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care practitioners, or other providers of health
care items or services.
‘‘(3) CONFIDENTIALITY AND PEER REVIEW PRO-
TECTIONS.—Notwithstanding any other provision of
law any information (including any data, reports,
records, memoranda, analyses, statements, and other
communications) developed by or on behalf of a health
care provider or provider of services with respect to
a medical event, that is contained in the National Pa-
tient Safety Database shall be confidential in accord-
ance with section 925.
‘‘(4) PATIENT SAFETY REPORTING SYSTEMS.—
The Director shall identify public and private sector
patient safety reporting systems and build scientific
knowledge and understanding regarding the most
effective—
‘‘(A) components of patient safety reporting
systems;
‘‘(B) incentives intended to increase the rate
of error reporting;
‘‘(C) approaches for undertaking root cause
analyses;
‘‘(D) ways to provide feedback to those fil-
ing error reports;
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‘‘(E) techniques and tools for collecting, in-
tegrating, and analyzing patient safety data;
and
‘‘(F) ways to provide meaningful informa-
tion to patients, consumers, and purchasers that
will enhance their understanding of patient safe-
ty issues.
‘‘(5) TRAINING.—The Director shall support
training initiatives to build the capacity of the health
care community in the United States to analyze pa-
tient safety data and to act on that data to improve
patient safety.
‘‘(d) EVALUATION.—The Director shall recommend
strategies for measuring and evaluating the national
progress made in implementing safe practices identified by
the Center through the research and analysis required under
subsection (b) and through the voluntary reporting system
established under subsection (c).
‘‘(e) IMPLEMENTATION.—In implementing strategies to
carry out the functions described in subsections (b), (c), and
(d), the Director may contract with public or private enti-
ties on a national or local level with appropriate expertise.
‘‘SEC. 923. MEDICAL EVENT ANALYSIS ENTITIES.
‘‘(a) IN GENERAL.—The Director, based on informa-
tion collected under section 922(c), shall provide for the cer-
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tification of entities to collect and analyze information on
medical errors, and to collaborate with health care providers
or providers of services in collecting information about, or
evaluating, certain medical events.
‘‘(b) COMPATIBILITY OF COLLECTED DATA.—To en-
sure that data reported to the National Patient Safety
Database under section 922(c)(2) concerning medical errors
and close calls are comparable and useful on an analytic
basis, the Director shall require that the entities described
in subsection (c) follow the recommendations regarding a
common set of core measures for reporting that are devel-
oped by the National Forum for Health Care Quality Meas-
urement and Reporting, or other voluntary private stand-
ard-setting organization that is designated by the Director
taking into account existing measurement systems and in
collaboration with experts from the public and private sec-
tor.
‘‘(c) DUTIES OF CERTIFIED ENTITIES.—
‘‘(1) IN GENERAL.—An entity that is certified
under subsection (a) shall collect and analyze infor-
mation, consistent with the requirement of subsection
(b), provided to the entity under section 924(a)(4) to
improve patient safety.
‘‘(2) INFORMATION TO BE REPORTED TO THE EN-
TITY.—A medical event analysis entity shall, on a
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periodic basis and in a format that is specified by the
Director, submit to the Director a report that
contains—
‘‘(A) a description of the medical events
that were reported to the entity during the pe-
riod covered under the report;
‘‘(B) a description of any corrective action
taken by providers of services with respect to
such medical events or any other measures that
are necessary to prevent similar events from oc-
curring in the future; and
‘‘(C) a description of the systemic changes
that entities have identified, through an analysis
of the medical events included in the report, as
being needed to improve patient safety.
‘‘(3) COLLABORATION.—A medical event analysis
entity that is collaborating with a health care pro-
vider or provider of services to address close calls and
adverse events may, at the request of the health care
provider or provider of services—
‘‘(A) provide expertise in the development of
root cause analyses and corrective action plan
relating to such close calls and adverse events; or
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‘‘(B) collaborate with such provider of serv-
ices to identify on-going risk reduction activities
that may enhance patient safety.
‘‘(d) CONFIDENTIALITY AND PEER REVIEW PROTEC-
TIONS.—Notwithstanding any other provision of law, any
information (including any data, reports, records, memo-
randa, analyses, statements, and other communications)
collected by a medical event analysis entity or developed
by or on behalf of such an entity under this part shall be
confidential in accordance with section 925.
‘‘(e) TERMINATION AND RENEWAL.—
‘‘(1) IN GENERAL.—The certification of an entity
under this section shall terminate on the date that is
3 years after the date on which such certification was
provided. Such certification may be renewed at the
discretion of the Director.
‘‘(2) NONCOMPLIANCE.—The Director may ter-
minate the certification of a medical event analysis
entity if the Director determines that such entity has
failed to comply with this section.
‘‘(f) IMPLEMENTATION.—In implementing strategies to
carry out the functions described in subsection (c), the Di-
rector may contract with public or private entities on a
national or local level with appropriate expertise.
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‘‘SEC. 924. PROVIDER OF SERVICES SYSTEMS FOR REPORT-
ING MEDICAL EVENTS.
