sources all simultaneously focused to irradiate cancer or other
neoplasms in the brain or cerebrovascular system abnormalities.
(e) "Health Planning Area" or "Planning Area"
means the geographic regions in Georgia for use in planning for MRT services.
1. The Health Planning Areas or Planning
Areas for non-special MRT services are the twelve state service delivery
regions established by O.C.G.A. §
50-4-7.
2. The Health Planning Areas or Planning
Areas for special purpose MRT services are five sub-state regions comprised as
follows:
(i) Special Purpose MRT Region 1,
including the following counties: Dade, Walker, Catoosa, Whitfield, Murray,
Gilmer, Fannin, Union, Towns, Rabun, Stephens, Habersham, White, Lumpkin,
Dawson, Pickens, Gordon, Chattooga, Floyd, Bartow, Cherokee, Forsyth, Hall,
Banks, Franklin, Hart, Gwinnett, Fulton, Cobb, Paulding, Polk, Haralson,
Douglas, DeKalb, Rockdale, Newton, Henry, Clayton, and Fayette;
(ii) Special Purpose MRT Region 2, including
the following counties: Elbert, Madison, Jackson, Barrow, Oconee, Clarke,
Oglethorpe, Greene, Morgan, Walton, Wilkes, Lincoln, Columbia, McDuffie,
Warren, Taliaferro, Glascock, Jefferson, Richmond, Burke, Screven, Jenkins, and
Emmanuel;
(iii) Special Purpose MRT
Region 3, including the following counties: Carroll, Coweta, Heard, Troup,
Meriwether, Pike, Spalding, Lamar, Upson, Harris, Talbot, Taylor, Muscogee,
Chattahoochee, Marion, Schley, Macon, Sumter, Webster, Stewart, Quitman,
Randolph, Terrell, Lee, Worth, Dougherty, Calhoun, Clay, Early, Baker,
Mitchell, Colquitt, Miller, Brooks, Thomas, Grady, Decatur, and
Seminole;
(iv) Special Purpose MRT
Region 4, including the following counties: Hancock, Putnam, Jasper, Butts,
Monroe, Jones, Baldwin, Washington, Johnson, Treutlen, Montgomery, Wheeler,
Telfair, Wilcox, Dodge, Laurens, Pulaski, Bleckley, Houston, Peach, Twiggs,
Wilkinson, Bibb, Crawford, Dooly, Crisp, Ben Hill, Irwin, Turner, Cook, Tift,
Berrien, Lanier, Echols, and Lowndes; and
(v) Special Purpose MRT Region 5, including
the following counties: Effingham, Bulloch, Candler, Toombs, Tattnall, Evans,
Bryan, Chatham, Liberty, Long, McIntosh, Wayne, Appling, Jeff Davis, Coffee,
Bacon, Pierce, Brantley, Glynn, Camden, Charlton, Ware, Atkinson, and
Clinch.
(f)
"Heavy particle accelerator" means a machine such as a cyclotron, which
produces beams of high-energy particles such as protons, neutrons, pions, or
heavy ions with rest masses greater than that of an electron (mc2 = 0.511
MeV).
(g) "Horizon Year" means the
last year of a five-year projection period for need determinations for MRT
services.
(h) "Intensity modulated
radiation therapy" or "IMRT" means a treatment delivery utilizing a
radiotherapy treatment plan optimized using an inverse or forward planning
technique to modulate the particle or energy fluence to create a highly
conformal dose distribution. This beam modulated treatment delivery can be
accomplished either by the use of the computer controlled multi-leaf collimator
or high resolution milled or cast compensators.
(i) "Intermediate treatment visit" means a
treatment visit involving two separate treatment sites, three or more fields to
a single treatment site, or the use of special blocking.
(j) "Megavoltage radiation therapy" or "MRT"
means a clinical modality in which patients with cancer, other neoplasms, or
cerebrovascular system abnormalities are treated with radiation which is
delivered by an MRT unit.
(k) "MRT
service" means the CON approved MRT utilization of a MRT unit(s) at one
geographic location.
