IB 
Union Calendar No. 117 
109TH CONGRESS 
1ST SESSION H. R. 3205 
[Report No. 109–197] 
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 affect patient safety, and for other purposes. 
IN THE HOUSE OF REPRESENTATIVES 
JULY 12, 2005 
Mr. BILIRAKIS (for himself, Mr. DEAL of Georgia, Mr. BROWN of Ohio, and 
Mr. WAXMAN) introduced the following bill; which was referred to the 
Committee on Energy and Commerce 
JULY 27, 2005 
Additional sponsors: Mr. MURPHY, Mr. BAIRD, Mr. WHITFIELD, Ms. ESHOO, 
Mr. BISHOP of Georgia, Mr. BURGESS, Mr. NORWOOD, Mr. WALDEN of 
Oregon, Mr. UPTON, Mrs. BONO, Mrs. DRAKE, Mr. GENE GREEN of 
Texas, Mr. EMANUEL, Mr. PICKERING, and Mr. MCDERMOTT 
JULY 27, 2005 
Reported with an amendment, committed to the Committee of the Whole 
House on the State of the Union, and ordered to be printed 
[Strike out all after the enacting clause and insert the part printed in italic] 
[For text of introduced bill, see copy of bill as introduced on July 12, 2005] 
A BILL 
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 affect pa-
tient safety, and for other purposes. 
Be it enacted by the Senate and House of Representa-
tives 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 ‘‘Pa-
tient 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 Serv-
ice Act (42 U.S.C. 299 et seq.) is amended— 
(1) in section 912(c), by inserting ‘‘, in accord-
ance 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 pro-
viders 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 speci-
fied 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 de-
fined in paragraph (2)). 
‘‘(4) PATIENT SAFETY ORGANIZATION.—The term 
‘patient safety organization’ means a private or pub-
lic 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 activi-
ties: 
‘‘(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 assist-
ance to effectively minimize patient risk. 
‘‘(E) The maintenance of procedures to pre-
serve confidentiality with respect to patient safe-
ty 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 pro-
vision 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 anal-
yses), 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 subpara-
graph (A) does not include a patient’s med-
ical record, billing and discharge informa-
tion, or any other original patient or pro-
vider record. 
‘‘(ii) Information described in sub-
paragraph (A) does not include information 
that is collected, maintained, or developed 
separately, or exists separately, from a pa-
tient safety evaluation system. Such sepa-
rate 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 admissi-
bility 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, com-
prehensive outpatient rehabilitation facility, 
home health agency, hospice program, renal 
dialysis facility, ambulatory surgical center,
pharmacy, physician or health care practi-
tioner’s office, long term care facility, be-
havior health residential treatment facility, 
clinical laboratory, or health center; or 
‘‘(ii) a physician, physician assistant, 
nurse practitioner, clinical nurse specialist, 
certified registered nurse anesthetist, cer-
tified nurse midwife, psychologist, certified 
social worker, registered dietitian or nutri-
tion professional, physical or occupational 
therapist, pharmacist, or other individual 
health care practitioner; or 
‘‘(B) any other individual or entity speci-
fied in regulations promulgated by the Secretary. 
‘‘SEC. 922. PRIVILEGE AND CONFIDENTIALITY PROTEC-
TIONS. 
‘‘(a) PRIVILEGE.—Notwithstanding any other provi-
sion 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, in-
cluding in a Federal, State, or local civil or adminis-
trative disciplinary proceeding against a provider;
‘‘(2) subject to discovery in connection with a 
Federal, State, or local civil, criminal, or administra-
tive 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 pro-
ceeding, administrative rulemaking proceeding, or ad-
ministrative adjudicatory proceeding, including any 
such proceeding against a provider; or 
‘‘(5) admitted in a professional disciplinary pro-
ceeding of a professional disciplinary body established 
or specifically authorized under State law. 
‘‘(b) CONFIDENTIALITY OF PATIENT SAFETY WORK 
PRODUCT.—Notwithstanding any other provision of Fed-
eral, State, or local law, and subject to subsection (c), pa-
tient 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
CON-
FIDENTIALITY.—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 deter-
mination 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 prod-
uct 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 prod-
uct to carry out patient safety activities.
‘‘(B) Disclosure of nonidentifiable patient 
safety work product. 
‘‘(C) Disclosure of patient safety work prod-
uct to grantees, contractors, or other entities car-
rying out research, evaluation, or demonstration 
projects authorized, funded, certified, or other-
wise 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 de-
termine, 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 prod-
uct 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 cir-
cumstances, 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 pa-
tient 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 pa-
tient 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 sub-
sections (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 dis-
closed in a criminal proceeding, the confiden-
tiality protections provided for in subsection (b) 
shall no longer apply to the work product so dis-
closed; and 
‘‘(B) if patient safety work product is dis-
closed as provided for in subsection (c)(2)(B) (re-
lating to disclosure of nonidentifiable patient 
safety work product), the privilege and confiden-
tiality protections provided for in subsections (a) 
and (b) shall no longer apply to such work prod-
uct. 
‘‘(3) CONSTRUCTION.—Paragraph (2) shall not 
be construed as terminating or limiting the privilege 
or confidentiality protections provided for in sub-
section (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 or-
ganization 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 in-
formation is identified, is not patient safety 
work product, and is not reasonably avail-
able from another source. 
‘‘(ii) NONAPPLICATION.—The limita-
tion contained in clause (i) shall not apply 
in an action against a patient safety orga-
nization or with respect to disclosures pur-
suant 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, re-
porting, or maintenance of patient safety work 
product in accordance with this part. An accred-
iting body may not require a provider to reveal 
its communications with any patient safety or-
ganization established in accordance with this 
part. 
‘‘(e) REPORTER PROTECTION.—
‘‘(1) IN GENERAL.—A provider may not take an 
adverse employment action, as described in para-
graph (2), against an individual based upon the fact 
that the individual in good faith reported informa-
tion— 
‘‘(A) to the provider with the intention of 
having the information reported to a patient 
safety organization; or 
‘‘(B) directly to a patient safety organiza-
tion. 
‘‘(2) ADVERSE EMPLOYMENT ACTION.—For pur-
poses of this subsection, an ‘adverse employment ac-
tion’ includes— 
‘‘(A) loss of employment, the failure to pro-
mote 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 iden-
tifiable 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 sub-
sections (a) and (b) and the first sentence of sub-
section (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 rem-
edies available to other parties, a civil action 
may be brought by any aggrieved individual to 
enjoin any act or practice that violates sub-
section (e) and to obtain other appropriate equi-
table relief (including reinstatement, back pay, 
and restoration of benefits) to redress such viola-
tion.
‘‘(B) AGAINST STATE EMPLOYEES.—An en-
tity that is a State or an agency of a State gov-
ernment may not assert the privilege described 
in subsection (a) unless before the time of the as-
sertion, the entity or, in the case of and with re-
spect 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 sec-
tion 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 con-
fidentiality 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 sec-
tion; 
‘‘(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, pa-
tient safety organization, or other entity to enter into
a contract requiring greater confidentiality or dele-
gating authority to make a disclosure or use in ac-
cordance 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 in-
formation regarding the safety of a product or activ-
ity 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 in-
volves issues identical to or similar to those for which infor-
mation was reported to or assessed by a patient safety orga-
nization or a patient safety evaluation system. 
‘‘(i) CLARIFICATION OF APPLICATION OF HIPAA CON-
FIDENTIALITY REGULATIONS TO PATIENT SAFETY ORGANI-
ZATIONS.—For purposes of applying the HIPAA confiden-
tiality regulations— 
‘‘(1) patient safety organizations shall be treated 
as business associates; and 
‘‘(2) patient safety activities of such organiza-
tions 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 consulta-
tion with the Director, shall prepare a draft report on 
effective strategies for reducing medical errors and in-
creasing 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 In-
stitute of Medicine for review. 
‘‘(2) FINAL
REPORT.—Not later than 1 year 
after the date described in paragraph (1), the Sec-
retary 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 data-
bases that provides an interactive evidence-based manage-
ment resource for providers, patient safety organizations, 
and other entities. The network of databases shall have the
capacity to accept, aggregate across the network, and ana-
lyze nonidentifiable patient safety work product voluntarily 
reported by patient safety organizations, providers, or other 
entities. The Secretary shall assess the feasibility of pro-
viding for a single point of access to the network for quali-
fied researchers for information aggregated across the net-
work and, if feasible, provide for implementation. 
‘‘(b) DATA STANDARDS.—The Secretary may deter-
mine common formats for the reporting to and among the 
network of patient safety databases maintained under sub-
section (a) of nonidentifiable patient safety work product, 
including necessary work product elements, common and 
consistent definitions, and a standardized computer inter-
face for the processing of such work product. To the extent 
practicable, such standards shall be consistent with the ad-
ministrative 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 re-
gional 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 
CERTIFI-
CATION 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 enti-
ty— 
‘‘(A) has policies and procedures in place to 
perform each of the patient safety activities de-
scribed in section 921(5); and 
‘‘(B) upon being listed under subsection (d), 
will comply with the criteria described in sub-
section (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 Sec-
retary that the entity— 
‘‘(A) is performing each of the patient safe-
ty activities described in section 921(5); and 
‘‘(B) is complying with the criteria de-
scribed 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), in-
cluding licensed or certified medical profes-
sionals. 
‘‘(C) The entity, within each 24-month pe-
riod that begins after the date of the initial list-
ing 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 compo-
nent of, a health insurance issuer (as defined in 
section 2791(b)(2)). 
‘‘(E) The entity shall fully disclose— 
‘‘(i) any financial, reporting, or con-
tractual relationship between the entity and 
any provider that contracts with the entity; 
and 
‘‘(ii) if applicable, the fact that the en-
tity is not managed, controlled, and oper-
ated independently from any provider that 
contracts with the entity. 
‘‘(F) To the extent practical and appro-
priate, the entity collects patient safety work 
product from providers in a standardized man-
ner that permits valid comparisons of similar 
cases among similar providers. 
‘‘(G) The utilization of patient safety work 
product for the purpose of providing direct feed-
back and assistance to providers to effectively 
minimize patient risk. 
‘‘(2) ADDITIONAL CRITERIA FOR COMPONENT OR-
GANIZATIONS.—If an entity that seeks to be a patient 
safety organization is a component of another organi-
zation, 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 or-
ganization, and establishes appropriate security 
measures to maintain the confidentiality of the 
patient safety work product. 
‘‘(B) The entity does not make an unau-
thorized disclosure under this part of patient