As Passed by the Senate

130th General Assembly
Regular Session
2013-2014
Sub. S. B. No. 54


Senators Kearney, Eklund 

Cosponsors: Senators Cafaro, Gentile, Smith, Sawyer, Tavares, Schiavoni, Turner, Lehner, Jones, Bacon, Balderson, Beagle, Burke, Coley, Faber, Gardner, Hite, Hughes, LaRose, Manning, Obhof, Oelslager, Patton, Peterson, Schaffer, Seitz, Skindell, Uecker, Widener 

A BILL
To enact section 3702.40 of the Revised Code to 1
require a mammography facility to include certain 2
information in the mammography report summary sent 3
to a patient under federal law if the patient's 4
mammogram demonstrates the presence of dense 5
breast tissue.6


BE IT ENACTED BY THE GENERAL ASSEMBLY OF THE STATE OF OHIO:

       Section 1. That section 3702.40 of the Revised Code be 7
enacted to read as follows:8

       Sec. 3702.40.  (A) As used in this section, "mammogram" and 9
"facility" have the same meanings as in section 263b(a) of the 10
"Mammography Quality Standards Act of 1992," 106 Stat. 3547 11
(1992), 42 U.S.C. 263b(a), as amended.12

        (B) As required by 21 C.F.R. 900.12(c)(2), a facility shall 13
send to each patient who has a mammogram at the facility a summary 14
of the written report containing the results of the patient's 15
mammogram. If, based on the breast imaging reporting and data 16
system established by the American college of radiology, the 17
patient's mammogram demonstrates that the patient has dense breast 18
tissue, the summary shall include the following statement:19

        "Your mammogram demonstrates that you have dense breast 20
tissue, which could hide abnormalities. Dense breast tissue, in 21
and of itself, is a relatively common condition. Therefore, this 22
information is not provided to cause undue concern; rather, it is 23
to raise your awareness and promote discussion with your health 24
care provider regarding the presence of dense breast tissue in 25
addition to other risk factors."26

       As required by 21 C.F.R. 900.12(c)(3), the facility shall 27
send to the patient's health care provider, if known, a copy of 28
the written report containing the results of the patient's 29
mammogram not later than thirty days after the mammogram was 30
performed.31

        (C) This section does not do either of the following:32

        (1) Create a new cause of action or substantive legal right 33
against a person, facility, or other entity.34

        (2) Create a standard of care, obligation, or duty for a 35
person, facility, or other entity that would provide the basis for 36
a cause of action or substantive legal right, other than the duty 37
to send the summary and written report described in division (B) 38
of this section.39