[Congressional Bills 109th Congress]
[From the U.S. Government Publishing Office]
[S. 544 Enrolled Bill (ENR)]
S.544
One Hundred Ninth Congress
of the
United States of America
AT THE FIRST SESSION
Begun and held at the City of Washington on Tuesday,
the fourth day of January, two thousand and five
An Act
To amend title IX of the Public Health Service Act to provide for the
improvement of patient safety and to reduce the incidence of events that
adversely effect patient safety.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE; TABLE OF CONTENTS.
(a) Short Title.--This Act may be cited as the ``Patient Safety and
Quality Improvement Act of 2005''.
(b) Table of Contents.--The table of contents for this Act is as
follows:
Sec. 1. Short title; table of contents.
Sec. 2. Amendments to Public Health Service Act.
``Part C--Patient Safety Improvement
``Sec. 921. Definitions.
``Sec. 922. Privilege and confidentiality protections.
``Sec. 923. Network of patient safety databases.
``Sec. 924. Patient safety organization certification and listing.
``Sec. 925. Technical assistance.
``Sec. 926. Severability.
SEC. 2. AMENDMENTS TO PUBLIC HEALTH SERVICE ACT.
(a) In General.--Title IX of the Public Health Service Act (42
U.S.C. 299 et seq.) is amended--
(1) in section 912(c), by inserting ``, in accordance with part
C,'' after ``The Director shall'';
(2) by redesignating part C as part D;
(3) by redesignating sections 921 through 928, as sections 931
through 938, respectively;
(4) in section 938(1) (as so redesignated), by striking ``921''
and inserting ``931''; and
(5) by inserting after part B the following:
``PART C--PATIENT SAFETY IMPROVEMENT
``SEC. 921. DEFINITIONS.
``In this part:
``(1) HIPAA confidentiality regulations.--The term `HIPAA
confidentiality regulations' means regulations promulgated under
section 264(c) of the Health Insurance Portability and
Accountability Act of 1996 (Public Law 104-191; 110 Stat. 2033).
``(2) Identifiable patient safety work product.--The term
`identifiable patient safety work product' means patient safety
work product that--
``(A) is presented in a form and manner that allows the
identification of any provider that is a subject of the work
product, or any providers that participate in activities that
are a subject of the work product;
``(B) constitutes individually identifiable health
information as that term is defined in the HIPAA
confidentiality regulations; or
``(C) is presented in a form and manner that allows the
identification of an individual who reported information in the
manner specified in section 922(e).
``(3) Nonidentifiable patient safety work product.--The term
`nonidentifiable patient safety work product' means patient safety
work product that is not identifiable patient safety work product
(as defined in paragraph (2)).
``(4) Patient safety organization.--The term `patient safety
organization' means a private or public entity or component thereof
that is listed by the Secretary pursuant to section 924(d).
``(5) Patient safety activities.--The term `patient safety
activities' means the following activities:
``(A) Efforts to improve patient safety and the quality of
health care delivery.
``(B) The collection and analysis of patient safety work
product.
``(C) The development and dissemination of information with
respect to improving patient safety, such as recommendations,
protocols, or information regarding best practices.
``(D) 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.
``(E) The maintenance of procedures to preserve
confidentiality with respect to patient safety work product.
``(F) The provision of appropriate security measures with
respect to patient safety work product.
``(G) The utilization of qualified staff.
``(H) Activities related to the operation of a patient
safety evaluation system and to the provision of feedback to
participants in a patient safety evaluation system.
``(6) Patient safety evaluation system.--The term `patient
safety evaluation system' means the collection, management, or
analysis of information for reporting to or by a patient safety
organization.
``(7) Patient safety work product.--
``(A) In general.--Except as provided in subparagraph (B),
the term `patient safety work product' means any data, reports,
records, memoranda, analyses (such as root cause analyses), or
written or oral statements--
``(i) which--
``(I) are assembled or developed by a provider for
reporting to a patient safety organization and are
reported to a patient safety organization; or
``(II) are developed by a patient safety
organization for the conduct of patient safety
activities;
and which could result in improved patient safety, health
care quality, or health care outcomes; or
``(ii) which identify or constitute the deliberations
or analysis of, or identify the fact of reporting pursuant
to, a patient safety evaluation system.
