License Requirements for Portable Mammography Facilities
If a mammography unit is utilized at the same location more than five (5) times a year, then that location needs to be specifically licensed with the Radiation Control Program as a mammography facility. Therefore, companies that make cyclical visits to the same medical office more than five (5) times a year using a portable mammography unit must apply for a license for each location.
Acquisition of New and Used Units
For existing licensed mammography facilities acquiring new or used mammography units, the following items are required of the licensee:
- Notify the Radiation Control Program that a new unit will be acquired and the date the new unit will first be used to perform mammography. The Agency will reply by letter along with a Machine Identification Form for completion and submittal.
- Submit a shielding design plan for the new unit's location for approval.
- Insure that the new unit be initially optimized by a qualified medical physicist before exposing patients.
- Insure that the new unit is included in the Quality Assurance program of the facility--all initial Quality Assurance tests must be performed and documented.
- Insure that the Responsible Physician has determined that the Mammography Radiological Technologist(s) has been trained on the proper operation of the unit.
- Submit the payment of the $300 fee for each additional unit.
In addition, the Radiation Control Program must conduct an inspection of any used unit prior to the unit's use by the facility.
Change in Mammography Facility Ownership
Reference Regulation: 105 CMR 127.027
Issued Date: March 1, 1995
Effective Date: March 1, 1995
Mammography facility licenses issued by the Commonwealth are not transferable from one owner (person. partnership, corporation) to another, see 105 CMR 127.027. The facility license issued by the Commonwealth to an owner expires upon a transfer of ownership. Note, a transfer of ownership is defined in 105 CMR 127.005 and includes not only the sale of the facility but also a change in the majority of stock, partnership interest, trustees, and in the case of a non-profit, a shift of control of the membership.
Current Owner(s) Must Provide Advance Written Notice of Proposed Change: Before the actual transfer of ownership, the licensed facility must notify DPH Radiation Control Program immediately and in writing of any proposed change in ownership.
New Owner(s) Must File New Application For Facility Licensure: When a change of ownership occurs, the new owner(s) must file a new application for license within 48 hours of the change. If timely filed, this application will stand as a provisional license until the Radiation Control Program acts upon the application, see 105 CMR 127.028(C). The application should be kept on file by the facility as provisional license status.
If the application is not submitted within 48 hours of the change of ownership, the application will not constitute a provisional license, see 105 CMR 127.028(D). In this case, the facility will be treated as a new facility and must meet all the requirements of a new facility before commencing operations.
Mammography Medical Reference Regulation: Physicist
Reference Regulation: 127.013 (A) and 127.013(B)
Issued Date: 2/3/94
Effective Date: none listed
A medical physicist must be identified as the medical physicist for the mammography facility; that the identified medical physicist perform the annual inspectional activity; that individual must also be known to the Responsible Physician, Interpreting Physician, the Licensee and the Mammography Radiologic Technologist for that facility: and, further that the identified medical physicist must be himself or herself readily available to respond to questions and comments from the above four mentioned individuals.
As long as the above requirements are met, other additional inspectional activities can be performed by other individuals specifically trained by the medical physicist to conduct the specific additional inspectional activity.
Supervision Requirement for a Mammography Permittee
Reference Regulation: 105 CMR 125.007 (B)
Issued Date: 4/1/94
Effective Date: 4/1/94
A technologist with a permit must be directly supervised by a full mammography technologist for each mammography exam he or she performs. Both technologists must sign off on the films.
Mammography Equipment Standards for Film Sizes
Reference Regulation: 105 CMR 127.017(G)(1)
Issued Date: 4/1/94
A mammographic x-ray unit must have cassettes of appropriate size so as to be able to obtain a complete breast image on one film. Specifically, if a facility only operates one mammography unit, that facility must have the capability to utilize both 24 x 30 cm as well as 18 x 24 cm film and cassettes. If a facility operates multiple mammography units, at least one machine must have capability to utilize both 24 x 30 cm, as well as 18 x 24 cm film and cassettes.
Reference Regulation: 105 CMR 127.017(E)
Issued Date: June 29, 1994
Effective Date: June 29, 1994
- Line Pair (test tool able to resolve at least 20 line pairs)
Line Pair = 1 x-ray opaque line and 1 adjacent space (1 cycle)
- Fine Grain Film in a cardboard cassette or "ready pack"
- Test Method:
- Place test object at 4.5 cm above the breast support at device at the chest wall
- Test object. Bars should be parallel to anode-cathode axis (width)
- Expose fine-grain film in a cardboard cassette or "ready pack"
Regulatory requirement: **Resolution of at least 12 cycles (line pairs) per millimeter.
This information is provided by the Radiation Control Program within the Department of Public Health.