(l) "MRT unit"
or "unit" means a CON approved linear accelerator; cobalt unit; or other piece
of medical equipment operating at an energy level equal to or greater than 1.0
million electron volts (megavolts or MeV) for the purpose of delivering doses
of radiation to patients with cancer, other neoplasms, or cerebrovascular
system abnormalities.
(m)
"Non-special MRT unit" or "non-special unit" means an MRT unit other than an
MRT unit meeting the definition of a special purpose MRT unit.
(n) "Operating room based intraoperative MRT
unit" or "OR-based IORT unit" means an MRT unit that is designed to emit only
electrons, is located in an operating room in the surgical department of a
licensed hospital and is available for the treatment of a patient undergoing a
surgical procedure with megavoltage radiation.
(o) "Simple treatment visit" means a
treatment visit involving a single treatment site, single treatment field, or
parallel opposed fields with the use of no more than simple blocks.
(p) "Simulation" is the process of defining
relevant normal and abnormal anatomy, acquiring the images and data necessary
to develop the patient's approved radiation treatment plan. Simulation always
occurs prior to treatment and may be repeated multiple times during the course
of treatment depending on the type of cancer, the radiation therapy technique
utilized and the patient's clinical response to treatment. Simulation is used
to direct the treatment beams to the specific volume.
(q) "Special purpose MRT unit" or "special
purpose unit" or "special unit" means any of the following types of MRT units:
(i) heavy particle accelerator;
(ii) gamma knife;
(iii) dedicated linear accelerator
stereotactic radiosurgery unit (SRS LINAC), including CyberKnife; or
(iv) an OR-based IORT unit.
(r) "Stereotactic body radiation
therapy (SBRT)" is a term used to describe extracranial stereotactic
radiosurgery (SRS) or radiotherapy (SRT). SBRT is a radiotherapy treatment
method to deliver a high dose of radiation to the target, utilizing either a
single dose or a small number of fractions with a high degree of precision
within the body.
(s) "Stereotactic
treatment visit" or "SRS treatment visit" means a visit involving SRS or SBRT
treatment techniques.
(t)
"Stereotactic Radiosurgery (SRS)" is performed in a limited number of treatment
visits (up to a maximum of five), using a rigidly attached stereotactic guiding
device, other immobilization technology and/or a stereotactic image-guidance
system to treat lesions in the body (extracranial) or brain (intracranial).
Technologies that are used to perform SRS include linear accelerators, particle
beam accelerators and multi source Cobalt-60 units.
(u) "SRS LINAC" is a dedicated linear
accelerator stereotactic radiosurgery unit that consists of three key
components:
(i) an advanced linear
accelerator (linac) (this device is used to produce a high energy megavoltage
of radiation),
(ii) a device which
can point the linear accelerator from a wide variety of angles, and
(iii) image-guidance patient positioning
system using kilovoltage x-rays for either in-room diagnostic x-rays or
tomographic images. The devices obtain pictures of the patient (planar x-ray or
computed tomography) before or during treatment and use this information to
target the radiation beam emitted by the linear accelerator, SRS LINAC includes
units such as CyberKnives.
(v) "Treatment site" means the anatomical
location of the MRT treatment.
(w)
"Treatment visit" means one patient encounter during which MRT is administered.
One treatment visit may involve one or more treatment ports or fields. Each
separate encounter by the same patient at different times of the same day shall
be counted as a separate treatment visit.
(x) "Unit" means a single machine used for
MRT services.
(y) "Urban County"
means a county with a projected population for the horizon year of 100,000 or
more and a population density for that year of 200 or more people per square
mile. All other counties are "rural."
(3)
Standards for Non-Special
MRT.
(a) The need for the addition of
a non-special MRT unit shall be determined through the application of a
Numerical Need method and an assessment of the aggregate utilization rate of
existing services not including units added through the exception in section
(3)(b)(2) of this Rule.
