Section 1. Amend Title 16 of the
Delaware Code by adding thereto a new chapter to read:
"CHAPTER 12B. PATIENT SAFETY AND HEALTH CARE QUALITY IMPROVEMENT
ACT OF 2005
§1201B. Short title.
This
chapter may be cited as the 'Patient Safety and Health Care Quality Improvement
Act of 2005'.
§1202B. Purposes of chapter.
The
health care system must identify and learn from errors that occur so that
systems of care can be improved. The voluntary reporting system established
under this chapter supports a learning environment focused on improving patient
safety.
Many
organizations currently collecting patient safety data have expressed a need
for legal protections that will allow them to review protected information and
collaborate in the development and implementation of patient safety improvement
strategies. Delaware's
current peer review protections are inadequate to allow the sharing of
information to promote patient safety.
This chapter establishes a patient safety organization for the State,
which will encourage a culture of safety and quality within Delaware's
health care system by providing for legal protection of information reported
voluntarily for the purposes of health care quality improvement and patient
safety. This chapter also ensures
accountability by raising standards and expectations for continuous quality
improvements in patient safety and health care.
§1203B. Definitions.
(1) The
term 'non-identifiable information' means, with respect to information, that
the information is presented in a form and manner that prevents the
identification of a patient, a reporter of patient safety data, or a provider. For purposes of this definition, the term 'presented
in a form and manner that prevents the identification of a patient' means, with
respect to information that has been subject to rules promulgated pursuant to
Sec. 264(c) of the Health Insurance Portability and Accountability Act of 1996
(HIPAA) (42 U.S.C. 1320d-2), that the information has been de-identified so
that it is no longer individually identifiable health information as defined in
those rules.
(2) The
term 'patient safety organization' (PSO) means the private or public entity
that contracts with the Centers for Medicare and Medicaid services (CMS) to be
the Medicare Quality Improvement Organization (QIO), or any similarly titled
organization, for the State of Delaware.
(3) The
term 'patient safety data' means:
(A) data,
reports, records, memoranda, or analyses (such as root cause analyses)
collected, transmitted, or stored either electronically or on paper by the PSO
or provider, that could result in improved patient safety, health care quality,
or health care outcomes and are (i) collected or developed by a provider, upon
becoming aware of a patient safety incident; (ii) requested by the PSO (including
the contents of such request), if reported to the PSO within 60 days of the
provider becoming aware of a patient safety incident; (iii) reported to a
provider by the PSO (including confirmation of receipt of patient safety data
from the provider by the PSO); or (iv) collected or developed by the PSO,
whether identifiable or not; or
(B) the
work product or process related to any patient safety data described in
definition subsection (3)(A) of this section, that is generated by the PSO or
provider.
(C) If the
original material from which data, reports, records, memoranda or analyses
(such as root cause analyses) are collected is not patient safety data, the act
of such collection does not make the original material patient safety data for
purposes of this chapter.
(D) The term
'patient safety data' does not include information (including a patient's
medical record, billing and discharge information, or any other patient or
provider record) that is collected or developed separately from and that exists
separately from patient safety data. Such
separate information or a copy thereof submitted to a patient safety
organization is not considered as patient safety data. Nothing in this chapter, except for §1204B(e)(1),
may be construed to limit (i) the discovery of or admissibility of information
described in this paragraph in a criminal, civil, or administrative proceeding;
(ii) the reporting of information described in this paragraph to a federal, State,
or local governmental agency for public health surveillance, investigation, or
other public health purposes or health oversight purposes; or (iii) a provider's
recordkeeping obligation with respect to information described in this paragraph
under federal, State, or local law.
(4) The
term 'patient safety organization (PSO) activities' means the following
activities which are considered to be necessary for the proper management and
administration of a patient safety organization:
(A) The
conduct, as its primary activity, of efforts to improve patient safety and the quality
of health care delivery;
(B) The
collection and analysis of patient safety data that are submitted by more than
one provider;
(C) The
development and dissemination of information to providers with respect to
improving patient safety, such as recommendations, protocols, or information
regarding best practices;
(D) The
utilization of patient safety data for the purposes of encouraging a culture of
safety and of providing direct feedback and assistance to providers to effectively
minimize patient risk;
(E) The
maintenance of procedures to preserve confidentiality with respect to patient
safety data;
(F) The
provision of appropriate security measures with respect to patient safety data;
and
(G) The
utilization of qualified staff.
