78R10536 YDB-D
By: Truitt, Capelo H.B. No. 1614
Substitute the following for H.B. No. 1614:
By: McReynolds C.S.H.B. No. 1614
A BILL TO BE ENTITLED
AN ACT
relating to the reporting of medical errors and the establishment
of a patient safety program in 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 a program
to:
(1) promote public accountability through the
detection of statewide trends in the occurrence of certain medical
errors by:
(A) requiring hospitals, ambulatory surgical
centers, and mental hospitals to report errors;
(B) providing the public with access to statewide
summaries of the reports; and
(C) requiring hospitals, ambulatory surgical
centers, and mental hospitals to implement risk-reduction
strategies; and
(2) encourage hospitals, ambulatory surgical centers,
and mental hospitals to share best practices and safety measures
that are effective in improving patient safety.
SECTION 2. Chapter 241, Health and Safety Code, is amended
by adding Subchapter H to read as follows:
SUBCHAPTER H. PATIENT SAFETY PROGRAM
Sec. 241.201. DUTIES OF DEPARTMENT. 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.
Sec. 241.202. ANNUAL REPORT. (a) 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 events during the preceding year:
(1) a medication error resulting in a patient's
unanticipated death or major permanent loss of bodily function in
circumstances unrelated to the natural course of the illness or
underlying condition of the patient;
(2) a perinatal death unrelated to a congenital
condition in an infant with a birth weight greater than 2,500 grams;
(3) the suicide of a patient in a setting in which the
patient receives care 24 hours a day;
(4) the abduction of a newborn infant patient from the
hospital or the discharge of a newborn infant patient from the
hospital 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
infant;
(5) the sexual assault of a patient during treatment
or while the patient was on the premises of the hospital or
facility;
(6) a hemolytic transfusion reaction in a patient
resulting from the administration of blood or blood products with
major blood group incompatibilities;
(7) a surgical procedure on the wrong patient or on the
wrong body part of a patient;
(8) a foreign object accidentally left in a patient
during a procedure; and
(9) a patient death or serious disability associated
with the use or function of a device designed for patient care that
is used or functions other than as intended.
(b) The department may not require the annual report to
include any information other than the number of occurrences of
each event listed in Subsection (a).
Sec. 241.203. ROOT CAUSE ANALYSIS AND ACTION PLAN. (a) In
this section, "root cause analysis" means the process of
identifying basic or causal factors underlying a variation in
performance that leads to an event listed in Section 241.202 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) Not later than the 45th day after the date a hospital
becomes aware of the occurrence of an event listed in Section
241.202, 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.
(c) The department may review a root cause analysis or
action plan related to an event listed in Section 241.202 during a
survey, inspection, or investigation of a hospital.
(d) The department may not require a root cause analysis or
action plan to be submitted to the department.
(e) The department or an employee or agent of the department
in any form, format, or manner may not remove, copy, reproduce,
redact, or dictate from any part of a root cause analysis or action
plan.
Sec. 241.204. CONFIDENTIALITY; ABSOLUTE PRIVILEGE. (a)
Except as provided by Sections 241.205 and 241.206, 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
241.203(c); 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) This section does not prohibit access to the patient's
medical records to the extent authorized by law by the patient or
the patient's legally authorized representative.
Sec. 241.205. ANNUAL DEPARTMENT SUMMARY. The department
annually shall compile and make available to the public a summary of
the events reported by hospitals as required by Section 241.202.
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 event or the circumstances or
individuals surrounding the event.
Sec. 241.206. BEST PRACTICES REPORT AND DEPARTMENT SUMMARY.
(a) A hospital shall provide to the department at least one report
of the best practices and safety measures related to a reported
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) compile a summary of best practices reports; and
(2) 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. 241.207. PROHIBITION. The hospital annual report,
the department summary, or the best practices report may not
distinguish between an event that occurred at an outpatient
facility owned or operated by the hospital and an event that
occurred at a hospital facility.
Sec. 241.208. REPORT TO LEGISLATURE. (a) Not later than
December 1, 2006, the commissioner of public health 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 public health 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. 241.209. 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.
Sec. 241.210. EXPIRATION. Unless continued in existence,
this subchapter expires September 1, 2007.
