Current through Register Vol. 47, No. 6, September 18, 2024
(1)
Purpose
and scope.
a. These standards
provide guidelines to assist the council in applying those criteria in Iowa
Code sections 10A.714(1)
"a" through "r" and 10A.714(3). Criteria that
are measured by a standard are cited in parentheses following each
standard.
b. Certificate of need
applications that are to be evaluated against these radiation therapy standards
include:
(1) Proposals to commence or expand
the kind or capacity of megavoltage radiation therapy services.
(2) Proposals to replace a megavoltage
radiation therapy unit.
(3) Any
other applications that relate to megavoltage radiation therapy.
(2)
Definitions.
"Conjoint radiation oncology center" or
"cancer center" means a multi-institution, multidisciplinary
network to provide radiation therapy for cancer patients. Integration of
patient care management, common utilization of personnel and equipment, and a
single system of records between center institutions ensures optimal care
regardless of entry portal.
"Dosimetrist" means a staff member who
calculates, verifies, and develops treatment plans for the radiation dose
distributions that will be delivered to patients. The dosimetrist is an
essential member of the treatment planning team and works closely with
radiation oncologists and radiation physicists.
"Megavoltage therapy" means the use of
ionizing radiation in excess of one million electron volts. Energies above one
million electron volts cause considerably less skin damage, increase depth dose
markedly, and result in much less scatter from the therapeutic beam.
Megavoltage machines are classified as follows:
1. Electron accelerator. A machine such as a
linear accelerator that uses a supply of electrons, which are accelerated into
high energy beams. These electron beams are either caused to strike a target
resulting in high energy X-ray production or are used themselves as the
treatment beam. Electron accelerators generate over one million electron
volts.
2. Heavy particle
accelerator. A machine such as a cyclotron that produces beams of high energy
particles such as protons, neutrons, pions, carbon ions, or other heavy ions
with masses greater than that of an electron.
3. Isotope sources (gamma ray teletherapy
units).
Cobalt 60 units-emit gamma rays of approximately 1.2 million
electron volts.
"Megavoltage therapy unit" means a piece of
megavoltage therapeutic radiologic equipment that provides megavoltage
therapy.
"New occurrence" means a course of treatment
for a new occurrence on a given patient at a given radiation therapy facility.
First-time radiation therapy at a new facility is based on each round of
treatment.
"Radiation modality" means the method of
applying ionizing radiation in the treatment of patients with malignant disease
using megavoltage external beam equipment.
"Radiation oncologist" means a physician
authorized user trained in accordance with 641-subrule 41.3(5).
"Radiation therapy facility" or
"facility" means the physical space that houses a megavoltage
therapy unit and accompanying support equipment.
"Radiation therapy physicist" means an
individual who works closely with radiation oncologists and is responsible for
the safe and accurate delivery of radiation to patients. A radiation therapy
physicist conducts quality control programs for the equipment and procedures,
as well as calibrating the equipment. A radiation therapy physicist shall
practice in accordance with 641-subrule 41.3(6).
"Radiation therapy technologist" means an
individual who possesses an Iowa permit to practice as a radiation therapist in
accordance with rule 641-42.7 (136C).
"Service area" means the county in which the
facility is located and any other counties from which the applicant expects to
draw patients with a cancer diagnosis who need radiation therapy
treatment.
"Simulation" means the precise mock-up of a
patient treatment with an apparatus that uses planar X-rays, magnetic resonance
imaging device, or computed tomography scanner, which is used in reproducing
the two-dimensional or three-dimensional internal or external geometry to the
patient, for use in treatment planning and delivery.
"Superficial X-ray therapy" means the use of a
conventional X-ray machine, which generates X-rays of up to 150 kilovolts (150
kv), to treat superficial lesions, such as skin cancer.
"Treatment" means radiation fields applied in
a single patient visit fraction or delivery session.
(3)
Availability.
a.
Minimum utilization.
(Iowa Code section 10A.714(1)
"c," "g," "h")
(1) A
megavoltage radiation therapy unit and cobalt units should treat at least 250
new occurrences annually within three years after initiation of the
service.
(2) The expected number of
new occurrences needing megavoltage radiation therapy annually in a service
area should be calculated as follows:
1.
Multiply the service area population times 0.00582 (5.82/1,000 population was
the mean cancer incidence rate in 2017 in Iowa as filed by the Surveillance,
Epidemiology, and End Results (SEER) Program).
2. Multiply this product times .5 (50 percent
of all new occurrences receive radiation therapy).
(3) The expected volume of utilization
sufficient to support the need for a new megavoltage therapy unit should be
calculated as follows: each unit shall provide a minimum of 5,000 treatments
per annum. Megavoltage treatments should be projected by multiplying the number
of projected new occurrences needing megavoltage therapy times 20, which will
result in no fewer than 5,000 treatments per annum.
(4) Applicants shall account for other
providers of radiation therapy in the service area including, but not limited
to, factors such as technological capability and quality. Applicants shall
address in their application other providers and the impact on those providers
in the service area and compare technological capability and quality.
(5) Applicants should provide a map of the
expected service area.
(6)
Institutions that form a conjoint oncology center should have at least 500 new
occurrences annually.
b.
Simulator availability. A simulator should be available within
a radiation oncology department.
(4)
Accessibility. (Iowa
Code section 10A.714(1)
"c," "d") Radiation therapy services should be provided
regardless of ability to pay, in consideration of those programs available in
the state that serve the medically indigent.
(5)
Quality. (Iowa Code
section 10A.714(1)
"i," "k")
a. Minimum
staffing requirements for radiation therapy facilities:
(1) Each facility will have the services of
at least one radiation oncologist.
(2) Each facility will have the services of
at least one radiation therapy physicist.
(3) Each facility will have the services of
radiation therapy technologists that should be staffed at a level of two
technologists per megavoltage unit.
(4) Each facility should have the services of
nurses.
(5) Each facility should
have the services of at least one dosimetrist.
(6) Each facility should have the services of
one radiation therapist or radiation technologist competent to operate a CT
simulator.
b. Each
conjoint center will have at least two cancer biologists available.
c. Each conjoint center will have one
radiation technologist available for each simulator.
d. The long-range plans for radiation therapy
services shall be submitted to the Iowa department of health and human
services.
e. Multidisciplinary
tumor boards should be established in all institutions housing megavoltage
machines.
f. A source of continuing
education should exist within each conjoint center to reach participating
community referral hospitals and physicians.
g. Each conjoint center should have a unified
training program in radiation therapy for radiation oncologists.
h. Each radiation therapy facility should
offer psychosocial counseling services and nutritional counseling.
(6)
Continuity.
(Iowa Code section 10A.714(1)
"g," "h," "i," "k") The applicant should demonstrate that an
attempt was made to solicit letters and establish referral agreements from area
hospitals and physicians to indicate their willingness to participate in a
cooperative endeavor to refer to the proposed service.
