Section 144-220-X-3 - Administrative RequirementsA. Administrative controls.(1) Registrant. The registrant shall be responsible for directing the operation of the therapeutic radiation machines under his/her administrative control. The registrant or the registrant's agent shall ensure that the requirements of Part X are met in the operation of the therapeutic radiation machine(s). (a) A therapeutic radiation machine that does not meet the provisions of this rule shall not be used for irradiation of patients.(b) Individuals who will be operating a therapeutic radiation machine for medical use shall be adequately instructed in the safe operating procedures and be competent in the safe use of the equipment. The licensing requirements pursuant to 32 MRSChapters 103 § 9851 et. seq. and 331 § 1100 I et.seq. as well as the associated rules established by the Radiologic Technology Board of Examiners shall be followed.(2) Written safety procedures and rules shall be developed by an authorized medical physicist and shall be available in the control area of a therapeutic radiation machine, including any restrictions required for the safe operation of the particular therapeutic radiation machine. The operator shall be able to demonstrate familiarity with these rules.(3) Individuals shall not be exposed to the useful beam except for medical therapy purposes unless such exposure has been ordered in writing by a licensed practitioner of the healing arts. This provision specifically prohibits deliberate exposure of an individual for training, demonstration or other non-healing arts purposes.(4) All individuals associated with the operation of a therapeutic radiation machine shall be instructed in and shall comply with the provisions of the registrant's quality management program.(5) Information and maintenance record and associated information. The registrant shall maintain the following information in a separate file or package for each therapeutic radiation machine, for inspection by the Agency: (a) Report of acceptance testing;(b) Records of all surveys, calibrations, and periodic quality assurance checks of the therapeutic radiation machine required by Part X, as well as the name(s) of person(s) who performed such activities;(c) Records of maintenance and/or modifications performed on the therapeutic radiation machine after August 1, 2001 as well as the name(s) of person(s) who performed such services;(d) Signature of person authorizing the return of therapeutic radiation machine to clinical use after service, repair, or upgrade.B. Records retention. (1) All records required by Part X shall be retained until disposal is authorized by the Agency, unless another retention period is specifically authorized in Part X.(2) All required records shall be retained in an active file from at least the time of generation until the next inspection.10-144 C.M.R. ch. 220, § X-3