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2003S0339-2 03/03/03
By: Truitt H.B. No. 1614
A BILL TO BE ENTITLED
AN ACT
relating to the reporting of medical errors by certain hospitals,
ambulatory surgical centers, and mental hospitals.
BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS:
SECTION 1. The purpose of this Act is to establish programs
that will promote public accountability through the detection of
statewide trends in the occurrence of certain medical errors by
requiring hospitals, licensed ambulatory surgical centers, and
licensed mental hospitals to report these errors, by providing the
public with access to statewide summaries of such reports, and by
requiring such facilities to implement risk-reduction strategies.
The programs also will encourage hospitals, licensed ambulatory
surgical centers, and licensed mental hospitals to share best
practices and safety measures that have been effective in improving
patient safety.
SECTION 2. Subchapter B, Chapter 241, Health and Safety
Code, is amended by adding Section 241.030 to read as follows:
Sec. 241.030. PATIENT SAFETY PROGRAM. (a) Using existing
resources, the department shall develop a patient safety program
for hospitals. The program shall:
(1) be administered by the hospital licensing program
within the department; and
(2) serve as a clearinghouse of information for
hospitals concerning best practices and quality improvement
strategies.
(b) A hospital shall submit an annual report to the
department, the due date to be based on the date of licensure or
relicensure of the hospital, of the following types of events:
(1) a medication error resulting in the unanticipated
death of a patient, or a major, permanent loss of a bodily function
by a patient, that is not related to the natural course of the
illness or underlying condition of the patient;
(2) any perinatal death unrelated to a congenital
condition in an infant having a birth weight greater than 2,500
grams;
(3) the abduction from the hospital of a newborn
infant patient, or the discharge from the hospital of a newborn
infant patient into the custody of an individual in circumstances
in which the hospital knew, or in the exercise of ordinary care
should have known, that the individual did not have legal custody of
the newborn infant patient;
(4) the suicide of a patient in a setting where the
patient receives around-the-clock care;
(5) the sexual assault of a patient while the patient
is being treated or while the patient is on the premises of the
facility;
(6) a hemolytic transfusion reaction in a patient
resulting from the administration of blood or blood products having
major blood group incompatibilities;
(7) the performance of surgery on the wrong patient or
on the wrong body part of a patient;
(8) a foreign object's accidentally being left in a
patient's body during a procedure; and
(9) the death or serious disability of a patient
associated with the use or function of a device in patient care in
which the device is used or functions in a manner other than that
intended.
(c) The department may not require the annual report under
Subsection (b) to include any information other than a listing of
the number of occurrences, if any, of the events listed in that
subsection.
(d) A hospital shall conduct a root cause analysis of an
event listed in Subsection (b) following identification of the
event.
(e) Following the performance of a root cause analysis of an
event listed in Subsection (b), a hospital shall develop an action
plan that identifies the strategies the hospital intends to use to
reduce the risk of similar events occurring in the future.
(f) A hospital must conduct a root cause analysis and
complete an action plan under Subsection (e) not later than 45 days
after becoming aware of an event that must be reported under
Subsection (b).
(g) The department may review a root cause analysis and
action plan regarding an event that must be reported under
Subsection (b) during a licensure or complaint survey but may not
require that the root cause analysis or action plan be reported to
the department. The department and its employees and agents are
prohibited from removing, copying, reproducing, redacting, or
dictating from, all or any part of a root cause analysis or action
plan. This prohibition applies to any form, format, or manner of
copying, reproducing, redacting, or dictating.
(h) All information and materials obtained or compiled by
the department under this section are confidential and not subject
to disclosure under Chapter 552, Government Code, and are not
subject to discovery, subpoena, or other means of legal compulsion
for release to anyone other than the department or its employees or
agents involved in the program. Information and materials obtained
or compiled by the department under this section may not be admitted
in evidence or otherwise disclosed in any civil, criminal, or
administrative proceeding.