1. The numerical need
for the addition of a non-special MRT unit in a planning area shall be
determined through the application of a demand-based forecasting model. The
model is outlined in the steps listed below, and all data elements relate to
each planning area:
(i) Calculate the
projected incidence of cancer excluding basal, epithelial, papillary, and
squamous cell carcinomas of the skin from other than a genital area for each
county by multiplying the most recent Cancer Incidence Rate, as published by
the State Cancer Registry, for each county by the horizon year population for
the county;
(ii) Multiply the
projected incidence of cancer by fifty percent (50%) to determine the number of
projected cancer cases in each county that could be treated with a non-special
MRT unit;
(iii) Add the number of
treatable cases for each county within a Health Planning Area to determine the
projected number of patients needing treatment with a non-special MRT unit
within the Health Planning Area in the horizon year;
(iv) Multiply the number obtained in step
(iii) above by the most recent two year average of treatment visits per patient
for the respective planning area of each county to project the number of
projected patient visits in the horizon year;
(v) Determine the percentage of total visits
in each planning area attributable to (1) Simple treatment visits, (2)
Intermediate treatment visits, (3) Complex treatment visits, (4) IMRT, and (5)
SRS treatment visits performed on non-special equipment as based on a running
average of the most recent two annual surveys for facilities located in each
respective planning area. Prior to the 2008 survey year, the percentage of
total visits in each planning area shall be based on the most recent annual
survey for facilities located in each respective planning area;
(vi) Determine the number of projected
equivalent visits in the horizon year for each planning area as follows:
A. Project the number of equivalent simple
visits by multiplying the percentage obtained in step (v) for simple visits by
the projected patient visits in the horizon year obtained in step
(iv);
B. Project the number of
equivalent intermediate visits by multiplying the percentage obtained in step
(v) for intermediate visits by the projected patient visits in the horizon year
obtained in step (iv) and multiply the product by the weighted equivalent for
intermediate visits, 1.1;
C.
Project the number of equivalent complex visits by multiplying the percentage
obtained in step (v) for complex visits by the projected patient visits in the
horizon year obtained in step (iv) and multiply the product by the weighted
equivalent for complex visits, 1.3;
D. Project the number of equivalent IMRT
visits by multiplying the percentage obtained in step (v) for IMRT visits by
the projected patient visits in the horizon year obtained in step (iv) and
multiply the product by the weighted equivalent for IMRT visits, 1.8;
E. Project the number of equivalent SRS
visits by multiplying the percentage obtained in step (v) for SRS visits by the
projected patient visits in the horizon year obtained in step (iv) and multiply
the product by the weighted equivalent for SRS visits, 7.0; and
F. Sum the products obtained in step (vi)A.
through step (vi)E.;
(vii) Calculate the number of needed
non-special MRT units by dividing the number of projected equivalent visits
obtained in step (iv)F. by 9,000, which represents the weighted equivalent
capacity of a non-special MRT unit within a given year; and
(viii) Determine the net numerical unmet need
for non-special MRT units by subtracting the total number of non-special MRT
units currently existing or approved for use, not including units approved
pursuant to the exception in section (3)(b)2. of this Rule, from the number of
needed non-special MRT units obtained in step (vii).
2. Prior to approval of an additional
non-special MRT unit in a planning area, the aggregate utilization rate for all
existing non-special MRT units, not including units approved pursuant to the
exception in section (3)(b)2. of this Rule, in that planning area shall equal
or exceed eighty percent (80%) of capacity based on 9,000 weighted equivalent
visits. For those existing non-special MRT units that have not reported data in
the most recent survey year, the Department shall include the non-reporting
unit at the statewide average utilization rate.
(b) Exceptions to the need standard
referenced in (3)(a) may be granted for applicants proposing any of the
following:
1. To assure geographic access to
non-special MRT services in rural areas when the proposed service is:
(i) to be located in a rural
county;
(ii) to be located a
minimum of 45 miles away from any existing or approved non-special MRT service;
and
(iii) projected to serve a
minimum of 150 patients per year. For purposes of this requirement, service
projections must be submitted by the applicant using, at a minimum, state
cancer registry data and documented cancer treatments within the service
area.