(5) The
term 'person' means an individual, or a trust, an estate, a partnership, a
corporation (including associations, joint stock companies, and insurance
companies), a state or political subdivision or instrumentality (including a
municipal corporation) of a state, or any other legal or commercial entity.
(6) The
term 'provider' means an individual or entity licensed or otherwise authorized
under State law to provide health care services, including (i) a hospital,
ambulatory surgical center, and physician or health care practitioner's office,
licensed by the state, or (ii) a physician, physician assistant, nurse
practitioner, clinical nurse specialist, certified registered nurse
anesthetist, or certified nurse midwife, licensed by the state.
§1204B. Privilege
and confidentiality protections.
(a) Notwithstanding
any other provision of federal, State, or local law, patient safety data is
privileged and, with the exception of the provisions of subsection (c)(1) of
this section, such data is not:
(1) subject
to a federal, State, or local civil, criminal, or administrative subpoena;
(2) subject
to discovery in connection with a federal, State, or local civil, criminal, or
administrative proceeding;
(3) subject
to disclosure pursuant to the Delaware
or United States Freedom of Information Acts or any other similar federal, State,
or local law;
(4) subject
to admission as evidence or other disclosure in any federal, State, or local
civil, criminal, or administrative proceeding; or
(5) subject
to use in a disciplinary proceeding against a provider.
(b) Notwithstanding
any other provision of federal, State, or local law, with the exception of the
provisions of subsections (c) and (d) of this section, patient safety data is
confidential and may not be disclosed.
(c) Nothing in this
section may be construed to prohibit the following uses or disclosures:
(1) Disclosure
by a provider or a PSO of relevant patient safety data for use in a criminal
proceeding, including but not limited to use through subpoena and discovery and
use as evidence, after a court makes an in
camera determination that the patient safety data contains evidence of a
wanton and criminal act to directly harm the patient; or
(2) Voluntary
disclosure of non-identifiable, aggregate patient safety data by a provider or
a PSO.
(3) Disclosure
of non-identifiable, aggregate patient safety data by a person that is a
provider, a PSO, or a contractor of a provider or a PSO to another person for
the purpose of carrying out PSO activities;
(4) Disclosure
of non-identifiable, aggregate patient safety data by a provider or a PSO to
grantees or contractors carrying out patient safety research, evaluation, or
demonstration projects initiated and authorized by the PSO;
(5) Disclosure
of non-identifiable, aggregate patient safety data by a provider to an
accrediting body that accredits that provider;
(6) Voluntary
disclosure of patient safety data by the PSO to the Secretary of Health and
Social Services for public health surveillance if the consent of each provider
identified in, or providing, the data is obtained prior to disclosure. Nothing in the preceding sentence may be
construed to prevent the release of patient safety data that is provided by, or
that relates solely to, a provider from whom consent is obtained because one or
more other providers do not provide consent with respect to the disclosure of
patient safety data that relates to nonconsenting providers. Consent for the future release of patient
safety data for such purposes may be requested by the PSO at the time the data
is submitted; or
(7) Voluntary
disclosure of patient safety data by a PSO to state or local government
agencies for public health surveillance if the consent of each provider identified
in, or providing, the data is obtained prior to disclosure. Nothing in the preceding sentence may be
construed to prevent the release of patient safety data that is provided by, or
that relates solely to, a provider from whom consent is obtained because one or
more other providers do not provide consent with respect to the disclosure of
patient safety data that relates to nonconsenting providers. Consent for the future release of patient
safety data for such purposes may be requested by the PSO at the time the data
is submitted.
(d) (1) Except as provided in paragraph (2) of this
subsection, patient safety data that is used or disclosed continues to be
privileged and confidential as provided for in subsections (a) and (b) of this
section, and the provisions of those subsections apply to such data in the
possession or control of a provider or PSO that possessed the data before the
use or disclosure, or of a person to whom the data was disclosed.
(2) Notwithstanding
paragraph (1) and subject to paragraph (3) of this section,
(A) if
patient safety data is used or disclosed as provided for in subsection (c)(1)
of this section, and such use or disclosure is in open court, the
confidentiality protections provided for in subsection (b) of this section do not
apply to the data; and
(B) if
patient safety data is used or disclosed as provided for in subsection (c)(2)
of this section, the privilege and confidentiality protections provided for in
subsections (a) and (b) of this section do not apply to the data.
