Section 370.120  Additional Administrative Requirements

a)         Every operator of a radiation installation at which mammography services are provided shall ensure and have confirmed by each mammography patient that the patient is provided with a pamphlet that is orally reviewed with the patient and that contains the following:

1)         How to perform breast self-examination;

2)         That early detection of breast cancer is maximized through a combined approach, using monthly breast self-examination, a thorough physical examination performed by a physician, and mammography performed at recommended intervals;

3)         That mammography is the most accurate method for making an early detection of breast cancer, however, no diagnostic tool is 100% effective;

4)         If the patient is self-referred and does not have a primary care physician, or if the patient is unfamiliar with the breast examination procedures, that the patient has received information regarding public health services where she can obtain a breast examination and instructions.  [420 ILCS 40/5(c)]

b)         Facility cleanliness.

1)         The facility shall establish and implement adequate protocols for maintaining darkroom, screen and view box cleanliness.

2)         The facility shall document that all cleaning procedures are performed at the frequencies specified in the protocols.

c)         Infection control.  Facilities shall establish and comply with a system specifying procedures to be followed by the facility for cleaning and disinfecting mammography equipment after contact with blood or other potentially infectious materials.  This system shall specify the methods for documenting facility compliance with the infection control procedures established and shall:

1)         Comply with the manufacturer's recommended procedures for the cleaning and disinfection of the mammography equipment used in the facility; or

2)         If adequate manufacturer's recommendations are not available, comply with generally accepted guidance on infection control, until such recommendations become available.

d)         Mammographic procedure and techniques for mammography of patients with breast implants.

1)         Each facility shall have a procedure to inquire whether or not the patient has breast implants prior to the actual mammographic exam.

2)         Except where contraindicated, or unless modified by a physician's directions, patients with breast implants undergoing mammography shall have mammographic views to maximize the visualization of breast tissue.

e)         Consumer complaint mechanism.  Each facility shall:

1)         Establish a written and documented system for collecting and resolving consumer complaints;

2)         Maintain a record of each serious complaint received by the facility for at least 3 years after the date the complaint was received;

3)         Provide the consumer with adequate directions for filing serious complaints with the facility's accreditation body if the facility is unable to resolve a serious complaint to the consumer's satisfaction;

4)         Report unresolved serious complaints to the accreditation body in a manner and timeframe specified by the accreditation body.

f)         Clinical image quality.  Clinical images produced by any certified facility shall continue to comply with the standards for clinical image quality established by that facility's accreditation body.