| (ii) after implantation but before completion of the
procedure: the radionuclide, the treatment site, the number of sealed
sources, the total sealed source strength, exposure time (or the total
dose), and the date.
(3) A written revision to an existing written directive.
(A) A written revision to an existing written directive
may be made if the revision is dated and signed by an authorized user
before the administration of the dosage of unsealed radioactive material,
the brachytherapy dose, the gamma stereotactic radiosurgery dose,
the teletherapy dose, or the next fractional dose.
(B) 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 is acceptable. The oral revision must be documented
as soon as possible in the patient's record. A revised written directive
must be signed by the authorized user within 48 hours of the oral
revision.
(4) The licensee shall retain the written directive
in accordance with subsection (xxx) of this section for inspection
by the department.
(5) Procedures for administrations requiring a written
directive.
(A) For any administration requiring a written directive,
the licensee shall develop, implement, and maintain written procedures
to provide high confidence that:
(i) the patient's or human research subject's identity
is verified before each administration; and
(ii) each administration is in accordance with the
written directive.
(B) The procedures required by subparagraph (A) of
this paragraph shall, at a minimum, address the following items that
are applicable for the licensee's use of radioactive material:
(i) verifying the identity of the patient or human
research subject;
(ii) verifying that the administration is in accordance
with the treatment plan, if applicable, and the written directive;
(iii) checking both manual and computer-generated dose
calculations; and
(iv) verifying that any computer-generated dose calculations
are correctly transferred into the consoles of therapeutic medical
units authorized by subsections (q) and (ddd) of this section;
(v) determining if a medical event, as defined in subsection
(uuu) of this section, has occurred; and
(vi) determining, for permanent implant brachytherapy,
within 60 calendar days from the date the implant was performed, the
total source strength administered outside of the treatment site compared
to the total source strength documented in the post-implantation portion
of the written directive, unless a written justification of patient
unavailability is documented.
(C) A licensee shall maintain a copy of the procedures
required by subparagraph (A) of this paragraph in accordance with
subsection (xxx) of this section.
(u) Suppliers for sealed sources or devices for medical
use. A licensee may only use the following for medical use:
(1) sealed sources or devices manufactured, labeled,
packaged, and distributed in accordance with a license issued under §289.252(o)
of this title or equivalent requirements of the NRC or an agreement
state;
(2) sealed sources or devices non-commercially transferred
from an NRC or agreement state medical use licensee; or
(3) teletherapy sources manufactured and distributed
in accordance with a license issued by the department, the NRC, or
an agreement state.
(v) Possession, use, and calibration of dose calibrators
to measure the activity of unsealed radioactive material.
(1) For direct measurements performed in accordance
with subsection (x) of this section, the licensee shall possess and
use instrumentation to measure the activity of unsealed radioactive
material before it is administered to each patient or human research
subject.
(2) The licensee shall calibrate the instrumentation
specified in paragraph (1) of this subsection in accordance with nationally
recognized standards or the manufacturer's instructions.
(3) The calibration required by paragraph (2) of this
subsection shall include tests for constancy, accuracy, linearity,
and geometry dependence, as appropriate to demonstrate proper operation
of the instrument. The tests for constancy, accuracy, linearity, and
geometry dependence shall be conducted at the following intervals:
(A) constancy at least once each day before assay of
patient dosages;
(B) linearity at installation, repair, relocation,
and at least quarterly thereafter;
(C) geometry dependence at installation; and
(D) accuracy at installation and at least annually
thereafter.
(4) The licensee shall maintain a record of each instrument
calibration in accordance with subsection (xxx) of this section. The
record shall include the following:
(A) model and serial number of the instrument and calibration
sources;
(B) complete date of the calibration including the
month, day and year;
(C) results of the calibration; and
(D) name of the individual who performed the calibration.
(w) Calibration of survey instruments. A licensee shall
calibrate the survey instruments used to show compliance with this
subsection and with §289.202 of this title before first use,
annually, and following a repair that affects the calibration. A licensee
shall:
(1) calibrate all scales with readings up to 10 millisieverts
(mSv) (1000 millirem (mrem)) per hour with a radiation source;
(2) calibrate two separated readings on each scale
or decade that will be used to show compliance;
(3) conspicuously note on the instrument the complete
date of the calibration including the month, day, and year;
(4) not use survey instruments if the difference between
the indicated exposure rate and the calculated exposure rate is more
than 20 percent; and
(5) maintain a record of each survey instrument calibration
in accordance with subsection (xxx) of this section.
(x) Determination of dosages of unsealed radioactive
material for medical use.
(1) Before medical use, the licensee shall determine
and record the activity of each dosage.
(2) For a unit dosage, this determination shall be
made by:
(A) direct measurement of radioactivity; or
(B) a decay correction, based on the activity or activity
concentration determined by the following:
(i) a manufacturer or preparer licensed in accordance
with §289.252(r) of this title, or under an equivalent NRC or
agreement state license;
(ii) an NRC or agreement state licensee for use in
research in accordance with a Radioactive Drug Research Committee-approved
protocol or an Investigational New Drug (IND) protocol accepted by
the FDA; or
(iii) a PET radioactive drug producer licensed in accordance
with §289.252(kk) of this title or equivalent NRC or agreement
state requirements.
(3) For other than unit dosages, this determination
shall be made by:
(A) direct measurement of radioactivity;
(B) combination of measurement of radioactivity and
mathematical calculations; or
(C) combination of volumetric measurements and mathematical
calculations, based on the measurement made by:
(i) a manufacturer or preparer licensed in accordance
with §289.252(r) of this title, or under an equivalent NRC or
agreement state license; or
(ii) a PET radioactive drug producer licensed in accordance
with §289.252(kk) of this title or equivalent NRC or agreement
state requirements.
(4) Unless otherwise directed by the authorized user,
a licensee shall not use a dosage if the dosage does not fall within
the prescribed dosage range or if the dosage differs from the prescribed
dosage by more than 20 percent.
(5) A licensee restricted to only unit doses prepared
in accordance with §289.252(r) of this title need not comply
with paragraph (2) of this subsection, unless the administration time
of the unit dose deviates from the nuclear pharmacy's pre-calibrated
time by 15 minutes or more.
(6) A licensee shall maintain a record of the dosage
determination required by this subsection in accordance with subsection
(xxx) of this section for inspection by the department. The record
shall contain the following:
(A) the radiopharmaceutical;
(B) patient's or human research subject's name or identification
number if one has been assigned;
(C) prescribed dosage;
Cont'd... |
