Current through all regulations passed and filed through March 18, 2024
(A) The handler shall be responsible for
directing the operation of the therapy equipmentto ensure that the
requirements of Chapter 3701:1-67 of the Administrative Code are met
.
(B)
The handler
shall not use therapy equipment that does not meet the provisions of
Chapter 3701:1-67 of the
Administrative Code to irradiate
patients.
(C) For any therapy
equipment subject to Chapter 3701:1-67 of the Administrative Code, the handler
shall require the physician or veterinarian who authorizes use of the therapy
equipment to be:
(1) Certified in one of the
following:
(a) Radiation oncology or
therapeutic radiology by the "American Board of Radiology" or combined
diagnostic and therapeutic radiology program by the "American Board of
Radiology" prior to 1976; or
(b)
Radiation oncology by the "American Osteopathic Board of Radiology";
or
(c) Radiology, with
specialization in radiotherapy, as a British "Fellow of the Faculty of
Radiology" or "Fellow of the Royal College of Radiology"; or
(d) Therapeutic radiology by the "Canadian
Royal College of Physicians and Surgeons"; or
(e) Radiation oncology by the "American
College of Veterinary Radiology"; or
(2) In active practice of therapeutic
radiology, and has completed two hundred hours of instruction in basic
radiation techniques applicable to the use of an external beam radiation
therapy unit, five hundred hours of supervised work experience, and supervised
clinical experience.
(a) To satisfy the
requirement for instruction, the classroom and laboratory training shall
include:
(i) Radiation physics and
instrumentation;
(ii) Radiation
protection;
(iii) Mathematics
pertaining to the use and measurement of ionization radiation; and
(iv) Radiation biology.
(b) To satisfy the requirement for supervised
work experience, training shall be under the supervision of a board certified
authorized user who meets the qualifications of paragraph (C)(1) of this rule,
and shall include:
(i) Review of the
calibration measurements and quality assurance performance testing;
(ii) Evaluation of prepared treatment plans
and calculation of treatment times/patient treatment settings;
(iii) Using administrative controls to
prevent medical events;
(iv) Implementing emergency procedures to be
followed in the event of the abnormal operation of an external beam radiation
therapy unit or console; and
(v)
Checking and using radiation survey meters.
(c) To satisfy the requirement for a period
of supervised clinical experience, training shall include one year in a formal
training program and an additional two years of clinical experience in
therapeutic radiology under the supervision of an authorized user.
(i) The one year in a formal training program
must be approved by either:
(a) The "Residency
Review Committee" for "Radiology of the Accreditation Council for Graduate
Medical Education"; or
(b) The
"Committee on Postdoctoral Training" of the "American Osteopathic
Association."
(ii) The
additional two years of clinical experience in therapeutic radiology under the
supervision of an authorized user shall include:
(a) Examining patients and reviewing their
case histories to determine their suitability for external beam radiation
therapy treatment, and any limitations or contraindications;
(b) Selecting proper dose and how it is to be
administered;
(c) Calculating the
therapy equipment doses and collaborating with the authorized user in the
review of patients' progress and consideration of the need to modify originally
prescribed doses and treatment plans as warranted by patients' reaction to
radiation; and
(d)
Post-administration follow-up and review of case histories.
(d) For veterinary
radiation oncology, completion of a formal training program approved by the
"Executive Council" of the "American College of Veterinary Radiology" shall
satisfy the requirement for supervised clinical experience.
(D) For any therapy equipment
subject to Chapter 3701:1-67 of the Administrative Code, the handler shall
require the qualified medical physicist to:
(1) Be certified by the "American Board of
Radiology" in one of the following:
(a)
Therapeutic radiological physics;
(b) Roentgen-ray and gamma-ray
physics;
(c) X-ray and radium
physics;
(d) Radiological physics;
or
(2) Be certified by
the "American Board of Medical Physics in Radiation Oncology Physics";
or
(3) Be certified by the
"Canadian College of Medical Physics"; or
(4) Meet all of the following:
(a) Hold a master's or doctor's degree in
physics, medical physics, other physical science, engineering, or applied
mathematics from an accredited college or university;
(b) Have completed one year of full time
training in medical physics and an additional year of full time work experience
under the supervision of a board certified medical physicist who meets the
qualifications of paragraph (D)(1), (D)(2) or (D)(3) of this rule at a medical
institution;
(i) This training and work
experience shall be conducted in clinical radiation facilities that provide
high-energy external beam radiation therapy with photons and electrons with
energies greater than or equal to one MV or one MeV; and
(ii) The individual shall have performed the
tasks listed in rules
3701:1-67-08
and
3701:1-67-09
of the Administrative Code under the supervision of a qualified medical
physicist during the year of work experience; and
(c) Obtain certification pursuant to
paragraph (D)(1), (D)(2), or (D)(3) of this rule within five years of
qualifying under paragraph (D)(4) of this rule.