``(B) Clarification.--
``(i) Information described in subparagraph (A) does
not include a patient's medical record, billing and
discharge information, or any other original patient or
provider record.
``(ii) Information described in subparagraph (A) does
not include information that is collected, maintained, or
developed separately, or exists separately, from a patient
safety evaluation system. Such separate information or a
copy thereof reported to a patient safety organization
shall not by reason of its reporting be considered patient
safety work product.
``(iii) Nothing in this part shall be construed to
limit--
``(I) the discovery of or admissibility of
information described in this subparagraph in a
criminal, civil, or administrative proceeding;
``(II) the reporting of information described in
this subparagraph 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 subparagraph
under Federal, State, or local law.
``(8) Provider.--The term `provider' means--
``(A) an individual or entity licensed or otherwise
authorized under State law to provide health care services,
including--
``(i) a hospital, nursing facility, comprehensive
outpatient rehabilitation facility, home health agency,
hospice program, renal dialysis facility, ambulatory
surgical center, pharmacy, physician or health care
practitioner's office, long term care facility, behavior
health residential treatment facility, clinical laboratory,
or health center; or
``(ii) a physician, physician assistant, nurse
practitioner, clinical nurse specialist, certified
registered nurse anesthetist, certified nurse midwife,
psychologist, certified social worker, registered dietitian
or nutrition professional, physical or occupational
therapist, pharmacist, or other individual health care
practitioner; or
``(B) any other individual or entity specified in
regulations promulgated by the Secretary.
``SEC. 922. PRIVILEGE AND CONFIDENTIALITY PROTECTIONS.
``(a) Privilege.--Notwithstanding any other provision of Federal,
State, or local law, and subject to subsection (c), patient safety work
product 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) 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.--
Notwithstanding any other provision of Federal, State, or local law,
and subject to subsection (c), patient safety work product shall be
confidential and shall not be disclosed.
``(c) Exceptions.--Except as provided in subsection (g)(3)--
``(1) Exceptions from privilege and confidentiality.--
Subsections (a) and (b) 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
for use in a criminal proceeding, but only after a court makes
an in camera determination that such patient safety work
product contains evidence of a criminal act and that such
patient safety work product is material to the proceeding and
not reasonably available from any other source.
``(B) Disclosure of patient safety work product to the
extent required to carry out subsection (f)(4)(A).
``(C) Disclosure of identifiable patient safety work
product if authorized by each provider identified in such work
product.
``(2) Exceptions from confidentiality.--Subsection (b) shall
not apply to (and shall not be construed to prohibit) one or more
of the following disclosures:
``(A) Disclosure of patient safety work product to carry
out patient safety activities.
``(B) Disclosure of nonidentifiable patient safety work
product.
``(C) Disclosure of patient safety work product 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 Secretary, for the purpose of conducting research to the
extent that disclosure of protected health information would be
allowed for such purpose under the HIPAA confidentiality
regulations.
``(D) Disclosure by a provider to the Food and Drug
Administration with respect to a product or activity regulated
by the Food and Drug Administration.
``(E) Voluntary disclosure of patient safety work product
by a provider to an accrediting body that accredits that
provider.
``(F) Disclosures that the Secretary may determine, by rule
or other means, are necessary for business operations and are
consistent with the goals of this part.
``(G) Disclosure of patient safety work product 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 that is
disclosed is necessary for criminal law enforcement purposes.
``(H) With respect to a person other than a patient safety
organization, the disclosure of patient safety work product
that does not include materials that--
``(i) assess the quality of care of an identifiable
provider; or
``(ii) describe or pertain to one or more actions or
failures to act by an identifiable provider.
``(3) Exception from privilege.--Subsection (a) shall not apply
to (and shall not be construed to prohibit) voluntary disclosure of
nonidentifiable patient safety work product.
``(d) Continued Protection of Information After Disclosure.--
``(1) In general.--Patient safety work product that is
disclosed under subsection (c) shall continue to be privileged and
confidential as provided for in subsections (a) and (b), and such
disclosure shall not be treated as a waiver of privilege or
confidentiality, and the privileged and confidential nature of such
work product shall also apply to such work product in the
possession or control of a person to whom such work product was
disclosed.
