ADMINISTRATIVE CONTROLS
§ 223.31. Registrant responsibilities.
(a) The registrant is responsible for directing the operation of X-ray systems under the registrant’s administrative control and shall assure that the requirements of this article are met for the operation of the X-ray systems.
(b) A person who operates an X-ray system shall be instructed adequately about safe X-ray operating procedures and be competent in the safe use of X-ray equipment. The instructions must include the subjects listed in Chapter 221, Appendix A (relating to determination of competence). The person shall receive continuing education at least every 4 years in radiation safety, biological effects of radiation, species-specific positioning techniques, QA and QC.
(c) Written safety procedures and rules shall be available at the facility and include restrictions of the operating technique required for the safe operation of the particular X-ray system. The operator shall be able to demonstrate familiarity with these procedures and rules.
(d) Only the staff, ancillary facility personnel or other persons required for the medical procedure or training may be within 2 meters of the device during the radiographic exposure. All of the following requirements apply to persons involved with the examination:
(1) An individual or extremity may not be positioned in the useful beam unless required to conduct the procedure.
(2) Individuals shall be positioned so that no part of the body will be struck by the useful beam unless protected by at least 0.5 millimeter lead equivalent material. The lead equivalent of the material is to be determined at 60 kV.
(3) Each person shall be protected from stray radiation by protective aprons or whole protective barriers of at least 0.25 millimeter lead equivalent or shall be positioned so that no person is in the direct line of the useful beam and the nearest portion of the body is at least 2 meters from both the tube head and the nearest edge of the image receptor.
(e) If an animal or image receptor requires auxiliary support during a radiation exposure, all of the following requirements apply:
(1) Mechanical holding devices or chemical restraint shall be used when the technique permits.
(2) An individual may not be used routinely to hold image receptors or subjects. Procedures and auxiliary equipment designed to minimize personnel exposure commensurate with the needed diagnostic information shall be used.
(3) An individual who holds the animal or image receptor shall be protected as required under subsection (d).
(f) The registrant shall have a QA program. The QA program must be documented and be in accordance with guidelines established by the Department or by another appropriate organization recognized by the Department. At a minimum, the QA program must address radiation safety to personnel and modifications to the QA program.
(g) Neither the X-ray tube housing nor the collimating device may be handheld during the exposure unless specifically designed and shielded to be handheld.
(h) CT systems used solely for nonhuman imaging are exempt from § § 221.202—221.205.
Authority The provisions of this § 223.31 issued under sections 301 and 302 of the Radiation Protection Act (35 P.S. § § 7110.301 and 7110.302); and section 1920-A of the Administrative Code (71 P.S. § 510.20).
Source The provisions of this § 223.31 adopted October 26, 2018, effective January 24, 2019, 48 Pa.B. 6791.
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