DAR File No. 29334

Environmental Quality, Radiation Control

R313-28

Use of X-Rays in the Healing Arts

NOTICE OF PROPOSED RULE

DAR File No.: 29334
Filed: 12/15/2006, 10:41
Received by: NL

RULE ANALYSIS

Purpose of the rule or reason for the change:

The proposed amendment updates references to incorporated federal rules, corrects a typographical error, and clarifies issues related to shielding plan reviews and the continuing qualifications of mammography imaging medical physicists.

Summary of the rule or change:

This amendment updates the incorporated material to the current editions of the federal regulations in Subsections R313-28-35(9) and (11), and R313-28-120(1)(a). A typographical error is corrected in Subsection R313-28-35(11). Wording in Sections R313-28-32 and R313-28-200 is changed so that floor plan and shielding calculation reviews of new or remodeled facilities are to be done by qualified experts instead of Division staff. This change is a result of changes to the Division's statutory authority allowing Qualified Experts to perform such reviews, and because of a business decision to not have the Division staff perform these reviews and be in competition with Qualified Experts. The Division also avoids potential conflicts of interest since the division inspectors verify the adequacy of shielding at new and remodeled facilities. Wording in Subsection R313-28-140(2) is changed to clarify the continuing qualifications for Mammography Imaging Medical Physicists.

State statutory or constitutional authorization for this rule:

Subsections 19-3-104(4) and 19-3-104(8)

This rule or change incorporates by reference the following material:

21 CFR 1020.30 and 1020.31 (2006)

Anticipated cost or savings to:

the state budget:

There are no anticipated financial impacts to the state budget from the proposed changes since the proposed changes do not modify existing requirements with a financial impact to the State.

local governments:

There are no anticipated financial impacts to local government from the proposed changes since the proposed changes do not modify existing requirements with a financial impact to local government.

other persons:

Since Qualified Experts will be providing X-ray facility plan reviews, the compliance costs to an individual is difficult to estimate because of the differing charges by the Qualified Experts, and the way those costs are paid by the registrant. These plan reviews are only to be done during the construction of a new facility or the remodeling of an existing facility. As a result, only a few individuals or businesses are affected each year. When compared to the cost of new X-ray equipment or the cost of building or remodeling a facility, the cost for a plan review to ensure that sufficient shielding is present in the facility is relatively small.

Compliance costs for affected persons:

Since Qualified Experts will be providing X-ray facility plan reviews, the compliance costs to affected persons is difficult to estimate because of the differing charges by the Qualified Experts, and the way those costs are paid by the registrant. These plan reviews are only to be done during the construction of a new facility or the remodeling of an existing facility. As a result, only a few individuals or businesses are affected each year. When compared to the cost of new X-ray equipment or the cost of building or remodeling a facility, the cost for a plan review to ensure that sufficient shielding is present in the facility is relatively small.

Comments by the department head on the fiscal impact the rule may have on businesses:

The costs of a plan review to ensure that a facility will provide adequate protection from radiation for workers and the public is small compared to the costs associated with corrective actions needed to bring a finished facility into compliance later on. Since the cost associated with plan reviews only affects a few registrants each year, the overall fiscal impact on businesses is relatively minor. Dianne R. Nielson, Executive Director

The full text of this rule may be inspected, during regular business hours, at the Division of Administrative Rules, or at:

Environmental Quality
Radiation Control
168 N 1950 W
SALT LAKE CITY UT 84116-3085

Direct questions regarding this rule to:

Philip Griffin at the above address, by phone at 801-536-4261, by FAX at 801-533-4097, or by Internet E-mail at pgriffin@utah.gov

Interested persons may present their views on this rule by submitting written comments to the address above no later than 5:00 p.m. on:

01/31/2007

This rule may become effective on:

03/16/2007

Authorized by:

Dane Finerfrock, Director

R313. Environmental Quality, Radiation Control.

R313-28. Use of X-Rays in the Healing Arts.

R313-28-10. Purpose and Scope.

(1) The purpose of the rules in R313-28 is to prescribe the requirements for the use of x-rays in the healing arts.

(2) The rules set forth herein are adopted pursuant to the provisions of Sections 19-3-104(4[3]) and 19-3-104(8[6]).

