IB
Union Calendar No. 468
107TH CONGRESS
2D SESSION
H. R. 4889
[Report No. 107–714, Part I]
To amend title XI of the Social Security Act to improve patient safety.
IN THE HOUSE OF REPRESENTATIVES
JUNE 6, 2002
Mrs. JOHNSON of Connecticut (for herself, Mr. THOMAS, Mr. HOUGHTON, Mr.
FLETCHER, Mrs. MORELLA, Mr. HAYWORTH, Mr. WELLER, and Mr.
CAMP) introduced the following bill; which was referred to the Committee
on Ways and Means, and in addition to the Committee on Energy and
Commerce, for a period to be subsequently determined by the Speaker,
in each case for consideration of such provisions as fall within the juris-
diction of the committee concerned
OCTOBER 1, 2002
Reported from the Committee on Ways and Means with an amendment
[Strike out all after the enacting clause and insert the part printed in italic]
OCTOBER 1, 2002
Referral to the Committee on Energy and Commerce extended for a period
ending not later than October 4, 2002
OCTOBER 4, 2002
Referral to the Committee on Energy and Commerce extended for a period
ending not later than October 11, 2002
OCTOBER 11, 2002
Additional sponsors: Mr. HERGER, Mr. LEWIS of Kentucky, Mr. ENGLISH,
Mr. SMITH of New Jersey, and Mr. PORTMAN
OCTOBER 11, 2002
Committee on Energy and Commerce discharged; committed to the Committee
of the Whole House on the State of the Union and ordered to be printed
[For text of introduced bill, see copy of bill as introduced on June 6, 2002]
A BILL
To amend title XI of the Social Security Act to improve
patient safety.
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 Improvement Act of 2002’’.
(b) TABLE OF CONTENTS.—The table of contents of this
Act is as follows:
Sec. 1. Short title; table of contents.
Sec. 2. Patient safety improvements.
‘‘PART D—PATIENT SAFETY IMPROVEMENTS
‘‘Sec. 1181. Voluntary reporting of patient safety data; definitions.
‘‘Sec. 1182. Confidentiality and peer review protections.
‘‘Sec. 1183. Center for Quality Improvement and Patient Safety.
‘‘Sec. 1184. Interoperability standards for health care information tech-
nology systems.
‘‘Sec. 1185. Voluntary adoption of methods to improve patient safety.
‘‘Sec. 1186. Evaluation and report.
Sec. 3. Medical Information Technology Advisory Board.
SEC. 2. PATIENT SAFETY IMPROVEMENTS.
Title XI of the Social Security Act is amended by add-
ing at the end the following new part:
with the explicit authorization for each such disclosure by
the reporting provider involved.
‘‘(c) FUNCTIONS OF CENTER.—The Center for Quality
Improvement and Patient Safety conducts patient safety
activities consistent with section 1183.
‘‘(d) HEALTH CARE PROVIDERS COVERED.—For pur-
poses of this part, the term ‘health care provider’ means—
‘‘(1) a provider of services (as defined in section
1861(u) and including a hospital, skilled nursing fa-
cility, home health agency, and hospice program) that
provides services for which payment may be made
under part A of title XVIII and the provider’s em-
ployees;
‘‘(2) a health care entity or individual that fur-
nishes medical or other health services (as defined in
section 1861(s)), other services described in section
1832(a)(2), or other items and services for which pay-
ment may be made under such title, including a phy-
sician (as defined in section 1861(r)); and
‘‘(3) an organization offering a plan under part
C of title XVIII.
‘‘(e) PATIENT SAFETY DATA COVERED.—
‘‘(1) IN GENERAL.—For purposes of this part,
the term ‘patient safety data’ means any data, re-
ports, records, memoranda, analyses, deliberative
work, statements, or root cause analyses that are col-
lected or developed to improve patient safety or health
care quality and that—
‘‘(A) are collected or developed by a health
care provider for the purpose of reporting to a
patient safety organization and that are reported
on a timely basis to such an organization;
‘‘(B) are collected or developed by a patient
safety organization or by (or on behalf of) the
Center for Quality Improvement and Patient
Safety, regardless of whether the data are trans-
mitted to the health care provider that reported
the original data; or
‘‘(C) describes corrective actions taken by a
health care provider in response to the provider’s
reporting of data to that organization, regardless
of whether the organization has transmitted
under subsection (f)(2) information to the health
care provider that reported the original data,
and that are reported on a timely basis to such
an organization.
‘‘(2) 
CONSTRUCTION
REGARDING
USE
OF
DATA.—
‘‘(A) INTERNAL
USE
PERMITTED
TO
IM-
PROVE
PATIENT
SAFETY, QUALITY, AND
EFFI-
CIENCY.—Nothing in this part shall be construed
to limit or discourage a health care provider
from developing and using patient safety data
within the provider to improve patient safety,
health care quality, or administrative efficiency
of the provider.
