In the Senate of the United States,
July 22, 2004.
Resolved, That the bill from the House of Representa-
tives (H.R. 663) entitled ‘‘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 ad-
versely affect patient safety, and for other purposes.’’, do
pass with the following
AMENDMENT:
Strike out all after the enacting clause and insert:
SECTION 1. SHORT TITLE.
This Act may be cited as the ‘‘Patient Safety and
Quality Improvement Act of 2004’’.
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SEC. 2. FINDINGS AND PURPOSES.
(a) FINDINGS.—Congress makes the following findings:
(1) In 1999, the Institute of Medicine released a
report entitled To Err is Human that described med-
ical errors as the eighth leading cause of death in the
United States, with as many as 98,000 people dying
as a result of medical errors each year.
(2) To address these deaths and injuries due to
medical errors, the health care system must identify
and learn from such errors so that systems of care can
be improved.
(3) In their report, the Institute of Medicine
called on Congress to provide legal protections with
respect to information reported for the purposes of
quality improvement and patient safety.
(4) The Health, Education, Labor, and Pensions
Committee of the Senate held 4 hearings in the 106th
Congress and 1 hearing in the 107th Congress on pa-
tient safety where experts in the field supported the
recommendation of the Institute of Medicine for con-
gressional action.
(5) Myriad public and private patient safety
initiatives have begun. The Quality Interagency Co-
ordination Taskforce has recommended steps to im-
prove patient safety that may be taken by each Fed-
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eral agency involved in health care and activities re-
lating to these steps are ongoing.
(6) The research on patient safety unequivocally
calls for a learning environment, rather than a puni-
tive environment, in order to improve patient safety.
(7) Voluntary data gathering systems are more
supportive than mandatory systems in creating the
learning environment referred to in paragraph (6) as
stated in the Institute of Medicine’s report.
(8) Promising patient safety reporting systems
have been established throughout the United States
and the best ways to structure and use these systems
are currently being determined, largely through
projects funded by the Agency for Healthcare Research
and Quality.
(9) Many organizations currently collecting pa-
tient safety data have expressed a need for legal pro-
tections that will allow them to review protected in-
formation and collaborate in the development and im-
plementation of patient safety improvement strate-
gies. Currently, the State peer review protections are
inadequate to allow the sharing of information to pro-
mote patient safety.
(b) PURPOSES.—It is the purpose of this Act to—
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(1) encourage a culture of safety and quality in
the United States health care system by providing for
legal protection of information reported voluntarily
for the purposes of quality improvement and patient
safety; and
(2) ensure accountability by raising standards
and expectations for continuous quality improvements
in patient safety.
SEC. 3. AMENDMENTS TO PUBLIC HEALTH SERVICE ACT.
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 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 934(d) (as so redesignated), by striking
the second sentence and inserting the following: ‘‘Pen-
alties provided for under this section shall be imposed
and collected by the Secretary using the administra-
tive and procedural processes used to impose and col-
lect civil money penalties under section 1128A of the
Social Security Act (other than subsections (a) and
(b), the second sentence of subsection (f), and sub-
sections (i), (m), and (n)), unless the Secretary deter-
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mines that a modification of procedures would be
more suitable or reasonable to carry out this sub-
section and provides for such modification by regula-
tion.’’;
(5) in section 938(1) (as so redesignated), by
striking ‘‘921’’ and inserting ‘‘931’’; and
(6) by inserting after part B the following:
‘‘PART C—PATIENT SAFETY IMPROVEMENT
‘‘SEC. 921. DEFINITIONS.
‘‘In this part:
‘‘(1) NON-IDENTIFIABLE INFORMATION.—
‘‘(A) IN GENERAL.—The term ‘non-identifi-
able information’ means, with respect to infor-
mation, that the information is presented in a
form and manner that prevents the identifica-
tion of a provider, a patient, or a reporter of pa-
tient safety data.
‘‘(B) IDENTIFIABILITY
OF
PATIENT.—For
purposes of subparagraph (A), the term ‘pre-
sented in a form and manner that prevents the
identification of a patient’ means, with respect
to information that has been subject to rules pro-
mulgated pursuant to section 264(c) of the
Health Insurance Portability and Accountability
Act of 1996 (42 U.S.C. 1320d–2 note), that the
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information has been de-identified so that it is
no longer individually identifiable health infor-
mation as defined in such rules.