SECTION 3. Sections 243.001 through 243.016, Health and
Safety Code, are designated as Subchapter A, Chapter 243, Health
and Safety Code, and a heading to Subchapter A is added to read as
follows:
SUBCHAPTER A. GENERAL PROVISIONS; LICENSING AND PENALTIES
SECTION 4. Chapter 243, Health and Safety Code, is amended
by adding Subchapter B to read as follows:
SUBCHAPTER B. PATIENT SAFETY PROGRAM
Sec. 243.051. 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. 243.052. ANNUAL REPORT. (a) 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 events during the
preceding year:
(1) a medication error resulting in a patient's
unanticipated death or major permanent loss of bodily function in
circumstances unrelated to the natural course of the illness or
underlying condition of the patient;
(2) the suicide of a patient;
(3) the sexual assault of a patient during treatment
or while the patient was on the premises of the center or facility;
(4) a hemolytic transfusion reaction in a patient
resulting from the administration of blood or blood products with
major blood group incompatibilities;
(5) a surgical procedure on the wrong patient or on the
wrong body part of a patient;
(6) a foreign object accidentally left in a patient
during a procedure; and
(7) a patient death or serious disability associated
with the use or function of a device designed for patient care that
is used or functions other than as intended.
(b) The department may not require the annual report to
include any information other than the number of occurrences of
each event listed in Subsection (a).
Sec. 243.053. ROOT CAUSE ANALYSIS AND ACTION PLAN. (a) In
this section, "root cause analysis" means the process of
identifying basic or causal factors underlying a variation in
performance that leads to an event listed in Section 243.052 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) Not later than the 45th day after an ambulatory surgical
center becomes aware of the occurrence of an event listed in Section
243.052, 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.
(c) The department may review a root cause analysis or
action plan related to an event listed in Section 243.052 during a
survey, inspection, or investigation of an ambulatory surgical
center.
(d) The department may not require a root cause analysis or
action plan to be submitted to the department.
(e) 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. 243.054. CONFIDENTIALITY; ABSOLUTE PRIVILEGE. (a)
Except as provided by Sections 243.055 and 243.056, 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
243.053(c); 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) This section does not prohibit access to the patient's
medical records to the extent authorized by law by the patient or
the patient's legally authorized representative.
Sec. 243.055. ANNUAL DEPARTMENT SUMMARY. The department
annually shall compile and make available to the public a summary of
the events reported by ambulatory surgical centers as required by
Section 243.052. 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 event or the circumstances or
individuals surrounding the event.
Sec. 243.056. BEST PRACTICES REPORT AND DEPARTMENT SUMMARY.
(a) An ambulatory surgical center shall provide to the department
at least one report of best practices and safety measures related to
a reported 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) compile a summary of best practices reports; and
(2) 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. 243.057. PROHIBITION. The annual report of an
ambulatory surgical center, the department summary, or the best
practices report may not distinguish between an event that occurred
at an outpatient facility owned or operated by the center and an
event that occurred at a center facility.
Sec. 243.058. REPORT TO LEGISLATURE. (a) Not later than
December 1, 2006, the commissioner of public health 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 public health 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. 243.059. 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.
Sec. 243.060. EXPIRATION. Unless continued in existence,
this subchapter expires September 1, 2007.
SECTION 5. Sections 577.001 through 577.019, Health and
Safety Code, are designated as Subchapter A, Chapter 577, Health
and Safety Code, and a heading to Subchapter A is added to read as
follows:
SUBCHAPTER A. GENERAL PROVISIONS; LICENSING AND PENALTIES
SECTION 6. Chapter 577, Health and Safety Code, is amended
by adding Subchapter B to read as follows:
SUBCHAPTER B. PATIENT SAFETY PROGRAM
Sec. 577.051. DUTIES OF DEPARTMENT. The department shall
develop a patient safety program for mental hospitals licensed
under Section 577.001(a). The program must:
(1) be administered by the licensing program within
the department; and
(2) serve as an information clearinghouse for
hospitals concerning best practices and quality improvement
strategies.
Sec. 577.052. ANNUAL REPORT. (a) On renewal of a license
under this chapter, a mental 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 events during the preceding year:
(1) a medication error resulting in a patient's
unanticipated death or major permanent loss of bodily function in
circumstances unrelated to the natural course of the illness or
underlying condition of the patient;
(2) the suicide of a patient in a setting in which the
patient receives care 24 hours a day;
(3) the sexual assault of a patient during treatment
or while the patient was on the premises of the hospital or
facility;
(4) a hemolytic transfusion reaction in a patient
resulting from the administration of blood or blood products with
major blood group incompatibilities; and
(5) a patient death or serious disability associated
with the use or function of a device designed for patient care that
is used or functions other than as intended.