 

R313-28-32. Plan Review.

(1) Prior to construction,the floor plans, shielding specifications and equipment arrangement of all new installations, or modifications of existing installations, utilizing ionizing radiation shall be submitted to a Qualified Expert for review[the Executive Secretary]. The required information is denoted in R313-28-200 and R313-28-450.

(2) A copy of the Qualified Expert's conclusions regarding shielding specifications[If the services of a consultant are used to review the shielding specifications, a copy of the report] must be submitted to the Executive Secretary within 14 working days.

(3) The Executive Secretary may require additional modifications should a subsequent analysis of operating conditions, for example, a change in workload or use and occupancy factors, indicate the possibility of an individual receiving a dose in excess of the limits prescribed in R313-15.

 

R313-28-35. General Requirements for Diagnostic X-Ray Systems.

In addition to other requirements of R313-28, all diagnostic x-ray systems shall meet the following requirements:

(1) Warning label. The control panel containing the main power switch shall bear the warning statement, legible and accessible to view: "WARNING: This x-ray unit may be dangerous to patient and operator unless safe exposure factors and operating instructions are observed."

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

(3) Leakage radiation from the diagnostic source assembly. The leakage radiation from the diagnostic source assembly measured at a distance of one meter in any direction from the source shall not exceed 25.8 uC/kg (100 milliroentgens) in one hour when the x-ray tube is operated at its leakage technique factors.

(4) Radiation from components other than the diagnostic source assembly. The radiation emitted by a component other than the diagnostic source assembly shall not exceed 0.516 uC/kg (two milliroentgens) in one hour at five centimeters from accessible surfaces of the component when it is operated in an assembled x-ray system under the conditions for which it was designed. Compliance shall be determined by measurements averaged over an area of 100 square centimeters with no linear dimension greater than 20 centimeters.

(5) Beam quality.

(a) The half value layer of the useful beam for a given x-ray tube potential shall not be less than the values shown in R313-28-35, Table I. If it is necessary to determine such half-value layer at an x-ray tube potential which is not listed in Table I, linear interpolation or extrapolation may be made.

 

TABLE I

DESIGN         MEASURED    DENTAL INTRA-ORAL       ALL OTHER

OPERATING      POTENTIAL   MANUFACTURED BEFORE     DIAGNOSTIC

RANGE (KILO    (KILOVOLTS  AUGUST 1, 1974 AND      X-RAY SYSTEMS

VOLTS PEAK     PEAK)       ON OR AFTER

                           DECEMBER 1, 1980

Below 51        30             (use prohibited)       0.3

                40             (use prohibited)       0.4

                50             1.5                    0.5

                51             1.5                    1.2

                60             1.5                    1.3

                70             1.5                    1.5

Above 70        71             2.1                    2.1

                80             2.3                    2.3

                90             2.5                    2.5

               100             2.7                    2.7

               110             3.0                    3.0

               120             3.2                    3.2

               130             3.5                    3.5

               140             3.8                    3.8

               150             4.1                    4.1

 

(b) For capacitor discharge equipment, compliance with the requirements of R313-28-35(5)(a) shall be determined with the system fully charged and a setting of 10 mAs for exposures.

(c) The required minimal half-value layer of the useful beam shall include the filtration contributed by materials which are permanently present between the focal spot of the tube and the patient.

(d) Filtration control. For x-ray systems which have variable kVp and variable filtration for the useful beam, a device shall link the kVp selector with the filters and shall prevent an exposure unless the minimum amount of filtration necessary to produce the HVL required by R313-28-35(5)(a) is in the useful beam for the given kVp which has been selected.

(6) Multiple tubes. When two or more radiographic tubes are controlled by one exposure switch, the tube or tubes which have been selected shall be clearly indicated prior to initiation of the exposure. For equipment manufactured after August 1, 1974, indications shall be both on the x-ray control panel and at or near the tube housing assembly which has been selected.

(7) Mechanical support of tube head. The tube housing assembly supports shall be adjusted so that the tube housing assembly will remain stable during an exposure unless the tube housing movement during exposure is a designed function of the x-ray system.

(8) Technique indicators.

