Chapter 3701:1-66 | Radiation Generating Equipment

Ohio Administrative Code

3701:1

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Rule

Rule 3701:1-66-01 | Definitions.

Effective:

December 20, 2019

Promulgated Under:

119.03

PDF:

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(A) As used in this chapter:

(1) "Air kerma" means the sum of the initial kinetic energy 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) "Air kerma rate" or "(AKR)" means the air kerma per unit time.

(3) "Aluminum equivalent" means the thickness of type 1100 aluminum alloy affording the same attenuation, under specified conditions, as the material in question.

(4) "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.

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

(6) "Bone densitometry equipment" means radiation-generating equipment used for the medical purpose of quantifying bone density and mineral content by x-ray measurements through the bone and adjacent tissues.

(7) "C-arm fluoroscope" means a fluoroscopic x-ray system in which the image receptor and the x-ray tube housing assembly are connected or coordinated to maintain a spatial relationship. Such a system allows a change in the direction of the beam axis with respect to the patient without moving the patient.

(8) "Calibration" 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.

(9) "Coefficient of variation" means the ratio of the standard deviation to the mean value of the observations.

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

(11) "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.

(12) "Computed tomography" or "(CT)" means an imaging procedure that uses multiple x-ray transmission measurements and computer programs to generate tomographic images.

(13) "Control panel" means that part of the radiation-generating equipment used for setting the technique factors.

(14) "CT conditions of operation" means all selectable parameters governing the operation of CT radiation-generating equipment including, but not limited to, nominal image thickness, filtration, milliampere (mA), kilovoltage peak (kVp), and scan time.

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

(16) "CT number" or "(CTN)" means the number used to represent the x-ray attenuation associated with each elemental area of the CT image.

(17) "Cumulative air kerma" means the total air kerma accrued from the beginning of an examination or procedure and includes all contributions from fluoroscopic and radiographic irradiation.

(18) "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.

(19) "Dental equipment" means radiation-generating equipment used for dental radiography.

(20) "Digital radiography" or "(DR)" means a general radiography system that utilizes an imaging plate to capture and produce a digital image for immediate viewing without the use of a laser scanning cassette reader.

(21) "Direct scattered radiation" means scattered radiation which has been deviated once in direction only by materials irradiated by the useful beam.

(22) "Executive administration" means individuals employed in the hospital's administration and having the authority to expend capital funds, approve personnel actions, and implement changes to hospital policy and procedure.

(23) "Filter" means material placed in the useful beam to preferentially attenuate selected radiations.

(24) "Fluoroscopic irradiation time" means the cumulative duration of x-ray tube activation in any fluoroscopic mode of operation.

(25) Fluoroscopic equipment" means radiation-generating equipment used for real time imaging of internal structures for medical purposes.

(26) "Fluoroscopically-guided interventional (FGI) procedures" means an interventional diagnostic or therapeutic procedure performed via percutaneous or other access routes, usually with local anesthesia or intravenous sedation, which uses external ionizing radiation in the form of fluoroscopy to localize or characterize a lesion, diagnostic site, or treatment site, to monitor the procedure, and to control and document therapy. This statement is focused on the FGI subset of potentially high-dose procedures.

(27) "Fluoroscopy" means a technique for generating x-ray images and presenting them simultaneously and continuously as visible images.

(28) "Full time training in medical physics" means having been engaged in the practice of clinical medical physics for a minimum of eighteen hundred hours within twelve consecutive months, under the supervision of a board-certified medical physicist.

(29) "Full time work experience" means a minimum of eighteen hundred hours of work experience earned within twelve consecutive months.

(30) "General purpose radiographic equipment" means stationary, mobile, and portable radiation-generating equipment used for medical purpose, but does not include dental intraoral, panoral, mammography, bone densitometry, computed tomography, fluoroscopy or spot film imaging and equipment used in radiation therapy.

(31) "Half-value layer (HVL)" means the thickness of specified material which attenuates the beam of radiation to an extent such that the AKR is reduced by one-half of its original value.

(32) "Hand-held radiation-generating equipment" means x-ray equipment that is specifically designed to be held in the hand during operation.

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

(34) "Hybrid imaging system" means a combination of systems that separately produce anatomic and functional images in very close temporal proximity without the need for patient repositioning and allow images to be co-registered and fused. These systems may be used for purposes including, but not limited to, attenuation correction, localization, registration, or fusion, but not used independently for diagnosis.

(35) "Image intensifier" means a device, installed in its housing, which instantaneously converts an x-ray pattern into a corresponding light image of higher intensity.

(36) "Image receptor" means any device that transforms incident x-ray photons into either a visible image or another form that can be made into a visible image by further transformation. In those cases, where means are provided to preselect a portion of the image receptor, the term "image receptor" means the preselected portion of the device.

(37) "Individual responsible for radiation protection (IRRP)" means an individual designated by the registrant who has the knowledge and responsibility for overall radiation safety and the quality assurance program at the facility, to include daily radiation safety operations and compliance with the rules.

(38) "Interventional procedure" means an invasive procedure that utilizes radiation-generating equipment for diagnostic or therapeutic purposes.

(39) "Kilovoltage peak (kVp)" means the maximum value of the electrical potential difference between the cathode and the anode of the x-ray tube during an exposure.

(40) "Last image hold" means an image obtained either by retaining one or more fluoroscopic images, which may be temporarily integrated, at the end of a fluoroscopic exposure or by initiating a separate and distinct radiographic exposure automatically and immediately in conjunction with termination of the fluoroscopic exposure.

(41) "Lateral fluoroscope" means the portion of a biplane system consisting of an x-ray tube housing assembly and an image receptor that are fixed in position to produce a horizontal x-ray beam.

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

(43) "Leakage radiation" means all radiation coming from within the x-ray tube housing except the useful beam.

(44) "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 and in accordance with the standard care arrangement.

(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.

(45) "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.

(46) "Medical event" means one or more of the following criteria have occurred to a human patient:

(a) Unintended skin dose to the same area in a single procedure greater than 2 sievert (200 rem);

(b) Unintended dose other than skin dose in a single procedure greater than:

(i) 0.5 sievert (50 rem) to any organ; or

(ii) 0.05 sievert (5 rem) effective dose equivalent;

(i) Greater than 0.5 sievert (50 rem) to any organ; or

(ii) Effective dose equivalent greater than or equal to 0.05 sievert (5 rem).

(47) "Medical, Medical use" or "Medical purpose" means using radiation-generating equipment to irradiate human beings or animals for diagnostic, localization, or other healing arts purposes.

(48) "Milliampere (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.

(49) "Mobile radiation-generating equipment" means x-ray equipment permanently mounted on a base with wheels or castors for moving while completely assembled and is not used in a fixed location.

(50) "Patient" means an individual or animal subjected to radiation for the purposes of examination or therapy.

(51) "Portable radiation-generating equipment" means radiation-generating equipment designed to be hand-carried.

(52) "Primary protective barrier" means a barrier sufficient to attenuate the useful beam to the required radiation level.

(53) "Protective apron" means an apron made of radiation-attenuating materials used to reduce radiation exposure.

(54) "Protective barrier" means a barrier of radiation-attenuating materials used to reduce radiation exposure.

(55) "Protective glove" means a glove made of radiation-attenuating materials used to reduce radiation exposure.

(56) "Radiation expert" means an individual who meets the qualifications of:

(a) Applicable paragraphs of rule 3701:1-66-03 of the Administrative Code;

(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) (as effective on the effective date of this rule) for any facility providing mammography services.

(57) "Radiation worker" means an individual engaged in activities registered by the department and controlled by the registrant.

(58) "Reference plane" means a plane which is displaced from and parallel to the computed tomographic plane.

(59) "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.

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

(61) "Scattered radiation" means radiation that, during passage through matter, has been deviated in direction.

(62) "Secondary protective barrier" means a barrier sufficient to attenuate stray ionizing radiation to a required level.

(63) "Source" means the point of origin of the useful radiation beam.

(64) "Source-to-image receptor distance" or "(SID)" means the distance from the source to the center of the input surface of the image receptor.

(65) "Source-to-skin distance" or "(SSD)" means the distance between the source and the skin of the patient.

(66) "Spot film" means a radiograph which is made during a fluoroscopic examination to permanently record conditions which exist during the fluoroscopic procedure.

(67) "Stationary radiation-generating equipment" means equipment which is installed in a fixed location.

(68) "Stray radiation" means leakage radiation or scattered radiation.

(69) "Table 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.

(70) "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.

(71) "Tomogram" means the depiction of the radiation attenuation properties of a section through a body.

(72) "Tomographic plane" means that geometric plane which is identified as corresponding to the output 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) "Unintended Dose" or "Unintended Skin Dose" means a patient radiation dose resulting from an error or equipment malfunction during a procedure.

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

(76) "Veterinary radiation-generating equipment" means radiation-generating equipment used for veterinary radiography.

(77) "Visible area" means that portion of the input surface of the image receptor over which incident x-ray photons are producing a visible image.

(78) "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 air kerma rate is one-fourth of the maximum in the intersection.

(B) Terms appearing in this chapter, which are not defined in this rule, may be defined in rule 3701:1-38-01 of the Administrative Code.