(E)
For any
therapy equipment subject to Chapter 3701:1-67 of the Administrative Code, the
handler shall require:
(1)
Every individual who performs radiation therapy
procedures on human beings holds a valid radiation therapist license as
required by Chapter 3701-72 of the Administrative Code;
(2)
Every individual
who performs radiation therapy procedures is adequately instructed in the
handler's safe operating procedures and can demonstrate competency in the safe
use of the equipment; and
(3)
The names and training of all personnel currently
operating the therapy equipment shall be kept on file at the facility. The
names and training of former operators shall be retained for a period of at
least three years beyond the last date they were authorized to operate the
therapy equipment at that facility.
(F)
The handler's
written safe operating procedures shall be developed by a qualified
medical physicist to include any operation restrictions
for the therapy equipment.
The written safe operating procedures shall be
available in the control area of the therapy equipment,
in hard copy or electronic format, and the operator
shall be able to demonstrate familiarity with these procedures. The written safe
operating procedures shall address at least the following
:
(1) The therapy equipment shall not be used
for irradiation of patients unless the applicable requirements of rule
3701:1-67-09
of the Administrative Code have been met;
(2) Therapy equipment shall not be left
unattended unless secured to prevent unauthorized use;
(3) When a patient must be held in position
for radiation therapy, mechanical supporting or restraining devices shall be
used;
(4) When only adjustable beam
limiting devices are used for patient positioning purposes, the position and
shape of the radiation field shall be indicated by a light field. The therapy
equipment shall not be used for irradiation of patients unless the light field
is operational;
(5) The therapy
equipment shall not be used for patient irradiation unless at least one viewing
system is operational;
(6) The
therapy equipment shall not be used for irradiation of patients unless
continuous two-way aural communication is possible;
(7) The equipment shall only be operated as
designed by the manufacturer;
(8)
No individual other than the patient shall be in the treatment room during
treatment or during any irradiation for testing or calibration purposes from
therapy equipment operating above one hundred fifty kV. At energies less than
or equal to one hundred fifty kV, any individual, other than the patient, in
the treatment room shall be protected by a barrier sufficient to meet the
requirements of rule
3701:1-38-12
of the Administrative Code; and
(9)
For equipment operating at less than one megavolt (MV), the tube housing
assembly shall not be held by an individual during operation unless the
assembly is designed to require such holding and the peak tube potential of the
system does not exceed fifty kV. In such cases, the holder shall wear
protective gloves and an apron of not less than 0.5 millimeters lead
equivalency at one hundred kV.
(10)
How to contact the qualified medical physicist for
problems or emergencies, as well as the specific actions, if any, to be taken
until the qualified medical physicist can be contacted.
(G)
An
individual shall not expose another individual to the useful beam
unless ordered
by a licensed practitioner acting within
his or her scope-of-practice for dental, medical or radiation therapy
purposes. Exposing
an individual for training, demonstration or other purposes is
prohibited unless otherwise specified in rules promulgated under Chapter 4773.
or 3748. of the Revised Code.
(H) All individuals
associated with the operation of therapy equipment shall be instructed in and
shall comply with the provisions of the handler's quality management program.
In addition to the requirements in Chapter 3701:1-67 of the Administrative
Code, these individuals are also subject to the applicable requirements in
Chapter 3701:1-38 and rule
3701:1-66-04
of the Administrative Code.
(I)
The handler shall assure the individual responsible for
radiation protection (IRRP) is qualified as one of the following:
(1)
Ohio licensed to
operate radiation-generating equipment excluding general x-ray machine
operators;
(2)
Registered veterinary technician and trained to operate
veterinary radiationgenerating equipment;
(3)
Certified by the
American registry of radiologic technologists in a pathway involving ionizing
radiation or certified by the nuclear medicine technologist certification
board;
(4)
A radiation expert as defined in rule
3701:1-66-01 of the
Administrative Code;
(5)
A health physicist certified by the American board of
health physics; or
(6)
An associate's degree or higher in health physics,
radiologic science, nuclear medicine or nuclear engineering.
(J) The handler shall maintain the
following information in a separate file or package for each piece of therapy
equipment, for inspection by the department:
(1) Report of acceptance testing;
(2) Records of all surveys, calibrations, and
quality assurance performance testing of the therapeutic radiation machine
required by Chapter 3701:1-67 of the Administrative Code, as well as the names
of people who performed such activities;
(3) Records of maintenance and/or
modifications performed on each piece of therapy equipment, as well as the
names of people who performed such services;
(4) Name and signature of the qualified
medical physicist or authorized individual, as delineated in the quality
assurance manual, authorizing the return of the therapy equipment to clinical
use after any service or intervention that significantly affects patient
treatment.
(K)
The director may, upon application thereof or upon his or her own initiative,
grant a variance to the requirements of this chapter as he or
she determines is authorized by law, provided that the handler shows to the
satisfaction of the director that there is good cause for the variance, and
that the variance shall not result in any undue hazard or effect on the public
health and safety. The terms, conditions, and expiration of the variance shall
be set forth in writing by the director. Failure to comply with the terms of
the variance may result in immediate revocation of the variance.