Chapter 3701:1-66 Radiation Generating Equipment

3701:1-66-01 Definitions.

(A) Terms defined in this rule are intended to be used only within this chapter of the Administrative Code.

(B) As used in this chapter:

(1) “Air kerma” means the sum of the initial kinetic energies of all charged ionizing particles liberated by uncharged ionizing radiation in a given mass of air. The unit for air kerma is joules per kilogram which is given the special name of gray (Gy). To determine air kerma in Gy from exposure in units of roentgens (R) multiply exposure by the conversion factor 0.00876 Gy/R.

(2) “Aluminum equivalent” means the thickness of aluminum affording the same attenuation, under specified conditions, as the material in question.

(3) “Automatic exposure control,” or “AEC,” means a device which automatically controls one or more technique factors in order to obtain, at a preselected location, a required quantity of radiation.

(4) “Beam-limiting device” means a collimator which provides a means to restrict the dimensions of the x-ray field.

(5) “Calibration” except as provided in rules 3701:1-66-14 and 3701:1-66-15 of the Administrative Code, means the determination of the response or reading of an instrument relative to a series of known radiation values over the range of the instrument, or the radiation output of a source of radiation relative to a standard.

(6) “Coefficient of variation” means the ratio of the standard deviation to the mean value of a sample of observations.

(7) “Collimator” means a device or mechanism by which the x-ray beam is restricted in size.

(8) “Computed radiography” means a system that utilizes a photostimulable phosphor (PSP) plate for capturing radiographic images. The components of the system include, at a minimum, the PSP plate and a computed radiography reader which laser scans the exposed plate, collects the stimulated light and ultimately creates the digital image.

(9) “Computed tomography,” or “CT,” means an imaging procedure that uses multiple x-ray transmission measurements and a computer program to generate tomographic images of a patient or material.

(10) “Contrast scale” means the change in the linear attenuation coefficient per CTN relative to water.

(11) “Control panel” means that part of the radiation-generating equipment used for setting the technique factors.

(12) “CT conditions of operation” means all selectable parameters governing the operation of CT radiation-generating equipment including, but not limited to, nominal tomographic section thickness, filtration, MA, KVP and scan time.

(13) “CT noise” means the per cent standard deviation of the fluctuations in CTN expressed as a percentage of the attenuation coefficient of water.

(14) “CT number,” or “CTN,” means the number used to represent the x-ray attenuation associated with each elemental area of the CT image.

(15) “Dead-man switch” means a switch so constructed that a circuit closing contact can be maintained only by continuous pressure on the switch by the operator.

(16) “Diagnostic radiation-generating equipment” means x-ray machines designed for irradiation of any part of a human body or animal, or phantom for the purpose of diagnosis or visualization, or teaching.

(17) “Direct scattered radiation,” means scattered radiation which has been deviated once in direction only by materials irradiated by the useful beam.

(18) “Enclosed system” means industrial radiation-generating equipment operated in an enclosure or cabinet and may include, but is not limited to, cabinet radiography, irradiation devices, and other equipment.

(19) “Executive administration” means individuals who belong to the two highest levels of authority within the hospital as listed on the hospital’s organizational chart. The highest level may include the president, chief executive officer, or hospital administrator. The second level may include vice president, chief financial officer, or an administrative director of hospital services groups.

(20) “Filter” means material placed in the useful beam to preferentially attenuate selected radiations.

(21) “Half-value layer,” or “HVL,” means the thickness of specified material which attenuates the beam of radiation to an extent such that the exposure rate is reduced by one-half.

(22) “Handle” means receive, possess, use, store, transfer, install, service, or dispose of radiation-generating equipment unless possession is solely for the purpose of transportation.

(23) “Handler” means a facility that handles radiation-generating equipment unless possession is solely for the purpose of transportation.

(24) “Image receptor” means any device, such as a fluorescent screen, radiographic film, or digital detector which transforms incident X-ray photons either into a visible image or into another form which can be made into a visible image by further chemical or computer signal processing.

(25) “Individual responsible for radiation protection” or “IRRP” means the person the registrant has designated the responsibility of assuring radiation safety and implementing the quality assurance program for that facility.

(26) “Industrial irradiation devices” means radiation-generating equipment used to alter the chemical, biological, or physical properties of materials or to sterilize materials.

(27) “Industrial radiation-generating equipment” means X-ray machines used to produce ionizing radiation for purposes other than dental, veterinary, medical or therapeutic uses on patients.

(28) “Industrial radiographer” means any individual who performs or personally supervises industrial radiographic operations and who is responsible to the registrant for assuring compliance with the requirements of these regulations and certification of registration conditions.

(29) “Industrial radiographer assistant” means any individual who, under the personal supervision of an industrial radiographer, uses radiation-generating equipment, related equipment, or radiation survey instruments in industrial radiography.

(30) “Inherent filtration” means the filtration in the useful beam due to the window of the X-ray tube and any permanent tube enclosure.

(31) “Ionizing radiation” means gamma rays and X-rays, alpha and beta particles, high-speed electrons, neutrons, protons, or other atomic or nuclear particles or rays with sufficient energy to form ions during an interaction with matter, but does not include sound or radio waves or visible, infrared, or ultraviolet light.

(32) “Kilovoltage peak,” or “kVp,” means the maximum value of the electrical potential difference between the cathode and the anode of the X-ray tube during an exposure.

(33) “Lead equivalent” means the thickness of lead affording the same attenuation, under specified conditions, as the material in question.

(34) “Leakage radiation” means all radiation coming from within the X-ray tube housing except the useful beam.

(35) “Licensed practitioner” means an individual licensed by the state of Ohio pursuant to:

(a) Chapter 4715. of the Revised Code to practice dentistry;

(b) Chapter 4731. of the Revised Code to practice medicine or surgery or osteopathic medicine or surgery;

(d) Chapter 4741. of the Revised Code to practice veterinary medicine;

(e) Chapter 4734. of the Revised Code to practice chiropractic medicine; and

(f) Chapter 4723. of the Revised Code to practice as a clinical nurse specialist within the scope of practice of his or her collaborating physician.

(g) Chapter 4730. of the Revised Code to practice as a physician assistant within the scope of practice of his or her supervising physician and in accordance with the utilization plan approved by the state medical board.

(36) “Light field” means that area of the intersection of the light beam from the beam-limiting device and one of the set of planes parallel to and including the plane of the image receptor, whose perimeter is the locus of points at which the illumination is one-fourth of the maximum in the intersection.

(37) “Local components” means parts of an analytical radiation-generating system and includes areas that are struck by X-rays such as radiation source housings, port and shutter assemblies, collimators, sample holders, cameras, goniometers, detectors, and shielding, but does not include power supplies, transformers, amplifiers, readout devices, and control panels.

(38) “Locked out and tagged” means a system of equipment security and safety in which radiation-generating equipment, rendered inoperable for storage or because of faulty operation is locked to prevent operation and tagged with specific information as to why it is not to be used. Suggested tag warning, “DO NOT USE — EQUIPMENT NEEDS REPAIR OR CALIBRATION — CONTACT RADIATION SAFETY OFFICER PRIOR TO USE.”

(39) “Milliampere,” or “MA,” means the measurement of tube current which reflects the number of electrons flowing from the cathode to the anode of an X-ray tube during X-ray production.

(40) “Mobile” means radiation-generating equipment mounted on a permanent base with wheels installed in a van, trailer, or mobile vehicle.

(41) “Multiple tomogram system” means a CT radiation-generating equipment which obtains X-ray transmission data simultaneously during a single scan to produce more than one tomogram.

(42) “Nondestructive testing” or “NDT” means the development and application of technical methods to examine materials or components in ways that do not impair future usefulness and serviceability in order to detect, locate, measure and evaluate flaws; to assess integrity, properties and composition; and to measure geometrical characterisitics.

(43) “Open-beam” means an analytical radiation-generating equipment in which an individual could place any part of his or her body in the primary beam during normal operation.

(44) “Patient” means an individual or animal subjected to a radiographic diagnosis or examination, or therapy.

(45) “Permanent radiographic installation” means a shielded installation or structure designed or intended for radiography and in which radiography is regularly performed.

(46) “Portable” means radiation-generating equipment designed to be hand-carried.

(47) “Primary protective barrier” means a barrier sufficient to attenuate the useful beam to the required radiation level.

(48) “Protective apron” means an apron made of radiation-attenuating materials used to reduce radiation exposure.

(49) “Protective barrier” means a barrier of radiation-attenuating materials used to reduce radiation exposure.

(50) “Protective glove” means a glove made of radiation-attenuating materials used to reduce radiation exposure.

(51) “Radiation expert” means an individual that meets the qualifications of:

(a) Applicable paragraphs of rule 3701:1-66-03 of the Administrative code for hospitals registered under section 3710.07 of the Revised Code as determined by the type of radiation equipment used for the radiation service;

(b) Paragraph (D) of rule 3701-83-45 of the Administrative Code for any facility providing radiation therapy services;

(c) Paragraph (C)(3) of rule 3701-83-52 of the Administrative Code for CT equipment or paragraph (F)(3) of rule 3701-83-52 of the Administrative Code for fluoroscopy at any facility providing CT or fluoroscopy services; or

(d) 21 C.F.R. 900.12(a)(3) for any facility providing mammography services.

(52) “Radiation-generating equipment” means any manufactured product or device or any component of such a product or device, or any machine or system that during operation can generate or emit ionizing radiation, except those that emit ionizing radiation only from radioactive material. The system includes, minimally, an x-ray high voltage generator, an x-ray control, a tube housing assembly, a beam-limiting device, and the necessary supporting structures. “Radiation-generating equipment” does not include either of the following:

(a) Diathermy machines; or

(b) Microwave ovens including food service microwave ovens used for commercial and industrial uses, television receivers, electric lamps, and other appliances and products such as computer monitors that generate very low levels of radiation.

(53) “Radiation worker” means an individual engaged in activities registered by the department and controlled by the registrant, but does not include the registrant.

(54) “Reference plane” means a plane which is displaced from and parallel to the computed tomographic plane.

(55) “Scan” means the complete process of collecting x-ray transmission data for the production of a tomogram. Data can be collected simultaneously during a single scan for the production of one or more tomograms.

(56) “Scan increment” means the amount of relative displacement of the patient with respect to the CT x-ray system between successive scans measured along the direction of such displacement.

(57) “Scan sequence” means a pre-selected set of two or more scans performed consecutively under pre-selected CT conditions of operation.

(58) “Scattered radiation” means radiation that, during passage through matter, has been deviated in direction.

(59) “Secondary protective barrier” means a barrier sufficient to attenuate stray ionizing radiation to a required level.

(60) “Shutter” means a device, fixed to any radiation-generating equipment housing to intercept the useful beam.

(61) “Single tomogram system” means a CT x-ray system which obtains x-ray transmission data during a scan to produce a single tomogram.

(62) “Source” means the point of origin of the useful radiation beam.

(63) “Source-to-image receptor distance,” or “SID,” means the distance from the source to the center of the input surface of the image receptor.

(64) “Source-to-skin distance,” or “SSD,” means the distance between the source and the skin of the patient.

(65) “Stationary equipment” means equipment which is installed in a fixed location.

(66) “Stray radiation” means leakage radiation or scattered radiation.

(67) “Technique factors” means any combination of the following which determines the exposure rate: KVP, MA, TIME, X-ray pulses, or the product of tube current and exposure time in MAs.

(68) “Temporary job site” means any location where industrial radiography is performed other than the location listed in the certificate of registration.

(69) “Therapeutic radiation-generating equipment” means x-ray or electron-producing machines designed and used for external beam radiation therapy.

(70) “Tomogram” means the depiction of the radiation attenuation properties of a section through a body.

(71) “Tomographic plane” means that geometric plane which is identified as corresponding to the output tomogram.

(72) “Tomographic section” means the volume of an object whose x-ray attenuation properties are imaged in a tomogram.

(73) “Tube housing assembly” means the tube housing with tube installed. It includes high-voltage or filament transformers and other appropriate elements when they are contained within the tube housing.

(74) “Useful beam” means that part of the radiation which passes through the window, aperture, cone, or other collimating device of the source housing.

(75) “X-ray field” means that area of the intersection of the useful beam and any one of the set of planes parallel to and including the plane of the image receptor, whose perimeter is the locus of points at which the exposure rate is one-fourth of the maximum in the intersection.

Effective: 06/01/2006

R.C. 119.032 review dates: 02/01/2006 and 02/01/2011

Promulgated Under: 119.03

Statutory Authority: 3748.04

Rule Amplifies: 3748.01, 3748.02, 3748.04 to 3748.07, 3748.12 to 3748.15, 3748.17 to 3748.20, 3748.22, 3748.99

Prior Effective Dates: 2/15/2001

3701:1-66-02 General administration requirements for handlers of radiation-generating equipment.

As used in this rule, “radiation-generating equipment” means x-ray machines, other than industrial and therapeutic radiation-generating equipment, which are used for dental, veterinary, or medical diagnosis. In addition to other applicable rules contained in Chapters 3701:1-38 and 3701:1-66 of the Administrative Code, handlers of radiation-generating equipment shall comply with the following:

(A) The director may, upon application thereof or upon his or her own initiative, grant a variance to the requirements of rules in this chapter as he or she determines is authorized by law, provided that the registrant shows to the satisfaction of the director that there is good cause for the variance, and that the variance will not result in any undue hazard or effect on the public health and safety or environment. The terms, conditions, and expiration of the variance shall be set forth in writing by the director. Failure to comply with the terms of the variance may result in immediate revocation of the variance.

(B) No person shall be exposed to the useful beam except the patient for dental or medical radiography procedures and unless such exposure has been authorized by a licensed practitioner within his or her scope of practice. This provision specifically prohibits deliberate exposure for the following purposes:

(1) Exposure of a person for training, demonstration, or other non-dental or nonmedical diagnostic purposes; and

(2) Exposure of a person for the purpose of self-referred screening except as authorized by the department in accordance with paragraph (C) of this rule.

(C) Any person proposing to conduct a self-referral screening program using radiation-generating equipment shall not initiate such a program without prior approval of the department. When requesting such approval, that person shall submit information on a form prescribed by the department. If any information submitted to the department becomes invalid or not current, the department shall be immediately notified in writing.

(D) The department may use interview or observation to determine that the handler assures:

(1) Every individual who performs radiologic procedures on human beings holds the appropriate radiologic license as required by Chapters 3701-72 and 4715-12 of the Administrative Code; and

(2) Every individual who is licensed to perform radiologic procedures is adequately instructed in the registrant’s safe operating procedures and can demonstrate competency in the safe use of the equipment.

(E) Any radiation-generating equipment that does not meet the provisions set forth in this rule or any other applicable equipment requirements of Chapter 3701:1-66 of the Administrative Code shall not be operated for diagnostic purposes unless the director or a radiation expert determines that the non-compliance will not pose a radiation risk and arrangements have been made to promptly correct the non-compliance.

(F) Each piece of radiation-generating equipment shall bear a warning label on the control panel which cautions individuals that radiation is produced when it is energized.

(G) All types of radiation-generating equipment shall meet the following standards:

(1) On battery-powered x-ray generators, visual means shall be provided on the control panel to indicate whether the battery is in a state of charge adequate for proper operation.

(2) The leakage radiation from the diagnostic source assembly measured at a distance of one meter in any direction from the source shall not exceed 0.88 milligray air kerma (one hundred milliroentgen exposure) in one hour when the x-ray tube is operated at its leakage technique factors. Compliance shall be determined by measurements averaged over an area of one hundred square centimeters with no linear dimension greater than twenty centimeters;

(3) Except for mammographic radiation-generating equipment, the half-value layer (HVL) of the useful beam for a given x-ray tube potential shall not be less than the values shown in table 1. If it is necessary to determine such HVL at an x-ray tube potential which is not listed in table 1, linear interpolation or extrapolation may be made.

Table 1

For Table 1 – To obtain the appendix, table, image, etc. please call LSC’s ERF Helpdesk at 614-387-2078 or send an email to erfhelpdesk@lsc.state.oh.us.

(a) For capacitor energy storage equipment, compliance with the requirements of this paragraph shall be determined with the system fully charged and a setting of ten milliampere-seconds (mAs) for each exposure; and

(b) The required minimal HVL of the useful beam shall include the filtration contributed by all materials which are permanently between the source and the patient.

(4) For x-ray systems which have variable kilovolt peak (kVp) setting and variable filtration for the useful beam, a device shall link the kVp selector with the filter and shall prevent an exposure unless the minimum amount of filtration necessary to produce the HVL required by paragraph (G)(3) of this rule is in the useful beam for the given kVp which has been selected.

(5) Where two or more x-ray tubes are controlled by one exposure switch, the tube that has been selected shall be clearly indicated prior to initiation of the exposure. This indication shall be both on the x-ray control panel and at or near the selected tube housing assembly.

(6) The x-ray tube housing assembly supports shall be adjusted such that the tube housing assembly will remain stable during an exposure unless tube housing movement is a feature design of the radiation-generating equipment.

(7) The technique factors to be used during an exposure shall be indicated before the exposure begins. If automatic exposure controls are used, the technique factors which are set prior to the exposure shall be indicated. This requirement may be met by permanent markings on equipment having fixed technique factors. Indication of technique factors shall be visible from the operator’s position except in the case of spot films taken during fluoroscopy procedures or dental intraoral or panoral films.

(8) All position locking, holding, and centering devices on radiation-generating equipment components shall function as designed by the manufacturer.

(H) In addition to other applicable radiation safety rules in Chapter 3701:1-66 of the Administrative Code, handlers of radiation-generating equipment shall meet the following radiation safety requirements:

(1) The registrant shall be responsible for developing safe operating procedures for the operation of the radiation-generating equipment, including any restrictions of the operating technique required for the safe operation of each radiation-generating equipment, and for documenting the instruction and assuring that all operators are competent in the safe use of the radiation-generating equipment.

(2) Except for radiation-generating equipment having preprogrammed or softwarebased techniques selections, a chart shall be provided in the vicinity of the radiation-generating equipment’s control panel which specifies, for examinations performed with that system, the following information:

(a) Patient’s body part, radiographic projection, anatomical size, or age in the case of pediatrics, and the technique factors to be utilized for each;

(b) Type and size of the image receptor to be used;

(d) Source-to-image receptor distance (SID) to be used, except for fluoroscopy, and dental intraoral or panoral radiography.

(3) Gonadal shielding of not less than 0.5 millimeter lead equivalent material shall be used for human patients, who have not passed the reproductive age, during radiographic procedures in which the gonads are in the useful beam, except for cases in which this would interfere with the radiographic procedure.

(4) Except for patients who cannot be moved out of the room, only the staff, ancillary personnel or other persons required for the medical procedure or training shall be in the room during the radiographic procedure. Other than the patient being examined:

(a) All individuals shall be positioned such that no part of the body shall be struck by the useful beam unless protected by not less than 0.5 millimeter lead equivalent material;

(b) The x-ray operator, other staff, ancillary personnel, and other persons required for the medical procedure shall be protected from the direct scatter radiation by protective aprons or whole body protective barriers of not less than 0.25 millimeter lead equivalent material; and

(c) Human patients who cannot be removed from the room shall be protected from the direct scatter radiation by whole body protective barriers of not less than 0.25 millimeter lead equivalent material or shall be so positioned that the nearest portion of the body is at least two meters (6.5 feet) from both the tube head and the nearest edge of the image receptor.

(5) When a patient requires auxiliary support for holding the patient or the image receptor during an exposure, the handler shall ensure the following:

(a) Mechanical holding devices shall be used when the procedure permits;

(b) Written safe operating procedures required by this rule shall indicate the requirements for selecting someone to hold, and the procedure that shall be followed. All holders must be at least eighteen years of age;

(d) No individual shall routinely hold patients or image receptors unless a licensed practitioner, within his or her scope of practice, declares that auxiliary support is necessary as described in the registrant’s safe operating procedures. The holder shall not be a radiation worker whenever possible;

(e) If it is declared necessary by a licensed practitioner within his or her scope of practice for an individual to routinely hold patients or image receptors, he or she shall be instructed in personal radiation safety and protection as documented in the registrant’s safe operating procedures. Notwithstanding the ten per cent individual dose monitoring requirements in paragraph (B) of rule 3701:1-38-14 of the Administrative Code, any person who routinely holds patients or films shall be provided with personal monitoring devices so as to ensure compliance with the occupational dose limits specified in rule 3701:1-38-12 of the Administrative code; and

(f) The facility shall have protective aprons and gloves available in sufficient numbers to provide protection to anyone who is involved with x-ray operations.

(6) Any radiation worker participating in fluoroscopic, veterinary, or mobile or portable x-ray procedures shall be required to wear an individual monitoring device unless the registrant demonstrates it is unlikely the radiation worker will receive in excess of the doses specified in paragraphs (B)(1)(a) to (B)(1)(c) of rule 3701:1-38-14 of the Administrative Code.