2. To allow
expansion of an existing service if the actual utilization of each radiation
therapy unit within that service has exceeded ninety percent (90%) of optimal
utilization over the most recent two years. Any such units approved pursuant to
this exception shall not be included in the calculation of need and aggregate
utilization for the applicable service delivery region but will be included in
the Department non-special MRT unit inventory.
3. To allow the addition of a non-special MRT
unit at the same defined location if the applicant has a substantial
out-of-state patient base. 'Substantial out of state patient base' shall be
defined as using at least thirty-three percent (33%) of capacity or 2,970
weighted equivalent visits at the applicant's own percentage of treatment
visits weighted by treatment type using the statewide weighted equivalent
factor for each non-special MRT unit over the most recent two years to treat
patients who reside outside of the State of Georgia.
4. To remedy an atypical barrier to
non-special MRT services based on cost, quality, financial access and
geographic accessibility.
(c) An applicant for a new or expanded
non-special MRT service shall document the impact on existing and approved
services which already provide non-special MRT to the residents of the planning
area with the goal of minimizing adverse impact on existing and approved
services of the same type in its planning area. An applicant for a new or
expanded non-special MRT service shall have an adverse impact on existing and
approved programs if it will:
1. decrease
annual utilization of an existing service, whose current utilization is at or
above eighty percent (80%), to a projected utilization of less than seventy
percent (70%) within the first twenty-four (24) months of the initial operation
of the service or additional non-special MRT unit; or
2. decrease annual utilization of an existing
service, whose current utilization is below eighty percent (80%), by ten
percent (10%) or more within the first twenty-four (24) months of the initial
operation of the service or additional non-special MRT unit.
An applicant shall provide evidence of projected impact by taking into account existing planning area market share of existing non-special MRT services and future population growth or by providing sufficient evidence that the current population is underserved by the existing non-special MRT services, if any, within the planning area. An applicant proposing an additional non-special MRT unit pursuant to the exceptions to need standards referenced in (3)(b)2. shall not be required to document impact on existing and approved services as required by this paragraph.
(d) An applicant for a new or expanded
non-special MRT service shall foster an environment that assures access to
individuals unable to pay, regardless of payment source or circumstances, by
the following:
1. providing evidence of
written administrative policies that prohibit the exclusion of services to any
patient on the basis of age, race, or ability to pay;
2. providing a written commitment that
services for indigent and charity patients will be offered at a standard which
meets or exceeds three percent (3%) of annual, adjusted gross revenues for the
non-special MRT service;
3.
providing a written commitment to participate in the Medicaid and Peach Care
programs;
4. providing a written
commitment to participate in any other state health benefits insurance programs
for which the radiation therapy service is eligible; and
5. providing documentation of the past record
of performance of the applicant, and any facility in Georgia owned or operated
by the applicant's parent organization, of providing services to Medicare,
Medicaid, and indigent and charity patients.
(e) An applicant for a new or expanded
non-special MRT service shall provide evidence of a cancer treatment program,
which shall include the provision of the following, either on-site or through
written agreements with other providers:
1.
Access to simulation capabilities, which may include a dedicated simulator, a
radiation therapy treatment unit, a virtual-reality based three-dimensional
simulation system, or other diagnostic X-ray, magnetic resonance, ultrasound,
or nuclear medicine equipment that has been modified to localize volumes to
define the area requiring treatment; and which must be at the defined location
of the non-special MRT service;
2.
Access to a computer-based treatment planning system, which shall be a computer
system capable of interfacing with diagnostic patient data acquisition systems
such as CT, MRI, PET-CT to obtain the patient specific anatomical data. The
planning system must be able to display radiation doses and 3-D dose
distributions within a patient's anatomical contour and utilize measured or
modeled radiation output data from the specific unit used to treat the patient.
The minimum software requirements for the treatment planning system are an
external beam program, an irregular field routine, and a Brachytherapy
package;
3. Non-Special MRT
capability including electron beam capability;
4. Capability to fabricate treatment aids;
and
5. Access to
brachytherapy;
(f) The
applicant must provide a written commitment that physicians providing
professional radiation oncology services at the MRT facility shall at all times
have privileges or be eligible for and have an active pending application for
privileges and be members in good standing of the medical staff, or are
eligible for and have an active pending application for privileges, of a
hospital with a comprehensive cancer treatment program located within the
applicant's service area which will provide those physicians with access to
participate in all of the following:
1.
