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H.B. 229
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BREAST IMPLANT SURGERY
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2000 GENERAL SESSION
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STATE OF UTAH
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Sponsor: David Ure
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AN ACT RELATING TO HEALTH; DEFINING TERMS; IMPOSING DUTIES ON THE
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DEPARTMENT OF HEALTH TO PREPARE AN INFORMED CONSENT FORM FOR
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BREAST IMPLANT SURGERY, A POST-SURGERY REPORT, AND A POST-SURGERY
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SURVEY; REQUIRING HEALTH CARE PROVIDERS TO PROVIDE INFORMED CONSENT
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BEFORE PERFORMING A BREAST IMPLANT SURGERY; REQUIRING HEALTH CARE
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FACILITIES TO SUBMIT A POST-SURGERY REPORT TO THE DEPARTMENT OF
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HEALTH; AND MAKING CONFORMING AMENDMENTS.
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This act affects sections of Utah Code Annotated 1953 as follows:
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AMENDS:
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26-21-11, as last amended by Chapter 209, Laws of Utah 1997
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26-21a-101, as enacted by Chapter 126, Laws of Utah 1991
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58-67-502, as enacted by Chapter 248, Laws of Utah 1996
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58-68-502, as enacted by Chapter 248, Laws of Utah 1996
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ENACTS:
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26-21a-401, Utah Code Annotated 1953
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26-21a-402, Utah Code Annotated 1953
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26-21a-403, Utah Code Annotated 1953
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26-21a-404, Utah Code Annotated 1953
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Be it enacted by the Legislature of the state of Utah:
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Section 1.
Section
26-21-11
is amended to read:
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26-21-11. Violations -- Denial or revocation of license -- Restricting or prohibiting
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new admissions -- Monitor.
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If the department finds a violation of this chapter, Section
26-21a-403
, or any rules adopted
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pursuant to this chapter the department may take one or more of the following actions:
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(1) serve a written statement of violation requiring corrective action, which shall include
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time frames for correction of all violations;
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(2) deny or revoke a license if it finds:
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(a) there has been a failure to comply with the rules established pursuant to this chapter;
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(b) evidence of aiding, abetting, or permitting the commission of any illegal act; or
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(c) conduct adverse to the public health, morals, welfare, and safety of the people of the
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state;
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(3) restrict or prohibit new admissions to a health care facility or revoke the license of a
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health care facility for:
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(a) violation of any rule adopted under this chapter; or
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(b) permitting, aiding, or abetting the commission of any illegal act in the health care
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facility;
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(4) place a department representative as a monitor in the facility until corrective action is
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completed;
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(5) assess to the facility the cost incurred by the department in placing a monitor;
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(6) assess an administrative penalty as allowed by Subsection
26-23-6
(1)(a); or
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(7) issue a cease and desist order to the facility.
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Section 2.
Section
26-21a-101
is amended to read:
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CHAPTER 21a. WOMEN'S HEALTH
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Part 1. Definitions
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26-21a-101. Definitions.
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As used in this chapter:
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(1) "Breast implant surgery" means a medical procedure designed to reconstruct or
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augment the size of a patient's breast by means of an implant.
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[(1)] (2) "Breast cancer screening mammography" means a standard two-view per breast,
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low-dose as defined by the National Cancer Institute, radiographic examination of the breasts to
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detect unsuspected breast cancer using equipment designed and dedicated specifically for
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mammography.
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[(2)] (3) "Diagnostic mammography" means mammography performed on a woman having
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suspected breast cancer.
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[(3)] (4) "Facility" means a facility that provides screening or diagnostic breast
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mammography services.
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(5) "Implant" means any object or substance that:
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(a) is foreign to the patient's body;
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(b) is purposefully left in a patient's chest cavity in connection with a breast implant
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surgery; and
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(c) is not intended or designed to be absorbed into the patient's body.
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(6) "Patient" means a person who is considering or undergoes a breast implant surgery.
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Section 3.
Section
26-21a-401
is enacted to read:
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Part 4. Breast Implant Surgery Act
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26-21a-401. Title.
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This part is known as the "Breast Implant Surgery Act."
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Section 4.
Section
26-21a-402
is enacted to read:
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26-21a-402. Duties of the department.
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(1) The department shall prepare:
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(a) an informed consent form for breast implant surgery;
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(b) a post-breast implant surgery report; and
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(c) a post-breast implant survey.
