‘‘(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, acting
through the Director of the Agency for Healthcare Research
and Quality, shall ensure that the Center for Quality Im-
provement and Patient Safety (in this section referred to
as the ‘Center’) supports public and private sector initia-
tives to improve patient safety for items and services fur-
nished through health care providers.
‘‘(b) DUTIES.—
‘‘(1) 
IN
GENERAL.—The 
Secretary, 
acting
through the Director, shall ensure that the Center car-
ries 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, 
acting
through the Director, 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) AUTHORIZATION OF APPROPRIATIONS.—There are
authorized to be appropriated such sums as may be nec-
essary 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 2002).
‘‘(c) DISSEMINATION.—The Secretary shall provide for
the dissemination of the standards developed and updated
under this section.
‘‘(d) AUTHORIZATION
OF APPROPRIATIONS.—There
are authorized to be appropriated such sums as may be nec-
essary 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).’’.
SEC. 3. MEDICAL INFORMATION TECHNOLOGY ADVISORY
BOARD.
(a) ESTABLISHMENT.—
(1) IN GENERAL.—Not later than 3 months after
the date of the enactment of this Act, the Secretary of
Health and Human Services (in this section referred
to as the ‘‘Secretary’’) shall appoint an advisory
board to be known as the ‘‘Medical Information Tech-
nology Advisory Board’’ (in this section referred to as
the ‘‘MITAB’’).
(2) CHAIRMAN.—The Secretary shall designate
one member as chairman. The chairman shall be an
individual affiliated with an organization having ex-
pertise creating American National Standards Insti-
tute (ANSI) accepted standards in health care infor-
mation technology and a member of the National
Committee for Vital and Health Statistics.
(b) COMPOSITION.—
(1) IN GENERAL.—The MITAB shall consist of
not more than 17 members that include—
(A) experts from the fields of medical infor-
mation, information technology, medical contin-
uous quality improvement, medical records secu-
rity and privacy, individual and institutional
health care clinical providers, health researchers,
and health care purchasers;
(B) one or more staff experts from each of
the following: the Centers for Medicare & Med-
icaid Services, the Agency for Healthcare Re-
search and Quality, and the Institute of Medi-
cine of the National Academy of Sciences;
(C) representatives of private organizations
with expertise in medical infomatics;
(D) a representative of a teaching hospital;
and
(E) one or more representatives of the health
care information technology industry.
(2) TERMS OF APPOINTMENT.—The term of any
appointment under paragraph (1) to the MITAB
shall be for the life of the MITAB.
(3) MEETINGS.—The MITAB shall meet at the
call of its chairman or a majority of its members.
(4) VACANCIES.—A vacancy on the MITAB shall
be filled in the same manner in which the original
appointment was made not later than 30 days after
the MITAB is given notice of the vacancy and shall
not affect the power of the remaining members to exe-
cute the duties of the MITAB.
(5) COMPENSATION.—Members of the MITAB
shall receive no additional pay, allowances, or bene-
fits by reason of their service on the MITAB.
(6) EXPENSES.—Each member of the MITAB
shall receive travel expenses and per diem in lieu of
subsistence in accordance with sections 5702 and
5703 of title 5, United States Code.
(c) DUTIES.—
(1) IN GENERAL.—The MITAB shall on an ongo-
ing basis advise, and make recommendations to, the
Secretary regarding medical information technology,
including the following:
(A) The best current practices in medical
information technology.
(B) Methods for the adoption (not later
than 2 years after the date of the enactment of
this section) of a uniform health care informa-
tion system interface between and among old
and new computer systems.
(C) Recommendations for health care vocab-
ulary, messaging, and other technology standards
(including a common lexicon for computer tech-
nology) necessary to achieve the interoperability
of health care information systems for the pur-
poses described in subparagraph (E).
(D) Methods of implementing—
(i) health care information technology
interoperability standardization; and
(ii) records security.
(E) Methods to promote information ex-
change among health care providers so that long-
term compatibility among information systems
is maximized, in order to do one or more of the
following:
(i) To maximize positive outcomes in
clinical care—
(I) by providing decision support
for diagnosis and care; and
(II) by assisting in the emergency
treatment of a patient presenting at a
facility where there is no medical
record for the patient.
(ii) To contribute to (and be consistent
with) the development of the patient assess-
ment instrument provided for under section
545 of the Medicare, Medicaid, and SCHIP
Benefits Improvement and Protection Act of
2000, and to assist in minimizing the need
for new and different records as patients
move from provider to provider.
