Texas 2009 - 81st Regular

Texas House Bill HB2294 Compare Versions

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1	1	81R29094 YDB-D
2	2	By: Gattis H.B. No. 2294
3	3	Substitute the following for H.B. No. 2294:
4	4	By: Coleman C.S.H.B. No. 2294
5	5
6	6
7	7	A BILL TO BE ENTITLED
8	8	AN ACT
9	9	relating to the establishment of the undiagnosed disease registry.
10	10	BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS:
11	11	SECTION 1. Subtitle D, Title 2, Health and Safety Code, is
12	12	amended by adding Chapter 82B to read as follows:
13	13	CHAPTER 82B. UNDIAGNOSED DISEASE REGISTRY
14	14	Sec. 82B.001. SHORT TITLE. This chapter may be cited as the
15	15	Undiagnosed Disease Reporting Act.
16	16	Sec. 82B.002. DEFINITIONS. In this chapter:
17	17	(1) "Clinical laboratory" means an accredited
18	18	facility in which:
19	19	(A) tests are performed identifying findings of
20	20	anatomical changes; and
21	21	(B) specimens are interpreted and pathological
22	22	diagnoses are made.
23	23	(2) "Executive commissioner" means the executive
24	24	commissioner of the Health and Human Services Commission.
25	25	(3) "Health care facility" means:
26	26	(A) a general or special hospital as defined by
27	27	Chapter 241;
28	28	(B) an ambulatory surgical center licensed under
29	29	Chapter 243;
30	30	(C) an institution licensed under Chapter 242; or
31	31	(D) any other facility, including an outpatient
32	32	clinic, that provides diagnosis or treatment services to patients
33	33	with an undiagnosed disease that results in death.
34	34	(4) "Physician" has the meaning assigned by Section
35	35	151.002, Occupations Code.
36	36	Sec. 82B.003. APPLICABILITY OF CHAPTER. This chapter
37	37	applies to records of cases of undiagnosed diseases that result in
38	38	death on or after January 1, 2010.
39	39	Sec. 82B.004. REGISTRY REQUIRED. The department shall
40	40	maintain for this state an undiagnosed disease registry for
41	41	undiagnosed diseases that result in death or other cases the
42	42	executive commissioner by rule requires to be included in the
43	43	registry.
44	44	Sec. 82B.005. CONTENT OF REGISTRY; SAMPLES. (a) The
45	45	undiagnosed disease registry must be a central data bank of
46	46	accurate, precise, and current information that medical
47	47	authorities agree serves as an invaluable tool in the early
48	48	recognition, prevention, cure, and control of undiagnosed
49	49	diseases.
50	50	(b) The undiagnosed disease registry must include:
51	51	(1) a record of the cases of undiagnosed diseases that
52	52	result in death in this state; and
53	53	(2) information concerning undiagnosed disease cases
54	54	the department considers necessary and appropriate for the
55	55	recognition, prevention, cure, or control of undiagnosed diseases.
56	56	(c) The undiagnosed disease registry may include cases of
57	57	undiagnosed diseases that do not result in death.
58	58	(d) The department shall store samples of tissues
59	59	corresponding to individual registry records that may be of future
60	60	benefit to medical professionals.
61	61	Sec. 82B.006. EXECUTIVE COMMISSIONER POWERS. To implement
62	62	this chapter, the executive commissioner may:
63	63	(1) adopt rules the executive commissioner considers
64	64	necessary;
65	65	(2) execute contracts the executive commissioner
66	66	considers necessary;
67	67	(3) receive the data from medical records of cases of
68	68	undiagnosed diseases that are in the custody or under the control of
69	69	clinical laboratories, health care facilities, and physicians to
70	70	record and analyze the data directly related to the diseases;
71	71	(4) compile and publish statistical and other studies
72	72	derived from the patient data obtained under this chapter to
73	73	provide, in an accessible form, information that is useful to
74	74	physicians, other medical personnel, and the general public;
75	75	(5) comply with requirements as necessary to obtain
76	76	federal funds in the maximum amounts and most advantageous
77	77	proportions possible;
78	78	(6) receive and use gifts made for the purpose of this
79	79	chapter; and
80	80	(7) limit undiagnosed disease reporting activities
81	81	under this chapter to specified geographic areas of this state to
82	82	ensure optimal use of funds available for obtaining the data.
83	83	Sec. 82B.007. REPORTS. (a) The department shall submit an
84	84	annual report to the legislature on the information obtained under
85	85	this chapter.
86	86	(b) The department, in cooperation with other undiagnosed
87	87	disease reporting organizations and research institutions, may
88	88	publish reports the department determines are necessary or
89	89	desirable to carry out the purpose of this chapter.
90	90	Sec. 82B.008. DATA FROM MEDICAL RECORDS; TISSUE SAMPLES.