(a) The technique factors to be used during an exposure shall be indicated before the exposure begins, except when automatic EXPOSURE controls are used, in which case the technique factors which are set prior to the exposure shall be indicated.

(b) On equipment having fixed technique factors, the requirements, in R313-28-35(8)(a) may be met by permanent markings. Indication of technique factors shall be visible from the operator's position except in the case of spot films made by the fluoroscopist.

(9) Maintaining compliance. Diagnostic x-ray systems and their associated components certified pursuant to the provisions of 21 CFR Part 1020 (2006) shall be maintained in compliance with applicable requirements of that standard.

(10) Locks. All position locking, holding, and centering devices on x-ray system components and systems shall function as intended.

(11) X-ray systems which have been granted a variance by the Director, Center for Devices and Radiological Health, Food and Drug Administration (Director), from the performance standards for ionizing radiation emitting products, in accordance with 21 CFR 1010.4 (2006)[, 1996 edition,] shall be deemed to satisfy the requirements in R313-28 that correspond[corresond] to the variance granted by the Director. The registrant shall insure that labeling pursuant to 21 CFR 1010.5(f) (2006) remains legible and visible on the x-ray system.

 

R313-28-120. Mammography X-Ray Systems - Equipment Design and Performance Standards.

Only x-ray equipment meeting the following standards shall be used for mammography examinations.

(1) Equipment Design.

(a) FDA Standards. The requirements of 21 CFR 1020.30 and 21 CFR 1020.31 (2006)[, 1990 ed.,] are adopted and incorporated by reference.

(b) Dedicated Equipment. The x-ray equipment shall be specifically designed for mammography.

(c) Compression. Devices parallel to the imaging plane shall be available to immobilize and compress the breast during mammography procedures.

(d) Image Receptor. The x-ray equipment shall have both an 18 cm by 24 cm and a 24 cm by 30 cm image receptor and moving grids matched to each image receptor size.

(e) Automatic Exposure Control. X-ray equipment used in healing arts screening shall have automatic exposure control capabilities with a post exposure meter which indicates either milliampere-seconds or time values.

(f) Focal Spot. The focal spot size and source to image receptor distance configurations shall be limited to those appropriate for mammography.

(g) Beam Limitation. The x-ray equipment must allow for the x-ray field to extend to or beyond the chest wall edge of the image receptor.

(h) Magnification. X-ray equipment used in a noninvasive manner, requiring techniques beyond those utilized in standard mammography of asymptomatic patients, shall have x-ray magnification capability for noninvasive procedures. The equipment shall be able to provide at least one magnification within the range of 1.4 to 2.0.

(2) Performance Standards.

(a) State Standards. The x-ray equipment shall meet the applicable performance standards in R313-28.

(b) Filtration. The useful beam shall have a half-value layer between the values of the measured kilovolts peak divided by 100 and the measured kilovolts peak divided by 100 plus 0.1 mm of aluminum equivalent. These values are to include the contribution to filtration by the compression device.

(c) Minimum Radiation Output. X-ray equipment installed after the effective date of this rule shall meet the following standard: at 28 kilovolts peak on the focal spot used in routine healing arts screening the x-ray equipment shall be capable of sustaining a minimum output of 500 mR per second for at least three seconds. This output shall be measured at a point 4.5 centimeters from the surface of the patient support device when the source to image receptor distance is at its maximum and the compression paddle is in the beam. Existing x-ray equipment shall meet this minimum radiation output standard within one year of the effective date of this rule.

(d) Exposure Linearity. For kilovolts peak settings used clinically, the exposure per mAs shall be within plus or minus ten percent of the average exposure per mAs for those mAs stations or time stations, if applicable, that are tested.

(e) Automatic Exposure Control. The automatic exposure control mode shall produce consistent film density under changing patient and examination conditions. These conditions include breast thickness, adiposity, kilovolts peak and density settings. This requirement will be deemed satisfied when:

(i) an automatic exposure control technique guide is posted, and

(ii) for a series of films obtained for attenuator thicknesses of two to seven centimeters the resulting radiographic optical densities are within plus or minus 0.2 of the average value when the kVp and density control setting are adjusted as indicated on the technique guide. The attenuator used for determining compliance shall be either acrylic or other tissue equivalent material.

