IB 
Union Calendar No. 24
108TH CONGRESS 
1ST SESSION 
H. R. 877
[Report No. 108–31, Part I] 
To amend title XI of the Social Security Act to improve patient safety. 
IN THE HOUSE OF REPRESENTATIVES 
FEBRUARY 25, 2003
Mrs. JOHNSON of Connecticut (for herself, Mr. STARK, Mr. THOMAS, Mr. 
CAMP, Mr. LEWIS of Kentucky, Mr. MCINNIS, Mr. HOUGHTON, Mr. 
HERGER, Mr. WELLER, Mr. SMITH of New Jersey, Mr. ENGLISH, and 
Mr. PETERSON of Pennsylvania) 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 de-
termined by the Speaker, in each case for consideration of such provisions 
as fall within the jurisdiction of the committee concerned 
MARCH 11, 2003
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] 
MARCH 11, 2003
Referral to the Committee on Energy and Commerce extended for a period 
ending not later than March 13, 2003
MARCH 13, 2003
Additional sponsors: Mr. PORTMAN, Mr. MCCRERY, and Mr. POMEROY 
MARCH 13, 2003
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 February 25, 2003] 
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 2003’’. 
(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:
‘‘PART D—PATIENT SAFETY IMPROVEMENTS 
‘‘VOLUNTARY REPORTING OF PATIENT SAFETY DATA; 
DEFINITIONS 
‘‘SEC. 1181. (a) COLLECTION AND VOLUNTARY RE-
PORTING OF PATIENT SAFETY DATA.—In order to improve 
patient safety and the quality of health care delivery, a 
health care provider (as defined in subsection (d)) may vol-
untarily collect and develop patient safety data (as defined 
in subsection (e)) and report such data to one or more pa-
tient safety organizations (as defined in subsection (f)) in 
a manner that is confidential and privileged (as described 
in section 1182). 
‘‘(b) USE OF PATIENT SAFETY DATA BY PATIENT 
SAFETY
ORGANIZATIONS.—Patient safety organizations 
shall analyze the patient safety data reported and develop 
(and report back to health care providers) information to 
improve patient safety and the quality of health care deliv-
ery and shall submit non-identifiable information derived 
from such data in a uniform manner to the Center for 
Quality Improvement and Patient Safety (for inclusion in 
the Patient Safety Database, if applicable). Such non-iden-
tifiable information may be disclosed and shared with other 
patient safety organizations. Identifiable patient safety 
data may be disclosed to other patient safety organizations
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 
a provider of services (as defined in section 1861(u) and 
including a hospital, skilled nursing facility, 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 employees, and includes physicians inso-
far as they furnish health care services in the health care 
provider. 
‘‘(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 
delivery 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) 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.—
‘‘(1) PROHIBITION.—It is unlawful for any per-
son to disclose any patient safety data in violation of 
the provisions of this section. 
‘‘(2) AMOUNT.—Any person who violates para-
graph (1) shall be subject to a civil monetary penalty 
of not more than $10,000 for each such violation in-
volved. The provisions of section 1128A (other than 
subsections (a) and (b)) shall apply to a civil money 
penalty under this paragraph in the same manner as 
they apply to a penalty or proceeding under section 
1128A(a). 
‘‘(3) RELATION TO HIPAA.—The penalty under 
paragraph (2) for a disclosure in violation of para-
graph (1) does not apply if the person would be sub-
ject to a penalty under section 264(c) of the Health 
Insurance Portability and Accountability Act of 1996 
(Public Law 104–191; 110 Stat. 2033), or any regu-
lation promulgated under such section, for the same 
disclosure.
‘‘(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. 
‘‘(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.— 
‘‘(1) SURVEY.—The Comptroller General of the 
United States shall conduct a survey of State laws 
that relate to patient safety data peer review systems, 
including laws that establish an evidentiary privilege
applicable to data developed in such systems, and 
shall review the manner in which such laws have been 
interpreted by the courts and the effectiveness of such 
laws in promoting patient safety. 
‘‘(2) REPORT.—Not later than 9 months after the 
date of enactment of this section, the Comptroller 
General shall prepare and submit to Congress a re-
port concerning the results of the survey conducted 
under paragraph (1). 
‘‘CENTER FOR QUALITY IMPROVEMENT AND PATIENT 
SAFETY 
‘‘SEC. 1183. (a) IN GENERAL.—The Secretary shall en-
sure that the Center for Quality Improvement and Patient 
Safety (in this section referred to as the ‘Center’) supports 
public and private sector initiatives to improve patient
safety for items and services furnished through health care 
providers. 
‘‘(b) DUTIES.—
‘‘(1) IN GENERAL.—The Secretary shall ensure 
that the Center carries out the following duties: 
‘‘(A) Provide for the certification and recer-
tification of patient safety organizations in ac-
cordance with subsection (d). 
‘‘(B) Collect and disseminate information 
related to patient safety.
‘‘(C) Establish a Patient Safety Database to 
collect, support, and coordinate the analysis of 
non-identifiable information submitted to the 
Database in accordance with subsection (e). 
‘‘(D) Facilitate the development of con-
sensus among health care providers, patients, 
and other interested parties concerning patient 
safety and recommendations to improve patient 
safety. 
‘‘(E) Provide technical assistance to States 
that have (or are developing) medical errors re-
porting systems, assist States in developing 
standardized methods for data collection, and 
collect data from State reporting systems for in-
clusion in the Patient Safety Database. 
‘‘(2) CONSULTATION.—In carrying out the duties 
under paragraph (1) (including the establishment of 
the Database), the Secretary shall consult with and 
develop partnerships, as appropriate, with health care 
organizations, health care providers, public and pri-
vate sector entities, patient safety organizations, 
health care consumers, and other relevant experts to 
improve patient safety. 