Last updated November 12, 2024 at 10:34 AM

Supplemental Information

Authorized By: ORC 3748.04
Amplifies: ORC 3748.01, 3701.02, 3748.04, 3748.05, 3748.06, 3748.07, 3748.12, 3748.121, 3748.13, 3748.14, 3748.15, 3748.17, 3748.18, 3748.19, 3748.20, 3748.22, 3748.99
Five Year Review Date: 10/28/2023
Prior Effective Dates: 7/1/2014

Rule 3701:1-66-02 | General administration requirements for medical radiation-generating equipment.

Effective:

December 13, 2024

Promulgated Under:

119.03

PDF:

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As used in this rule, "radiation-generating equipment" means radiation-generating equipment used for dental, veterinary, or medical purpose but does not include therapeutic radiation-generating equipment.

(A) The director may, upon application thereof or upon his or her own initiative, grant a variance to the obligations 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 will 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) An individual will not expose any individual or animal to the useful beam unless ordered by a licensed practitioner acting within his or her scope-of-practice for dental, medical or radiation therapy purposes. Exposing an individual for training, demonstration or other purposes is forbidden unless otherwise specified in rules promulgated under Chapter 4773. or 3748. of the Revised Code.

(1) Every individual who performs radiologic procedures on human beings holds the appropriate radiologic license as obligated by Chapter 3701-72 of the Administrative Code and Chapter 4715. of the Revised Code.

(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.

(3) The individual responsible for radiation protection (IRRP) is qualified as one of the following:

(a) Ohio licensed to operate radiation-generating equipment;

(b) Dental assistant certified to operate dental radiation-generating equipment;

(d) Certified by the American registry of radiologic technologists in a pathway involving ionizing radiation or certified by the nuclear medicine technologist certification board;

(e) A radiation expert as defined in rule 3701:1-66-01 of the Administrative Code;

(f) A health physicist certified by the American board of health physics; or

(g) An associate's degree or higher in health physics, radiologic science, nuclear medicine or nuclear engineering.

(D) Any radiation-generating equipment that does not meet the provisions set forth in this rule or any other applicable equipment obligations of Chapter 3701:1-66 of the Administrative Code will not be used to irradiate patients 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.

(E) Radiation-generating equipment will bear a warning label on the control panel, by the exposure switch or by the main power switch which cautions individuals that radiation is produced when it is energized.

(F) Unless otherwise specified in this paragraph, radiation-generating equipment will meet the following standards:

(1) On battery-powered x-ray generators, visual means will 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 will 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 will 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 will 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.

X-Ray TubeVoltage (kilovolt peak)	Minimum HVL(millimeter of aluminum)
Designed Operating Range	Measured Operating Potential	Specified Dental Systems¹	I-Other X-Ray Systems²	II - Other X-Ray Systems³
Below 51	30	1.5	0.3	0.3
	40	1.5	0.4	0.4
	50	1.5	0.5	0.5
51 to70	51	1.5	1.2	1.3
	60	1.5	1.3	1.5
	70	1.5	1.5	1.8
Above70	71	2.1	2.1	2.5
	80	2.3	2.3	2.9
	90	2.5	2.5	3.2
	100	2.7	2.7	3.6
	110	3.0	3.0	3.9
	120	3.2	3.2	4.3
	130	3.5	3.5	4.7
	140	3.8	3.8	5.0
	150	4.1	4.1	5.4
¹ Dental x-raysystems designed for use with intraoral image receptors and manufactured afterDecember 1, 1980.
² Dental x-raysystems designed for use with intraoral image receptors and manufactured beforeor on December 1, 1980, and all other x-ray systems subject to this section andmanufactured before June 10, 2006.
³ All x-ray systems,except dental x-ray systems designed for use with intraoral image receptors,subject to this section and manufactured on or after June 10,2006.

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

(b) The obligated minimal HVL of the useful beam will 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 will link the kVp selector with the filter and will prevent an exposure unless the minimum amount of filtration necessary to produce the HVL obligated by paragraph (F)(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 will be clearly indicated prior to initiation of the exposure. This indication will be both on the x-ray control panel and for dental equipment at or near the selected tube housing assembly;

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

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

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

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

(1) Software-based technique selections, a chart, or a combination of the two will 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, 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;

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

(a) All individuals will be positioned such that no part of the body will 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 needed for the medical procedure will 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 will be protected from the direct scatter radiation by whole body protective barriers of not less than 0.25 millimeter lead equivalent material or will 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;

(3) If performing a radiologic procedure requires auxiliary support for holding a patient or an image receptor, the handler will ensure the following:

(a) Mechanical holding devices will be used when the procedure permits their use in lieu of having an individual hold the patient or image receptor;

(b) Written safe operating procedures obligated by paragraph (B)(4) of rule 3701:1-66-04 of the Administrative Code will indicate the obligations for selecting someone to hold a patient or image receptor, and the procedure that will be followed. All individuals holding a patient or image receptor during radiation exposures will be at least eighteen years of age; and

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

(5) Any radiation worker participating in fluoroscopic, veterinary, or mobile or portable x-ray procedures is obligated to wear an individual monitoring device unless the IRRP or radiation expert determines 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;

(6) The entrance air kerma resulting from the technique used for the specified average adult human patient for routine diagnostic radiography will not exceed the values listed in table 2. The entrance air kerma resulting from the technique used for routine intraoral bitewing exams will 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 will be used for an x-ray tube potential (kVp) not listed in table 3.;

Table2.
Radiographictechnique	Adult thicknesscm	Entrance air kerma mGy(mR)
Chest (pa),(non-grid)	23	0.26 (30)
Chest (pa), (grid)	23	0.35(40)
Abdomen(kub)	23	5.26 (600)
Lumbo-sacral spine (ap)	23	6.13(700)
Thoracic spine(ap)	23	3.50 (400)
Full spine	23	3.50(400)
Cervical spine(ap)	13	1.75 (200)
Skull (lateral)	15	1.75(200)
Foot(dp)	8	0.88 (100)

Table3.
Tube VoltagekVp	D-Speed Film mGy(mR)	F-Speed Film Digital ReceptormGy (mR)
50	4.82 (550)	2.45 (280)
55	4.56(520)	2.19(250)
60	4.12 (470)	1.93 (220)
65	3.64(415)	1.66(190)
70	3.15 (360)	1.45 (165)
75	2.72(310)	1.23(140)
80	2.28 (260)	1.01 (115)
85	2.06(235)	0.92(105)
90	1.84 (210)	0.83 (95)
95	1.71(195)	0.74(85)
100	1.58 (180)	0.61 (70)

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

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

(b) Radiation-generating equipment subject to rule 3701:1-66-05 of the Administrative Code will 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 will 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;

(8) Except for radiation-generating equipment used for veterinary, portable, dental panoral, dental intraoral, lithotripsy, or bone densitometry applications, the operator will be behind a protective barrier, either in a separate room, in a protected booth, or behind a shield and be able to see the patient without leaving the protected barrier; and

(9) Each radiographic image, or a record linked with each radiographic image, will contain the following:

(a) Patient identification;

(b) Date of examination; and

(H) In addition to other applicable structural shielding obligations in Chapter 3701:1-66 of the Administrative Code, handlers of radiation-generating equipment will:

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

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

(i) Prior to new construction, or renovation; and

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

(b) Prior to patient use, use a radiation expert to determine compliance with exposure levels in accordance with rule 3701:1-38-14 of the Administrative Code by performing:

(i) An area radiation survey for new installation of radiation-generating equipment.

(ii) An area radiation survey for reinstallation or after any change in structural shielding unless, in the documented determination of a radiation expert, the reinstallation or change will not cause a significant increase in radiation hazard.

(c) Use a radiation expert to perform a re-calculation of area radiation survey results after any increase in clinical workload that exceeds the assumptions used in the existing radiation survey.

(d) Obtain a written report of the shielding design and the area radiation survey. A copy of the report will be made available to the department's inspector upon request.

(2) 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 will 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) 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) Provide a window of lead equivalency affording protection equal to that obligated 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.

(5) Assure the stationary CT and mobile CT radiation-generating equipment used in a fixed location provides for two-way aural communications between the human patient and operator.

(I) Notwithstanding paragraph (H)(1)(b)(ii) of this rule, reinstallation of radiation-generating equipment of the same operating parameters, location and geometry does not obligate another area radiation survey as long as the previous documented area radiation survey is maintained and available for inspection.

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

(1) X-ray systems and associated components used on humans and certified pursuant to 21 C.F.R. part 1020 (as effective on the effective date of this rule) will be maintained in compliance with applicable requirements of that standard, any modifications to the original components or systems will comply with that standard, and handlers will maintain documentation of compliance between inspections;

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

(a) User's manuals;

(b) Records of surveys, calibrations, maintenance, and modifications performed on the radiation-generating equipment which will 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, will 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 will be constructed of mechanically rigid, corrosion resistant material; and

(ii) The temperature of solutions in the tanks will be maintained within the range of 15.6 to 26.7 degrees Celsius (sixty to eighty degrees Fahrenheit). Film will 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-TemperatureChart
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 will be utilized which will indicate the actual temperature of the developer and signal the passage of a preset time appropriate to the developing time needed;

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

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

Developer Temperature (Degrees)	Minimum Immersion Time^a/
C	F	Seconds
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 timeonly, no crossover time included.

