Texas 2009 - 81st Regular

Texas House Bill HB3099 Compare Versions

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

Old	New	Differences
1	1	81R10764 YDB-F
2	2	By: Leibowitz H.B. No. 3099
3	3
4	4
5	5	A BILL TO BE ENTITLED
6	6	AN ACT
7	7	relating to the reporting of preventable adverse events and the
8	8	establishment of a patient safety program in hospitals and
9	9	ambulatory surgical centers; providing an administrative penalty.
10	10	BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS:
11	11	SECTION 1. Chapter 241, Health and Safety Code, is amended
12	12	by adding Subchapter H to read as follows:
13	13	SUBCHAPTER H. PATIENT SAFETY PROGRAM
14	14	Sec. 241.201. DEFINITION. In this subchapter, "serious
15	15	disability" means:
16	16	(1) a physical or mental impairment that substantially
17	17	limits one or more major life activities of an individual such as
18	18	seeing, hearing, speaking, walking, or breathing, or a loss of a
19	19	bodily function, if the impairment or loss lasts more than seven
20	20	days or is still present at the time of discharge from a hospital;
21	21	or
22	22	(2) loss of a body part.
23	23	Sec. 241.202. DUTIES OF DEPARTMENT. (a) The department
24	24	shall develop a patient safety program for hospitals. The program
25	25	must:
26	26	(1) be administered by the hospital licensing program
27	27	within the department; and
28	28	(2) serve as an information clearinghouse for
29	29	hospitals concerning best practices and quality improvement
30	30	strategies.
31	31	(b) The department shall group hospitals by size for the
32	32	reports required by this chapter as follows:
33	33	(1) fewer than 50 beds;
34	34	(2) 50 to 99 beds;
35	35	(3) 100 to 199 beds;
36	36	(4) 200 to 399 beds; and
37	37	(5) 400 beds or more.
38	38	(c) The department shall combine two or more categories
39	39	described by Subsection (b) if the number of hospitals in any
40	40	category falls below 40.
41	41	Sec. 241.203. ANNUAL REPORT. (a) This section applies only
42	42	to a hospital located in a county with a population of more than
43	43	350,000.
44	44	(b) On renewal of a license under this chapter, a hospital
45	45	shall submit to the department an annual report that lists the
46	46	number of occurrences at the hospital or at an outpatient facility
47	47	owned or operated by the hospital of each of the following
48	48	preventable adverse events during the preceding year:
49	49	(1) the unintended retention of a foreign object in a
50	50	patient after surgery or another procedure;
51	51	(2) death or serious disability of a patient caused by
52	52	an intravascular air embolism that occurs while the patient is
53	53	receiving care in the hospital, excluding a death associated with a
54	54	neurological procedure known to present a high risk of
55	55	intravascular air embolism;
56	56	(3) death or serious disability of a patient caused by
57	57	a hemolytic reaction resulting from the administration of ABO- or
58	58	HLA-incompatible blood or blood products;
59	59	(4) stage three or four pressure ulcers acquired after
60	60	admission to the hospital, excluding progression from stage two to
61	61	stage three if stage two was recognized on admission;
62	62	(5) death or serious disability caused by an electric
63	63	shock while a patient is receiving care in the hospital, excluding
64	64	an event involving a planned treatment such as electric
65	65	countershock;
66	66	(6) death or serious disability caused by a burn
67	67	incurred from any source while a patient is receiving care in the
68	68	hospital;
69	69	(7) death or serious disability caused by a fall or
70	70	trauma resulting in a fracture, dislocation, intracranial injury,
71	71	or crushing injury while a patient is receiving care in the
72	72	hospital;
73	73	(8) death or serious disability directly related to
74	74	the following manifestations of poor glycemic control, the onset of
75	75	which occurred while the patient was receiving care at the
76	76	hospital:
77	77	(A) diabetic ketoacidosis;
78	78	(B) nonketotic hyperosmolar coma;
79	79	(C) hypoglycemic coma;
80	80	(D) secondary diabetes with ketoacidosis; and
81	81	(E) secondary diabetes with hyperosmolarity;
82	82	(9) death or serious disability caused by a urinary
83	83	tract infection resulting from the insertion of a catheter by an
84	84	individual health care provider;
85	85	(10) death or serious disability caused by an
86	86	infection resulting from the insertion of a vascular catheter by an
87	87	individual health care provider;
88	88	(11) death or serious disability caused by a surgical
89	89	site infection occurring as a result of the following procedures:
90	90	(A) a coronary artery bypass graft;
91	91	(B) bariatric surgery such as laparoscopic
92	92	gastric bypass surgery, gastroenterostomy, and laparoscopic
93	93	gastric restrictive surgery; and
94	94	(C) orthopedic procedures involving the spine,
95	95	neck, shoulder, or elbow; and
96	96	(12) death or serious disability caused by a pulmonary
97	97	embolism or deep vein thrombosis that occurred while the patient
98	98	was receiving care at the hospital following an orthopedic
99	99	procedure, including a total knee replacement or hip replacement.