‘‘(B) TREATMENT.—Information that is col-
lected or developed as patient safety data is not
disqualified from being treated as patient safety
data because of its development or use for the
purposes described in subparagraph (A) and
such development or use shall not constitute a
waiver of any privilege or protection established
under section 1182 or under State law.
‘‘(f) QUALIFICATIONS OF PATIENT SAFETY ORGANIZA-
TIONS.—
‘‘(1) IN GENERAL.—For purposes of this part,
the term ‘patient safety organization’ means a private
or public organization that conducts activities to im-
prove patient safety and the quality of health care de-
livery by assisting health care providers that report
to such organizations and that has been certified by
the Secretary as—
‘‘(A) performing each of the activities de-
scribed in paragraph (2); and
‘‘(B) meets the other requirements of para-
graphs (3) through (5).
‘‘(2) ACTIVITIES DESCRIBED.—The activities re-
ferred to in paragraph (1)(A) are the following:
‘‘(A) The collection and analysis of patient
safety data that are voluntarily reported by more
than one health care provider on a local, re-
gional, State, or national basis.
‘‘(B) The development and dissemination of
information to health care providers and other
patient safety organizations with respect to im-
proving patient safety, such as recommendations,
protocols, or information regarding best prac-
tices.
‘‘(C) The utilization of patient safety data
to carry out activities under this paragraph to
improve patient safety and to provide assistance
to health care providers to minimize patient
risk.
‘‘(3) CONDUCT
OF
ACTIVITIES.—In conducting
activities under paragraph (2), a patient safety orga-
nization shall—
‘‘(A) maintain confidentiality with respect
to individually identifiable health information;
‘‘(B) submit non-identifiable information to
the Center for Quality Improvement and Patient
Safety in a format established by the Secretary;
and
‘‘(C) maintain appropriate security meas-
ures with respect to patient safety data.
‘‘(4) ORGANIZATION
REQUIREMENTS.—The re-
quirements of this paragraph for an organization are
that—
‘‘(A) the organization is managed, con-
trolled, and operated independently from health
care providers which report patient safety data
to it under this part;
‘‘(B) if the organization no longer qualifies
as a patient safety organization, with respect to
any patient safety data that it received from a
health care provider, the organization shall do
one of the following:
‘‘(i) with the approval of the provider
and another patient safety organization,
transfer such data to such other organiza-
tion;
‘‘(ii) if practicable, return the data to
the provider; or
‘‘(iii) destroy the patient safety data;
‘‘(C) if the organization charges a fee for the
activities it performs with respect to health care
providers, the fee shall be uniform among all
classes or types of health care providers (taking
into account the size of the health care provider);
‘‘(D) the organization seeks to collect data
from health care providers in a standardized
manner that permits valid comparisons of simi-
lar cases among similar health care providers;
and
‘‘(E) the organization meets such other re-
quirements as the Secretary may by regulation
require.
For purposes of subparagraph (A), an organization is
controlled by a health care provider if the provider is
able to significantly influence or direct the actions or
policies of the organization.
‘‘(5) LIMITATION ON USE OF PATIENT SAFETY
DATA BY PATIENT SAFETY ORGANIZATIONS.—A pa-
tient safety organization may not use patient safety
data reported by a health care provider in accordance
with this part to take regulatory or enforcement ac-
tions it otherwise performs (or is responsible for per-
forming) in relation to such provider.
‘‘(6) TECHNICAL
ASSISTANCE.—The Secretary
may provide technical assistance to patient safety or-
ganizations in providing recommendations and ad-
vice to health care providers reporting patient safety
data under this part. Such assistance shall include
advice with respect to methodology, communication,
dissemination of information, data collection, secu-
rity, and confidentiality concerns.
‘‘(g) CONSTRUCTION.—Nothing in this part shall be
construed to limit or discourage the reporting of informa-
tion relating to patient safety within a health care provider.
‘‘CONFIDENTIALITY AND PEER REVIEW PROTECTIONS
‘‘SEC. 1182. (a) IN GENERAL.—Notwithstanding any
other provision of law, patient safety data shall be privi-
leged and confidential in accordance with this section.
‘‘(b) SCOPE OF PRIVILEGE.—Subject to the succeeding
provisions of this section, such data shall not be—
‘‘(1) subject to a civil or administrative sub-
poena;
‘‘(2) subject to discovery in connection with a
civil or administrative proceeding;
‘‘(3) disclosed pursuant to section 552 of title 5,
United States Code (commonly known as the Freedom
of Information Act) or any other similar Federal or
State law; or
‘‘(4) admitted as evidence or otherwise disclosed
in any civil or administrative proceeding.
‘‘(c) CLARIFICATION OF SCOPE.—The privilege estab-
lished by this section with respect to patient safety data
described in section 1181(e)(1)(A) shall apply to informa-
tion, such as records of a patient’s medical diagnosis and
treatment, other primary health care information, and
other information, to the extent that such information was
collected or developed for the purpose specified in such sec-
tion and is reported in accordance with such section. Such
privilege shall not apply to information merely by reason
of its inclusion, or the fact of its submission, in a report
under such section. Information available from sources
other than a report made under such section may be discov-
ered or admitted in a civil or administrative proceeding,
if discoverable or admissible under applicable state law.