(iii) To reduce or eliminate the need
for redundant records, paperwork, and the
repetitive taking of patient histories and
administering of tests.
(iv) To minimize medical errors, such
as administration of contraindicated drugs.
(v) To provide a compatible informa-
tion technology architecture that facilitates
future quality and cost-saving needs and
that avoids the financing and development
of information technology systems that are
not readily compatible.
(2) REPORTS.—
(A) INITIAL
REPORT.—No later than 18
months after the date of the enactment of this
Act, the MITAB shall submit to Congress and the
Secretary an initial report concerning the mat-
ters described in paragraph (1). The report shall
include—
(i) the practices described in para-
graph (1)(A), including the status of health
care information technology standards being
developed by private sector and public-pri-
vate groups;
(ii) recommendations for accelerating
the development of common health care ter-
minology standards;
(iii) recommendations for completing
development of health care information sys-
tem messaging standards; and
(iv) progress toward meeting the dead-
line described in paragraph (1)(B) for
adoption of methods described in such para-
graph.
(B) SUBSEQUENT REPORTS.—During each
of the 2 years after the year in which the report
is submitted under subparagraph (A), the
MITAB shall submit to Congress and the Sec-
retary an annual report relating to additional
recommendations, best practices, results of infor-
mation technology improvements, analyses of
private sector efforts to implement the interoper-
ability standards established in section 1184 of
the Social Security Act, and such other matters
as may help ensure the most rapid dissemination
of best practices in health care information tech-
nology.
(d) STAFF AND SUPPORT SERVICES.—
(1) EXECUTIVE DIRECTOR.—
(A) APPOINTMENT.—The Chairman shall
appoint an executive director of the MITAB.
(B) COMPENSATION.—The executive director
shall be paid the rate of basic pay for level V of
the Executive Schedule.
(2) STAFF.—With the approval of the MITAB,
the executive director may appoint such personnel as
the executive director considers appropriate.
(3) APPLICABILITY OF CIVIL SERVICE LAWS.—
The staff of the MITAB shall be appointed without re-
gard to the provisions of title 5, United States Code,
governing appointments in the competitive service,
and shall be paid without regard to the provisions of
chapter 51 and subchapter III of chapter 53 of such
title (relating to classification and General Schedule
pay rates).
(4) EXPERTS AND CONSULTANTS.—With the ap-
proval of the MITAB, the executive director may pro-
cure temporary and intermittent services under sec-
tion 3109(b) of title 5, United States Code.
(e) POWERS.—
(1) HEARINGS AND OTHER ACTIVITIES.—For the
purpose of carrying out its duties, the MITAB may
hold such hearings and undertake such other activities
as the MITAB determines to be necessary to carry out
its duties.
(2) DETAIL OF FEDERAL EMPLOYEES.—Upon the
request of the MITAB, the head of any Federal agency
is authorized to detail, without reimbursement, any of
the personnel of such agency to the MITAB to assist
the MITAB in carrying out its duties. Any such de-
tail shall not interrupt or otherwise affect the civil
service status or privileges of the Federal employee.
(3) TECHNICAL ASSISTANCE.—Upon the request
of the MITAB, the head of a Federal agency shall pro-
vide such technical assistance to the MITAB as the
MITAB determines to be necessary to carry out its
duties.
(4) OBTAINING INFORMATION.—The MITAB may
secure directly from any Federal agency information
necessary to enable it to carry out its duties, if the
information may be disclosed under section 552 of
title 5, United States Code. Upon request of the
Chairman of the MITAB, the head of such agency
shall furnish such information to the MITAB.
(f) TERMINATION.—The MITAB shall terminate 30
days after the date of submission of its final report under
subsection (c)(2)(B).
(g) APPLICABILITY OF FACA.—The provisions of the
Federal Advisory Committee Act (5 U.S.C. App.) shall
apply to the MITAB.
(h) AUTHORIZATION OF APPROPRIATIONS.—There are
authorized to be appropriated to the Secretary of Health
and Human Services such sums as are necessary to carry
out this section.
Union Calendar No. 468
107TH CONGRESS
2D SESSION
H. R. 4889
[Report No. 107–714, Part I]
A BILL
To amend title XI of the Social Security Act to
improve patient safety.
OCTOBER 11, 2002
Committee on Energy and Commerce discharged; com-
mitted to the Committee of the Whole House on the
State of the Union and ordered to be printed