TITLE 16

Health and Safety

Regulatory Provisions Concerning Public Health

CHAPTER 30I. Mammograms

84 Del. Laws, c. 483, § 5
§ 3001I. Provision of information relating to mammography reports.

(a) On completion of a mammogram, a mammography facility certified by the United States Food and Drug Administration shall provide to each patient a notice containing the results of the mammogram, including information about the patient’s breast density based on the Breast Imaging Reporting and Data System established by the American College of Radiology. The form of the notice shall be based on the guidance established by the American College of Radiology. The Delaware Radiological Society shall work with mammogram facilities in this State regarding the content of the notice and shall provide mammogram facilities with any updated language based on guidance from the American College of Radiology. The notice shall include a statement that a report of the results has been sent to the patient’s physician, and the patient should discuss the report, including the findings regarding breast density, with the patient’s physician. If the patient has no physician, or has not provided the mammography facility with the physician’s name or other identifying information, the notice must include a referral to at least 1 of the following:

(1) A hospital licensed under Chapter 10 of this title, whether a nonprofit subject to 26 U.S.C. § 501(c)(3), a not-for-profit entity, or a for-profit entity, known or believed by the mammography facility to have sufficient equipment and staff to discuss the results with the patient and coordinate or recommend appropriate care based on the results of the mammogram.

(2) An outpatient clinic or facility affiliated with a hospital or operating under the license of a hospital as defined in Chapter 10 of this title, known or believed by the mammography facility to have sufficient equipment and staff to discuss the results with the patient and coordinate or recommend appropriate care based on the results of the mammogram.

(b) Notwithstanding any other law, this section does not create a cause of action or create a standard of care, obligation, or duty that provides a basis for a cause of action.

(c) The information required by this section or evidence that a person violated this section is not admissible in a civil, judicial or administrative proceeding.

(d) This section may not be construed to require a notice regarding breast density to be sent to a patient that is inconsistent with the provisions of the Federal Mammography Quality Standards Act of 1992 [Pub. L. 102-539, 106 Stat. 3547], or regulations adopted under the Act.

(e) This notice may be sent with the patient’s mammogram results or as a separate communication to the patient.

80 Del. Laws, c. 48, §  170 Del. Laws, c. 186, §  184 Del. Laws, c. 483, § 5

§ 3002I. Provision of mammograms or referrals for self-referred patients.

A mammography facility must either provide a mammogram to a patient who requests a mammogram without a referral from a physician or provide written notice to the patient that the facility does not perform mammograms on self-referred patients and provide a written referral to at least 1 of the following:

(1) A hospital licensed under Chapter 10 of this title, whether a nonprofit subject to 26 U.S.C. § 501(c)(3), a not-for-profit entity, or a for-profit entity, known or believed by the mammography facility to have sufficient equipment and staff to assist the patient with obtaining a mammogram, discussing the results with the patient, and coordinating or recommending appropriate care based on the results of the mammogram.

(2) An outpatient clinic or facility affiliated with a hospital or operating under the license of a hospital as defined in Chapter 10 of this title, known or believed by the mammography facility to have sufficient equipment and staff to assist the patient with obtaining a mammogram, discussing the results with the patient, and coordinating or recommending appropriate care based on the results of the mammogram.

84 Del. Laws, c. 483, § 5