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

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

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

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

(5) The darkroom will 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 will:

(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 will provide a method to prevent accidental entry of light while undeveloped films are being handled or processed;

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

(8) Expired x-ray film will not be used for diagnostic radiographs;

(9) Cassettes, intensifying screens, and computed radiographic imaging plates will be:

(a) Cleaned according to manufacturer's specifications or an alternate frequency approved and documented by a radiation expert in the quality assurance program;

(b) Inspected for damage; and

(10) For those registrants employing computed and digital radiography imaging systems, the following will 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, x-ray exposures will not be made during processing;

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

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

(d) Facilities other than dental, podiatric, and veterinary will complete at least annually image quality evaluations appropriate for the equipment as established by a radiation expert or system manufacturer;

(11) Annual evaluation of the integrity of all necessary protective apparel.

(K) Upon discovery of a medical event, the handler will:

(1) Contact the department regarding the medical event within one business day;

(2) Provide a written report, including the analysis of the medical event, by a radiation expert to the department within fifteen business days of the medical event. The written report will include:

(a) The handler or registrant's name;

(b) The name of the prescribing physician;

(d) Why the event occurred;

(e) The effect, if any, on the individual who received the medical event;

(f) Actions, if any, that have been taken, or are planned, to prevent recurrence; and

(g) Certification that the handler notified the individual, or the individual's responsible relative or guardian, and if not, why not.

(3) Provide a clinical summary to the prescribing physician and patient within fifteen business days; and

(4) Maintain record of the medical event as part of the patient's permanent medical record.

(L) The written report in paragraph (K)(2) of this rule will not contain the individual's name or any other information that could lead to the identification of the individual.

Last updated December 13, 2024 at 8:19 AM

Supplemental Information

Authorized By: 3748.04
Amplifies: 3748.01, 3748.02, 3748.04, 3748.05, 3748.06, 3748.07, 3748.12, 3748.121, 3748.13, 3748.14, 3748.15, 3748.17, 3748.18, 3748.19, 3748.20, 3748.22, 3748.99
Five Year Review Date: 12/13/2029
Prior Effective Dates: 6/20/2010

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

Effective:

December 13, 2024

Promulgated Under:

119.03

PDF:

Download Authenticated PDF

(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.

(B) An individual seeking certification or renewal of certification as a radiation expert will apply to the department on a form prescribed and provided by the director. The application will 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, electronic payment, 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;

(4) Evidence that the applicant has appropriate training and qualifications to perform oversight and maintenance of quality assurance programs obligated 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; and

(5) As applicable, a certified copy of any felony conviction.

(6) Individuals that submit with their applications, proof that they are a service member or veteran, or the spouse or surviving spouse of a service member or veteran will receive priority expedited certification processing. Their applications will be reviewed within five business days of receipt and before all other applications for certification.

(a) The acceptable proof of service member/veteran status documents are:

(i) Department of defense identification card (active, retired, temporary disability retirement list (TDRL));

(ii) DD214 military discharge certificate indicating disposition of discharge;

(iii) Report of separation from the national archives national personnel records center in St. Louis, Missouri; or

(iv) Veterans identification card from the department of veterans affairs.

(b) All acceptable proof documents, except veterans identification card, will show the veteran status as honorable, general, general under honorable conditions, or discharged or released under conditions other than dishonorable.

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

(1) Certification by the "American Board of Radiology" in one of the following:

(a) Therapeutic radiologic physics;

(b) Therapeutic medical physics;

(2) Certification by the "American Board of Medical Physics in Radiation Oncology Physics"; or

(3) Certification by the "Canadian College of Physicists in Medicine in Radiation Oncology Physics"; or

(4) A master's or doctorate degree in physics, medical physics, other physical science, engineering, or applied mathematics from an accredited college or university; or equivalent international degree as evaluated and determined by an international credential evaluation service approved by the Ohio department of education or the United States department of education; and

(a) Have completed a clinical residency applicable to this category from an accredited program, or one year of full time training in medical physics and an additional year of full time work experience under the supervision of a board certified medical physicist who meets the qualifications of paragraph (C)(1), (C)(2) or (C)(3) of this rule at a medical institution. This training and work experience will be conducted in clinical radiation facilities that provide high-energy external beam radiation therapy with photons and electrons with energies greater than or equal to one MV or one MeV;

(b) The individual will have performed the applicable tasks listed in rules 3701:1-67-08 and 3701:1-67-09 of the Administrative Code under the supervision of a qualified medical physicist during the year of work experience; and

(c) Obtain certification pursuant to paragraph (C)(1), (C)(2), or (C)(3) of this rule within six years of qualifying as an Ohio therapeutic radiation expert under paragraphs (C)(4), (C)(4)(a) and (C)(4)(b) of this rule.

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

(1) Certification by the "American Board of Radiology" in radiologic physics, diagnostic radiologic physics or diagnostic medical physics;

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

(3) A master's or doctorate degree in physics, biophysics, medical physics, radiological physics or health physics, engineering, or applied mathematics with a minor in physics from an accredited college or university; or equivalent international degree as evaluated and determined by an international credential evaluation service approved by the Ohio department of education or the United States department of education; and completed a clinical residency applicable to this category from an accredited program, or completed one year of full time training in medical physics and an additional year of full time work experience 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 will have at least one of the following:

(1) Certification by the "American Board of Radiology" in radiologic physics, diagnostic radiologic physics or diagnostic medical 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; or equivalent international degree as evaluated and determined by an international credential evaluation service approved by the Ohio department of education or the United States department of education; 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 will respond to the director's request for additional information within twenty days of receiving the request.

(G) A certificate issued under this rule will 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 will mail or email a notice and application for renewal to the certificate holder. The certificate holder will complete the application and return it to the treasurer of state with the certification renewal fee in the form of a check, electronic payment, 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 will, 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 obligations 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 will 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 this rule;

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

(11) Has any felony conviction that indicates that the individual may pose a risk to public health and safety.

(I) An individual certified as a radiation expert will 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 will provide the director upon request with any other information regarding the obligations set forth in this rule.

(K) Each certified radiation expert will obtain continuing education for each certification period in accordance with the following:

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

(4) Individuals in active military service during the certification renewal period may have the continuing education period extended in accordance with section 5903.12 of the Revised Code.

(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 as continuing education for his or her certification period.

(N) In accordance with section 3748.12 of the Revised Code, a certification renewal fee that remains unpaid on the ninety-first day after the original invoice date will be assessed an additional amount equal to ten per cent of the original 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 need or want certification in that category.

(P) If an individual allows his or her certification to expire and the individual applies for the same certification within one year following the expiration of that certification, the individual will submit evidence of completing the continuing education obligations provided in this rule.

Last updated December 13, 2024 at 7:31 AM

Supplemental Information

Rule 3701:1-66-04 | Quality assurance program for medical radiation-generating equipment.

Effective:

December 13, 2024

Promulgated Under:

119.03

PDF:

Download Authenticated PDF

(A) Each registrant will develop, implement and maintain a written quality assurance program in the form of a readily available manual or manuals, either in hard copy format or electronic format. For purposes of this chapter and Chapter 3701:1-67 of the Administrative Code, quality assurance program means a program providing for verification by written procedures such as testing, auditing, and inspection to ensure that deficiencies, deviations, defective equipment, or unsafe practices, or a combination thereof, relating to the use, disposal, management, or manufacture of radiation devices are identified, promptly corrected, and reported to the appropriate regulatory authorities.

(B) The written quality assurance program of each registrant will address and include records to verify implementation of at least the following:

(1) The intervals of and procedures for the evaluation of all radiation-generating equipment to ensure compliance with all applicable rules of this chapter;

(2) Procedures for maintaining compliance with occupational and public exposure limits;

(3) Procedures for notifying the director when individuals are occupationally over-exposed to radiation, pursuant to Chapter 3701:1-38 of the Administrative Code;

(4) Safe operating procedures for each type of radiation-generating equipment to be handled;

(5) Training of operators of each type of radiation-generating equipment to be handled in order to assure competency in the operating procedures;

(6) In addition to the obligations of paragraph (B)(1) of rule 3701:1-38-10 of the Administrative Code, individuals likely to receive an annual occupational dose in excess of one millisievert (one hundred millirem) will be instructed in the following:

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

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

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

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

(9) The dissemination of quality assurance policies and a method to educate affected workers on those policies and any policy changes;

(10) Radiation workers' role and responsibility for following and supporting the quality assurance program;

(11) Policies regarding personnel protection, including time, distance, and shielding;

(12) Policies regarding occupational exposure of pregnant workers;

(13) Policies regarding radiation safety training for ancillary personnel;

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

(15) Policies regarding human patient protection, including screening for pregnancy, exposure of pregnant patients, patient shielding, patient education;

(16) Policies regarding verification of human patient identity and exam to be performed, including identification of the appropriate body part;

(17) Policies to only permit licensed practitioners to order radiographic examinations;

(18) An inventory of radiation-generating equipment, including the location and description of each unit.