(7) The entrance air kerma resulting from the technique used for the specified average adult patient for routine diagnostic radiography shall not exceed the values listed in table 2. The entrance air kerma resulting from the technique used for routine intraoral bitewing exams shall not exceed the values listed in table 3. All values of entrance air kerma are specified as free-in-air, without backscatter. The corresponding entrance exposure in milliroentgens is listed in parentheses. Linear extrapolation or interpolation shall be used for an x-ray tube potential (kVp) not listed in table 3.

Table 2

Table 3

For Tables – To obtain the appendix, table, image, etc. please call LSC’s ERF Helpdesk at 614-387-2078 or send an email to erfhelpdesk@lsc.state.oh.us.

(8) Procedures and auxiliary equipment designed to minimize patient and radiation worker exposure shall be utilized as follows:

(a) For facilities utilizing radiographic film, the speed of the screen and film combinations used shall be the fastest speed consistent with the diagnostic objective of the examinations. Film cassettes without intensifying screens shall not be used for any routine diagnostic radiography, with the exception of veterinary, dental intraoral, and specimen radiography;

(b) Radiation-Generating equipment subject to rule 3701:1-66-05 of the Administrative Code shall not be utilized in procedures where the source-to-skin distance (SSD) is less than thirty centimeters, except for veterinary x-ray systems;

(c) If grids are used between the patient and the image receptor to decrease scatter to the image receptor and improve contrast, the grid shall be:

(i) Properly aligned, with the x-ray tube side facing the correct direction, and the grid centered to the central ray; and

(ii) The proper focal distance for the SID being used.

(9) Except for radiation-generating equipment used for veterinary, portable, dental panoral, dental intraoral, lithotripsy, or bone densitometry, the operator shall stand behind a protective barrier, either in a separate room, in a protected booth, or behind a shield from which the patient can be viewed while an exposure is made.

(I) In addition to other applicable structural shielding requirements in Chapter 3701:1-66 of the Administrative Code, handlers of radiation-generating equipment shall comply with the following:

(1) For all units, except those used for bone densitometry, mammography, dental panoral or dental intraoral radiography:

(a) Handlers shall utilize a radiation expert to prepare a shielding design to include specifications for all structural radiation barriers:

(ii) Prior to new construction, renovation, or

(ii) For new radiation-generating equipment installations which might cause a significant increase in radiation hazard.

(b) The individual responsible for radiation protection shall obtain a written report of the shielding design from the radiation expert, and a copy of the report shall be made available to the director upon request.

(c) Handlers shall utilize a radiation expert to conduct an area radiation survey of the installation prior to patient use:

(i) Upon a new installation of radiation-generating equipment, or

(ii) After any change in the radiation-generating equipment, its structural shielding, or workload which might cause a significant increase in radiation hazard.

(d) The individual responsible for radiation protection shall obtain a written report of the area radiation survey from the radiation expert. A copy of the report shall be made available to the director upon request.

(2) Handlers shall assure that no individual operates or permits the operation of radiation-generating equipment unless structural shielding and protective barriers are used such that no person other than the patient being examined shall receive a total effective dose equivalent in excess of the limits prescribed in rules 3701:1-38-12 and 3701:1-38-13 of the Administrative Code.

(3) Handlers shall provide a protective barrier either in a separate room, in a protected booth, or use a mobile barrier that will intercept the useful beam and any direct scattered radiation.

(4) Handlers shall provide a window of lead equivalency affording protection equal to that required by the adjacent barrier, a television monitoring system, or a mirror system large enough and so placed that the operator can see the patient without having to leave the protected area during exposure.

(J) In addition to all applicable rules in Chapter 3701:1-66 of the Administrative Code, handlers of radiation-generating equipment shall meet the following quality assurance requirements:

(1) X-ray systems and associated components used on humans and certified pursuant to 21 C.F.R. part 1020. Shall be maintained in compliance with applicable requirements of that standard, and handlers shall maintain documentation of compliance between inspections.

(2) The handler shall maintain the following information for each radiation-generating equipment for inspection by the department:

(a) Model and serial numbers of all major components such as generators, control panels, and tubes, and user’s manual for those components;

(b) Records of surveys, calibrations, maintenance, and modifications performed on the radiation-generating equipment which shall be maintained between inspections; and

(3) Unless otherwise specified in another rule in this chapter, each installation using a piece of radiation-generating equipment and using analog image receptors, such as radiographic film, shall have available suitable equipment for handling and processing radiographic images in accordance with the following provisions:

(a) For manually processing film:

(i) Developer and fixer tanks shall be constructed of mechanically rigid, corrosion resistant material; and

(ii) The temperature of solutions in the tanks shall be maintained within the range of 15.6 to 26.7 degrees celsius (sixty to eighty degrees fahrenheit). Film shall be developed in accordance with the time-temperature relationships recommended by the film manufacturer, or, in absence of such recommendations, with the following time-temperature chart:

Time-Temperature Chart

Thermometer Reading (Degrees) Minimum Developing Time (Minutes)

�C �F

26.7 80 2

26.1 79 2

25.6 78 2.5

25.0 77 2.5

24.4 76 3

23.9 75 3

23.3 74 3.5

22.8 73 3.2

22.2 72 4

21.7 71 4

21.1 70 4.5

20.6 69 4.5

20.0 68 5

19.4 67 5.5

18.9 66 5.5

18.3 65 6

17.8 64 6.5

17.2 63 7

16.7 62 8

16.1 61 8.5

15.6 60 9.5

(iii) Devices shall be utilized which will indicate the actual temperature of the developer and signal the passage of a preset time appropriate to the developing time required;

(b) For automatic processors and other closed processing systems:

(i) Films shall be developed in accordance with the time-temperature relationships recommended by the film manufacturer; in the absence of such recommendations, the film shall be developed using the following chart:

Developer Temperature (Degrees) Minimum Immersion Time a/(Seconds)

�C �F

35.5 96 19

35 95 20

34.5 94 21

34 93 22

33.5 92 23

33 91 24

32 90 25

31.5 89 26

31 88 27

30.5 87 28

30 86 29

29.5 85 30

a/ Immersion time only, no crossover time included.

(ii) The specified developer temperature and immersion time shall be posted in the darkroom, on the automatic processor, or be readily available to the operator; and

(c) Processing deviations from the requirements listed above shall be documented by the handler in such manner that the requirements of this rule are shown to be met or exceeded, such as with extended processing, and special rapid chemistry.

(d) Film processing solutions shall be prepared in accordance with the directions given by the film manufacturer, and shall be maintained in strength by replenishment or renewal so that full development is accomplished within the time specified by the manufacturer.

(4) Pass boxes, if provided, shall be so constructed as to exclude light from entering the darkroom when cassettes are placed in or removed from the boxes, and shall incorporate adequate shielding from stray radiation to prevent exposure of undeveloped film.

(5) The darkroom shall be light tight and use proper safelighting such that any film which would produce an optical density between one and two when exposed in a cassette to x-radiation and then processed shall:

(a) Not suffer an increase in optical density greater than 0.1 when exposed in the darkroom for two minutes with all safelights on; and

(b) Not suffer an increase in optical density greater than 0.05 for mammography when exposed to the darkroom for two minutes with all safelights on.

(6) Darkrooms typically used by more than one individual shall provide a method to prevent accidental entry of light while undeveloped films are being handled or processed.

(7) Film shall be stored in a cool, dry place and shall be protected from exposure to stray radiation. Film in open packages shall be stored in a light-tight container. If used, daylight film handling boxes shall preclude fogging of the film.

(8) Expired x-ray film shall not be used for diagnostic radiographs.

(9) Cassettes, intensifying screens, and computed radiographic imaging plates shall be inspected, cleaned according to its manufacturer’s specification, and replaced as necessary to assure radiographs of good diagnostic quality. Documentation of quality control results shall be made available for review by the department.

(10) For those registrants employing computed radiography imaging systems, the following shall apply:

(a) If the computed radiography reader is located in the same room as the radiation-generating equipment and it is not behind a protective barrier, the quality assurance procedures shall preclude x-ray exposures during image processing;

(b) Computed radiography plates shall be processed as soon as possible after exposure and shall not exceed eight hours under any circumstances; and

(c) Computed radiography plates shall be adequately shielded from stray radiation. Registrants shall develop a process that will ensure that computed radiography plates are used frequently enough or erased so as to produce diagnostic quality images.

Effective: 07/03/2006

R.C. 119.032 review dates: 02/01/2006 and 02/01/2011

Promulgated Under: 119.03

Statutory Authority: 3748.04

Rule Amplifies: 3748.01, 3748.02, 3748.04 to 3748.07, 3748.12 to 3748.15, 3748.17 to 3748.20, 3748.22, 3748.99

Prior Effective Dates: 2/15/2001

3701:1-66-03 Certification of radiation experts.

(A) An individual may seek certification from the Ohio department of health as a radiation expert in one or more of the following categories of radiation-generating equipment:

(1) Therapeutic;

(2) Diagnostic other than mammography; or

(3) Mammography.

An individual certified as a radiation expert is qualified to develop, provide periodic review of, and conduct audits of the quality assurance program required under division (A) of section 3748.13 of the Revised Code for that category of radiation-generating equipment for which the individual is certified. A certified radiation expert shall be responsible for conducting oversight and maintenance and filing audit reports of quality assurance programs required under division (A) of section 3748.13 of the Revised Code.

(B) An individual seeking certification as a radiation expert shall apply to the department on a form prescribed and provided by the director. The application must contain at least the following:

(1) Name and address of the applicant;

(2) Category or categories for which application is being made;

(3) A non-refundable check or money order payable to “treasurer, state of Ohio” for the appropriate certification fee in the amount of one hundred dollars for each category specified in paragraph (A) of this rule; and:

(4) Evidence that the applicant has appropriate training and qualifications to perform oversight and maintenance of quality assurance programs required by division (A) of section 3748.13 of the Revised Code for the category for which the applicant is applying as set forth in paragraphs (C) to (E) of this rule.

(C) An applicant for radiation expert certification for the category of therapeutic radiation-generating equipment shall have at least one of the following:

(1) Certification by the “American Board of Radiology” in radiological physics or therapeutic radiological physics;

(2) Certification by the “American Board of Medical Physics” in medical physics with a specialty in radiation oncology physics; or

(3) A master’s degree or doctorate from an accredited college or university in physics, biophysics, medical physics, radiological physics, nuclear engineering or health physics, and three years of experience within the five years prior to the date of application under the direct supervision of a certified individual as provided in paragraph (C)(1) or (C)(2) of this rule or a radiation expert certified in therapeutic radiation-generating equipment in developing and performing oversight of quality assurance for therapeutic x-ray equipment including performance evaluations and safety checks.

(D) An applicant for radiation expert certification for the category of diagnostic radiation-generating equipment shall have at least one of the following:

(1) Certification by the “American Board of Radiology” in radiological physics or diagnostic radiological physics;

(2) Certification by the “American Board of Medical Physics” in medical physics with a specialty in diagnostic imaging physics;

(3) A masters degree or doctorate from an accredited college or university in physics, biophysics, medical physics, radiological physics or health physics, or mechanical, electrical, or nuclear engineering, or applied mathematics with a minor in physics; and three years of experience within the five years prior to the date of application under the direct supervision of a certified individual as provided in paragraph (D)(1) or (D)(2) of this rule or a radiation expert certified in diagnostic radiation-generating equipment in developing and performing oversight of quality assurance for diagnostic radiation-generating equipment.

(E) An applicant for radiation expert certification for the category of mammography radiation-generating equipment shall have at least one of the following:

(1) Certification by the “American Board of Radiology” in radiological physics or diagnostic radiological physics;

(2) Certification by the “American Board of Medical Physics” with a specialty in diagnostic imaging physics;

(3) A master’s degree or higher in a physical science from an accredited college or university, and at least the following:

(a) Twenty semester hours or thirty quarter hours of graduate or undergraduate level physics;

(b) Twenty contact hours of documented specialized training in conducting surveys of mammography facilities; and

(c) Have the experience of conducting surveys of at least ten mammography x-ray units under the direct supervision of a certified individual as provided in paragraph (E)(1) or (E)(2) of this rule or a radiation expert certified in mammography.

(F) The department may return an incomplete application for certification or certification renewal. The applicant shall respond to the director’s request for additional information within twenty days of receiving the request.

(G) A certificate issued under this rule shall expire two years after the date of its issuance and may be renewed in accordance with the standard renewal procedures established in Chapter 4745. of the Revised Code. On or before thirty days prior to the expiration of a certificate, the department shall mail a notice and application for renewal to the certificate holder. The certificate holder shall complete the application and return it to the treasurer of state with the certification renewal fee in the form of a check or money order payable to “treasurer, state of Ohio,”, in the amount of one hundred dollars for each category specified in paragraph (A) of this rule.

(H) Within sixty days of receiving a complete application for certification or certification renewal, the director shall, pursuant to Chapter 119. of the Revised Code, either issue a certification or certification renewal or, deny the application, or the director may at any time suspend or revoke a certification if the applicant or certificate holder:

(1) Does not meet the applicable requirements specified in this rule for attaining and maintaining certification as a radiation expert;

(2) Previously had a radiation expert certificate revoked or currently has a certificate suspended pursuant to this paragraph;

(3) Has provided services for a category of radiation-generating equipment that is not identified on his or her radiation expert certificate;

(4) Misrepresents the types of quality assurance programs for which he or she is certified to provide services or otherwise has provided services for which he or she was not certified to provide;

(5) Misrepresents information on the application or has misrepresented an audit report filed with the director pursuant to rule 3701:1-66-04 of the Administrative Code;

(6) Has submitted an audit report to the director that the radiation expert did not personally perform or supervise the individual assisting in the performance of quality assurance tests;

(7) Does not respond to the request for additional information within twenty days of receiving the request as provided in paragraph (F) of this rule;

(8) Does not comply with paragraphs (C) to (E) of this rule, as applicable, in which case the director shall deny the application only for that certification for the affected category of radiation-generating equipment;

(9) Fails to pay any fee assessed in accordance with paragraph (G) of this rule; or

(10) Fails to comply with Chapter 3748. of the Revised Code or the rules adopted thereunder.

The radiation expert certificate or renewal certification issued by the director shall contain a statement identifying the category or categories of radiation-generating equipment for which the radiation expert is qualified to provide quality assurance services and the date of expiration of that certificate.

(I) An individual certified as a radiation expert shall immediately notify the director in writing of the following:

(1) If the radiation expert is no longer practicing as a CRE;

(2) A change in the name, address, or phone number of the radiation expert;

(3) A change to the listing of hospitals in which the radiation expert is designated as CRE; and

(4) Any other change that would render an application or certificate no longer accurate.

(J) The individual certified as a radiation expert shall provide the director upon request with any other information regarding the requirements set forth in this rule.

(K) Each certified radiation expert shall obtain continuing education for each certification period in accordance with the requirements of this rule. Individuals initially certified prior to the effective date of this rule, and prior to their first renewal following the effective date of this rule, shall obtain five hours of continuing education for each category specified in paragraph (A) of this rule for which the radiation expert is certified. During each subsequent renewal period, individuals initially certified as radiation experts prior to the effective date of this rule shall meet the applicable requirements of paragraphs (K)(1) to (K)(3) of this rule. For individuals initially certified as a radiation expert after the effective date of this rule, the following continuing education standards shall be met:

(1) Certified radiation experts having certification in one category specified in paragraph (A) of this rule shall obtain fifteen hours of continuing education pertaining to the category of certification;

(2) Certified radiation experts having certification in two categories specified in paragraph (A) of this rule shall obtain twenty hours of continuing education pertaining to one or both categories of certification; and

(3) Certified radiation experts having certification in three categories specified in paragraph (A) of this rule shall obtain twenty-five hours of continuing education pertaining to one or more categories of certification.

(L) Continuing education programs are subject to approval by the director.

(M) A certified radiation expert who provides instruction in a continuing education program related to radiation safety is eligible to claim up to five hours of instruction time for the required continuing education for his or her certification period.

(N) In accordance with section 3748.12 of the Revised Code, a certification renewal fee that has not been paid within ninety days after the issuance date of the notice required under paragraph (G) of this rule shall be assessed at two times the original invoiced fee. Any fee that has not been paid within one hundred eighty days after the issuance date of the notice required under paragraph (G) of this rule shall be assessed at five times the original invoiced fee.

(O) Application for the same certification category may be denied after the expiration date of the previous certification for individuals who do not renew their certification according to this rule, and who do not provide written notification that they no longer require or want certification in that category.

Effective: 02/10/2006

R.C. 119.032 review dates: 11/07/2005 and 02/01/2011

Promulgated Under: 119.03

Statutory Authority: 3748.04

Rule Amplifies: 3748.12, 3748.13, 3748.17, 3748.18, 3748.19, 3748.99

Prior Effective Dates: 6/1/1998, 9/7/01, 12/1/03

3701:1-66-04 Quality assurance program.

(A) In accordance with Chapter 3748. of the Revised Code, each registrant shall develop and maintain a written quality assurance program. For purposes of this chapter 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 quality assurance program of each registrant shall address and document 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) Radiation monitoring requirements such as, surveys, occupational exposure limits, maintenance of records, and procedures regarding the use of area and personnel monitoring;

(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) Radiation safety 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 be working in a restricted area or to receive an annual occupational dose in excess of one mSv (one hundred mrem) shall be instructed in the potential hazards of being present in such an area, to include the following:

(a) The location, boundaries, and purpose of restricted areas;

(b) A description of the radiation-generating equipment and its location;

(7) The quality control tests to be performed, and the frequency of the quality control tests to be performed as applicable to the radiation-generating equipment type and use;

(8) Policies regarding the state license of each person operating radiation-generating equipment as required by Chapters 4773. and 4715. of the Revised Code;

(9) Quality assurance policies and a method to educate the workers on 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 prenatal exposure;

(13) Policies regarding radiation training for ancillary personnel;

(14) Policies regarding training for personnel with quality control responsibilities;

(15) Policies regarding patient protection, including screening for pregnancy, patient shielding, patient protection, patient identity verification; and

(16) Policies regarding protection of public to include identification of all radiation areas, warning signs, warning lights, and interlocks.

(C) In addition to the requirements of paragraphs (A) and (B) of this rule the quality assurance program of hospital registrants shall be maintained in the form of a readily available quality assurance manual and shall comply with the following:

(1) A certified radiation expert shall conduct oversight and maintenance of quality assurance programs for hospital registrants, by:

(a) Auditing the quality assurance program on an annual basis;

(b) Performing quarterly reviews;

(c) Completing and submitting all required information with the annual audit form in accordance with paragraph (C)(6) of this rule, and;

(d) Serving on the quality assurance committee.

(2) Employees working in the radiation areas shall be made aware of the identity, scope of authority, and a method for contacting the certified radiation expert and the individual responsible for radiation protection. This information, or a specific location where this information may be obtained, shall be conspicuously posted in each area where radiation-generating equipment is used.

(3) Each hospital registrant shall establish a quality assurance committee for the management of the quality assurance program. Membership to the committee may include an appointed member and a similarly qualified alternate. If an appointed member cannot attend a quarterly meeting, the appointed alternate is authorized to attend in his/her place. The quality assurance committee shall include at least the following appointed members:

(a) A radiologist;

(b) An administrative director of radiology;

(i) Radiation therapy services,

(ii) Mammography, or

(iii) Diagnostic radiography other than mammography;

(d) A member of the hospital’s executive administration;

(e) The individual responsible for radiation protection; and

(f) A representative of each department of the hospital which has responsibilities involving the handling of radiation-generating equipment.

(4) The quality assurance committee shall meet as often as is deemed necessary to carry out its duties, but at least on a quarterly basis. To establish a quorum at least one-half of the committee’s membership must be present, and must include the individual responsible for radiation protection for the hospital, and the member of the executive administration of the hospital. A record of each meeting shall be maintained and distributed to each appointed member which shall include the following:

(a) The date of the meeting;

(b) An indication of members present and absent; and

(5) Each quarter, the certified radiation expert shall submit, to each appointed quality assurance committee member, a review of the quality assurance plan which shall contain, as applicable:

(a) Proposed radiation safety policy revisions;

(b) Occupational exposure record reviews;

(d) Equipment performance evaluation summaries; and

(e) Any recommended corrective actions necessary to comply with the requirements of this chapter.