100	100	(c) The department may not require the annual report to
101	101	include any information other than the number of occurrences of
102	102	each preventable adverse event listed in Subsection (b).
103	103	Sec. 241.204. ROOT CAUSE ANALYSIS AND ACTION PLAN. (a) In
104	104	this section, "root cause analysis" means the process that
105	105	identifies basic or causal factors underlying a variation in
106	106	performance leading to a preventable adverse event listed in
107	107	Section 241.203 and that:
108	108	(1) focuses primarily on systems and processes;
109	109	(2) progresses from special causes in clinical
110	110	processes to common causes in organizational processes; and
111	111	(3) identifies potential improvements in processes or
112	112	systems.
113	113	(b) This section applies only to a hospital located in a
114	114	county with a population of more than 350,000.
115	115	(c) Not later than the 45th day after the date a hospital
116	116	becomes aware of the occurrence of a preventable adverse event
117	117	listed in Section 241.203, the hospital shall:
118	118	(1) conduct a root cause analysis of the event; and
119	119	(2) develop an action plan that identifies strategies
120	120	to reduce the risk of a similar event occurring in the future.
121	121	(d) The department may review a root cause analysis or
122	122	action plan related to a preventable adverse event listed in
123	123	Section 241.203 during a survey, inspection, or investigation of a
124	124	hospital.
125	125	(e) The department may not require a root cause analysis or
126	126	action plan to be submitted to the department.
127	127	(f) The department or an employee or agent of the department
128	128	may not in any form, format, or manner remove, copy, reproduce,
129	129	redact, or dictate from any part of a root cause analysis or action
130	130	plan.
131	131	Sec. 241.205. CONFIDENTIALITY; ABSOLUTE PRIVILEGE. (a)
132	132	Except as provided by Sections 241.206 and 241.207, all information
133	133	and materials obtained or compiled by the department under this
134	134	subchapter or compiled by a hospital under this subchapter,
135	135	including the root cause analysis, annual hospital report, action
136	136	plan, best practices report, department summary, and all related
137	137	information and materials, are confidential and:
138	138	(1) are not subject to disclosure under Chapter 552,
139	139	Government Code, or discovery, subpoena, or other means of legal
140	140	compulsion for release to any person, subject to Section
141	141	241.204(d); and
142	142	(2) may not be admitted as evidence or otherwise
143	143	disclosed in any civil, criminal, or administrative proceeding.
144	144	(b) The confidentiality protections under Subsection (a)
145	145	apply without regard to whether the information or materials are
146	146	obtained from or compiled by a hospital or an entity that has an
147	147	ownership or management interest in a hospital.
148	148	(c) The transfer of information or materials under this
149	149	subchapter is not a waiver of a privilege or protection granted
150	150	under law.
151	151	(d) Information reported by a hospital under this
152	152	subchapter and analyses, plans, records, and reports obtained,
153	153	prepared, or compiled by a hospital under this subchapter and all
154	154	related information and materials are subject to an absolute
155	155	privilege and may not be used in any form against the hospital or
156	156	the hospital's agents, employees, partners, assignees, or
157	157	independent contractors in any civil, criminal, or administrative
158	158	proceeding, regardless of the means by which a person came into
159	159	possession of the information, analysis, plan, record, report, or
160	160	related information or material. A court shall enforce this
161	161	privilege for all matters covered by this subsection.
