Chapter 175
2008 -- S 2677
SUBSTITUTE A AS AMENDED
Enacted 07/02/08
A N A C T
RELATING
TO HEALTH AND SAFETY -- DEPARTMENT OF HEALTH
Introduced
By: Senators Perry, Goodwin, Pichardo, Miller, and Sosnowski
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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LC01643/SUB A
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