(b) The department may not require the annual report to
include any information other than the number of occurrences of
each event listed in Subsection (a).
Sec. 577.053. ROOT CAUSE ANALYSIS AND ACTION PLAN. (a) In
this section, "root cause analysis" means the process of
identifying basic or causal factors underlying a variation in
performance that leads to an event listed in Section 577.052 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) Not later than the 45th day after the date a mental
hospital becomes aware of an event listed in Section 577.052, 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.
(c) The department may review a root cause analysis or
action plan related to an event listed in Section 577.052(a) during
a survey, inspection, or investigation of a mental hospital.
(d) The department may not require a root cause analysis or
action plan to be submitted to the department.
(e) 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 all or any part of a root cause analysis or
action plan.
Sec. 577.054. CONFIDENTIALITY; ABSOLUTE PRIVILEGE. (a)
Except as provided by Sections 577.055 and 577.056, all information
and materials obtained or compiled by the department under this
subchapter or compiled by a mental hospital under this subchapter,
including the root cause analysis, annual report of the hospital,
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
577.053(c); 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 mental 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 mental 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) This section does not prohibit access to the patient's
medical records to the extent authorized by law by the patient or
the patient's legally authorized representative.
Sec. 577.055. ANNUAL DEPARTMENT SUMMARY. The department
annually shall compile and make available to the public a summary of
the events reported by mental hospitals as required by Section
577.052. The summary may contain only aggregated information and
may not directly or indirectly identify:
(1) a specific mental hospital or group of hospitals;
(2) an individual; or
(3) a specific reported event or the circumstances or
individuals surrounding the event.
Sec. 577.056. BEST PRACTICES REPORT AND DEPARTMENT SUMMARY.
(a) A mental hospital shall provide to the department at least one
report of best practices and safety measures related to a reported
event.
(b) A mental hospital may provide to the department a report
of other best practices and the safety measures 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 mental hospital to a
patient safety organization.
(d) The department periodically shall:
(1) compile a summary of best practices reports; and
(2) make the summary available to the public.
(e) The summary may not directly or indirectly identify:
(1) a specific mental hospital or group of hospitals;
(2) an individual; or
(3) a specific reported event or the circumstances or
individuals surrounding the event.
Sec. 577.057. PROHIBITION. The annual report of a mental
hospital, the department summary, or the best practices report may
not distinguish between an event that occurred at an outpatient
facility owned or operated by the hospital and an event that
occurred at a hospital facility.
Sec. 577.058. REPORT TO LEGISLATURE. (a) Not later than
December 1, 2006, the commissioner of public health 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 public health shall conduct the
evaluation in consultation with mental 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. 577.059. 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.
Sec. 577.060. EXPIRATION. Unless continued in existence,
this subchapter expires September 1, 2007.
SECTION 7. (a) Not later than January 1, 2004, the Texas
Department of Health, 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, under Subchapter B, Chapter 243, Health and Safety Code,
as added by this Act, and under Subchapter B, Chapter 577, Health
and Safety Code, as added by this Act.
(b) Beginning July 1, 2004, a hospital, ambulatory surgical
center, or mental hospital on renewal of a license under Chapter 241
or 243 or Section 577.001(a), Health and Safety Code, shall submit
the annual report required by Section 241.202, 243.052, or 577.052,
Health and Safety Code, as added by this Act.
SECTION 8. The expiration of Subchapter H, Chapter 241,
Health and Safety Code, as added by this Act, Subchapter B, Chapter
243, Health and Safety Code, as added by this Act, and Subchapter B,
Chapter 577, Health and Safety Code, as added by this Act, in
accordance with Sections 241.209, 243.060, and 577.060, Health and
Safety Code, as added by this Act, does not affect the
confidentiality of and privilege applicable to information and
materials or the authorized disclosure of summary reports of that
information and materials under Sections 241.204, 241.205,
241.206, 241.207, 243.054, 243.055, 243.056, 243.058, 577.054,
577.055, 577.056, and 577.058, Health and Safety Code, as added by
this Act, and these laws are continued in effect for this purpose.
SECTION 9. 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.