[House Report 107-714]
[From the U.S. Government Publishing Office]
107th Congress Rept. 107-714
HOUSE OF REPRESENTATIVES
2d Session Part 1
======================================================================
PATIENT SAFETY IMPROVEMENT ACT OF 2002
_______
October 1, 2002.--Ordered to be printed
_______
Mr. Thomas, from the Committee on Ways and Means, submitted the
following
R E P O R T
[To accompany H.R. 4889]
[Including cost estimate of the Congressional Budget Office]
The Committee on Ways and Means, to whom was referred the
bill (H.R. 4889) to amend title XI of the Social Security Act
to improve patient safety, having considered the same, report
favorably thereon with an amendment and recommend that the bill
as amended do pass.
CONTENTS
Page
I. Introduction......................................................9
A. Purpose and Summary................................... 9
B. Legislative History................................... 10
II. Explanation of Provisions........................................11
A. Analysis of Legislation and Comparison With Present
Law.................................................. 11
a. Section 1, Short Title, Table of Contents......... 11
b. Section 2, Patient Safety Improvements............ 11
c. Section 3, Medical Information Technology Advisory
Board............................................ 16
III.Votes of the Committee...........................................18
IV. Budget Effects of the Bill.......................................19
A. Committee Estimate of Budgetary Effects............... 19
B. Statement Regarding New Budget Authority and Tax
Expenditures......................................... 19
C. Cost Estimate Prepared by the Congressional Budget
Office............................................... 19
V. Other Matters To Be Discussed Under the Rules of the House.......22
A. Committee Oversight Findings and Recommendations...... 22
B. Constitutional Authority Statement.................... 22
C. Information Relating to Unfunded Mandates............. 22
D. Summary of General Performance Goals and Objectives... 22
VI. Changes in Existing Law Made by the Bill as Reported.............23
The amendment is as follows:
Strike all after the enacting clause and insert the
following:
SECTION 1. SHORT TITLE; TABLE OF CONTENTS.
(a) Short Title.--This Act may be cited as the ``Patient 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 technology 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 adding 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 Reporting 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 voluntarily collect and develop patient safety data (as defined in
subsection (e)) and report such data to one or more patient 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
delivery 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-identifiable 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 purposes 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 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;
``(2) a health care entity or individual that furnishes
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 payment may be made under
such title, including a physician (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, reports, records,
memoranda, analyses, deliberative work, statements, or root
cause analyses that are collected 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 transmitted 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 improve patient
safety, quality, and efficiency.--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 collected 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 Organizations.--
``(1) In general.--For purposes of this part, the term
`patient safety organization' means a private or public
organization that conducts activities to improve 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 described in
paragraph (2); and
``(B) meets the other requirements of paragraphs (3)
through (5).
``(2) Activities described.--The activities referred 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, regional, State, or
national basis.
``(B) The development and dissemination of
information to health care providers and other patient
safety organizations with respect to improving patient
safety, such as recommendations, protocols, or
information regarding best practices.
``(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 organization 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 measures with
respect to patient safety data.
``(4) Organization requirements.--The requirements of this
paragraph for an organization are that--
``(A) the organization is managed, controlled, 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 organization;
``(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 similar cases among
similar health care providers; and
``(E) the organization meets such other requirements
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 patient safety organization may not
use patient safety data reported by a health care provider in
accordance with this part to take regulatory or enforcement
actions it otherwise performs (or is responsible for
performing) in relation to such provider.
``(6) Technical assistance.--The Secretary may provide
technical assistance to patient safety organizations in
providing recommendations and advice 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,
security, and confidentiality concerns.
``(g) Construction.--Nothing in this part shall be construed to limit
or discourage the reporting of information 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 privileged 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 subpoena;
``(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 established by this
section with respect to patient safety data described in section
1181(e)(1)(A) shall apply to information, 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 section
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 discovered 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
inclusion 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 Administration, with respect to an
Administration-regulated product or activity for which that
entity has responsibility, for the purposes of activities
related to quality, safety, or effectiveness of such
Administration-regulated 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 patient safety organization to
the Patient Safety Database 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 employment 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 organization, or
``(B) directly to a patient safety organization,
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 safety organization in
accordance with such section.
``(2) Adverse employment action.--For purposes of this
subsection, an `adverse employment action' 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 relation 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 sentence 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 disclose any patient
safety data in violation of the provisions of this section. Any person
violating such provisions shall subject to the same sanctions under
section 1160(c) (relating to, upon conviction, a fine of not more than
$1,000, imprisonment for not more than 6 months, or both, per
disclosure 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 provided for in this section.
``(2) No effect on state mandatory reporting 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 provider 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 organization.
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 construed as precluding
a health care provider from waiving the privilege or confidentiality
protections under this section. Disclosure of patient safety data under
subsection (d)(2) shall not constitute a waiver of any privilege or
protection 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 confidential, 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 report 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 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, acting through the
Director, shall ensure that the Center carries out the
following duties:
``(A) Provide for the certification and
recertification of patient safety organizations in
accordance 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 consensus 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 reporting
systems, assist States in developing standardized
methods for data collection, and collect data from
State reporting systems for inclusion 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 private sector entities, patient safety
organizations, health care consumers, and other relevant
experts to improve patient safety.
``(c) Certification and Recertification Process.--
``(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 recertification
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 provided for a
patient safety organization shall terminate (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 revokes the
certification.
``(d) Implementation and Consultation.--In carrying 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 voluntary
reporting of data under subparagraph (A), including the
establishment of necessary data elements, common and
consistent definitions, and a standardized computer
interface for the processing of such data.
``(2) Database.--In carrying out this subsection, the
Secretary--
``(A) shall establish and modify as necessary
criteria to determine the organizations that may
voluntarily contribute to, and the data that comprises,
the Patient Safety Database;
``(B) shall ensure that the Patient Safety Database
is only used by qualified entities or individuals as
determined appropriate by the Secretary in accordance
with criteria applied by the Secretary; and
``(C) may enter into contracts for the administration
of the Database with private and public entities with
experience in the administration of similar databases.