(C) In addition to the obligations of paragraphs (A) and (B) of this rule, the quality assurance program of hospital registrants will comply with the following:

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

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

(b) Performing reviews of the quality assurance program each quarter;

(c) Completing and submitting all necessary 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 will 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, will be conspicuously posted in each area where radiation-generating equipment is used;

(3) Each hospital registrant will establish a quality assurance committee for the management of the quality assurance program. The members of the quality assurance committee will be approved by an executive administrator. Committee meetings may be attended by the members or similarly qualified, designated alternates. The quality assurance committee will include at least the following members:

(a) A member of the hospital's executive administration;

(b) The individual responsible for radiation protection;

(d) A certified radiation expert representing each of the following as applicable in each hospital;

(i) Radiation therapy services,

(ii) Mammography, or

(iii) Diagnostic radiography other than mammography; and

(e) A management representative of each department of the hospital which has responsibilities involving the handling of radiation-generating equipment;

(4) The quality assurance committee will meet as often as is deemed necessary to carry out its duties, but at least annually. To establish a quorum at least one-half of the committee's membership will be present either in person or by telecommunication, and will 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 will be maintained and distributed to each member which will include the following:

(a) The date of the meeting;

(b) An indication of members present; and

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

(a) Radiation safety policy revisions proposed by the certified radiation expert;

(b) A review of occupational exposure records by the certified radiation expert;

(d) Performance evaluation summaries for radiation-generating equipment including a description of any issues found; and

(e) Any corrective actions recommended by the certified radiation expert that are necessary to comply with the obligations of this chapter;

(6) The quality assurance program will be audited at least annually by a certified radiation expert. The certified radiation expert will 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 will review the audit report and implement any corrective actions determined to be necessary. The certified radiation expert will file the audit report with the director within ninety days of completing the audit. Every audit report will 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 obligations of this chapter. The audit report will become a part of the inspection record.

(D) In addition to the obligations of paragraphs (A) and (B) of this rule, the quality assurance program of registrants performing fluoroscopically-guided interventional other than veterinary procedures, and computed tomography (CT) other than veterinary and cone beam CT procedures will establish a radiation dose review committee in accordance with the following:

(1) The registrant may establish a system-wide committee if the registrant has more than one site;

(2) If the registrant is a subsidiary of a hospital, the obligations of paragraph (D) of this rule may be delegated to the hospital quality assurance committee provided its members meet the obligations of paragraph (D)(3) of this rule;

(3) The radiation dose review committee will include at least the following members:

(a) The individual responsible for radiation protection;

(b) A diagnostic radiation expert;

(c) As applicable, a physician that performs fluoroscopically-guided interventional and/or computed tomography procedures; and

(d) As applicable, a technologist that performs fluoroscopically-guided interventional and/or computed tomography procedures;

(4) A quorum of the radiation dose review committee will meet as often as necessary to carry out its duties, but at least annually. To establish a quorum at least one-half of the committee's membership will be present either in person or by telecommunication, and will include the individual responsible for radiation protection. A record of each meeting will be maintained and include the following:

(a) The date of the meeting;

(b) An indication of members present; and

(5) The radiation dose review committee for fluoroscopically-guided interventional procedures will establish and implement written policies that include but are not limited to the following:

(a) Identification of individuals who are authorized to use fluoroscopic systems for interventional purpose;

(b) A method to be used to monitor patient radiation dose during fluoroscopically-guided interventional procedures;

(c) Dose notification levels, as appropriate, at which the physician is notified and appropriate actions are taken for patient safety;

(d) Substantial radiation dose level values following nationally recognized standards;

(e) Actions to be taken for cases when a substantial radiation dose level is exceeded which may include patient follow-up; and

(f) Reviewing policies identified in paragraphs (C)(5)(a) to (C)(5)(e) of this rule at least annually;

(6) The radiation dose review committee for computed tomography will determine and review written protocols to improve image quality and minimize patient dose. The review will include acquisition and reconstruction protocols, image quality, and radiation dose. At a minimum, the review will be performed annually and include the following clinical protocols, if performed:

(a) Pediatric head;

(b) Pediatric abdomen;

(d) Adult abdomen;

(e) Adult chest; and

(f) Brain perfusion.

(E) Records obligated by this chapter and Chapter 3701:1-67 of the Administrative Code will be maintained in accordance with the following:

(1) Data and test results of evaluations and calibrations of all radiation-generating equipment for no less than five years;

(2) Data and test results of evaluations of shielding and surroundings of all radiation-generating equipment until the director terminates the registration or five years after the equipment is transferred or disposed;

(3) Maintenance logs for radiation-generating equipment for five years;

(4) Medical event reports involving radiation exposure to individuals for all radiation-generating equipment until the director terminates the registration;

(5) Copies of current licenses or the department's licensure verification web page for everyone who is obligated to possess a license at the facility; and

(6) Biennial calibration certificates or cross calibration documentation for all instruments used to perform area radiation surveys, calibrations, and evaluations for five years.

Last updated December 13, 2024 at 7:31 AM

Supplemental Information

Rule 3701:1-66-05 | Medical general purpose radiographic equipment.

Effective:

December 13, 2024

Promulgated Under:

119.03

PDF:

Download Authenticated PDF

The obligations of this rule do not apply to radiation-generating equipment used for dental intraoral or panoral, mammography, bone densitometry, computed tomography, fluoroscopy or spot film imaging, and equipment used in radiation therapy.

(A) General purpose radiographic equipment will meet the following equipment standards:

(1) A means will be provided for limiting the x-ray beam to the image receptor and area of clinical interest;

(2) For radiographic equipment having a variable x-ray field limitation device, the limitation device will have means for independent stepless adjustment of both the length and width of the x-ray field;

(3) For radiographic equipment that employs a light field for visually defining the perimeter of the x-ray field, the light source will 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 will not exceed two per cent of the source-to-image distance (SID);

(4) In addition to the obligations of paragraphs (A)(1), (A)(2) and (A)(3) of this rule stationary radiographic equipment having a variable x-ray field limitation device will have:

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

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

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

(e) Compliance measurements made to discrete SID's and image receptor dimensions in common clinical use, or at any other specific dimensions at which the beam-limiting device or its associated diagnostic x-ray system is uniquely designed to operate;

(5) General purpose radiographic equipment designed with only one image receptor size at a fixed SID will have:

(a) A means 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

(b) A means to align the field such that the x-ray field at the plane of the image receptor will not extend beyond any edge of the image receptor;

(6) General purpose radiographic equipment designed with multiple removable or selectable fixed apertures will have:

(a) A means 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 to align the center of the x-ray field with the center of the image receptor to within two per cent of the SID or for equipment uniquely designed where the beam axis is intended to be offset from the center of the image receptor, the x-ray field at the plane of the image receptor will not extend beyond the image receptor; and

(i) An assortment of removable, fixed-aperture, beam limiting devices sufficient to meet the obligation 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 obligation for each combination of image receptor size and SID for which the unit is designed. Permanent, clearly legible markings will indicate the image receptor size and SID for which each aperture is designed and will indicate which aperture is in position for use;

(7) If a positive beam limitation (PBL) device is used, it will meet the following additional obligations:

(a) The PBL will prevent the production of x-rays when any of the following conditions are met:

(i) 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, except as permitted by paragraph (A)(7)(c) of this rule;

(ii) The sum of the length and width differences as stated in paragraph (A)(7)(a)(i) of this rule without regard to sign exceeds four per cent of the SID; or

(iii) The beam-limiting device is at an SID for which PBL is not designed for sizing;

(b) Compliance with paragraph (A)(7)(a) of this rule will 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 will 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 will be equal to or less than five centimeters by five centimeters;

(d) The PBL system will be designed such that if a change in image receptor does not cause an automatic return to PBL function as described in paragraph (A)(7)(a) of this rule, then any change of image receptor size or SID will cause an automatic return; and

(e) The PBL system will function as described in paragraph (A)(7) of this rule whenever all the following conditions are met:

(i) The image receptor is inserted into a permanently mounted cassette holder;

(ii) The image receptor length and width are less than fifty centimeters;

(iii) The x-ray beam axis is within plus or minus three degrees of vertical in any direction and the SID is ninety to one hundred thirty centimeters inclusive; or the x-ray beam axis is within plus or minus three degrees of horizontal and the SID is ninety to two hundred five centimeters inclusive;

(iv) The x-ray beam axis is perpendicular to the plane of the image receptor to within plus or minus three degrees; and

(v) Neither tomographic nor stereoscopic radiography is being performed;

(8) A device will be provided to terminate the exposure at a preset time interval, preset product of current and time, preset number of pulses, or preset radiation exposure to the image receptor;

(9) For radiographic equipment that provides manual exposure control, the operator will 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;

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

(a) The control panel will 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 will be indicated; and

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

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

(12) The exposure control switch will meet the following obligations:

(a) The switch will be a "dead-man switch;"

(b) It will not be possible to initiate an exposure when the timer is set to the "zero" or "off" position if either position is provided; and

(c) The switch will be permanently mounted in a protected area so that it cannot be operated outside the protected area except for portable, mobile, or veterinary radiation-generating equipment.

