Massachusetts § 5Q - Mammography facilities; rules and regulations; licensing; inspections

§ 5Q. Mammography facilities; rules and regulations; licensing; inspections

Section 5Q. (a) The department shall promulgate rules and regulations for the licensing of mammography facilities. Said rules and regulations shall establish mandatory requirements for facilities that offer diagnostic mammography services within the commonwealth, and shall be no less stringent than the most current standards of the American College of Radiology. Such rules and regulations shall require that a physician be designated by the facility to be responsible for the overall quality assurance of said facility. Such rules and regulations shall also include, but not be limited to, the following provisions: optimum exposure ranges; equipment standards and requirements; mandated quality assurance programs; phantom image quality requirements; operator training and experience requirements; annual evaluation and calibration of the mammography unit by a qualified radiation physicist; registration of the mammography facility and specific inspection procedures by department inspectors; reporting and recordkeeping requirements, as well as others so determined to be appropriate. The department may accept, in lieu of the above, certification by the American College of Radiology or other recognized organization as deemed status for licensing; provided, however, that the standards of said organization shall be no less stringent than the most current standards of the American College of Radiology. For purposes of this section, a mammography facility shall be defined as any facility, whether stationary or mobile, that offers diagnostic mammography services to any person in the commonwealth, including but not limited to, any facility owned or operated by any health care provider as defined in section one, a health maintenance organization licensed pursuant to chapter one hundred and seventy-six G or any other entity that offers such services as defined by rules and regulations of the department.

(b) All mammograms shall be read and interpreted by a physician practicing in accordance with the requirements of section five L of chapter one hundred and twelve.

Every provider of mammography services shall, if a patient's mammogram reveals dense breast tissue, as determined by the interpreting physician based on standards promulgated by the American College of Radiology, provide written notification to the patient, in terms easily understood by a lay person. The notification shall include, at minimum, the following information:

(1) that the patient's mammogram shows dense breast tissue;

(2) that the degree of density apparent and an explanation of that degree of density;

(3) that dense breast tissue is common and not abnormal but that dense breast tissue may increase the risk of breast cancer;

(4) that dense breast tissue can make it more difficult to find cancer on a mammogram and that additional testing may be needed for reliable breast cancer screening;

(5) that additional screening may be advisable and that the patient should discuss the results of the mammogram with the patient's referring physician or primary care physician;

(6) that the patient has the right to discuss the results of the patient's mammogram with the interpreting radiologist or the referring physician;

(7) that a report of the patient's mammogram has been sent to the referring physician and will become part of the patient's medical record; and

(8) where the patient can find additional information about dense breast tissue.

(c) The radiologic technologist performing the mammography procedure shall be responsible for ensuring that the resulting radiographs meet the technical and diagnostic requirements of the physician reading the mammogram.

(d) The department may establish a separate registration fee for diagnostic radiographic machines used for mammography under section five N; provided, however, that registration fees established pursuant to this section shall be sufficient in the aggregate to support the net state cost, subject to appropriation, for meeting the purposes of this section, after consideration of any amounts available from the federal government for said purposes.

(e) The department shall require the use of radiographic systems specifically designed for, and exclusively used for, mammography.

(f) The department may issue temporary licenses as an interim measure until all requirements for full licensure are met, and may revoke said license if the facility is found to be in noncompliance with the department's rules and regulations.

(g) The department shall establish appropriate procedures for application and licensing for facilities seeking a license to operate as a mammography facility.

(h) The department shall inspect mammography facilities annually, and shall notify the board of registration in medicine of any physician practicing in violation of the requirements of section five L of chapter one hundred and twelve regarding the reading and interpretation of mammography.

(i) The department shall issue a certificate of inspection after each inspection, which the facility shall post near the mammography unit in full public view.

(j) The department may suspend or revoke a license to conduct mammography should a facility not meet any of the requirements set forth in this section.