‘‘(2) PATIENT SAFETY DATA.—
‘‘(A) IN GENERAL.—The term ‘patient safe-
ty data’ means—
‘‘(i) any data, reports, records, memo-
randa, analyses (such as root cause anal-
yses), or written or oral statements that
are—
‘‘(I) collected or developed by a
provider for reporting to a patient
safety organization, provided that they
are reported to the patient safety orga-
nization within 60 days;
‘‘(II) requested by a patient safety
organization (including the contents of
such request), if they are reported to
the patient safety organization within
60 days;
‘‘(III) reported to a provider by a
patient safety organization; or
‘‘(IV) collected by a patient safety
organization from another patient safe-
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ty organization, or developed by a pa-
tient safety organization;
that could result in improved patient safety,
health care quality, or health care outcomes;
or
‘‘(ii) any deliberative work or process
with respect to any patient safety data de-
scribed in clause (i).
‘‘(B) LIMITATION.—
‘‘(i) COLLECTION.—If the original ma-
terial from which any data, reports, records,
memoranda, analyses (such as root case
analyses), or written or oral statements re-
ferred to in subclause (I) or (IV) of sub-
paragraph (A)(i) are collected and is not
patient safety data, the act of such collec-
tion shall not make such original material
patient safety data for purposes of this
part.
‘‘(ii) SEPARATE DATA.—The term ‘pa-
tient safety data’ shall not include informa-
tion (including a patient’s medical record,
billing and discharge information or any
other patient or provider record) that is col-
lected or developed separately from and that
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exists separately from patient safety data.
Such separate information or a copy thereof
submitted to a patient safety organization
shall not itself be considered as patient safe-
ty data. Nothing in this part, except for sec-
tion 922(f)(1), 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.
‘‘(3) PATIENT SAFETY ORGANIZATION.—The term
‘patient safety organization’ means a private or pub-
lic entity or component thereof that is currently listed
by the Secretary pursuant to section 924(c).
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‘‘(4) PATIENT
SAFETY
ORGANIZATION
ACTIVI-
TIES.—The term ‘patient safety organization activi-
ties’ means the following activities, which are deemed
to be necessary for the proper management and ad-
ministration of a patient safety organization:
‘‘(A) The conduct, as its primary activity,
of efforts to improve patient safety and the qual-
ity 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 improv-
ing patient safety, such as recommendations,
protocols, or information regarding best prac-
tices.
‘‘(D) The utilization of patient safety data
for the purposes of encouraging a culture of safe-
ty and of providing direct feedback and assist-
ance to providers to effectively minimize patient
risk.
‘‘(E) The maintenance of procedures to pre-
serve confidentiality with respect to patient safe-
ty data.
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‘‘(F) The provision of appropriate security
measures with respect to patient safety data.
‘‘(G) The utilization of qualified staff.
‘‘(5) PERSON.—The term ‘person’ includes Fed-
eral, State, and local government agencies.
‘‘(6) PROVIDER.—The term ‘provider’ means—
‘‘(A) a person licensed or otherwise author-
ized under State law to provide health care serv-
ices, 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
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ing in the preceding sentence shall be construed to
prevent the release of patient safety data that is pro-
vided by, or that relates solely to, a provider from
which the consent described in such sentence is ob-
tained because one or more other providers do not
provide such consent with respect to the disclosure of
patient safety date that relates to such nonconsenting
providers. Consent for the future release of patient
safety data for such purposes may be requested by the
patient safety organization at the time the data is
submitted.
‘‘(e) CONTINUED PROTECTION OF INFORMATION AFTER
DISCLOSURE.—
‘‘(1) IN GENERAL.—Except as provided in para-
graph (2), patient safety data that is used or dis-
closed shall continue to be privileged and confidential
as provided for in subsections (a) and (b), and the
provisions of such subsections shall apply to such
data in the possession or control of—
‘‘(A) a provider or patient safety organiza-
tion that possessed such data before the use or
disclosure; or
‘‘(B) a person to whom such data was dis-
closed.
