| (vi) what improvements are needed to prevent recurrence;
(vii) actions taken to prevent recurrence;
(viii) whether the registrant notified the patient,
or the patient's responsible relative or guardian (this person will
be subsequently referred to as "the patient"); and if not, why not;
and
(ix) if the patient was notified, what information
was provided to the patient; and
(D) furnish the following to the patient within 15
days after discovery of the event if the patient was notified:
(i) a copy of the report that was submitted to the
agency; or
(ii) a brief description of both the event and the
consequences, as they may affect the patient, provided a statement
is included that the report submitted to the agency can be obtained
from the registrant.
(2) Each registrant shall retain a record of each event
in accordance with subsection (l) of this section for inspection by
the agency. The record shall contain the following:
(A) the names of all individuals involved (including
the prescribing physician, allied health personnel, the patient, and
the patient's referring physician);
(B) the patient's identification number;
(C) a brief description of the event;
(D) why it occurred;
(E) the effect on the patient;
(F) what improvements are needed to prevent recurrence;
and
(G) the actions taken to prevent recurrence.
(3) Aside from the notification requirement, nothing
in subsection (i) of this section and paragraphs (1) and (2) of this
subsection shall affect any rights or duties of registrants, and physicians
in relation to each other, patients, or the patient's responsible
relatives or guardians.
(k) Additional requirements for electronic brachytherapy
devices.
(1) Technical requirements for electronic brachytherapy
devices.
(A) The timer shall:
(i) have a display provided at the treatment control
panel and a pre-set time selector;
(ii) activate with the production of radiation and
retain its reading after irradiation is interrupted. After irradiation
is terminated and before irradiation can be reinitiated, it shall
be necessary to reset the elapsed time indicator to zero;
(iii) terminate irradiation when a pre-selected time
has elapsed, if any dose monitoring system present has not previously
terminated irradiation;
(iv) permit selection of exposure times as short as
1 second;
(v) not permit an exposure if set at zero; and
(vi) be accurate to within 1.0% of the selected value
or 1 second, whichever is greater.
(B) The control panel, in addition to the displays
required in subparagraph (A) of this paragraph, shall have the following:
(i) an indication of whether electrical power is available
at the control panel and if activation of the x-ray tube is possible;
(ii) means for indicating x-rays are being produced;
(iii) means for indicating x-ray tube potential and
current; and
(iv) means for terminating an exposure at any time.
(C) All emergency buttons/switches shall be clearly
labeled as to their functions.
(2) Surveys, calibrations, and spot checks.
(A) Surveys shall be performed as follows.
(i) All facilities having electronic brachytherapy
device(s) shall have an initial survey made by a licensed medical
physicist, with a specialty in therapeutic radiological physics, who
shall provide a written report of the survey to the registrant. Additional
surveys shall be done as follows:
(I) when making any change in the portable shielding;
(II) when making any change in the location where the
electronic brachytherapy device is used within the treatment room;
and
(III) when relocating the electronic therapy device.
(ii) The registrant shall maintain a copy of the initial
survey report and all subsequent survey reports in accordance with
subsection (l) of this section for inspection by the agency.
(iii) The survey report shall indicate all instances
where the installation is in violation of applicable requirements
of this chapter.
(B) Calibrations shall be performed as follows.
(i) Calibration procedures shall be in writing, or
documented in an electronic reporting system, and shall have been
developed by a licensed medical physicist with a specialty in therapeutic
radiological physics.
(ii) The registrant shall make calibration measurements
required by this section in accordance with any current recommendations
from a recognized, national professional association (such as the
American Association of Physicists in Medicine Report Number 152)
for electronic brachytherapy, when available. Equivalent alternative
methods are acceptable. In the absence of a protocol by a national
professional association, published protocol included in the device
manufacturer operator's manual should be followed.
(iii) The calibration of the electronic brachytherapy
device shall be performed after change of the x-ray tube or replacement
of components that could cause a change in the radiation output. The
calibrations shall be such that the dose at a reference point in water
or plastic phantom can be calculated to within an uncertainty of 5.0%.
(iv) The calibration of the radiation output of the
electronic brachytherapy device shall be performed by a licensed medical
physicist with a specialty in therapeutic radiological physics who
is physically present at the facility during such calibration.
(v) The calibration of the therapeutic electronic brachytherapy
device shall include verification that the electronic brachytherapy
device is operating in compliance with the design specifications.
(vi) Calibration of the radiation output of the electronic
brachytherapy device shall be performed with a calibrated dosimetry
system. The dosimetry calibration shall be traceable to a national
standard. The calibration interval shall not exceed 24 months.
(vii) Records of calibration measurements shall be
maintained by the registrant in accordance with subsection (l) of
this section for inspection by the agency.
(viii) A copy of the latest calibrated absorbed dose
rate measured on the electronic brachytherapy device shall be available
at a designated area within the therapy facility housing the electronic
brachytherapy device.
(C) Spot check procedures.
(i) Spot check procedures shall be in writing, or documented
in an electronic reporting system, and shall have been developed by
a licensed medical physicist with a specialty in therapeutic radiological
physics.
(ii) If a licensed medical physicist does not perform
the spot check measurements, the results of the spot check measurements
shall be reviewed by a licensed medical physicist with a specialty
in therapeutic radiological physics within 2 treatment days and a
record made of the review.
(iii) The written spot check procedures shall specify
the operating instructions that shall be carried out whenever a parameter
exceeds an acceptable tolerance as established by the licensed medical
physicist.
(iv) The certified physician or licensed medical physicist
shall prevent the clinical use of a malfunctioning device until the
malfunction identified in the spot check has been evaluated and corrected
or, if necessary, the equipment repaired.
(v) Records of the written spot checks and any necessary
corrective actions shall be maintained by the registrant in accordance
with subsection (l) of this section for inspection by the agency.
A copy of the most recent spot check shall be available at a designated
area within the therapy facility housing that therapeutic radiation
system.
(vi) Spot checks shall be obtained using a dosimetry
system satisfying the requirements of subparagraph (B)(vi) of this
paragraph.
(l) Records for agency inspection. The registrant shall
maintain the following records at the time intervals specified, for
inspection by the agency. The records may be maintained in electronic
format.
Attached Graphic
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