| |
| |
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A BILL TO BE ENTITLED
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AN ACT
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relating to the reporting of preventable adverse events and the |
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|
establishment of a patient safety program in hospitals and |
|
|
ambulatory surgical centers; providing an administrative penalty. |
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BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS: |
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SECTION 1. Chapter 241, Health and Safety Code, is amended |
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|
by adding Subchapter H to read as follows: |
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|
SUBCHAPTER H. PATIENT SAFETY PROGRAM |
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|
Sec. 241.201. DEFINITION. In this subchapter, "serious |
|
|
disability" means: |
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|
(1) a physical or mental impairment that substantially |
|
|
limits one or more major life activities of an individual such as |
|
|
seeing, hearing, speaking, walking, or breathing, or a loss of a |
|
|
bodily function, if the impairment or loss lasts more than seven |
|
|
days or is still present at the time of discharge from a hospital; |
|
|
or |
|
|
(2) loss of a body part. |
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|
Sec. 241.202. DUTIES OF DEPARTMENT. (a) The department |
|
|
shall develop a patient safety program for hospitals. The program |
|
|
must: |
|
|
(1) be administered by the hospital licensing program |
|
|
within the department; and |
|
|
(2) serve as an information clearinghouse for |
|
|
hospitals concerning best practices and quality improvement |
|
|
strategies. |
|
|
(b) The department shall group hospitals by size for the |
|
|
reports required by this chapter as follows: |
|
|
(1) fewer than 50 beds; |
|
|
(2) 50 to 99 beds; |
|
|
(3) 100 to 199 beds; |
|
|
(4) 200 to 399 beds; and |
|
|
(5) 400 beds or more. |
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|
(c) The department shall combine two or more categories |
|
|
described by Subsection (b) if the number of hospitals in any |
|
|
category falls below 40. |
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|
Sec. 241.203. ANNUAL REPORT. (a) This section applies only |
|
|
to a hospital located in a county with a population of more than |
|
|
350,000. |
|
|
(b) On renewal of a license under this chapter, a hospital |
|
|
shall submit to the department an annual report that lists the |
|
|
number of occurrences at the hospital or at an outpatient facility |
|
|
owned or operated by the hospital of each of the following |
|
|
preventable adverse events during the preceding year: |
|
|
(1) the unintended retention of a foreign object in a |
|
|
patient after surgery or another procedure; |
|
|
(2) death or serious disability of a patient caused by |
|
|
an intravascular air embolism that occurs while the patient is |
|
|
receiving care in the hospital, excluding a death associated with a |
|
|
neurological procedure known to present a high risk of |
|
|
intravascular air embolism; |
|
|
(3) death or serious disability of a patient caused by |
|
|
a hemolytic reaction resulting from the administration of ABO- or |
|
|
HLA-incompatible blood or blood products; |
|
|
(4) stage three or four pressure ulcers acquired after |
|
|
admission to the hospital, excluding progression from stage two to |
|
|
stage three if stage two was recognized on admission; |
|
|
(5) death or serious disability caused by an electric |
|
|
shock while a patient is receiving care in the hospital, excluding |
|
|
an event involving a planned treatment such as electric |
|
|
countershock; |
|
|
(6) death or serious disability caused by a burn |
|
|
incurred from any source while a patient is receiving care in the |
|
|
hospital; |
|
|
(7) death or serious disability caused by a fall or |
|
|
trauma resulting in a fracture, dislocation, intracranial injury, |
|
|
or crushing injury while a patient is receiving care in the |
|
|
hospital; |
|
|
(8) death or serious disability directly related to |
|
|
the following manifestations of poor glycemic control, the onset of |
|
|
which occurred while the patient was receiving care at the |
|
|
hospital: |
|
|
(A) diabetic ketoacidosis; |
|
|
(B) nonketotic hyperosmolar coma; |
|
|
(C) hypoglycemic coma; |
|
|
(D) secondary diabetes with ketoacidosis; and |
|
|
(E) secondary diabetes with hyperosmolarity; |
