Current through Register No. 40, October 3, 2024
(a) The registrant
shall ensure that radiation protection surveys of all new facilities, and
existing facilities not previously surveyed, are performed with an operable
radiation measurement survey instrument calibrated in accordance with
He-P
4047.08.
(b) The radiation protection survey shall be
performed by, or under the direction of, a radiation therapy physicist or a
qualified expert.
(c) The radiation
protection survey shall verify that, with the therapeutic radiation machine in
a "BEAM-ON" condition, with the largest clinically available treatment field
and with a scattering phantom in the useful beam of radiation, the following
requirements are met:
(1) Radiation levels in
restricted areas are not likely to cause personnel exposures in excess of the
limits specified in He-P 4020.05; and
(2) Radiation levels in unrestricted areas do
not exceed the limits specified in
He-P
4020.13(a) and (b) .
(d) In addition to the
requirements of He-P 4047.05(a)
, a radiation protection survey shall also be
performed prior to any subsequent medical use; and:
(1) After making any change in the treatment
room shielding;
(2) After making
any change in the location of the therapeutic radiation machine within the
treatment room;
(3) After
relocating the therapeutic radiation machine to a different treatment room;
or
(4) Before using the therapeutic
radiation machine in a manner that could result in increased radiation levels
in areas outside the external radiation therapy treatment room.
(e) The survey record required in
He-P
4047.05(d) shall include:
(1) All instances where the facility is in
violation of applicable rules;
(2)
The date of the measurements;
(3)
The reason for the survey;
(4) The
manufacturer's name;
(5) Model
number of the therapeutic radiation machine;
(6) Serial number of the therapeutic
radiation machine;
(7) The
instrument(s) used to measure radiation levels;
(8) A diagram of the areas surrounding the
treatment room that were surveyed;
(9) The measured dose rate at several points
in each area expressed in microsieverts or millirems per hour;
(10) The calculated maximum level of
radiation over a period of 1 week for each restricted and unrestricted area;
and
(11) The signature of the
individual responsible for conducting the survey.
(f) If the results of the surveys required by
He-P
4047.05(a) and (d) indicate any
radiation levels in excess of the respective limit specified in He-P 4020, the
registrant shall lock the control in the "OFF" position and not use the unit
except as may be necessary to repair, replace, or test the therapeutic
radiation machine, test the therapeutic radiation machine shielding, or test
the treatment room shielding.
(g)
If the survey required by
He-P
4047.05(a) and (d) indicates that an
individual in an unrestricted area may be exposed to levels of radiation
greater than those permitted by
He-P
4020.13(a) and (b) , before beginning
the treatment program the registrant shall:
(1) Equip the unit with beam direction
interlocks or add additional radiation shielding to ensure compliance with
He-P
4020.13(a) and (b) ;
(2) Perform the survey required by
He-P
4047.05(a) again; and
(3) Include in the record required by
He-P
4047.05(e) :
a. The results of the initial
survey;
b. A description of the
modification made to comply with
He-P
4047.05(g) (1) ; and
c. The results of the second
survey.
(h)
The registrant shall have a dosimetry system available for use which has been
calibrated by the National Institute for Standards and Technology (NIST) or by
an American Association of Physicists in Medicine (AAPM) Accredited Dosimetry
Calibration Laboratory (ADCL) as follows:
(1)
For beams with energies greater than 1 MV (1 MeV), the dosimetry system shall
have been calibrated for Cobalt-60; and
(2) For beams with energies equal to or less
than 1 MV (1 MeV), the dosimetry system shall have been calibrated at an energy
or for an energy range appropriate for the radiation being measured.
(i) The calibration of the
dosimetry system required in
He-P
4047.05(h) shall have been performed
within the previous 24 months, and after any servicing that may have affected
system calibration.
(j) An
independent survey shall be conducted by a radiation therapy physicist or
qualified expert other than the person performing the original survey prior to
the system being used except as described in
He-P
4047.05(f) .
(k) The registrant shall have available for
use a dosimetry system for quality assurance check measurements. To meet this
requirement, the system shall be compared with a system that has been
calibrated in accordance with
He-P
4047.05(h) through (j) . This
comparison shall have been performed within the previous 12 months, and after
each servicing that may have affected system calibration. The quality assurance
check system shall be the same system used to meet the requirements in
He-P
4047.05(h) through (j) .
(l) The registrant shall maintain a record of
each dosimetry system calibration, intercomparison, and comparison for each
therapeutic radiation machine.
(m)
For each calibration, intercomparison, or comparison, the record shall include:
(1) The date;
(2) The model numbers of the instruments that
were calibrated;
(3) The serial
numbers of the instruments that were calibrated, intercompared, compared, or
used to meet the requirements in
He-P
4047.05(h) through (k) ;
(4) The correction factors that were
determined;
(5) The names of the
individuals who performed the calibration, intercomparison, or comparison;
and
(6) Evidence that the
intercomparison was performed by, or under the direct supervision and in the
physical presence of, a radiation therapy physicist.
(n) The registrant for any therapeutic
radiation machine shall be able to furnish a copy of the records required in
He-P
4047.05 to DHHS/RHS upon request, within 30 days
following completion of the action that initiated the record
requirement.
(o) Each registrant
using radiation therapy machines shall establish and maintain a quality
management program to provide high confidence that radiation will be
administered as directed by the authorized user.
(p) The registrant shall make modifications
to the quality management program to increase the program's
efficiency.