162	162	(e) The provisions of this section regarding the
163	163	confidentiality of information or materials compiled or reported by
164	164	a hospital in compliance with or as authorized under this
165	165	subchapter do not restrict access, to the extent authorized by law,
166	166	by the patient or the patient's legally authorized representative
167	167	to records of the patient's medical diagnosis or treatment or to
168	168	other primary health records.
169	169	Sec. 241.206. ANNUAL DEPARTMENT SUMMARY. The department
170	170	annually shall compile and make available to the public a summary of
171	171	the preventable adverse events reported by hospitals as required by
172	172	Section 241.203. The summary may contain only aggregated
173	173	information and may not directly or indirectly identify:
174	174	(1) a specific hospital or group of hospitals;
175	175	(2) an individual; or
176	176	(3) a specific reported preventable adverse event or
177	177	the circumstances or individuals surrounding the event.
178	178	Sec. 241.207. BEST PRACTICES REPORT AND DEPARTMENT SUMMARY.
179	179	(a) A hospital located in a county with a population of more than
180	180	350,000 shall provide to the department at least one report of the
181	181	best practices and safety measures related to a reported
182	182	preventable adverse event.
183	183	(b) A hospital may provide to the department a report of
184	184	other best practices and the safety measures, such as marking a
185	185	surgical site and involving the patient in the marking process,
186	186	that are effective in improving patient safety.
187	187	(c) The department by rule may prescribe the form and format
188	188	of a best practices report. The department may not require a best
189	189	practices report to exceed one page in length. The department shall
190	190	accept, in lieu of a report in the form and format prescribed by the
191	191	department, a copy of a report submitted by a hospital to a patient
192	192	safety organization.
193	193	(d) The department periodically shall:
194	194	(1) review the best practices reports;
195	195	(2) compile a summary of the best practices reports
196	196	determined by the department to be effective and recommended as
197	197	best practices; and
198	198	(3) make the summary available to the public.
199	199	(e) The summary may not directly or indirectly identify:
200	200	(1) a specific hospital or group of hospitals;
201	201	(2) an individual; or
202	202	(3) a specific reported event or the circumstances or
203	203	individuals surrounding the event.
204	204	Sec. 241.208. PROHIBITION. The hospital annual report,
205	205	the department summary, or the best practices report may not
206	206	distinguish between a preventable adverse event that occurred at an
207	207	outpatient facility owned or operated by the hospital and a
208	208	preventable adverse event that occurred at a hospital facility.
209	209	Sec. 241.209. REPORT TO LEGISLATURE. (a) Not later than
210	210	December 1 of each even-numbered year, the commissioner of state
211	211	health services shall:
212	212	(1) evaluate the patient safety program established
213	213	under this subchapter; and
214	214	(2) report the results of the evaluation and make
215	215	recommendations to the legislature.
216	216	(b) The commissioner of state health services shall conduct
217	217	the evaluation in consultation with hospitals licensed under this
218	218	chapter.
219	219	(c) The evaluation must address:
220	220	(1) the degree to which the department was able to
221	221	detect statewide trends in errors based on the types and numbers of
222	222	events reported;
223	223	(2) the degree to which the statewide summaries of
224	224	events compiled by the department were accessed by the public;
225	225	(3) the effectiveness of the department's best
226	226	practices summary in improving hospital patient care; and
227	227	(4) the impact of national studies on the
228	228	effectiveness of state or federal systems of reporting medical
229	229	errors.
230	230	Sec. 241.210. GIFTS, GRANTS, AND DONATIONS. The department
231	231	may accept and administer a gift, grant, or donation from any source
232	232	to carry out the purposes of this subchapter.