‘‘(c) CERTIFICATION
AND RECERTIFICATION PROC-
ESS.—
‘‘(1) IN GENERAL.—The initial certification and 
recertification of a patient safety organization under 
subsection (b)(1)(A) shall be made under a process 
that is approved by the Secretary and is consistent 
with criteria published by the Secretary. 
‘‘(2) REVOCATION.—Such a certification or re-
certification may be revoked by the Secretary upon a 
showing of cause (including the disclosure of data in 
violation of section 1182). 
‘‘(3) TERMINATION.—Such a certification pro-
vided for a patient safety organization shall termi-
nate (subject to recertification) on the earlier of—
‘‘(A) the date that is 3 years after the date 
on which such certification was provided; or 
‘‘(B) the date on which the Secretary re-
vokes the certification. 
‘‘(d) IMPLEMENTATION AND CONSULTATION.—In car-
rying out subsection (c)(1), the Secretary shall— 
‘‘(1) facilitate the development of patient safety 
goals and track the progress made in meeting those 
goals; and 
‘‘(2) ensure that data submitted by a patient 
safety organization to the Patient Safety Database, as 
provided for under subsection (e), are comparable and 
useful for research and analysis and that the research
findings and patient safety alerts that result from 
such analyses are presented in clear and consistent 
formats that enhance the usefulness of such alerts. 
‘‘(e) PATIENT SAFETY DATABASE.—
‘‘(1) IN GENERAL.—The Secretary shall—
‘‘(A) establish a Patient Safety Database to 
collect non-identifiable information concerning 
patient safety that is reported on a voluntary 
basis; and 
‘‘(B) establish common formats for the vol-
untary reporting of data under subparagraph 
(A), including the establishment of necessary 
data elements, common and consistent defini-
tions, and a standardized computer interface for 
the processing of such data. 
‘‘(2) DATABASE.—In carrying out this sub-
section, the Secretary— 
‘‘(A) shall establish and modify as necessary 
criteria to determine the organizations that may 
voluntarily contribute to, and the data that com-
prises, the Patient Safety Database; 
‘‘(B) shall ensure that the Patient Safety 
Database is only used by qualified entities or in-
dividuals as determined appropriate by the Sec-
retary in accordance with criteria applied by the 
Secretary; and 
‘‘(C) may enter into contracts for the ad-
ministration of the Database with private and 
public entities with experience in the adminis-
tration of similar databases. 
‘‘(3) 
NON-IDENTIFIABLE
INFORMATION.—For 
purposes of this part, the term ‘non-identifiable infor-
mation’ means information that is presented in a 
form and manner that prevents the identification of 
any health care provider, patient, and the reporter of 
the information. 
‘‘(f) FUNDING.—The Secretary shall transfer from the 
Federal Hospital Insurance Trust Fund established under 
section 1817 such sums as are necessary for each fiscal year 
to carry out this section. 
‘‘INTEROPERABILITY STANDARDS FOR HEALTH CARE 
INFORMATION TECHNOLOGY SYSTEMS 
‘‘SEC. 1184. (a) IN GENERAL.—By not later than 2 
years after the date of the enactment of this part, the Sec-
retary shall develop or adopt (and shall periodically review 
and update) voluntary, national standards that promote 
the interoperability of health care information technology 
systems across all health care settings. In promulgating reg-
ulations to carry out this section, the Secretary shall take 
into account the cost that meeting such standards would
have on providing health care in the United States and the 
increased efficiencies in providing such care achieved under 
the standards. 
‘‘(b) CONSULTATION AND COORDINATION.—The Sec-
retary shall develop and update such standards in consulta-
tion with (and with coordination between)—
‘‘(1) the National Committee for Vital and 
Health Statistics, and 
‘‘(2) the Medical Information Technology Advi-
sory Board (established under section 3 of the Patient 
Safety Improvement Act of 2003). 
‘‘(c) DISSEMINATION.—The Secretary shall provide for 
the dissemination of the standards developed and updated 
under this section.
‘‘(d) FUNDING.—The Secretary shall transfer from the 
Federal Hospital Insurance Trust Fund established under 
section 1817 such sums as are necessary for each fiscal year 
to carry out this section. 
‘‘VOLUNTARY ADOPTION OF METHODS TO IMPROVE PATIENT 
SAFETY 
‘‘SEC. 1185. The Secretary shall encourage health care 
providers to adopt appropriate evidence-based methods to 
improve patient safety. Such methods shall not constitute 
national practice guidelines.
‘‘EVALUATION AND REPORT 
‘‘SEC. 1186. (a) EVALUATION.—The Comptroller Gen-
eral of the United States shall conduct a comprehensive 
evaluation of the implementation of this part. Such evalua-
tion shall include an examination of the following: 
‘‘(1) The health care providers that reported pa-
tient safety data under this part and the patient safe-
ty organizations to which they reported the informa-
tion. 
‘‘(2) What types of events were so reported on. 
‘‘(3) The usefulness of the analyses, information, 
and recommendations provided by patient safety or-
ganizations in response to such reported information. 
‘‘(4) The response of health care providers to 
such analyses, information, and recommendations, in-
cluding a survey of providers to obtain estimates of 
the percentage of providers by category who have 
adopted specific error-reduction methods and, if ap-
plicable, reasons for not adopting specific practices. 
‘‘(5) The effectiveness of the program under this 
part in reducing medical errors. 
‘‘(b) REPORT.—Not later than 5 years after the date 
the provisions of this part are first implemented, the Comp-
troller General shall submit to Congress a report on the 
evaluation conducted under subsection (a).’’.