(i) The root cause analysis and action plan compiled by a
hospital in compliance with Subsections (d) and (e) and all related
information and materials, and the report of best practices and
safety measures described in Subsection (m) and all related
information and materials, are confidential and not subject to
disclosure under Chapter 552, Government Code, and are not subject
to discovery, subpoena, or other means of legal compulsion for
release to anyone. The root cause analysis and action plan and all
related information and materials, and the report of best practices
and safety measures and all related information and materials, may
not be admitted in evidence or otherwise disclosed in any civil,
criminal, or administrative proceeding. Information reported by a
hospital and analyses, plans, records, and reports obtained,
prepared, or compiled by a hospital as required by this section, and
all related information and materials, are subject to an absolute
privilege and may not be used in any form against the hospital or
its agents, employees, partners, assignees, or independent
contractors in any civil, criminal, or administrative proceeding,
regardless of the means by which the information, analyses, plans,
records, reports, or related information and materials came into
the possession of the person attempting to use them. A court shall
enforce this privilege as to all matters covered by this section.
(j) The confidentiality protections provided by Subsections
(h) and (i) apply regardless of 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.
(k) The transfer of information or materials under this
section shall not be treated as a waiver of any privilege or
protection.
(l) Notwithstanding the provisions of Subsection (h), the
department shall on an annual basis compile and make publicly
available a summary of the events that were reported by hospitals
under Subsection (b). The summary shall contain only aggregated
information and may not directly or indirectly identify a specific
hospital or group of hospitals, an individual, a specific reported
event, or the circumstances or individuals surrounding or involved
in a specific reported event.
(m) A hospital may provide to the department a report of its
best practices and safety measures that have been effective in
improving patient safety. The department may adopt rules regarding
the form and format of the report. The department shall
periodically compile a summary of such reports and make the summary
publicly available. The summary may not directly or indirectly
identify a specific hospital or group of hospitals, an individual,
a specific reported event, or the circumstances or individuals
surrounding or involved in a specific reported event.
(n) The provisions of this section also apply to the events
listed in Subsection (b) that occur in an offsite outpatient
facility that is owned or operated by a hospital, and the report
described in Subsection (m) shall not distinguish between those
offsite outpatient facilities that are owned or operated by a
hospital and those facilities that are included under the
hospital's license.
(o) The commissioner of public health shall evaluate the
program established under this section and submit the evaluation,
together with recommendations, to the legislature not later than
December 1, 2006. The evaluation shall be made in consultation with
hospitals that are required to make a report under Subsection (b).
(p) The evaluation under Subsection (o) shall include the
following:
(1) the degree to which the department was able to
detect statewide trends in errors based on the types and numbers of
errors reported;
(2) the extent to which the statewide summaries
required to be compiled by the department under Subsection (l) were
accessed by the public;
(3) the effectiveness of the summary of reported best
practices and safety measures in assisting hospitals in improving
patient care; and
(4) the impact of national studies regarding the
effectiveness of state or federal systems of reporting medical
errors.
(q) In this section, "root cause analysis" means a process
for identifying basic or causal factors that underlie variation in
performance, focusing primarily on systems and processes,
progressing from special causes in clinical processes to common
causes in organizational processes, and identifying potential
improvements in processes or systems.
(r) This section, except for Subsections (h)-(k) and (q),
expires September 1, 2007.
SECTION 3. Chapter 243, Health and Safety Code, is amended
by adding Section 243.0101 to read as follows:
Sec. 243.0101. PATIENT SAFETY PROGRAM. (a) Using existing
resources, the department shall develop a patient safety program
for licensed ambulatory surgical centers. The program shall:
(1) be administered by the ambulatory surgical center
licensing program within the department; and
(2) serve as a clearinghouse of information for
licensed ambulatory surgical centers concerning best practices and
quality improvement strategies.