233	233	SECTION 2. Chapter 243, Health and Safety Code, is amended
234	234	by adding Subchapter B to read as follows:
235	235	SUBCHAPTER B. PATIENT SAFETY PROGRAM
236	236	Sec. 243.051. DEFINITION. In this subchapter, "serious
237	237	disability" means:
238	238	(1) a physical or mental impairment that substantially
239	239	limits one or more major life activities of an individual such as
240	240	seeing, hearing, speaking, walking, or breathing, or a loss of a
241	241	bodily function, if the impairment or loss lasts more than seven
242	242	days or is still present at the time of discharge from an ambulatory
243	243	surgical center; or
244	244	(2) loss of a body part.
245	245	Sec. 243.052. DUTIES OF DEPARTMENT. The department shall
246	246	develop a patient safety program for ambulatory surgical centers.
247	247	The program must:
248	248	(1) be administered by the ambulatory surgical center
249	249	licensing program within the department; and
250	250	(2) serve as an information clearinghouse for
251	251	ambulatory surgical centers concerning best practices and quality
252	252	improvement strategies.
253	253	Sec. 243.053. ANNUAL REPORT. (a) This section applies only
254	254	to an ambulatory surgical center located in a county with a
255	255	population of more than 350,000.
256	256	(b) On renewal of a license under this chapter, an
257	257	ambulatory surgical center shall submit to the department an annual
258	258	report that lists the number of occurrences at the center or at an
259	259	outpatient facility owned or operated by the center of each of the
260	260	following preventable adverse events during the preceding year:
261	261	(1) the unintended retention of a foreign object in a
262	262	patient after surgery or another procedure;
263	263	(2) death or serious disability of a patient caused by
264	264	an intravascular air embolism that occurs while the patient is
265	265	receiving care at the ambulatory surgical center, excluding a death
266	266	associated with a neurological procedure known to present a high
267	267	risk of intravascular air embolism;
268	268	(3) death or serious disability of a patient caused by
269	269	a hemolytic reaction resulting from the administration of ABO- or
270	270	HLA-incompatible blood or blood products;
271	271	(4) stage three or four pressure ulcers acquired after
272	272	admission to the ambulatory surgical center, excluding progression
273	273	from stage two to stage three if stage two was recognized on
274	274	admission;
275	275	(5) death or serious disability caused by an electric
276	276	shock while a patient is receiving care at the ambulatory surgical
277	277	center, excluding an event involving a planned treatment such as
278	278	electric countershock;
279	279	(6) death or serious disability caused by a burn
280	280	incurred from any source while a patient is receiving care at the
281	281	ambulatory surgical center;
282	282	(7) death or serious disability caused by a fall or
283	283	trauma resulting in a fracture, dislocation, intracranial injury,
284	284	or crushing injury while a patient is receiving care at the
285	285	ambulatory surgical center;
286	286	(8) death or serious disability directly related to
287	287	the following manifestations of poor glycemic control, the onset of
288	288	which occurred while the patient was receiving care at the
289	289	ambulatory surgical center:
290	290	(A) diabetic ketoacidosis;
291	291	(B) nonketotic hyperosmolar coma;
292	292	(C) hypoglycemic coma;
293	293	(D) secondary diabetes with ketoacidosis; and
294	294	(E) secondary diabetes with hyperosmolarity;
295	295	(9) death or serious disability caused by a urinary
296	296	tract infection resulting from the insertion of a catheter by an
297	297	individual health care provider;
298	298	(10) death or serious disability caused by an
299	299	infection resulting from the insertion of a vascular catheter by an
300	300	individual health care provider;
301	301	(11) death or serious disability caused by a surgical
302	302	site infection occurring as a result of the following procedures:
303	303	(A) a coronary artery bypass graft;
304	304	(B) bariatric surgery such as laparoscopic
305	305	gastric bypass surgery, gastroenterostomy, and laparoscopic
306	306	gastric restrictive surgery; and
307	307	(C) orthopedic procedures involving the spine,
308	308	neck, shoulder, or elbow; and
309	309	(12) death or serious disability caused by a pulmonary
310	310	embolism or deep vein thrombosis that occurred while the patient
311	311	was receiving care at the ambulatory surgical center following an
312	312	orthopedic procedure, including a total knee replacement or hip
313	313	replacement.