``(3) Non-identifiable information.--For purposes of this
part, the term `non-identifiable information' 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 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 Secretary 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
regulations 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 Secretary shall develop and
update such standards in consultation with (and with coordination
between)--
``(1) the National Committee for Vital and Health Statistics,
and
``(2) the Medical Information Technology Advisory 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 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 General of the United
States shall conduct a comprehensive evaluation of the implementation
of this part. Such evaluation shall include an examination of the
following:
``(1) The health care providers that reported patient safety
data under this part and the patient safety organizations to
which they reported the information.
``(2) What types of events were so reported on.
``(3) The usefulness of the analyses, information, and
recommendations provided by patient safety organizations in
response to such reported information.
``(4) The response of health care providers to such analyses,
information, and recommendations, including a survey of
providers to obtain estimates of the percentage of providers by
category who have adopted specific error-reduction methods and,
if applicable, 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 Comptroller 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 Technology 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 expertise creating American National
Standards Institute (ANSI) accepted standards in health care
information 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 information,
information technology, medical continuous quality
improvement, medical records security 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 & Medicaid
Services, the Agency for Healthcare Research and
Quality, and the Institute of Medicine 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 execute the duties of the MITAB.
(5) Compensation.--Members of the MITAB shall receive no
additional pay, allowances, or benefits 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 ongoing 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 information system interface
between and among old and new computer systems.
(C) Recommendations for health care vocabulary,
messaging, and other technology standards (including a
common lexicon for computer technology) necessary to
achieve the interoperability of health care information
systems for the purposes described in subparagraph (E).
(D) Methods of implementing--
(i) health care information technology
interoperability standardization; and
(ii) records security.
(E) Methods to promote information exchange 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 assessment
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 information
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 matters described in paragraph (1). The
report shall include--
(i) the practices described in paragraph
(1)(A), including the status of health care
information technology standards being
developed by private sector and public-private
groups;
(ii) recommendations for accelerating the
development of common health care terminology
standards;
(iii) recommendations for completing
development of health care information system
messaging standards; and
(iv) progress toward meeting the deadline
described in paragraph (1)(B) for adoption of
methods described in such paragraph.
(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 Secretary an annual report relating to
additional recommendations, best practices, results of
information technology improvements, analyses of
private sector efforts to implement the
interoperability 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 technology.
(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 regard 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 approval of the MITAB,
the executive director may procure temporary and intermittent
services under section 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 detail 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 provide 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.
I. INTRODUCTION
A. Purpose and Summary
PURPOSE
More than three years ago, the Institute of Medicine (IOM)
reported that preventable medical errors are the eighth leading
cause of death in America--ahead of breast cancer, AIDS, and
traffic deaths. Up to 100,000 patients die in hospitals each
year as a result of preventable mistakes. The number of injured
is far greater.
A recent report by Auburn University analyzed data from 36
hospitals and nursing homes in Colorado and Georgia over an 81-
day period and found medication errors in about 20 percent of
the doses administered in a ``typical'' 300-bed facility;
researchers considered seven percent of the errors
``potentially harmful.''
Not only can avoidable patient errors result in poorer
health outcomes--the most dramatic being death--they often
drive up health costs by requiring expensive medical
interventions to correct the subsequent medical problems. For
example, adverse drug events (ADEs) and interactions in
hospitals are prevalent and costly, yet could be dramatically
reduced by adopting technology to reduce prescribing errors.
According to the Pittsburgh Regional Healthcare Initiative,
medication errors result in $3,500 to $4,000 in additional
costs per incident. According to estimates from Cardinal
Health, Inc., there were more than 625,000 preventable ADEs in
hospitals in 2000 at a cost of $2.9 billion. The IOM also
estimates that medical errors cost the economy about $38
billion each year, of which $17 billion is the result of
preventable errors.
These unacceptable financial costs are borne by providers,
individuals, insurers and employers and public programs such as
Medicare.
The purpose of the bill is to provide for the improvement
of patient safety and to reduce the incidence of events that
adversely affect health outcomes. Specifically, this act will
encourage a culture of safety by providing for the legal
protection of information reported voluntarily for the purposes
of quality improvement and the reduction of medical errors.
B. Legislative History
In the 106th Congress, the Subcommittee on Health held a
hearing on the prevalence and nature of medical errors on
February 10, 2002. During the 107th Congress, the Subcommittee
on Health held a hearing on March 7, 2002 (107-76), on
improving health quality by reducing the incidence and
prevalence of medical errors. At that hearing, a number of
experts testified to the Committee. Specifically, Dr. James
Bagian, Director, National Center for Patient Safety,
Department of Veterans Affairs, testified the VA has adopted a
successful reporting system that has improved patient safety.
Also, Dr. Karen Wolk Feinstein, Chair of the Pittsburgh
Regional Healthcare Initiative, testified as to the
Initiative's success in implementing an ambitious zero
tolerance policy for medical errors and how a voluntary,
confidential reporting system will help reduce medical errors
by promoting a culture of safety.
Academic expert Donald M. Berwick, the President and CEO of
the Institute for Healthcare Improvement testified limited
reporter protections and new information technology standards
will promote better clinical outcomes, and the adoption of
computerized physician order entry technology for electronic
prescribing is critical to reduce avoidable medication errors.
Dr. Matthew Alan Miller from Danbury Hospital (Connecticut),
testified on behalf of the American Hospital Association on
their perspectives to improve health outcomes and patient
safety. Dr. Miller testified additional resources should be
added to Medicare to encourage the purchase of information
technology. Lastly, Mary Foley, President of the American
Nurses Association, focused her testimony on mandatory overtime
and dangerous working conditions in health facilities that lead
to medical errors.
The information gained from that hearing led to the
introduction of H.R. 4889, the ``Patient Safety Improvement Act
of 2002,'' that would provide incentives to report error
information and glean knowledge about medical mistakes and
system failures in order to reduce medical errors.
On September 10, 2002, the Subcommittee on Health held a
legislative hearing on the draft substitute amendment to H.R.
4889. At the hearing Health and Human Services Secretary Tommy
Thompson expressed the Administration's strong support for H.R.