(6) The quality assurance program shall be audited at least annually as defined in paragraph (A)(17) of rule 3701:1-38-01 of the Administrative Code by a certified radiation expert. The certified radiation expert shall develop a written report of the audit findings on forms prescribed by the director and submit the report to the quality assurance committee within thirty days of completing the audit. The quality assurance committee shall review the audit report and implement any corrective actions determined to be necessary. The certified radiation expert shall file the audit report with the director, within ninety days of completing the audit. Every audit report shall include a determination of whether the quality assurance program properly addresses the matters described in this rule and whether it is being carried out in accordance with the written quality assurance program, and any corrective actions to be taken to comply with the requirements of this chapter. The audit report shall become a part of the inspection record.

(D) At the time of the state inspection the following items shall be readily available for review:

(1) A complete listing of the inventory of radiation-generating equipment, including the location and description of each unit;

(2) All quality assurance documents as required under this rule;

(3) Data and test results of the evaluation of each unit of radiation-generating equipment and its shielding and surroundings;

(4) Maintenance logs and incident reports for each radiation-generating equipment system;

(5) Current copies of department’s licensure verification web page for each individual who is required to possess a license at the facility; and

(6) Records required for each type of radiation-generating equipment indicating the following:

(a) Personnel responsible for monitoring and performing quality control tests;

(b) A brief description of the procedures to be used for each quality control test to be performed;

(d) The manner in which the performance of quality control tests will be documented; and

(e) Instrumentation used to perform area radiation surveys, calibrations and evaluations, as appropriate for each type of radiation-generating equipment, including at least biennial calibration certificates or cross-calibration documentation done within the biennium.

Effective: 12/22/2008

R.C. 119.032 review dates: 09/15/2008 and 12/01/2013

Promulgated Under: 119.03

Statutory Authority: 3748.04

Rule Amplifies: 3748.04

Prior Effective Dates: 6/1/1998, 12/1/03

3701:1-66-05 General radiographic equipment.

As used in this rule, “radiographic equipment” means radiation-generating equipment that is designed for diagnostic imaging. The requirements of this rule do not apply to radiation-generating equipment used for dental intraoral or panoral, mammography, bone densitometry, computed tomography, fluoroscopy, and radiation therapy simulators. In addition to other applicable rules contained in Chapters 3701:1-38 and 3701:1-66 of the Administrative Code, handlers of radiographic equipment shall comply with the following:

(A) Radiographic equipment shall meet the following equipment standards:

(1) The useful beam shall be limited to the area of clinical interest. This shall be deemed to have been met if a positive beam limiting device, or “PBL,” meeting manufacturer’s specifications and the requirements of paragraph (A)(17) of this rule has been met.

(2) In the case of radiographic equipment installed after February 15, 2001, the radiographic equipment shall:

(a) Have means for independent adjustment of at least two dimensions of the x-ray field; and

(b) Provide a method for visually defining the perimeter of the x-ray field. In the case of radiographic equipment that employs a light field, the light source shall be functional and the total misalignment of the edges of the visually defined field with the respective edges of the x-ray field along either the length or width of the visually defined field shall not exceed two per cent of the source-to-image distance or “SID.”

(3) In the case of stationary radiographic equipment, the requirements of paragraph (A)(2) of this rule shall be met in addition to the following requirements:

(a) Means shall be provided to indicate when the axis of the x-ray beam is perpendicular to the plane of the image receptor;

(b) Means shall be provided to align the center of the x-ray field with respect to the center of the image receptor to within two per cent of the SID, when the x-ray beam is perpendicular to the plane of the image receptor;

(c) A means shall be provided to indicate the SID to within two per cent. If it is a fixed SID, the distance shall be indicated with a permanent marking; and

(d) The beam limiting device shall indicate numerically the field size in the plane of the image receptor to which it is adjusted and shall be accurate to within two per cent of the SID.

(4) In the case of radiographic equipment designed for only one image receptor size at a fixed SID, a means shall be provided to limit the field at the plane of the image receptor to dimensions no greater than those of the image receptor, and to align the center of the x-ray field with the center of the image receptor within two per cent of the SID, or shall be provided with means to align the field such that the x-ray field at the plane of the image receptor shall not extend beyond any edge of the image receptor by more than two per cent.

(5) Radiographic equipment installed prior to February 15, 2001, shall be exempt from paragraphs (A)(2) to (A)(4) of this rule, and shall comply with the following:

(a) A means shall be provided to limit the x-ray field in the plane of the receptor so that such field does not exceed each dimension of the image receptor by more than two per cent of the SID when the axis of the x-ray beam is perpendicular to the plane of the image receptor;

(b) A means shall be provided to align the center of the x-ray field with the center of the image receptor to within two per cent of the SID; and

(c) Paragraphs (A)(5)(a) and (A)(5)(b) of this rule may be met with a system that meets the requirements for a general purpose x-ray system as specified in paragraph (A)(2) of this rule, or when alignment means are also provided, may be met with either:

(i) An assortment of removable, fixed-aperture, beam limiting devices sufficient to meet the requirement for each combination of image receptor size and SID for which the unit is designed with each such device having clear and permanent markings to indicate the image receptor size and SID for which it is designed; or

(ii) A beam-limiting device having multiple fixed apertures sufficient to meet the requirement for each combination of image receptor size and SID for which the unit is designed. Permanent, clearly legible markings shall indicate the image receptor size and SID for which each aperture is designed and shall indicate which aperture is in position for use.

(6) A device shall be provided to terminate the exposure at a preset time interval, preset product of current and time, preset number of pulses, or preset technique or radiation exposure to the image receptor.

(7) For radiographic equipment that provides manual exposure control, the operator shall be able to terminate the exposure at any time unless:

(a) The exposure is 0.5 second or less; or

(b) During serial radiography, means are provided to permit completion of any single exposure of the series in progress.

(8) In the case of radiographic equipment that provides automatic exposure control:

(a) A device on the control panel shall indicate when this mode of operation is selected;

(b) The density setting and automatic exposure control detector positions that are selected prior to the exposure shall be indicated; and

(c) A visible signal shall indicate when an exposure has been terminated at the back-up limit. Manual resetting shall be required before further automatic timed exposures can be made.

(9) The x-ray control panel shall provide visual indication when x-rays are produced and an audible signal shall indicate when the exposure has terminated.

(10) The accuracy of the timing device shall be within plus or minus ten per cent of the indicated setting. The timing device shall be tested at a minimum of two settings within the operative range of fifty milliseconds to one thousand milliseconds.

(11) The exposure control switch shall be of the “dead-man” type and shall be so arranged that it cannot be operated outside a shielded area. Exposure switches for portable or mobile radiographic equipment and “spot film” devices used in conjunction with fluoroscopic tables are exempt from this shielding requirement. In addition, it shall not be possible to initiate an exposure when the timer is set to a “zero” or “off” position if either position is provided.

(12) The kVp accuracy shall be within plus or minus ten per cent of the indicated value.

(13) The coefficient of variation:

(a) Of the kVp reproducibility for at least four consecutive exposures shall not exceed 0.05;

(b) Of the timing device reproducibility for at least four consecutive exposures shall not exceed 0.05; and

(c) Of radiation exposure reproducibility for at least four consecutive exposures shall not exceed 0.05 for any specific combination of selected technique factors.

(14) For radiographic equipment having independent selection of x-ray tube current, or “mA,” the average ratios of exposure to the indicated mA-seconds product obtained at any two consecutive tube current settings shall not differ by more than ten per cent of their sum.

(15) For radiographic equipment having a combined x-ray tube current-exposure time product, or “mAs,” selector, but not a separate tube current, or “ma,” selector, the average ratios of exposure to the indicated milliampere-seconds product, or “mR/mAs,” values obtained at any two consecutive mAs selector settings shall not differ by more than ten per cent of their sum.

(16) The average exposure ratio for paragraphs (A) (14) and (A) (15) of this rule shall be expressed as follows:

|X1 – X2| <0.10 (X1+X2)

Where the value of X1and X2are the average mR/mAs values obtained at each of the two consecutive tube mA or mAs settings, or at two settings differing by no more than a factor of two where the mA or mAs selector provides continuous selection.

(17) If a positive beam limitation, or “PBL” device is used on stationary radiographic equipment incorporating one or more certified components, it shall be required to comply with the following additional requirements:

(a) PBL shall prevent the production of x-rays when:

(i) Except as permitted by paragraph (A) (17) (c) of this rule, either the length or width of the x-ray field in the plane of the image receptor differs from the corresponding image receptor dimensions by more than three per cent of the SID; or

(ii) The sum of the length and width differences as stated in paragraph (a)(17)(a)(i) of this rule without regard to sign exceeds four per cent of the SID;

(b) Compliance with paragraph (A)(17)(a) of this rule shall be determined:

(i) When the equipment indicates that the beam axis is perpendicular to the plane of the image receptor; and

(ii) No sooner than five seconds after insertion of the image receptor;

(c) The PBL system shall be capable of operation, at the discretion of the operator, such that the size of the field may be made smaller than the size of the image receptor through stepless adjustment of the field size. The minimum field size at a SID of one hundred centimeters shall be equal to or less than five centimeters by five centimeters; and

(d) The PBL system shall be designed such that if a change in image receptor does not cause an automatic return to PBL function as described in paragraph (A)(17)(a) of this rule, then any change of image receptor size or SID must cause an automatic return.

(18) Beam limitation for portable x-ray systems shall meet the beam limitation requirements of paragraph (A)(1) or (A)(5)(a) of this rule.

(B) Handlers of radiographic equipment shall comply with the structural shielding requirements in paragraph (I) of rule 3701:1-66-02 of the Administrative Code.

(C) Handlers of radiographic equipment shall comply with radiation safety rules in Chapter 3701:1-38 of the Administrative Code, and other applicable radiation safety requirements in rules 3701:1-66-02 and 3701:1-66-04 of the Administrative Code.

(D) Handlers of radiographic equipment shall comply with all applicable quality assurance requirements found in rules 3701:1-66-02 and 3701:1-66-04 of the Administrative Code.

(E) Handlers of mobile or portable radiographic equipment shall comply with all requirements of this rule, except paragraphs (A)(4) and (B) of this rule, and shall comply with the following:

(1) A mobile or portable radiographic unit shall be provided with either a protective barrier at least 6.5 feet high for operator protection during exposures, or means shall be provided to allow the operator to be at least six feet from the tube housing assembly during exposures and the operator shall wear a protective apron of not less than 0.25 millimeter lead equivalent when making exposures.

(2) Radiation emitted from the x-ray tube when the system is fully charged and the exposure switch or timer is not activated shall not exceed a rate of two milliroentgens per hour (0.5 microcoloumb per kilogram) or, at five centimeters from any accessible surface of the diagnostic source assembly, with the beam-limiting device fully open.

(3) A tube stand or other mechanical support shall be used so that the x-ray tube housing assembly shall not be hand-held during exposures.

(F) Handlers of radiographic equipment for veterinary use shall meet the following special requirements:

(1) Stationary, mobile, or portable veterinary radiographic equipment shall be provided with either a 6.5 foot high protective barrier for operator protection during exposures, or shall be provided with means to allow the operator to be at least six feet from the tube housing assembly during exposures. If the operator or assistant is not behind the protective barrier, a lead apron of not less than 0.25 millimeter lead equivalent shall be worn when making exposures.

(2) Mobile or portable veterinary radiographic equipment shall comply with all applicable requirements of this rule except paragraphs (B) and (E)(1) of this rule and Chapter 3701-72 of the Administrative Code.

(3) Stationary veterinary radiographic equipment shall comply with all requirements of this rule except paragraphs (I)(2) and (I)(3) of rule 3701:1-66-02 of the Administrative Code.

Effective: 02/10/2006

R.C. 119.032 review dates: 11/07/2005 and 02/01/2011

Promulgated Under: 119.03

Statutory Authority: 3748.04

Rule Amplifies: 3748.01 to 3748.02, 3748.04 to 3748.07, 3748.12 to 3748.15, 3748.17 to 3748.20, 3748.22, and 3748.99

Prior Effective Dates: 2/15/2001

3701:1-66-06 Dental radiation-generating equipment.

As used in this rule, “dental equipment” means radiation-generating equipment used for dental radiography. In addition to other applicable rules adopted pursuant to Chapter 3748. of the Revised Code and Chapter 3701:1-66 of the Administrative Code, handlers of dental equipment shall comply with the following:

(A) Dental equipment for intraoral use shall meet the following equipment standards:

(1) A means shall be provided to limit the source-to-skin distance (SSD) to not less than:

(a) Eighteen centimeters if operable above fifty kVp; or

(b) Ten centimeters if operable at fifty kVp.

(2) The x-ray field at the minimum SSD shall be containable in a circle having a diameter of no more than seven centimeters if operable at or above fifty kVp.

(3) A means shall be provided to terminate the exposure at a preset time interval, a preset product of current and time, a preset number of pulses, or a preset radiation exposure to the image receptor.

(4) The operator shall be able to terminate the exposure at any time during an exposure of greater than one-half second. Termination of the exposure shall cause automatic resetting of the timer to its initial setting or to zero. It shall not be possible to make an exposure when the timer is set to a “zero” or “off” position.

(5) The kVp accuracy shall be within plus or minus ten per cent of the indicated value.

(6) For manual exposures, the accuracy of the timing device shall be within plus or minus ten per cent of the indicated setting. The timing device shall be tested at a minimum of two settings within the operative range of fifty milliseconds to one thousand milliseconds.

(7) Visual indication shall be provided whenever x-rays are produced. Certified equipment also shall provide audible indication to the operator while x-rays are produced or on termination of the exposure.

(8) The coefficient of variation for reproducibility of kVp, timing, and radiation exposure shall not exceed 0.05 for four consecutive exposures

(B) In addition to other structural shielding requirements in rule 3701:1-66-02 of the Administrative Code, handlers of dental equipment shall comply with the following:

(1) Intraoral and panoral units shall be provided with primary barriers at all areas struck by the useful beam. Consideration may be given to the attenuation provided by the patient as a result of direct interaction with the useful beam.

(2) When intraoral or panoral units are in adjacent patient occupied rooms or areas, protective barriers shall be provided between the rooms or areas, unless safety procedures are documented and implemented to require that no patients shall be present in the adjacent rooms or areas while exposures are being made.

(C) In addition to the radiation safety requirements listed in rule 3701:1-66-02 of the Administrative Code, handlers of dental equipment shall comply with the following:

(1) No individual shall be permitted to hold any part of the x-ray tube housing, cone, or mechanical support of the x-ray tube during exposure.

(2) Each installation shall be provided with a protective barrier for the operator or shall be so arranged that the operator stands at a minimum distance of six feet from the patient and out of the useful beam.

(D) Handlers of dental equipment shall comply with all applicable quality assurance requirements of rules 3701:1-66-02 and 3701:1-66-04 of the Administrative Code.

(E) Handlers of dental panoral equipment shall comply with all requirements of paragraphs (A) to (D) of this rule, except for paragraphs (A)(1) and (A)(2) of this rule, and must comply with the following:

(1) Dental panoral x-ray machines shall be certified pursuant to 21 C.F.R. part 1020 (as published in the April 1, 2008, Code of Federal Regulations).

(2) When the operator is behind a protective barrier, a viewing system shall be provided large enough and so placed that the operator can see the patient without having to leave the protected area during exposure.

(3) The x-ray field shall be limited to the dimensions of the slit in the image receptor holder.

(F) Except for dental equipment used for panoral use, handlers of radiographic equipment used for extraoral dental procedures shall meet the requirements of paragraphs (A) and (B) of rule 3701:1-66-05 of the Administrative Code.

(G) Fluoroscopy shall not be used for dental examinations.

(H) Handlers of radiation-generating equipment capable of sectional imaging, used only for dental procedures, shall comply with all manufacturer’s specifications and be included in the registrant’s quality assurance plan as specified in rule 3701:1-66-04 of the Administrative Code.

(I) Handlers of hand-held radiation-generating equipment used for dental procedures shall meet the requirements of paragraphs (A), (B), and (D) of this rule, and shall document compliance with the following:

(1) Hand-held radiation-generating equipment shall be used for intraoral purposes only;

(2) Operators of the hand-held radiation-generating equipment shall wear a full lead apron of not less than 0.25 millimeter lead equivalent;

(3) The back scatter shield for the hand-held radiation-generating equipment shall be in place during all radiographic exposures;

(4) All operators of hand-held radiation-generating equipment shall be provided and wear a personnel dosimeter to monitor the dose to the operator’s hand. The operator must wear the personnel dosimeter on the hand holding the beam limiting device;

(5) Storage and security procedures shall be developed and implemented to assure hand-held radiation-generating equipment is secured against unauthorized use or removal when not under the control and constant surveillance of the registrant;

(6) Safe operating procedures specific to the hand-held radiation-generating equipment shall be developed and implemented; and

(7) Operator training as required in paragraph (B)(5) of rule 3701:1-66-04 of the Administrative Code, shall include documented specific instruction to the x-ray operator regarding the prohibition on placing any part of their body into the useful beam.

(J) Dental equipment with a nominal fixed kVp of less than fifty shall not be used to make diagnostic dental radiographs of human beings.

(K) Dental equipment used by veterinarians shall comply with all requirements of this rule except paragraphs (A) (1), (E), and (J) of this rule. Additionally, the useful beam shall be limited to the area of clinical interest.

(L) Extraoral dental equipment used by veterinarians shall follow the requirements of paragraph (F) of rule 3701:1-66-05 of the Administrative Code.

Effective: 04/15/2009

R.C. 119.032 review dates: 01/05/2009 and 04/15/2014

Promulgated Under: 119.03

Statutory Authority: 3748.04

Rule Amplifies: 3748.04

Prior Effective Dates: 2/15/2001, 2/1/05

3701:1-66-07 Fluoroscopic radiation-generating equipment.

For the purposes of this rule, “fluoroscopic equipment” means a type of radiation-generating equipment that is used for real-time imaging of internal structures for medical purposes. In addition to other applicable rules adopted pursuant to Chapter 3748. of the Revised Code, handlers of fluoroscopic equipment shall comply with the following:

(A) Fluoroscopic equipment shall meet the following standards:

(1) Unless the United States food and drug administration (FDA) has granted a variance for the specific fluoroscopic equipment, the source-to-skin distance (SSD) shall not be less than:

(a) Thirty-eight centimeters on stationary fluoroscopic equipment manufactured on or after August 1, 1974;

(b) 35.5 centimeters on stationary fluoroscopic equipment manufactured prior to August 1, 1974;

(c) Thirty centimeters on mobile fluoroscopic equipment unless a particular procedure prohibits that distance, in which case it shall not be less than twenty centimeters; or

(d) Nineteen centimeters for c-arm type fluoroscopic equipment having a maximum source-to-image distance (SID) less than forty-five centimeters unless a particular procedure prohibits that distance, in which case it shall not be less than ten centimeters. Such systems shall be used for imaging extremities only.

(2) The fluoroscopic imaging assembly shall be provided with a primary protective barrier which intercepts the entire cross section of the useful beam at any SID and shall prevent further exposures when the primary barrier is not in the path of the entire x-ray beam.

(3) All fluoroscopic equipment shall provide intensified imaging. As used in this rule “intensified imaging” will include the use of digital image receptors.

(4) Fluoroscopic equipment shall meet the following field limitation specifications:

(a) For fluoroscopic equipment manufactured before June 10, 2006, the following applies:

(i) Neither the length nor the width of the x-ray field in the plane of the image receptor shall exceed that of the visible area of the image receptor by more than three per cent of the SID. The sum of the excess length and the excess width shall be no greater than four per cent of the SID.

(ii) For rectangular x-ray fields used with circular image receptors, the error in alignment shall be determined along the length and width dimensions of the x-ray field which pass through the center of the visible area of the image receptor.

(b) For fluoroscopic equipment with a circular image receptor manufactured on or after June 10, 2006, the maximum area of the x-ray field in the plane of the circular image receptor shall conform with one of the following requirements. When any linear dimension of the visible area of the image receptor measured through the center of the visible area is:

(i) Less than or equal to thirty-four centimeters in any direction, at least eighty per cent of the area of the x-ray field shall overlap the visible area of the image receptor, or

(ii) Greater than thirty-four centimeters in any direction, the x-ray field measured along the direction of greatest misalignment with the visible area of the image receptor shall not extend beyond the edge of the visible area of the image receptor by more than two centimeters.

(c) For fluoroscopic equipment with a rectangular image receptor manufactured on or after June 10, 2006, the following applies:

(ii) The error in alignment shall be determined along the length and width dimensions of the x-ray field which pass through the center of the visible area of the image receptor.

(d) If the fluoroscopic x-ray field size is adjusted automatically as the SID or image receptor size is changed, a capability may be provided for overriding the automatic adjustment in case of system failure. If it is so provided, a signal visible at the fluoroscopist’s position shall indicate whenever the automatic field adjustment is overridden. Each such system failure override switch shall be clearly labeled as follows:

“For X-ray Field Limitation System Failure”

(e) Beam-limiting devices shall be provided with a means for stepless adjustment of the x-ray field; and

(f) Stepless adjustment shall, at the greatest SID, provide continuous field sizes from the maximum obtainable to a field size of five centimeters by five centimeters or less.