Consultative services from all major disciplines needed to develop a
comprehensive treatment plan.
2. A
multi-disciplinary cancer committee, which shall be a standing committee that:
(i) includes representatives from the medical
specialties or sub-specialties which refer patients to the MRT service;
representatives from the specialties of diagnostic radiology, radiation
oncology, and pathology; representatives from those who oversee the tumor
registry; and representatives from administration, nursing, social services,
pharmacy, and rehabilitation;
(ii)
meets at least on a quarterly basis; and
(iii) is responsible for the following:
A. establishing educational and problem
oriented multi-disciplinary, facility-wide cancer conferences that include the
major anatomic locations of cancer seen at the facility;
B. monitoring, evaluating, and reporting to
the medical staff and governing body on the quality of care provided to
patients with cancer; and
C.
oversight of the applicant's tumor registry for quality control, staging, and
abstracting;
3.
Patient care evaluation studies, which shall be a system of patient care
evaluation, conducted annually, that documents the methods used to identify
problems and the opportunities to improve patient care. Examples of patient
care evaluation studies include nationwide patient evaluation studies; facility
quality assurance activities; and ongoing monitoring, evaluating, and action
planning; and
4. Cancer prevention
and education programs.
(g) The applicant must participate and report
to the Georgia Comprehensive Cancer Registry of the Georgia Department of
Public Health.
(h) An applicant
shall demonstrate that the following staff, at a minimum, will be identified
and available:
1. One (1) FTE board-certified
or board-qualified physician trained in radiation oncology, which shall be
available by continuous means of direct communication with the non-special MRT
unit in person or by radio, telephone, or telecommunication;
2. One (1) medical radiation physicist, who
shall be an individual who is board-certified or board-qualified by the
American Board of Radiology in therapeutic radiological physics; or
board-certified by the American Board of Medical Physics in medical physics
with a special competence in radiation oncology physics; and who shall be
available by means of direct communication with the non-special MRT unit in
person or by radio, telephone, or telecommunication;
3. One (1) medical dosimetrist, who shall be
a member of the radiation oncology team who has the knowledge of the overall
characteristics and clinical relevance of radiation oncology treatment machines
and equipment, is cognizant of procedures commonly used in brachytherapy and
has the education and expertise necessary to generate radiation dose
distributions and dose calculations in collaboration with the medical physicist
and radiation oncologists; and who shall be available by means of direct
communication with the non-special MRT unit in person or by radio, telephone,
or telecommunication;
4. Two (2)
radiation therapy technologists, who shall be registered or eligible by the
American Registry of Radiological Technologists (ARRT) or the American Registry
of Clinical Radiography Technologists (ARCRT); and who shall be on-site at all
times of operation of the facility; and
5. One (1) program director, who shall be a
board-certified physician trained in radiation oncology who may also be the
physician required under (h)1.; and who shall be available by means of direct
communication with the non-special MRT unit in person or by radio, telephone,
or telecommunication;
(i)
An applicant for a new or expanded non-special MRT service shall agree to
provide the Department with all requested information and statistical data
related to the operation and provision of services and to report that data to
the Department in the time frame and format requested by the
Department.
(4)
Standards for Special Purpose MRT.
(a) The need for the addition of a special
purpose MRT unit shall be determined through analysis of the capacity and
utilization of the existing units of the same type in the planning area and an
applicant's reasonable and documented projection of a minimum volume as
follows:
|
Special MRT Equipment |
Capacity |
Minimum Aggregate Utilization |
Minimum Projected Volume |
|
Gamma Knife |
500 |
80% |
300 by 3rd Year of Operation |
|
Heavy Particle Accelerator |
4,000 per Gantry |
80% |
2,400 per Gantry by 3ed Year of Operation |
|
Dedicated SRS LINAC (including CyberKnife) |
850 |
80% |
510 by 3rd Year of Operation |
|
OR-based IORT |
350 |
80% |
150 by 3rd Year of Operation |
Where capacity is measured in annual procedures; where minimum aggregate utilization is the aggregate utilization rate for all existing special purpose MRT units of the same type (Gamma Knife utilization for Gamma Knife, etc.) in the planning area, except that for those existing special purpose MRT units that have not reported data in the most recent survey year, the Department shall include the non-reporting unit at the statewide average utilization rate for special purpose equipment of the same type; and where the minimum projected volume is measured in procedures per year.