(3) Paragraph
(2) of this subsection may not be construed as terminating or limiting the
privilege or confidentiality protections provided for in subsection (a) or (b)
of this section with respect to data other than the specific data used or
disclosed as provided for in subsection (c) of this section.
(e) (1) Except to enforce disclosures pursuant to
subsection (c)(1) of this section, no action may be brought or process served
against a patient safety organization to compel disclosure of information
collected or developed under this chapter, whether or not the information is
patient safety data, unless the information is specifically identified, is not
patient safety data, and cannot otherwise be obtained.
(2) An
accrediting body may 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 data in accordance with this
chapter. An accrediting body may not
require a provider to reveal its communications with any patient safety
organization established in accordance with this chapter.
(f) (1) A provider may not take an adverse
employment action, as described in paragraph (2) of this subsection, against an
individual based upon the fact that the individual in good faith reported
information to the provider with the intention of having the information
reported to the PSO or reported information directly to the PSO.
(2) For
purposes of this subsection, an 'adverse employment action' includes loss of the
individual's employment, failure to promote the individual, failure to provide
any other employment-related benefit for which the individual would otherwise
be eligible, or an adverse evaluation or decision made in relation to
accreditation, certification, credentialing, or licensing of the individual.
(g) (1) Except as provided in subsections (c) and
(d) of this section and as otherwise provided for in this section, it is
unlawful for a person to disclose patient safety data in violation of this chapter. A person who discloses patient safety data in
violation of this chapter is subject to a civil monetary penalty of not more
than $10,000 for each violation.
(2) The
penalty provided for under paragraph (1) of this subsection does not apply if
the defendant is sentenced under the regulations promulgated under Sec. 264(c)
of the Health Insurance Portability and Accountability Act of 1996 (42 U.S.C.
1320d-2) or under Sec. 1176 of the Social Security Act (42 U.S.C. 1320d-5) for
the same disclosure.
(3) Without
limiting remedies available to other parties, a civil action may be brought by
any aggrieved individual to enjoin any act or practice that violates subsection
(f) of this section and to obtain other appropriate equitable relief, including
reinstatement, back pay, and restoration of benefits, to redress the violation.
(4) An
entity that is the State or an agency of the State government may not assert
the privilege described in subsection (a) of this section unless before the
time of the assertion, the entity or, in the case of and with respect to an
agency, the State has consented to be subject to an action as described in this
subsection, and that consent has remained in effect.
(h) Nothing in this
section may be construed to:
(1) limit,
alter, or effect other confidentiality protections and privileges that are
available under federal, State, or local laws that provide greater
confidentiality protections and privileges than the confidentiality protections
and privileges provided for in this section;
(2) limit,
alter, or affect the requirements of federal, State, or local law pertaining to
information that is not privileged or confidential under this section;
(3) limit,
alter, or affect the implementation of any provision of Sec. 264(c) of the
Health Insurance Portability and Accountability Act of 1996 (42 U.S.C.
1320d-2), Sec. 1176 of the Social Security Act (42 U.S.C. 1320d-5), or any regulation
promulgated under these sections;
(4) limit,
alter, or affect the authority of any provider, PSO, or other person to enter
into a contract requiring greater confidentiality or a contract delegating
authority to disclose or use patient safety data in accordance with subsection
(c) of this section; or
(5) prohibit
a provider from reporting a crime to law enforcement authorities, regardless of
whether knowledge of the existence of, or the description of, the crime is
based on patient safety data, so long as the provider does not disclose or use patient
safety data in making the report.
(i) In addition to
the protections and limitations prescribed in subsections (a)-(h) of this
section, all parties and patient safety data subject to this chapter have the
immunities and protections granted in 24 Del. C. §1768.
§1205B. Interoperability of health care information
technology systems.
The technology standards used by the PSO in
the administration of patient safety data must be consistent with the standards
used by the Delaware Health Information Network if the Network is implemented
in Delaware.".
Section 2. Studies and reports.
(a)
On an annual basis the Patient Safety Organization (PSO)
shall issue a report to the legislature summarizing the data that it collected
and analyzed within the State. The
report may include only non-identifiable, aggregate patient safety data.
(b)
The PSO may issue at its discretion other reports that
relate to patient safety and that highlight either the issues which must be
addressed to increase patient safety or potential remedies to patient safety
issues, or both. The reports may include
only non-identifiable, aggregate patient safety data.
Section 3. Effective date.
This Act takes
effect on January 1 of the year immediately following the date on which the Act
is enacted into law.