(B) In addition to the applicable quality assurance obligations of Chapter 3701:1-66 of the Administrative Code, handlers of general purpose radiographic equipment will comply with the following:

(1) The kilovoltage peak (kVp) accuracy will be within plus or minus ten per cent of the indicated value;

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

(3) The coefficient of variation:

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

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

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

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

(5) 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 (milligray/mAs) values obtained at any two consecutive mAs selector settings will not differ by more than ten per cent of their sum;

(6) The average exposure ratio for paragraphs (B)(4) and (B)(5) of this rule will be expressed as follows:

|X₁ - X₂| < 0.10(X₁+X₂)

Where the value of X₁ and X₂ are the average milligray/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.

(C) In addition to the applicable radiation safety rules in Chapter 3701:1-38 and rules 3701:1-66-02 and 3701:1-66-04 of the Administrative Code, the operator of general purpose radiographic equipment will limit the useful beam to the area of clinical interest, not to exceed the size of the image receptor by more than two per cent of the source-to-image distance.

(D) Handlers of mobile or portable radiation-generating equipment will not be obligated to comply with the obligations of paragraph (H) of rule 3701:1-66-02 of the Administrative Code, and will comply with the following:

(1) Mobile and portable radiation-generating equipment which are:

(a) Used continuously for greater than one week in the same location, such as a room or suite, will have the x-ray control permanently mounted behind a protected barrier so that the operator can remain entirely behind the protected barrier and see the patient without leaving the protective barrrier during the entire exposure; or

(b) Used for less than one week at the same location will be provided with either a protective barrier at least 6.5 feet high for operator protection that allows the operator to see the patients without leaving the protective barrier during exposures, or means will be provided to allow the operator to be at least six feet from the tube housing assembly during exposures and the operator will 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 a capacitor energy storage system is fully charged and the exposure switch, timer, or any discharge mechanism is not activated will not exceed an air kerma of 0.26 microgray in one minute at five centimeters from any accessible surface of the diagnostic source assembly, with the beam-limiting device fully open; and

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

(E) Handlers of stationary veterinary radiation-generating equipment will not be obligated to comply with the obligations of paragraph (H)(4) of rule 3701:1-66-02 of the Administrative Code. However, stationary veterinary radiation-generating equipment will be provided with either a 6.5 foot high protective barrier for operator protection during exposures, or will 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 will be worn when making exposures.

(F) Handlers of mobile or portable veterinary radiation-generating equipment will not be obligated to comply with the obligations of paragraph (H) of rule 3701:1-66-02 of the Administrative Code. However, mobile or portable veterinary radiation-generating equipment will be provided with either a 6.5 foot high protective barrier for operator protection during exposures, or will 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 will be worn when making exposures.

(G) Handlers of certified radiation-generating equipment specifically designed by the manufacturer to be hand-held during radiographic exposures will not be obligated to comply with the obligations of paragraph (H) of rule 3701:1-66-02 of the Administrative Code. The handler will develop and implement safe operating procedures as part of the quality assurance program specified in rule 3701:1-66-04 of the Administrative Code, which will address and document at least the following:

(1) Hand-held radiation-generating equipment will be used for intraoral, extremity or small animal purposes only;

(2) Examination specific source-to-image distances will be developed and implemented to assure the useful beam is limited to the area of clinical interest or no larger than the image receptor;

(3) Operators of the hand-held radiation-generating equipment and individuals participating in the x-ray procedure will be protected from direct scatter radiation by protective aprons of not less than 0.25 millimeter lead equivalent material;

(4) If the hand-held radiation-generating equipment is designed with a back scatter shield, the backscatter shield will be in place during all radiographic exposures;

(5) Storage and security procedures will 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 handler;

(6) Hand-held radiation generating equipment will not be used in hallways or waiting rooms; and

(7) Operator training will include documented specific instruction to the x-ray operator regarding:

(a) Not placing any part of their body into the useful beam unless protected by not less than 0.5 millimeter lead equivalent material;

(b) The proper use of source-to-image distance for the examination to assure the size of the radiation beam is no larger than necessary;

(c) Ensuring that all individuals obligated for the examination are wearing the appropriate lead equivalent aprons and no bystanders are in the vicinity;

(d) The areas of use, proper storage and security procedures for the hand-held radiation-generating equipment; and

(e) The use of the dead-man switch and software safety devices such as locks and sensors.

Last updated December 13, 2024 at 7:32 AM

Supplemental Information

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

Effective:

December 13, 2024

Promulgated Under:

119.03

PDF:

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(A) Dental equipment will meet the following equipment standards:

(1) For dental intraoral equipment, a means will be provided to limit the source-to-skin distance (SSD) to not less than eighteen centimeters;

(2) For dental intraoral equipment, the x-ray field at the minimum SSD will be containable in a circle having a diameter of no more than seven centimeters;

(3) A means will 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 exposure control switch will meet the following obligations:

(a) The switch will be of the "dead-man" type;

(b) The operator will be able to terminate the exposure at any time during an exposure of greater than one-half second. Except during panoramic radiography, termination of the exposure will cause automatic resetting of the timer to its initial setting or to zero; and

(c) It will not be possible to make an exposure when the timer is set to "zero" or "off" position if either position is provided;

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

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

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

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

(B) Handlers of dental intraoral and panoral equipment are exempt from paragraph (H) of rule 3701:1-66-02 of the Administrative Code and will comply with the following:

(1) All areas struck by the useful beam will be provided with primary barriers;

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

(3) Intraoral and panoral units will be provided with a protective barrier for the operator or will be so arranged that the operator is located at a minimum distance of six feet from the patient and out of the useful beam. The operator's position will be arranged so that the operator views the patient during the entire exposure; and

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

(C) In addition to the radiation safety obligations listed in rule 3701:1-66-02 of the Administrative Code, handlers of dental equipment will not permit any individual to hold any part of the x-ray tube housing, cone, or mechanical support of the x-ray tube during exposure.

(D) In addition to the quality assurance obligations of rules 3701:1-66-02 and 3701:1-66-04 of the Administrative Code, handlers of dental radiation-generating equipment, with the exception of dental equipment used in hospitals, will conduct annual evaluations of x-ray operators to include the following:

(1) Positioning of the x-ray tube;

(2) Image processing;

(3) Operator location during x-ray exposure;

(4) Appropriate radiologic protocol; and

(5) Applicable regulatory obligations.

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

(1) Dental panoral x-ray machines will be certified pursuant to 21 C.F.R. part 1020 (as effective on the effective date of this rule); and

(2) The x-ray field will be limited to the dimensions of the slit in the image receptor holder or limited to the dimensions of the active portion of the image receptor.

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

(G) Fluoroscopy without image intensification will not be used for dental examinations. Handlers of image intensified fluoroscopic equipment will comply with the applicable obligations of rule 3701:1-66-07 of the Administrative Code.

(H) Handlers of dental cone-beam CT radiation-generating equipment will comply with the applicable obligations of rule 3701:1-66-10 of the Administrative Code, except paragraph (H)(3) of rule 3701:1-66-02 of the Administrative Code if a radiation expert has determined that the public dose limit specified in rule 3701:1-38-13 of the Administrative Code are not exceeded.

(I) Handlers of hand-held radiation-generating equipment used for dental procedures will meet the obligations of paragraphs (A), (B), and (D) of this rule, and will develop and implement safe operating procedures as part of the quality assurance program specified in rule 3701:1-66-04 of the Administrative Code, which will address at least the following:

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

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

(3) Hand-held radiation-generating equipment will be equipped with a backscatter shield of not less than 0.25 millimeters lead equivalent and 15.2 centimeters in diameter that is positioned as close as practicable to the distal end of the device;

(4) Storage and security procedures will 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;

(5) Operator training, as obligated in paragraph (B)(5) of rule 3701:1-66-04 of the Administrative Code, will include documented specific instruction to the x-ray operator regarding not placing any part of their body into the useful beam and ensuring there are no bystanders within a radius of at least six feet from the patient being examined during exposure; and

(6) Hand-held radiation-generating equipment will not be used in hallways or waiting rooms.

(J) Dental equipment will not be operated at less than a measured fifty-one kVp.

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

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

Last updated December 13, 2024 at 7:32 AM

Supplemental Information

Rule 3701:1-66-07 | Medical fluoroscopic equipment.

