81R10764 YDB-F
By: Leibowitz H.B. No. 3099
A BILL TO BE ENTITLED
AN ACT
relating to the reporting of preventable adverse events and the
establishment of a patient safety program in hospitals and
ambulatory surgical centers; providing an administrative penalty.
BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS:
SECTION 1. Chapter 241, Health and Safety Code, is amended
by adding Subchapter H to read as follows:
SUBCHAPTER H. PATIENT SAFETY PROGRAM
Sec. 241.201. 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 a hospital;
or
(2) loss of a body part.
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.
(c) The department shall combine two or more categories
described by Subsection (b) if the number of hospitals in any
category falls below 40.
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
individuals surrounding the event.
Sec. 243.058. PROHIBITION. The annual report of an
ambulatory surgical center, 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 center and a preventable adverse event that occurred at a center
facility.
Sec. 243.059. 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 ambulatory surgical centers.
(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.
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.
SECTION 3. (a) Not later than December 1, 2009, the
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.
(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.
SECTION 4. This Act takes effect September 1, 2009.