4889. Testifying with Secretary Thompson was Carolyn Clancy,
Acting Director of the Agency for Healthcare Research and
Quality, which is the primary federal agency responsible for
quality improvement and patient safety. In addition, letters of
support from Secretary Thompson, Treasury Secretary Paul
O'Neil, Centers for Medicare and Medicaid Services
Administrator Tom Scully and Director Clancy for H.R. 4889 were
presented at the hearing.
Dr. Lucian Leape of Harvard University testified that error
reporting for all but the most serious events should be
voluntary and confidential and that certain changes needed to
be made in the underlying bill prior to his support. Those
changes were made. It is important to note that Dr. Leape was
one of the authors of the 1999 Institute of Medicine report.
Michael B. Wood, President and Chief Executive Officer of
the Mayo Foundation, testified on behalf of the Healthcare
Leadership Council. He stated that reporting systems should be
voluntary and confidential, and that the Secretary should
develop standards for the interoperability of health
information technology in order to reduce medical mistakes and
improve health outcomes.
Ken Segel, Director of the Pittsburgh Regional Healthcare
Initiative, testified that mandatory reporting should not be
pursued prior to a voluntary, confidential and cooperative
approach had been tested. In addition, Herbert Pardes,
President of New York-Presbyterian, and Chief Executive Officer
of the New York-Presbyterian Healthcare System testified that
the interoperability and Advisory Board provisions of H.R. 4889
are critical to promoting the adoption of information
technology to reduce medical errors. Lastly, the Committee
heard from Jill Rosenthal who is a Project Manager at the
National Academy for State Health Policy and who encouraged the
Committee to protect state laws in this area and provide
support for current and future efforts.
On September 12, 2002, the Subcommittee on Health ordered
favorably reported to the full Committee H.R. 4889, the
``Patient Safety Improvement Act of 2002,'' on a voice vote
with a quorum present.
On September 18, 2002, the Full Committee on Ways and Means
ordered favorably reported H.R. 4889, the ``Patient Safety
Improvement Act,'' as amended, by a recorded vote of 33 to 4.
II. EXPLANATION OF PROVISIONS
A. Analysis of Legislation and Comparison With Present Law
Section 1. Short title; table of contents
Current Law. No provision.
Explanation of Provision. The legislation would be cited as
the Patient Safety Improvement Act of 2002 and would amend
Title XI of the Social Security Act by adding Part D--Patient
Safety Improvements--with six new sections (Sections 1181-
1186). A Medical Information Technology Advisory Board would
also be established.
Reason for Change. Not applicable.
Effective Date. Upon enactment.
Section 2. Patient safety improvements
Current Law. No statutory provisions. The Institute of
Medicine's (IOM) 1999 report, To Err is Human, focused
attention on the problem of preventable medical errors and the
need for systematic steps to reduce their incidence to enhance
patient safety. Among other proposals, IOM recommended that
Congress create a Center for Patient Safety within the Agency
for Healthcare Research and Quality (then called the Agency for
Health Care Policy and Research) to promote knowledge and
prevention of medical errors, set national goals for patient
safety, fund patient safety research, evaluate methods for
identifying and preventing medical errors, disseminate
information on effective safety practices, and issue an annual
report to the President and Congress on patient safety. The IOM
recommended two systems for identifying and learning from
medical errors. First, they recommended a nationwide, mandatory
reporting system for serious adverse events such as death. The
IOM also recommended a voluntary reporting system for less
serious errors, or for situations that could be prevented. The
Committee has addressed the later recommendation, based on the
advice of numerous experts, academicians and providers. In
addition, the IOM recommended that the Center for Patient
Safety encourage the development of voluntary reporting systems
and outlined various actions that could be undertaken.
Furthermore, IOM recommended that Congress pass legislation to
extend peer review protections to information collected under
such voluntary systems. While existing law often shields data
about errors within a given institution, the IOM report noted
that this protection may be lost if the information is
transmitted elsewhere, even to a voluntary reporting system
serving as the backbone of a collaborative effort to reduce
medical errors.
Explanation of Provision. The provision would establish a
new Part D in Title XI of the Social Security Act to encourage
a voluntary reporting system for patient safety data.
A new Section 1181 would be added that would permit a
health care provider to voluntarily collect, develop and report
patient safety data to a patient safety organization in a
manner that is confidential and privileged. Patient safety
organizations would analyze the reported data, report back to
providers information to improve patient safety, and submit
non-identifiable information to the Center for Quality
Improvement and Patient Safety for inclusion in the Patient
Safety Database. Patient safety organizations would be
permitted to share non-identifiable information, but the
disclosure of identifiable information from one such
organization to another would require for each disclosure the
explicit authorization of the provider who initially reported
the information, and the information could only be shared for
purposes consistent with the Act.
In this legislation, a health care provider would mean: (1)
facilities and their employees that provide services under
Medicare Part A; (2) a health care entity or individual
(including a physician) who furnishes Medicare Part B services;
and (3) an organization offering a Medicare+Choice plan.
Patient safety data would mean any data, reports, records,
memoranda, analyses, deliberative work, statements, or root
cause analyses that are collected or developed to improve
patient safety or health care quality. That would include
patient safety data collected or developed by a provider to
report to a patient safety organization on a timely basis, as
well as data 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 transmitted back to the health care provider that supplied
the information originally. Patient safety data would also
encompass descriptions of corrective actions taken by providers
in response to the provider's reporting of data to a patient
safety organization (on a timely basis to such an
organization), regardless of whether the organization has
provided feedback to the provider. To further knowledge,
providers would have to report the corrective actions to the
patient safety organization. Nothing in the bill should be
construed as limiting a provider's ability to waive the
privilege or confidentiality protections established by the
legislation.
A patient safety organization (PSO) would mean a private or
public organization that conducts activities to improve patient
safety and health care quality by assisting health care
entities that report to them. Such entities must meet certain
requirements and be certified by the Secretary. Activities
performed by the PSO would include: (1) the collection and
analysis of patient safety data that are voluntarily reported
by more than one provider on a local, state, regional, or
national basis; (2) the development of and dissemination to
providers and other patient safety organizations information
such as recommendations, protocols, and best practice data; and
(3) the utilization of patient safety data to help providers
minimize patient risk. Patient safety organizations would be
required to ensure the confidentiality of individually
identifiable health information, submit non-identifiable
information to the Center for Quality Improvement and Patient
Safety, if applicable, in a format established by the
Secretary, and maintain appropriate data security measures.
