Section R12-1-614. Mammography Systems

A.      Equipment. A registrant shall ensure that:

1.        Only radiation machines specifically designed for mam- mographic 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 Agency has approved an alternate system;

4.        If used with screen-film image receptors, and the contri- bution 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/100

+ 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 dis- tance and magnification produces a radiograph with a res- olution of at least 12 line pairs per millimeter at an object- to-image receptor distance of 4.5 centimeters; or the stan- dards in Table 3-3 of the American Association of Physi- cists 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  R12-1-101.  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 [phone].);

6.        The compression device used with the mammographic unit, unless specifically manufactured otherwise, is paral- lel 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 sec- onds; 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 expo- sure 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 den- sity 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 capa- ble 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 mam- mography 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 R12-1-101. 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 [phone]; e-mail at: [e-mail]).

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 R12-1-615(A)(1)(c) evaluates the operation of a mam- mographic 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.

B.       Operating Procedures. A registrant shall ensure that:

1.        Each mammographic facility has a quality assurance pro- gram, and that the quality assurance program includes performance and documentation of the quality control tests in subsection (B)(2), conducted at the required time intervals. Test results shall fall within the specified limits in subsection (B)(2) or the registrant shall take corrective action and maintain documentation that the results are within specified limits before performing or processing any further examinations using the system that failed. A radiologic physicist, as defined in R12-1-615(A)(1)(c), shall review the program and make any recommendations necessary for the facility to comply with this Section;

2.        The quality assurance  program meets federal  require- ments (Contained in 21 CFR 900.12(d)(1), and (e)(1) through (e)(10), revised April 1, 2013, incorporated by reference and available under R12-1-101. This incorpo- rated material contains no future editions or amend- ments.); or the following requirements:

a.         Daily sensitometric and densitometric evaluation of the image processing system demonstrates that Base

+ Fog < +0.03 optical density of operating level, Mid Density ± 0.15 optical density of operating level, and Density Difference ± 0.15 optical density of operating level;

b.        Weekly phantom image quality evaluations demon- strate the visualization of at least four fibers, three speck groups, and three masses with a background of greater than 1.40 optical density, not varying by

0.20 optical density of operating level;

c.         Monthly technique chart evaluations demonstrate updates for all equipment changes and that all exam-

inations are being performed according to a physi- cist’s density control recommendation;

d.        Quarterly fixer retention evaluations demonstrate an acceptable limit of less than or equal to 5.0 micro- grams per square centimeter;

e.         Quarterly repeat analysis demonstrates an accept- able limit of less than 2 percent increase in repeats;

f.         Semiannual darkroom fog evaluations meet the limit of less than or equal to 0.05 optical density of fog, using the two minute exposed film method;

g.        Semiannual screen film contact evaluations meet the limit of less than one area of poor contact of 1 centi- meter squared, using a 40 mesh screen on all clini- cally-used screens;

h.        Semiannual automatic compression force evalua- tions meet the limit of greater than or equal to 25 pounds (111 Newtons) and less than 45 pounds (200 Newtons);

i.         A survey shall be conducted annually and whenever indicated for installation, major repairs, parts replacement, or as deemed necessary by a qualified expert when quality control test results indicate a survey is necessary; the survey shall include all of the following tests:

i.         Automatic exposure control performance and thickness response;

ii.        Accuracy and reproducibility of kVp;

iii.      System resolution;

iv.       Breast entrance air kerma and automatic expo- sure control reproducibility;

v.        Average glandular dose;

vi.       X-ray   field,  light   field,  and  image  receptor alignment;

vii.     Compression paddle alignment;

viii.    Uniformity of screen speed;

ix.       System artifacts;

x.        Radiation output;

xi.       Decompression;

xii.     Beam quality and half value layer;

j.         For systems with image receptor modalities other than screen film:

i.         The quality assurance and quality control pro- gram for the acquisition system meets or exceeds the recommendations by the manufac- turer; and

ii.        The quality assurance and quality control pro- gram for the printer meets or exceeds the rec- ommendations by the image receptor manufacturer. In the absence of recommenda- tions by the image receptor manufacturer for the specified printer, the quality control and assurance program meets or exceeds the recom- mendations of the printer manufacturer; and

iii.      The quality assurance and quality control pro- gram for the interpretation monitors meets or exceeds the recommendations by the image receptor manufacturer. In the absence of rec- ommendations by the image receptor manufac- turer for the specified monitor or monitors, the quality control and assurance program meets or exceeds the recommendations of the interpreta- tion monitor or monitors manufacturer; and

k.        The registrant maintains records documenting com- pliance with the provisions in this subsection for three years from the date each requirement is met.

The records  shall be made  available for Agency inspection.

C.      Mammographic films and reports.

1.        A registrant shall maintain films and reports for a mini- mum of five years. In those cases where no subsequent mammographic procedures are performed, the registrant shall maintain films and associated reports for 10 years. If the mammographic facility is closed, the registrant shall make arrangements for storage of the films and associ- ated reports for five years after the closure; and

2.        A registrant shall make films and reports available for comparison upon  request  for temporary or  permanent transfer to other mammographic facilities.

Historical Note

Adopted effective January 2, 1996 (Supp. 96-1).

Amended effective June 13, 1997 (Supp. 97-2). Amended by final rulemaking at 9 A.A.R. 4302, effective Novem- ber 14, 2003 (Supp. 03-3). Amended by final rulemaking

at 10 A.A.R. 4458, effective December 4, 2004 (Supp. 04-4). Amended by final rulemaking at 15 A.A.R. 1023, effective August 1, 2009 (Supp. 09-2). Amended by final rulemaking at 19 A.A.R. 3882, effective January

4, 2014 (Supp. 13-4).