Texas Register, Volume 32, Number 23, Pages 3077-3422, June 8, 2007 Page: 3,165
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(i) reviewing full calibration measurements and pe-
aks;
(ii) preparing treatment plans and calculating treat-(iii) using administrative controls to prevent a med-
ical event involving the use of radioactive material;
(iv) implementing emergency procedures to be fol-
lowed in the event of the abnormal operation of a medical unit or con-
sole;
(v) checking and using survey meters; and
(vi) selecting the proper dose and how it is to be ad-
ministered; and
(C) has completed three years of supervised clinical ex-
perience in radiation therapy, under an authorized user who meets the
requirements of this subsection as part of a formal training program ap-
proved by the Residency Review Committee for Radiation Oncology of
the Accreditation Council for Graduate Medical Education, the Royal
College of Physicians and Surgeons of Canada, or the Committee on
Postdoctoral Training of the American Osteopathic Association. This
experience may be obtained concurrently with the supervised work ex-
perience required by paragraph (2)(B) of this subsection: and
(D) has obtained written attestation that the individual
has satisfactorily completed the requirements of paragraphs (1)(A) or
(2), and (3) of this subsection, and has achieved a level of competency
sufficient to function independently as an authorized user of each type
of therapeutic medical unit for which the individual is requesting autho-
rized user status. The written attestation shall be signed by a preceptor
authorized user who meets the requirements in this subsection; and
(3) has received training in device operation, safety proce-
dures, and clinical use for the type(s) of use for which authorization
is sought. This training requirement may be satisfied by satisfactory
completion of a training program provided by the vendor for new users
or by receiving training supervised by an authorized user or authorized
medical physicist, as appropriate, who is authorized for the type(s) of
use for which the individual is seeking authorization.
(uuu) Report and notification of a medical event.
(1) The licensee shall report any event, except for events
that result from intervention by a patient or human research subject,
in which the administration of radioactive material, or radiation from
radioactive material, results in the following:
(A) a dose that differs from the prescribed dose or dose
that would have resulted from the prescribed dosage by more than 5
rem (0.05 Sievert (Sv)) effective dose equivalent, 50 rem (0.5 Sv) to an
organ or tissue, or 50 rem (0.5 Sv) shallow dose equivalent to the skin
and either:
(i) the total dose delivered differs from the pre-
scribed dose by 20% or more;
(ii) the total dosage delivered differs from the pre-
scribed dosage by 20% or more or falls outside the prescribed dosage
range; or
(iii) the fractionated dose delivered differs from the
prescribed dose, for a single fraction, by 50% or more;
(B) a dose that exceeds 5 rem (0.05 Sv) effective dose
equivalent, 50 rem (0.5 Sv) to an organ or tissue, or 50 rem (0.5 Sv)
shallow dose equivalent to the skin from any of the following:riodic spot chec
ment times;PROPOSED RULES June 8, 2007 32 TexReg 3165
(i) an administration of a wrong radioactive drug
containing radioactive material;
(ii) an administration of a radioactive drug contain-
ing radioactive material by the wrong route of administration;
(iii) an administration of a dose or dosage to the
wrong individual or human research subject;
(iv) an administration of a dose or dosage delivered
by the wrong mode of treatment; or
(v) a leaking sealed source; or
(C) a dose to the skin or an organ or tissue other than
the treatment site that exceeds by 50 rem (0.5 Sv) to an organ or tissue
and 50% or more of the dose expected from the administration defined
in the written directive (excluding, for permanent implants, seeds that
were implanted in the correct site but migrated outside the treatment
site).
(2) The licensee shall report any event resulting from inter-
vention of a patient or human research subject in which the adminis-
tration of radioactive material, or radiation from radioactive material,
results or will result in an unintended permanent functional damage to
an organ or a physiological system, as determined by a physician.
(3) The licensee shall notify the agency by telephone no
later than the next calendar day after discovery of the medical event.
(4) The licensee shall submit a written report to the agency
within 15 calendar days after discovery of the medical event. The writ-
ten report shall include the following, excluding the individual's name
or any other information that could lead to identification of the individ-
ual:
(A) the licensee's name and radioactive material license
number;
(B) the name of the prescribing physician;
(C) a brief description of the medical event;
(D) why the event occurred;
(E) the effect, if any, on the individual(s) who received
the administration;
(F) actions, if any, that have been taken, or are planned,
to prevent recurrence; and
(G) certification that the licensee notified the individual
(or the individual's responsible relative or guardian), and if not, why
not.
(5) The licensee shall notify the referring physician and
also notify the individual who is the subject of the medical event no
later than 24 hours after its discovery, unless the referring physician
personally informs the licensee either that he or she will inform the
individual or that, based on medical judgment, telling the individual
would be harmful. The licensee is not required to notify the individual
without first consulting the referring physician. If the referring physi-
cian or the affected individual cannot be reached within 24 hours, the
licensee shall notify the individual as soon as possible thereafter. The
licensee shall not delay any appropriate medical care for the individual,
including any necessary remedial care as a result of the medical event,
because of any delay in notification. To meet the requirements of this
subsection, the notification of the individual who is the subject of the
medical event may be made instead to that individual's responsible rel-
ative or guardian. If a verbal notification is made, the licensee shall
inform the individual or appropriate responsible relative or guardian,
that a written description of the event can be obtained from the licensee
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Texas. Secretary of State. Texas Register, Volume 32, Number 23, Pages 3077-3422, June 8, 2007, periodical, June 8, 2007; Austin, Texas. (https://texashistory.unt.edu/ark:/67531/metapth97400/m1/88/?rotate=180: accessed July 16, 2024), University of North Texas Libraries, The Portal to Texas History, https://texashistory.unt.edu.; crediting UNT Libraries Government Documents Department.