Current through Register 1531, September 27, 2024
(A)
Administrative Controls. The registrant shall be
responsible for directing the operation of the therapeutic radiation machines
which have been registered with the Agency. The registrant or the registrant's
agent shall ensure that the requirements of 105 CMR 120.430 are met in the
operation of the therapeutic radiation machine(s).
(B)
Prohibition A
therapeutic radiation machine which does not meet the provisions of 105 CMR
120.000 shall not be used for irradiation of patients.
(C)
Training for Therapeutic
Radiation Machine Authorized Users The registrant for any
therapeutic radiation machine subject to
105 CMR
120.436 or
120.437
shall require the authorized user to be a physician who:
(1) Is certified in:
(a) Radiology or therapeutic radiology by the
American Board of Radiology; 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.
(2) Is in the active practice of therapeutic
radiology, and has completed 200 hours of instruction in basic radiation
techniques applicable to the use of an external beam radiation therapy unit,
500 hours of supervised work experience, and a minimum of three years of
supervised clinical experience.
(a) To
satisfy the requirement for instruction in 105 CMR 120.433(C)(2), the classroom
and laboratory training shall include:
1.
Radiation physics and instrumentation;
2. Radiation protection;
3. Mathematics pertaining to the use and
measurement of ionization radiation; and
4. Radiation biology.
(b) To satisfy the requirement for supervised
work experience, training shall be under the supervision of an authorized user
and shall include:
1. Review of the full
calibration measurements and periodic quality assurance checks;
2. Evaluation of prepared treatment plans and
calculation of treatment times/patient treatment settings;
3. Using administrative controls to prevent
misadministrations;
4. Implementing
emergency procedures to be followed in the event of the abnormal operation of a
external beam radiation therapy unit or console; and,
5. 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 approved by the Residency Review
Committee for Radiology of the Accreditation Council for Graduate Medical
Education or the Committee on Postdoctoral Training of the American Osteopathic
Association and an additional year years of clinical experience in therapeutic
radiology under the supervision of an authorized user. The supervised clinical
experience shall include:
1. Examining
individuals and reviewing their case histories to determine their suitability
for external beam radiation therapy treatment, and any limitations/
contraindications;
2. Selecting
proper dose and how it is to be administered;
3. Calculating the therapeutic radiation
machine doses and collaborating with the authorized user in the review of
patients' progress and consideration of the need to modify originally
prescribed doses and/or treatment plans as warranted by patients' reaction to
radiation; and,
4. Post
administration follow up and review of case histories.
(d) Notwithstanding the requirements of 105
CMR 120.433(C)(1) and (2), the registrant for any therapeutic radiation machine
subject to
105 CMR
120.436 may also submit the training of the
prospective authorized user physician for Agency review on a case by case
basis.
(e) A physician shall not
act as an authorized user for any therapeutic radiation machine until such time
as said physician's training has been reviewed and approved by the
Agency.
(D)
Training for Qualified Medical Physicist for Radiation
Therapy. The registrant for any therapeutic radiation machine
subject to
105 CMR
120.436 or
120.437
shall require the Qualified Medical Physicist to:
(1) Be registered with the Agency, under the
provisions of
105 CMR
120.026, as a provider of radiation services
in the area of calibration and compliance surveys of external beam radiation
therapy units; and,
(2) Be
certified by the American Board of Radiology in:
(a) Therapeutic radiological physics;
or
(b) Roentgen-ray and gamma-ray
physics; or
(c) X-ray and radium
physics; or
(d) Radiological
physics; or,
(3) Be
certified by the American Board of Medical Physics in Radiation Oncology
Physics; or,
(4) Be certified by
the Canadian College of Medical Physics.
(E)
Qualifications of
Operators.
(1) Individuals who
will be operating a therapeutic radiation machine for medical use shall possess
a valid Massachusetts License as a Radiologic Technologists in Radiation
Therapy.
(2) The names and the
respective training records of all personnel currently operating a therapeutic
radiation machine shall be kept on file at the facility. Information on former
operators shall be retained for a period of at least two years beyond the last
date they were authorized to operate a therapeutic radiation machine at that
facility.
(F) Written
safety procedures and rules shall be developed by a Qualified Medical Physicist
and shall be available in the control area of a therapeutic radiation machine,
including any restrictions required for the safe operation of the particular
therapeutic radiation machine. The operator shall be able to demonstrate
familiarity with these rules.
(G)
Individuals shall not be exposed to the useful beam except for medical therapy
purposes and unless such exposure has been ordered in writing by an authorized
user meeting the requirements of 105 CMR 120.433(C) who is specifically
identified on the Certificate of Registration. 105 CMR 120.433(G) specifically
prohibits deliberate exposure of an individual for training, demonstration or
other non-healing-arts purposes.
(H)
Visiting Authorized
User. Notwithstanding the provisions of 105 CMR 120.433(G), a
registrant may permit any physician to act as a visiting authorized user under
the term of the registrant's Certificate of Registration for up to 60 days per
calendar year under the following conditions:
(1) The visiting authorized user has the
prior written permission of the registrant's management and, if the use occurs
on behalf of an institution, the institution's Radiation Safety Committee;
and
(2) The visiting authorized
user meets the requirements established for authorized user(s) in 105 CMR
120.433(C)(1) and (2); and
(3) The
registrant maintains copies of all records specified by 105 CMR 120.433(H) for
five years from the date of the last visit.
(I) All individuals associated with the
operation of a therapeutic radiation machine shall be instructed in and shall
comply with the provisions of the registrant's written directive program. In
addition to the requirements of 105 CMR 120.430, these individuals are also
subject to the requirements of
105 CMR 120.201 and
120.205.
(J)
Information and Maintenance Record and Associated
Information. The registrant shall maintain the following
information in a separate file or package for each therapeutic radiation
machine, for inspection by the Agency:
(1)
Report of acceptance testing;
(2)
Records of all surveys, calibrations, and periodic quality assurance checks of
the therapeutic radiation machine required by 105 CMR 120.430, as well as the
name(s) of person(s) who performed such activities;
(3) Records of maintenance and/or
modifications performed on the therapeutic radiation machine after July 9,
1999, as well as the name(s) of person(s) who performed such
services;
(4) Signature of the
Radiation therapy Physicist or Authorized User authorizing the return of
therapeutic radiation machine to clinical use after service, repair, or
upgrade.
(K)
Records Retention. All records required by 105 CMR
120.430 shall be retained until disposal is authorized by the Agency unless
another retention period is specifically authorized in 105 CMR 120.430. All
required records shall be retained in an active file from at least the time of
generation until the next Agency inspection. Any required record generated
prior to the last Agency inspection may be microfilmed or otherwise archived as
long as a complete copy of said record can be retrieved until such time as the
Agency authorizes final disposal.