(b) An ambulatory surgical center licensed by the
department shall submit an annual report to the department, the due
date to be based on the date of licensure or relicensure of the
ambulatory surgical center, of the following types of events:
(1) a medication error resulting in the unanticipated
death of a patient, or a major, permanent loss of a bodily function
by the patient, that is not related to the natural course of the
illness or underlying condition of the patient;
(2) the suicide of a patient in an ambulatory surgical
center;
(3) the sexual assault of a patient while the patient
is being treated or while the patient is on the premises of the
facility;
(4) a hemolytic transfusion reaction in a patient
resulting from the administration of blood or blood products having
major blood group incompatibilities;
(5) the performance of surgery on the wrong patient or
on the wrong body part of a patient;
(6) a foreign object's accidentally being left in a
patient's body during a procedure; and
(7) the death or serious disability of a patient
associated with the use of or function of a device in patient care
in which the device is used or functions in a manner other than that
intended.
(c) The department may not require the annual report under
Subsection (b) to include any information other than a listing of
the number of occurrences, if any, of the events listed in that
subsection.
(d) A licensed ambulatory surgical center shall conduct a
root cause analysis of an event listed in Subsection (b) following
identification of the event.
(e) Following the performance of a root cause analysis of an
event listed in Subsection (b), a licensed ambulatory surgical
center shall develop an action plan that identifies the strategies
the licensed ambulatory surgical center intends to use to reduce
the risk of similar events occurring in the future.
(f) A licensed ambulatory surgical center must conduct a
root cause analysis and complete an action plan under Subsection
(e) not later than 45 days after becoming aware of an event that
must be reported under Subsection (b).
(g) The department may review a root cause analysis and
action plan regarding an event that must be reported under
Subsection (b) during a licensure or complaint survey but may not
require that the action plan be reported to the department. The
department and its employees and agents are prohibited from
removing, copying, reproducing, redacting, or dictating from all or
any part of a root cause analysis or action plan. This prohibition
applies to any form, format, or manner of copying, reproducing,
redacting, or dictating.
(h) All information and materials obtained or compiled by
the department under this section are confidential and not subject
to disclosure under Chapter 552, Government Code, and are not
subject to discovery, subpoena, or other means of legal compulsion
for release to anyone other than the department or its employees or
agents involved in the program. Information and materials obtained
or compiled by the department under this section may not be admitted
in evidence or otherwise disclosed in any civil, criminal, or
administrative proceeding.
(i) The root cause analysis and action plan compiled by a
licensed ambulatory surgical center in compliance with Subsections
(d) and (e) and all related information and materials, and the
report of best practices and safety measures described in
Subsection (m) and all related information and materials, are
confidential and not subject to disclosure under Chapter 552,
Government Code, and are not subject to discovery, subpoena, or
other means of legal compulsion for release to anyone. The root
cause analysis and action plan and all related information and
materials, and the report of best practices and safety measures and
all related information and materials may not be admitted in
evidence or otherwise disclosed in any civil, criminal, or
administrative proceeding. Information reported by a licensed
ambulatory surgical center and analyses, plans, records, and
reports obtained, prepared, or compiled by a licensed ambulatory
surgical center as required by this section, and all related
information and materials, are subject to an absolute privilege and
may not be used in any form against the licensed ambulatory surgical
center or its agents, employees, partners, assignees, or
independent contractors in any civil, criminal, or administrative
proceeding, regardless of the means by which the information,
analyses, plans, records, reports, or related information and
materials came into the possession of the person attempting to use
them. A court shall enforce this privilege as to all matters
covered by this section.
(j) The confidentiality protections provided by Subsections
(h) and (i) apply regardless of whether the information or
materials are obtained from or compiled by a licensed ambulatory
surgical center or an entity that has an ownership or management
interest in a licensed ambulatory surgical center.
(k) The transfer of information or materials under this
section shall not be treated as a waiver of any privilege or
protection.
(l) Notwithstanding the provisions of Subsection (h), the
department shall on an annual basis compile and make publicly
available a summary of the events that were reported by licensed
ambulatory surgical centers under Subsection (b). The summary
shall contain only aggregated information and may not directly or
indirectly identify a specific licensed ambulatory surgical center
or group of licensed ambulatory surgical centers, an individual, a
specific reported event, or the circumstances or individuals
surrounding or involved in a specific reported event.