|
|
(9) death or serious disability caused by a urinary |
|
|
tract infection resulting from the insertion of a catheter by an |
|
|
individual health care provider; |
|
|
(10) death or serious disability caused by an |
|
|
infection resulting from the insertion of a vascular catheter by an |
|
|
individual health care provider; |
|
|
(11) death or serious disability caused by a surgical |
|
|
site infection occurring as a result of the following procedures: |
|
|
(A) a coronary artery bypass graft; |
|
|
(B) bariatric surgery such as laparoscopic |
|
|
gastric bypass surgery, gastroenterostomy, and laparoscopic |
|
|
gastric restrictive surgery; and |
|
|
(C) orthopedic procedures involving the spine, |
|
|
neck, shoulder, or elbow; and |
|
|
(12) death or serious disability caused by a pulmonary |
|
|
embolism or deep vein thrombosis that occurred while the patient |
|
|
was receiving care at the hospital following an orthopedic |
|
|
procedure, including a total knee replacement or hip replacement. |
|
|
(c) The department may not require the annual report to |
|
|
include any information other than the number of occurrences of |
|
|
each preventable adverse event listed in Subsection (b). |
|
|
Sec. 241.204. ROOT CAUSE ANALYSIS AND ACTION PLAN. (a) In |
|
|
this section, "root cause analysis" means the process that |
|
|
identifies basic or causal factors underlying a variation in |
|
|
performance leading to a preventable adverse event listed in |
|
|
Section 241.203 and that: |
|
|
(1) focuses primarily on systems and processes; |
|
|
(2) progresses from special causes in clinical |
|
|
processes to common causes in organizational processes; and |
|
|
(3) identifies potential improvements in processes or |
|
|
systems. |
|
|
(b) This section applies only to a hospital located in a |
|
|
county with a population of more than 350,000. |
|
|
(c) Not later than the 45th day after the date a hospital |
|
|
becomes aware of the occurrence of a preventable adverse event |
|
|
listed in Section 241.203, the hospital shall: |
|
|
(1) conduct a root cause analysis of the event; and |
|
|
(2) develop an action plan that identifies strategies |
|
|
to reduce the risk of a similar event occurring in the future. |
|
|
(d) The department may review a root cause analysis or |
|
|
action plan related to a preventable adverse event listed in |
|
|
Section 241.203 during a survey, inspection, or investigation of a |
|
|
hospital. |
|
|
(e) The department may not require a root cause analysis or |
|
|
action plan to be submitted to the department. |
|
|
(f) The department or an employee or agent of the department |
|
|
may not in any form, format, or manner remove, copy, reproduce, |
|
|
redact, or dictate from any part of a root cause analysis or action |
|
|
plan. |
|
|
Sec. 241.205. CONFIDENTIALITY; ABSOLUTE PRIVILEGE. (a) |
|
|
Except as provided by Sections 241.206 and 241.207, all information |
|
|
and materials obtained or compiled by the department under this |
|
|
subchapter or compiled by a hospital under this subchapter, |
|
|
including the root cause analysis, annual hospital report, action |
|
|
plan, best practices report, department summary, and all related |
|
|
information and materials, are confidential and: |
|
|
(1) are not subject to disclosure under Chapter 552, |
|
|
Government Code, or discovery, subpoena, or other means of legal |
|
|
compulsion for release to any person, subject to Section |
|
|
241.204(d); and |
|
|
(2) may not be admitted as evidence or otherwise |
|
|
disclosed in any civil, criminal, or administrative proceeding. |
|
|
(b) The confidentiality protections under Subsection (a) |
|
|
apply without regard to whether the information or materials are |
|
|
obtained from or compiled by a hospital or an entity that has an |
|
|
ownership or management interest in a hospital. |
|
|
(c) The transfer of information or materials under this |
|
|
subchapter is not a waiver of a privilege or protection granted |
|
|
under law. |
|
|
(d) Information reported by a hospital under this |
|
|
subchapter and analyses, plans, records, and reports obtained, |
|
|
prepared, or compiled by a hospital under this subchapter and all |
|
|
related information and materials are subject to an absolute |
|
|
privilege and may not be used in any form against the hospital or |
|
|
the hospital's agents, employees, partners, assignees, or |
|
|
independent contractors in any civil, criminal, or administrative |
|
|
proceeding, regardless of the means by which a person came into |
|
|
possession of the information, analysis, plan, record, report, or |
|
|