``(2) Exception.--Notwithstanding paragraph (1), and subject to
paragraph (3)--
``(A) if patient safety work product is disclosed in a
criminal proceeding, the confidentiality protections provided
for in subsection (b) shall no longer apply to the work product
so disclosed; and
``(B) if patient safety work product is disclosed as
provided for in subsection (c)(2)(B) (relating to disclosure of
nonidentifiable patient safety work product), the privilege and
confidentiality protections provided for in subsections (a) and
(b) shall no longer apply to such work product.
``(3) Construction.--Paragraph (2) shall not be construed as
terminating or limiting the privilege or confidentiality
protections provided for in subsection (a) or (b) with respect to
patient safety work product other than the specific patient safety
work product disclosed as provided for in subsection (c).
``(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 unless such information is
identified, is not patient safety work product, and is not
reasonably available from another source.
``(ii) Nonapplication.--The limitation contained in
clause (i) shall not apply in an action against a patient
safety organization or with respect to disclosures pursuant
to subsection (c)(1).
``(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 in
accordance with this part. An accrediting body may not require a
provider 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 an adverse
employment action, as described in paragraph (2), against an
individual based upon the fact that the individual in good faith
reported 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 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 paragraphs (2) and
(3), a person who discloses identifiable patient safety work
product in knowing or reckless violation of subsection (b) shall be
subject to a civil monetary penalty of not more than $10,000 for
each act constituting such violation.
``(2) Procedure.--The provisions of section 1128A of the Social
Security Act, other than subsections (a) and (b) and the first
sentence of subsection (c)(1), shall apply to civil money penalties
under this subsection in the same manner as such provisions apply
to a penalty or proceeding under section 1128A of the Social
Security Act.
``(3) Relation to hipaa.--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.
``(4) Equitable relief.--
``(A) In general.--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 (e) and to obtain other appropriate equitable relief
(including reinstatement, back pay, and restoration of
benefits) to redress such violation.
``(B) Against state employees.--An entity that is a State
or an agency of a State government may not assert the privilege
described in subsection (a) 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
described in subparagraph (A), and that consent has remained in
effect.
``(g) Rule of Construction.--Nothing in this section shall be
construed--
``(1) to limit the application of other Federal, State, or
local laws that provide greater privilege or confidentiality
protections than the privilege and confidentiality protections
provided for in this section;
``(2) to 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) except as provided in subsection (i), to alter or affect
the implementation of any provision of the HIPAA confidentiality
regulations or section 1176 of the Social Security Act (or
regulations promulgated under such section);
``(4) to limit the authority of any provider, patient safety
organization, or other entity to enter into a contract requiring
greater confidentiality or delegating authority to make a
disclosure or use in accordance with this section;
``(5) as preempting or otherwise affecting any State law
requiring a provider to report information that is not patient
safety work product; or
``(6) to limit, alter, or affect any requirement for reporting
to the Food and Drug Administration information regarding the
safety of a product or activity regulated by the Food and Drug
Administration.
``(h) Clarification.--Nothing in this part prohibits any person
from conducting additional analysis for any purpose regardless of
whether such additional analysis involves issues identical to or
similar to those for which information was reported to or assessed by a
patient safety organization or a patient safety evaluation system.
``(i) Clarification of application of hipaa confidentiality
regulations to patient safety organizations.--For purposes of applying
the HIPAA confidentiality regulations--
``(1) patient safety organizations shall be treated as business
associates; and
``(2) patient safety activities of such organizations in
relation to a provider are deemed to be health care operations (as
defined in such regulations) of the provider.
``(j) Reports on Strategies to Improve Patient Safety.--
``(1) Draft report.--Not later than the date that is 18 months
after any network of patient safety databases is operational, the
Secretary, in consultation with the Director, shall prepare a draft
report on effective strategies for reducing medical errors and
increasing patient safety. The draft report shall include any
measure determined appropriate by the Secretary to encourage the
appropriate use of such strategies, including use in any federally
funded programs. The Secretary shall make the draft report
available for public comment and submit the draft report to the
Institute of Medicine for review.
``(2) Final report.--Not later than 1 year after the date
described in paragraph (1), the Secretary shall submit a final
report to the Congress.
``SEC. 923. NETWORK OF PATIENT SAFETY DATABASES.