(m) A licensed ambulatory surgical center may provide to the
department a report of its best practices and safety measures that
have been effective in improving patient safety. The department
may adopt rules regarding the form and format of the report. The
department shall periodically compile a summary of the reports and
make the summary publicly available. The summary may not directly
or indirectly identify a specific licensed ambulatory surgical
center or group of licensed ambulatory surgical centers, an
individual, a specific reported event, or the circumstances or
individuals surrounding or involved in a specific reported event.
(n) The commissioner of public health shall evaluate the
program established under this section and report the evaluation,
together with recommendations, to the legislature not later than
December 1, 2006. The evaluation shall be made in consultation with
licensed ambulatory surgical centers that are required to make a
report under Subsection (b).
(o) The evaluation under Subsection (n) shall include the
following:
(1) the degree to which the department was able to
detect statewide trends in errors based on the types and numbers of
errors reported;
(2) the extent to which the statewide summaries
required to be compiled by the department under Subsection (l) were
accessed by the public;
(3) the effectiveness of the summary of reported best
practices and safety measures in assisting licensed ambulatory
surgical centers in improving patient care; and
(4) the impact of national studies regarding the
effectiveness of state or federal systems of reporting medical
errors.
(p) In this section, "root cause analysis" means a process
for identifying basic or causal factors that underlie variation in
performance, focusing primarily on systems and processes,
progressing from special causes in clinical processes to common
causes in organizational processes, and identifying potential
improvements in processes or systems.
(q) This section, except for Subsections (h)-(k) and (p),
expires September 1, 2007.
SECTION 4. Chapter 577, Health and Safety Code, is amended
by adding Section 577.0102 to read as follows:
Sec. 577.0102. PATIENT SAFETY PROGRAM. (a) Using existing
resources, the department shall develop a patient safety program
for mental hospitals licensed under Section 577.001(a). The
program shall:
(1) be administered by the hospital licensing program
within the department; and
(2) serve as a clearinghouse of information for
licensed mental hospitals concerning best practices and quality
improvement strategies.
(b) A licensed mental hospital shall submit an annual report
to the department, the due date to be based on the date of licensure
or relicensure of the licensed mental hospital, of the following
types of events:
(1) a medication error resulting in the unanticipated
death of a patient, or a major, permanent loss of a bodily function
by the patient, that is not related to the natural course of the
illness or underlying condition of the patient;
(2) the suicide of a patient in a setting where the
patient receives around-the-clock care;
(3) the sexual assault of a patient while the patient
is being treated or while the patient is on the premises of the
facility;
(4) a hemolytic transfusion reaction in a patient
resulting from the administration of blood or blood products having
major blood group incompatibilities; and
(5) the death or serious disability of a patient
associated with the use or function of a device in patient care in
which the device is used or functions in a manner other than that
intended.
(c) The department may not require the annual report under
Subsection (b) to include any information other than a listing of
the number of occurrences, if any, of the events listed in that
subsection.
(d) A licensed mental hospital shall conduct a root cause
analysis of an event listed in Subsection (b) following
identification of the event.
(e) Following the performance of a root cause analysis of an
event listed in Subsection (b), a licensed mental hospital shall
develop an action plan that identifies the strategies the licensed
mental hospital intends to use to reduce the risk of similar events
occurring in the future.
(f) A licensed mental hospital must conduct a root cause
analysis and complete an action plan under Subsection (e) not later
than 45 days after becoming aware of an event that must be reported
under Subsection (b).
(g) The department may review a root cause analysis and
action plan regarding an event that must be reported under
Subsection (b) during a licensure or complaint survey but may not
require that the root cause analysis or action plan be reported to
the department. The department and its employees and agents are
prohibited from removing, copying, reproducing, redacting, or
dictating from all or any part of a root cause analysis or action
plan. This prohibition applies to any form, format, or manner of
copying, reproducing, redacting, or dictating.
(h) All information and materials obtained or compiled by
the department under this section are confidential and not subject
to disclosure under Chapter 552, Government Code, and are not
subject to discovery, subpoena, or other means of legal compulsion
for release to anyone other than the department or its employees or
agents involved in the program. Information and materials obtained
or compiled by the department under this section may not be admitted
in evidence or otherwise disclosed in any civil, criminal, or
administrative proceeding.
