Texas 2009 - 81st Regular

Texas House Bill HB1672 Compare Versions

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1	1	H.B. No. 1672
2	2
3	3
4	4	AN ACT
5	5	relating to newborn screening.
6	6	BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS:
7	7	SECTION 1. Subchapter A, Chapter 33, Health and Safety
8	8	Code, is amended by adding Section 33.0021 to read as follows:
9	9	Sec. 33.0021. SICKLE-CELL TRAIT. Notwithstanding any
10	10	provision of this chapter, the department shall include sickle-cell
11	11	trait in the detection and treatment program established under this
12	12	chapter, in the screening for heritable diseases conducted under
13	13	Subchapter B, and in the newborn screening services provided under
14	14	Subchapter C.
15	15	SECTION 2. Subchapter B, Chapter 33, Health and Safety
16	16	Code, is amended by adding Sections 33.0111 and 33.0112 to read as
17	17	follows:
18	18	Sec. 33.0111. DISCLOSURE. (a) The department shall
19	19	develop a disclosure statement that clearly discloses to the
20	20	parent, managing conservator, or guardian of a newborn child
21	21	subjected to screening tests under Section 33.011:
22	22	(1) that the department or a laboratory established or
23	23	approved by the department under Section 33.016 may retain for use
24	24	by the department or laboratory genetic material used to conduct
25	25	the newborn screening tests and discloses how the material is
26	26	managed and used; and
27	27	(2) that the parent, managing conservator, or guardian
28	28	may limit the use of the genetic material by providing to the
29	29	department in accordance with Section 33.0112 a written statement
30	30	prohibiting the department or laboratory from retaining the genetic
31	31	material or using the genetic material for any purpose other than
32	32	the conduct of newborn screening tests authorized under this
33	33	chapter.
34	34	(b) The disclosure statement required by Subsection (a)
35	35	must be included on the form developed by the department to inform
36	36	parents about newborn screening. The disclosure statement must:
37	37	(1) be on a separate sheet of the form;
38	38	(2) be presented together with the written statement
39	39	described by Subsection (a)(2) in a format that allows a parent,
40	40	managing conservator, or guardian of a newborn child to either:
41	41	(A) sign, detach, and mail a portion of the form
42	42	to the department to require the department or laboratory to
43	43	destroy the genetic material on completion of the newborn screening
44	44	tests; or
45	45	(B) check a box and sign next to the box on the
46	46	form a statement indicating the parent, managing conservator, or
47	47	guardian is requiring the department or laboratory to destroy the
48	48	genetic material on completion of the newborn screening tests;
49	49	(3) include instructions on how to complete the
50	50	portions of the form described by Subdivisions (2)(A) and (B);
51	51	(4) include the department's mailing address; and
52	52	(5) be made available to a parent, managing
53	53	conservator, or guardian of a newborn child through alternative
54	54	sources.
55	55	(c) At the time a newborn child is subjected to screening
56	56	tests under Section 33.011, the physician attending a newborn child
57	57	or the person attending the delivery of a newborn child that is not
58	58	attended by a physician shall provide the parent, managing
59	59	conservator, or guardian of a newborn child a copy of the written
60	60	disclosure statement developed by the department under this
61	61	section.
62	62	(d) The department shall establish procedures for a
63	63	physician attending a newborn child or the person attending the
64	64	delivery of a newborn child to provide verification to the
65	65	department that the physician or person has provided the parent,
66	66	managing conservator, or guardian of the newborn child the
67	67	disclosure required under this section.
68	68	Sec. 33.0112. STATEMENT PROHIBITING RETENTION OF GENETIC
69	69	MATERIAL. (a) A parent, managing conservator, or guardian of a
70	70	newborn child may file with the department a signed written
71	71	statement prohibiting the department or a laboratory established or
72	72	approved by the department from retaining any genetic material
73	73	related to the newborn screening tests conducted under this chapter
74	74	or using the genetic material for any purpose other than the conduct
75	75	of the newborn screening tests. A parent, managing conservator, or
76	76	guardian may file the written statement on a form provided by the
77	77	department.
78	78	(b) Not later than the 60th day after the department
79	79	receives the written statement, the department or laboratory shall
80	80	destroy the genetic material used in the screening tests.
81	81	(c) An adult individual may file with the department a
82	82	written statement instructing the department or a laboratory
83	83	established or approved by the department to destroy any genetic
84	84	material of the individual that is retained and used under this
85	85	chapter.
86	86	SECTION 3. Subchapter B, Chapter 33, Health and Safety
87	87	Code, is amended by adding Section 33.017 to read as follows:
88	88	Sec. 33.017. CONFIDENTIALITY. (a) Reports, records, and
89	89	information obtained or developed by the department under this
90	90	chapter are confidential and are not subject to disclosure under
91	91	Chapter 552, Government Code, are not subject to subpoena, and may
92	92	not otherwise be released or made public except as provided by this
93	93	section.
