Part 6Irradiation of people for diagnostic, therapeutic or research purposes

Part 6—Irradiation of people for diagnostic, therapeutic or research purposes Division 1—Interpretation 103—Interpretation In this Part— Code for Radiation Protection in Medical Exposure means the Code for Radiation Protection in Medical Exposure (2019) published by ARPANSA (as in force from time to time); Code of Practice and Safety Guide for Radiation Protection in Dentistry means the Code of Practice and Safety Guide for Radiation Protection in Dentistry (2005) published by ARPANSA, as in force from time to time; Code of Practice for Radiation Protection in the Application of Ionizing Radiation by Chiropractors means the Code of Practice for Radiation Protection in the Application of Ionizing Radiation by Chiropractors (2009) published by ARPANSA, as in force from time to time; exposure authorisation means an authorisation under Division 2 authorising the exposure of a person to ionising radiation for the purpose of diagnosis or treatment. Division 2—Diagnostic and therapeutic purposes 104—Prohibition on exposures to ionising radiation without authorisation and justification A person must not expose themself or any other person to ionising radiation for the purposes of diagnosis or treatment unless the exposure has first been justified and authorised in accordance with this Division. 105—Justification and optimisation of medical, dental and chiropractic procedures (1) An employer must have protocols in place to ensure that a procedure involving the exposure of a person to ionising radiation for the purposes of diagnosis or treatment is not carried out unless the procedure has been justified by a health practitioner of a class who may, under regulation 106, authorise the procedure. (2) An employer must have protocols in place to ensure that a procedure involving the exposure of a woman to ionising radiation for the purposes of diagnosis or treatment is not carried out unless— (a) in the case of a procedure that may result in a dose of ionising radiation of more than 1 mSv to an embryo or fetus—the health practitioner authorising the procedure has taken reasonable steps to determine the pregnancy status of the person; or (b) in the case of a procedure involving the administration of a radiopharmaceutical that may result in a dose of ionising radiation of more than 1 mSv to a breast‑fed child—the health practitioner authorising the procedure has taken reasonable steps to determine the breast‑feeding status of the person. (3) For the purposes of subregulation (1), in determining whether a procedure involving the exposure of a person to ionising radiation for the purposes of diagnosis or treatment is justified, the health practitioner authorising the procedure must determine the net benefit to the person from the procedure, taking into account— (a) the specific objectives of the procedure; and (b) the characteristics of the person; and (c) the total potential clinical benefits, including— (i) direct health benefits to the person; and (ii) if relevant—benefits to society in general; and (d) the individual detriment to the person that may result from the procedure; and (e) the efficacy, benefits and risks of available alternate techniques having the same objectives with less exposure, or no exposure, to ionising radiation; and (f) any medical data and patient records relevant to the procedure; and (g) if the person is a female of child‑bearing capacity—the pregnancy status of the person; and (h) if there is the potential for a dose of ionising radiation of more than 1 mSv to a breast‑fed child from the administration of a radiopharmaceutical to a female person—the breast‑feeding status of the person. (4) A health practitioner who is responsible for the overall conduct of a procedure involving the exposure of a person to ionising radiation for the purposes of diagnosis or treatment must ensure that the radiation dose to be received by the person as a result of the procedure is optimised. (5) The operator of radiation apparatus must ensure that, in delivering a procedure involving the exposure of a person to ionising radiation for the purposes of diagnosis or treatment— (a) the person is not exposed unless— (i) a health practitioner of a class who may, under regulation 106, authorise such a procedure has given an exposure authorisation; and (ii) that exposure authorisation has not been revoked by a health practitioner of a class who may, under regulation 106, revoke the authorisation; and (b) the established protocol for the procedure is followed in accordance with the radiation management plan of the employer of the operator (if the employer is the holder of a radiation management licence and required to comply with the radiation management plan submitted under section 34 of the Act); and (c) the protection of the patient is optimised within the scope of the parameters under the control of the operator; and (d) the protection of persons other than the patient to ionising radiation from the procedure is optimised; and (e) in the case of radiation therapy— (i) a radiation treatment plan for the person has been approved by the health practitioner who authorised the radiation therapy; and (ii) the dose of ionising radiation from the radiation therapy is delivered to the person in accordance with the person's radiation treatment plan; and (iii) there is continuous oversight of the operating parameters of the radiation apparatus during the delivery of the dose of ionising radiation; and (iv) the exposure to ionising radiation from the radiation apparatus is immediately terminated if there is any concern that the apparatus will not deliver the correct dose of ionising radiation to the person. 