Rhode Island 2023 Regular Session

Rhode Island Senate Bill S0096 Compare Versions

Only one version of the bill is available at this time.

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5	5	2023 -- S 0096
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7	7	LC000860
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9	9	S TATE OF RHODE IS LAND
10	10	IN GENERAL ASSEMBLY
11	11	JANUARY SESSION, A.D. 2023
12	12	____________
13	13
14	14	A N A C T
15	15	RELATING TO HEALTH AND SAFETY -- EMBRYO SAFETY AND STORAGE
16	16	Introduced By: Senators Miller, DiMario, Gu, Lawson, Valverde, and Lauria
17	17	Date Introduced: February 01, 2023
18	18	Referred To: Senate Health & Human Services
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20	20
21	21	It is enacted by the General Assembly as follows:
22	22	SECTION 1. Title 23 of the General Laws entitled "HEALTH AND SAFETY" is hereby 1
23	23	amended by adding thereto the following chapter: 2
24	24	CHAPTER 13.8 3
25	25	EMBRYO SAFETY AND STORAGE ACT OF 2023 4
26	26	23-13.8-1. Title. 5
27	27	This act shall be known as and may be cited as the “Embryo Safety and Storage Act of 6
28	28	2023.” 7
29	29	23-13.8-2. Findings. 8
30	30	The general assembly finds as follows: 9
31	31	(1) In vitro fertilization, commonly known as IVF, is a widely used method of assisted 10
32	32	reproductive technology (ART). ART has helped an estimated six million (6,000,000) couples in 11
33	33	the United States who have trouble getting or maintaining a pregnancy start families. 12
34	34	(2) IVF provides a pathway for people to parenthood. 13
35	35	(3) It is in the best interest of the people of this state to direct the department of health to 14
36	36	promulgate rules and regulations governing the storage of human eggs, pre-embryos, and embryos 15
37	37	in embryo storage facilities to guard against catastrophic storage system failure and the potential 16
38	38	loss of such specimens that may result from long-term power outages during storms and other 17
39	39	natural disasters. 18
40	40	23-13.8-3. Definitions. 19
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42	42
43	43	LC000860 - Page 2 of 6
44	44	As used in this chapter, the following terms shall have the following meanings, unless the 1
45	45	context clearly indicates otherwise: 2
46	46	(1) "Department" means the Rhode Island department of health. 3
47	47	(2) "Director" means the director of the Rhode Island department of health. 4
48	48	(3) "Embryo storage facility" means a facility which cryopreserves and stores human eggs, 5
49	49	pre-embryos, and embryos for later use in in vitro fertilization, embryo transfer, gamete transfer, 6
50	50	pronuclear stage transfer and zygote transfer, and other procedures performed to achieve a 7
51	51	pregnancy or pregnancies. Embryo storage facility shall also include the office of a licensed health 8
52	52	care provider which stores human eggs, pre-embryos, or embryos. 9
53	53	(4) "Person" means any individual, corporation, company, association, organization, 10
54	54	society, firm, partnership, joint stock company, or the state or any political subdivision thereof. 11
55	55	23-13.8-4. Prohibited activities. 12
56	56	(a) No person shall conduct, maintain, or operate an embryo storage facility in this state 13
57	57	unless licensed by the department pursuant to the provisions of this chapter. A separate license shall 14
58	58	be required for each embryo storage facility location. The license shall be posted and displayed at 15
59	59	all times in a prominent location within the facility. No license issued pursuant to this chapter shall 16
60	60	be transferable. A change in the ownership of the facility shall require notification to the department 17
61	61	within fourteen (14) calendar days and reapplication for licensure. 18
62	62	(b) The department shall not license a person to conduct, maintain, or operate an embryo 19
63	63	storage facility pursuant to this chapter unless the department is satisfied that the person has 20
64	64	demonstrated good character, competency, and integrity, and has furnished such information to the 21
65	65	director as the director may require for this purpose. 22
66	66	23-13.8-5. Rules and regulations. 23
67	67	(a) The department shall promulgate rules and regulations governing the storage and care 24
68	68	of human eggs, pre-embryos, and embryos by an embryo storage facility in accordance with: 25
69	69	(1) Standards ISO 9001 and ISO 20387 of the International Organization for 26
70	70	Standardization; 27
71	71	(2) Standards for biorepositories established by the College of American Pathologists 28
72	72	Biorepository Accreditation Program; and 29
73	73	(3) The U.S. Food and Drug Administration guidance on current good tissue practices. 30
74	74	(b) The rules and regulations authorized by this section shall promote safety and best 31
75	75	practices among embryo storage facilities and, at a minimum prescribe standards governing the 32
76	76	operation, maintenance, and administration of embryo storage facilities the safety and adequacy of 33
77	77	the physical plant or the facilities compliance with state and local fire safety codes the number of 34
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81	81	staff and the qualifications of each staff member, the protection and safety of the equipment used 1
82	82	by embryo storage facilities to process and store human eggs, pre-embryos, and embryos, the 2
83	83	maintenance and confidentiality of records and furnishing of required information, the maintenance 3
84	84	of all appropriate accreditations and the establishment of a quality management program the review 4
85	85	of the scope of internal audits. 5
86	86	(c) The department shall conduct an on-site facility inspection and shall evaluate the 6
87	87	embryo storage facility to determine whether the facility complies with the provisions of this 7
88	88	chapter. 8
89	89	(d) The department shall have the authority to inspect and examine the physical plant or 9
90	90	facilities of an embryo storage facility and to inspect all documents, records, files, or other data 10
