Cal. Code Regs. tit. 17 § 30305.5

Current through Register 2024 Notice Reg. No. 44, November 1, 2024
Section 30305.5 - Radiologic Technology Act Compliance and Movement of Patient or Equipment During X-ray Procedures Using Fluoroscopy
(a) A user shall assure that all persons under his or her jurisdiction that are operating or supervising the operation of X-ray equipment for purposes of radiologic technology, as defined in section 30400, comply with the Radiologic Technology Act (RT Act) (Health & Safety Code section 27) and the regulations adopted pursuant to the RT Act (commencing at section 30400 of Subchapter 4.5). For purposes of this section, the following terms apply:
(1) "Non-permitted individual" means a person who is:
(A) Not certified or permitted pursuant to the RT Act; or
(B) A CRT who does not hold a radiologic technologist fluoroscopy (RTF) permit issued pursuant to section 30451, an XT, or a certified supervisor and operator (S&O) who does not hold a fluoroscopy S&O permit issued pursuant to section 30466. The terms "CRT," "XT," and "certified supervisor and operator" are as defined in section 30400.
(2) "Patient" means a living human being exposed to X-ray for medical treatment.
(b) A user may allow a non-permitted individual, during use of fluoroscopy X-ray equipment on a patient while the equipment is not emitting X-rays, to move the patient or fluoroscopy X-ray equipment when all of the following conditions exist:
(1) A certified S&O holding either a radiology S&O certificate or fluoroscopy S&O permit, issued pursuant to section 30466:
(A) Is physically present in the room personally directing the actions of the non-permitted individual;
(B) Establishes or, after any movement of the patient or equipment, re-establishes the spatial relationship between the patient and the equipment; and
(C) Assesses or reassess the exposure technique and radiation safety consequences prior to initiation of or any subsequent radiation exposure to the patient; and
(2) The non-permitted individual does not actuate or energize the equipment to emit radiation or select the equipment's technique factors (e.g., kVp, mA) or mode of operation such as normal fluoroscopy (analog or digital), high-level control fluoroscopy, cineradiography (analog or digital), digital subtraction, electronic radiography using the fluoroscopic image receptor, and photospot recording, or adjust other system variables such as image magnification, X-ray field size, pulse modes, or optical aperture that affect a patient's radiation exposure.
(c) A user may allow a non-permitted individual, during use of fluoroscopy X-ray equipment on a patient while the equipment is emitting radiation exposing the patient, for the purpose of manipulating the patient if required for the procedure, to move the patient, or for the purpose of re-centering the equipment to the area of clinical interest, to move the equipment when all of the following conditions exist:
(1) A certified S&O holding either a radiology S&O certificate or fluoroscopy S&O permit is physically present in the room personally directing the non-permitted individual to perform the actions;
(2) Either a certified diagnostic radiologic technologist (RT), as defined in section 30400, holding a RTF permit issued pursuant to section 30451 or physician assistant (PA) holding a PA fluoroscopy (PAF) permit issued pursuant to section 30456.2 is physically present in the procedure room managing the patient's radiation exposure and actions of the non-permitted individual. Subject to the certified S&O's judgement, the RT or PA may stop the non-permitted individual from performing the actions and personally perform the actions if the RT or PA determines the use is unsafe or would unnecessarily increase the patient's radiation exposure;
(3) Prior to performing the actions, the non-permitted individual has completed the training specified in subsection (d) within the previous 12 months; and
(4) The non-permitted individual does not:
(A) Actuate or energize the fluoroscopy equipment to emit radiation;
(B) Select the equipment's technique factors (e.g., kVp, mA) or mode of operation such as normal fluoroscopy (analog or digital), high-level control fluoroscopy, cineradiography (analog or digital), digital subtraction angiography, electronic radiography using the fluoroscopic image receptor, or photospot recording, or adjust other system variables such as image magnification, X-ray field size (e.g., collimating), pulse modes (e.g., rate, duration), or optical aperture that affect a patient's radiation exposure; or
(C) Move the table or C-arm (i.e., equipment component on which the X-ray source and image receptor are connected) while radiation is continuously being emitted so as to continually observe the movement of guidewires, catheters or other radiopaque objects being introduced into or advanced through, or withdrawn from the patient (e.g., following the movement of a guidewire from insertion to the coronary arteries), movement of contrast material through vessels (e.g. panning), or for any other purpose other than those purposes specified in subsection (c).
(d) A user implementing subsection (c) shall ensure the non-permitted individual has satisfactorily completed instruction in the subject areas identified in paragraphs (1) through (5). This instruction shall be no less than 120 minutes in length, and be provided by a RTF or PAF permit holder, a holder of a radiology S&O certificate or fluoroscopy S&O permit, or an individual (such as a diagnostic medical physicist) deemed qualified to teach the instruction by holding academic or professional credentials appropriate to the instruction content, and being knowledgeable of educational instruction, evaluation, and the equipment to be used by the non-permitted individual. The instruction shall be provided to the non-permitted individual at intervals not to exceed 12 months. An individual meeting the criteria of subsection (a)(1)(B), for both the initial instruction and the 12-month re-instruction, need not meet the instruction specified in paragraphs (2), (3) and (5) provided the individual's certificate or permit issued pursuant to the RT Act is current and valid and the instruction length for paragraphs (1) and (4) is no less than one hour:
(1) Equipment set up and hands-on manipulation of the equipment by the prospective non-permitted individual and demonstration that they are able to safely set up and move or manipulate the equipment for the purposes specified in subsection (c). This equipment shall be the same equipment that the individual would be directed to move or manipulate for purposes of subsection (c). Exposure of human beings to X-ray is prohibited;
(2) Fundamentals of radiation protection including methods of controlling radiation dose to the patient, self and others: time, distance, shielding;
(3) Significance of radiation dose, to include hazards of excessive exposure to radiation, biological effects of radiation dose, and radiation protection standards;
(4) Expected levels of radiation from fluoroscopy equipment; and
(5) Characteristics and use of personnel monitoring equipment.
(e) If applicable, the user shall maintain for Department inspection documentation demonstrating compliance with subsection (d). This documentation shall include the following:
(1) Name of the individual and signature or initials of the individual;
(2) Date of the training;
(3) Instructor's name and documentation demonstrating the instructor meets the criteria specified in subsection (d); and
(4) Written and signed attestation by the instructor that the individual has satisfactorily completed the training and demonstrated they are able to competently and safely move or manipulate the fluoroscopy X-ray equipment for the purposes specified in subsection (c).
(f) Nothing in this section may be construed to authorize a non-permitted individual to perform tasks subject to the RT Act other than as specified in subsection (b) or (c), or to apply X-ray to a human being. For non-permitted individuals meeting subsection (a)(1)(B), this subsection may not be construed to affect any rights, responsibilities, obligations, exclusions, or limitations the RT Act or the regulations of subchapter 4.5 (commencing at section 30400) place on the individual's certificate or permit issued under the RT Act.
(g) For purposes of subsections (b) and (c), nothing in this section may be construed to authorize a RTF or PAF permit holder to substitute for the certified S&O.

Cal. Code Regs. Tit. 17, § 30305.5

1. New section filed 8-18-2020; operative 10-1-2020 (Register 2020, No. 34).

Note: Authority cited: Sections 114870(a), 114975, 115060 and 131200, Health and Safety Code. Reference: Sections 106965, 106980, 106985, 114870, 115060, 131050, 131051 and 131052, Health and Safety Code.

1. New section filed 8-18-2020; operative 10/1/2020 (Register 2020, No. 34).