Chapter
157
2008 -- H 7561 SUBSTITUTE B
Enacted 07/01/08
A N A C T
RELATING TO HEALTH
AND SAFETY -- DEPARTMENT OF HEALTH
Introduced By: Representatives McNamara, Mumford, Corvese, and Kilmartin
Date Introduced: February
26, 2008
It is enacted by the General Assembly as follows:
SECTION
1. Title 23 of the General Laws entitled "HEALTH AND SAFETY" is
hereby
amended
by adding thereto the following chapter:
CHAPTER 17.21
THE RHODE ISLAND PATIENT SAFETY ACT OF 2008
23-17.21-1.
Title. – This act shall be known and may be cited as "The Rhode
Island
Patient
Safety Act of 2008."
23-17.21-2.
Legislative findings. – The general assembly finds:
(a)
There are an unacceptable high number of preventable patient safety events in
the
health
care system;
(b)
Current solutions that focus on reporting, discipline and retraining of
individuals have
proven
inadequate alone to address this systemic problem.
23-17.21-3.
Legislative purpose and intent. – The general assembly proposes a
Rhode
Island
patient safety organization that:
(a)
Works with hospitals, nursing facilities, and freestanding ambulatory surgical
centers
for
both the reporting of patient safety events including situations in which a
patient safety event
was
averted (near misses) and evaluating the root causes of the patient safety
event;
(b)
Recommends to health care providers changes to improve their patient safety
through
investigating
system causes related to the patient safety events and, on at least an annual
basis, to
the
department for statewide changes and policies that will advance patient safety
and quality
improvement;
(c)
Facilitates the creation and maintenance of a non-identifiable patient safety
database.
The
database shall have the capacity to accept, aggregate, and analyze
non-identifiable patient
safety
work product and data reported by entities and provide this to the national
network of
patient
safety databases.
23-17.21-4
Definitions. – For the purposes of this chapter, the following terms
shall have
the
following meanings:
(a)
"Department" means the Rhode Island department of health.
(b)
"Director" means the director of the Rhode Island department of
health.
(c)
"Health care facility" means any corporation, limited liability
company, facility, or
institution
licensed by this state to provide health care or professional services, or an
officer,
employee
or agent thereof acting in the course and scope of his or her employment.
(d)
"Near misses" means circumstances in which a patient safety event is
narrowly
averted.
(e)
"Patient safety activities" means: (1) efforts to improve patient
safety and the quality
of
health care delivery; (2) the collection and analysis of patient safety work
product; (3) the
development
and dissemination of information with respect to improving patient safety, such
as
recommendations,
protocols, or information regarding best practices; (4) the utilization of
patient
safety
work product for the purposes of encouraging a culture of safety and of
providing feedback
and
assistance to effectively minimize patient risk; (5) the maintenance of
procedures to preserve
confidentiality
with respect to patient safety work product; and (6) the provision of
appropriate
security
measures with respect to patient safety work product.
(f)
"Patient safety event" means those events as defined by the national
quality forum,
institute
of medicine, center for Medicare and Medicaid Services (CMS), and as further
defined
by
the quality of care advisory committee, as established herein, and shall
include near misses.
(g)
"Patient safety organization (PSO)" means any public or private
organization certified
by
the director, or component of any such organization, whose activity is to
improve patient
safety
and the quality of health care delivery for patients receiving care through the
collection,
aggregation,
analysis, investigation, and/or processing of medical or health care related
information
submitted to it by reporting entities. A PSO shall not mean any agency or
public
body
as defined in subsection 38-2-2(i).
(h)
"Patient safety work product" means all reports, records, memoranda,
analyses,
statements,
root cause analyses, or written or oral statements, that: (1) a health care
facility or
provider
prepares for the purpose of disclosing a patient safety event, or is disclosed,
to a patient
safety
organization; (2) is received from a reporting entity, or is created or analyzed
by a patient
safety
organization; or (3) directly or indirectly contains deliberations, analytical
process,
recommendations,
conclusions, or other communications of a patient safety organization or
between
a patient safety organization and health care providers or facilities.