(b) Exceptions to the need
standards referenced in (3)(a) may be granted for applicants proposing to
remedy an atypical barrier to special purpose MRT services based on cost,
quality, financial access and geographic accessibility.
(c) An applicant for a new or expanded
special purpose MRT service shall document the impact on existing and approved
services of the same type (Gamma Knife for Gamma Knife application, etc.) which
already provide special purpose MRT to the residents of the planning area with
the goal of minimizing adverse impact on existing and approved services of the
same type in its planning area. An applicant for a new or expanded special
purpose MRT service shall have an adverse impact on existing and approved
programs if it will:
1. decrease annual
utilization of an existing service of the same type, whose current utilization
is at or above seventy percent (70%), to a projected utilization of less than
sixty percent (60%) within the first twenty-four (24) months of the initial
operation of the service or additional special purpose MRT unit; or
2. decrease annual utilization of an existing
service of the same type, whose current utilization is below seventy percent
(70%), by ten percent 10% or more within the first twenty-four (24) months of
the initial operation of the service or additional special purpose MRT unit.
An applicant shall provide evidence of projected impact by taking into account existing planning area market share of existing special purpose MRT services and future population growth or by providing sufficient evidence that the current population is underserved by the existing special purpose MRT services, if any, within the planning area.
(d) An applicant for a new or
expanded special purpose MRT service shall foster an environment that assures
access to individuals unable to pay, regardless of payment source or
circumstances, by the following:
1. providing
evidence of written administrative policies that prohibit the exclusion of
services to any patient on the basis of age, race, or ability to pay;
2. providing a written commitment that
services for indigent and charity patients will be offered at a standard which
meets or exceeds three percent (3%) of annual, adjusted gross revenues for the
special purpose MRT service;
3.
providing a written commitment to participate in the Medicaid and PeachCare for
Kids® programs;
4. providing a
written commitment to participate in any other state health benefits insurance
programs for which the radiation therapy service is eligible; and
5. providing documentation of the past record
of performance of the applicant, and any facility in Georgia owned or operated
by the applicant's parent organization, of providing services to Medicare,
Medicaid, and indigent and charity patients.
(e) An applicant for a new or expanded
special purpose MRT service shall provide evidence of a cancer treatment
program, which shall include the provision of the following, either on-site or
through written agreements with other providers:
1. Access to simulation capabilities, which
may include a dedicated simulator, a radiation therapy treatment unit, a
virtual-reality based three-dimensional simulation system, or other diagnostic
X-ray, magnetic resonance, ultrasound, or nuclear medicine equipment that has
been modified to localize volumes to define the area requiring treatment; and
which must be at the defined location of the special purpose MRT
service;
2. Access to a
computer-based treatment planning system, which shall be a computer system
capable of interfacing with diagnostic patient data acquisition systems such as
CT, MRI, PET-CT to obtain the patient specific anatomical data. The planning
system must be able to display radiation doses and 3-D dose distributions
within a patient's anatomical contour and utilize measured or modeled radiation
output data from the specific unit used to treat the patient; and
3. Capability to fabricate treatment aids as
applicable.
(f) The
applicant must provide written commitment that physicians providing
professional radiation oncology services at the special purpose MRT facility
shall at all times have privileges or be eligible for and have an active
pending application for privileges and be members in good standing of the
medical staff of a hospital with a comprehensive cancer treatment program
located within the applicant's service area which will provide those physicians
with access to participate in all of the following:
1. Consultative services from all major
disciplines needed to develop a comprehensive treatment plan.