(5) Timers shall meet the following specifications:

(a) A means shall be provided to preset the cumulative on-time timer of the fluoroscopic tube. The maximum cumulative time of the timer shall not exceed five minutes without resetting; and

(b) The timer shall terminate the exposure or emit a signal audible to the fluoroscopist when the exposure time reaches a maximum of five minutes. The signal shall continue to sound while x-rays are produced until the timer is reset.

(i) A display of the fluoroscopic irradiation time at the fluoroscopist’s working position. This display shall function independently of the audible signal described in paragraph (A)(5)(c)(ii) of this rule. The following requirements apply:

(a) When the x-ray tube is activated, the fluoroscopic irradiation time in minutes and tenths of minutes shall be continuously displayed and updated at least once every six seconds.

(b) The fluoroscopic irradiation time shall also be displayed within six seconds of termination of an exposure and remain displayed until reset.

(c) Means shall be provided to reset the display to zero prior to the beginning of a new examination or procedure.

(ii) A signal audible to the fluoroscopist shall sound for each passage of five minutes of fluoroscopic irradiation time during an examination or procedure. The signal shall sound until manually reset or, if automatically reset, for at least two seconds.

(6) X-ray production in the fluoroscopic mode shall be controlled by a device which requires continuous pressure by the fluoroscopist for the entire time of any exposure. When recording serial fluoroscopic images, the fluoroscopist shall be able to terminate the x-ray exposure at any time, but means may be provided to permit completion of any single exposure of the series in progress.

(7) Fluoroscopic systems shall meet the following air kerma rate limits:

(a) Fluoroscopic equipment provided with only automatic exposure rate control, or provided with both automatic exposure rate control and manual mode capabilities, shall not exceed an air kerma rate of eighty-eight milligray per minute (ten roentgens per minute exposure rate) in either mode at any combination of tube potential and current, at the point where the center of the useful beam enters the patient;

(b) Fluoroscopic equipment provided with only manual mode capabilities shall not exceed an air kerma rate of forty-four milligray per minute (five roentgens per minute exposure rate) at any combination of tube potential and current, at the point where the center of the useful beam enters the patient; and

(c) For fluoroscopic equipment that is provided with high-level control, and the high-level control is activated, the air kerma rate shall not exceed one hundred seventy-six milligray per minute (twenty roentgens per minute exposure rate) at any combination of tube potential and current, at the point where the center of the useful beam enters the patient;

(i) For all fluoroscopy equipment that is provided with high-level control, special means of activation of high level control, such as manual pressure applied continuously by the fluoroscopist, shall be required to avoid accidental use; and

(ii) A continuous signal audible to the fluoroscopist shall indicate that high level control is being employed.

(8) Compliance with air kerma rate allowable limits shall be determined as follows:

(a) If the source is below the x-ray table, the air kerma rate shall be measured at one centimeter above the tabletop or cradle;

(b) If the source is above the x-ray table, the air kerma rate shall be measured at thirty centimeters above the tabletop with the end of the beam limiting device or spacer positioned as closely as possible to the point of measurement;

(c) For c-arm type fluoroscopic equipment, the air kerma rate shall be measured at thirty centimeters from the input surface of the image receptor with the source positioned at any SID; and

(d) For fixed SID lateral fluoroscopes attached to the x-ray table, the maximum air kerma rate shall be measured at a point fifteen centimeters from the centerline of the x-ray table and in the direction of the x-ray source with the end of the beam-limiting device or spacer positioned as closely as possible to the point of measurement. If the table top is moveable, it shall be positioned as closely as possible to the lateral x-ray source, with the end of the beam-limiting device or spacer no closer than fifteen centimeters to the centerline of the table.

(e) For c-arm type fluoroscopic equipment having a SID less than forty-five centimeters, the air kerma rate shall be measured at the minimum SSD.

(f) The maximum air kerma rate shall be determined with the kVp, mA and/or other selectable parameters adjusted to those settings which give the maximum air kerma rate. X-ray systems that incorporate automatic exposure control shall have sufficient attenuative material placed in the useful beam to produce the maximum exposure rate of the system.

(9) During fluoroscopy and cinefluorography the x-ray tube potential and current shall be continuously indicated.

(10) For undertable fluoroscopic equipment, a shielding device of at least 0.25 millimeter lead equivalent shall cover the bucky-slot.

(11) For undertable fluoroscopic equipment, protective drapes, or other devices, at least 0.25 millimeter lead equivalent shall be provided between the patient and the individual operating the fluoroscopic equipment to intercept scattered radiation which would otherwise reach the fluoroscopist and others near the x-ray unit, except when such drapes or other devices would compromise the sterile field. Such devices shall not substitute for wearing required protective apparel.

(12) Spot film devices shall meet the following specifications:

(a) A means shall be provided between the source and the patient which will automatically limit the x-ray field at the time the exposure is initiated to no more than the portion of the image receptor selected by the fluoroscopist on the spot film selector. If the x-ray field size is less than the size of the selected portion of the image receptor, the field size shall not open automatically to the size of the selected portion of the image receptor unless the fluoroscopist has selected such a mode of operation;

(b) Neither the length nor the width of the x-ray field in the plane of the image receptor shall differ from the corresponding dimensions of the selected portion of the image receptor by more than three per cent of the SID when adjusted for full coverage of the selected portion of the image selector;

(c) The center of the x-ray field in the plane of the image receptor shall be aligned with the center of the selected portion of the image receptor to within two per cent of the SID;

(d) Means shall be provided to reduce the x-ray field size in the plane of the image receptor to a size smaller than the selected portion of the image receptor. The minimum field size at the greatest SID shall not exceed five centimeters by five centimeters; and

(13) For c-arm fluoroscopic equipment equipped with a removable spacer cone, the spacer cone shall be attached to the x-ray source during use at all times unless it interferes with the clinical procedure.

(14) Fluoroscopic equipment manufactured on or after June 10, 2006, shall display at the fluoroscopist’s working position the air kerma rate and cumulative air kerma in accordance with the requirements of 21 C.F.R. 1020 (as published in the April 1, 2008, Code of Federal Regulations.)

(B) In addition to other applicable structural shielding requirements in rule 3701:1-66-02 of the Administrative Code, handlers of fluoroscopic equipment shall:

(1) Provide secondary barriers in all wall, floor, and ceiling areas;

(2) Have a radiation expert complete an area radiation survey upon installation, or after any change in the fluoroscopic equipment or its structural shielding which might cause a significant increase in radiation hazard; and

(3) Have the individual responsible for radiation protection obtain a written report of the area radiation survey from the radiation expert and make a copy of the report available to the director upon request.

(C) In addition to other applicable radiation safety rules adopted pursuant to Chapter 3748. of the Revised Code, handlers of fluoroscopic radiation-generating equipment shall comply with the following:

(1) Any individual who is in the room during the fluoroscopic procedure shall be adequately protected by standing behind a whole body protective barrier or shall be required to wear a protective lead apron of not less than 0.25 millimeter lead equivalent.

(2) Protective lead or lead equivalent gloves shall be used by individuals who are required to have their hands in or near the useful beam.

(3) In accordance with Chapter 3701-72 of the Administrative Code, individuals who perform fluoroscopic procedures on human beings shall hold a radiographer license or shall be a licensed practitioner, except for those individuals that are listed in paragraph (C) of rule 3701-72-04 of the Administrative Code who are limited to performing only the radiologic tasks related to cardiac catherization procedures as specified in paragraph (D) of rule 3701-72-04 of the Administrative Code. Personnel working for veterinarians that use radiation generating equipment are not required to comply with this paragraph.

(4) For each fluoroscopic procedure, handlers of fluoroscopic equipment shall maintain a record of the following:

(a) Patient identification;

(b) Type of examination;

(d) Operator’s name.

(5) Handlers of fluoroscopic equipment used for interventional or cardiac procedures or on pediatric or pregnant patients shall maintain a record of:

(a) Cumulative air kerma or dose area product used for each examination, if the display of either is available on the fluoroscopic equipment; or

(b) The following items if the cumulative air kerma or dose area product is not displayed on the fluoroscopic equipment:

(i) Mode of operation such as high-level or pulsed mode;

(ii) Cumulative fluoroscopic exposure time; and

(iii) Number of spot films.

(D) In addition to other applicable quality assurance requirements of Chapter 3701:1-66 of the Administrative Code, handlers of fluoroscopic equipment shall comply with the following:

(1) Handlers shall designate and utilize a radiation expert who shall develop in writing and perform fluoroscopic image quality evaluations appropriate for the fluoroscopic equipment including written procedures to include time intervals and system conditions for the evaluation of image quality.

(2) On new installations prior to patient exposure, handlers shall utilize a radiation expert to perform the following:

(a) Spot film device tests to determine compliance with allowable limits as specified in paragraph (A)(12) of this rule;

(b) Fluoroscopic image quality evaluations as specified in paragraph (D)(1) of this rule; and

(3) After initial evaluations of fluoroscopic equipment have been performed, the test and evaluations in paragraph (D)(2) of this rule shall be performed by a radiation expert annually within periods not to exceed fourteen months.

(4) After any maintenance to the fluoroscopic equipment which may alter the radiation output, including but not limited to re-installations, changing x-ray tubes or major components, and prior to patient use:

(a) The registrant shall utilize a radiation expert to perform measurements of air kerma rates as specified in paragraph (A)(8) of this rule, or

(b) The registrant shall have the radiation expert provide the IRRP at the facility with criteria for qualifying a designee to perform air kerma measurements after such maintenance. The IRRP shall document the name and organization of the designees; and

(c) If the air kerma rate measurements were taken by a designee, the reason the measurements were taken and the results of the measurements shall be documented in accordance with paragraphs (D)(6) of this rule, and the radiation expert shall subsequently re-test the air kerma rate within ninety days of the designee’s test.

(5) Results of air kerma rate measurements shall be posted where any fluoroscopy operator may have ready access to such results while using the fluoroscopy unit. The name of the individual performing the measurements and the date the measurements were performed shall be included in the results.

(6) The results of all tests performed in accordance with paragraphs (D)(2) to (D)(4) of this rule shall:

(a) Include the technique factors used in determining such results;

(b) Include the name of the individual performing the measurements;

(d) Be maintained by the IRRP between inspections for review by the department.

(E) Handlers of mobile fluoroscopic equipment shall not be required to comply with the requirements of paragraphs (A)(10), (A)(11), and (B) of this rule.

(F) Handlers of c-arm fluoroscopic equipment having a maximum SID less than forty-five centimeters shall not be required to comply with the requirements of paragraphs (A)(4)(e), (A)(4)(f), (A)(10), (A)(11), (B), and (E) of this rule.

(G) All individuals operating fluoroscopic equipment, and individuals likely to receive an annual effective dose equivalent in excess of one millisievert (one hundred millirem) from participating in fluoroscopic procedures, shall receive at least two hours of radiation protection training specific to fluoroscopy in addition to the training required by rule 3701:1-38-10 of the Administrative Code prior to performing or participating in fluoroscopic procedures. Additionally, each individual shall receive one hour of re-training whenever the individual receives in excess of thirty per cent of the allowable occupational dose measured over one calendar year.

(H) The training required by paragraph (G) of this rule shall be provided by an Ohio registrant, approved by the registrant’s designated radiation expert, and be specific to the type of fluoroscopic equipment used. In the case of a veterinary fluoroscopy application, the director may approve the training required by this rule in lieu of a radiation expert. Documentation of receiving the training required by paragraph (G) of this rule shall be retained by the registrant and be available for review upon inspection. At a minimum, training topics shall include, but not be limited to:

(1) Principles and operation of the fluoroscopic equipment to be used;

(2) Fluoroscopic outputs including high-level control options as applicable;

(3) Dose reduction techniques for fluoroscopic equipment; and

(4) A review of the safe operating procedures of each piece of fluoroscopic equipment that may be used by each individual.

(I) Fluoroscopic equipment used for radiation therapy simulation is regulated pursuant to rule 3701:1-66-15 of the Administrative Code.

(J) Computed tomography scanners equipped with fluoroscopic capabilities are regulated pursuant to rule 3701:1-66-10 of the Administrative Code.

Replaces: 3701:1-66-07

Effective: 04/15/2009

R.C. 119.032 review dates: 04/15/2014

Promulgated Under: 119.03

Statutory Authority: 3748.04

Rule Amplifies: 3748.04

Prior Effective Dates: 2/15/2001, 12/1/03

3701:1-66-08 Mammography radiation-generating equipment.

This rule provides standards for radiation-generating equipment used for screening and diagnostic mammography, and mammography equipment used for invasive localization and stereotactically-guided breast biopsy purposes, except as provided by paragraph (E) of this rule. In addition to Chapters 3701:1-38 and 3701:1-66 of the Administrative Code, a handler of mammography radiation-generating equipment that uses either stationary or mobile installations, other than dedicated stereotactic systems, shall comply with all applicable standards in 21 C.F.R. 1020 (as published in the April 1, 2008, Code of Federal Regulations) and the following:

(A) In addition to meeting the applicable equipment standards in rule 3701:1-66-02 of the Administrative Code, mammography radiation-generating equipment shall be specifically designed for mammography in accordance with all applicable standards of 21 C.F.R. 1020, and comply with applicable standards in Mammography Quality Standards Act (MQSA) regulations, 21 C.F.R. 900.12(b) (as published in the April 1, 2008, Code of Federal Regulations).

(B) A handler of all types of mammography radiation-generating equipment shall comply with the shielding requirements in paragraph (I) of rule 3701:1-66-02 of the Administrative Code.

(C) In addition to applicable radiation safety requirements in rules adopted pursuant to Chapter 3748. of the Revised Code and rule 3701:1-66-02 of the Administrative Code, a handler of all types of screening and diagnostic mammography radiation-generating equipment shall comply with the following:

(1) When a film/screen mammography system is used, clinical films shall be processed as soon as possible, but not to exceed twenty-four hours from the time the first clinical image is taken. Facilities utilizing batch processing shall:

(a) Use a container to transport clinical films that will protect the film from exposure to light, excessive heat and radiation; and

(b) Maintain a log to include date and identification of each patient, time of first exposure of each batch, and date and time of each batch processing.

(2) An individual, other than a licensed practitioner, operating any type of mammography or stereotactically-guided biopsy equipment shall possess an Ohio radiographer license in accordance with rules in Chapter 3701-72 of the Administrative Code and meet the training and continuing education requirements of 21 C.F.R. 900.12(a)(2) and to include at least one of the following:

(a) Documented evidence of having completed twelve classroom hours of educational courses in mammography as accepted by the department; or

(b) Proof of advanced certification in mammography issued to the operator by the “American Registry of Radiologic Technology.”

(D) In addition to all applicable quality assurance requirements in rules 3701:1-66-02 and 3701:1-66-04 of the Administrative Code, a handler of screening and diagnostic mammography radiation-generating equipment shall comply with the following:

(1) Designate and utilize a medical physicist who meets the qualifications under 21 C.F.R. 900.12(a)(3) who shall:

(a) Document and verify that the facility is taking proper corrective actions when results of the quality control tests indicate the need;

(b) Conduct surveys of the equipment in accordance with 21 C.F.R. 900; and

(c) Provide oversight and maintenance over the quality assurance program; For hospitals registered under division (A) of section 3701.07 of the Revised Code, the medical physicist also shall be certified as a radiation expert under paragraph (E)(3) of rule 3701:1-66-03 of the Administrative Code.

(2) The facility shall conduct testing procedures and maintain written records of all MQSA quality assurance and quality control tests between inspections in accordance with 21 C.F.R. 900, and phantom and quality control films for three months.

(E) Mammography radiation-generating equipment used exclusively for radiography of breast tissue from a biopsy, shall be exempt from paragraphs (A) to (D) of this rule, and shall comply with the requirements set forth in paragraphs (A), (D)(2), (F), (G)(2), (H)(1), (I) and (J) of rule 3701:1-66-02 of the Administrative Code.

(F) Testing by a medical physicist shall be conducted on mammography radiation-generating equipment having stereotactically-guided breast biopsy capability and shall follow the “American College of Radiology (ACR) Guideline for the Performance of Stereotactically Guided Breast Interventional Procedures” (as amended in 2006). This document is available from the “American College of Radiology, 1891 Preston White Drive, Reston, Virginia 20191, telephone (703) 648-8900.” The medical physicist shall meet the requirements of the aforementioned ACR document.

Replaces: 3701:1-66-08

Effective: 04/15/2009

R.C. 119.032 review dates: 04/15/2014

Promulgated Under: 119.03

Statutory Authority: 3748.04

Rule Amplifies: 3748.04

Prior Effective Dates: 2/15/2001, 2/01/05

3701:1-66-10 Computed tomography radiation-generating equipment.

As used in this rule, “computed tomography (CT) radiation-generating equipment” means CT units used for medical diagnostic imaging as defined in paragraph (B)(9) of rule 3701:1-66-01 of the Administrative Code, except for fluoroscopy units with CT capability, tomographic therapy units, and dedicated dental CT units. In addition to other applicable rules adopted pursuant to Chapter 3748. of the Revised Code and Chapter 3701:1-66 of the Administrative Code, handlers of CT radiation-generating equipment that includes either mobile or stationary installations shall comply with the following:

(A) CT radiation-generating equipment shall be maintained to meet the following equipment standards:

(1) The operator shall be able to terminate x-ray exposure at any time during a scan, or series of scans under CT radiation-generating equipment control of greater than 0.5 second duration.

(2) The CT x-ray control and gantry shall provide visual indication whenever x-rays are produced.

(3) Each emergency button or switch shall be clearly labeled as to its function.

(4) The CT radiation-generating equipment shall be designed such that the CT imaging parameters are indicated prior to the initiation of a scan or a scan sequence.

(5) If the x-ray production period is less than 0.5 second, the indication of x-ray production shall be actuated for at least 0.5 second. Indicators at or near the gantry shall be discernible from any point external to the patient opening where insertion of any part of the human body into the primary beam is possible.

(6) The indicated table increment versus actual table increment shall comply with the manufacturer’s specifications.

(7) In the case of premature termination of the x-ray exposure by the operator, the CT radiation-generating equipment shall require the operator to reset CT conditions of operation prior to the initiation of another scan.

(8) For any single tomographic system, means shall be provided to permit visual determination of the tomographic plane or a reference plane offset from the tomographic plane.

(9) For any multiple tomographic system, means shall be provided to permit visual determination of the location of a reference plane. The reference plane can be offset from the location of the tomographic planes.

(10) If a device using a light source is used to satisfy paragraph (D)(8) or (D)(9) of this rule, the light source shall provide illumination levels sufficient to permit visual determination of the location of the tomographic plane or reference plane under ambient light conditions of up to five hundred lux.

(11) The total error in the indicated location of the tomographic plane or reference plane shall not exceed five millimeters.

(B) In addition to paragraph (I) of rule 3701:1-66-02 of the Administrative Code, handlers of CT radiation-generating equipment shall meet the following facility design requirements:

(1) Windows, mirrors, closed-circuit television, or an equivalent system shall be provided to permit continuous observation of the patient during irradiation and shall be so located that the operator can observe the patient from the control panel.

(2) When the primary viewing system is by electronic means, an alternative viewing system, which may be electronic, shall be available for use in the event of failure of the primary viewing system.

(3) Provision shall be made for two-way aural communication between the patient and operator.

(C) In addition to paragraph (H) of rule 3701:1-66-02 of the Administrative Code, handlers of CT radiation-generating equipment shall meet the following radiation safety requirements:

(1) CT radiation-generating equipment which does not meet the provisions of this rule shall not be operated for diagnostic purposes.

(2) Information shall be available regarding the CT radiation-generating equipment and shall include the following:

(a) Dates of the latest radiation dose measurements and image quality evaluations and the location within the facility where the results of those tests may be obtained;

(b) Instructions on the use of the CT image quality phantom including a schedule of image quality evaluations appropriate for the system, allowable variations for the indicated parameters, and the results of at least the most recent image quality evaluations conducted on the system;

(c) The distance in millimeters between the tomographic plane and the reference plane if a reference plane is utilized; and

(d) Techniques shall be provided in the vicinity of the control panel or on a pre-programmed menu, based on patient age, weight, body mass index, or patient dimensions, as appropriate, that specifies for each routine examination the CT conditions of operation, including techniques specific to pediatric patient examinations.

(3) In consultation with the radiation expert, develop and implement a written plan, to include but not be limited to, delivering appropriate patient dose that uses ALARA principles. This plan shall be reviewed on an annual basis, not to exceed a fourteen month period.

