Florida Senate - 2022 SB 1460
By Senator Bradley
5-01164-22 20221460__
1 A bill to be entitled
2 An act relating to informed consent for mammograms;
3 creating s. 381.934, F.S.; requiring certain
4 facilities to provide each patient with an informed
5 consent form before performing a mammogram; requiring
6 the form to be signed by the patient; requiring
7 facilities to notify patients of the form at a
8 specified time; requiring facilities to post the form
9 on their websites; providing requirements for the
10 form; requiring the Department of Health to develop
11 the form; providing an effective date.
12
13 WHEREAS, breast cancer is the second leading cause of
14 cancer-related deaths among women in the United States, and
15 WHEREAS, when the disease is detected and treated early,
16 women diagnosed with breast cancer have been shown to have a 93
17 percent or higher survival rate in the first 5 years after
18 diagnosis, and
19 WHEREAS, early detection and best practices for detecting
20 breast cancer are keys to increasing the chances for successful
21 treatment, and
22 WHEREAS, each woman’s breast tissue is unique and may
23 appear similar to both cancerous tissue as well as normal breast
24 tissue, and
25 WHEREAS, mammograms are the best primary tool for breast
26 cancer screening, and
27 WHEREAS, the Florida Cancer Control and Research Advisory
28 Council within the H. Lee Moffitt Cancer Center and Research
29 Institute, Inc., created the 2020-2025 Florida Cancer Plan,
30 which includes a goal to “reduce breast cancer mortality through
31 early detection of breast cancer,” and
32 WHEREAS, the Legislature finds that the early detection of
33 breast cancer and establishing best practices for breast cancer
34 screenings may reduce breast cancer mortality, NOW, THEREFORE,
35
36 Be It Enacted by the Legislature of the State of Florida:
37
38 Section 1. Section 381.934, Florida Statutes, is created to
39 read:
40 381.934 Informed consent for mammograms.—
41 (1)(a) Before performing a mammogram, a facility as defined
42 in 21 C.F.R. s. 900.2(q), as that definition exists on the
43 effective date of this act, shall provide each patient with an
44 informed consent form that must be signed by the patient.
45 (b) The facility must notify a patient of the informed
46 consent form at the time of scheduling the patient’s
47 appointment. The facility shall also post the form on its
48 website in a location readily accessible to patients.
49 (2) The informed consent form must include, but need not be
50 limited to, all of the following:
51 (a) A statement explaining that in 2011, the United States
52 Food and Drug Administration approved three-dimensional (3-D)
53 advanced mammography devices that provide informative images of
54 breast tissue and may be helpful in evaluating dense breast
55 tissue.
56 (b) A statement explaining that studies have shown that 3-D
57 digital mammography has improved breast cancer detection rates
58 and has reduced the number of patients who may be required to
59 return to a facility for follow-up screenings.
60 (c) Information regarding the differences between a
61 standard two-dimensional (2-D) digital mammogram and a 3-D
62 digital mammogram.
63 (d) A statement indicating whether a patient will be
64 receiving a 2-D digital mammogram or a 3-D digital mammogram.
65 (e) A statement recommending that a patient follow the
66 advice of his or her primary care physician.
67 (3) The Department of Health shall develop the patient
68 informed consent form required under this section.
69 Section 2. This act shall take effect July 1, 2022.