106—Exposure authorisation (1) The Minister may, by notice in the Gazette— (a) specify the classes of health practitioners who may authorise exposure to ionising radiation from specified classes of procedures carried out for the purposes of diagnosis or treatment; and (b) specify the classes of health practitioners who may vary or revoke an exposure authorisation given in relation to specified classes of procedures carried out for the purposes of diagnosis or treatment. (2) Subject to this regulation, a health practitioner making an exposure authorisation must ensure that the authorisation— (b) contains the full name and date of birth of the person to be examined or treated; and (c) contains details of the examination or treatment that is authorised; and (d) contains the clinical indications for the examination or treatment; and (e) is signed by the health practitioner. (3) An exposure authorisation, or variation or revocation of an exposure authorisation, must be given before the examination or treatment that is that the subject of the authorisation has been carried out. (4) If an exposure authorisation is varied, the person making the variation must ensure that the variation— (b) contains the full name and date of birth of the person to be examined or treated; and (c) contains details of the examination or treatment that is authorised; and (d) contains in detail the reason for which the authorisation must be varied (including clinical indications for why the examination or treatment must be varied); and (e) is signed by the person making the variation. (5) If an exposure authorisation is revoked by a person, the person must ensure that the revocation— (b) contains the full name and date of birth of the person that was to be examined or treated; and (c) contains in detail the reason for which the authorisation must be revoked (including clinical indications for why the examination or treatment must not be carried out); and (d) is signed by the person making the revocation. (6) If— (a) a person authorises an examination or treatment under this Division; and (b) the person certifies in writing that they reasonably consider that the health of the patient will be compromised if the examination or treatment that is the subject of the authorisation is not carried out, the examination or treatment may be carried out without compliance with subregulation (2), provided that— (c) the authorisation is given before the examination or treatment begins; and (d) the person who gave the authorisation confirms the authorisation within 24 hours of giving the authorisation; and (e) the confirmation of the authorisation is— (i) given in writing or by an approved electronic system; and (ii) contains details of the examination or treatment that had been authorised; and (iii) contains the clinical indications for the examination or treatment; and (iv) is signed by the person who gave the authorisation. (7) A person who fails to confirm an authorisation as required under subregulation (6)(d) or (e) is guilty of an offence. 107—Duties of persons giving authorisation and carrying out treatment to make records (1) A person who authorises the exposure of a person to ionising radiation for the purposes of radiation therapy must, immediately after giving the authorisation, make a record containing the following information: (a) the full name, date of birth and residential address of the person to be treated; (b) the type of ionising radiation to be given as treatment; (c) the date on which treatment was authorised; (d) the equivalent doses to be given; (e) details of the organs and tissues (or anatomical regions) to be given those equivalent doses; (f) the indications for the treatment. (2) A person carrying out a treatment referred to in subregulation (1) must, immediately after carrying out that treatment— (a) enter in the record— (i) the date on which the treatment was carried out; and (ii) full details of the treatment factors and parameters actually employed to deliver the dose to the patient; and (b) sign the entry immediately after it has been made. (3) A person must not destroy or dispose of a record made under this regulation except as is approved by the Minister. Division 3—Research purposes 108—Prohibition on in vivo research without prior approval (1) In this regulation— Code of Practice for the Exposure of Humans to Ionizing Radiation for Research Purposes means the Code of Practice for the Exposure of Humans to Ionizing Radiation for Research Purposes (2005) published by ARPANSA, as in force from time to time and as modified by subregulation (2); in vivo research means research in vivo, the subject of which is a human being and during the course of which that human being is exposed to ionising radiation which they would not have received but for the research. (2) The Code of Practice for the Exposure of Humans to Ionizing Radiation for Research Purposes is modified as follows: (a) a reference to the relevant regulatory authority is to be taken to be a reference to the Minister; (b) a reference to the responsible person for radioactive material, radiation apparatus, facility or premises is to be taken to be a reference to the owner of the radioactive material, radiation apparatus, facility or premises. (3) A person must not undertake in vivo research or expose themself or any other person to ionising radiation in the course of in vivo research unless the research has been approved in accordance with the requirements of the Code of Practice for the Exposure of Humans to Ionizing Radiation for Research Purposes. (4) A person who undertakes in vivo research must ensure that the research is conducted in accordance with the Code of Practice for the Exposure of Humans to Ionizing Radiation for Research Purposes.