related information or material. A court shall enforce this |
|
|
privilege for all matters covered by this subsection. |
|
|
(e) The provisions of this section regarding the |
|
|
confidentiality of information or materials compiled or reported by |
|
|
a hospital in compliance with or as authorized under this |
|
|
subchapter do not restrict access, to the extent authorized by law, |
|
|
by the patient or the patient's legally authorized representative |
|
|
to records of the patient's medical diagnosis or treatment or to |
|
|
other primary health records. |
|
|
Sec. 241.206. ANNUAL DEPARTMENT SUMMARY. The department |
|
|
annually shall compile and make available to the public a summary of |
|
|
the preventable adverse events reported by hospitals as required by |
|
|
Section 241.203. The summary may contain only aggregated |
|
|
information and may not directly or indirectly identify: |
|
|
(1) a specific hospital or group of hospitals; |
|
|
(2) an individual; or |
|
|
(3) a specific reported preventable adverse event or |
|
|
the circumstances or individuals surrounding the event. |
|
|
Sec. 241.207. BEST PRACTICES REPORT AND DEPARTMENT SUMMARY. |
|
|
(a) A hospital located in a county with a population of more than |
|
|
350,000 shall provide to the department at least one report of the |
|
|
best practices and safety measures related to a reported |
|
|
preventable adverse event. |
|
|
(b) A hospital may provide to the department a report of |
|
|
other best practices and the safety measures, such as marking a |
|
|
surgical site and involving the patient in the marking process, |
|
|
that are effective in improving patient safety. |
|
|
(c) The department by rule may prescribe the form and format |
|
|
of a best practices report. The department may not require a best |
|
|
practices report to exceed one page in length. The department shall |
|
|
accept, in lieu of a report in the form and format prescribed by the |
|
|
department, a copy of a report submitted by a hospital to a patient |
|
|
safety organization. |
|
|
(d) The department periodically shall: |
|
|
(1) review the best practices reports; |
|
|
(2) compile a summary of the best practices reports |
|
|
determined by the department to be effective and recommended as |
|
|
best practices; and |
|
|
(3) make the summary available to the public. |
|
|
(e) The summary may not directly or indirectly identify: |
|
|
(1) a specific hospital or group of hospitals; |
|
|
(2) an individual; or |
|
|
(3) a specific reported event or the circumstances or |
|
|
individuals surrounding the event. |
|
|
Sec. 241.208. PROHIBITION. The hospital annual report, |
|
|
the department summary, or the best practices report may not |
|
|
distinguish between a preventable adverse event that occurred at an |
|
|
outpatient facility owned or operated by the hospital and a |
|
|
preventable adverse event that occurred at a hospital facility. |
|
|
Sec. 241.209. REPORT TO LEGISLATURE. (a) Not later than |
|
|
December 1 of each even-numbered year, the commissioner of state |
|
|
health services shall: |
|
|
(1) evaluate the patient safety program established |
|
|
under this subchapter; and |
|
|
(2) report the results of the evaluation and make |
|
|
recommendations to the legislature. |
|
|
(b) The commissioner of state health services shall conduct |
|
|
the evaluation in consultation with hospitals licensed under this |
|
|
chapter. |
|
|
(c) The evaluation must address: |
|
|
(1) the degree to which the department was able to |
|
|
detect statewide trends in errors based on the types and numbers of |
|
|
events reported; |
|
|
(2) the degree to which the statewide summaries of |
|
|
events compiled by the department were accessed by the public; |
|
|
(3) the effectiveness of the department's best |
|
|
practices summary in improving hospital patient care; and |
|
|
(4) the impact of national studies on the |
|
|
effectiveness of state or federal systems of reporting medical |
|
|
errors. |
|
|
Sec. 241.210. GIFTS, GRANTS, AND DONATIONS. The department |
|
|
may accept and administer a gift, grant, or donation from any source |
|
|
to carry out the purposes of this subchapter. |
|
|
SECTION 2. Chapter 243, Health and Safety Code, is amended |
|
|
by adding Subchapter B to read as follows: |
|
|
SUBCHAPTER B. PATIENT SAFETY PROGRAM |
|
|
Sec. 243.051. DEFINITION. In this subchapter, "serious |
|
|
disability" means: |
|
|
(1) a physical or mental impairment that substantially |
|
|
limits one or more major life activities of an individual such as |
|
|
seeing, hearing, speaking, walking, or breathing, or a loss of a |