``(a) In General.--The Secretary shall facilitate the creation of,
and maintain, a network of patient safety databases that provides an
interactive evidence-based management resource for providers, patient
safety organizations, and other entities. The network of databases
shall have the capacity to accept, aggregate across the network, and
analyze nonidentifiable patient safety work product voluntarily
reported by patient safety organizations, providers, or other entities.
The Secretary shall assess the feasibility of providing for a single
point of access to the network for qualified researchers for
information aggregated across the network and, if feasible, provide for
implementation.
``(b) Data Standards.--The Secretary may determine common formats
for the reporting to and among the network of patient safety databases
maintained under subsection (a) of nonidentifiable patient safety work
product, including necessary work product elements, common and
consistent definitions, and a standardized computer interface for the
processing of such work product. To the extent practicable, such
standards shall be consistent with the administrative simplification
provisions of part C of title XI of the Social Security Act.
``(c) Use of Information.--Information reported to and among the
network of patient safety databases under subsection (a) shall be used
to analyze national and regional statistics, including trends and
patterns of health care errors. The information resulting from such
analyses shall be made available to the public and included in the
annual quality reports prepared under section 913(b)(2).
``SEC. 924. PATIENT SAFETY ORGANIZATION CERTIFICATION AND LISTING.
``(a) Certification.--
``(1) Initial certification.--An entity that seeks to be a
patient safety organization shall submit an initial certification
to the Secretary that the entity--
``(A) has policies and procedures in place to perform each
of the patient safety activities described in section 921(5);
and
``(B) upon being listed under subsection (d), will comply
with the criteria described in subsection (b).
``(2) Subsequent certifications.--An entity that is a patient
safety organization shall submit every 3 years after the date of
its initial listing under subsection (d) a subsequent certification
to the Secretary that the entity--
``(A) is performing each of the patient safety activities
described in section 921(5); and
``(B) is complying with the criteria described in
subsection (b).
``(b) Criteria.--
``(1) In general.--The following are criteria for the initial
and subsequent certification of an entity as a patient safety
organization:
``(A) The mission and primary activity of the entity are to
conduct activities that are to improve patient safety and the
quality of health care delivery.
``(B) The entity has appropriately qualified staff (whether
directly or through contract), including licensed or certified
medical professionals.
``(C) The entity, within each 24-month period that begins
after the date of the initial listing under subsection (d), has
bona fide contracts, each of a reasonable period of time, with
more than 1 provider for the purpose of receiving and reviewing
patient safety work product.
``(D) The entity is not, and is not a component of, a
health insurance issuer (as defined in section 2791(b)(2)).
``(E) The entity shall fully disclose--
``(i) any financial, reporting, or contractual
relationship between the entity and any provider that
contracts with the entity; and
``(ii) if applicable, the fact that the entity is not
managed, controlled, and operated independently from any
provider that contracts with the entity.
``(F) To the extent practical and appropriate, the entity
collects patient safety work product from providers in a
standardized manner that permits valid comparisons of similar
cases among similar providers.
``(G) The utilization of patient safety work product for
the purpose of providing direct feedback and assistance to
providers to effectively minimize patient risk.
``(2) Additional criteria for component organizations.--If an
entity that seeks to be a patient safety organization is a
component of another organization, the following are additional
criteria for the initial and subsequent certification of the entity
as a patient safety organization:
``(A) The entity maintains patient safety work product
separately from the rest of the organization, and establishes
appropriate security measures to maintain the confidentiality
of the patient safety work product.
``(B) The entity does not make an unauthorized disclosure
under this part of patient safety work product to the rest of
the organization in breach of confidentiality.
``(C) The mission of the entity does not create a conflict
of interest with the rest of the organization.
``(c) Review of Certification.--
``(1) In general.--
``(A) Initial certification.--Upon the submission by an
entity of an initial certification under subsection (a)(1), the
Secretary shall determine if the certification meets the
requirements of subparagraphs (A) and (B) of such subsection.
``(B) Subsequent certification.--Upon the submission by an
entity of a subsequent certification under subsection (a)(2),
the Secretary shall review the certification with respect to
requirements of subparagraphs (A) and (B) of such subsection.