(i) The root cause analysis and action plan compiled by a
licensed mental hospital in compliance with Subsections (d) and (e)
and all related information and materials, and the report of best
practices and safety measures described in Subsection (m) and all
related information and materials, are confidential and not subject
to disclosure under Chapter 552, Government Code, and are not
subject to discovery, subpoena, or other means of legal compulsion
for release to anyone. The root cause analysis and action plan and
all related information and materials and the report of best
practices and safety measures and all related information and
materials may not be admitted in evidence or otherwise disclosed in
any civil, criminal, or administrative proceeding. Information
reported by a licensed mental hospital and analyses, plans,
records, and reports obtained, prepared, or compiled by a licensed
mental hospital as required by this section, and all related
information and materials, are subject to an absolute privilege and
may not be used in any form against the licensed mental hospital or
its agents, employees, partners, assignees, or independent
contractors in any civil, criminal, or administrative proceeding,
regardless of the means by which the information, analyses, plans,
records, reports, or related information and materials came into
the possession of the person attempting to use them. A court shall
enforce this privilege as to all matters covered by this section.
(j) The confidentiality protections provided by Subsections
(h) and (i) apply regardless of whether the information or
materials are obtained from or compiled by a licensed mental
hospital or an entity that has an ownership or management interest
in a licensed mental hospital.
(k) The transfer of information or materials under this
section shall not be treated as a waiver of any privilege or
protection.
(l) Notwithstanding the provisions of Subsection (h), the
department shall on an annual basis compile and make publicly
available a summary of the events that were reported by licensed
mental hospitals under Subsection (b). The summary shall contain
only aggregated information and may not directly or indirectly
identify a specific licensed mental hospital or group of licensed
mental hospitals, an individual, a specific reported event, or the
circumstances or individuals surrounding or involved in a specific
reported event.
(m) A licensed mental hospital may provide to the department
a report of its best practices and safety measures that have been
effective in improving patient safety. The department may adopt
rules regarding the form and format of the report. The department
shall periodically compile a summary of the reports and make the
summary publicly available. The summary may not directly or
indirectly identify a specific licensed mental hospital or group of
licensed mental hospitals, an individual, a specific reported
event, or the circumstances surrounding or involved in a specific
reported event.
(n) The commissioner of public health shall evaluate the
program established under this section and submit the evaluation,
together with recommendations, to the legislature not later than
December 1, 2006. The evaluation shall be made in consultation with
licensed mental hospitals that are required to make a report under
Subsection (b).
(o) The evaluation under Subsection (n) shall include the
following:
(1) the degree to which the department was able to
detect statewide trends in errors based on the types and numbers of
errors reported;
(2) the extent to which the statewide summaries
required to be compiled by the department under Subsection (l) were
accessed by the public;
(3) the effectiveness of the summary of reported best
practices and safety measures in assisting licensed mental
hospitals in improving patient care; and
(4) the impact of national studies regarding the
effectiveness of state or federal systems of reporting medical
errors.
(p) In this section, "root cause analysis" means a process
for identifying basic or causal factors that underlie variation in
performance, focusing primarily on systems and processes,
progressing from special causes in clinical processes to common
causes in organizational processes, and identifying potential
improvements in processes or systems.
(q) This section, except for Subsections (h)-(k) and (p),
expires September 1, 2007.
SECTION 5. The 80th Legislature shall assess the
effectiveness of the patient safety programs developed for:
(1) hospitals, under Section 241.030, Health and
Safety Code, as added by Section 2 of this Act;
(2) licensed ambulatory surgical centers, under
Section 243.0101, Health and Safety Code, as added by Section 3 of
this Act; and
(3) licensed mental hospitals, under Section
577.0102, Health and Safety Code, as added by Section 4 of this Act.
SECTION 6. This Act takes effect immediately if it receives
a vote of two-thirds of all the members elected to each house, as
provided by Section 39, Article III, Texas Constitution. If this
Act does not receive the vote necessary for immediate effect, this
Act takes effect September 1, 2003.