Authority: IC 16-41-35-26; IC 16-41-35-29
Affected: IC 16-41-35
Accountability, Storage and Transit.
Except as otherwise specifically authorized by the board, each licensee shall
provide accountability of sealed sources and shall keep a record of the issue
and return of all sealed sources to their place of storage.
Each licensee or registrant shall conduct
a physical inventory at intervals not to exceed 6 months to account for all
sources and devices received and possessed. Records of the inventories shall be
maintained for inspection by the board and shall include the quantities and
kinds of radioactive material, location of sources and devices, and the date of
1/ The U.S. Nuclear Regulatory
Commission requires these inventories to be done on a quarterly basis.
(3) Each licensee shall follow the
radiation safety and handling instructions approved by the board, the U.S.
Nuclear Regulatory Commission, an agreement state, or a licensing state and
furnished by the manufacturer on the label attached to the source, device, or
permanent container thereof, or in the leaflet or brochure which accompanies
the source or device, and maintain such instruction in a legible and
conveniently available form.
Each licensee or registrant shall assure that needles or standard medical
applicator cells containing cobalt-60 as wire, radium-226, or cesium-137 are
not opened while in the licensee's or registrant's possession unless
specifically authorized by a license or permit issued by the board.
Testing Sealed Sources for
Leakage and Contamination.
(1) All sealed
sources, containing more than 100 microcuries of radioactive material with a
half-life greater than 30 days, or 10 microcuries of radium-226, shall be
tested for leakage and/or contamination at intervals not to exceed 6 months or
at such other intervals as are approved by the board, the U.S. Nuclear
Regulatory Commission, an agreement state or a licensing state and described by
the manufacturer on the label attached to the source, device or permanent
container thereof, or in the leaflet or brochure which accompanies the source
or device. Each source or device shall be so tested prior to its first use
unless the supplier furnishes a certificate that the source or device has been
so tested within 6 months prior to the transfer.
Leak tests shall be capable of detecting
the presence of 0.005 microcurie of radioactive material on the test sample or,
in the case of radium, the escape of radon at the rate of 0.001 microcurie per
24 hours. The test sample shall be taken from the source or from the surfaces
of the device in which the source is permanently or semipermanently mounted or
stored on which one might expect contamination to accumulate. Any test
conducted pursuant to 410 IAC 5-7-2
(b)(1) which reveals the presence of 0.005
microcurie or more of removable contamination or, in the case of radium, the
escape of radon at the rate of 0.001 microcurie or more per 24 hours shall be
considered evidence that the sealed source is leaking. The licensee shall
immediately withdraw the source from use and shall cause it to be
decontaminated and repaired or to be disposed of in accordance with applicable
provisions of 410 IAC 5-4
. A report shall be filed with the board within 5 days
of the source withdrawal describing the equipment involved, the test results,
and the corrective action taken.
(3) Leak test results shall be recorded in
units of microcuries and maintained for inspection by the board.
The maximum radiation level at a distance
of one meter from the patient in whom brachytherapy sources have been inserted
shall be determined by measurement or calculation. This radiation level shall
be entered on the patient's chart and other signs as required under 410 IAC
(2) The radiation levels
in the patient's room and the surrounding area shall be determined, recorded,
and maintained for inspection by the board.
(3) The licensee or registrant shall assure
that patients treated with the cobalt-60, cesium-137, iridium-192 or radium-226
implants remain hospitalized until a source count and radiation survey of the
patient confirm that all implants have been removed.
Signs and Records.
In addition to the requirements of
, the bed, cubicle, or room of the hospital
brachytherapy patient shall be marked with a sign indicating the presence of
brachytherapy sources. This sign shall incorporate the radiation symbol and
specify the radionuclide, the activity, date, and the individual(s) to contact
for radiation safety instructions. The sign is not required provided the
The following information shall be
included in the patient's chart:
radionuclide administered, number of sources, activity in millicuries and time
and date of administration;
The exposure rate at 1 meter, the time the determination was made, and the name
of the individual who made the determination;
(iii) The radiation symbol; and
The precautionary instructions necessary
to assure that the exposure of individuals does not exceed that permitted under
Indiana State Department
of Health; Rule HRH-2, PT G, Sec G.2; filed May 26, 1978, 3:30 pm: 1 IR 221;
filed Feb 29, 1984, 10:10 am: 7 IR 966; readopted filed Jul 11, 2001, 2:23
p.m.: 24 IR 4234; readopted filed May 22, 2007, 1:44 p.m.:
20070613-IR-410070141RFA; readopted filed Sep 11, 2013, 3:19 p.m.:
filed 11/13/2019, 3:14 p.m.: