Patient Safety and Quality Improvement Act of 2005
PL 109-41 (S.544), enacted 07/29/2005

119 STAT. 424
PUBLIC LAW 109–41—JULY 29, 2005
Public Law 109–41
109th Congress
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 promul-
gated under section 264(c) of the Health Insurance Portability
and Accountability Act of 1996 (Public Law 104–191; 110 Stat.
2033).
42 USC 299b–21.
42 USC 299c–7.
42 USC
299c—299c–7.
42 USC 299b–1.
Patient Safety
and Quality
Improvement Act
of 2005.
July 29, 2005
[S. 544]
VerDate 14-DEC-2004
08:19 Oct 26, 2006
Jkt 039194
PO 00001
Frm 00422
Fmt 6580
Sfmt 6581
E:\PUBLAW\PUBL001.119
APPS06
PsN: PUBL001
119 STAT. 425
PUBLIC LAW 109–41—JULY 29, 2005
‘‘(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 confiden-
tiality 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 compo-
nent 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 rec-
ommendations, 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 con-
fidentiality 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, manage-
ment, 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
VerDate 14-DEC-2004
08:19 Oct 26, 2006
Jkt 039194
PO 00001
Frm 00423
Fmt 6580
Sfmt 6581
E:\PUBLAW\PUBL001.119
APPS06
PsN: PUBL001
119 STAT. 426
PUBLIC LAW 109–41—JULY 29, 2005
‘‘(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 dis-
charge information, or any other original patient or
provider record.
‘‘(ii) Information described in subparagraph (A)
does not include information that is collected, main-
tained, 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 surveil-
lance, investigation, or other public health pur-
poses 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 out-
patient rehabilitation facility, home health agency, hos-
pice program, renal dialysis facility, ambulatory sur-
gical center, pharmacy, physician or health care practi-
tioner’s office, long term care facility, behavior health
residential treatment facility, clinical laboratory, or
health center; or
‘‘(ii) a physician, physician assistant, nurse practi-
tioner, clinical nurse specialist, certified registered
nurse anesthetist, certified nurse midwife, psycholo-
gist, certified social worker, registered dietitian or
nutrition professional, physical or occupational thera-
pist, pharmacist, or other individual health care practi-
tioner; or
‘‘(B) any other individual or entity specified in regula-
tions promulgated by the Secretary.
VerDate 14-DEC-2004
08:19 Oct 26, 2006
Jkt 039194
PO 00001
Frm 00424
Fmt 6580
Sfmt 6581
E:\PUBLAW\PUBL001.119
APPS06
PsN: PUBL001
119 STAT. 427
PUBLIC LAW 109–41—JULY 29, 2005
‘‘SEC. 922. PRIVILEGE AND CONFIDENTIALITY PROTECTIONS.
‘‘(a) PRIVILEGE.—Notwithstanding any other provision of Fed-
eral, 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, administra-
tive rulemaking proceeding, or administrative adjudicatory pro-
ceeding, 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 pro-
ceeding 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.
42 USC 299b–22.
VerDate 14-DEC-2004
08:19 Oct 26, 2006
Jkt 039194
PO 00001
Frm 00425
Fmt 6580
Sfmt 6581
E:\PUBLAW\PUBL001.119
APPS06
PsN: PUBL001
119 STAT. 428
PUBLIC LAW 109–41—JULY 29, 2005
‘‘(D) Disclosure by a provider to the Food and Drug
Administration with respect to a product or activity regu-
lated 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 oper-
ations 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 DISCLO-
SURE.—
‘‘(1) IN GENERAL.—Patient safety work product that is dis-
closed 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 sub-
ject to paragraph (3)—
‘‘(A) if patient safety work product is disclosed in a
criminal proceeding, the confidentiality protections pro-
vided for in subsection (b) shall no longer apply to the
work product so disclosed; and
‘‘(B) if patient safety work product is disclosed as pro-
vided 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 protec-
tions 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
VerDate 14-DEC-2004
08:19 Oct 26, 2006
Jkt 039194
PO 00001
Frm 00426
Fmt 6580
Sfmt 6581
E:\PUBLAW\PUBL001.119
APPS06
PsN: PUBL001
119 STAT. 429
PUBLIC LAW 109–41—JULY 29, 2005
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 equi-
table relief (including reinstatement, back pay, and restora-
tion of benefits) to redress such violation.