94	94	(b) Notwithstanding other law, reports, records, and
95	95	information obtained or developed by the department under this
96	96	chapter may be disclosed:
97	97	(1) for purposes of diagnosis or follow-up authorized
98	98	under Section 33.014;
99	99	(2) with the consent of each identified individual or
100	100	an individual authorized to consent on behalf of an identified
101	101	child;
102	102	(3) as authorized by court order;
103	103	(4) to a medical examiner authorized to conduct an
104	104	autopsy on a child or an inquest on the death of a child; or
105	105	(5) to public health programs of the department for
106	106	public health research purposes provided that the disclosure is
107	107	approved by an institutional review board or privacy board of the
108	108	department as authorized by the federal privacy requirements
109	109	adopted under the Health Insurance Portability and Accountability
110	110	Act of 1996 (Pub. L. No. 104-191) contained in 45 C.F.R. Part 160
111	111	and 45 C.F.R. Part 164, Subparts A and E.
112	112	(c) Notwithstanding other law, reports, records, and
113	113	information that do not identify a child or the family of a child
114	114	may be released without consent if the disclosure is for:
115	115	(1) statistical purposes;
116	116	(2) purposes related to obtaining or maintaining
117	117	certification, approval, or quality assurance for the department's
118	118	laboratory or a public or private laboratory to perform newborn
119	119	screening tests;
120	120	(3) purposes relating to review, quality assurance, or
121	121	improvement of the department's newborn screening under this
122	122	chapter or the department's newborn screening program services
123	123	under Subchapter C;
124	124	(4) research purposes, provided that the disclosure is
125	125	approved by an institutional review board or privacy board of the
126	126	department; or
127	127	(5) quality assurance related to equipment and
128	128	supplies, provided that:
129	129	(A) the assessment is performed by a person who
130	130	is not a laboratory;
131	131	(B) only newborn screening specimens are
132	132	disclosed; and
133	133	(C) the disclosure is approved by an
134	134	institutional review board or privacy board of the department.
135	135	(d) A state officer or employee, a department contractor, or
136	136	a department contractor's employee, officer, director, or
137	137	subcontractor may not be examined in a civil, criminal, special, or
138	138	other judicial or administrative proceeding as to the existence or
139	139	contents of records, reports, or information made confidential by
140	140	this section unless disclosure is authorized by this section.
141	141	SECTION 4. (a) The speaker of the house of representatives
142	142	shall charge a committee of members selected by the speaker or a
143	143	house standing committee to conduct an interim study on newborn
144	144	screening in this state.
145	145	(b) The committee designated under Subsection (a) of this
146	146	section shall:
147	147	(1) study the time frame and procedures for the
148	148	disclosure required by Chapter 33, Health and Safety Code, to the
149	149	parent, managing conservator, or guardian of a newborn child;
150	150	(2) analyze whether procedures should be developed by
151	151	the Department of State Health Services to provide confirmation to
152	152	a parent, managing conservator, or guardian of a newborn child that
153	153	a stored specimen has been destroyed as required by a written
154	154	statement submitted by the parent, managing conservator, or
155	155	guardian; and
156	156	(3) study standardization of the disclosure process
157	157	for health care facilities in this state.
158	158	(c) Not later than December 15, 2010, the committee
159	159	designated under Subsection (a) of this section shall file a report
160	160	on the results of the interim study conducted under this section
161	161	with both houses of the legislature.
162	162	SECTION 5. As soon as practicable after the effective date
163	163	of this Act, the Department of State Health Services shall
164	164	implement Section 33.0021, Health and Safety Code, as added by this
165	165	Act.
166	166	SECTION 6. As soon as practicable after the effective date
167	167	of this Act, the Department of State Health Services shall develop
168	168	the disclosure statement required by Section 33.0111, Health and
169	169	Safety Code, as added by this Act. The department shall modify an
170	170	existing form for use for purposes of that section.
171	171	SECTION 7. This Act takes effect immediately if it receives
172	172	a vote of two-thirds of all the members elected to each house, as
173	173	provided by Section 39, Article III, Texas Constitution. If this
174	174	Act does not receive the vote necessary for immediate effect, this
175	175	Act takes effect September 1, 2009.
176	176	______________________________ ______________________________
177	177	President of the Senate Speaker of the House
178	178	I certify that H.B. No. 1672 was passed by the House on April
179	179	8, 2009, by the following vote: Yeas 141, Nays 4, 1 present, not
180	180	voting; and that the House concurred in Senate amendments to H.B.
181	181	No. 1672 on May 18, 2009, by the following vote: Yeas 143, Nays 0,
182	182	2 present, not voting.
183	183	______________________________
184	184	Chief Clerk of the House
185	185	I certify that H.B. No. 1672 was passed by the Senate, with
186	186	amendments, on May 15, 2009, by the following vote: Yeas 29, Nays
187	187	1.
188	188	______________________________
189	189	Secretary of the Senate
190	190	APPROVED: __________________
191	191	Date
192	192	__________________
193	193	Governor