(f) Patient Dose. The x-ray equipment must be capable of giving an average glandular dose to an average size breast of average tissue density that does not exceed 3.0 mGy (0.3 rad) with a grid or 1.0 mGy (0.1 rad) without a grid. This will be deemed satisfied when using an acrylic phantom of 4.5 cm thickness. In addition, under all clinical use conditions, the average glandular dose to the breast must be less than 5.0 mGy (0.5 rad) per film for healing arts screening procedures.

(3) Mammography X-ray Equipment Quality Control.

(a) Initial Installation. Upon completion of the initial installation of the x-ray equipment, and before it is commissioned for clinical use, the equipment shall be evaluated by a mammography imaging medical physicist who has been approved by the Board. The evaluation results shall be submitted to the Executive Secretary for review and approval.

(b) Annual Evaluation. At intervals not to exceed 12 months or at the request of the Executive Secretary, the x-ray equipment shall be evaluated by a mammography imaging medical physicist who has been approved by the Board.

(c) The registrant shall develop and implement a quality control testing procedure for monitoring the radiation performance of the x-ray equipment.

 

R313-28-140. Qualifications of Mammography Imaging Medical Physicist.

An individual seeking certification by the Board for approval as a mammography imaging medical physicist shall file an application for certification on forms furnished by the Division. The Board may certify individuals who meet the requirements for initial qualifications. To remain certified by the Board as a mammography imaging medical physicist, an individual shall satisfy the requirements for continuing qualifications.

(1) Initial qualifications.

(a) Be certified by the American Board of Radiology in Radiological Physics or Diagnostic Radiological Physics, or the American Board of Medical Physicists in Diagnostic Imaging Physics; or

(b) Satisfy the following educational and experience requirements:

(i) Have a master's or higher degree from an accredited university or college in physical sciences; and

(ii) Have two years full-time experience conducting mammography surveys. Five mammography surveys shall be equal to one year full-time experience.

(2) Continuing qualifications.

(a) During the three-year period after initial certification and for each subsequent three-year period, the individual shall earn 15 hours of continuing educational credits in mammography imaging; and

(b) Perform at least two mammography surveys during the 12-month period from June 1 and May 31 to remain certified by the Board[annually].

(3) Mammography imaging medical physicists who fail to maintain the required continuing qualifications stated in R313-28-140(2) shall re-establish their qualifications before independently surveying another mammography facility. To re-establish their qualifications, mammography imaging physicists who fail to meet:

(a) The continuing education requirements of R313-28-140(2)(a) must obtain a sufficient number of continuing educational credits to bring their total credits up to the required 15 in the previous three years.

(b) The continuing experience requirement of R313-28-140(2)(b) must obtain experience by surveying two mammography facilities for each year of not meeting the continuing experience requirements under the supervision of a mammography imaging medical physicist approved by the Board.

 

R313-28-200. Information on Radiation Shielding Required for Plan Reviews.

In order to evaluate a need for radiation shielding associated with a plan review, the following information shall[must] be submitted to a Qualified Expert so that an adequate review may be performed.

(1) The plans showing, as a minimum, the following:

(a) the normal location of the radiation producing equipment's radiation port, the port's travel and traverse limits, general directions of the radiation beam, locations of windows, the location of the operator's booth, and the location of the x-ray control panel;

(b) structural composition and thickness of walls, doors, partitions, floor, and ceiling of the rooms concerned;

(c) the dimensions, including height, floor to floor, of the rooms concerned;

(d) the type of occupancy of adjacent areas inclusive of space above and below the rooms concerned. If there is an exterior wall, show distance to the closest existing occupied areas;

(e) the make and model of the x-ray equipment, the maximum energy output, and the energy waveform; and

(f) the type of examination or treatment which will be performed with the equipment.

(2) Information on the anticipated workload of the x-ray systems in mA-minutes per week.

(3) A report showing all basic assumptions used in the development of the shielding specifications.

 

KEY: dental, x-ray, mammography, beam limitation

Date of Enactment or Last Substantive Amendment: [March 14, 2003]2007

Notice of Continuation: October 5, 2006

Authorizing, and Implemented or Interpreted Law: 19-3-104; 19-3-108