|
|
bodily function, if the impairment or loss lasts more than seven |
|
|
days or is still present at the time of discharge from an ambulatory |
|
|
surgical center; or |
|
|
(2) loss of a body part. |
|
|
Sec. 243.052. DUTIES OF DEPARTMENT. The department shall |
|
|
develop a patient safety program for ambulatory surgical centers. |
|
|
The program must: |
|
|
(1) be administered by the ambulatory surgical center |
|
|
licensing program within the department; and |
|
|
(2) serve as an information clearinghouse for |
|
|
ambulatory surgical centers concerning best practices and quality |
|
|
improvement strategies. |
|
|
Sec. 243.053. ANNUAL REPORT. (a) This section applies only |
|
|
to an ambulatory surgical center located in a county with a |
|
|
population of more than 350,000. |
|
|
(b) On renewal of a license under this chapter, an |
|
|
ambulatory surgical center shall submit to the department an annual |
|
|
report that lists the number of occurrences at the center or at an |
|
|
outpatient facility owned or operated by the center of each of the |
|
|
following preventable adverse events during the preceding year: |
|
|
(1) the unintended retention of a foreign object in a |
|
|
patient after surgery or another procedure; |
|
|
(2) death or serious disability of a patient caused by |
|
|
an intravascular air embolism that occurs while the patient is |
|
|
receiving care at the ambulatory surgical center, excluding a death |
|
|
associated with a neurological procedure known to present a high |
|
|
risk of intravascular air embolism; |
|
|
(3) death or serious disability of a patient caused by |
|
|
a hemolytic reaction resulting from the administration of ABO- or |
|
|
HLA-incompatible blood or blood products; |
|
|
(4) stage three or four pressure ulcers acquired after |
|
|
admission to the ambulatory surgical center, excluding progression |
|
|
from stage two to stage three if stage two was recognized on |
|
|
admission; |
|
|
(5) death or serious disability caused by an electric |
|
|
shock while a patient is receiving care at the ambulatory surgical |
|
|
center, excluding an event involving a planned treatment such as |
|
|
electric countershock; |
|
|
(6) death or serious disability caused by a burn |
|
|
incurred from any source while a patient is receiving care at the |
|
|
ambulatory surgical center; |
|
|
(7) death or serious disability caused by a fall or |
|
|
trauma resulting in a fracture, dislocation, intracranial injury, |
|
|
or crushing injury while a patient is receiving care at the |
|
|
ambulatory surgical center; |
|
|
(8) death or serious disability directly related to |
|
|
the following manifestations of poor glycemic control, the onset of |
|
|
which occurred while the patient was receiving care at the |
|
|
ambulatory surgical center: |
|
|
(A) diabetic ketoacidosis; |
|
|
(B) nonketotic hyperosmolar coma; |
|
|
(C) hypoglycemic coma; |
|
|
(D) secondary diabetes with ketoacidosis; and |
|
|
(E) secondary diabetes with hyperosmolarity; |
|
|
(9) death or serious disability caused by a urinary |
|
|
tract infection resulting from the insertion of a catheter by an |
|
|
individual health care provider; |
|
|
(10) death or serious disability caused by an |
|
|
infection resulting from the insertion of a vascular catheter by an |
|
|
individual health care provider; |
|
|
(11) death or serious disability caused by a surgical |
|
|
site infection occurring as a result of the following procedures: |
|
|
(A) a coronary artery bypass graft; |
|
|
(B) bariatric surgery such as laparoscopic |
|
|
gastric bypass surgery, gastroenterostomy, and laparoscopic |
|
|
gastric restrictive surgery; and |
|
|
(C) orthopedic procedures involving the spine, |
|
|
neck, shoulder, or elbow; and |
|
|
(12) death or serious disability caused by a pulmonary |
|
|
embolism or deep vein thrombosis that occurred while the patient |
|
|
was receiving care at the ambulatory surgical center following an |
|
|
orthopedic procedure, including a total knee replacement or hip |
|
|
replacement. |
|
|
(c) The department may not require the annual report to |
|
|
include any information other than the number of occurrences of |
|
|
each preventable adverse event listed in Subsection (b). |
|
|
Sec. 243.054. ROOT CAUSE ANALYSIS AND ACTION PLAN. (a) In |
|
|
this section, "root cause analysis" means the process that |
|
|
identifies basic or causal factors underlying a variation in |
|
|
performance leading to a preventable adverse event listed in |
|
|
Section 243.053 and that: |
|
|
(1) focuses primarily on systems and processes; |
|
|