Such organizations would also be required: (1) to be
managed, controlled (i.e. the provider is able to significantly
influence or direct its actions or policies), and operated
independently from providers that report data to it; (2) to
collect data from providers in a standardized manner to
facilitate comparisons of similar cases across similar
providers; and (3) to meet other requirements specified by the
Secretary. An entity that no longer qualified as a patient
safety organization would be required to destroy its patient
safety data, return (if practicable) the data to the reporting
providers, or transfer data to another patient safety
organization with the approval of the provider and that
organization. Patient safety organizations that charge fees for
their activities would be required to impose a uniform fee
across all types and classes of providers, taking into account
the size of the health care provider. A patient safety
organization could not use data reported by a provider to take
regulatory or enforcement actions it otherwise performs in
relation to the provider, though the Committee does not intend
for this to interfere with established oversight and regulatory
activities. The Secretary would be able to give technical
assistance to patient safety organizations in providing
recommendations and advice to providers on methodology,
communication, data collection, dissemination of information,
security and confidentiality concerns. Nothing in this part
would be construed to limit or discourage reporting patient
safety data within a health care provider.
A new Section 1182 would designate patient safety data as
privileged and confidential. That designation would apply to
information, such as medical records and other primary health
care information, to the extent it was collected and developed
for the purpose of improving patient safety and health care
quality, and reported to a patient safety organization on a
timely basis. Such privilege would not apply to information
merely by reason of its inclusion in reported patient safety
data. Information available from sources other than a report
made under such section may be discovered or admitted in a
civil or administrative proceeding, if discoverable or
admissible under applicable state law. With some limitations
under this new privilege, patient safety data would not be
subject to: (1) a civil or administrative subpoena; (2)
discovery in connection with a civil or administrative
proceeding; (3) disclosure pursuant to a Freedom of Information
Act request; or (4) admission as evidence or disclosure in any
civil or administrative proceeding.
The privilege established by this section would not apply
to: (1) Records of a patient's medical diagnosis and treatment
and other primary health records of a health care provider; (2)
information disclosed by a provider or patient safety
organization of data to the Food and Drug Administration (FDA),
or to a person subject to FDA jurisdiction, regarding an FDA-
regulated product or activity; and (3) disclosures of non-
identifiable information from a patient safety organization to
the Patient Safety Database and the further disclosure of such
information by the Center for Quality Improvement and Patient
Safety. Disclosures in violation of the provisions of this
section would be unlawful. Persons found in violation would be
subject to the same penalties as those relating to
inappropriate disclosures made by peer review organizations
under the Medicare program, which provide for fines of up to
$1,000 per disclosure, up to six months in prison, or both, and
payment of the costs of prosecution. A health care provider
would not be permitted to take an adverse employment action,
including actions related to licensing or credentialing,
against an individual who reported patient safety data to a
patient safety organization. A health care provider who does
undertake such retaliation may be subject to civil monetary
penalties up to $50,000 in the same manner they are applied in
the Social Security Act relating to illegal kickbacks.
Nothing in this part would be construed as preempting or
otherwise affecting any state mandatory reporting requirements
for health care providers. Consistent with protecting state
mandatory reporting requirements, nothing shall be construed as
affecting other privileges that are available under Federal or
State laws that provide greater peer review protection than the
peer review and confidentiality protections provided under this
bill.
The health information privacy provisions in the Health
Insurance Portability and Accountability Act (HIPAA) of 1996
and related implementing regulations would not be affected by
this legislation. Disclosure of individually identifiable
health information under this bill would fall under the same
confidentiality protections required by the HIPAA
confidentiality rule as any other disclosure of individually
identifiable health information (e.g. providers would be
subject to the Rule's minimum necessary requirements). The
Committee believes it is unnecessary for providers to report,
and PSOs to collect, patient safety data that includes a
patient's name or Social Security number. Patient safety
organizations would be treated as business associates under
HIPAA's privacy rule.
Permissible disclosures to FDA under these provisions would
not waive any privilege established by this legislation or
under State law. Patient safety data of an organization that
loses its certification as a patient safety organization would
continue to be privileged and confidential until returned to
the providers that supplied the data, transferred to another
patient safety organization, or otherwise destroyed.
The GAO would be required to conduct a survey of State laws
regarding patient safety peer review systems, evidentiary
privilege applicable to data developed in such systems, court
interpretations of such laws, and the effectiveness of such
laws in promoting patient safety. The GAO would be required to
submit a report on this subject to Congress within nine months
of enactment.
Under Section 1183, the Secretary, through the existing
Center for Quality Improvement and Patient Safety in the Agency
for Healthcare Research and Quality, would be required to: (1)
provide for the certification and recertification of patient
safety organizations; (2) collect and disseminate information
related to patient safety; (3) establish a Patient Safety
Database to collect, support and coordinate the analysis of
non-identifiable information submitted to the database; and (4)
facilitate the development of consensus among providers and
interested parties concerning patient safety and related
recommendations. The Secretary, acting through the director of
the Agency for Healthcare Research and Quality would be
required to consult with and develop appropriate partnerships
with health care organizations, providers, public and private
sector entities, patient safety organizations, health care
consumers and other relevant experts.
The Secretary would certify patient safety organizations
under a process consistent with published criteria. The
Secretary would be able to revoke such certification upon a
showing of cause, including the inappropriate disclosure of
patient safety data. Certification would terminate, subject to
recertification, upon three years from the date of
certification or upon revocation. In carrying out these
responsibilities, the Secretary would be required to facilitate
the development of patient safety goals, track progress in
meeting these goals, ensure that data submitted by a patient
safety organization to the Patient Safety Database are
comparable and useful for research and analysis, and ensure
that research findings and patient safety alerts are presented
in clear and consistent formats.