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‘‘(2) EXCEPTION.—Notwithstanding paragraph
(1), and subject to paragraph (3)—
‘‘(A) if patient safety data is used or dis-
closed as provided for in subsection (c)(1), and
such use or disclosure is in open court, the con-
fidentiality protections provided for in sub-
section (b) shall no longer apply to such data;
and
‘‘(B) if patient safety data is used or dis-
closed as provided for in subsection (c)(2), the
privilege and confidentiality protections pro-
vided for in subsections (a) and (b) shall no
longer apply to such data.
‘‘(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 data other than the
specific data used or disclosed as provided for in sub-
section (c).
‘‘(f) LIMITATION ON ACTIONS.—
‘‘(1) PATIENT SAFETY ORGANIZATIONS.—Except
to enforce disclosures pursuant to subsection (c)(1), no
action may be brought or process served against a pa-
tient safety organization to compel disclosure of infor-
mation collected or developed under this part whether
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or not such information is patient safety data unless
such information is specifically identified, is not pa-
tient safety data, and cannot otherwise be obtained.
‘‘(2) 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 data in accordance with this part. An
accrediting body may not require a provider to reveal
its communications with any patient safety organiza-
tion established in accordance with this part.
‘‘(g) 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
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 organiza-
tion.
‘‘(2) ADVERSE EMPLOYMENT ACTION.—For pur-
poses of this subsection, an ‘adverse employment ac-
tion’ includes—
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‘‘(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.
‘‘(h) ENFORCEMENT.—
‘‘(1) PROHIBITION.—Except as provided in sub-
sections (c) and (d) and as otherwise provided for in
this section, it shall be unlawful for any person to
negligently or intentionally disclose any patient safe-
ty data, and any such person shall, upon adjudica-
tion, be assessed in accordance with section 934(d).
‘‘(2) RELATION
TO
HIPAA.—The penalty pro-
vided for under paragraph (1) shall not apply if the
defendant would otherwise be subject to a penalty
under the regulations promulgated under section
264(c) of the Health Insurance Portability and Ac-
countability Act of 1996 (42 U.S.C. 1320d–2 note) or
under section 1176 of the Social Security Act (42
U.S.C. 1320d–5) for the same disclosure.
‘‘(3) EQUITABLE RELIEF.—
‘‘(A) IN GENERAL.—Without limiting rem-
edies available to other parties, a civil action
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may be brought by any aggrieved individual to
enjoin any act or practice that violates sub-
section (g) 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 as described by this para-
graph, and that consent has remained in effect.
‘‘(i) RULE OF CONSTRUCTION.—Nothing in this sec-
tion shall be construed to—
‘‘(1) limit other privileges that are available
under Federal, State, or local laws that provide great-
er confidentiality protections or privileges than the
privilege and confidentiality protections 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 sec-
tion;
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‘‘(3) alter or affect the implementation of any
provision of section 264(c) of the Health Insurance
Portability and Accountability Act of 1996 (Public
Law 104–191; 110 Stat. 2033), section 1176 of the
Social Security Act (42 U.S.C. 1320d–5), or any reg-
ulation promulgated under such sections;
‘‘(4) limit the authority of any provider, patient
safety organization, or other person to enter into a
contract requiring greater confidentiality or dele-
gating authority to make a disclosure or use in ac-
cordance with subsection (c) or (d); and
‘‘(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 patient safety data in mak-
ing such report.
‘‘SEC. 923. PATIENT SAFETY NETWORK OF DATABASES.
‘‘(a) IN GENERAL.—The Secretary shall maintain a
patient safety network of databases that provides an inter-
active evidence-based management resource for providers,
patient safety organizations, and other persons. The net-
work of databases shall have the capacity to accept, aggre-
gate, and analyze nonidentifiable patient safety data volun-
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tarily reported by patient safety organizations, providers,
or other persons.
‘‘(b) NETWORK OF DATABASE STANDARDS.—The Sec-
retary may determine common formats for the reporting to
the patient safety network of databases maintained under
subsection (a) of nonidentifiable patient safety data, includ-
ing necessary data elements, common and consistent defini-
tions, and a standardized computer interface for the proc-
essing of such data. To the extent practicable, such stand-
ards shall be consistent with the administrative simplifica-
tion provisions of Part C of title XI of the Social Security
Act.
‘‘SEC. 
924. 
PATIENT 
SAFETY 
ORGANIZATION 
CERTIFI-
CATION AND LISTING.