‘‘(a) INTERNAL MEDICAL EVENT REPORTING SYS-
TEMS.—Each provider of services that elects to participate
in a medical error reporting system under this part shall—
‘‘(1) establish a system for—
‘‘(A) identifying, collecting information
about, and evaluating medical events that occur
with respect to a patient in the care of the pro-
vider of services or a practitioner employed by
the provider of services, that may include—
‘‘(i) the provision of a medically coher-
ent description of each event so identified;
‘‘(ii) the provision of a clear and thor-
ough accounting of the results of the inves-
tigation of such event under the system; and
‘‘(iii) a description of all corrective
measures taken in response to the event; and
‘‘(B) determining appropriate follow-up ac-
tions to be taken with respect to such events;
‘‘(2) establish policies and procedures with re-
spect to when and to whom such events are to be re-
ported;
‘‘(3) take appropriate follow-up action with re-
spect to such events; and
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‘‘(4) submit to the appropriate medical event
analysis entity information that contains descriptions
of the medical events identified under paragraph
(1)(A).
‘‘(b) PROMOTING IDENTIFICATION, EVALUATION, AND
REPORTING OF CERTAIN MEDICAL EVENTS.—
‘‘(1) IN GENERAL.—Notwithstanding any other
provision of law any information (including any
data, reports, records, memoranda, analyses, state-
ments, and other communications) developed by or on
behalf of a provider of services with respect to a med-
ical event pursuant to a system established under sub-
section (a) shall be privileged in accordance with sec-
tion 925.
‘‘(2) RULES OF CONSTRUCTION.—Nothing in this
subsection shall be construed as prohibiting—
‘‘(A) disclosure of a patient’s medical record
to the patient;
‘‘(B) a provider of services from complying
with the requirements of a health care oversight
agency or public health authority; or
‘‘(C) such an agency or authority from dis-
closing information transferred by a provider of
services to the public in a form that does not
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identify or permit the identification of the health
care provider or provider of services or patient.
‘‘SEC. 925. CONFIDENTIALITY.
‘‘(a) CONFIDENTIALITY AND PEER REVIEW PROTEC-
TIONS.—Notwithstanding any other provision of law—
‘‘(1) any information (including any data, re-
ports, records, memoranda, analyses, statements, and
other communications) developed by or on behalf of a
health care provider or provider of services with re-
spect to a medical event, that is contained in the Na-
tional Patient Safety Database, collected by a medical
event analysis entity, or developed by or on behalf of
such an entity, or collected by a health care provider
or provider or services for use under systems that are
developed for safety and quality improvement pur-
poses under this part—
‘‘(A) shall be privileged, strictly confiden-
tial, and may not be disclosed by any other per-
son to which such information is transferred
without the authorization of the health care pro-
vider or provider of services; and
‘‘(B) shall—
‘‘(i) be protected from disclosure by
civil, criminal, or administrative subpoena;
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‘‘(ii) not be subject to discovery or oth-
erwise discoverable in connection with a
civil, criminal, or administrative pro-
ceeding;
‘‘(iii) not be subject to disclosure pur-
suant to section 552 of title 5, United States
Code (the Freedom of Information Act) and
any other similar Federal or State statute
or regulation; and
‘‘(iv) not be admissible as evidence in
any civil, criminal, or administrative pro-
ceeding;
without regard to whether such information is
held by the provider or by another person to
which such information was transferred;
‘‘(2) the transfer of any such information by a
provider of services to a health care oversight agency,
an expert organization, a medical event analysis enti-
ty, or a public health authority, shall not be treated
as a waiver of any privilege or protection established
under paragraph (1) or established under State law.
‘‘(b) PENALTY.—It shall be unlawful for any person
to disclose any information described in subsection (a) other
than for the purposes provided in such subsection. Any per-
son violating the provisions of this section shall, upon con-
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viction, be fined in accordance with title 18, United States
Code, and imprisoned for not more than 6 months, or both.
‘‘(c) APPLICATION OF PROVISIONS.—The protections
provided under subsection (a) and the penalty provided for
under subsection (b) shall apply to any information (in-
cluding any data, reports, memoranda, analyses, state-
ments, and other communications) collected or developed
pursuant to research, including demonstration projects,
with respect to medical error reporting supported by the
Director under this part.
‘‘SEC. 926. AUTHORIZATION OF APPROPRIATIONS.
‘‘There is authorized to be appropriated to carry out
this part, $50,000,000 for fiscal year 2001, and such sums
as may be necessary for subsequent fiscal years.’’.
SEC. 2504. EFFECTIVE DATE.
The amendments made by section 2503 shall become
effective on the date of the enactment of this Act.
This Act may be cited as the ‘‘Departments of Labor,
Health and Human Services, and Education, and Related
Agencies Appropriations Act, 2001’’.
Passed the House of Representatives June 14, 2000.
Attest:
JEFF TRANDAHL,
Clerk.
Passed the Senate June 30, 2000.
Attest:
GARY SISCO,
Secretary.