(4) If the radiation dose measurement or image quality evaluation of the CT radiation-generating equipment identifies that a system operating parameter has exceeded a tolerance established by a radiation expert as provided in paragraph (D) of this rule, use of the CT radiation-generating equipment on patients shall be limited to those uses permitted by established written instruction of the radiation expert.

(5) Operators of CT radiation-generating equipment shall possess an Ohio radiologic license in accordance with rules in Chapter 3701-72 of the Administrative Code.

(D) In addition to other applicable quality assurance requirements in rule 3701:1-66-04 of the Administrative Code, handlers of CT radiation-generating equipment shall comply with the following quality assurance requirements:

(1) The registrant shall designate and utilize a radiation expert who shall:

(a) Perform an area radiation survey upon installation, or after any change in the CT radiation-generating equipment, its workload, or its structural shielding which may cause a significant increase in radiation hazard;

(b) Perform measurements of the radiation dose upon installation and prior to scanning patients. The measurements shall be made at least annually, not to exceed a fourteen month period, and after any change in the system which may cause a significant increase in the radiation dose.

(c) Develop written procedures to include system conditions and tolerance limits for the evaluation of image quality. The procedures shall incorporate the use of a CT phantom which has the capability of providing an indication of CT number accuracy for at least three materials, noise, tomographic section thickness, slice position, and the resolution capability of the system for low and high contrast objects.

(d) Perform evaluations of image quality according to the written procedures upon installation and prior to scanning patients and at least annually, not to exceed a fourteen month period, thereafter.

(2) Written records of all image quality evaluations shall be maintained between inspections for review by the director.

(3) The images for quality shall be retained until a new image quality evaluation is performed as follows:

(a) Photographic copies of the images obtained from the image display device; or

(b) Images stored in digital form on a storage medium compatible with the CT x-ray system.

(4) The individual responsible for radiation protection shall obtain a written report of the area radiation survey from the radiation expert, and a copy of the report shall be made available to the department’s inspector upon request.

(5) The limits of radiation dose shall not exceed a volume computed tomography dose index (CTDI VOL) of:

(a) Eighty milligray (eight rad) for the facility’s routine head scan;

(b) Thirty milligray (three rad) for the facility’s routine adult abdomen scan; and

(6) Compliance with the radiation dose limits shall be determined as follows:

(a) Radiation dose measurements shall be performed using the facility’s routine head, routine adult abdomen, and routine five-year old pediatric abdomen scan protocol. The specific CT conditions of operation shall be documented for each protocol;

(b) Radiation dose measurements shall be expressed in terms of CTDI VOL;

(c) Radiation dose measurements shall be performed using a CT dosimetry phantom that meets the following specifications and conditions of use:

(i) The CT dosimetry phantom shall be a right circular cylinder of a material having approximate tissue equivalence of one gram per cubic centimeter. The phantom shall be at least fourteen centimeters in length and shall have diameters of thirty-two centimeters for measuring radiation dose from the adult abdomen scan protocol and sixteen centimeters for measuring radiation dose from the head and pediatric abdomen scan protocols;

(ii) The CT dosimetry phantom shall provide a means for the placement of a dosimeter along the axis of rotation and along a line parallel to the axis of rotation on the outer surface or within one centimeter from the outer surface and within the phantom. Means for the placement of dosimeters or alignment devices at other locations may be provided;

(iii) Any effects on the doses measured due to the removal of phantom material to accommodate dosimeters shall be accounted for through appropriate corrections to the reported data or included in the statement of maximum deviation for the values obtained using the phantom; and

(iv) All dose measurements shall be performed with the CT dosimetry phantom placed on the patient couch or support device without additional attenuation materials present; and

(d) Radiation dose measurements shall be performed with a calibrated dosimetry system. The calibration of such system shall be traceable to a national standard, or cross-calibrated with a dosimetry system whose calibration is traceable to a national standard. Records of these calibrations shall be readily available for review upon inspection. The dosimetry system shall have been calibrated within the preceding two years.

(7) CT radiation-generating equipment manufactured after July 31, 1974, shall have sufficient maintenance to keep it in compliance with 21 C.F.R. 1020 (as published in the April 1, 2008, Code of Federal Regulations). The handler shall maintain documentation of such maintenance between inspections.

Replaces: 3701:1-66-10

Effective: 04/15/2009

R.C. 119.032 review dates: 04/15/2014

Promulgated Under: 119.03

Statutory Authority: 3748.04

Rule Amplifies: 3748.04

Prior Effective Dates: 2/15/2001, 2/15/05

3701:1-66-11 Bone densitometry radiation-generating equipment.

For the purposes of this rule, “bone densitometry equipment” means radiation-generating equipment intended for the medical purpose of quantifying bone density and mineral content by x-ray measurements through the bone and adjacent tissues. In addition to the applicable rules in Chapters 3701:1-38 and 3701:1-66 of the Administrative Code, handlers of bone densitometry equipment shall comply with the following:

(A) Handlers of bone densitometry equipment shall assure that the equipment is certified by the manufacturer in accordance with the requirements of 21 C.F.R. 1010.2, as published in the April 1, 2008, Code of Federal Regulations, and maintained in accordance with the manufacturer’s specifications.

(B) In addition to other applicable radiation safety requirements in Chapters 3701:1-38 and 3701:1-66 of the Administrative Code, handlers of bone densitometry equipment shall comply with the following:

(1) The operator shall be positioned at least one meter (3.3 feet) from the primary beam or behind a protective barrier containing a minimum of 0.25 millimeter of lead equivalent materials.

(2) Operators of bone densitometry equipment shall possess an Ohio radiologic license in accordance with rules in Chapter 3701-72 of the Administrative Code.

(C) In addition to other applicable quality assurance requirements in rules 3701:1-66-02 and 3701:1-66-04 of the Administrative Code, handlers of bone densitometry equipment shall comply with the following:

(1) The quality assurance program shall include quality control test records which shall be maintained between inspections and shall include the following:

(a) A list of the tests to be performed as specified by the manufacturer;

(b) The frequency of performance as specified by the manufacturer;

(d) A brief description of the procedures and test equipment to be used for each test.

(2) Maintain a readily available copy of the manufacturer’s operating manual.

(3) The operator shall advise the patient that the bone densitometry examination is a type of x-ray procedure.

Effective: 04/15/2009

R.C. 119.032 review dates: 01/05/2009 and 04/15/2014

Promulgated Under: 119.03

Statutory Authority: 3748.04

Rule Amplifies: 3748.04

Prior Effective Dates: 2/15/2001, 2/01/05

3701:1-66-12 Industrial radiography and irradiation devices utilizing radiation-generating equipment.

(A) Terms defined in rules 3701:1-38-01 and 3701:1-66-01 of the Administrative Code shall have the same meaning when used in this rule except terms redefined within this paragraph. As used in this rule:

(1) “Cabinet irradiation” means irradiation conducted using a cabinet x-ray system.

(2) “Cabinet radiography” means industrial radiography conducted using a cabinet x-ray system.

(3) “Cabinet x-ray system” means an x-ray system with the x-ray tube installed in a shielded enclosure, hereinafter termed a cabinet, such that every location on the exterior of the cabinet meets the dose limits for individual members of the public as specified in rule 3701:1-38-13 of the Administrative Code. A cabinet x-ray system is independent of existing architectural structures except the floor on which it may be placed; is intended to contain at least that portion of a material being irradiated; and must exclude all personnel, including extremities, from its interior during the generation of radiation.

(4) “Independent certifying organization” means an independent organization that meets all of the criteria of appendix A to this rule.

(5) “Individual responsible for radiation protection” or “IRRP,” as used in this rule, means an individual designated by the registrant who has the knowledge and responsibility for the overall radiation safety program at the facility, to include the implementation of the daily radiation safety operations and compliance with the rules.

(6) “Industrial radiation-generating equipment” means industrial radiography equipment and irradiator devices.

(7) “Industrial radiography equipment” means industrial radiation-generating equipment which produces ionizing radiation to examine the macroscopic structures of material by nondestructive methods.

(8) “Irradiation devices” means industrial radiation-generating equipment used to alter the chemical, biological, or physical properties of materials or to sterilize materials.

(9) “Permanent radiographic installation” means an enclosed shielded room, cell, or vault, not located at a temporary jobsite, in which industrial radiography is performed. Permanent radiographic installation includes a cabinet x-ray system used for industrial radiography that is large enough to walk into.

(10) “Temporary jobsite,” as used in this rule, means a location where radiographic operations are performed and where sources of radiation may be stored other than the location(s) of use authorized on the registration.

(B) A handler of industrial radiation-generating equipment shall meet the following equipment standards:

(1) A lock designed to prevent unauthorized or accidental production of ionizing radiation shall be provided.

(2) Permanent installations having a high radiation area shall be equipped with the following:

(a) Failsafe interlock at each entrance used for personnel access to the high radiation area;

(b) A visible signal that is activated when radiation is produced; and

(c) An audible signal that is activated when an attempt is made to enter the high radiation area while radiation is being produced.

(3) A readily visible warning light, labeled with the words “x-ray on” or words or symbols having a similar intent, shall be located on or near the source of radiation and its controls and shall be illuminated when the radiation source is energized;

(4) All industrial radiation-generating equipment shall be labeled with a readily discernible sign or signs bearing the radiation symbol and the words:

(a) “Caution – high intensity x-ray beam”, or appropriate words having a similar intent, on or near the housing of the source of radiation; and

(b) “Caution – this equipment produces radiation when energized”, or appropriate words having a similar intent, near any switch or control that directly energizes the unit.

(C) In addition to paragraph (B) of this rule, handlers of industrial radiation-generating equipment shall comply with the following radiation safety requirements:

(1) Handlers shall conduct a quarterly physical inventory of all industrial radiation-generating equipment. All records of the inventories shall be maintained between inspections and shall include:

(a) The number and type of radiation-generating equipment;

(b) The location of each piece of radiation-generating equipment;

(d) The name of the individual making the inventory;

(e) The manufacturer, model number, and the serial number of each piece of radiation-generating equipment.

(2) Industrial radiation-generating equipment shall be kept locked at all times, to prevent tampering or removal by unauthorized personnel, except when under the direct surveillance of a industrial radiographer or industrial radiographer assistant, or as may be otherwise authorized pursuant to this rule.

(3) The handler shall maintain sufficient calibrated and operable radiation survey instruments to make physical radiation surveys as required by this rule and rule 3701:1-38-14 of the Administrative Code.

(a) Instrumentation required by this rule shall have a range such that 0.02 millisievert (two millirem) per hour through 0.01 sievert (one rem) per hour can be measured.

(b) A radiation survey instrument shall be calibrated:

(i) For the type of radiation to be monitored;

(ii) At intervals not to exceed six months and after each instrument servicing other than battery replacement;

(iii) Such that accuracy within plus or minus twenty per cent can be demonstrated;

(iv) At two points located approximately one third and two thirds of full-scale on each scale for linear scale instruments

(v) At midrange of each decade, and at two points of at least one decade for logarithmic scale instruments; and

(vi) At appropriate points for digital instruments.

(4) At each location where industrial radiation-generating equipment operations are performed, all of the following shall be supplied by the handler:

(a) At least one operable, calibrated survey instrument;

(b) A current whole body personnel dosimeter assigned to each radiation worker;

(c) An operable, calibrated direct reading dosimeter with a range of zero to two millisieverts (two hundred millirem), or an appropriate electronic dosimeter, for each radiation worker; and

(d) Appropriate barriers, such as ropes and tapes and signs.

(5) Each handler shall maintain utilization logs between inspections showing the following information for each piece of radiography equipment used:

(a) At temporary job sites:

(i) Manufacturer, model number, and serial number;

(ii) Locations and dates of use;

(iii) Results of radiation surveys as required by rule 3701:1-38-14 and Chapter 3701:1-66 of the Administrative Code;

(iv) Dates that each piece of industrial radiation-generating equipment is removed from storage and returned to storage;

(v) Operating kilovoltage, tube current, and exposure time for each radiographic exposure; and

(vi) Identity and signature of the industrial radiographer to whom the equipment was assigned.

(b) At permanent radiographic installations:

(i) Manufacturer, model number, and serial number;

(ii) Dates each radiation machine is energized;

(iii) Results of radiation surveys as required by rule 3701:1-38-14 and Chapter 3701:1-66 of the Administrative Code;

(iv) Dates that each piece of industrial radiation-generating equipment is removed from storage and returned to storage;

(v) Operating kilovoltage, tube current, and exposure time for each radiographic exposure; and

(vi) Identity and signature of the industrial radiographer.

(6) Operating and emergency procedures shall include instructions in at least the following:

(a) Handling and use of industrial radiation-generating equipment to be employed such that no individual is likely to be exposed to radiation doses in excess of the limits established in rules 3701:1-38-12 and 3701:1-38-13 of the Administrative Code;

(b) Methods and occasions for conducting radiation surveys;

(d) Methods and occasions for locking and securing industrial radiation-generating equipment;

(e) Personnel monitoring and the use of personnel monitoring equipment, including all steps that must be taken immediately by monitored personnel in the event a dosimeter is found to be beyond its range, such as “off scale;”

(f) If appropriate, security and control of radiation-generating equipment during transportation to field locations;

(g) Minimizing additional exposure of individuals in the event of an accident;

(h) The procedure for notifying proper personnel in the event of an accident;

(i) Maintenance of records; and

(j) The inspection and maintenance of radiation-generating equipment.

(7) If the provisions set forth in this rule or any other applicable equipment requirements of Chapter 3701:1-66 of the Administrative Code are not met, the industrial radiation-generating equipment shall not be operated.

(8) Industrial radiation-generating equipment shall not be used to intentionally irradiate human beings for any purpose.

(9) At least two qualified individuals shall be present at temporary job sites when industrial radiation-generating equipment is being used. At least one of the individuals shall be an industrial radiographer to whom the industrial radiation-generating equipment is assigned and the other individual shall be either an industrial radiographer or an industrial radiographer assistant.

(10) No individual other than an industrial radiographer or an industrial radiographer assistant who is under the personal supervision of an industrial radiographer shall manipulate controls or operate equipment used in radiographic operations. The personal supervision must include:

(a) The industrial radiographer’s physical presence at the site where the radiation-generating equipment is being used;

(b) The availability of the industrial radiographer to give immediate assistance if required; and

(c) The industrial radiographer’s direct observation of the industrial radiographer assistant’s performance of the operations referred to in this rule.

(11) The handler shall not permit any individual to act as an industrial radiographer or as an industrial radiographer assistant unless, at all times during radiographic operations, each such individual wears an appropriate direct reading dosimeter and a personnel dosimeter. Pocket dosimeters shall have a range from zero to two millisieverts (two hundred millirem) and analog dosimeters shall be recharged at the start of each shift. Electronic dosimeters shall be battery-tested at the beginning of each shift. Each personnel dosimeter shall be assigned to and worn by only one individual and the handler shall assure that:

(a) Direct reading dosimeters are read and exposures are recorded at the beginning and end of each shift. These records shall be maintained between inspections;

(b) Direct reading dosimeters are checked for correct response to radiation at periods not to exceed twelve months. Acceptable dosimeters shall read within plus or minus twenty per cent of the true radiation exposure. Records of this check shall be maintained between inspections;

(c) If an individual’s pocket dosimeter is found to be off-scale, or the electronic personnel dosimeter reads greater than two millisieverts (two hundred mrem), the individual’s personnel dosimeter must be sent for processing within twenty-four hours. In addition, the individual may not resume work associated with the use of sources of radiation until a determination of the individual’s radiation exposure has been made. This determination must be made by the individual responsible for radiation protection (IRRP) or the IRRP’s designee. The results of this determination must be documented and maintained until the department terminates the registration.

(d) Dosimetry reports received from the accredited NVLAP personnel dosimeter processor are kept for review during inspection in accordance with rule 3701:1-38-20 of the Administrative Code;

(e) If a personnel dosimeter is lost or damaged, the worker shall cease work immediately until a replacement personnel dosimeter is provided and the exposure is calculated for the time period from issuance to loss or damage of the personnel dosimeter. This calculation must be made by the IRRP or the IRRP’s designee. The results of the calculated exposure and the time period for which the personnel dosimeter was lost or damaged must be included in the records maintained until the department terminates the registration;

(f) Personnel dosimeters shall be exchanged monthly unless the IRRP has performed an evaluation that indicates a longer frequency is adequate. Under no circumstances shall the frequency exceed three months. Documentation of the evaluation shall be maintained for inspection.

(g) After replacement, each personnel dosimeter must be returned to the supplier for processing within fourteen calendar days of the end of the monitoring period, or as soon as practicable. In circumstances that make it impossible to return each personnel dosimeter in fourteen calendar days, such circumstances must be documented and available for review by the department.

(12) No radiographic operation shall be conducted unless calibrated and operable radiation survey instrumentation is available and used at each site where radiographic exposures are made.

(13) A physical radiation survey shall be made after each radiographic exposure to verify that the radiation-generating device is not still producing radiation.

(14) Records shall be kept of the surveys in accordance with paragraph (C) of rule 3701:1-38-20 of the Administrative Code.

(15) During each radiographic operation, the industrial radiographer or industrial radiographer assistant shall maintain surveillance of the operation to protect against unauthorized entry into a high radiation area, except:

(a) When the high radiation area is equipped with a control device or alarm system as described in paragraph (B)(2) of this rule; or

(b) When the high radiation area is locked to protect against unauthorized or accidental entry.

(16) When performing radiographic operations at a location other than a permanent radiographic installation having the control devices specified in paragraph (C)(16) of this rule, the industrial radiographer shall be responsible for:

(a) Posting “caution high radiation area” signs at the perimeter of the calculated high radiation area;

(b) Restricting access and posting “caution radiation area” signs at the perimeter of the restricted area; and

(c) Maintaining constant visual surveillance of the restricted area boundary to prevent access by unauthorized personnel.

(17) Radiographic operations shall not be performed if any of the items in paragraph (C)(5) of this rule are not available at the jobsite or are inoperable.

(D) Handlers of industrial radiation-generating equipment shall comply with the following quality assurance requirements:

(1) Each radiation survey instrument described in paragraph (C)(3) of this rule shall be checked at the beginning of each day of use and at the beginning of each work shift using check sources or other appropriate means to ensure it is operating accurately.

(2) Each handler shall ensure that checks for obvious defects in industrial radiation-generating equipment are performed prior to each day or shift of use. If any check conducted reveals damage to components critical to radiation safety, the industrial radiation-generating equipment shall be locked out and tagged until repairs have been made.

(3) The entrance control device or alarm system described in paragraph (B)(2) of this rule, shall be tested for proper operation at the beginning of each day of equipment use. If an entrance control device or an alarm system is operating improperly, it shall be immediately labeled as defective and repaired or replaced within seven calendar days. The facility may continue operations during this seven-day period, provided the handler implements the continuous surveillance requirements of this rule. Records of these tests shall be maintained between inspections from the date of the event.

(4) Each handler shall evaluate operable industrial radiation-generating equipment every three months, not to exceed fourteen weeks, to assure proper functioning of components important to safety unless the radiation-generating equipment has been locked out and tagged “DO NOT USE” and is under the administrative control of the individual responsible for radiation protection. All appropriate parts shall be maintained in accordance with the manufacturer’s specifications. Records of evaluations shall be maintained between inspections.

(5) Each handler conducting industrial radiography at a temporary jobsite shall have the following documents and records available at the site for inspection:

(a) Appropriate certificate of registration;

(b) Operating and emergency procedures;

(d) Records of surveys required pursuant to this rule and rule 3701:1-38-14 of the Administrative Code for the period of operation at the site;

(e) Daily dosimeter records for the period of operation at the site; and

(f) The latest instrument calibration records for specific devices in use at the site. Acceptable records include tags or labels which are affixed to the device or survey meter.

(E) The IRRP for industrial radiography shall ensure that radiation safety activities are being performed in accordance with approved procedures and regulatory requirements in the daily operation of the registrant’s program.

(1) The minimum qualifications, training, and experience for IRRPs for industrial radiography are as follows:

(a) Completion of the training and testing requirements of paragraph (F) of this rule;

(b) Two thousand hours of hands-on experience as a qualified radiographer in industrial radiographic operations; and

(2) The department will consider alternatives to paragraph (E)(1) of this rule when the IRRP officer for industrial radiography has appropriate training and/or experience in the field of ionizing radiation, and in addition, has adequate formal training with respect to the establishment and maintenance of a radiation safety protection program.

(3) The specific duties and authorities of the IRRP for industrial radiography include, but are not limited to:

(a) Establishing and overseeing all operating, emergency, and ALARA procedures as required by Chapter 3701:1-38 of the Administrative Code, and reviewing them regularly to ensure that the procedures in use conform to current regulatory requirements, and to the license conditions.