(2) progresses from special causes in clinical |
|
|
processes to common causes in organizational processes; and |
|
|
(3) identifies potential improvements in processes or |
|
|
systems. |
|
|
(b) This section applies only to an ambulatory surgical |
|
|
center located in a county with a population of more than 350,000. |
|
|
(c) Not later than the 45th day after the date an ambulatory |
|
|
surgical center becomes aware of the occurrence of a preventable |
|
|
adverse event listed in Section 243.053, the center shall: |
|
|
(1) conduct a root cause analysis of the event; and |
|
|
(2) develop an action plan that identifies strategies |
|
|
to reduce the risk of a similar event occurring in the future. |
|
|
(d) The department may review a root cause analysis or |
|
|
action plan related to a preventable adverse event listed in |
|
|
Section 243.053 during a survey, inspection, or investigation of an |
|
|
ambulatory surgical center. |
|
|
(e) The department may not require a root cause analysis or |
|
|
action plan to be submitted to the department. |
|
|
(f) The department or an employee or agent of the department |
|
|
may not in any form, format, or manner remove, copy, reproduce, |
|
|
redact, or dictate from any part of a root cause analysis or action |
|
|
plan. |
|
|
Sec. 243.055. CONFIDENTIALITY; ABSOLUTE PRIVILEGE. (a) |
|
|
Except as provided by Sections 243.056 and 243.057, all information |
|
|
and materials obtained or compiled by the department under this |
|
|
subchapter or compiled by an ambulatory surgical center under this |
|
|
subchapter, including the root cause analysis, annual report of an |
|
|
ambulatory surgical center, action plan, best practices report, |
|
|
department summary, and all related information and materials, are |
|
|
confidential and: |
|
|
(1) are not subject to disclosure under Chapter 552, |
|
|
Government Code, or discovery, subpoena, or other means of legal |
|
|
compulsion for release to any person, subject to Section |
|
|
243.054(d); and |
|
|
(2) may not be admitted as evidence or otherwise |
|
|
disclosed in any civil, criminal, or administrative proceeding. |
|
|
(b) The confidentiality protections under Subsection (a) |
|
|
apply without regard to whether the information or materials are |
|
|
obtained from or compiled by an ambulatory surgical center or an |
|
|
entity that has an ownership or management interest in an |
|
|
ambulatory surgical center. |
|
|
(c) The transfer of information or materials under this |
|
|
subchapter is not a waiver of a privilege or protection granted |
|
|
under law. |
|
|
(d) Information reported by an ambulatory surgical center |
|
|
under this subchapter and analyses, plans, records, and reports |
|
|
obtained, prepared, or compiled by the center under this subchapter |
|
|
and all related information and materials are subject to an |
|
|
absolute privilege and may not be used in any form against the |
|
|
center or the center's agents, employees, partners, assignees, or |
|
|
independent contractors in any civil, criminal, or administrative |
|
|
proceeding, regardless of the means by which a person came into |
|
|
possession of the information, analysis, plan, record, report, or |
|
|
related information or material. A court shall enforce this |
|
|
privilege for all matters covered by this subsection. |
|
|
(e) The provisions of this section regarding the |
|
|
confidentiality of information or materials compiled or reported by |
|
|
an ambulatory surgical center in compliance with or as authorized |
|
|
under this subchapter do not restrict access, to the extent |
|
|
authorized by law, by the patient or the patient's legally |
|
|
authorized representative to records of the patient's medical |
|
|
diagnosis or treatment or to other primary health records. |
|
|
Sec. 243.056. ANNUAL DEPARTMENT SUMMARY. The department |
|
|
annually shall compile and make available to the public a summary of |
|
|
the preventable adverse events reported by ambulatory surgical |
|
|
centers as required by Section 243.053. The summary may contain |
|
|
only aggregated information and may not directly or indirectly |
|
|
identify: |
|
|
(1) a specific ambulatory surgical center or group of |
|
|
centers; |
|
|
(2) an individual; or |
|
|
(3) a specific reported preventable adverse event or |
|
|
the circumstances or individuals surrounding the event. |
|
|
Sec. 243.057. BEST PRACTICES REPORT AND DEPARTMENT SUMMARY. |
|
|
(a) An ambulatory surgical center located in a county with a |
|
|
population of more than 350,000 shall provide to the department at |
|
|
least one report of best practices and safety measures related to a |