91	91	maintained pursuant to this chapter during normal operating hours and without prior notice. 11
92	92	(e) The department shall request the appropriate state and local fire, health, and building 12
93	93	officials to conduct examinations and inspections to determine compliance with state and local 13
94	94	ordinances, codes, and regulations by an embryo storage facility. The inspections shall be 14
95	95	conducted and the results reported to the department within sixty (60) days after the request. 15
96	96	(f) If an embryo storage facility meets the requirements of this chapter and the rules and 16
97	97	regulations promulgated hereunder, the department shall issue a license to the facility. A license 17
98	98	shall be valid for a period of one year and may be renewed at the end of that period, subject to 18
99	99	continued compliance with the provisions of this of this chapter. 19
100	100	(g) All rules and regulations promulgated pursuant to this chapter shall be adopted and 20
101	101	amended in accordance with chapter 35 of title 42 ("administrative procedures"). 21
102	102	23-13.8-6. Licensing of active facilities. 22
103	103	(a) Any person operating an embryo storage facility on or after the effective date of this 23
104	104	chapter or desiring to operate an embryo storage facility shall make application for licensure in the 24
105	105	manner and on the forms prescribed by the director. The license application form shall include, but 25
106	106	shall not be limited to, the following information: 26
107	107	(1) The name and address of the embryo storage facility, the operator of the facility, and 27
108	108	the staff; 28
109	109	(2) The qualifications of the staff members, each member of the board of directors of the 29
110	110	corporation, and the embryo storage facility operator; a description of the facility's premises and 30
111	111	facilities and the hours of its operation; and 31
112	112	(3) Any other information the director deems necessary to include on the license 32
113	113	application form. 33
114	114	(b) If an embryo storage facility meets the requirements of this chapter and of the rules and 34
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117	117	LC000860 - Page 4 of 6
118	118	regulations promulgated hereunder, the department shall issue a license to the facility. A license 1
119	119	shall be valid for a period of one year and may be renewed at the end of that period, subject to 2
120	120	continued compliance with the provisions of this chapter. 3
121	121	23-13.8-7. Fees. 4
122	122	(a) The director shall establish a minimum fee to be paid by each embryo storage facility 5
123	123	at the time of application for a license and at every renewal of a license. 6
124	124	(b) The income received from licensure and renewal fees pursuant to this section shall be 7
125	125	appropriated to the department to effectuate the purposes of this chapter. 8
126	126	23-13.8-8. License revocation. 9
127	127	The department may deny, suspend, revoke, or refuse to renew a license for good cause, 10
128	128	including, but not limited to: 11
129	129	(1) Failure of an embryo storage facility or its operator to comply with the provisions of 12
130	130	this chapter; 13
131	131	(2) Violation of the terms and conditions of a license by an embryo storage facility or its 14
132	132	operator; 15
133	133	(3) Use of fraud or misrepresentation by an embryo storage facility or its operator in 16
134	134	obtaining a license or in the subsequent operation of the facility; 17
135	135	(4) Refusal by an embryo storage facility or its operator to furnish the department with 18
136	136	required files, reports, or records; or 19
137	137	(5) Refusal by an embryo storage facility or its operator to permit an inspection by an 20
138	138	authorized representative of the department during normal operating hours. 21
139	139	23-13.8-9. Hearings. 22
140	140	(a) The department, before denying, suspending, revoking, or refusing to renew a license, 23
141	141	shall give notice to the operator personally, or by certified or registered mail to the last known 24
142	142	address of the operator with return receipt requested. The notice shall afford the operator with an 25
143	143	opportunity to be heard in person or by an attorney, and to offer evidence pertinent to the subject 26
144	144	of the hearing. 27
145	145	(b) The hearing shall take place within sixty (60) days from the issuance or mailing of the 28
146	146	notice and shall be conducted in accordance with chapter 35 of title 42 ("administrative 29
147	147	procedures"). 30
148	148	23-13.8-10. Acting without a license. 31
149	149	Any person who operates or assists in the operation of an embryo storage facility which 32
150	150	does not have a license, who has used fraud or misrepresentation in obtaining a license or in the 33
151	151	subsequent operation of a facility, who offers, advertises, or provides any service not authorized by 34
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154	154	LC000860 - Page 5 of 6
155	155	a valid license, or who violates any other provision of this chapter shall be guilty of a felony and 1
156	156	upon conviction thereof, shall be subject to a fine of up to five thousand dollars ($5,000), or 2
157	157	imprisonment for a period of up to two (2) years, or both. 3
158	158	SECTION 2. This act shall take effect on January 1, 2024 4
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160	160	LC000860
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164	164	LC000860 - Page 6 of 6
165	165	EXPLANATION
166	166	BY THE LEGISLATIVE COUNCIL
167	167	OF
168	168	A N A C T
169	169	RELATING TO HEALTH AND SAFETY -- EMBRYO SAFETY AND ST ORAGE
170	170	***
171	171	This act would create the “Embryo Safety and Storage Act of 2023.” The act would require 1
172	172	the department of health to regulate and license embryo storage facilities. 2
173	173	This act would take effect on January 1, 2024. 3
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175	175	LC000860
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