The Secretary, acting through the Center, would: (1)
establish a Patient Safety Database to collect voluntarily
reported, non-identifiable information concerning patient
safety; and (2) establish common formats for PSOs reporting
data to the Patient Safety Database. The Secretary would also
be required to establish criteria to determine the
organizations and individuals that may voluntarily contribute
to, and the data that comprises, the Patient Safety Database,
and to ensure that the database is only used by qualified
entities and individuals. The Secretary would also be permitted
to enter into contracts with private and public entities to
administer the database. Non-identifiable information would
mean information that is presented in a form that precludes the
identification of any provider, patient, or reporter of the
information. There would be authorized to be appropriated such
sums as may be necessary for each fiscal year to carry out this
section.
A new Section 1184 would require the Secretary within two
years of enactment to develop or adopt (and periodically review
and update) voluntary, national standards that promote the
interoperability of health care information technology systems
across all health care settings. The Secretary must take into
account the costs to the health care system and any
efficiencies that accrue as a result of the adoption of these
standards. These standards would be developed in consultation
with the National Committee for Vital and Health Statistics,
and the Medical Information Technology Advisory Board
(established under Section 3). The Secretary would be required
to disseminate these standards. The Secretary is encouraged to
use existing demonstration authority to test standards across
health settings. In doing so, the Secretary should consult with
the Medical Information Technology Advisory Board established
under Section 3. There would be authorized to be appropriated
such sums as may be necessary for each fiscal year to carry out
this section.
A new Section 1185 would require the Secretary to encourage
providers to adopt appropriate evidence-based methods to
improve patient safety. These methods would not constitute
national practice guidelines.
A new Section 1186 would require GAO to conduct a
comprehensive evaluation of the implementation of Sections
1181-1185 and report to Congress within five years of
enactment. Such an evaluation would include: (1) an examination
of the health care providers who reported patient safety data
and the patient safety organizations to which they reported the
information; (2) what types of events were reported; (3) the
usefulness of the analyses, information, and recommendations
provided by the patient safety organizations in response to
such reported data; (4) the response of providers to such
analysis, information, and recommendations, including a survey
of providers to determine the percentage of providers by
category that have adopted specific error reduction methods and
the reasons, if applicable, for not adopting such methods; and
(5) the effectiveness of these efforts in reducing medical
errors. The Committee intends for this report to be a thorough
and vigorous review of the new system including its utility and
effectiveness.
Reason for Change. According to the IOM, nearly 100,000
patients die in hospitals each year as a result of preventable
mistakes. The number of injured is far greater. The Committee
believes these provisions, taken together, will reduce
preventable medical errors and improve quality. In addition,
the Committee believes the development and promulgation of
voluntary interoperability standards by HHS will promote
efficiency and quality of health care delivery, while helping
to reduce costs, to the extent such standards are adopted by
health care systems.
Effective Date. Upon enactment.
Section 3. Medical Information Technology Advisory Board
Current Law. No provision.
Explanation of Provision. Within three months of enactment,
the Secretary would be required to appoint the Medical
Information Technology Advisory Board (MITAB) and designate a
chairman. The chairman would be required to be affiliated with
an organization having expertise in creating American National
Standards Institute (ANSI) standards governing health care
information technology and to be a member of the National
Committee for Vital and Health Statistics. The MITAB would
consist of no more than 17 members that include: (1) experts
from the fields of medical information, information technology,
medical continuous quality improvement, medical records
security and privacy, individual and institutional clinical
providers, health researchers, and health care purchasers; (2)
one or more staff experts from the Centers for Medicare and
Medicaid Services, the Agency for Healthcare Research and
Quality, and the Institute of Medicine of the National Academy
of Sciences; (3) representatives of private organizations with
expertise in medical infomatics; (4) a representative of a
teaching hospital; and (5) one or more representatives of the
health care information technology industry. Individuals would
be appointed for the life of the MITAB, with any vacancy filled
in the same manner in which the original appointment was made.
The new appointment would be made no later than 30 days after
the MITAB is given notice of the vacancy. Such a vacancy would
not affect the ability of the remaining members to perform the
duties of the MITAB.
The MITAB would meet at the call of its Chairman or a
majority of its members. MITAB members would receive no
additional pay, allowances, or benefits stemming from their
service on the board, but would receive travel expenses and per
diem in lieu of subsistence as directed by Sections 5702 and
5703 of Title 5 of the United States Code (USC). The Chairman
would appoint an executive director of the MITAB who would be
paid at level V of the Executive Schedule. With the approval of
the MITAB, the director would be able to appoint appropriate
personnel without regard to the provisions of Title 5 USC
governing appointments in the competitive services or those
relating to job classification and pay rates. The MITAB
director would also be able to procure temporary and
intermittent services under Section 3109(b) of Title 5 USC.
Upon the request of MITAB, the head of any Federal agency would
be able to detail, without reimbursement, any personnel of that
agency to MITAB. The detail would not interrupt or affect the
civil service status of the Federal employee.
MITAB would be able to hold hearings and undertake other
activities as necessary to carry out its duties. If requested
by MITAB, a Federal agency would be required to provide
technical assistance to the MITAB as deemed necessary. At the
request of the MITAB chairman, the MITAB would be able to
secure directly from any Federal agency information necessary
to carry out its duties, if the information may be disclosed
under the Freedom of Information Act (Section 552 of Title 5
USC). The Federal Advisory Committee Act (FACA) applies to the
MITAB.
MITAB would advise, and make recommendations to, the
Secretary regarding medical information technology, including:
(1) best practices in medical information technology; (2)
methods of implementing health care information technology
interoperability standards, and records security; (3) a
recommendation for a common lexicon for computer technology;
and (4) and adoption within two years of a uniform health
information system interface between old and new systems. MITAB
would also be required to make recommendations on methods to
promote information exchange to enhance compatibility among
information systems in order to: (1) maximize positive outcomes
in clinical care by providing decision support for diagnosis
and care, and assisting in the emergency treatment of a patient
at a facility where there is no medical record of the patient;
(2) contribute to the development of a patient assessment
instrument that minimizes the need for different records when
patients move from provider to provider; (3) reduce redundant
paperwork; (4) minimize medical errors; and (5) contribute to
compatible information technology architecture.
MITAB would be required within 18 months of enactment to
submit to Congress and the Secretary an initial report of its
deliberations and recommendations. Subsequent annual reports
would be due in each of the following two years after the
initial report is submitted.