(i)
"Identifiable patient safety work product" means patient safety work
product that: (1)
is
presented in a form and manner that allows the identification of any provider
or reporting entity
that
is a subject of the work product, or any providers or reporting entities that
participate in
activities
that are a subject of the work product; (2) constitutes individually
identifiable health
information
as that term is defined in the Health Insurance Portability and Accountability
Act of
1996
and its implementing regulations (45 C.F.R. Parts 160-164); or (3) is presented
in a form
and
manner that allows the identification of an individual.
(j)
"Nonidentifiable patient safety work product" means patient safety work
product that
is
not identifiable patient safety work product as defined in subsection (h)
herein.
(k)
"Reporting entities" means all hospitals, nursing facilities, and
freestanding
ambulatory
surgical centers licensed under chapter 23-17.
23-17.21-5.
Powers and duties of the department. – The powers necessary to carry
out
the
duties of this chapter shall be vested in the director and are as follows:
(a)
The director shall certify a patient safety organization that has met the
following
criteria:
(1)
has a mission statement with one of its purposes to conduct activities to
improve
patient
safety;
(2)
has qualified staff and professionals capable of reviewing and producing
patient
safety
work product and recommendations for system changes;
(3)
is not a component of a health insurer or other entity that provides health
insurance to
individuals
or group health plans; and
(4)
has a mission that does not create a conflict of interest with the health care
providers
who
will submit patient safety work product to it.
(b)
The director shall establish a quality of care advisory committee that shall
advise the
department
on PSO related issues. The advisory committee shall consist of fourteen (14)
members
who are appointed by the director and shall include no less than three (3)
representatives
of the hospital community; three (3) representatives of the nursing
facility/long
term
care community; three (3) members of the freestanding ambulatory surgical
center
community;
and five (5) others from the community as determined by the director. The term
of
office
shall be for three (3) years. No member shall serve more than two (2)
consecutive terms.
The
committee shall advise the department on effective methods for sharing with
health care
providers
the quality improvement information learned from the department's review of
reports
and
corrective action plans, including quality improvement practices, patient
safety issues, and
preventative
strategies.
(c)
The director may promulgate rules and regulations in order to carry out the
provisions
of
this chapter.
23-17.21-6
Requirements for reporting entities. – (a) Each reporting entity may
enter
into a
written contract with a certified PSO in accordance with the requirements of
this chapter.
(b)
Beginning January 1, 2009, a reporting entity may enter into a written contract
with a
patient
safety organization to which it sends patient safety work product. Each
contract shall
require
the reporting entity to maintain a document log itemizing the types of
documents
submitted
to the PSO without indicating the content of such documents. Such document log
shall
be
accessible to the department for the sole purpose of allowing the department to
verify the type
of
information submitted to PSOs. The department shall not have access to patient
safety work
product.
Such document log shall not be subject to a disclosure to, or use by, any
person or entity,
other
than the PSO and the reporting entity with which it has contracted, and by the
department
for
the sole purpose provided in this subsection.
(c)
Reporting entities shall not be exempt from the requirements of section
23-17-40 or
section
5-37-9.
(d)
Patient safety work product (whether identifiable of nonidentifiable) and any
document
log submitted to the director under subsection (a) shall not be a public record
for the
purposes
of chapter 38-2. Reporting entities shall not be considered a public body or
agency for
the
purposes of chapter 38-2.
23-17.21-7
Requirements for patient safety organizations – (a) PSO shall be
certified
by
the department before entering into a contract with a reporting entity.
(b)
A PSO shall provide guidance to reporting entities on reporting matters, and
shall
maintain
all reports and associated documents as confidential and privileged, including
any
reports
or information with identifiable information.
(c)
A PSO shall, as appropriate, disseminate to health care providers and
facilities, the
department,
the quality of care advisory committee, and the public, information or
recommendations,
including suggested policies, procedures or protocols, on best medical
practices
or potential system changes designed to improve patient safety and the overall
quality of
care.
