Arizona Administrative Code › Title 9 - HEALTH SERVICES › Chapter 7 - DEPARTMENT OF HEALTH SERVICES - RADIATION CONTROL › Article 6 - USE OF X-RAYS IN THE HEALING ARTS › Section R9-7-614 - Mammography Systems

Current through Register Vol. 30, No. 28, July 12, 2024
A.
				Equipment. A registrant shall ensure that:
1.
				Only radiation machines specifically designed for mammographic examinations are
				used;
2. The film processor used in
				the registrant's facility is maintained in accordance with the film processor's
				and film manufacturer's recommendations;
3. Each facility has an image development
				system onsite unless the Department has approved an alternate system;
4. If used with screen-film image receptors,
				and the contribution to filtration made by the compression device is included,
				the useful beam has a half-value layer between the values of: "measured kVp/100
				and measured kVp/ + L millimeters" of aluminum equivalent, where L = 0.12 for
				Mo/Mo, L= 0.19 for Mo/Rh, L=0.22 for Rh/Rh, L=0.30 for W/Rh target filtration
				combinations and L= 0.33 for other target filtration combinations not otherwise
				specified.
5. The combination of
				focal spot size, source-to-image distance and magnification produces a
				radiograph with a resolution of at least 12 line pairs per millimeter at an
				object-to-image receptor distance of 4.5 centimeters; or the standards in Table
				3-3 of the American Association of Physicists in Medicine (AAPM), Report No.
				29, Equipment Requirements and Quality Control for Mammography, August 1990,
				published by the American Institute of Physics, Suite 1NO1, 2 Huntington
				Quadrangle, Melville, NY 11747 (This report is incorporated by reference and
				available under
				R9-7-101. The incorporated material
				contains no future editions or amendments. The report is available online at:
http://www.aapm.org/pubs/reports
;
				print copies may be purchased from Medical Physics Publishing, 4513 Vernon
				Blvd., Madison, WI 53705; toll free at (800) 442-5778.);
6. The compression device used with the
				mammographic unit, unless specifically manufactured otherwise, is parallel to
				the imaging plane, not varying at any spot by more than 1 centimeter;
7. The mammographic x-ray system with initial
				power drive:
a. Has compression paddles
				compatible with each size of image receptor;
b. Is capable of compressing the breast with
				a force of at least 25 pounds, but not more than 45 pounds, and maintaining the
				compression for at least three seconds; and
c. Is used in a manner so that the chest wall
				edge of the compression device is aligned just beyond the chest wall edge of
				the image receptor so that the chest wall edge of the compression device does
				not appear on the image receptor;
8. A mammographic x-ray system using
				screen-film image receptors has:
a. At least
				two different sizes of moving anti-scatter grids, including one for each size
				of image receptor utilized; and
b.
				Automatic exposure control;
9. All mammographic x-ray systems indicate or
				provide a means of determining, the mAs resulting from each exposure made with
				automatic exposure control;
10. The
				collimation provided limits the useful beam to the image receptor so that the
				beam does not extend beyond any edge of the image receptor at any designated
				source to image receptor distance by more than 2 percent of the source to image
				receptor distance;
11. The accuracy
				of the indicated kVp is within plus or minus 2kVp;
12. Mammographic x-ray systems operating with
				automatic exposure control are capable of maintaining a film density within
				plus or minus 0.15 optical density units over the clinical range of kVp used,
				for a breast having an equivalent phantom thickness from 2 to 6 centimeters. If
				a technique chart is used, the operator shall maintain the film density within
				plus or minus 0.15 optical density units of the mean optical density;
13. At a kVp of 28, the mammographic x-ray
				system is capable of generating at least 2.0 µC/kg/mAs (8mR/mAs) and at least
				200 µC/kg/second (800 mR/second), measured at a point 4.5 centimeters above the
				surface of the patient support device when the Source-image receptor distance
				is at its maximum;
14. Screens are
				not used for mammography if one or more areas of greater than 1 centimeter
				squared of poor screen-film contact are seen when tested, using a 40 mesh
				screen test;
15. Mammographic image
				quality meets the minimum mammography film standards for phantom performance in
				Mammography Quality Control Manual, 1999 edition, published by the American
				College of Radiology (ACR). (This manual is incorporated by reference and
				available under R9-7-101. The incorporated material contains no future editions
				or amendments. The manual is available from ACR Publication Sales, P.O. Box
				533, Annapolis Junction, MD 20701: toll free at (800) 227-7762; e-mail at:
				acr@brightkey.net).
16. The mean
				glandular dose for one cranio-caudal view of a 4.2 centimeter (1.8 inch)
				compressed breast, composed of 50 percent adipose and 50 percent glandular
				tissue, does not exceed 300 millirads (3 milligray); and
17. A radiologic physicist who meets the
				requirements in R9-7-615(A)(1)(c) evaluates the operation of a mammographic
				x-ray system:
a. When first installed and
				annually thereafter,
b. Following
				any major change in equipment or replacement of parts, and
c. When quality assurance tests indicate
				calibration is necessary.