MITAB would terminate 30 days after the date of submission
of its final report. The provision provides such sums as
necessary for the operations of MITAB.
Reason for Change. The Committee believes an advisory board
on medical technology will promote the adoption of better, more
efficient and effective health information technology systems.
These systems will help health care providers reduce errors by
making patient information more readily available, and
promoting quality by providing expert advice to HHS on the
adoption of interoperability standards and through promotion of
information technology.
Effective Date. Upon enactment.
III. VOTES OF THE COMMITTEE
In compliance with clause 3(b) of rule XIII of the Rules of
the House of Representatives, the following statements are made
concerning the votes of the Committee on Ways and Means in its
consideration of the bill, H.R. 4889.
MOTION TO REPORT THE BILL
The bill, H.R. 4889, as amended, was ordered favorably
reported by a roll call vote of 33 yeas to 4 nays (with a
quorum being present). The vote was as follows:
----------------------------------------------------------------------------------------------------------------
Representatives Yea Nay Present Representative Yea Nay Present
----------------------------------------------------------------------------------------------------------------
Mr. Thomas..................... X ........ ......... Mr. Rangel....... ........ ........ .........
Mr. Crane...................... X ........ ......... Mr. Stark........ X ........ .........
Mr. Shaw....................... X ........ ......... Mr. Matsui....... X ........ .........
Mrs. Johnson................... X ........ ......... Mr. Coyne........ X ........ .........
Mr. Houghton................... ........ ........ ......... Mr. Levin........ X ........ .........
Mr. Herger..................... ........ ........ ......... Mr. Cardin....... ........ ........ .........
Mr. McCrery.................... X ........ ......... Mr. McDermott.... ........ X .........
Mr. Camp....................... X ........ ......... Mr. Kleczka...... ........ X .........
Mr. Ramstad.................... X ........ ......... Mr. Lewis (GA.... ........ X .........
Mr. Nussle..................... X ........ ......... Mr. Neal......... X ........ .........
Mr. Johnson.................... X ........ ......... Mr. McNulty...... X ........ .........
Ms. Dunn....................... X ........ ......... Mr. Jefferson.... X ........ .........
Mr. Collins.................... X ........ ......... Mr. Tanner....... X ........ .........
Mr. Portman.................... X ........ ......... Mr. Becerra...... X ........ .........
Mr. English.................... X ........ ......... Mrs. Thurman..... X ........ .........
Mr. Watkins.................... X ........ ......... Mr. Doggett...... ........ X .........
Mr. Hayworth................... X ........ ......... Mr. Pomeroy...... X ........ .........
Mr. Weller..................... X ........ .........
Mr. Hulshof.................... X ........ .........
Mr. McInnis.................... X ........ .........
Mr. Lewis (KY)................. X ........ .........
Mr. Foley...................... X ........ .........
Mr. Brady...................... X ........ .........
Mr. Ryan....................... X ........ .........
----------------------------------------------------------------------------------------------------------------
IV. BUDGET EFFECTS OF THE BILL
A. Committee Estimate of Budgetary Effects
In compliance with clause 3(c)(3) of rule XIII of the Rules
of the House of Representatives, the following statement is
made:
The Committee agrees with the estimate prepared by the
Congressional Budget Office (CBO), which is included below.
B. Statement Regarding New Budget Authority and Tax Expenditures
In compliance with clause 3(c)(2) of rule XIII of the Rules
of the House of Representatives, the Committee states the bill
will increase direct spending and government receipts by less
than $500,000 annually.
C. Cost Estimate Prepared by the Congressional Budget Office
In compliance with clause 3(c)(3) of rule XIII of the Rules
of the House of Representatives requiring a cost estimate
prepared by the Congressional Budget Office, the following
report prepared by CBO is provided.
U.S. Congress,
Congressional Budget Office,
Washington, DC, September 26, 2002.
Hon. William ``Bill'' M. Thomas,
Chairman, Committee on Ways and Means,
House of Representatives, Washington, DC.
Dear Mr. Chairman: The Congressional Budget Office has
prepared the enclosed cost estimate for H.R. 4889, the Patient
Safety Improvement Act of 2002.
If you wish further details on this estimate, we will be
pleased to provide them. The CBO staff contacts are Chris
Topoleski and Margaret Nowak.
Sincerely,
Steven Lieberman
(For Dan L. Crippen, Director).
Enclosure.
H.R. 4889--Patient Safety Improvement Act 2002
Summary: H.R. 4889 would expand the duties of the Center
for Quality Improvement and Patient Safety (CQuIPS) within the
Agency for Healthcare Research and Quality (AHRQ). CQuIPS would
establish credentialing procedures for patient safety
organizations (PSOs), which collect patient safety data
voluntarily submitted by health care providers for including in
a patient safety database. The bill also would establish
privacy protections and impose fines and civil monetary
penalties for violations of those protections.
In addition H.R. 4889 would establish the Medical
Information Technology Advisory Board (MITAB, which would
provide advice and recommendations on the compatibility of
medical information technologies. The bill would require the
Secretary of Health and Human Services, with the National
Committee for Vital and Health Statistics and the MITAB, to
develop voluntary national standards for uniform reporting of
health care information.
CBO estimates that implementing H.R. 4889 would cost $6
million in 2003 and $58 million over the 2003-2007 period,
assuming the appropriation of the necessary amounts. CBO
estimates that receipts from fines for violation of the privacy
protections would amount to less than $500,000 a year. Because
the legislation would affect receipts and direct spending, pay-
as-you-go procedures would apply.
H.R. 4889 would preempt any state freedom-of-information
law that would require the disclosure of information provided
by a health care provider to a certified patient safety
organization. This preemption would be an intergovernmental
mandate as defined in the Unfunded Mandates Reform Act (UMRA)
because it would limit the application of such state laws. CBO
estimates that this mandate would impose no requirement on
states that would result in additional spending; thus, the
threshold established by UMRA ($58 million in 2002, adjusted
annually for inflation) would not be exceeded.
H.R. 4889 contains no private-sector mandates as defined in
UMRA.
