| (2) conduct a physical inventory at intervals not to
exceed six months to account for all sealed sources in its possession.
Records of the inventory shall be made and maintained for inspection
by the agency in accordance with subsection (www) of this section
and shall include the following:
(A) model number of each source and serial number if
one has been assigned;
(B) identity of each source and its nominal activity;
(C) location of each source;
(D) date of the inventory; and
(E) identification of the individual who performed
the inventory.
(aa) Labeling of vials and syringes. Each syringe and
vial that contains a radiopharmaceutical shall be labeled to identify
the radioactive drug. Each syringe shield and vial shield shall also
be labeled unless the label on the syringe or vial is visible when
shielded.
(bb) Surveys for ambient radiation exposure rate.
(1) In addition to the requirements of §289.202(p)
of this title and except as provided in paragraph (2) of this subsection,
a licensee shall survey with a radiation detection survey instrument
at the end of each day of use all areas where radioactive material
requiring a written directive was prepared for use or administered.
(2) A licensee does not need to perform the surveys
required by paragraph (1) of this subsection in an area(s) where patients
or human research subjects are confined when they cannot be released
in accordance with subsection (cc) of this section or an animal that
is confined. Once the patient or human or animal research subject
is released from confinement, the licensee shall survey with a radiation
survey instrument, the area in which the patient or human or animal
research subject was confined.
(3) A record of each survey shall be retained in accordance
with subsection (www) of this section for inspection by the agency.
The record shall include the following:
(A) date of the survey;
(B) results of the survey;
(C) manufacturer's name, model, and serial number of
the instrument used to make the survey; and
(D) name of the individual who performed the survey.
(cc) Release of individuals containing radioactive
drugs or implants containing radioactive material.
(1) The licensee may authorize the release from its
control any individual who has been administered radioactive drugs
or implants containing radioactive material if the total effective
dose equivalent (TEDE) to any other individual from exposure to the
released individual is not likely to exceed 0.5 rem (5 mSv). Patients
treated with temporary eye plaques may be released from the hospital
provided that the procedures ensure that the exposure rate from the
patient is less than 5 mrem (0.05 mSv) per hour at a distance of 1
meter from the eye plaque location.
(2) The licensee shall provide the released individual,
or the individual's parent or guardian, with written instructions
on actions recommended to maintain doses to other individuals ALARA
if the TEDE to any other individual is likely to exceed 0.1 rem (1
mSv). If the TEDE to a nursing infant or child could exceed 0.1 rem
(1 mSv), assuming there was no interruption of breast-feeding, the
instructions shall also include the following:
(A) guidance on the interruption or discontinuation
of breast-feeding; and
(B) information on the potential consequences, if any,
of failure to follow the guidance.
(3) The licensee shall maintain for inspection by the
agency, a record in accordance with subsection (www) of this section
of each patient released in accordance with paragraph (1) of this
subsection. The record shall include the following:
(A) the basis for authorizing the release of an individual;
and
(B) the instructions provided to a breast-feeding woman.
if the radiation dose to the infant or child from continued breast-feeding
could result in a TEDE exceeding 0.5 rem (5 mSv).
(dd) Mobile nuclear medicine service. A license for
a mobile nuclear medicine service for medical or veterinary use of
radioactive material will be issued if the agency approves the documentation
submitted by the applicant in accordance with the requirements of
subsections (f) and (n) of this section. The clients of the mobile
nuclear medicine service shall be licensed if the client receives
or possesses radioactive material to be used by the mobile nuclear
medicine service.
(1) A licensee providing mobile nuclear medicine service
shall:
(A) obtain a letter signed by the management of each
client for which services are rendered that permits the use of radioactive
material at the client's address and clearly delineates the authority
and responsibility of the licensee and the client;
(B) check instruments used to measure the activity
of unsealed radioactive material for proper function before medical
or veterinary use at each client's address or on each day of use,
whichever is more frequent. At a minimum, the check for proper function
required by this subparagraph shall include a constancy check;
(C) have at least one fixed facility where records
may be maintained and radioactive material may be delivered by manufacturers
or distributors each day prior to the mobile nuclear medicine licensee
dispatching its vans to client sites;
(D) agree to have an authorized physician user directly
supervise each technologist at a reasonable frequency;
(E) check survey instruments for proper operation with
a dedicated check source before use at each client's address; and
(F) before leaving a client's address, survey all areas
of use to ensure compliance with the requirements of §289.202
of this title.
(2) A mobile nuclear medicine service shall not have
radioactive material delivered from the manufacturer or the distributor
to the client unless the client has a license allowing possession
of the radioactive material. Radioactive material delivered to the
client shall be received and handled in conformance with the client's
license.
(3) A licensee providing mobile nuclear medicine services
shall maintain records, for inspection by the agency, in accordance
with subsection (www) of this section including the letter required
in paragraph (1)(A) of this subsection and the record of each survey
required in paragraph (1)(F) of this subsection.
(ee) Decay-in-storage.
(1) The licensee may hold radioactive material with
a physical half-life of less than or equal to 120 days for decay-in-storage
and dispose of it without regard to its radioactivity if the licensee
does the following:
(A) monitors radioactive material at the surface before
disposal and determines that its radioactivity cannot be distinguished
from the background radiation level with an appropriate radiation
detection survey meter set on its most sensitive scale and with no
interposed shielding; and
(B) removes or obliterates all radiation labels, except
for radiation labels on materials that are within containers and that
will be handled as biomedical waste after it has been released from
the licensee.
(2) The licensee shall retain a record of each disposal
as required by paragraph (1) of this subsection in accordance with
subsection (www) of this section for inspection by the agency. The
record shall include the following:
(A) date of the disposal;
(B) manufacturer's name, model number and serial number
of the survey instrument used;
(C) background radiation level;
(D) radiation level measured at the surface of each
waste container; and
(E) name of the individual who performed the survey.
(ff) Use of unsealed radioactive material for uptake,
dilution, and excretion studies that do not require a written directive.
Except for quantities that require a written directive in accordance
with subsection (t) of this section, a licensee may use any unsealed
radioactive material prepared for medical or veterinary use for uptake,
dilution, or excretion studies that meets the following:
(1) is obtained from:
(A) a manufacturer or preparer licensed in accordance
with §289.252 of this title or equivalent NRC or agreement state
requirements; or
(B) a PET radioactive drug producer licensed in accordance
with §289.252(kk) of this title or equivalent NRC or agreement
state requirements; or
(2) excluding production of PET radionuclides, prepared
by:
(A) an authorized nuclear pharmacist; or
(B) a physician who is an authorized user and who meets
the requirements specified in subsections (jj) or (nn) and (jj)(1)(C)(ii)(VII)
of this section; or
Cont'd... |
