OAR 333-106-0730
Mammography Requirements: Additional Requirements


(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 (Mammography Requirements: Equipment Standards), 333-106-0720 (Mammography Requirements: Quality Assurance Program), 333-106-0730 (Mammography Requirements: Additional Requirements), and 333-106-0750 (Mammography Requirements: Mammography Personnel Qualifications), 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 (Mammography Requirements: Quality Assurance Program) 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.

Source: Rule 333-106-0730 — Mammography Requirements: Additional Requirements, https://secure.­sos.­state.­or.­us/oard/view.­action?ruleNumber=333-106-0730.

333‑106‑0001
Purpose and Scope
333‑106‑0005
Definitions
333‑106‑0010
Administrative Controls
333‑106‑0015
General Requirements: Technique Chart
333‑106‑0020
General Requirements: Written Rules and Procedures
333‑106‑0025
General Requirements: Protection of Patients and Personnel
333‑106‑0035
General Requirements: Deliberate Exposures Restricted
333‑106‑0040
General Requirements: Patient Holding and Restraint
333‑106‑0045
General Requirements: Use of Best Procedures and Equipment
333‑106‑0050
General Requirements: Personnel Monitoring
333‑106‑0055
General Requirements: X-ray Operator Training
333‑106‑0060
General Requirements: Radiation Use and Safety Instructor Qualifications
333‑106‑0101
General Requirements: Diagnostic X-ray Systems
333‑106‑0105
General Requirements: Information and Maintenance Record and Associated Information
333‑106‑0110
General Requirements: Plan Review
333‑106‑0120
General Requirements: Information on Radiation Shielding for Plan Reviews — Optional
333‑106‑0130
General Requirements: Design Requirements for an Operator’s Booth
333‑106‑0201
Fluoroscopic X-ray Systems
333‑106‑0205
Fluoroscopic X-ray Systems Requirements: Activation of the Fluoroscopic Tube
333‑106‑0210
Fluoroscopic X-ray Systems Requirements: Fluoroscopic Entrance Exposure Rates
333‑106‑0215
Fluoroscopic X-ray Systems Requirements: Fluoroscopic Barrier Transmitted Radiation Rate Limits
333‑106‑0220
Fluoroscopic X-ray Systems Requirements: Fluoroscopic Indication of Potential and Current
333‑106‑0225
Fluoroscopic X-ray Systems Requirements: Fluoroscopic Source-to-Skin Distance
333‑106‑0230
Fluoroscopic X-ray Systems Requirements: Fluoroscopic Timer
333‑106‑0235
Fluoroscopic X-ray Systems Requirements: Mobile Fluoroscopes
333‑106‑0240
Fluoroscopic X-ray Systems Requirements: Fluoroscopic Control of Scattered Radiation
333‑106‑0245
Fluoroscopic X-ray Systems Requirements: Fluoroscopic Radiation Therapy Simulation Systems
333‑106‑0301
Additional Requirements for Radiographic Machines: Beam Limitation for Radiographic Systems Other Than Fluoroscopic, Dental Intraoral, Veterinary Systems, or Computed Tomography(CT)
333‑106‑0305
Additional Requirements for Radiographic Machines: Radiation Exposure Control Devices
333‑106‑0310
Additional Requirements for Radiographic Machines: Source-to-Skin Distance
333‑106‑0315
Additional Requirements for Radiographic Machines: Exposure Reproducibility
333‑106‑0320
Additional Requirements for Radiographic Machines: Radiation from Capacitor Energy Storage Equipment in Standby Status
333‑106‑0325
Additional Requirements for Radiographic Machines: Intraoral Dental Radiographic Systems
333‑106‑0345
Purpose and Scope
333‑106‑0350
Computed Tomography X-ray Systems: Definitions
333‑106‑0355
CT Equipment Requirements
333‑106‑0360
Computed Tomography X-ray Systems: Facility Design Requirements
333‑106‑0361
Computed Tomography X-ray Systems: Radiation Protection Surveys
333‑106‑0362
Computed Tomography X-ray Systems: Operating Procedures and Conditions of Operation
333‑106‑0363
Computed Tomography X-ray Systems: Quality Control Program
333‑106‑0364
Computed Tomography X-ray Systems: Initial and Annual Qualified CT Medical Physicist Scanner Performance Evaluations
333‑106‑0366
Computed Tomography X-ray Systems: Dose Limits
333‑106‑0367
Computed Tomography X-ray Systems: Records and Report Retention
333‑106‑0368
Computed Tomography X-ray Systems: Qualified CT Medical Physicist
333‑106‑0369
Computed Tomography X-ray Systems: Report and Notification of a CT Medical Event
333‑106‑0370
Computed Tomography X-ray Systems: Operator Requirements
333‑106‑0601
Veterinary X-ray Systems: Veterinary Medicine Radiographic Installations Additional Requirements
333‑106‑0700
Mammography Requirements: Mammography X-Ray Systems Definitions
333‑106‑0710
Mammography Requirements: Equipment Standards
333‑106‑0720
Mammography Requirements: Quality Assurance Program
333‑106‑0730
Mammography Requirements: Additional Requirements
333‑106‑0735
Mammography Requirements: Breast Density Notification
333‑106‑0750
Mammography Requirements: Mammography Personnel Qualifications
Last Updated

Jun. 8, 2021

Rule 333-106-0730’s source at or​.us