``(2) Notice of acceptance or non-acceptance.--If the Secretary
determines that--
``(A) an entity's initial certification meets requirements
referred to in paragraph (1)(A), the Secretary shall notify the
entity of the acceptance of such certification; or
``(B) an entity's initial certification does not meet such
requirements, the Secretary shall notify the entity that such
certification is not accepted and the reasons therefor.
``(3) Disclosures regarding relationship to providers.--The
Secretary shall consider any disclosures under subsection (b)(1)(E)
by an entity and shall make public findings on whether the entity
can fairly and accurately perform the patient safety activities of
a patient safety organization. The Secretary shall take those
findings into consideration in determining whether to accept the
entity's initial certification and any subsequent certification
submitted under subsection (a) and, based on those findings, may
deny, condition, or revoke acceptance of the entity's
certification.
``(d) Listing.--The Secretary shall compile and maintain a listing
of entities with respect to which there is an acceptance of a
certification pursuant to subsection (c)(2)(A) that has not been
revoked under subsection (e) or voluntarily relinquished.
``(e) Revocation of Acceptance of Certification.--
``(1) In general.--If, after notice of deficiency, an
opportunity for a hearing, and a reasonable opportunity for
correction, the Secretary determines that a patient safety
organization does not meet the certification requirements under
subsection (a)(2), including subparagraphs (A) and (B) of such
subsection, the Secretary shall revoke the Secretary's acceptance
of the certification of such organization.
``(2) Supplying confirmation of notification to providers.--
Within 15 days of a revocation under paragraph (1), a patient
safety organization shall submit to the Secretary a confirmation
that the organization has taken all reasonable actions to notify
each provider whose patient safety work product is collected or
analyzed by the organization of such revocation.
``(3) Publication of decision.--If the Secretary revokes the
certification of an organization under paragraph (1), the Secretary
shall--
``(A) remove the organization from the listing maintained
under subsection (d); and
``(B) publish notice of the revocation in the Federal
Register.
``(f) Status of Data After Removal from Listing.--
``(1) New data.--With respect to the privilege and
confidentiality protections described in section 922, data
submitted to an entity within 30 days after the entity is removed
from the listing under subsection (e)(3)(A) shall have the same
status as data submitted while the entity was still listed.
``(2) Protection to continue to apply.--If the privilege and
confidentiality protections described in section 922 applied to
patient safety work product while an entity was listed, or to data
described in paragraph (1), such protections shall continue to
apply to such work product or data after the entity is removed from
the listing under subsection (e)(3)(A).
``(g) Disposition of Work Product and Data.--If the Secretary
removes a patient safety organization from the listing as provided for
in subsection (e)(3)(A), with respect to the patient safety work
product or data described in subsection (f)(1) that the patient safety
organization received from another entity, such former patient safety
organization shall--
``(1) with the approval of the other entity and a patient
safety organization, transfer such work product or data to such
patient safety organization;
``(2) return such work product or data to the entity that
submitted the work product or data; or
``(3) if returning such work product or data to such entity is
not practicable, destroy such work product or data.
``SEC. 925. TECHNICAL ASSISTANCE.
``The Secretary, acting through the Director, may provide technical
assistance to patient safety organizations, including convening annual
meetings for patient safety organizations to discuss methodology,
communication, data collection, or privacy concerns.
``SEC. 926. SEVERABILITY.
``If any provision of this part is held to be unconstitutional, the
remainder of this part shall not be affected.''.
(b) Authorization of Appropriations.--Section 937 of the Public
Health Service Act (as redesignated by subsection (a)) is amended by
adding at the end the following:
``(e) Patient Safety and Quality Improvement.--For the purpose of
carrying out part C, there are authorized to be appropriated such sums
as may be necessary for each of the fiscal years 2006 through 2010.''.
(c) GAO Study on Implementation.--
(1) Study.--The Comptroller General of the United States shall
conduct a study on the effectiveness of part C of title IX of the
Public Health Service Act (as added by subsection (a)) in
accomplishing the purposes of such part.
(2) Report.--Not later than February 1, 2010, the Comptroller
General shall submit a report on the study conducted under
paragraph (1). Such report shall include such recommendations for
changes in such part as the Comptroller General deems appropriate.
Speaker of the House of Representatives.
Vice President of the United States and
President of the Senate.