‘‘(a) CERTIFICATION.—
‘‘(1) INITIAL
CERTIFICATION.—Except as pro-
vided in paragraph (2), an entity that seeks to be a
patient safety organization shall submit an initial
certification to the Secretary that the entity intends
to perform the patient safety organization activities.
‘‘(2) DELAYED CERTIFICATION OF COLLECTION
FROM MORE THAN ONE PROVIDER.—An entity that
seeks to be a patient safety organization may—
‘‘(A) submit an initial certification that it
intends to perform patient safety organization
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activities other than the activities described in
subparagraph (B) of section 921(4); and
‘‘(B) within 2 years of submitting the ini-
tial certification under subparagraph (A), sub-
mit a supplemental certification that it performs
the patient safety organization activities de-
scribed in subparagraphs (A) through (F) of sec-
tion 921(4).
‘‘(3) EXPIRATION AND RENEWAL.—
‘‘(A) EXPIRATION.—An initial certification
under paragraph (1) or (2)(A) shall expire on
the date that is 3 years after it is submitted.
‘‘(B) RENEWAL.—
‘‘(i) IN
GENERAL.—An entity that
seeks to remain a patient safety organiza-
tion after the expiration of an initial cer-
tification under paragraph (1) or (2)(A)
shall, within the 3-year period described in
subparagraph (A), submit a renewal certifi-
cation to the Secretary that the entity per-
forms the patient safety organization activi-
ties described in section 921(4).
‘‘(ii) TERM OF RENEWAL.—A renewal
certification under clause (i) shall expire on
the date that is 3 years after the date on
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which it is submitted, and may be renewed
in the same manner as an initial certifi-
cation.
‘‘(b) ACCEPTANCE OF CERTIFICATION.—Upon the sub-
mission by an organization of an initial certification pur-
suant to subsection (a)(1) or (a)(2)(A), a supplemental cer-
tification pursuant to subsection (a)(2)(B), or a renewal
certification pursuant to subsection (a)(3)(B), the Secretary
shall review such certification and—
‘‘(1) if such certification meets the requirements
of subsection (a)(1), (a)(2)(A), (a)(2)(B), or (a)(3)(B),
as applicable, the Secretary shall notify the organiza-
tion that such certification is accepted; or
‘‘(2) if such certification does not meet such re-
quirements, as applicable, the Secretary shall notify
the organization that such certification is not accept-
ed and the reasons therefor.
‘‘(c) LISTING.—
‘‘(1) IN GENERAL.—Except as otherwise provided
in this subsection, the Secretary shall compile and
maintain a current listing of patient safety organiza-
tions with respect to which the Secretary has accepted
a certification pursuant to subsection (b).
‘‘(2) REMOVAL
FROM
LISTING.—The Secretary
shall remove from the listing under paragraph (1)—
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‘‘(A) an entity with respect to which the
Secretary has accepted an initial certification
pursuant to subsection (a)(2)(A) and which does
not submit a supplemental certification pursu-
ant to subsection (a)(2)(B) that is accepted by
the Secretary;
‘‘(B) an entity whose certification expires
and which does not submit a renewal applica-
tion that is accepted by the Secretary; and
‘‘(C) an entity with respect to which the
Secretary revokes the Secretary’s acceptance of
the entity’s certification, pursuant to subsection
(d).
‘‘(d) REVOCATION OF ACCEPTANCE.—
‘‘(1) IN GENERAL.—Except as provided in para-
graph (2), if the Secretary determines (through a re-
view of patient safety organization activities) that a
patient safety organization does not perform one of
the patient safety organization activities described in
subparagraph (A) through (F) of section 921(4), the
Secretary may, after notice and an opportunity for a
hearing, revoke the Secretary’s acceptance of the cer-
tification of such organization.
‘‘(2) DELAYED CERTIFICATION OF COLLECTION
FROM
MORE
THAN
ONE
PROVIDER.—A revocation
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under paragraph (1) may not be based on a deter-
mination that the organization does not perform the
activity described in section 921(4)(B) if—
‘‘(A) the listing of the organization is based
on its submittal of an initial certification under
subsection (a)(2)(A);
‘‘(B) the organization has not submitted a
supplemental 
certification 
under 
subsection
(a)(2)(B); and
‘‘(C) the 2-year period described in sub-
section (a)(2)(B) has not expired.