‘‘(d) INFORMATION NOT SUBJECT TO PRIVILEGE.—
The privilege established by this section shall not apply to
one or more of the following:
‘‘(1) MEDICAL RECORDS AND OTHER PRIMARY
HEALTH RECORDS.—Records of a patient’s medical
diagnosis and treatment and other primary health
records of a health care provider. Such privilege shall
not apply to such information by reason of its inclu-
sion within patient safety data.
‘‘(2) FDA.—Relevant information disclosed by a
health care provider or patient safety organization to
the Food and Drug Administration, or to a person
that is subject to the jurisdiction of such Administra-
tion, with respect to an Administration-regulated
product or activity for which that entity has responsi-
bility, for the purposes of activities related to quality,
safety, or effectiveness of such Administration-regu-
lated product or activity, subject to section 520(c) of
the Federal Food, Drug, and Cosmetic Act.
‘‘(3) NON-IDENTIFIABLE INFORMATION USED BY
DATABASE.—Non-identifiable information from a pa-
tient safety organization to the Patient Safety Data-
base and the further disclosure of such data by the
Center for Quality Improvement and Patient Safety.
‘‘(e) REPORTER PROTECTION.—
‘‘(1) IN GENERAL.—A health care provider may
not use against an individual in an adverse employ-
ment action described in paragraph (2) the fact that
the individual in good faith reported—
‘‘(A) to the provider with the intention of
having it reported to a patient safety organiza-
tion, or
‘‘(B) directly to a patient safety organiza-
tion,
information that would constitute patient safety data
under section 1181(e)(1)(A) if the provider were to
have submitted it on a timely basis to a patient safe-
ty organization in accordance with such section.
‘‘(2) ADVERSE EMPLOYMENT ACTION.—For pur-
poses of this subsection, an ‘adverse employment ac-
tion’ includes—
‘‘(A) the failure to promote an individual or
provide any other employment-related benefit for
which the individual would otherwise be eligible;
‘‘(B) an evaluation or decision made in re-
lation 
to 
accreditation, 
certification,
credentialing or licensing of the individual; and
‘‘(C) a personnel action that is adverse to
the individual concerned.
‘‘(3) REMEDIES.—The provisions of the first sen-
tence of section 1128A(a) shall apply with respect to
a health care provider’s violation of paragraph (1) in
the same manner as they apply to an act referred to
in section 1128A(a)(7).
‘‘(f) PENALTY.—It is unlawful for any person to dis-
close any patient safety data in violation of the provisions
of this section. Any person violating such provisions shall
be subject to the same sanctions under section 1160(c) (re-
lating to, upon conviction, a fine of not more than $1,000,
imprisonment for not more than 6 months, or both, per dis-
closure and payment of the costs of prosecution) as a person
who discloses any information described in section 1160(a).
‘‘(g) RULES OF CONSTRUCTION.—
‘‘(1) NO LIMITATION OF OTHER PRIVILEGES.—
Subject to paragraph (2), nothing in this section shall
be construed as affecting other privileges that are
available under Federal or State laws that provide
greater peer review or confidentiality protections than
the peer review and confidentiality protections pro-
vided for in this section.
‘‘(2) NO EFFECT ON STATE MANDATORY REPORT-
ING REQUIREMENTS.—Nothing in this part shall be
construed as preempting or otherwise affecting any
State law mandatory reporting requirement for health
care providers.
‘‘(h) APPLICATION OF PRIVACY REGULATIONS.—For
purposes of applying the regulations promulgated pursuant
to section 264(c) of the Health Insurance Portability and
Accountability Act of 1996 (Public Law 104–191; 110 Stat.
2033)—
‘‘(1) patient safety organizations shall be treated
as business associates;
‘‘(2) activities of such organizations described in
section 1181(f)(2)(A) in relation to a health care pro-
vider are deemed to be health care operations of the
provider; and
‘‘(3) the disclosure of identifiable information
under the voluntary program under this part by such
an organization shall be treated as necessary for the
proper management and administration of the orga-
nization.
Nothing in this section shall be construed to alter or affect
the implementation of such regulation or such section
264(c).
‘‘(i) WAIVERS.—Nothing in this part shall be con-
strued as precluding a health care provider from waiving
the privilege or confidentiality protections under this sec-
tion. Disclosure of patient safety data under subsection
(d)(2) shall not constitute a waiver of any privilege or pro-
tection established under this section or under State law.
‘‘(j) CONTINUATION
OF PRIVILEGE.—Patient safety
data of an organization that is certified as a patient safety
organization shall continue to be privileged and confiden-
tial, in accordance with this section, if the organization’s
certification is terminated or revoked or if the organization
otherwise ceases to qualify as a patient safety organization
until the data are otherwise disposed of in accordance with
section 1181(f)(4).
‘‘(k) SURVEY AND REPORT.—