(b) Overseeing and approving all phases of the training program for radiographic personnel, ensuring that appropriate and effective radiation protection practices are taught;

(c) Ensuring that required radiation surveys are performed and documented in accordance with the regulations, including any corrective measures when levels of radiation exceed established limits;

(d) Ensuring that personnel monitoring devices are calibrated and used properly by occupationally-exposed personnel, that records are kept of the monitoring results, and that timely notifications are made as required by paragraph (C) of rule 3701:1-38-21 of the Administrative Code; and

(e) Ensuring that operations are conducted safely and to assume control for instituting corrective actions including stopping of operations when necessary.

(F) No individual shall act as an industrial radiographer or industrial radiographer assistant unless such individual has received copies of, been instructed in, and has demonstrated understanding and competency in the subjects identified in this paragraph. Training provided to qualify as industrial radiographers and industrial radiographer assistants shall be in compliance with paragraph (F) of this rule and shall be presented on a formal basis. The training subjects shall include:

(1) Fundamentals of radiation safety;

(a) Characteristics of radiation;

(b) Units of radiation dose;

(i) Radiation protection standards;

(ii) Biological effects of radiation; and

(iii) Case histories of radiography accidents;

(d) Levels of radiation from sources of radiation; and

(e) Methods of controlling radiation dose;

(i) Working time;

(ii) Working distance; and

(iii) Shielding.

(2) Radiation detection instrumentation to be used;

(a) Use of radiation survey instruments;

(i) Operation;

(ii) Calibration; and

(iii) Limitations;

(b) Survey techniques; and

(3) Applicable requirements of federal and state regulations;

(4) Registrant’s written operating and emergency procedures; and

(5) Radiographic equipment to be used;

(a) Operation and control of x-ray equipment;

(b) Handling equipment; and

(G) Handlers of industrial radiation-generating equipment used for industrial radiography shall assure that personnel performing industrial radiography meet the following requirements.

(1) Industrial radiographers shall be certified through an independent program approved by the United States nuclear regulatory commission, the “Conference of Radiation Control Program Directors Inc.,” or equivalent certification approved by the director in accordance with the requirements in the appendix to this rule.

(2) Each industrial radiographer at a job site shall have on his or her person a valid certification identification card issued by the independent program reference in paragraph (G)(1) of this rule.

(3) Prior to any individual acting as an industrial radiographer, he or she shall demonstrate two months of prior on-the-job experience.

(4) Prior to an individual acting as an industrial radiographer assistant, he or she shall demonstrate competence in the training subjects identified in paragraph (F) of this rule.

(5) Industrial radiographers performing industrial radiography using only a cabinet x-ray system that does not permit an individual to walk into it, are exempt from the requirements of paragraphs (G)(1) and (G)(2) of this rule.

(H) Handlers shall assure that the following requirements are met regarding the individuals operating the radiography equipment:

(1) Each industrial radiographer and industrial radiographer assistant shall be audited by the registrant’s individual responsible for radiation protection to ensure that the registrant’s operating procedures are followed;

(2) The handler shall provide refresher safety training for each industrial radiographer and industrial radiographer assistant at intervals not to exceed twelve months. The training shall include, as a minimum, any results of internal inspections, new procedures or equipment, new or revised regulations, and accidents or errors that have been observed. The review shall also provide opportunities for employees to ask safety questions.

(3) Records of internal audits shall be maintained between inspections from the date of the audit; and

(4) Records of each industrial radiographer and industrial radiographer assistant training, including certificates of successful completion, oral, written, and practical examinations, and refresher training shall be maintained until termination of an individual’s employment or the next inspection, which ever period is longer.

(I) Handlers utilizing a cabinet x-ray system shall ensure the following:

(1) A cabinet x-ray system that is large enough to walk into, shall:

(a) Comply with all applicable requirements of this rule; and

(b) Be evaluated with at least one operable calibrated survey instrument at intervals not to exceed twelve months. Records of these evaluations shall be maintained between inspections.

(2) A cabinet x-ray system that is not large enough to walk into and designed to exclude all personnel, including extremities, from the interior of the cabinet during the generation of radiation, is exempt from the requirements of paragraphs (B) to (I)(1) of this rule, except that:

(a) No handler shall permit any individual to operate a cabinet x-ray system until such individual has received a copy of, and instruction in, the operating procedures for the equipment and has demonstrated competence in its use. Records which demonstrate compliance with this paragraph shall be maintained between inspections; and

(b) Tests for proper operation of high radiation area control devices, interlocks, warning lights, and labels specified in paragraphs (B)(2) to (B)(4) of this rule, where applicable, shall be conducted, recorded, and maintained in accordance with paragraph (D)(4) of this rule.

(3) The handler shall perform an evaluation, at intervals not to exceed twelve months, to determine compliance with rules adopted pursuant to Chapter 3748. of the Revised Code. Records of these evaluations shall be maintained between inspections.

(4) A certified enclosed system shall be maintained in compliance with requirement in 21 C.F.R. 1020.40 (as published in the April 1, 2007 Code of Federal Regulations) and the handler shall maintain documentation of compliance between inspections.

(5) Radiation emitted from the cabinet x-ray system shall not exceed a dose equivalent of five microsieverts (0.5 millirem) in one hour at any point five centimeters outside the external surface.

(J) The director may, upon application thereof or upon his or her own initiative, grant a variance to the requirements of this rule as he or she determines is authorized by law, provided that the registrant shows to the satisfaction of the director that there is good cause for the variance, and that the variance will not result in any undue hazard or effect on the public health and safety or environment. The terms, conditions, and expiration of the variance shall be set forth in writing by the director. Failure to comply with the terms of the variance may result in immediate revocation of the variance.

(K) Handlers of industrial radiation-generating equipment used for bomb detection purposes shall be exempt from paragraphs (C)(1), (C)(3), (C)(5)(b), (C)(5)(c), (C)(7)(e), (C)(10) to (C)(14), (C)(16), (C)(17), (D)(1) to (D)(3), (D)(5)(e) and (G) of this rule. In addition to these exemptions, the interval for calibrating radiation survey instruments as listed in paragraph (C)(4)(b) of this rule, and the frequency for the evaluation of operable radiation-generating equipment as listed in paragraph (D)(4) of this rule may be changed to annually.

Appendix A

I. Requirements for an Independent Certifying Organization

An independent certifying organization shall:

1. Be an organization such as a society, association, or educational institution whose members or faculty participate in, or have an interest in, the fields of industrial radiography;

2. Make its membership available to the general public nationwide that is not restricted because of race, color, religion, sex, age, national origin or disability;

3. Have a certification program open to nonmembers, as well as members;

4. Be an incorporated, nationally recognized organization that is involved in setting national standards of practice within its fields of expertise;

5. Have an adequate staff, a viable system for financing its operations, and a policy and decision-making review board;

6. Have a set of written organizational by-laws and policies that provide adequate assurance of lack of conflict of interest and a system for monitoring and enforcing those by-laws and policies;

7. Have a committee, whose members can carry out their responsibilities impartially, to review and approve the certification guidelines and procedures, and to advise the organization’s staff in implementing the certification program;

8. Have a committee, whose members can carry out their responsibilities impartially, to review complaints against certified individuals and to determine appropriate sanctions;

9. Have written procedures describing all aspects of its certification program, maintain records of the current status of each individual’s certification and the administration of its certification program;

10. Have procedures to ensure that certified individuals are provided due process with respect to the administration of its certification program, including the process of becoming certified and any sanctions imposed against certified individuals;

11. Have procedures for proctoring examinations, including qualifications for proctors. These procedures must ensure that the individuals proctoring each examination are not employed by the same company or corporation (or a wholly-owned subsidiary of such company or corporation) as any of the examinees;

12. Exchange information about certified individuals with other independent certifying organizations, the department, and radiological regulatory agencies in other states, and allow the department periodic review of its certification and examination program and related records; and

13. Provide a description to the director of its procedures for choosing examination sites and for providing an appropriate examination environment.

II. Requirements for Certification Programs

All certification programs must:

1. Require applicants for certification to:

(a) Receive training in the topics set forth in paragraph (F) of rule 3701:1-66-12 of the Administrative Code; and

(b) Satisfactorily complete a written examination covering these topics;

2. Require applicants for certification to provide documentation that demonstrates that the applicant has:

(a) Received training in the topics set forth in paragraph (F) of rule 3701:1- 66-12 of the Administrative Code;

(b) Satisfactorily completed a minimum period of on-the-job training; and

(c) Received verification by another state having requirements equal to or greater than Ohio’s requirements, and that the applicant has demonstrated the capability of independently working as a radiographer;

3. Include procedures to ensure that all examination questions are protected from disclosure;

4. Include procedures for denying an application, revoking, suspending, and reinstating a certificate;

5. Provide a certification period of not less than 3 years nor more than 5 years;

6. Include procedures for renewing certifications and, if the procedures allow renewals without examination, require evidence of recent full-time employment and annual refresher training;

7. Provide a timely response to inquiries, by telephone or letter, from members of the public, about an individual’s certification status.

III. Requirements for Written Examinations

All examinations must be:

1. Designed to test an individual’s knowledge and understanding of the topics listed in paragraph (F) of rule 3701:1-66-12 of the Administrative Code;

2. Written in a multiple-choice format;

3. Have test items drawn from a question bank containing psychometrically valid questions based on the material in paragraph (F) of rule 3701:1-66-12 of the Administrative Code.

Replaces: 3701:1-66-12

Effective: 10/01/2009

R.C. 119.032 review dates: 10/01/2014

Promulgated Under: 119.03

Statutory Authority: 3748.04

Rule Amplifies: 3748.04

Prior Effective Dates: 2/15/2001, 5/17/04

3701:1-66-13 Industrial analytical radiation-generating equipment.

As used in this rule “industrial analytical radiation-generating equipment” means a group or system of components which produce ionizing radiation as either a primary or a secondary result and is used to determine or alter properties of materials being measured or analyzed. This type of radiation-generating equipment includes, but is not limited to, gauging units, electron microscopes, x-ray diffraction, and spectrometer devices. This rule does not apply to industrial radiography and irradiation devices covered in rule 3701:1-66-12 of the Administrative Code, industrial particle accelerators specified in rule 3701:1-66-17 of the Administrative Code or incidental uses of medical radiation-generating equipment that are specified in other rules within Chapter 3701:1-66 of the Administrative Code. In addition to the applicable rules adopted pursuant to Chapter 3701:1-38 of the Administrative Code and rules 3701:1-66-01 and 3701:1-66-04 of the Administrative Code, handles of industrial analytical radiation-generating equipment shall comply with the following:

(A) Handlers of industrial analytical radiation-generating equipment shall meet the following equipment standards:

(1) Open beam configurations shall have a device or an automatic shut-off feature that prevents any part of a person’s body from being exposed to the primary x-ray beam path. The director may grant a variance to this requirement for registrants that provide sufficient documentation demonstrating effective alternate engineering or administrative controls. The documentation shall include the following:

(a) The reason these devices or features cannot be used;

(b) A description of alternate engineering and administrative safety controls that effectively prevent personnel exposure to the primary x-ray beam; and

(c) A description of the procedures to assure that operators and others in the area who may be affected by the variance have been informed of the applicable protective measures.

(2) Open-beam configurations and all other equipment installed after the effective date of this rule shall be provided with a readily visible warning light labeled with the words “x-ray on” or symbols having a similar intent, and be located near the x-ray source and its controls and be illuminated when the x-ray source is energized. In addition, open beam configurations shall be provided with a readily discernible indication of:

(a) X-ray source power “on-off” status located near the radiation source housing, if the primary beam is controlled in this manner; or

(b) Shutter “open-closed” status located near each radiation port on the source housing, if the primary beam is controlled in this manner.

(3) Except for gauging units, open-beam systems installed after the effective date of this rule shall have warning devices, or a system of warning devices, such as redundant lights with fail-safe characteristics. Fail-safe characteristics means a design feature which causes beam port shutters to close, or otherwise prevents emergence of the primary beam, upon failure of a safety or warning device. Malfunctions shall be repaired as soon as possible.

(4) All analytical radiation-generating equipment shall conspicuously display a clearly legible label or labels bearing the radiation symbol and the words “caution – this equipment produces radiation when energized” or appropriate words having a similar intent, near any switch or control that directly energizes the unit. Analytical radiation-generating equipment with open-beam configurations shall have an additional warning label on or near the x-ray housing with the radiation symbol with the words “caution – high intensity x-ray beam” or appropriate words having a similar intent.

(5) Each radiation source housing shall be equipped with an interlock that shuts off the radiation beam before the source is removed from the radiation source housing or before the housing is disassembled. For each radiation source installed prior to the effective date of this rule and not equipped with an interlock, administrative controls shall be instituted to include that the power shall be disconnected before any disassembly.

(6) Unused radiation ports on radiation source housings shall be secured in the closed position, or mechanically blocked.

(7) All industrial analytical radiation-generating equipment other than open beam shall be supplied with a protective cabinet which limits leakage radiation measured at a distance of five centimeters from its surface such that it is not capable of producing a dose in excess of 2.5 microsievert (0.25 millirem) in one hour.

(B) Handlers of industrial analytical radiation-generating equipment shall comply with the following radiation safety requirements:

(1) Operating procedures relative to radiation safety shall be written and available to all industrial analytical radiation-generating equipment operators. No individual shall be permitted to operate industrial analytical radiation-generating equipment in any manner other than that specified in the procedures unless such individual has obtained written approval of the individual responsible for radiation protection.

(2) Any temporary alteration to safety devices, such as by-passing interlocks or removing shielding shall be:

(a) Documented and maintained for inspection for a minimum of three years. This record shall contain such information as date the alteration was made, type of alteration, length of time alteration remained in place, and signature of the individual who made the alteration and the individual who restored the safety device to the original condition; and

(b) Approved, and signed in advance for a specified period of time by the individual responsible for radiation protection, and posted near the radiation-generating source housing with the signatures of approval

(3) Except as specified in paragraph (B)(2) of this rule, no operation involving removal of covers, shielding materials or radiation source housings or modifications to shutters, collimators, or beam stops shall be performed without ascertaining that the radiation source is off and will remain off until safe conditions have been restored. The radiation source power switch, in conjunction with appropriate interlocks, shall be used for routine shutdown in preparation for repairs.

(4) Industrial analytical radiation-generating equipment shall not be used to intentionally irradiate human beings.

(C) Handlers of industrial analytical radiation-generating equipment shall comply with the following quality assurance requirements:

(1) The local components of an industrial analytical radiation-generating system shall be located, be arranged, and include sufficient shielding or access control such that no radiation levels exist in any area surrounding the local component group which could result in a dose to an individual present therein in excess of the dose limits given in Chapter 3701:1-38 of the Administrative Code. These levels shall be met at any specified radiation source rating.

(2) Radiation surveys of all industrial analytical radiation-generating systems shall be performed in compliance with the rules of Chapter 3701:1-38 of the Administrative Code:

(a) Upon Installation of the radiation-generating equipment;

(b) Following any change in the initial arrangement, number, or type of local components in the system;

(d) During the performance of maintenance and alignment procedures if the procedures require the presence of a primary x-ray beam when any local component in the system is disassembled or removed;

(e) Any time a visual inspection of the local components in the system reveals an abnormal condition; and

(f) Whenever personnel monitoring reports show an unexplained increase over the previous monitoring period or the readings are approaching the limits specified in rules adopted pursuant to 3701:1-38 of the Administrative Code.

(3) Proper operation of all radiation safety devices, such as interlocks, lights, and labels, shall be checked at least every six months. Checks shall be performed by individuals qualified according to paragraph (C) (4) of this rule. Documentation shall be maintained and available for inspection for a minimum of three years and shall include any corrective actions taken.

(4) No individual shall be permitted to operate or maintain industrial analytical x-ray equipment unless that individual has received training and demonstrated competence regarding the following:

(a) Identification of radiation hazards associated with the use of the equipment;

(b) Significance of the various radiation warning, safety devices, and interlocks incorporated into the equipment, or the reasons they have not been installed on certain pieces of equipment and the extra precautions required in such cases;

(d) Recognition of symptoms of an acute localized exposure;

(e) Proper procedures for reporting an actual or suspected exposure in accordance with paragraph (C)(1) of this rule.

The individual responsible for radiation protection shall verify and document compliance with this paragraph and maintain and make the documentation available for inspection for a minimum of three years.

(5) Finger or wrist radiation monitoring devices shall be provided to and shall be used by:

(a) Industrial analytical radiation-generating equipment workers using systems having an open-beam configuration without provisions for engineering or administrative controls as provided in paragraph (A) (1) of this rule; and

(b) Personnel maintaining industrial analytical radiation-generating equipment if the maintenance procedures require the presence of an external radiation beam when any local component in the industrial analytical radiation-generating system is disassembled or removed.

(D) Handlers of electron microscopes and photoelectron spectrometers shall be exempt from the requirements of paragraphs (C)(2)(b) to (c)(2)(f), (C)(3), and (C)(4)(a)(b)(d)(e) of this rule.

(E) Handlers of gauging units shall be exempt from the requirements of paragraphs (C)(2)(c) to (C)(2)(e) of this rule.

(F) The director may, upon application thereof or upon his or her own initiative, grant a variance to the requirements of this rule as he or she determines is authorized by law, provided that the registrant shows to the satisfaction of the director that there is good cause for the variance, and that the variance will not result in any undue hazard or effect on the public health and safety or environment. The terms, conditions, and expiration of the variance shall be set forth in writing by the Director. Failure to comply with the terms of the variance may result in immediate revocation of the variance.

Effective: 02/10/2006

R.C. 119.032 review dates: 11/07/2005 and 02/01/2011

Promulgated Under: 119.03

Statutory Authority: 3748.04

Rule Amplifies: 3748.01 to 3748.02, 3748.04 to 3748.07, 3748.12 to 3748.15, 3748.17 to 3748.20, 3748.22 and 3748.99

Prior Effective Dates: 2/15/2001

3701:1-66-14 Other than megavoltage therapeutic radiation -generating equipment.

As used in this rule, “therapy equipment” means other than megavoltage therapeutic equipment that uses energy less than one megavolt (MV) mV for radiation therapy use only. In addition to the applicable rules Chapter 3701:1-38 and Chapter 3701:1-66 of the Administrative Code, handlers of therapy equipment shall comply with the following:

(A) Therapy equipment manufactured or installed after 1976 shall meet original manufacturer’s specifications and be United States “Food and Drug Administration” approved, or the following equipment standards shall apply:

(1) The tube housing shall be certified by the United States “Food and Drug Administration” with no modifications to the original design.

(2) Permanent diaphragms or cones used for collimating the useful beam shall afford the same degree of protection as the tube housing. Adjustable or removable beam-defining diaphragms, cones, or adjustable beam-limiting devices shall transmit not more than five per cent of the useful beam obtained at the maximum kilovoltage and with maximum treatment filter.

(3) When adjustable beam-limiting devices are used, the position and shape of the radiation field shall be indicated by a corresponding light beam.

(4) Filters shall be secured in place to prevent accidental displacement at any possible tube orientation. The filter slot shall be so constructed that the radiation escaping through it does not exceed one roentgen per hour at one meter, or, if the radiation from the slot is accessible to the patient, thirty roentgens per hour at five centimeters from the external opening.

(5) The filter system shall be so designed that each filter is marked as to its material of construction and its thickness.

(6) For therapy equipment installed after February 15, 2001, an interlock system must be present to prevent irradiation if the proper filter is not in place.

(7) Each x-ray tube shall be so mounted that it cannot turn or slide with respect to the aperture.

(8) Means shall be provided to immobilize the tube housing during stationary portal treatment.

(9) A method to determine the location of the source to within five millimeters shall be present.

(10) When radiation is produced during warm-up periods, contact therapy tube housing assemblies shall have a removable shield of material equivalent in attenuation to 0.5 millimeter of lead at one hundred kVp, which can be positioned over the entire useful beam exit port during periods when the beam is not in use.

(11) A timing control device shall be provided to terminate the irradiation after a preset time interval and shall:

(a) Be provided with a display at the treatment control panel. The timer shall have a preset time selector and an elapsed time or time remaining indicator;

(b) Be a cumulative timer that activates with an indication of “beam-on” and retains its reading after irradiation is interrupted or terminated. After irradiation is terminated and before irradiation can be reinitiated, it shall be necessary to reset the elapsed time indicator;

(c) Terminate irradiation when a preselected time has elapsed, if any dose monitoring system present has not previously terminated irradiation;

(d) Permit accurate presetting and determination of exposure times as short as one second;

(e) Not permit an exposure if set at zero;

(f) Not activate until the shutter is opened when irradiation is controlled by a shutter mechanism unless calibration includes a timer error correction to compensate for mechanical lag; and

(g) Shall be accurate to within one per cent of the selected value or one second, whichever is greater.