‘‘(e) NOTIFICATION
OF REVOCATION
OR REMOVAL
FROM LISTING.—
‘‘(1) SUPPLYING
CONFIRMATION
OF
NOTIFICA-
TION TO PROVIDERS.—Within 15 days of a revocation
under subsection (d)(1), a patient safety organization
shall submit to the Secretary a confirmation that the
organization has taken all reasonable actions to no-
tify each provider whose patient safety data is col-
lected or analyzed by the organization of such revoca-
tion.
‘‘(2) PUBLICATION.—Upon the revocation of an
acceptance of an organization’s certification under
subsection (d)(1), or upon the removal of an organiza-
tion from the listing under subsection (c)(2), the Sec-
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retary shall publish notice of the revocation or re-
moval in the Federal Register.
‘‘(f) STATUS OF DATA AFTER REMOVAL FROM LIST-
ING.—
‘‘(1) NEW DATA.—With respect to the privilege
and confidentiality protections described in section
922, data submitted to an organization within 30
days after the organization is removed from the list-
ing under subsection (c)(2) shall have the same status
as data submitted while the organization was still
listed.
‘‘(2) PROTECTION TO CONTINUE TO APPLY.—If
the privilege and confidentiality protections described
in section 922 applied to data while an organization
was listed, or during the 30-day period described in
paragraph (1), such protections shall continue to
apply to such data after the organization is removed
from the listing under subsection (c)(2).
‘‘(g) DISPOSITION OF DATA.—If the Secretary removes
an organization from the listing as provided for in sub-
section (c)(2), with respect to the patient safety data that
the organization received from providers, the organization
shall—
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‘‘(1) with the approval of the provider and an-
other patient safety organization, transfer such data
to such other organization;
‘‘(2) return such data to the person that sub-
mitted the data; or
‘‘(3) if returning such data to such person is not
practicable, destroy such data.
‘‘SEC. 925. TECHNICAL ASSISTANCE.
‘‘The Secretary, acting through the Director, may pro-
vide technical assistance to patient safety organizations, in-
cluding convening annual meetings for patient safety orga-
nizations to discuss methodology, communication, data col-
lection, or privacy concerns.
‘‘SEC. 
926. 
PROMOTING 
THE 
INTEROPERABILITY 
OF
HEALTH CARE INFORMATION TECHNOLOGY
SYSTEMS.
‘‘(a) DEVELOPMENT.—Not later than 36 months after
the date of enactment of the Patient Safety and Quality
Improvement Act of 2004, the Secretary shall develop or
adopt voluntary standards that promote the electronic ex-
change of health care information.
‘‘(b) UPDATES.—The Secretary shall provide for the
ongoing review and periodic updating of the standards de-
veloped under subsection (a).
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‘‘(c) DISSEMINATION.—The Secretary shall provide for
the dissemination of the standards developed and updated
under this section.
‘‘SEC. 927. AUTHORIZATION OF APPROPRIATIONS.
‘‘There is authorized to be appropriated such sums as
may be necessary to carry out this part.’’.
SEC. 4. STUDIES AND REPORTS.
(a) IN GENERAL.—The Secretary of Health and
Human Services shall enter into a contract (based upon
a competitive contracting process) with an appropriate re-
search organization for the conduct of a study to assess the
impact of medical technologies and therapies on patient
safety, patient benefit, health care quality, and the costs of
care as well as productivity growth. Such study shall
examine—
(1) the extent to which factors, such as the use
of labor and technological advances, have contributed
to increases in the share of the gross domestic product
that is devoted to health care and the impact of med-
ical technologies and therapies on such increases;
(2) the extent to which early and appropriate in-
troduction and integration of innovative medical
technologies and therapies may affect the overall pro-
ductivity and quality of the health care delivery sys-
tems of the United States; and
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(3) the relationship of such medical technologies
and therapies to patient safety, patient benefit, health
care quality, and cost of care.
(b) REPORT.—Not later than 18 months after the date
of enactment of this Act, the Secretary of Health and
Human Services shall prepare and submit to the appro-
priate committees of Congress a report containing the re-
sults of the study conducted under subsection (a).
Attest:
Secretary.