Ohio Administrative Code › Title 3701:1 - Radiation Control › Chapter 3701:1-66 - Radiation Generating Equipment › Section 3701:1-66-04 - Quality assurance program for medical radiation-generating equipment

Current through all regulations passed and filed through July 1, 2024
(A) Each registrant
			 shall develop, implement and maintain a written quality assurance program
			 in the form of a readily available manual or manuals,
			 either in hard copy format or electronic format. For purposes of this
			 chapter and Chapter 3701:1-67 of the Administrative Code, quality assurance
			 program means a program providing for verification by written procedures such
			 as testing, auditing, and inspection to ensure that deficiencies, deviations,
			 defective equipment, or unsafe practices, or a combination thereof, relating to
			 the use, disposal, management, or manufacture of radiation devices are
			 identified, promptly corrected, and reported to the appropriate regulatory
			 authorities.
(B) The written
			 quality assurance program of each registrant shall address and include records
			 to verify implementation of at least the following:
(1) The intervals of and procedures for the
			 evaluation of all radiation-generating equipment to ensure compliance with all
			 applicable rules of this chapter;
(2) Procedures for maintaining compliance
			 with occupational and public exposure limits;
(3) Procedures for notifying the director
			 when individuals are occupationally over exposed to radiation, pursuant to
			 Chapter 3701:1-38 of the Administrative Code;
(4) Safe operating procedures for each type
			 of radiation-generating equipment to be handled;
(5) Training of operators of each type of
			 radiation-generating equipment to be handled in order to assure competency in
			 the operating procedures;
(6) In
			 addition to the requirements of paragraph (B)(1) of rule
			 3701:1-38-10
			 of the Administrative Code, individuals likely to receive an annual
			 occupational dose in excess of one millisievert (one hundred millirem) shall be
			 instructed in the following:
(a) The
			 location, boundaries, and purpose of restricted areas; and
(b) A
			 description of the radiation-generating equipment and its location;
(7) The quality control tests to
			 be performed, the frequency of the quality control tests to be performed and
			 the personnel responsible for the performance of the quality control tests as
			 applicable to the radiation-generating equipment type and use;
(8) Policies regarding the state licensure or
			 certification of each person operating radiation-generating equipment as
			 required by Chapters 4773. and 4715. of the Revised Code;
(9) The dissemination of quality assurance
			 policies and a method to educate affected workers on those policies and any
			 policy changes;
(10) Radiation
			 workers' role and responsibility for following and supporting the quality
			 assurance program;
(11) Policies
			 regarding personnel protection, including time, distance, and
			 shielding;
(12) Policies regarding
			 occupational exposure of pregnant workers;
(13) Policies regarding radiation safety
			 training for ancillary personnel;
(14) Policies regarding training for
			 personnel with quality control responsibilities;
(15) Policies regarding
			 human patient protection, including screening for
			 pregnancy, exposure of pregnant patients, patient shielding, patient
			 education;
(16)
									Policies
			 regarding verification of human patient identity and exam to be performed,
			 including identification of the appropriate body part;
(17)
									Policies to only
			 permit licensed practitioners to order radiographic
			 examinations;
(18)
									An inventory of radiation-generating equipment,
			 including the location and description of each unit.