(12) Unless it is possible to bring the x-ray output to the prescribed exposure parameters within five seconds after the x-ray “on” switch is energized, equipment utilizing shutters to control the useful beam shall have a lead equivalency not less than that of the tube housing, shall be controlled by the operator from the control panel, and shall have a shutter position indicator on the control panel.

(13) The control panel shall have:

(a) Indication of whether x-rays are being produced;

(b) Indication of x-ray tube potential and current;

(d) A locking device which will prevent unauthorized use of the x-ray system;

(e) Indication of whether electrical power is available at the control panel and if activation of the x-ray tube is possible;

(f) A positive display of specific filters in the beam for therapeutic radiation-generating equipment manufactured after the effective date of these regulations; and

(g) Bear a warning label on the control console indicating that radiation is produced when the therapy equipment is energized and that the unit may be dangerous to patients and operators unless safety and operating instructions are observed.

(14) When a control panel may energize more than one x-ray tube:

(a) It shall be possible to activate only one x-ray tube at any time;

(b) There shall be an indication at the control panel identifying which x-ray tube is activated; and

(15) There shall be a means of determining the central axis, or target-to-skin distance, to within one centimeter and of reproducing this measurement to within two millimeters thereafter.

(16) Each piece of therapy equipment equipped with a beryllium or other low-filtration window shall be clearly labeled as such upon the tube housing assembly and shall be provided with a permanent warning device on the control panel that is activated when no additional filtration is present, to indicate that the dose rate is very high.

(17) In the event of an electrical power failure, the therapeutic radiation unit shall be mechanically locked in position.

(B) Handlers of therapy equipment shall comply with the following structural shielding and design requirements:

(1) Each unit of therapy equipment shall be provided with primary or secondary barriers as are necessary to ensure compliance with rules in Chapter 3701:1-38 of the Administrative Code.

(2) Provision shall be made for continuous two-way audible communication between the patient and the operator at the control panel.

(3) Windows, mirrors, closed-circuit television, or an equivalent system shall be provided to permit continuous observation of the patient during irradiation and shall be so located that the operator can observe the patient from the control panel.

(4) Should the viewing system fail or be inoperative, treatment shall not be performed with the unit until the viewing system is restored.

(5) Except for portable contact therapy equipment, each entrance to a treatment room shall be equipped with easily observable warning lights that operate only when radiation is being produced.

(6) For therapy equipment operating above one hundred and fifty kVp:

(a) All protective barriers shall be fixed except for entrance doors or beam interceptors;

(b) The control station shall be outside the treatment room; and

(c) Interlocks shall be provided such that all entrance doors must be closed before treatment can be initiated or continued. If the radiation beam is interrupted by any door opening, it shall not be possible to restore the machine to operation without closing the door and reinitiating irradiation by manual action at the control panel.; and

(C) In addition to applicable radiation safety rules in Chapter 3701:1-38 and Chapter 3701:1-66 of the Administrative Code, handlers of therapy equipment shall comply with the following:

(1) No person shall permit or arrange for the intentional use of machine-produced external beam radiation on human beings except for the purposes of medical therapy and as authorized by a licensed physician within his or her scope of work;

(2) No individual other than the patient being treated shall be in the treatment room during exposures from therapy equipment operating above 150 kVp.

(3) No individual other than the patient shall be in the treatment room during exposures from therapy equipment operating at one hundred and fifty kVp or below unless that individual is required for the procedure, and such individual is protected by a barrier sufficient to meet the requirements of paragraph (B)(1) of this rule.

(4) Every individual who performs radiation therapy procedures on human beings shall be a licensed practitioner or hold a valid radiation therapist license as required by Chapter 3701-72 of the Administrative Code.

(5) Representatives of the department may use interview or observation to determine that the registrant assures:

(a) Every individual who performs radiation therapy procedures on human beings holds a valid radiation therapist license as required by Chapter 3701-72 of the Ohio Administrative Code; and

(b) Every individual who performs radiation therapy procedures is adequately instructed in the registrant’s safe operating procedures and can demonstrate competency in the safe use of the equipment.

(6) The therapy equipment shall not be used for irradiation of patients unless the requirements of paragraph (D) of this rule have been met.

(7) Therapy equipment shall not be left unattended unless secured pursuant to paragraph (A)(13)(d) of this rule.

(8) When a patient is immobilized for radiation therapy, mechanical supporting or positioning devices shall be used.

(9) Each registrant shall be responsible for developing safe operating procedures for the operation of therapy equipment, including any restrictions specific to the required safe operation of each piece of therapy equipment, and for instructing and assuring all operators are competent in the safe use of the therapy equipment.

(10) A copy of the current operating and emergency procedures shall be maintained, and the emergency procedures shall be posted, at the therapy equipment control console.

(11) Each facility utilizing therapy equipment shall possess appropriately calibrated portable monitoring equipment. As a minimum, such equipment shall include a survey instrument capable of measuring dose rates over the range ten uSv (one mrem) per hour to ten mSv (one rem) per hour. Each survey instrument shall be operable and calibrated in accordance with paragraph (A)(2) of rule 3701:1-38-14 of the Administrative Code.

(12) The registrant shall designate and utilize a radiation expert who shall be physically present at the facility to perform or supervise the following:

(a) Radiation protection surveys of areas outside the treatment room; and

(b) Full, annual and output calibrations. As used in this rule for therapy equipment:

(i) “full calibration” means initial measurements, including output calibration, beam quality, mechanical checks, and all other applicable measurements described in the document “Dosimetry of X-ray and Gamma-Ray Beams for Radiation Therapy in the Energy Range 10 keV to 50 MeV, National Council on Radiation Protection and Measurements Report No. 69 (NCRP 69);”

(ii) “annual calibration” means a set of measurements conducted every twelve months on a piece of therapy equipment to measure the output, beam quality, applicable radiation safety, dosimetry and mechanical parameters as specified in the quality assurance program as developed by the registrant’s radiation expert; and

(iii) “output calibration” means the procedure to determine the radiation output of therapy equipment for a specific reference field size, source-dosimeter distance, and dosimeter depth using a dosimetry protocol published by a professional organization such as the “American Association of Physicists in Medicine” and which is usually performed during full calibration or annual calibration.

(13) A radiation protection survey shall be performed:

(a) As soon as possible following installation or reinstallation of therapy equipment and prior to irradiation of a patient;

(b) After any structural changes;

(c) After making any change in the location of the therapy equipment within the treatment room, except for portable contact therapy machines;

(d) After relocating the therapy equipment, except for portable contact therapy machines; or

(e) Before using the therapy equipment in a manner that could result in increased radiation levels in areas outside the external beam radiation therapy treatment room.

(14) The radiation protection survey shall be conducted with the therapy equipment in a “beam-on” condition with the largest clinically available treatment field selected and with for secondary barriers, a scattering phantom shall be placed in the useful beam. The survey shall verify:

(a) Radiation levels in restricted areas are not likely to cause personnel exposures in excess of the limits specified in Chapter 3701:1-38 of the Administrative Code; and

(b) Radiation levels in unrestricted areas do not exceed the limits specified in Chapter 3701:1-38 of the Administrative Code.

(15) If the results of the radiation protection surveys indicate any radiation levels in excess of the respective limits in paragraph (C)(14) of this rule, the registrant shall lock the control in the “off” position and not use the unit:

(a) Except as may be necessary to repair, replace, or test the therapy equipment, the therapy shielding or the treatment room shielding; or

(b) Until the registrant has received a specific variance from the director.

(16) The individual responsible for radiation protection shall obtain a written report of the radiation protection survey results from the radiation expert.

(17) A copy of the most recent radiation protection survey report shall be kept between inspections and available for review by the department.

(18) The radiation protection survey and report shall indicate all instances where the installation did not meet state compliance.

(19) The therapy equipment installation shall be operated in compliance with any limitations indicated by the radiation protection survey.

(20) The radiation protection survey report shall include:

(a) Date of the measurements;

(b) Reason survey is required;

(d) Manufacturer name, model number, serial number and the date of the most recent calibration for each instrument used to measure radiation levels;

(e) Plan of the areas surrounding each treatment room surveyed;

(f) Measured dose rates at several points in each area expressed in microsieverts per hour or millirems per hour;

(g) Calculated maximum levels of radiation over a period of one week for each restricted and unrestricted area; and

(h) Signature or initials of the radiation expert responsible for conducting the survey.

(D) In addition to the applicable quality assurance requirements of rule 3701:1-66-04 of the Administrative Code, handlers of therapy equipment shall comply with the following:

(1) NCRP Report 69 shall be used as the basis for the quality assurance program. The quality assurance program shall be developed by the radiation expert and shall to include specific measurements to be performed, frequency of measurement, and the acceptable tolerance for each parameter measured. Any variation from the frequency of measurement of any parameter shall be based upon equipment performance, and documented in the quality assurance manual. The quality assurance program shall be reviewed annually by the radiation expert.

(2) Specific quality assurance measurements shall include:

(a) Full calibration to determine the radiation output of the therapy equipment and measurements of all other applicable physical and dosimetry parameters. A full calibration shall be performed following installation or reinstallation of the therapy equipment and prior to irradiation of a patient;

(b) Annual calibrations to be performed every twelve months, but not to exceed fourteen months;

(c) Periodic spot checks to be performed at least monthly, or prior to use if not used monthly. For purposes of this rule, “spot check” means periodic compliance tests as specified in the quality assurance program developed by the registrant’s radiation expert; and

(d) Following any component replacement, major repair, or modification of components that could significantly affect the characteristics of the radiation beam, the appropriate part of a full calibration shall be performed prior to irradiation of a patient.

(3) Output calibration of the therapy equipment shall be performed with a calibrated dosimetry system. The calibration of the dosimetry system shall be performed every twenty-four months and after any servicing that may have affected the calibration system. Each registrant shall maintain the most recent record of each dosimetry system calibration or intercomparison.

(a) The dosimetry system shall be calibrated by:

(i) The “National Institute for Standards and Technology” (NIST), or an “American Association of Physicists in Medicine” (AAPM) “Accredited Dosimetry Calibration Laboratory” (ADCL); or

(ii) A radiation expert through intercomparison with a dosimetry system that was calibrated by one of the organizations in paragraph (D)(3)(a)(i) of this rule within the last twenty-four months; and

(b) For each dosimetry system calibration or intercomparison, the record shall include:

(i) Date;

(ii) Manufacturer name, model, and serial number of the instruments calibrated, or intercompared, as required by this rule;

(iii) Correction factors determined;

(iv) Names of the individuals who performed the calibration or intercomparison; and

(v) Signature of the radiation expert who performed or directly supervised the intercomparison.

(4) The record of the quality assurance measurements and checks specified in paragraph (D)(2) of this rule shall include:

(a) Date of the measurements and checks;

(b) Manufacturer name, model number, and serial number for all therapy equipment;

(c) Manufacturer name, model number, and serial number, and the date of the most recent calibration for each instrument used to measure radiation output of all therapy equipment; and

(d) Signature or initials of the radiation expert responsible for performing the measurements and checks.

(5) Records of all calibrations shall be maintained and shall be made available for inspection for the duration of the registration of all therapy equipment.

(6) Written spot check procedures shall include special operating instructions that shall be carried out when a parameter exceeds an acceptable tolerance.

(7) The cause for a parameter exceeding a tolerance set by the radiation expert shall be investigated and corrected before the system is used for medical irradiation.

(8) Spot checks, at a minimum, shall include testing the following:

(a) Radiation dose output for therapy equipment operating at or above 50 kVp;

(b) Electrical interlocks at each external beam radiation therapy room entrance, if required by paragraph (B)(6)(c) of this rule;

(d) Beam condition indicator lights on the access doors, control console, and in the radiation therapy room; and

(e) Viewing systems.

(9) Records of spot checks and any necessary corrective actions shall be maintained at the facility for three years and comply with paragraph (D)(4) of this rule.

(10) When a spot check involves a radiation measurement, such measurement may be obtained using a system as described in paragraph (D)(3) of this rule.

(E) A quality management program shall be implemented which, at a minimum, shall include the following:

(1) Written procedures to provide assurance that radiation is administered to patients as directed by the licensed practitioner within his or her scope of practice;

(2) Written procedures to evaluate and respond to incidents;

(3) As used in this rule “incident” means:

(a) All instances of treatment of the wrong subject, wrong treatment site, or wrong modality of treatment;

(b) When the treatment consists of three or fewer fractions and the calculated total administered dose differs from the total prescribed dose by more than ten percent of the total prescribed dose;

(c) When the treatment consists of more than three fractions and the calculated total administered dose differs from the total prescribed dose by more than twenty percent of the total prescribed dose;

(d) For stereotactic radiosurgery treatment, when the calculated total administered dose differs from the total prescribed dose by more than ten percent of the total prescribed dose; or

(e) Nonelective admission to the hospital as a result of a treatment during or within thirty days of completion of course of treatment;

(4) Written procedures to evaluate and respond to incidents within thirty days after discovery by assembling the relevant facts, identifying the cause of the incident and taking appropriate action, if any is required, to prevent recurrence; and

(5) Conduct an annual evaluation of the patient administration program including any recommendations for changes to be made, any modifications made since the last evaluation, and if required, revise procedures to assure the radiation is administered as directed by the licensed practitioner acting within his or her scope of practice.

(6) Retain, for three years, the following:

(a) Each physician order for a therapeutic procedure;

(b) Record of each administered radiation dose;

(d) Record of each incident, relevant facts, and any corrective actions taken.

(F) The director may, upon application by the registrant or upon the director’s own initiative, grant a variance to the requirements of this rule as he or she determines is authorized by law, provided that the registrant shows to the satisfaction of the director that there is good cause for the variance, and that the variance will not result in any undue hazard or effect on the public health and safety. The terms, conditions, and expiration of the variance shall be set forth in writing by the director. Failure to comply with the terms of the variance may result in immediate revocation of the variance.

Effective: 09/01/2005

R.C. 119.032 review dates: 05/02/2005 and 09/01/2010

Promulgated Under: 119.03

Statutory Authority: 3748.04

Rule Amplifies: 3748.01, 3748.02, 3748.04 to 3748.07, 3748.12 to 3748.15, 3748.17 to 3748.20, 3748.22, 3748.99

Prior Effective Dates: 12/15/2001

3701:1-66-15 Megavoltage therapeutic radiation-generating equipment.

As used in this rule, “therapy equipment” means megavoltage therapeutic radiation-generating equipment that uses energy having one megavolt (MV) and above for therapy use only, and does not include equipment used for superficial radiation therapy, or radiation generated by material sources or other types of radiation therapy equipment using less than one MV. In addition to the applicable rules adopted pursuant to Chapter 3748. of the Revised Code and this chapter of the Administrative Code, handlers of therapy equipment shall comply with the following:

(A) Therapy equipment shall comply with the documented manufacturer’s specifications approved by the U.S. “Food and Drug Administration,” or in the absence of such, the following equipment standards:

(1) An interlock shall be provided to prevent irradiation if any accessory selection operation carried out in the treatment room does not agree with the accessory selection operation carried out at the treatment control panel.

(2) Irradiation shall not be possible until a selection of a number of dose monitor units has been made at the treatment control panel.

(3) The pre-selected number of dose monitor units shall be displayed at the treatment control panel until reset manually for the next irradiation.

(4) After termination of irradiation, it shall be necessary to reset the dosimeter display to zero before subsequent treatment can be initiated.

(5) For therapy equipment manufactured after February 15, 2001, after termination of irradiation, it shall be necessary for the operator to set the appropriate dose monitor units before irradiation can be initiated.

(6) Each primary system shall terminate irradiation when the pre-selected number of dose monitor units has been detected by the system.

(7) If the original design of the equipment included a secondary dose monitoring system, that system shall be capable of terminating irradiation when not more than fifteen per cent or forty dose monitor units above the pre-selected number of dose monitor units set at the control panel has been detected by the secondary dose monitoring system.

(8) For therapy equipment manufactured after February 15, 2001, an indicator on the control panel shall show which monitoring system has terminated irradiation.

(9) It shall be possible to interrupt irradiation and equipment movements at any time from the therapy equipment treatment control panel. Following an interruption, it shall be possible to restart irradiation by operator action without any reselection of operating conditions. If any change is made of a pre-selected value during an interruption, irradiation and equipment movements shall be automatically terminated.

(10) It shall be possible to terminate irradiation and therapy equipment movements or move from an interruption condition to termination condition at any time from the treatment control panel.

(11) A timer display shall be provided at the therapy equipment treatment control panel. The timer shall have a preset time selector and an elapsed time indicator.

(12) The timer shall be a cumulative timer that activates with an indication of “beam-on” and retains its reading after irradiation is interrupted or terminated. After irradiation is terminated and before irradiation can be reinitiated, it shall be necessary to reset the elapsed time indicator.

(13) The timer shall terminate irradiation when a pre-selected time has elapsed, if the dose monitoring systems have not previously terminated irradiation.

(14) Therapy equipment capable of both x-ray therapy and electron therapy shall meet the following:

(a) Irradiation shall not be possible until a selection of radiation type has been made at the treatment control panel;

(b) An interlock system shall be provided to ensure that the equipment can only emit the radiation type which has been selected;

(c) An interlock system shall be provided to prevent irradiation if any selected operations carried out in the treatment room do not agree with the selected operations carried out at the treatment control panel;

(d) The radiation type selected shall be displayed at the treatment control panel before and during irradiation;

(e) An interlock system shall be provided to prevent irradiation with x-rays, except to obtain an image, when electron applicators are installed; and

(f) An interlock system shall be provided to prevent irradiation with electrons when accessories specific for x-ray therapy are installed or, if applicable, when no electron applicator is installed.

(15) Therapy equipment capable of generating radiation beams of different energies shall meet the following requirements:

(a) Irradiation shall not be possible until a selection of energy has been made at the treatment control panel;

(b) The nominal energy value selected shall be displayed at the treatment control panel until reset manually for the next irradiation. After termination of irradiation, it shall be necessary to reset the nominal energy value selected before subsequent treatment can be initiated; and

(c) Irradiation shall not be possible until the appropriate flattening filter or scattering foil for the selected energy is in its proper location.

(16) Therapy equipment capable of both stationary beam therapy and moving beam therapy shall meet the following requirements:

(a) Irradiation shall not be possible until a selection of stationary beam therapy or moving beam therapy has been made at the treatment control panel;

(b) An interlock system shall be provided to ensure that the equipment can operate only in the mode which has been selected;

(d) The mode of operation shall be displayed at the treatment control panel; and

(e) An interlock shall be provided to require that a selection of direction be made at the treatment control panel in all units which are capable of both clockwise and counter-clockwise moving beam radiation therapy.

(17) Each wedge filter shall be uniquely identified.

(18) At least one emergency power cutoff switch shall be located in the radiation therapy room and shall terminate all equipment electrical power including radiation and mechanical motion; in addition, all emergency power cutoff switches shall include a manual reset so therapeutic x-ray systems cannot be restarted from the unit’s control console without resetting the emergency cutoff switch.

(19) All therapy equipment shall be provided with two independent integrating dose monitors, alternatively, common elements may be used if the production of radiation is terminated upon failure of any common element.

(20) Each therapy equipment beam monitoring system shall have a legible display at the treatment control panel. For equipment manufactured after February 15, 2001 each display shall:

(a) Maintain a reading until intentionally reset;

(b) Have only one scale and no electrical or mechanical scale multiplying factors;

(d) In the event of power failure, the beam monitoring information displayed at the control panel at the time of failure shall be retrievable in at least one system for a twenty minute period of time.

(21) The therapy equipment control panel shall:

(a) Be located outside the treatment room;

(b) Provide an indication whenever electrical power is available at the control panel and if activation of the radiation is possible;

(d) Include an access control, or locking device that will prevent unauthorized use of the therapeutic radiation system; and

(e) Bear a warning label which cautions that radiation is produced when it is energized.

(B) In addition to applicable structural shielding rules in Chapter 3701:1-38 of the Administrative Code a handler of therapy equipment shall comply with the following:

(1) All protective barriers shall be fixed, except for entrance doors or beam interceptors.

(2) Each therapy equipment shall be provided with primary or secondary barriers as are necessary to ensure compliance with rules adopted pursuant to Chapter 3701:1-38 of the Administrative Code.

(3) Interlocks shall be provided such that all access controls must be closed before treatment can be initiated or continued. If the radiation beam is interrupted by any access control, it shall not be possible to restore the machine to operation without reinitiating irradiation by manual action at the control panel.

(4) All safety interlocks shall be designed so that any defect or component failure in the safety interlock system prevents operation of the system.

(5) Provision shall be made for two-way audible communication between the patient and the operator at the control panel. The therapeutic radiation unit shall not be used for irradiation of patients unless continuous two-way audible communication is possible.