Effective:

December 13, 2024

Promulgated Under:

119.03

PDF:

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(A) Fluoroscopic equipment will meet the following standards:

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

(a) Thirty-eight centimeters on stationary fluoroscopic equipment unless a particular procedure application prevents that distance, in which case the SSD will not be less than twenty centimeters;

(b) Thirty centimeters on mobile fluoroscopic equipment unless a particular procedure prevents that distance, in which case it will not be less than twenty centimeters; and

(c) 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 prevents that distance, in which case it will not be less than ten centimeters. Such systems will be used for extremity or dental purposes only;

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

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

(4) All fluoroscopic equipment will provide intensified imaging. As used in this rule "intensified imaging" will include the use of digital image receptors;

(5) Fluoroscopic equipment will 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 will 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 will be no greater than four per cent of the SID; and

(ii) For rectangular x-ray fields used with circular image receptors, the error in alignment will 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 will conform with one of the following obligations:

(i) When any linear dimension of the visible area of the image receptor measured through the center of the visible area is less than or equal to thirty-four centimeters in any direction, at least eighty per cent of the area of the x-ray field will overlap the visible area of the image receptor; or

(ii) When any linear dimension of the visible area of the image receptor measured through the center of the visible area is 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 will 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 will 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 operator's position will indicate whenever the automatic field adjustment is overridden. Each such system failure override switch will be clearly labeled as follows:

"For X-ray Field Limitation System Failure;"

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

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

(6) Timers will meet the following specifications:

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

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

(i) A display of the fluoroscopic irradiation time at the operator's working position. This display will function independently of the audible signal described in paragraph (A)(6)(c)(ii) of this rule. The following obligations apply:

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

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

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

(7) X-ray production in the fluoroscopic mode will be controlled by a device which requires continuous pressure by the operator for the entire time of any exposure. When recording serial fluoroscopic images, the operator will 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;

(8) Fluoroscopic systems will 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, will 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 measurement point specified in paragraph (C)(6) of this rule;

(b) Fluoroscopic equipment provided with only manual mode capabilities will 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 measurement point specified in paragraph (C)(6) of this rule; and

(c) For fluoroscopic equipment that is provided with high-level control, and the high-level control is activated, the air kerma rate will 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 measurement point specified in paragraph (C)(6) of this rule;

(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 operator, will be needed to avoid accidental use; and

(ii) A continuous signal audible to the operator will indicate that high level control is being employed;

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

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

(11) For undertable fluoroscopic equipment, protective drapes, or other devices, at least 0.25 millimeter lead equivalent will 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 will not substitute for wearing obligated protective apparel;

(12) Radiography using the fluoroscopic imaging assembly will meet the following specifications:

(a) A means will 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 operator for spot films or radiographic images. If the x-ray field size is less than the size of the selected portion of the image receptor, the field size will not open automatically to the size of the selected portion of the image receptor unless the operator 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 will 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 will be aligned with the center of the selected portion of the image receptor to within two per cent of the SID; and

(d) Means will 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 will not exceed five centimeters by five centimeters;

(13) Fluoroscopic equipment manufactured on or after June 10, 2006, will display at the operator's working position the air kerma rate (AKR) and cumulative air kerma in accordance with the following obligations:

(a) When the x-ray tube is activated and the number of images produced per unit time is greater than six images per second, the AKR in milligrays per minute will be continuously displayed and updated at least once every second;

(b) The cumulative air kerma in units of milligrays will be displayed either within five seconds of termination of an exposure or displayed continuously and updated at least once every five seconds;

(d) The AKR and cumulative air kerma will represent the value for conditions of free-in-air irradiation at one of the following reference locations specified according to the type of fluoroscope;

(i) For fluoroscopes with x-ray source below the x-ray table, x-ray source above the table, or of lateral type, the reference location will be the respective locations specified in paragraph (C)(6)(a), (C)(6)(b) or (C)(6)(d) of this rule; or

(ii) For C-arm fluoroscopes, the reference location will be fifteen centimeters from the isocenter toward the x-ray source along the beam axis. Alternatively, the reference location will be at a point specified by the manufacturer to represent the location of the intersection of the x-ray beam with the patient's skin;

(e) Means will be provided to reset to zero the display of cumulative air kerma prior to the commencement of a new examination or procedure; and

(f) The displayed AKR and cumulative air kerma will not deviate from the actual values by more than plus or minus thirty-five per cent;

(14) Fluoroscopic equipment manufactured on or after June 10, 2006 will be equipped with means to display a last image hold (LIH) image following termination of the fluoroscopic exposure:

(a) For a LIH image obtained by retaining pre-termination fluoroscopic images, if the number of images and method of combining images are selectable by the user, the selection will be indicated prior to initiation of the fluoroscopic exposure;

(b) For a LIH image obtained by initiating a separate radiographic exposure at termination of the fluoroscopic imaging, the technique factors for the LIH image will be selectable prior to the fluoroscopic exposure, and the combination selected will be indicated prior to initiation of the fluoroscopic exposure; and

(c) Means will be provided to clearly indicate to the user whether a displayed image is the LIH radiograph or fluoroscopy. Display of the LIH radiograph will be replaced by the fluoroscopic image concurrently with re-initiation of the fluoroscopic exposure unless separate displays are provided.

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

(1) Any individual who is in the room during the fluoroscopic procedure will be adequately protected by standing behind a whole body protective barrier or will wear a protective lead apron of not less than 0.25 millimeter lead equivalent. If a handler's radiation expert includes documented evidence and specifies in the quality assurance program a distance and time interval in the room from the source at which an individual is unlikely to receive a total effective dose equivalent of greater than two millirem in any one hour or one hundred millirem in a year, the handler can forgo the use of a protective barrier or lead apron for that time at that distance;

(2) Protective lead or lead equivalent gloves will be used by individuals who are obligated to have their hands in the useful beam; and

(3) Handlers of fluoroscopic equipment used for interventional or cardiac procedures or on pediatric or pregnant patients will 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 radiographs and number of acquisitions.

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

(1) Handlers will designate and utilize a radiation expert who will 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 or reinstallations of existing equipment prior to patient exposure, handlers will utilize a radiation expert to perform the following:

(a) Radiographic 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 (C)(1) of this rule;

(d) High contrast and low contrast resolution evaluations in both fluoroscopic and radiographic modes;

(e) Five minute timer evaluations; and

(f) Evaluation of the accuracy of technique factor indicators and integrated radiation dose displays;

(3) After initial evaluations of fluoroscopic equipment have been performed, the test and evaluations in paragraph (C)(2) of this rule will be performed by a radiation expert annually;

(4) After repair or replacement of any component of the fluoroscopic equipment which may alter the radiation output or image quality, prior to patient use, a radiation expert will perform and document measurements of air kerma rates as specified in paragraph (C)(6) of this rule and image quality as specified in paragraph (C)(1) of this rule unless in the documented determination of a radiation expert, the repair or replacement will not cause a significant change in radiation output or significant degradation of image quality as specified in the quality assurance program;

(a) The radiation expert may designate qualified individuals to perform and document the measurements specified in paragraphs (C)(6) and (C)(1) of this rule;

(b) The radiation expert will provide the criteria for qualifying these designees in the quality assurance program; and

(5) The results of all tests performed in accordance with paragraphs (C)(2) to (C)(4) of this rule will:

(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;

(6) Compliance with air kerma rate allowable limits in paragraph (A)(8) of this rule will be determined as follows:

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

(b) If the source is above the x-ray table, the air kerma rate will 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 will be measured at thirty centimeters from the input surface of the image receptor with the source positioned at any SID;

(d) For fixed SID lateral fluoroscopes attached to the x-ray table, the maximum air kerma rate will 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 will 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 will be determined at the minimum SSD; and

(f) The maximum air kerma rate will 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 will have sufficient attenuative material placed in the useful beam to produce the maximum exposure rate of the system.

(D) Handlers of mobile fluoroscopic equipment will not be obligated to comply with the obligations of paragraphs (A)(10), and (A)(11) of this rule and paragraph (H) of rule 3701:1-66-02 of the Administrative Code.

(E) Handlers of c-arm fluoroscopic equipment having a maximum SID less than forty-five centimeters will not be obligated to comply with the obligations of paragraphs (A)(5)(e), (A)(5)(f), (A)(10), (A)(11), and (A)(12) of this rule and paragraph (H) of rule 3701:1-66-02 of the Administrative Code. In addition, if a radiation expert has specified in the registrant's quality assurance program that an individual is unlikely to receive a total effective dose equivalent of greater than two millirem in any one hour or one hundred millirem in a year, the handler will not be obligated to comply with the obligations of paragraph (B)(1) of this rule.

(F) 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, will receive at least two hours of radiation protection training specific to fluoroscopy in addition to the training obligated by rule 3701:1-38-10 of the Administrative Code prior to performing or participating in fluoroscopic procedures. Additionally, each individual will 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.

(G) The training obligated by paragraph (F) of this rule will be approved by the registrant's designated radiation expert, and be specific to the type of fluoroscopic equipment used. Documentation of receiving the training obligated by paragraph (F) of this rule will be retained by the registrant and be available for review upon inspection. At a minimum, training topics will include, but not be limited to:

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

(2) Fluoroscopic and radiographic outputs of each mode of operation, including high-level control options clinically used;

(3) Dose management, including dose reduction techniques for fluoroscopic equipment;

(4) Safe operating procedures of each piece of fluoroscopic equipment that may be used by each individual.

(5) Units of measurement and dose, including dose-area product values and air kerma;

(6) Radiation protection methods for patient and staff;

(7) Basic properties of radiation; and

(8) Biological effects of radiation.

(H) Fluoroscopic equipment used for radiation therapy procedures is regulated pursuant to rule 3701:1-67-09 of the Administrative Code.

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

Last updated December 13, 2024 at 7:32 AM

Supplemental Information

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

Effective:

December 13, 2024

Promulgated Under:

119.03

PDF:

Download Authenticated PDF

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 paragraphs (E) and (F) of this rule. In addition, a handler of mammography radiation-generating equipment that uses either stationary or mobile installations, will comply with all applicable standards in 21 C.F.R. part 1020 (as effective on the effective date of this rule).