|
|
reported preventable adverse event. |
|
|
(b) An ambulatory surgical center may provide to the |
|
|
department a report of other best practices and the safety |
|
|
measures, such as marking a surgical site and involving the patient |
|
|
in the marking process, that are effective in improving patient |
|
|
safety. |
|
|
(c) The department by rule may prescribe the form and format |
|
|
of a best practices report. The department may not require a best |
|
|
practices report to exceed one page in length. The department shall |
|
|
accept, in lieu of a report in the form and format prescribed by the |
|
|
department, a copy of a report submitted by an ambulatory surgical |
|
|
center to a patient safety organization. |
|
|
(d) The department periodically shall: |
|
|
(1) review the best practices reports; |
|
|
(2) compile a summary of the best practices reports |
|
|
determined by the department to be effective and recommended as |
|
|
best practices; and |
|
|
(3) make the summary available to the public. |
|
|
(e) The summary may not directly or indirectly identify: |
|
|
(1) a specific ambulatory surgical center or group of |
|
|
centers; |
|
|
(2) an individual; or |
|
|
(3) a specific reported event or the circumstances or |
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|
individuals surrounding the event. |
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|
Sec. 243.058. PROHIBITION. The annual report of an |
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|
ambulatory surgical center, the department summary, or the best |
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|
practices report may not distinguish between a preventable adverse |
|
|
event that occurred at an outpatient facility owned or operated by |
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|
the center and a preventable adverse event that occurred at a center |
|
|
facility. |
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|
Sec. 243.059. REPORT TO LEGISLATURE. (a) Not later than |
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|
December 1 of each even-numbered year, the commissioner of state |
|
|
health services shall: |
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|
(1) evaluate the patient safety program established |
|
|
under this subchapter; and |
|
|
(2) report the results of the evaluation and make |
|
|
recommendations to the legislature. |
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|
(b) The commissioner of state health services shall conduct |
|
|
the evaluation in consultation with ambulatory surgical centers. |
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|
(c) The evaluation must address: |
|
|
(1) the degree to which the department was able to |
|
|
detect statewide trends in errors based on the types and numbers of |
|
|
events reported; |
|
|
(2) the degree to which the statewide summaries of |
|
|
events compiled by the department were accessed by the public; |
|
|
(3) the effectiveness of the department's best |
|
|
practices summary in improving patient care; and |
|
|
(4) the impact of national studies on the |
|
|
effectiveness of state or federal systems of reporting medical |
|
|
errors. |
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|
Sec. 243.060. GIFTS, GRANTS, AND DONATIONS. The department |
|
|
may accept and administer a gift, grant, or donation from any source |
|
|
to carry out the purposes of this subchapter. |
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|
SECTION 3. (a) Not later than December 1, 2009, the |
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|
executive commissioner of the Health and Human Services Commission |
|
|
shall adopt the rules necessary to implement the changes in law made |
|
|
by this Act. |
|
|
(b) Not later than January 1, 2010, the Department of State |
|
|
Health Services, using existing resources available to the |
|
|
department, shall establish a patient safety program as required |
|
|
under Subchapter H, Chapter 241, Health and Safety Code, as added by |
|
|
this Act, and under Subchapter B, Chapter 243, Health and Safety |
|
|
Code, as added by this Act. |
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|
(c) Beginning July 1, 2010, a hospital or ambulatory |
|
|
surgical center on renewal of a license under Chapter 241 or 243, |
|
|
Health and Safety Code, shall submit the annual report required by |
|
|
Section 241.203 or 243.053, Health and Safety Code, as added by this |
|
|
Act. |
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|
SECTION 4. This Act takes effect September 1, 2009. |