(6) Windows, mirrors, closed-circuit television, or an equivalent system shall be provided to permit continuous observation of the patient during irradiation and shall be so located so that the operator can observe the patient from the control panel.

(7) Should the viewing system fail or be inoperative, treatment shall not be performed with the unit until the viewing system is restored.

(8) Each entrance to a treatment room shall be equipped with easily observable warning lights that operate only when radiation is produced.

(C) In addition to all applicable radiation safety rules in Chapter 3701:1-38 of the Administrative Code, a handler of therapy equipment or therapy simulators shall comply with the following:

(1) No person shall permit or arrange for the intentional use of therapeutic radiation on human beings except for the purposes of medical therapy and as authorized by a licensed practitioner working within his or her scope of practice.

(2) No individual other than the patient being treated shall be in the treatment room during radiation treatment.

(3) Therapy equipment shall not be left unattended unless secured pursuant to paragraph (A)(21)(d) of this rule.

(4) When a patient is immobilized for radiation therapy, mechanical supporting or positioning devices shall be used.

(5) Each registrant shall be responsible for developing emergency procedures and safe operating procedures for the operation of therapy equipment, including any restrictions specific to the required safe operation of each therapeutic radiation system, and for instructing and assuring all operators are competent in the safe use of the equipment.

(6) A copy of rule 3701:1-66-01 and rule 3701:1-66-15 of the Administrative Code and the current operating and emergency procedures shall be readily available. The emergency procedures shall be posted at the therapeutic radiation system control console.

(7) Every individual who performs radiation therapy procedures on human beings shall be a licensed practitioner or hold a valid radiation therapist license as required by Chapter 3701-72 of the Administrative Code.

(8) Representatives of the department may use interview or observation to determine that the registrant assures:

(a) Every individual who performs radiation therapy procedures on human beings holds a radiation therapist license as required by Chapter 3701-72 of the Administrative Code; and

(9) Leakage radiation outside the maximum useful beam in photon and electron modes shall not exceed manufacturer specifications.

(10) The registrant shall designate and utilize a radiation expert who shall be physically present at the facility to perform or supervise the following:

(a) Radiation protection surveys of areas outside the treatment room; and

(b) Full, annual, and output calibrations. As used in this rule for therapy equipment:

(i) “Full calibration” means initial measurements, including output calibration, beam quality, mechanical checks, and all other applicable measurements shown in table II of the document “Comprehensive Quality Assurance for Radiation Oncology: Report of the American Association of Physicists in Medicine Radiation Therapy Task Group 40; med. phys. 21(4), April 1994, pp. 581-615 (TG 40).”

(ii) “Annual calibration” means a set of measurements conducted every twelve months on a piece of therapy eqeuipment to measure the output, beam quality, applicable radiation safety, dosimetry and mechanical parameters as specified in the quality assurance program as developed by the registrant’s radiation expert; and

(iii) “Output calibration” means the procedure to determine the radiation output of therapy equipment for a specific reference field size, source-dosimeter distance, and dosimeter depth using a dosimetry protocol published by a professional organization such as the “American Association of Physicists in Medicine.”

(11) A radiation protection survey shall be performed:

(a) As soon as possible following installation or reinstallation of system therapy equipment and prior to irradiation of a patient;

(b) After any structural changes;

(d) After relocating the therapy equipment; or

(e) Before using the therapy equipment in a manner that could result in increased radiation levels in areas outside the external beam radiation therapy treatment room.

(12) The radiation protection survey shall be conducted with the therapy equipment in a “beam-on” condition, the largest clinically available treatment field selected, and for secondary barriers a scattering phantom shall be placed in the useful beam. The survey shall verify:

(a) Radiation levels in restricted areas are not likely to cause personnel exposures in excess of the limits specified in chapter 3701:1-38 3748. of the Administrative Revised Code; and

(b) Radiation levels in unrestricted areas do not exceed the limits specified in rule 3701:1-38 of the Ohio Administrative Code.

(13) If the results of the radiation protection surveys indicate any radiation levels in excess of the respective limits in paragraph (C)(12) of this rule, the registrant shall lock the control in the “off” position and not use the unit:

(a) Except as may be necessary to repair, replace, or test the therapy equipment, the therapy equipment shielding, or the treatment room shielding; or

(b) Until the registrant has received a specific variance from the department.

(14) The individual responsible for radiation protection shall obtain a written report of the radiation protection survey results from the radiation expert.

(15) A copy of the most recent radiation protection survey report shall be kept and available for review by the department of health.

(16) The radiation protection survey and report shall indicate all instances where the installation did not meet state compliance.

(17) The therapy equipment installation shall be operated in compliance with any limitations indicated by the radiation protection survey.

(18) The radiation protection survey report shall include:

(a) Date of measurements;

(b) Reason survey is required;

(d) Manufacturer name, model number, serial number and the date of the most recent calibration for each instrument used to measure radiation levels;

(e) Plan of the areas surrounding each treatment room surveyed;

(f) Measured dose rates at several points in each area expressed in microsieverts or millirems per hour;

(g) Calculated maximum level of radiation over a period of one week for each restricted and unrestricted area; and

(h) Signature or initials of the radiation expert responsible for conducting the survey.

(D) In addition to the applicable quality assurance requirements of rule 3701:1-66-04 of the Administrative Code, handlers of therapy equipment shall comply with the following:

(1) Table II of TG 40 shall be used as the basis for the quality assurance program. The quality assurance program shall be developed by the radiation expert and shall include all of the applicable parameters and tolerances of table II. Any variation from the frequency of measurement of any parameter shall be based upon equipment performance, and documented in the quality assurance manual. The quality assurance program shall be reviewed annually by the radiation expert.

(2) Specific quality assurance measurements shall include:

(b) Annual calibration to be performed every twelve months, but not to exceed fourteen months;

(c) Periodic spot checks to be performed at least monthly. For the purposes of this rule, “spot check” means periodic compliance tests as specified in the quality assurance program developed by the registrant’s radiation expert; and

(d) The appropriate part of a full calibration following any component replacement, major repair, or modification of components that could significantly affect the characteristics of the radiation beam. This shall be performed prior to irradiation of a patient.

(3) Output calibration of the therapy equipment shall be performed with a calibrated dosimetry system. The calibration of the dosimetry system shall be performed every twenty-four months and after any servicing that may have affected the calibration system. Each registrant shall maintain the most recent record for each dosimetry system calibration or intercomparison.

(a) The dosimetry system shall be calibrated by:

(i) The “National Institute for Standards and Technology” (NIST), or an “American Association of Physicists in Medicine” (AAPM) “Accredited Dosimetry Calibration Laboratory” (ADCL); or

(ii) A radiation expert through intercomparison with a dosimetry system that was calibrated by one of the organizations in paragraph (D)(3)(a)(i) of this rule within the last twenty-four months; and

(b) For each dosimetry system calibration or intercomparison, the record shall include:

(i) Date;

(ii) Manufacturer name, model and serial numbers of the instruments calibrated or intercompared as required in this rule;

(iii) Correction factors determined;

(iv) Names of the individuals who performed the calibration or intercomparison; and

(v) Signature of the radiation expert who performed or directly supervised the intercomparison.

(4) The record of the quality assurance measurements and checks specified in paragraph (D)(2) of this rule shall include:

(a) Date of the measurements and checks;

(b) Manufacturer name, model number, and serial number for all therapy equipment;

(c) Manufacturer name, model number, serial number, and the date of the most recent calibration for each instrument used to measure radiation output of all therapy equipment; and

(d) Signature or initials of the radiation expert responsible for performing the measurements and checks.

(5) Records of all calibrations shall be maintained and shall be made available for inspection for the duration of the registration of all therapy equipment.

(6) An independent measurement of the output of all photon beams and a sample of available electron beams shall be performed annually by:

(a) A radiation expert using a dosimetry system other than the dosimetry system that was used during the annual calibration; or

(b) A thermoluminescence dosimetry service or an equivalent method which is capable of measuring doses with an accuracy within five per cent.

(7) Output checks shall be performed in accordance with the quality assurance program, developed by the registrant’s radiation expert, using either a calibrated dosimetry system or a dosimetry system that has been intercompared within the previous twelve months with a system described in paragraph (D)(3) of this rule. For the purposes of this rule, “output check” means a spot check performed to ensure that a previous output calibration continues to be valid and constant.

(8) Results of each spot check, including output checks, shall be reviewed according to the following procedures:

(a) The radiation expert shall review and sign or initial the results of the spot checks at intervals not to exceed one month;

(b) The radiation expert shall be immediately notified if any parameter is not within a factor of two of the tolerance given in table II of TG 40. The therapy equipment shall not be made available for subsequent medical use until the radiation expert has determined what restrictions must be placed on the use of the therapy equipment or until the parameters are brought within acceptable tolerances.; The radiation expert shall immediately contact the radiation oncologist if the unacceptable tolerance requires patient treatment to be disrupted; and

(c) After all spot check parameters are brought within acceptable tolerances, the spot checks shall be reviewed and signed by the radiation expert within three treatment days.

(9) Written spot check procedures shall include special operating instructions that shall be carried out whenever a parameter exceeds an acceptable tolerance.

(10) When a spot check indicates a significant change in the dosimetric characteristics of a system, the system shall be recalibrated and;

(11) Records of spot checks and any necessary corrective actions shall be maintained at the facility for three years and comply with paragraph (D)(4) of this rule.

(E) As used in this rule, “therapy simulator” means any radiation-generating equipment intended for localizing the volume to be exposed during radiation therapy and reproducing the position and size of the therapeutic irradiation field. Handlers of therapy simulators shall comply with following:

(1) Rule 3701:1-66-07 of the Administrative Code for fluoroscopy simulators except for paragraphs (A)(2), (A)(4), (A)(5), (A)(7), and (A)(8) of rule 3701:1-66-07 of the Administrative Code;

(2) Rule 3701:1-66-05 of the Administrative Code for radiographic simulators except for paragraphs (A)(1), (A)(3), (A)(4), (A)(5)(c), (A)(7)(b), (A)(17), (A)(18), (E) and (F) of rule 3701:1-66-05 of the Administrative Code.

(3) The quality assurance program for radiographic and fluoroscopic therapy simulators shall be developed by the radiation expert, using table III of TG 40 as the basis for the quality assurance program to include specific measurements to be performed, frequency of measurement, and the acceptable tolerance for each parameter measured. Any variation from the frequency of measurement or tolerance limits shall be:

(a) Based upon equipment performance;

(b) Documented in the quality assurance manual; and

(4) Rule 3701:1-66-10 of the Administrative Code for CT simulators except for paragraphs (C)(2)(c), (C)(2)(d), (D)(1)(b), (D)(5), (D)(6), (D)(7), (D)(8), (D)(9), (D)(10), (D)(11) and (D)(12). The quality assurance program for CT therapy simulators shall be developed by the radiation expert using paragraph G of Part II of TG 40 as the basis for equipment performance in the quality assurance program. Performance measurements shall be performed in accordance with the written quality assurance manual. Any variation from the frequency of measurement or tolerance limits shall be:

(a) Based upon equipment performance;

(b) Documented in the quality assurance manual; and

(5) Each radiation simulator shall be provided with primary or secondary barriers as are necessary to ensure compliance with rules in Chapter 3701:1-38 of the Administrative Code.

(F) A quality management program shall be implemented which, at a minimum, shall include the following:

(1) Written procedures to provide assurance that radiation is administered to patients as directed by the licensed practitioner within his or her scope of practice;

(2) Written procedures to evaluate and respond to incidents. “Incidents” as used in this rule means:

(a) All instances of treatment of the wrong subject, wrong treatment site, or wrong modality of treatment;

(b) When the treatment consists of three or fewer fractions and the calculated total administrated dose differs from the total prescribed dose by more than ten per cent of the total prescribed dose;

(d) For stereotactic radiosurgery treatment, when the calculated total administered dose differs from the total prescribed dose by more than ten per cent of the total prescribed dose; or

(e) Nonelective admission to the hospital as a result of the treatment during or within thirty days of completion of the course of treatment.

(3) Written procedures to evaluate and respond to incidents within thirty days after discovery by assembling the relevant facts, identifying the cause of the incident and taking appropriate action, if any is required, to prevent recurrence;

(4) Conduct an annual evaluation of the patient administration program including any recommendations for changes to be made, any modifications made since the last evaluation, and if required revise procedures to assure the radiation is administered as directed by the licensed practitioner within his or her scope of practice; and

(5) Retain, for three years, the following:

(a) Each physician order for a therapeutic procedure;

(b) Record of each administered radiation dose;

(d) Record of each incident, relevant facts, and any corrective actions taken.

(G) The director may, upon application by the registrant or upon the director’s own initiative, grant a variance to the requirements of this rule as he or she determines is authorized by law, provided that the registrant shows to the satisfaction of the director that there is good cause for the variance, and that the variance will not result in any undue hazard or effect on the public health and safety. The terms, conditions, and expiration of the variance shall be set forth in writing by the director. Failure to comply with the terms of the variance may result in immediate revocation of the variance.

Effective: 09/01/2005

R.C. 119.032 review dates: 05/02/2005 and 09/01/2010

Promulgated Under: 119.03

Statutory Authority: 3748.04

Rule Amplifies: 3748.01, 3748.02, 3748.04 to 3748.07, 3748.12 to 3748.15, 3748.17 to 3748.20, 3748.22, 3748.99

Prior Effective Dates: 2/15/2001

3701:1-66-17 Industrial particle accelerator.

As used in this rule “particle accelerator” means a system of components which produce particles that are used to determine or alter properties of materials being measured, modified or analyzed, and does not include industrial analytical equipment to which rule 3701:1-66-13 of the Administrative Code applies, such as but not limited to, electron microscopes, gauging units, x-ray diffraction and spectrometer devices, and does not apply to radiation-generating equipment that is used in health care for therapeutic applications. In addition to the applicable rules adopted pursuant to Chapter 3701:1-38 of the Administrative Code and rules 3701:1-66-01 and 3701:1-66-04 of the Administrative Code, handlers of particle accelerators shall comply with the following:

(A) Particle accelerators shall meet the following equipment standards:

(1) A device or provision shall be provided to prevent the entry of workers into an area where high radiation is present and that causes the source of radiation to be shut off upon entry by workers into an area where high radiation is present.

(2) All safety instrumentation, readouts, and controls on the particle accelerator control console are clearly identified and easily discernible.

(3) Each safety interlock is on a circuit which allows it to operate independently of all other safety interlocks.

(4) All safety systems or interlocks shall be designed so that any defect or component failure in the safety interlock system prevents production of radiation by the accelerator.

(5) The safety interlock system shall only allow production of radiation by the particle accelerator to be resumed by manually resetting controls at the position where the safety interlock has been tripped, or at the control console if it is in clear view of the position where the safety interlock has been tripped.

(6) Each area where high radiation may be present has an audible and visual warning device which shall be activated for at least fifteen seconds prior to the possible creation of a high radiation area. Such warning devices shall be clearly discernible in all high radiation areas.

(7) Each particle accelerator shall bear a warning label on the control console which cautions individuals that radiation is produced when it is energized, and any other warning label required by rules adopted pursuant to Chapter 3701:1-38 of the Administrative Code.

(B) For a particle accelerator installed after February 15, 2001, handlers shall comply with the following structural shielding requirements:

(1) Utilize an independent health physicist approved by the registrant, and who is not involved with daily operations, to perform required shielding audits and radiation surveys as follows:

(a) Perform and approve the design of the particle accelerator installation; and

(b) Perform a radiation survey when the particle accelerator is first capable of producing radiation.

(2) Provide each industrial particle accelerator installation with such shielding as is necessary to assure compliance with the general radiation protection rules adopted pursuant to Chapter 3701:1-38 of the Administrative Code.

(1) The particle accelerator shall be secured when not in operation to prevent unauthorized use.

(2) The safety interlock system shall not be used to turn off the particle accelerator beam, except in an emergency or when testing of the safety interlock system.

(3) Handlers shall develop and maintain a particle accelerator handbook that describes the electrical circuits and the associated interlock systems, and shall be kept current as to any changes in the system.

(4) A copy of the current operating and the emergency procedures shall be maintained at the particle accelerator control console.

(5) Handlers shall maintain sufficient calibrated and operable radiation survey instruments to make physical radiation surveys as required by general radiation protection rules adopted pursuant to Chapter 3701:1-38 of the Administrative Code. Instrumentation required by this rule shall have a range such that 0.02 millisievert (two millirem) per hour to one millisievert (one hundred millirem) per hour can be measured.

(6) Records of instrument calibrations required by this paragraph shall be maintained for three years after the calibration date and be available for inspection. Each radiation survey instrument shall be calibrated:

(a) For the type of radiation to be monitored;

(b) At intervals not to exceed twelve months and after each instrument servicing other than battery replacement;

(d) At two points located approximately one third and two thirds of full-scale on each scale for linear scale instruments, or as described in the corresponding instrument manual;

(e) At midrange of each decade, and at two points of at least one decade for logarithmic scale instruments, or as described in the corresponding instrument manual; and

(f) At appropriate points for digital instruments.

(7) The handler shall assure that each particle accelerator location is supplied the following:

(a) At least one operable survey instrument for every type of radiation produced by the particle accelerator incidental to or as a direct result of its operations;

(b) A whole body personnel monitor, such as a thermoluminescent dosimeter or film badge, assigned to each radiation worker; and

(c) Appropriate barriers, such as ropes and tapes and signs, around areas or equipment where radiation is above background levels but is not greater than 0.020 millisievert (two millirem) per hour at the barrier.

(D) Handlers of particle accelerators shall comply with the following quality assurance requirements:

(1) Each portable radiation survey instrument shall be checked once per day, when used. Operability of an instrument may be determined by ensuring that it is correctly energized.

(2) Any safety equipment described in paragraph (A) of this rule shall be checked for proper operation at the beginning of each day of use. In the event the safety equipment is operating improperly, it immediately shall be repaired or replaced and never bypassed so as to enable radiation production.

(3) A radiation protection survey shall be performed and documented by a health physicist approved by the registrant when changes such as permanent shielding, operation, equipment, or occupancy of adjacent areas have been made that could produce a greater radiation hazard than before.

(4) In a facility where there is a potential for nuclear activation, radiation levels in all high radiation areas shall be continuously monitored. The monitoring devices shall be electrically independent of the particle accelerator control and safety interlock systems and capable of providing a readout at the control console. If an individual is to enter the target area after the beam is shut off, the individual must monitor the area for residual radiation.

(5) No individual shall act as a particle accelerator operator unless that individual has received instruction in, and has demonstrated an understanding of:

(a) The subjects outlined in appendix A of this rule;

(b) The requirements of this rule and the applicable requirements of Chapter 3701:1-38 of the Administrative Code; and

(6) No individual shall act as a particle accelerator operator until the registrant has documented that the individual has demonstrated competency in the use of the particle accelerator, related equipment, and radiation survey instruments that will be used to monitor the particle accelerator at that facility. The particle accelerator operator shall have immediate access to copies of the document required by paragraph (D)(5)(c) of this rule.

(E) The director may, upon application thereof or upon his or her own initiative, grant a variance to the requirements of this rule as he or she determines is authorized by law, provided that the registrant shows to the satisfaction of the director that there is good cause for the variance, and that the variance will not result in any undue hazard or effect on the public health and safety or environment. The terms, conditions, and expiration of the variance shall be set forth in writing by the director. Failure to comply with the terms of the variance may result in immediate revocation of the variance.

APPENDIX A

FUNDAMENTALS OF RADIATION SAFETY

A. Characteristics of radiation

B. Units of radiation dose

C. Significance of radiation dose

1. Fundementals of radiation dose

2. Radiation protection standards

3. Biological effects of radiation

D. Levels of radiation from particle accelerator sources

E. Methods of controlling radiation dose

1. Exposure time

2. Working distance

3. Shielding

II. Use of radiation detection instruments

A. Instrument operation

B. Calibration

C. Limitations on detection

D. Monitoring procedures

III. Personnel monitoring equipment (dosimetry)

A. Procedures for issuance, wearing, and exchange of dosimetry

B. Typical exposures expected

C. Methods to keep exposures ALARA

IV. Applicable requirements of Ohio Administrative Code

V. Registrant’s policies and procedures

A. Safe operating procedures

B. Emergency procedures

C. Interlock testing procedures

D. Specific concerns relating to the accelerator

VI. Operation and control of accelerator

Effective: 06/01/2006

R.C. 119.032 review dates: 02/01/2006 and 02/01/2011

Promulgated Under: 119.03

Statutory Authority: 3748.04

Rule Amplifies: 3748.01, 3748.02, 3748.04 to 3748.07, 3748.12 to 3748.15, 3748.17 to 3748.20, 3748.22, 3748.99

Prior Effective Dates: 2/15/2001