314	314	(c) The department may not require the annual report to
315	315	include any information other than the number of occurrences of
316	316	each preventable adverse event listed in Subsection (b).
317	317	Sec. 243.054. ROOT CAUSE ANALYSIS AND ACTION PLAN. (a) In
318	318	this section, "root cause analysis" means the process that
319	319	identifies basic or causal factors underlying a variation in
320	320	performance leading to a preventable adverse event listed in
321	321	Section 243.053 and that:
322	322	(1) focuses primarily on systems and processes;
323	323	(2) progresses from special causes in clinical
324	324	processes to common causes in organizational processes; and
325	325	(3) identifies potential improvements in processes or
326	326	systems.
327	327	(b) This section applies only to an ambulatory surgical
328	328	center located in a county with a population of more than 350,000.
329	329	(c) Not later than the 45th day after the date an ambulatory
330	330	surgical center becomes aware of the occurrence of a preventable
331	331	adverse event listed in Section 243.053, the center shall:
332	332	(1) conduct a root cause analysis of the event; and
333	333	(2) develop an action plan that identifies strategies
334	334	to reduce the risk of a similar event occurring in the future.
335	335	(d) The department may review a root cause analysis or
336	336	action plan related to a preventable adverse event listed in
337	337	Section 243.053 during a survey, inspection, or investigation of an
338	338	ambulatory surgical center.
339	339	(e) The department may not require a root cause analysis or
340	340	action plan to be submitted to the department.
341	341	(f) The department or an employee or agent of the department
342	342	may not in any form, format, or manner remove, copy, reproduce,
343	343	redact, or dictate from any part of a root cause analysis or action
344	344	plan.
345	345	Sec. 243.055. CONFIDENTIALITY; ABSOLUTE PRIVILEGE. (a)
346	346	Except as provided by Sections 243.056 and 243.057, all information
347	347	and materials obtained or compiled by the department under this
348	348	subchapter or compiled by an ambulatory surgical center under this
349	349	subchapter, including the root cause analysis, annual report of an
350	350	ambulatory surgical center, action plan, best practices report,
351	351	department summary, and all related information and materials, are
352	352	confidential and:
353	353	(1) are not subject to disclosure under Chapter 552,
354	354	Government Code, or discovery, subpoena, or other means of legal
355	355	compulsion for release to any person, subject to Section
356	356	243.054(d); and
357	357	(2) may not be admitted as evidence or otherwise
358	358	disclosed in any civil, criminal, or administrative proceeding.
359	359	(b) The confidentiality protections under Subsection (a)
360	360	apply without regard to whether the information or materials are
361	361	obtained from or compiled by an ambulatory surgical center or an
362	362	entity that has an ownership or management interest in an
363	363	ambulatory surgical center.
364	364	(c) The transfer of information or materials under this
365	365	subchapter is not a waiver of a privilege or protection granted
366	366	under law.
367	367	(d) Information reported by an ambulatory surgical center
368	368	under this subchapter and analyses, plans, records, and reports
369	369	obtained, prepared, or compiled by the center under this subchapter
370	370	and all related information and materials are subject to an
371	371	absolute privilege and may not be used in any form against the
372	372	center or the center's agents, employees, partners, assignees, or
373	373	independent contractors in any civil, criminal, or administrative
374	374	proceeding, regardless of the means by which a person came into
375	375	possession of the information, analysis, plan, record, report, or
376	376	related information or material. A court shall enforce this
377	377	privilege for all matters covered by this subsection.
378	378	(e) The provisions of this section regarding the
379	379	confidentiality of information or materials compiled or reported by
380	380	an ambulatory surgical center in compliance with or as authorized
381	381	under this subchapter do not restrict access, to the extent
382	382	authorized by law, by the patient or the patient's legally
383	383	authorized representative to records of the patient's medical
384	384	diagnosis or treatment or to other primary health records.