Estimated cost to the Federal Government: The estimated
budgetary impact of H.R. 4889 is shown in the following table.
The costs of this legislation fall within budget function 550
(health).
----------------------------------------------------------------------------------------------------------------
By fiscal year, in millions of dollars--
-----------------------------------------------------
2002 2003 2004 2005 2006 2007
----------------------------------------------------------------------------------------------------------------
CHANGES IN SPENDING SUBJECT TO APPROPRIATION
Estimated Authorization Level............................. 0 12 14 15 13 13
Estimated Outlays......................................... 0 6 11 14 14 13
CHANGES IN REVENUES
Estimated Revenues........................................ 0 * * * * *
CHANGES IN DIRECT SPENDING
Estimated Budget Authority................................ 0 * * * * *
Estimated Outlays......................................... 0 * * * * *
----------------------------------------------------------------------------------------------------------------
Note.--* = Less than $500,000.
Basis of estimate
Spending subject to appropriation
H.R. 4889 would expand the current duties of CQuIPS. The
new duties would include the provision of technical assistance
to states that have (or are developing) systems for reporting
medical errors. CQuIPS also would provide for the certification
and recertification of PSOs, which collect patient safety data
from health care providers. (PSOs are private or public
organizations that conduct activities to improve patient safety
and the quality of health care delivery). PSOs would not
receive funding under this bill. In addition, CQuIPS would
establish a patient safety database to collect, support, and
coordinate the analysis of patient safety data that is reported
on a voluntary basis. Based on information from AHRQ, CBO
expects that these tasks would require increased staff for
providing assistance to states, oversight of PSOs, and
collection and maintenance of the patient safety database. They
would also require additional computer resources for the
database. Based on information from AHRQ, CBO estimates that
the agency would need additional appropriations of $10 million
in 2003 and $61 million over the 2003-2007 period to carry out
these responsibilities. CBO estimates that outlays would total
$4 million in fiscal year 2003 and $51 million over the 2003-
2007 period, assuming the necessary amounts are appropriated.
The bill would require the Secretary to develop voluntary,
national standards that promote the compatibility of health
care information technology systems across all health care
settings. CBO estimates that this effort would not involve
significant additional costs.
In addition, H.R. 4889 would require the Comptroller
General of the United States to report to the Congress the
findings of comprehensive evaluation of PSOs, the usefulness of
the reported information and the overall effectiveness of the
program in reducing medical errors. CBO estimates that these
tasks would cost the General Accounting Office $1 million in
2003 and $2 million over the 2003-2007 period.
Finally, the bill would establish the MITAB to provide
recommendations regarding medical information technology. The
MITAB would terminate 30 days after the submisswion of its
final report. For purposes of this estimate, CBO assumed that
the MITAB would be created in January 2003, and therefore would
terminate in July 2006. As stated in the bill, the MITAB would
require one Executive Level V employee and support staff. In
addition, while board members would not be compensated for
their time serving on the MITAB, reimbursement for travel and
per-diem expenses would be allowed. CBO estimates that the
MITAB would require appropriations of about $1 million a year
over the 2003-2007 period. We estimate that outlays would total
$0.6 million in fiscal year 2003 and $5 million over the 2003-
2007 period, assuming the necessary amounts are appropriated.
Direct spending and revenues
Because those prosecuted and convicted for violation of the
bill's privacy provisions could be subject to criminal fines
and civil monetary penalties, the federal government might
collect additional fines if the bill is enacted. Collections of
civil fines are recorded in the budget as governmental receipts
(revenues). Criminal fines are deposited as receipts in the
Crime Victims Fund and later spent. CBO estimates that any
additional receipts and direct spending would be less than
$500,000.
Pay-as-you-go considerations: The Balanced Budget and
Emergency Deficit Control Act sets up pay-as-you-go procedures
for legislation affecting direct spending or receipts. Enacting
H.R. 4889 could affect receipts and direct spending through the
collection of fines for noncompliance with the privacy
standards, but CBO estimates that any such effects would be
less than $500,000 a year.
Estimated impact on state, local, and tribal governments:
H.R. 4889 would preempt any state freedom-of-information law
that would require the disclosure of information provided by a
health care provider to a certified patient safey organization.
This preemption would be an intergovernmental mandate as
defined in UMRA because it would limit the application of such
state laws. CBO estimates that this mandate would impose no
requirement on states that would result in additional spending;
thus, the threshold established by UMRA ($58 million in 2002,
adjusted annually for inflation) would not be exceeded.
Estimated impact on the private sector: H.R. 4889 contains
no private-sector mandates as defined in UMRA.
Estimate prepared by: Federal Revenues and Outlays: Chris
Topoleski and Margaret Nowak; Impact on State, Local, and
Tribal Governments: Leo Lex; and Impact on the Private Sector:
Daniel Wilmoth.
Estimate approved by: Robert A. Sunshine, Assistant
Director for Budget Analysis.
V. OTHER MATTERS REQUIRED TO BE DISCUSSED UNDER THE RULES OF THE HOUSE
A. Committee Oversight Findings and Recommendations
In compliance with clause 3(c)(1) of rule XIII of the Rules
of the House of Representatives, the Committee reports that the
need for this legislation was verified by the two hearings
conducted by the Committee. Details of these hearings are
included in Section I. Introduction, Part B. Legislative
History.
B Constitutional Authority Statement
In compliance with clause 3(d)(1) of rule XIII of the Rules
of the House of Representatives, the Committee states that the
Committee's action in reporting this bill is derived from
Article I of the Constitution, Section 8 (``The Congress shall
have Power to lay and collect taxes, duties, imposts and
excises, to pay the debts and to provide for * * * the
General Welfare.'')
C. Information Relating to Unfunded Mandates
This information is provided in accordance with section 423
of the Unfunded Mandates Act of 1995 (P.O. 104-4).
The Committee has determined that the bill does not contain
Federal mandates on the private sector. The Committee has
determined that the bill does not impose a Federal
intergovernmental mandate on State, local, or tribal
governments, but that such mandate will have no budgetary
impact on those entities. The bill, however, also provides
assistance to State governments. It requires the Secretary of
Health and Human Services to provide technical assistance to
State governments in developing or maintaining State reporting
systems, developing standardized methods of data collection,
and in collecting data from State governments for inclusion in
the Patient Safety Database. In addition, the legislation
allows the Secretary to provide technical assistance to the
patient safety organizations established under the bill.