VerDate 14-DEC-2004
08:19 Oct 26, 2006
Jkt 039194
PO 00001
Frm 00427
Fmt 6580
Sfmt 6581
E:\PUBLAW\PUBL001.119
APPS06
PsN: PUBL001
119 STAT. 430
PUBLIC LAW 109–41—JULY 29, 2005
‘‘(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 privi-
leged or confidential under this section;
‘‘(3) except as provided in subsection (i), to alter or affect
the implementation of any provision of the HIPAA confiden-
tiality 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 disclo-
sure 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 busi-
ness associates; and
‘‘(2) patient safety activities of such organizations in rela-
tion 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 oper-
ational, the Secretary, in consultation with the Director, shall
prepare a draft report on effective strategies for reducing med-
ical 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.
Public
information.
VerDate 14-DEC-2004
08:19 Oct 26, 2006
Jkt 039194
PO 00001
Frm 00428
Fmt 6580
Sfmt 6581
E:\PUBLAW\PUBL001.119
APPS06
PsN: PUBL001
119 STAT. 431
PUBLIC LAW 109–41—JULY 29, 2005
‘‘(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 pro-
vides an interactive evidence-based management resource for pro-
viders, 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, pro-
viders, 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 ele-
ments, common and consistent definitions, and a standardized com-
puter 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 sub-
section (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.
Deadlines.
42 USC 299b–24.
Public
information.
42 USC 299b–23.
VerDate 14-DEC-2004
08:19 Oct 26, 2006
Jkt 039194
PO 00001
Frm 00429
Fmt 6580
Sfmt 6581
E:\PUBLAW\PUBL001.119
APPS06
PsN: PUBL001
119 STAT. 432
PUBLIC LAW 109–41—JULY 29, 2005
‘‘(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 rela-
tionship between the entity and any provider that con-
tracts 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
ORGANIZA-
TIONS.—If an entity that seeks to be a patient safety organiza-
tion 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 confiden-
tiality of the patient safety work product.
‘‘(B) The entity does not make an unauthorized disclo-
sure 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 submis-
sion by an entity of a subsequent certification under sub-
section (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
VerDate 14-DEC-2004
08:19 Oct 26, 2006
Jkt 039194
PO 00001
Frm 00430
Fmt 6580
Sfmt 6581
E:\PUBLAW\PUBL001.119
APPS06
PsN: PUBL001
119 STAT. 433
PUBLIC LAW 109–41—JULY 29, 2005
‘‘(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
PRO-
VIDERS.—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 deter-
mining 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 oppor-
tunity for a hearing, and a reasonable opportunity for correc-
tion, the Secretary determines that a patient safety organiza-
tion does not meet the certification requirements under sub-
section (a)(2), including subparagraphs (A) and (B) of such
subsection, the Secretary shall revoke the Secretary’s accept-
ance of the certification of such organization.
‘‘(2) SUPPLYING CONFIRMATION OF NOTIFICATION TO PRO-
VIDERS.—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 main-
tained 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 confiden-
tiality 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 Sec-
retary 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—
Federal Register,
publication.
Deadline.
VerDate 14-DEC-2004
08:19 Oct 26, 2006
Jkt 039194
PO 00001
Frm 00431
Fmt 6580
Sfmt 6581
E:\PUBLAW\PUBL001.119
APPS06
PsN: PUBL001
119 STAT. 434
PUBLIC LAW 109–41—JULY 29, 2005
LEGISLATIVE HISTORY—S. 544 (H.R. 3205):
HOUSE REPORTS: No. 109–197 accompanying H.R. 3205 (Comm. on Energy and
Commerce).
CONGRESSIONAL RECORD, Vol. 151 (2005):
July 21, considered and passed Senate.
July 27, considered and passed House.
WEEKLY COMPILATION OF PRESIDENTIAL DOCUMENTS, Vol. 41 (2005):
July 29, Presidential remarks.
‘‘(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 tech-
nical assistance to patient safety organizations, including convening
annual meetings for patient safety organizations to discuss method-
ology, 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 pur-
pose 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 Comp-
troller General shall submit a report on the study conducted
under paragraph (1). Such report shall include such rec-
ommendations for changes in such part as the Comptroller
General deems appropriate.
Approved July 29, 2005.
42 USC 299c–6.
42 USC 299b–26.
42 USC 299b–25.
VerDate 14-DEC-2004
08:19 Oct 26, 2006
Jkt 039194
PO 00001
Frm 00432
Fmt 6580
Sfmt 6580
E:\PUBLAW\PUBL001.119
APPS06
PsN: PUBL001