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(2) (a) The informed consent form for breast implant surgery shall require that the
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following information be given to a patient:
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(i) the chemical make up of any implant to be used;
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(ii) the name of the manufacturer and any bin, lot number, and other related identifying
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information associated with any implant to be used;
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(iii) the potential risks of breast implant surgery based on:
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(A) the best, available research;
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(B) state-specific health data; and
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(C) information regarding breast implants published by the federal Food and Drug
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Administration;
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(iv) the statistical chances of an adverse result;
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(v) the potential warning signs associated with an adverse result; and
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(vi) a telephone number to call in the event the patient believes that an adverse result may
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have occurred.
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(b) In addition to the requirements of Subsection (2)(a), an informed consent form for
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breast implant surgery shall request the permission of the patient to forward the patient's name to
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the department for future follow-up on the patient's health status.
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(3) The post-breast implant surgery report shall record the following information for a
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patient who has undergone a breast implant surgery:
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(a) the date on which informed consent was given, explained, and signed;
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(b) the date on which the surgery was performed;
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(c) the name of the manufacturer of any implant left in the body of the patient;
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(d) the lot number, bin number, and other related identifying information associated with
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any implant left in the body of the patient; and
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(e) the name and address of the patient if the patient consented to follow-up contact by the
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department.
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(4) The post-breast implant survey shall be designed as a follow-up tool for determining
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the ongoing health status of patients who have undergone breast implant surgery.
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(5) (a) The department shall distribute informed consent forms for breast implant surgery
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and post-breast implant reports to health care providers and facilities.
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(b) The department shall, in its discretion, distribute post-breast implant surveys to
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patients.
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(6) The department shall use the information produced from the post-implant surveys:
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(a) in preparing the informed consent form for breast implant surgery;
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(b) to inform women generally regarding the health issues associated with breast implant
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surgery;
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(c) to track the long-term health status of women who have undergone breast implant
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surgery; and
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(d) for other health-related purposes identified by the department.
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(7) In preparing the forms, reports, and surveys required by Subsection (1), the department
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shall seek the input of:
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(a) the Utah Medical Association;
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(b) the Utah Hospital Association;
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(c) one or more women who have undergone breast implant surgery; and
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(d) others who, in the opinion of the department, may be able and willing to provide
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helpful information or insight on breast implant surgery.
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Section 5.
Section
26-21a-403
is enacted to read:
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26-21a-403. Duties of health care providers and facilities.
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(1) At the initial consultation for breast implant surgery, and in no event less than 72 hours
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before the surgery is performed, the patient's health care provider shall:
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(a) give the patient the informed consent form for breast implant surgery prepared by the
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department; and
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(b) thoroughly explain the provisions of the informed consent form.
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(2) Before a breast implant surgery may be performed within a health care facility, the
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facility shall verify that:
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(a) the informed consent has been obtained from the patient in accordance with Subsection
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(1); and
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(b) the patient has signed the form.
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(3) After a breast implant surgery has been performed, the health care facility shall:
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(a) fill out the post-breast augmentation surgery report; and
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(b) send the report and a copy of the patient's signed informed consent to the department
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within 30 days of the surgery unless an extension of time is requested.
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(4) The health care provider that obtained the patient's informed consent and performed
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the surgery shall cooperate with the health care facility in filling out the post-breast augmentation
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surgery report.
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Section 6.
Section
26-21a-404
is enacted to read:
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26-21a-404. Failure to comply.
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The failure of a health care provider or health care facility to comply with the provisions
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of this chapter may be grounds for disciplinary action for unprofessional conduct against the
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license of the provider pursuant to Title 58, Occupations and Professions, or facility pursuant to
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Chapter 21, Health Care Facility Licensing and Inspection Act.
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Section 7.
Section
58-67-502
is amended to read:
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58-67-502. Unprofessional conduct.
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"Unprofessional conduct" includes, in addition to the definition in Section
58-1-501
and
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a violation of the informed consent requirement of Section
26-21a-403
, using or employing the
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services of any individual to assist a licensee in any manner not in accordance with the generally
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recognized practices, standards, or ethics of the profession, state law, or division rule.
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Section 8.
Section
58-68-502
is amended to read:
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58-68-502. Unprofessional conduct.
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"Unprofessional conduct" includes, in addition to the definition in Section
58-1-501
and
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a violation of the informed consent requirement of Section
26-21a-403
, using or employing the
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services of any individual to assist a licensee in any manner not in accordance with the generally
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recognized practices, standards, or ethics of the profession, state law, or division rule.
Legislative Review Note
as of 1-14-00 7:15 AM
A limited legal review of this legislation raises no obvious constitutional or statutory concerns.