(A) In addition to meeting the applicable equipment standards in rule 3701:1-66-02 of the Administrative Code, a handler performing screening or diagnostic mammography will have a valid certificate issued by the U.S. department of health and human services, pursuant to the Mammography Quality Standards Reauthorization Act of 1998, Public Law 105-248, and 21 C.F.R. Part 900 (as effective on the effective date of this rule).

(B) A handler of all types of mammography radiation-generating equipment will comply with the shielding obligations in paragraphs (H)(2) to (H)(4) of rule 3701:1-66-02 of the Administrative Code.

(C) In addition to applicable radiation safety obligations 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 will comply with the following:

(1) When a film/screen mammography system is used, clinical films will 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 will:

(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) Individuals who perform mammography procedures on human beings will hold an Ohio radiographer license in accordance with Chapter 3701-72 of the Administrative Code and will meet at least one of the following qualifications:

(a) Documented evidence of having completed the forty contact hours of training obligated by 21 C.F.R. 900.12(a)(2)(ii); or

(b) Hold advanced certification in mammography issued by the "American Registry of Radiologic Technologists."

(D) In addition to all applicable quality assurance obligations in rules 3701:1-66-02 and 3701:1-66-04 of the Administrative Code, the facility will maintain phantom and quality control images for three months.

(E) Radiation-generating equipment designed for mammography, but used exclusively for radiography of tissue from a biopsy, will be exempt from paragraphs (A) to (D) of this rule, and will comply with paragraphs (E), (H)(2), (H)(3) and (J) of rule 3701:1-66-02 of the Administrative Code.

(F) Radiation-generating equipment used for radiography of tissue from a biopsy and equipped with an x-ray tube enclosure designed to exclude personnel from its interior during x-ray generation will be exempt from paragraphs (A) to (E) of this rule, and will comply with the obligations set forth in rule 3701:1-68-06 of the Administrative Code.

(G) Quality control testing by a radiation expert will be conducted on mammography radiation-generating equipment used for invasive localization or having stereotactically-guided breast biopsy capability. Quality control testing for stereotactically-guided breast biopsy equipment will follow the "American College of Radiology (ACR) Practice Parameter for the Performance of Stereotactic-Guided Breast Interventional Procedures" (as revised in 2016). This document is available from the "American College of Radiology, 1891 Preston White Drive, Reston, Virginia 20191, telephone (703) 648-8900."

(1) The radiation expert will meet the obligations of the aforementioned ACR guideline; and

(2) The radiation expert will document and verify that the facility is taking proper corrective actions when results of the quality control tests indicate the need.

Last updated December 13, 2024 at 7:32 AM

Supplemental Information

Rule 3701:1-66-10 | Medical computed tomography radiation-generating equipment.

Effective:

December 13, 2024

Promulgated Under:

119.03

PDF:

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This rule applies to mobile and stationary computed tomography (CT) radiation-generating equipment, except for fluoroscopy units with CT capability, CT units used exclusively for radiotherapy simulation, and CT units integrated with linear accelerators.

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

(1) The operator will be able to terminate x-ray exposure at any time during a scan or series of scans of greater than 0.5 second duration;

(2) In the case of premature termination of the x-ray exposure by the operator, the CT radiation-generating equipment will need the operator to reset CT conditions of operation prior to the initiation of another scan;

(3) The CT x-ray control and gantry will provide visual indication whenever x-rays are produced;

(4) If the x-ray production period is less than 0.5 second, the indication of x-ray production will be actuated for at least 0.5 second. Visual indicators at or near the gantry will 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;

(5) Each emergency button or switch will be clearly labeled as to its function;

(6) The CT radiation-generating equipment will be designed such that the CT conditions of operation are indicated prior to the initiation of a scan or a scan sequence;

(7) The indicated table increment will not deviate from the actual table increment by more than one millimeter;

(8) Means will be provided to permit visual determination of the location of the tomographic plane or a reference plane. A reference plane may be offset from the location of the tomographic plane(s);

(9) If a device using a light source is used to satisfy paragraph (A)(8) of this rule, the light source will 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; and

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

(B) In addition to paragraph (G) of rule 3701:1-66-02 of the Administrative Code, handlers of CT radiation-generating equipment will meet the following radiation safety obligations:

(1) Techniques will 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, if applicable;

(2) The limits of radiation dose will not exceed a volume computed tomography dose index (CTDIvol):

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

(b) Thirty milligray (three rad) for the facility's routine adult or seventy kilogram (one hundred fifty-four pound) abdomen scan;

(c) Twenty milligray (two rad) for the facility's routine pediatric five-year old or eighteen kilogram (forty pound) abdomen scan; and

(d) Forty milligray (four rad) for the facility's routine (one-year old) pediatric head scan;

(3) If the results of the quality control tests, the image quality evaluations, or the radiation dose measurements exceed a tolerance limit established by a radiation expert, use of the CT radiation-generating equipment on patients will be limited to those uses permitted by written instruction of a radiation expert;

(4) Mobile CT radiation-generating equipment, except for stationary CT radiation-generating equipment installed in a van, trailer, or mobile vehicle and operator behind a protective control booth, will be provided with protective curtains of not less than 0.25 millimeter lead equivalent that completely surrounds the gantry bore during exposures, unless the protective curtains interfere with the sterile field of a surgical procedure; and

(5) Any individual who is in the room during a CT exposure will stand clear of the gantry bore, and will stand behind a whole body protective barrier or wear a protective lead apron of not less than 0.25 millimeter lead equivalent.

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

(1) The handler will designate and utilize a radiation expert who will:

(a) Perform measurements of the radiation dose and image quality prior to medical use:

(i) Upon installation;

(ii) After repair or replacement of any component of the CT equipment which may alter the radiation output or image quality, prior to medical use, a radiation expert will perform and document measurements of radiation output, using a method specified by a radiation expert in the quality assurance program, and image quality as specified in paragraph (C)(1)(c) of this rule unless in the documented determination of a radiation expert, the repair or replacement will not cause a significant change in radiation output or significant degradation of image quality as defined in the quality assurance program according to paragraph (C)(1)(c) of this rule.

(a) The radiation expert may designate qualified individuals to perform and document the measurements specified in paragraph (C)(1)(a)(ii) of this rule;

(b) The criteria for qualifying the designees specified in paragraph (C)(1)(a)(ii)(a) of this rule will be specified by a radiation expert in the quality assurance program; and

(b) Perform measurements of radiation dose annually;

(c) Perform evaluations of image quality at least annually using a CT phantom which has the capability of providing an indication of CT number accuracy for at least three materials. The evaluation of image quality will include CT number accuracy and uniformity, noise, artifacts, radiation beam width, resolution for low and high contrast, alignment light accuracy, and table travel accuracy; and

(d) Develop the written quality control program conducted by the CT technologist appropriate for the evaluation of the CT system that includes the tests and allowable tolerance limits. The quality control evaluation for image quality will include the use of a water equivalent phantom, and at a minimum, the evaluation of artifacts, noise, and CT number accuracy. The evaluation of image quality will be at a minimum completed weekly;

(2) Written records of all image quality evaluations and radiation dose measurements will be maintained between inspections for review by the department's inspector;

(3) The images for quality will 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) In consultation with a radiation expert, develop and implement a written program for radiation dose optimization and scan protocol review. The protocol review will include perfusion studies, if performed. The written program will be audited by a radiation expert on an annual basis;

(5) Radiation dose measurements will be performed using clinical protocols representative of the utilization of the CT unit. If protocols are estimated, measurements will be based on a sample of actual patient data. The specific CT conditions of operation will be documented for each protocol:

(a) Radiation dose measurements will be expressed in terms of CTDIvol;

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

(i) The CT dosimetry phantom will be a right circular cylinder of a material having approximate tissue equivalence of one gram per cubic centimeter. The phantom will be at least fourteen centimeters in length and will 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 will 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 will 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 will be performed with the CT dosimetry phantom placed on the patient couch or support device without additional attenuation materials present;

(c) Radiation dose measurements will be performed with a calibrated dosimetry system. The calibration of such system will 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 will be readily available for review upon inspection. The dosimetry system will have been calibrated within the preceding two years; and

(d) Obligations of paragraphs (C)(5)(a) and (C)(5)(b) of this rule may be satisfied by an alternative nationally-recognized standard for CT dosimetry. If an alternate dosimetry method is used, a radiation expert will document the procedures in the written quality assurance program.

(D) Cone beam computed tomography (CBCT) scanners and hybrid imaging systems, with the exception of CBCT units integrated with linear accelerators, will comply with the following rules:

(1) Under the guidance of a radiation expert, handlers of CBCT units will develop and implement a written quality control testing program to include test procedures, test frequencies, and tolerance limits;

(2) The written quality control testing program will include an annual testing component to be performed by a radiation expert. This annual testing component will be performed upon installation of new CBCT units and annually thereafter;

(3) The annual tests to be performed by a radiation expert will include an assessment of radiation dose and an evaluation of image quality;

(4) Records of all quality control tests will be documented and retained between inspections;

(5) CBCT scanners are exempt from paragraphs (B)(2) and (C)(5) of this rule; and

(6) SPECT/CT and PET/CT units used exclusively for hybrid imaging will be in compliance with paragraph (B)(2) of this rule if protocols used to scan the head satisfy the limits of paragraph (B)(2)(a) of this rule and protocols used to scan the abdomen satisfy the limits of paragraph (B)(2)(b) of this rule.

