| (A) When removing temporary implants from storage,
the licensee shall record the number and activity of sources, time
and date the sources were removed, the name of the individual who
removed the sources, and the location of use. When temporary implants
are returned to storage, record the number and activity of sources,
the time and date, and the name of the individual who returned them.
(B) When removing permanent implants from storage,
the licensee shall record the number and activity of sources, date,
the name of the individual who removed the sources, and the number
and activity of sources permanently implanted in the patient or human
research subject. Record the number and activity of sources not implanted
and returned to storage, the date, and the name of the individual
who returned them to storage.
(uu) Safety instruction to personnel. The licensee
shall provide radiation safety instruction, initially and at least
annually, to personnel caring for patients or human or animal research
subjects who are receiving brachytherapy and who cannot be released
in accordance with subsection (cc) of this section or animals that
are confined.
(1) The instruction shall be appropriate to the personnel's
assigned duties and include the following:
(A) size and appearance of brachytherapy sources;
(B) safe handling and shielding instructions;
(C) patient or human research subject control;
(D) visitor control to include visitation to hospitalized
individuals in accordance with §289.202(n) of this title; and
(E) notification of the RSO, or his or her designee,
and an authorized user if the patient or the human or animal research
subject has a medical emergency or dies.
(2) A licensee shall maintain a record, for inspection
by the department, in accordance with subsection (xxx) of this section,
of individuals receiving instruction. The record shall include the
following:
(A) list of the topics covered;
(B) date of the instruction or training;
(C) name(s) of the attendee(s); and
(D) name(s) of the individual(s) who provided the instruction.
(vv) Safety precautions for the use of brachytherapy.
(1) For each patient or human research subject who
is receiving brachytherapy and cannot be released in accordance with
subsection (cc) of this section the licensee shall:
(A) provide a private room with a private sanitary
facility;
(B) post the patient's or the research subject's room
with a "Radioactive Materials" sign and note on the door or in the
patient's or research subject's chart where and how long visitors
may stay in the patient's or the research subject's room; and
(C) have available near each treatment room applicable
emergency response equipment to respond to a sealed source that is
inadvertently dislodged from the patient or inadvertently lodged within
the patient following removal of the sealed source applicators.
(2) The RSO, or his or her designee, and the authorized
user shall be notified if the patient or research subject has a medical
emergency and, immediately, if the patient dies.
(ww) Calibration measurements of brachytherapy sealed
sources.
(1) Before the first medical use of a brachytherapy
sealed source on or after October 1, 2000, the licensee shall do the
following:
(A) determine the sealed source output or activity
using a dosimetry system that meets the requirements of subsection
(iii)(1) of this section;
(B) determine sealed source positioning accuracy within
applicators; and
(C) use published protocols accepted by nationally
recognized bodies to meet the requirements of subparagraphs (A) and
(B) of this paragraph.
(2) Instead of the licensee making its own measurements
as required in paragraph (1) of this subsection, the licensee may
use measurements provided by the source manufacturer or by a calibration
laboratory accredited by the American Association of Physicists in
Medicine that are made in accordance with paragraph (1) of this subsection.
(3) The licensee shall mathematically correct the outputs
or activities determined in paragraph (1) of this subsection for physical
decay at intervals consistent with one percent physical decay.
(4) The licensee shall retain a record of each calibration
in accordance with subsection (xxx) of this section for inspection
by the department. The record shall include the following:
(A) complete date of the calibration including the
month, day, and year;
(B) manufacturer's name and model and serial number
for the sealed source and instruments used to calibrate the sealed
source;
(C) sealed source output or activity;
(D) sealed source positioning accuracy within applicators;
and
(E) name of the individual, the source manufacturer,
or the calibration laboratory that performed the calibration.
(xx) Strontium-90 sources for ophthalmic treatments.
(1) A licensee who uses strontium-90 for ophthalmic
treatments must ensure that certain activities as specified in paragraph
(2) of this subsection are performed by either:
(A) an authorized medical physicist; or
(B) an individual who:
(i) is identified as an ophthalmic physicist on a specific
medical use license issued by the department, the NRC, or an agreement
state; permit issued by the department, the NRC, or an agreement state
broad scope medical use licensee; medical use permit issued by an
NRC master material licensee; or permit issued by an NRC master material
licensee broad scope medical use permittee; and
(ii) holds a master's or doctor's degree in physics,
medical physics, other physical sciences, engineering, or applied
mathematics from an accredited college or university; and
(iii) has successfully completed one year of full-time
training in medical physics and an additional year of full-time work
experience under the supervision of a medical physicist; and
(iv) has documented training in:
(I) the creation, modification, and completion of written
directives;
(II) procedures for administrations requiring a written
directive; and
(III) performing the calibration measurements of brachytherapy
sources as detailed in subsection (ww) of this section.
(2) The individual who is identified in paragraph (1)
of this subsection must:
(A) calculate the activity of each strontium-90 source
that is used to determine the treatment times for ophthalmic treatments,
and the decay must be based on the activity determined under subsection
(ww) of this section; and
(B) assist the licensee in developing, implementing,
and maintaining written procedures to provide high confidence that
the administration is in accordance with the written directive. These
procedures must include the frequencies that the individual meeting
the requirements in paragraph (1) of this subsection will observe
treatments, review the treatment methodology, calculate treatment
time for the prescribed dose, and review records to verify that the
administrations were in accordance with the written directives.
(3) A licensee shall maintain a record of the activity
of a strontium-90 source in accordance with subsection (xxx) of this
section for inspection by the department. The record shall include
the following:
(A) date and initial activity of the source as determined
under subsection (ww) of this section; and
(B) for each decay calculation, the date and the source
activity as determined under this subsection.
(yy) Therapy-related computer systems for manual brachytherapy.
The licensee shall perform acceptance testing on the treatment planning
system of therapy-related computer systems in accordance with published
protocols accepted by nationally recognized bodies. At a minimum,
the acceptance testing shall include, as applicable, verification
of the following:
(1) the sealed source-specific input parameters required
by the dose calculation algorithm;
(2) the accuracy of dose, dwell time, and treatment
time calculations at representative points;
(3) the accuracy of isodose plots and graphic displays;
and
(4) the accuracy of the software used to determine
radioactive sealed source positions from radiographic images.
(zz) Training for use of manual brachytherapy sealed
sources. Except as provided in subsection (l) of this section, the
licensee shall require an authorized user of a manual brachytherapy
source for the uses authorized in subsection (rr) of this section
to be a physician who:
Cont'd... |
