Section 410IAC5-7-2. Interstitial, intracavitary, and superficial applications

 

                                (a) Accountability, Storage and Transit.

(1) 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.

(2) 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 the inventory.^1/

                                ^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.

(4) 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.

                                (b) 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.

(2) 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.

                                (c) Radiation Surveys.

(1) 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 5-7-2(d).

(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.

                                (d) Signs and Records.

(1) In addition to the requirements of 410 IAC 5-4-11, 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 exception in 410 IAC 5-4-12(b) is met.

(2) The following information shall be included in the patient's chart:

(i) The radionuclide administered, number of sources, activity in millicuries and time and date of administration;

(ii) 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

(iv) The precautionary instructions necessary to assure that the exposure of individuals does not exceed that permitted under 410 IAC 5-4-2.

(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.: 20131009-IR-410130346RFA)