91	91	(a) To ensure an accurate and continuing source of data concerning
92	92	undiagnosed disease, each clinical laboratory, health care
93	93	facility, and physician shall furnish to the department or its
94	94	representative, on request, data that the executive commissioner
95	95	considers necessary and appropriate and that is derived from each
96	96	medical record pertaining to a case of an undiagnosed disease that
97	97	is in the custody or under the control of the clinical laboratory,
98	98	health care facility, or physician. The department may not request
99	99	data that is more than three years old unless the department is
100	100	investigating a possible undiagnosed disease cluster.
101	101	(b) A clinical laboratory, health care facility, or
102	102	physician shall furnish the data requested under Subsection (a) in
103	103	a reasonable format prescribed by the department and within six
104	104	months of the patient's death or treatment for an undiagnosed
105	105	disease unless a different period is prescribed by the United
106	106	States Department of Health and Human Services.
107	107	(c) The data required to be furnished under this section
108	108	must include patient identification, symptoms, tests conducted,
109	109	and any other information the department requires.
110	110	(d) The department may access medical records that would
111	111	identify cases of undiagnosed diseases, establish characteristics
112	112	or treatment of undiagnosed diseases, or determine the medical
113	113	status of any identified patient from the following sources:
114	114	(1) a health care facility or clinical laboratory
115	115	providing screening or therapeutic services to a patient related to
116	116	an undiagnosed disease; or
117	117	(2) a physician providing treatment to a patient with
118	118	an undiagnosed disease.
119	119	(e) The executive commissioner shall adopt procedures that
120	120	ensure adequate notice is given to the clinical laboratory, health
121	121	care facility, or physician before the department accesses data
122	122	under Subsection (d).
123	123	(f) The data required to be furnished under this section may
124	124	be shared with undiagnosed disease registries of clinical
125	125	laboratories or health care facilities subject to the
126	126	confidentiality provisions in Section 82B.009.
127	127	(g) Each clinical laboratory, health care facility, and
128	128	physician shall furnish to the department or its representative, on
129	129	request, any available tissue samples that the executive
130	130	commissioner considers necessary.
131	131	Sec. 82B.009. CONFIDENTIALITY. (a) Reports, records, and
132	132	information obtained under this chapter are confidential and are
133	133	not subject to disclosure under Chapter 552, Government Code, are
134	134	not subject to subpoena, and may not otherwise be released or made
135	135	public except as provided by this section or Section 82B.008(f).
136	136	The reports, records, and information obtained under this chapter
137	137	are for the confidential use of the department and the persons or
138	138	public or private entities that the department determines are
139	139	necessary to carry out the intent of this chapter.
140	140	(b) Medical or epidemiological information may be released:
141	141	(1) for statistical purposes in a manner that prevents
142	142	identification of individuals, clinical laboratories, health care
143	143	facilities, or physicians;
144	144	(2) with the consent of each person identified in the
145	145	information; or
146	146	(3) to promote undiagnosed disease research,
147	147	including release of information to other undiagnosed disease
148	148	registries and appropriate state and federal agencies, under rules
149	149	adopted by the executive commissioner to ensure confidentiality as
150	150	required by state and federal laws.
151	151	(c) A state employee may not testify in a civil, criminal,
152	152	special, or other proceeding as to the existence or contents of
153	153	records, reports, or information concerning an individual whose
154	154	medical records have been used in submitting data required under
155	155	this chapter unless the individual consents in advance.
156	156	(d) Data furnished to an undiagnosed disease registry or an
157	157	undiagnosed disease researcher under Subsection (b) or Section
158	158	82B.008(f) is for the confidential use of the undiagnosed disease
159	159	registry or the undiagnosed disease researcher, as applicable, and
160	160	is subject to Subsection (a).
161	161	Sec. 82B.010. IMMUNITY FROM LIABILITY. The following
162	162	persons subject to this chapter that act in compliance with this
163	163	chapter are not civilly or criminally liable for furnishing the
164	164	information required under this chapter:
165	165	(1) a health care facility or clinical laboratory;
166	166	(2) an administrator, officer, or employee of a health
167	167	care facility or clinical laboratory;
168	168	(3) a physician or employee of a physician; and
169	169	(4) an employee of the department.
170	170	Sec. 82B.011. EXAMINATION AND SUPERVISION NOT REQUIRED.
171	171	This chapter does not require an individual to submit to any medical
172	172	examination or supervision or to examination or supervision by the
173	173	executive commissioner or the executive commissioner's
174	174	representatives.
175	175	SECTION 2. (a) Not later than December 1, 2009, the
176	176	executive commissioner of the Health and Human Services Commission
177	177	shall adopt the rules and procedures required to establish the
178	178	undiagnosed disease registry under Chapter 82B, Health and Safety
179	179	Code, as added by this Act.
180	180	(b) Not later than January 1, 2010, the Department of State
181	181	Health Services shall establish the undiagnosed disease registry
182	182	under Chapter 82B, Health and Safety Code, as added by this Act.
183	183	(c) Notwithstanding Chapter 82B, Health and Safety Code, as
184	184	added by this Act, a clinical laboratory, health care facility, or
185	185	physician is not required to report the data required under Chapter
186	186	82B until January 1, 2010.
187	187	SECTION 3. This Act takes effect September 1, 2009.