(q) The quality
management program required by
He-P
4047.05(o) shall include written
policies and procedures to meet the following specific objectives:
(1) Prior to administration, a written
directive shall be prepared for any external beam radiation therapy
dose;
(2) Notwithstanding
He-P
4047.05(q) (1) above, a written
revision to an existing written directive shall be acceptable provided that the
revision is dated and signed by an authorized user prior to administration of
the external beam radiation therapy dose or the next external beam radiation
therapy fractional dose;
(3) If,
because of the patient's condition, a delay in order to provide a written
revision to an existing written directive would jeopardize the patient's
health, an oral revision to an existing written directive shall be acceptable,
provided that the oral revision is documented immediately in the patient's
record and a revised written directive is signed by an authorized user within
48 hours of the oral revision;
(4)
The written directive shall contain the patient or human research subject's
name, the type and energy of the beam, the total dose, dose per fraction,
treatment site and number of fractions;
(5) A written revision to an existing written
directive shall be made provided that the revision is dated and signed by an
authorized user prior to the administration of the therapeutic radiation
machine dose, or the next fractional dose; and
(6) The registrant shall retain a copy of
each written directive for 3 years.
(r) The registrant shall develop, implement
and maintain written procedures to provide high confidence that:
(1) Prior to the administration of each
course of radiation treatment, the patient's identity is verified, by more than
one method, as the individual named in the written directive;
(2) Each administration is in accordance with
the written directive;
(3) The
therapeutic radiation machine final treatment plans and related calculations
are in accordance with the respective written directives by:
a. Checking both manual and computer
generated dose calculations to verify they are correct and in accordance with
the written directive; and
b.
Verifying that any computer generated calculations are correctly transferred
into consoles of authorized therapeutic medical units;
(4) Any unintended deviation from the written
directive is identified and evaluated, and appropriate action is taken;
and
(5) The registrant retains a
copy of the procedures for administrations for the duration of the
registration.
(s) Each
registrant using radiation therapy equipment shall have a quality management
program that specifies staff, staff duties and responsibilities, equipment, and
procedures.
(t) Each existing
registrant shall submit to DHHS/RHS a copy of the written quality management
program that has been implemented.
(u) The registrant shall include as a part of
the quality management program the following:
(1) An evaluation of a representative sample
of patient administrations and a review of all recordable events, and all
misadministrations, if any, to verify compliance with all aspects of the
quality management program;
(2)
Reviews conducted at intervals not to exceed 12 months;
(3) An evaluation of each review to determine
the effectiveness of the quality management program and, if necessary to make
modifications to meet the requirements of these rules; and
(4) Records of each review, including the
evaluations and findings of the review, which shall be retained for 3
years.
(v) Each
registrant shall report any event resulting from intervention of a patient or
human research subject in which the administration of therapeutic radiation
machine results, or will result in, unintended permanent functional damage to
an organ or a physiological system as determined by a physician.
(w) Other than events that result from
intervention by a patient or human research subject each registrant shall
report any event in which the administration of a therapeutic radiation machine
therapy dose:
(1) Involved the wrong patient,
wrong treatment modality or wrong treatment site; or
(2) The calculated weekly administered dose
differing from the weekly prescribed dose by more than 30 percent; or
(3) The calculated total administered dose
differing from the total prescribed dose by more than 20 percent of the total
prescribed dose.
(x) The
registrant shall evaluate and respond, within 30 days after discovery of a
recordable event, by:
(1) Assembling the
relevant facts including the cause;
(2) Identifying what, if any, corrective
action is required to prevent recurrence; and
(3) Retaining a record, for 3 years, of the
relevant facts, and the corrective action, if any, which was taken.
(y) The registrant shall evaluate
each misadministration.
(z) The
registrant shall take the following actions in response to a misadministration:
(1) Notify DHHS/RHS by telephone no later
than the next business day after discovery of the misadministration;
(2) Submit a written report to DHHS/RHS
within 15 days after discovery of the misadministration including:
a. The registrant's name;
b. The prescribing physician's
name;
c. A brief description of the
event;
d. Why the event
occurred;
e. The effect on the
patient;
f. What improvements are
needed to prevent recurrence;
g.
Actions taken to prevent recurrence;
h. Whether the registrant notified the
patient or the patient's responsible relative or guardian; and
i. What information was provided to the
patient; but
j. Shall not include
the patient's name or other information that could lead to identification of
the patient;
(3) Notify
the referring physician;
(4) Notify
the patient of the misadministration no later than 24 hours after its
discovery, unless the referring physician personally informs the registrant
either that he/she will inform the patient or that, based on medical judgment,
telling the patient would be harmful;
(5) Notify the patient as soon as possible
thereafter if the referring physician or patient cannot be reached within 24
hours;
(6) Not delay any
appropriate medical care for the patient, including any necessary remedial care
as a result of the misadministration, because of any delay in
notification;
(7) If a verbal
notification is made, the registrant shall inform the patient, or appropriate
responsible relative or guardian, that a written description of the event can
be obtained from the registrant upon request. The registrant shall provide such
a written description if requested; and
(8) Retain a record of each misadministration
for 3 years, including:
a. The names of all
individuals involved;
b. The
patient's Social Security number or other identification number;
c. A brief description of the
event;
d. Why it occurred and the
effect on the patient;
e. What
improvements are needed to prevent recurrence;
f. The actions taken to prevent recurrence;
and
g. Whether the patient was
notified or not.
(aa) Aside from the notification requirements
in (z) above, nothing in this section shall affect any rights or duties of
registrants and physicians in relation to each other, to the patient affected
by the event, or to that patient's responsible relative or guardian.
#6827, eff 8-6-98; ss by #8692, INTERIM, eff 7-27-06,
EXPIRES: 2-2-07; ss by #8808, eff
1-24-07