385	385	Sec. 243.056. ANNUAL DEPARTMENT SUMMARY. The department
386	386	annually shall compile and make available to the public a summary of
387	387	the preventable adverse events reported by ambulatory surgical
388	388	centers as required by Section 243.053. The summary may contain
389	389	only aggregated information and may not directly or indirectly
390	390	identify:
391	391	(1) a specific ambulatory surgical center or group of
392	392	centers;
393	393	(2) an individual; or
394	394	(3) a specific reported preventable adverse event or
395	395	the circumstances or individuals surrounding the event.
396	396	Sec. 243.057. BEST PRACTICES REPORT AND DEPARTMENT SUMMARY.
397	397	(a) An ambulatory surgical center located in a county with a
398	398	population of more than 350,000 shall provide to the department at
399	399	least one report of best practices and safety measures related to a
400	400	reported preventable adverse event.
401	401	(b) An ambulatory surgical center may provide to the
402	402	department a report of other best practices and the safety
403	403	measures, such as marking a surgical site and involving the patient
404	404	in the marking process, that are effective in improving patient
405	405	safety.
406	406	(c) The department by rule may prescribe the form and format
407	407	of a best practices report. The department may not require a best
408	408	practices report to exceed one page in length. The department shall
409	409	accept, in lieu of a report in the form and format prescribed by the
410	410	department, a copy of a report submitted by an ambulatory surgical
411	411	center to a patient safety organization.
412	412	(d) The department periodically shall:
413	413	(1) review the best practices reports;
414	414	(2) compile a summary of the best practices reports
415	415	determined by the department to be effective and recommended as
416	416	best practices; and
417	417	(3) make the summary available to the public.
418	418	(e) The summary may not directly or indirectly identify:
419	419	(1) a specific ambulatory surgical center or group of
420	420	centers;
421	421	(2) an individual; or
422	422	(3) a specific reported event or the circumstances or
423	423	individuals surrounding the event.
424	424	Sec. 243.058. PROHIBITION. The annual report of an
425	425	ambulatory surgical center, the department summary, or the best
426	426	practices report may not distinguish between a preventable adverse
427	427	event that occurred at an outpatient facility owned or operated by
428	428	the center and a preventable adverse event that occurred at a center
429	429	facility.
430	430	Sec. 243.059. REPORT TO LEGISLATURE. (a) Not later than
431	431	December 1 of each even-numbered year, the commissioner of state
432	432	health services shall:
433	433	(1) evaluate the patient safety program established
434	434	under this subchapter; and
435	435	(2) report the results of the evaluation and make
436	436	recommendations to the legislature.
437	437	(b) The commissioner of state health services shall conduct
438	438	the evaluation in consultation with ambulatory surgical centers.
439	439	(c) The evaluation must address:
440	440	(1) the degree to which the department was able to
441	441	detect statewide trends in errors based on the types and numbers of
442	442	events reported;
443	443	(2) the degree to which the statewide summaries of
444	444	events compiled by the department were accessed by the public;
445	445	(3) the effectiveness of the department's best
446	446	practices summary in improving patient care; and
447	447	(4) the impact of national studies on the
448	448	effectiveness of state or federal systems of reporting medical
449	449	errors.
450	450	Sec. 243.060. GIFTS, GRANTS, AND DONATIONS. The department
451	451	may accept and administer a gift, grant, or donation from any source
452	452	to carry out the purposes of this subchapter.
453	453	SECTION 3. (a) Not later than December 1, 2009, the
454	454	executive commissioner of the Health and Human Services Commission
455	455	shall adopt the rules necessary to implement the changes in law made
456	456	by this Act.
457	457	(b) Not later than January 1, 2010, the Department of State
458	458	Health Services, using existing resources available to the
459	459	department, shall establish a patient safety program as required
460	460	under Subchapter H, Chapter 241, Health and Safety Code, as added by
461	461	this Act, and under Subchapter B, Chapter 243, Health and Safety
462	462	Code, as added by this Act.
463	463	(c) Beginning July 1, 2010, a hospital or ambulatory
464	464	surgical center on renewal of a license under Chapter 241 or 243,
465	465	Health and Safety Code, shall submit the annual report required by
466	466	Section 241.203 or 243.053, Health and Safety Code, as added by this
467	467	Act.
468	468	SECTION 4. This Act takes effect September 1, 2009.