2. A multi-disciplinary cancer committee,
which shall be a standing committee that:
(i)
includes representatives from the medical specialties or sub-specialties which
refer patients to the MRT service; representatives from the specialties of
diagnostic radiology, radiation oncology, and pathology; representatives from
those who oversee the tumor registry; and representatives from administration,
nursing, social services, pharmacy, and rehabilitation;
(ii) meets at least on a quarterly basis;
and
(iii) is responsible for the
following:
A. establishing educational and
problem oriented multi-disciplinary, facility-wide cancer conferences that
include the major anatomic locations of cancer seen at the facility;
B. monitoring, evaluating, and reporting to
the medical staff and governing body on the quality of care provided to
patients with cancer; and
C.
oversight of the applicant's tumor registry for quality control, staging, and
abstracting;
3.
Patient care evaluation studies, which shall be a system of patient care
evaluation, conducted annually, that documents the methods used to identify
problems and the opportunities to improve patient care. Examples of patient
care evaluation studies include nationwide patient care evaluation studies;
facility quality assurance activities; and ongoing monitoring, evaluating, and
action planning; and
4. Cancer
prevention and education programs.
(g) The applicant must participate and report
to the Georgia Comprehensive Cancer Registry of the Georgia Department of
Public Health.
(h) An applicant
shall demonstrate that the following staff, at a minimum, will be identified
and available;
1. For applicants seeking the
addition of a Gamma Knife:
(i) One (1) FTE
board-certified or board-qualified physician trained in radiation oncology, who
shall have received special training in operating a Gamma Knife and who shall
be available on-site; and
(ii) One
(1) medical radiation physicist, who shall be an individual who is
board-certified or board-qualified by the American Board of Radiology in
therapeutic radiological physics; or board-certified by the American Board of
Medical Physics in medical physics with special competence in radiation
oncology physics; who shall have received special training in operating a Gamma
Knife; and who shall be available on-site;
2. For applicants seeking the addition of a
Heavy Particle Accelerator, Two (2) radiation therapy technologists, who shall
be registered or eligible by the American Registry of Radiological
Technologists ("ARRT") or the American Registry of Clinical Radiography
Technologists ("ARCRT"); who shall have received special training in operating
a Heavy Particle Accelerator and who shall be on-site at all times of operation
of the facility;
3. For applicants
seeking the addition of a dedicated SRS LINAC:
(i) One (1) FTE board-certified or
board-qualified physician trained in radiation oncology, who shall have
received special training in operating an SRS LINAC and who shall be available
on-site; and
(ii) One (1) medical
radiation physicist, who shall be an individual who is board-certified or
board-qualified by the American Board of Radiology in therapeutic radiological
physics; or board-certified by the American Board of Medical Physics in medical
physics with special competence in radiation oncology physics; who shall have
received special training in operating an SRS LINAC; and who shall be available
on-site;
(iii) One (1) radiation
therapy technologist, who shall be registered or eligible by the American
Registry of Radiological Technologists or the American Registry of Clinical
Radiography Technologists; who shall have received special training in
operating an SRS LINAC; and who shall be on-site at all times of operation of
the facility; and
4. For
applicants seeking the addition of an OR-Based IORT unit:
(i) One (1) FTE board-certified or
board-qualified physician trained in radiation oncology; who shall have
received special training in operating an OR-Based IORT unit; and who shall be
available on-site; and
(ii) One (1)
medical radiation physicist, who shall be an individual who is board-certified
or board-qualified by the American Board of Radiology in therapeutic
radiological physics; or board-certified by the American Board of Medical
Physics in medical physics with special competence in radiation oncology
physics; who shall have received special training in operating an OR-Based IORT
unit; and who shall be available on-site.
(i) An applicant for a new or expanded
special purpose MRT service shall agree to provide the Department with all
requested information and statistical data related to the operation and
provision of services and to report that data to the Department in the time
frame and format requested by the Department.
Notes
State regulations are updated quarterly; we currently have two versions available. Below is a comparison between our most recent version and the prior quarterly release. More comparison features will be added as we have more versions to compare.
No prior version found.