D. Summary of General Performance Goals and Objectives
In compliance with clause 3(c)(4) of rule XIII of the Rules
of the House of Representatives, the Committee states that the
primary purpose of H.R. 4889 is to reduce medical errors,
thereby improving patient safety.
VI. CHANGES IN EXISTING LAW MADE BY THE BILL, AS REPORTED
In compliance with clause 3(e) of rule XIII of the Rules of
the House of Representatives, changes in existing law made by
the bill, as reported, are shown as follows (new matter is
printed in italic and existing law in which no change is
proposed is shown in roman):
SOCIAL SECURITY ACT
* * * * * * *
TITLE XI--GENERAL PROVISIONS, PEER REVIEW, AND ADMINISTRATIVE
SIMPLIFICATION
* * * * * * *
Part D--Patient Safety Improvements
VOLUNTARY REPORTING OF PATIENT SAFETY DATA; DEFINITIONS
Sec. 1181. (a) Collection and Voluntary Reporting 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 voluntarily collect and develop
patient safety data (as defined in subsection (e)) and report
such data to one or more patient 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 delivery 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-identifiable 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 purposes 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
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;
(2) a health care entity or individual that furnishes
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
payment may be made under such title, including a
physician (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, reports,
records, memoranda, analyses, deliberative work,
statements, or root cause analyses that are collected
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
transmitted 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 improve patient
safety, quality, and efficiency.--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 collected
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 Organizations.--
(1) In general.--For purposes of this part, the term
``patient safety organization'' means a private or
public organization that conducts activities to improve
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
described in paragraph (2); and
(B) meets the other requirements of
paragraphs (3) through (5).
(2) Activities described.--The activities referred 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,
regional, State, or national basis.
(B) The development and dissemination of
information to health care providers and other
patient safety organizations with respect to
improving patient safety, such as
recommendations, protocols, or information
regarding best practices.
(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 organization
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 measures
with respect to patient safety data.
(4) Organization requirements.--The requirements of
this paragraph for an organization are that--
(A) the organization is managed, controlled,
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 organization;
(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
similar cases among similar health care
providers; and
(E) the organization meets such other
requirements 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 patient safety
organization may not use patient safety data reported
by a health care provider in accordance with this part
to take regulatory or enforcement actions it otherwise
performs (or is responsible for performing) in relation
to such provider.
(6) Technical assistance.--The Secretary may provide
technical assistance to patient safety organizations in
providing recommendations and advice 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, security, and
confidentiality concerns.
(g) Construction.--Nothing in this part shall be construed to
limit or discourage the reporting of information 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 privileged 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 subpoena;
(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 established by
this section with respect to patient safety data described in
section 1181(e)(1)(A) shall apply to information, 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 section 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 discovered 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 inclusion 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 Administration,
with respect to an Administration-regulated product or
activity for which that entity has responsibility, for
the purposes of activities related to quality, safety,
or effectiveness of such Administration-regulated
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 patient safety
organization to the Patient Safety Database 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 employment 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
organization, or
(B) directly to a patient safety
organization,
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 safety
organization in accordance with such section.
(2) Adverse employment action.--For purposes of this
subsection, an ``adverse employment action'' 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
relation 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 sentence
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 disclose any
patient safety data in violation of the provisions of this
section. Any person violating such provisions shall subject to
the same sanctions under section 1160(c) (relating to, upon
conviction, a fine of not more than $1,000, imprisonment for
not more than 6 months, or both, per disclosure 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
provided for in this section.
(2) No effect on state mandatory reporting
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
provider 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
organization.
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 construed as
precluding a health care provider from waiving the privilege or
confidentiality protections under this section. Disclosure of
patient safety data under subsection (d)(2) shall not
constitute a waiver of any privilege or protection 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 confidential, 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 report
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 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, acting through the
Director, shall ensure that the Center carries out the
following duties:
(A) Provide for the certification and
recertification of patient safety organizations
in accordance 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 consensus
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
reporting systems, assist States in developing
standardized methods for data collection, and
collect data from State reporting systems for
inclusion 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
private sector entities, patient safety organizations,
health care consumers, and other relevant experts to
improve patient safety.
(c) Certification and Recertification Process.--
(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
recertification 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 provided for a
patient safety organization shall terminate (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 revokes
the certification.
(d) Implementation and Consultation.--In carrying 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
voluntary reporting of data under subparagraph
(A), including the establishment of necessary
data elements, common and consistent
definitions, and a standardized computer
interface for the processing of such data.
(2) Database.--In carrying out this subsection, the
Secretary--
(A) shall establish and modify as necessary
criteria to determine the organizations that
may voluntarily contribute to, and the data
that comprises, the Patient Safety Database;
(B) shall ensure that the Patient Safety
Database is only used by qualified entities or
individuals as determined appropriate by the
Secretary in accordance with criteria applied
by the Secretary; and
(C) may enter into contracts for the
administration of the Database with private and
public entities with experience in the
administration of similar databases.
(3) Non-identifiable information.--For purposes of
this part, the term ``non-identifiable information''
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 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 Secretary 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 regulations 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 Secretary shall
develop and update such standards in consultation with (and
with coordination between)--
(1) the National Committee for Vital and Health
Statistics, and
(2) the Medical Information Technology Advisory 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 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 General of the
United States shall conduct a comprehensive evaluation of the
implementation of this part. Such evaluation shall include an
examination of the following:
(1) The health care providers that reported patient
safety data under this part and the patient safety
organizations to which they reported the information.
(2) What types of events were so reported on.
(3) The usefulness of the analyses, information, and
recommendations provided by patient safety
organizations in response to such reported information.
(4) The response of health care providers to such
analyses, information, and recommendations, including a
survey of providers to obtain estimates of the
percentage of providers by category who have adopted
specific error-reduction methods and, if applicable,
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 Comptroller
General shall submit to Congress a report on the evaluation
conducted under subsection (a).
* * * * * * *