Or. Admin. R. 333-106-0730 - Additional Requirements

Current through Register Vol. 61, No. 4, April 1, 2022

(1) Masks. Masks shall be provided on the view boxes to block extraneous light from the viewer's eye when the illuminated surface of the view box is larger than the area of clinical interest.
(2) Film processors utilized for mammography shall be:
(a) Used with X-ray film for mammography that has been designated by the film manufacturer as appropriate for mammography.
(b) Use chemical solutions that are capable of developing the films used by the facility in a manner equivalent to the minimum requirements specified by the film manufacturer.
(c) Be adjusted to and operated at the specifications recommended by the mammographic film manufacturer, or at other settings such that the sensitometric performance is at least equivalent.
(3) Instruments and devices. The following instruments and devices shall be available and properly maintained;
(a) FDA accepted image quality phantom;
(b) 21 step sensitometer;
(c) Densitometer.
(4) Image retention. Clinical images shall be retained for a minimum of five years or not less than 10 years if no additional mammograms of the patient are performed.
(5) Mobile Mammography. In addition to meeting the requirements of this rule as well as OAR 333-106-0710, 333-106-0720, 333-106-0730, and 333-106-0750, registrants shall ensure that for a mammography system that is used at more than one location:
(a) The film processor is operated in accordance with the requirements of OAR 333-106-0720 of these rules, and is located where the mammography examinations are performed (batch processing is prohibited).
(b) The following tests are conducted, evaluated and documented after every move and before any mammography examinations are conducted, in order to verify that the unit's performance continues to meet quality requirements:
(A) Phantom image;
(B) The measured radiation output or the data from the post exposure mAs display does not deviate by more than 10 percent of the established operating level.
(6) Technique charts. Mammography technique charts shall posted in the vicinity of the mammography system's X-ray control. The technique chart shall indicate;
(a) Technique factors for 3, 3-5, 5-7, and > 7 cm compressed breast thicknesses for fatty, 50 percent fatty-50 percent dense, and dense breast tissue;
(b) The target/filter combination to be used;
(c) The kVp to be selected for the patient sizes and breast tissue compositions indicated in subsection (6)(a) of this rule, or if an auto-kVp mode is used, indicate the post kVp that is selected;
(d) The exposure mode to be used (i.e. auto-kVp, manual, etc.);
(e) The manual technique factors to be used for small, medium, and large sized breast tissue specimens, and Implanted breasts;
(f) The film/screen combination to be used;
(g) The date that the technique chart was last reviewed for accuracy and the name of the reviewer.


Or. Admin. R. 333-106-0730
HD 15-1994, f. & cert. ef. 5-6-94; PH 3-2003, f. & cert. ef. 3-27-03; PH 31-2004(Temp), f. & cert. ef. 10-8-04 thru 4-5-05; PH 36-2004, f. & cert. ef. 12-1-04; PH 5-2005, f. & cert. ef. 4-11-05; PH 12-2006, f. & cert. ef. 6-16-06; PH 14-2008, f. & cert. ef. 9-15-08

Stat. Auth.: ORS 453.605 - 453.807

Stats. Implemented: ORS 453.605 - 453.807

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