Notwithstanding the foregoing, the PSO shall not disclose identifiable patient
safety work
product
to the department, the quality of care advisory committee, or the public.
(d)
A PSO shall have in place appropriate safeguards and security measures to
ensure the
technical
integrity, physical safety, and confidentiality of any patient safety work
product. As
provided
for in section 23-17.21-8, patient safety work product shall be confidential,
and shall not
be
subject to any discovery, access or use by any person or entity other than the
PSO and the
reporting
entity with which the PSO has contracted. Nothing in this chapter shall be
construed to
prohibit
a PSO from choosing to disclose patient safety work product, or portions of
patient safety
work
product solely to a reporting entity, in conformity with the PSO's mission and
within its
contractual
obligations to the reporting entity submitted the information. No patient safety
organization
may release protected health information or patient identifying information
without
meeting
the requirements of state laws and the federal Health Insurance Portability and
Accountability
Act of 1996 as amended from time to time.
(e)
The PSO shall adopt appropriate physical, technical and procedural safeguards
to
ensure
the privacy and security of the patient safety work product. Such safeguards
shall comply
with
the state and federal confidentiality laws including, without limitation, the
Health Insurance
Portability
and Accountability Act of 1996 and its implementing regulations (45 C.F.R.
Parts
160-164).
23-17.21-8
Privilege and confidentiality protections – (a) Privilege.
Notwithstanding
any
other provision of federal, state, or local law to the contrary, and subject to
subsection (c)
herein,
patient safety work product and a document log shall be privileged and shall
not be: (1)
subject
to a federal, state, or local civil, criminal, or administrative subpoena or order,
including
in a
federal, state, or local civil or administrative disciplinary proceeding
against a provider; (2)
subject
to discovery in connection with a federal, state, or local civil, criminal, or
administrative
proceeding,
including in a federal, state, or local civil or administrative disciplinary
proceeding
against
a provider; (3) subject to disclosure pursuant to section 552 of title 5,
United States Code
(commonly
known as the Freedom of Information Act), Title 38, chapter 2 of the general
laws
(commonly
known as the Access to Public Records Law), or any other similar federal,
state, or
local
law; (4) admitted as evidence in any federal, state, or local governmental
civil proceeding,
criminal
proceeding, administrative rulemaking proceeding, or administrative
adjudicatory
proceeding,
including any such proceeding against a provider; or (5) admitted in a
professional
disciplinary
proceeding of a professional disciplinary body established or specifically
authorized
under
state law.
(b)
Confidentiality of patient safety – work product and document log –
notwithstanding
any
other provision of federal, state or local law to the contrary, and subject to
subsection (c)
herein,
the patient safety work product and document log shall be confidential and
shall not be
disclosed.
(c)
Exceptions.
(1)
Exceptions from privilege and confidentiality. Subsections (a) and (b) herein
shall not
apply
to, and shall not be construed to prohibit, one or more of the following
disclosures:
(A)
Disclosure of relevant patient safety work product and document log for use in
a
criminal
proceeding, but only after a court makes an in camera determination that such
patient
safety
work product and document log contains evidence of a criminal act and that such
patient
safety
work product and document log is material to the proceeding and not reasonably
available
from
any other source; or
(B)
Disclosure of identifiable patient safety work product and document log if
authorized
by
each provider or reporting entity identified in such work product.
(2)
Exceptions from confidentiality – subsection (b) herein shall not apply to, and
shall
not
be construed to prohibit one or more of the following voluntary disclosures:
(A)
Disclosure of patient safety work product and document log to a reporting
entity to
carry
out patient safety activities;
(B)
Disclosure of patient safety work product and document log to grantees,
contractors,
or
other entities carrying out research, evaluation, or demonstration projects
authorized, funded,
certified,
or otherwise sanctioned by rule or other means by the director, for the purpose
of
conducting
research to the extent that disclosure of protected health information would be
allowed
for such purpose under the Health Insurance Portability and Accountability Act
of 1996,
and
its implementing regulations (45 C.F.R. Parts 160-164);
(C)
Disclosure by a provider to the Food and Drug Administration with respect to a
product
or activity regulated by the Food and Drug Administration;
(D)
Voluntary disclosure of patient safety work product and document log by a
provider
to an
accrediting body that accredits that provider; or
(E)
Disclosure of patient safety work product and document log to law enforcement
authorities
relating to the commission of a crime, or to an event reasonably believed to be
a
crime,
if the person making the disclosure believes, reasonably under the
circumstances, that the
patient
safety work product and document log that is disclosed is necessary for
criminal law
enforcement
purposes.