(E) Micro-CT units equipped with an x-ray tube enclosure designed to exclude personnel from its interior during x-ray generation will be exempt from paragraphs (A) to (D) of this rule, and will comply with the obligations set forth in rule 3701:1-68-06 of the Administrative Code.

(F) Mobile CT radiation-generating equipment permanently mounted on a base with wheels or castors for moving while completely assembled and not used in one place are exempt from paragraphs (H)(4) and (H)(5) of rule 3701:1-66-02 of the Administrative Code.

(G) Handlers of CT radiation-generating equipment used for veterinary purposes are exempt from the obligations of paragraphs (B)(2) and (C)(4) of this rule.

Last updated December 13, 2024 at 7:32 AM

Supplemental Information

Rule 3701:1-66-11 | Medical bone densitometry radiation-generating equipment.

Effective:

December 13, 2024

Promulgated Under:

119.03

PDF:

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(A) Handlers of bone densitometry equipment will assure that the equipment is certified by the manufacturer in accordance with the obligations of 21 C.F.R. part 1010.2, (as effective on the effective date of this rule), and maintained in accordance with the manufacturer's specifications.

(B) In addition to other applicable radiation safety obligations in Chapters 3701:1-38 and 3701:1-66 of the Administrative Code, the operator of bone densitometry equipment will 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.

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

(1) The quality assurance program will include quality control test records which will be maintained between inspections and will 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; and

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

Last updated December 13, 2024 at 7:33 AM

Supplemental Information

Rule 3701:1-66-16 | Security screening systems.

Effective:

December 13, 2024

Promulgated Under:

119.03

PDF:

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(A) Definitions for the purpose of this rule:

(1) "Ambient dose equivalent area product (ADAP)" will be determined using the american national standards institute publication "ANSI/HPS N43.17-2009 Radiation Safety for Personnel Security Screening Systems Using X-Ray or Gamma Radiation."

(2) "Interlock" means a device preventing the start or continued operation of equipment that could cause a radiation hazard.

(3) "Mode of operation" means a selectable set of technique factors or machine settings that is pre-determined by the manufacturer for a specific purpose.

(4) "Scan" means the operation necessary to produce one image (e.g., front view) from one radiation source. One radiation source simultaneously producing multiple images also constitutes one scan. Two sources simultaneously producing two images constitute two scans. In some cases several scans may be necessary for a single screening of the subject.

(5) "Screening" means the sum of radiation exposures or scans necessary to image objects concealed on all sides of the body as intended by the system design under normal conditions:

(a) For backscatter systems a screening typically consists of four scans, one from each side.

(b) For transmission systems a screening typically consists of one scan.

(6) "Security screening system" means radiation-generating equipment used for the sole purpose of screening an individual who is in custody of a law enforcement agency to identify contraband items that would present a security threat within a secured facility perimeter.

(7) "Technique factors" means the x-ray settings including:

(a) The peak kilovoltage applied to the x-ray tube;

(b) The electric current passing through the x-ray tube; and

(B) Security screening systems will meet the following equipment standards:

(1) Indicators that light only when a scan is in process will be provided and clearly visible to all security screening system operators and anyone approaching the restricted area;

(2) Power to the system will be controlled by a key switch;

(3) A device to terminate x-ray exposure at any time during a scan;

(4) Access panels to x-ray source and detector will be provided with at least one safety interlock;

(5) Operational safety interlocks will terminate the x-ray exposure in the event of any system problem that could result in abnormal or unintended radiation emission;

(6) Following any premature termination, the security screening system will prevent resumption of x-ray generation until the normal control sequence is reset for a new scan;

(7) Equipment designed to control the exposure output using multiple modes of operation will indicate the selected mode prior to each scan;

(8) Technique factors can not be adjustable and will be preset by the manufacturer for each mode of operation;

(9) A means will be provided to terminate the exposure at a preset time interval or exposure;

(10) When the x-ray tube is operated at its maximum rated tube current for the maximum kilovoltage, the leakage dose will not be greater than 2.5 microsievert (0.25 millirem) in any one hour at any point thirty centimeters from any external surface; and

(11) The primary x-ray beam will be attenuated by at least one millimeter of aluminum- equivalent total filtration.

(C) Handlers of security screening systems will comply with the following administrative and radiation safety obligations:

(1) No individual will be exposed to the useful beam unless authorized by a law enforcement agency for security benefit;

(2) No individual will be exposed to the useful beam for demonstration or frivolous purpose;

(3) The individual responsible for radiation protection will ensure that all operators are trained in the safe operation of the security screening systems;

(4) Any radiation-generating equipment that does not meet the provisions set forth in this rule will not be used to irradiate individuals unless the director determines that the continued use will not pose a radiation risk and arrangements have been made to promptly correct the deficiency;

(5) The handler will follow the manufacturer's recommended maintenance schedule;

(6) Radiation-generating equipment will bear a warning label on the control panel or by the exposure switch which cautions individuals that radiation is produced when it is energized; and

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

(D) Handlers of security screening systems will comply with the obligations of rule 3701:1-66-04 of the Administrative Code, except for paragraphs (B)(8), (B)(15), (B)(17), (B)(18)(e) and (C). In addition, the written quality assurance program will include the following:

(1) Policy banning the frivolous use of security screening systems where no security benefit is to be derived;

(2) Policy obligating individuals undergoing screening to be positioned facing away from the source of radiation when using transmission security screening systems;

(3) Policy banning the exposure of pregnant women;

(4) Policy banning the exposure of minors;

(5) Policy that operator training will follow the topics listed in the "Personnel Training" section of the american national standards institute publication "ANSI/HPS N43.17-2009 Radiation Safety for Personnel Security Screening Systems Using X-Ray or Gamma Radiation;"

(6) For general-use full-body security screening systems capable of delivering a maximum effective dose equivalent less than or equal to 0.1 microsievert (ten microrem) per scan: policies and records to show that administrative controls are applied to limit the number of screenings received by any individual such that the reference effective dose equivalent will not exceed:

(a) 0.25 microseivert (twenty-five microrem) per screening; and

(b) Two hundred fifty microsievert (twenty-five millirem) over any twelve month period;

(7) For limited-use full-body security screening systems capable of delivering a maximum effective dose equivalent greater than 0.1 microsievert (ten microrem) per scan: policies and records to show that administrative controls are applied to limit the number of screenings received by any individual such that the reference effective dose equivalent will not exceed:

(a) Ten microsievert (one millirem) per screening; and

(b) Two hundred fifty microsievert (twenty-five millirem) over any twelve month period;

(8) For general-use partial-body security imaging systems capable of delivering a maximum effective dose equivalent less than or equal to 0.1 microsievert (ten microrem) per scan: policies and records to show that administrative controls will be applied to limit the number of screenings received by any individual, such that:

(a) The ADAP will not exceed 0.03 microsievert per square meter (three microrem per square meter) per scan; and

(b) The total number of scans received at the facility in a twelve month period will not exceed N, where N = seventy-five microsievert per square meter per ADAP (seven thousand five hundred microrem per square meter per ADAP);

(9) For limited-use partial-body security imaging systems capable of delivering a maximum effective dose equivalent greater than 0.1 microsievert (ten microrem) per scan: policies and records to show that administrative controls will be applied to limit the number of screenings received by any individual, such that:

(a) The ADAP will not exceed three microsievert per square meter (three hundred microrem per square meter) per scan; and

(E) Facility, design, shielding and restricted area obligations:

(1) A clearly marked restricted area will be established. The dose outside of the restricted area will not exceed twenty microseivert (two millirem) in any one hour;

(2) A means will be provided for the operator responsible for initiating the scan to maintain a full visual surveillance of the screening and restricted area; and

(3) Engineering or administrative controls will be provided to ensure that individuals do not reenter the scanning area from the exit while x-rays are being produced.

(F) A health physicist, a radiation expert or a qualified individual designated by a radiation expert will use the american national standards institute publication "ANSI/HPS N43.17-2009 Radiation Safety for Personnel Security Screening Systems Using X-ray or Gamma Radiation" to determine reference dose equivalent limits, as specified in paragraphs (D)(6) and (D)(7) of this rule, and ADAP, as specified in paragraphs (D)(8) and (D)(9) of this rule, as follows:

(1) Upon installation;

(2) Annually; and

(3) After any maintenance or change that may affect the reference effective dose or ADAP.

(G) Screening systems capable of delivering an effective dose equivalent greater than ten microsievert (one millirem) per scan will not be used for non-medical screening of human beings for security purposes.

Last updated December 13, 2024 at 7:33 AM

Supplemental Information

Rule 3701:1-66-17 | Medical screening and research.

Effective:

December 13, 2024

Promulgated Under:

119.03

PDF:

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This rule provides standards for self-referral screening and medical research. Notwithstanding paragraph (B) of rule 3701:1-66-02 of the Administrative Code:

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

(B) No person will use radiation-generating equipment to conduct research on human beings unless the research has been approved by an institutional review board (IRB) as obligated by 45 CFR Part 46 (as effective on the effective date of this rule) and 21 CFR Part 56 (as effective on the effective date of this rule).

Last updated December 13, 2024 at 7:33 AM