(d)
Continued protection of information after disclosure.
(1)
In general. Patient safety work product and/or document log that is disclosed
under
subsection
(c) herein shall continue to be privileged and confidential as provided for in
subsections
(a) and (b) herein, and such disclosure shall not be treated as a waiver of
privilege or
confidentiality,
and the privileged and confidential nature of such work product and/or document
log
shall also apply to such work product and/or document log in the possession or
control of a
person
to whom such work product and log was disclosed.
(2)
Exception. Notwithstanding subsection (1) herein and subject to subsection (3)
herein,
if
patient safety work product and/or document log is admitted into evidence in a
criminal
proceeding,
the confidentiality protections provided for in subsection (b) herein shall no
longer
apply
to the work product and/or log so disclosed; and
(3)
Construction. Subsection (2) herein shall not be construed as terminating or
limiting
the
privilege or confidentiality protections provided for in subsections (a) or (b)
herein with
respect
to patient safety work product and document log other than the specific patient
safety
work
product and document log disclosed as provided for in subsection (c) herein.
(4)
Limitations on actions.
(A)
Patient safety organizations.
(i)
In general. A patient safety organization shall not be compelled to disclose
information
collected or developed under this part whether or not such information is
patient
safety
work product and/or a document log unless such information is identified, it is
not patient
safety
work product and/or a document log, and it is not reasonably available from
another
source.
(ii)
Nonapplication. The limitation contained in clause (i) herein shall not apply
in an
action
against a patient safety organization or with respect to disclosures pursuant
to subsection
(c)(1)
herein.
(B)
Providers. An accrediting body shall not take an accrediting action against a
provider
based
on the good faith participation of the provider in the collection, development,
reporting, or
maintenance
of patient safety work product and a document log in accordance with this part.
An
accrediting
body may not require a provider or reporting entity to reveal its
communications with
any
patient safety organization established in accordance with this part.
(e)
Reporter protection.
(1)
In general. A provider may not take any adverse employment action, as described
in
subsection
(2) herein, against an individual based upon the fact that the individual, in
good faith,
reported
the information:
(A)
to the provider with the intention of having the information reported to a
patient
safety
organization; or
(B)
directly to a patient safety organization.
(2)
Adverse employment action. For the purposes of this subsection, an adverse
employment
action includes:
(A)
loss of employment, the failure to promote an individual, or the failure to
provide any
other
employment related benefit for which the individual would otherwise be
eligible; or
(B)
an adverse evaluation or decision made in relation to accreditation,
certification,
credentialing,
or licensing of the individual.
(f)
Enforcement.
(1)
Civil monetary penalty. Subject to subsection (3) herein, a person who
discloses
identifiable
patient safety work product and/or document log in a knowing or reckless
violation of
subsection
(b) herein shall be subject to a civil monetary penalty of not more than ten
thousand
dollars
($10,000) for each act constituting such violation.
(2)
Relation to Health Insurance Portability and Accountability Act of 1996.
Penalties
shall
not be imposed both under this subsection and under the regulations issued
pursuant to
section
264(c)(1) of the Health Insurance Portability and Accountability Act of 1996
(42 U.S.C.
1320d-2
note) for a single act or omission.
23-17.21-9
Severability – If any provision of this chapter, or the application
thereof to
any
person or circumstances shall be held invalid, any invalidity shall not affect
the provisions or
application
of this chapter which can be given effect without the invalid provision or
application,
and
to this end the provisions of the chapter are declared to be severable.
SECTION
2. This act shall take effect upon passage.
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LC01606/SUB B
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