[Congressional Record Volume 149, Number 40 (Wednesday, March 12, 2003)]
[House]
[Pages H1766-H1774]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]
PATIENT SAFETY AND QUALITY IMPROVEMENT ACT
Mr. BILIRAKIS. Mr. Speaker, I move to suspend the rules and pass the
bill (H.R. 663) to amend title IX of the Public Health Service Act to
provide for the improvement of patient safety and to reduce the
incidence of events that adversely affect patient safety, and for other
purposes, as amended.
The Clerk read as follows:
H.R. 663
Be it enacted by the Senate and House of Representatives of
the United States of America in Congress assembled,
SECTION 1. SHORT TITLE; TABLE OF CONTENTS.
(a) Short Title.--This Act may be cited as the ``Patient
Safety and Quality Improvement Act''.
(b) Table of Contents.--The table of contents of this Act
is as follows:
Sec. 1. Short title; table of contents.
Sec. 2. Findings and purposes.
TITLE I--PATIENT SAFETY AND QUALITY IMPROVEMENT
Sec. 101. Amendments to Public Health Service Act.
``Part C--Patient Safety Improvement
``Sec. 921. Definitions.
``Sec. 922. Privilege for patient safety work product.
``Sec. 923. National Patient Safety Database.
``Sec. 924. Technical assistance.
``Sec. 925. Certification of patient safety organizations.
Sec. 102. Promoting the diffusion and interoperability of information
technology systems involved with health care delivery.
Sec. 103. Required use of product identification technology.
Sec. 104. Grants for electronic prescription programs.
Sec. 105. Grants to hospitals and other health care providers for
information technologies.
Sec. 106. Authorization of appropriations for grants under sections 104
and 105.
[[Page H1767]]
TITLE II--MEDICAL INFORMATION TECHNOLOGY ADVISORY BOARD.
Sec. 201. Medical Information Technology Advisory Board.
SEC. 2. FINDINGS AND PURPOSES.
(a) Findings.--The Congress finds as follows:
(1) In 1999, the Institute of Medicine released a report
entitled ``To Err Is Human'' that described medical errors as
the 8th leading cause of death in the United States, with as
many as 98,000 people dying as a result of medical errors
each year.
(2) To address these deaths and injuries due to medical
errors, the health care system must identify and learn from
such errors so that systems of care can be improved.
(3) Myriad public and private patient safety initiatives
have begun. The Quality Interagency Coordination Task Force
has recommended steps to improve patient safety that may be
taken by each Federal agency involved in health care and
activities relating to these steps are ongoing.
(4) The Department of Health and Human Services has
initiated several patient safety projects. The Joint
Commission on Accreditation of Healthcare Organizations
issued a patient safety standard that went into effect on
July 1, 2001, and the peer review organizations are
conducting ongoing studies of clinical performance
measurement of care delivered to beneficiaries under the
medicare program under title XVIII of the Social Security
Act.
(5) Several steps can be taken now to improve patient
safety. For example, according to the Centers for Disease
Control and Prevention, hand washing is the single most
important means of preventing the spread of infection.
Repeated studies indicate that lack of or improper hand
washing still contributes significantly to disease
transmission in health care settings. Working with experts
from the private sector, the Centers for Disease Control and
Prevention has drafted ``Guidelines for Hand Hygiene in
Healthcare Settings'' setting forth recommendations to
promote improved hand hygiene practices and reduce
transmission of pathogenic microorganisms to patients and
personnel in health care settings.
(6) According to the Centers for Disease Control and
Prevention, nosocomial infections affect approximately 2
million patients annually in acute care facilities in the
United States at an estimated direct patient care cost of
approximately $3.5 billion each year.
(7) The Congress encourages the continuation and
acceleration of private sector efforts to take immediate
steps to improve patient safety and recognizes the need for
action in the public sector to complement these efforts.
(8) The research on patient safety unequivocally calls for
a learning environment, where providers will feel safe to
report health care errors, in order to improve patient
safety.
(9) Voluntary data gathering systems are more supportive
than mandatory systems in creating the learning environment
referred to in paragraph (8) as stated in the Institute of
Medicine's report.
(10) Promising patient safety reporting systems have been
established throughout the United States, and the best ways
to structure and use these systems are currently being
determined, largely through projects funded by the Agency for
Healthcare Research and Quality.
(11) Many organizations currently collecting patient safety
information have expressed a need for protections that will
allow them to review protected information so that they may
collaborate in the development and implementation of patient
safety improvement strategies. Currently, the State peer
review protections provide inadequate conditions to allow the
sharing of information to promote patient safety.
(12) In 2001, the Institute of Medicine released a report
entitled ``Crossing the Quality Chasm'' that found that the
United States health care system does not consistently
deliver high-quality care to patients.
(b) Purposes.--The purposes of this Act are--
(1) to encourage a culture of safety and quality in the
United States health care system by providing for a health
care errors reporting system that both protects information
and improves patient safety and quality of health care; and
(2) to ensure accountability by raising standards and
expectations for continuous quality improvements in patient
safety through the actions of the Secretary of Health and
Human Services.
TITLE I--PATIENT SAFETY AND QUALITY IMPROVEMENT
SEC. 101. AMENDMENTS TO PUBLIC HEALTH SERVICE ACT.
(a) In General.--Title IX of the Public Health Service Act
(42 U.S.C. 299 et seq.) is amended--
(1) in section 912(c), by inserting ``, in accordance with
part C,'' after ``The Director shall'';
(2) by redesignating part C as part D;
(3) by redesignating sections 921 through 928, as sections
931 through 938, respectively;
(4) in section 938(1) (as so redesignated), by striking
``921'' and inserting ``931''; and
(5) by inserting after part B the following:
``PART C--PATIENT SAFETY IMPROVEMENT
``SEC. 921. DEFINITIONS.
``In this part:
``(1) Identifiable information.--The term `identifiable
information' means information that is presented in a form
and manner that allows the identification of any provider,
patient, or reporter of patient safety work product. With
respect to patients, such information includes any
individually identifiable health information as that term is
defined in 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).
``(2) Nonidentifiable information.--The term
`nonidentifiable information' means information that is
presented in a form and manner that prevents the
identification of any provider, patient, or reporter of
patient safety work product. With respect to patients, such
information must be de-identified consistent with 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).
``(3) Patient safety evaluation system.--The term `patient
safety evaluation system' means a process that involves the
collection, management, or analysis of information for
submission to or by a patient safety organization.
``(4) Patient safety organization.--The term `patient
safety organization' means a private or public organization
or component thereof that is certified, through a process to
be determined by the Secretary under section 925, to perform
each of the following activities:
``(A) The conduct, as the organization or component's
primary activity, of efforts to improve patient safety and
the quality of health care delivery.
``(B) The collection and analysis of patient safety work
product that is submitted by providers.
``(C) The development and dissemination of evidence-based
information to providers with respect to improving patient
safety, such as recommendations, protocols, or information
regarding best practices.
``(D) The utilization of patient safety work product to
carry out activities limited to those described under this
paragraph and for the purposes of encouraging a culture of
safety and of providing direct feedback and assistance to
providers to effectively minimize patient risk.
``(E) The maintenance of confidentiality with respect to
identifiable information.
``(F) The provision of appropriate security measures with
respect to patient safety work product.
``(G) The submission of nonidentifiable information to the
Agency consistent with standards established by the Secretary
under section 923(b) for any National Patient Safety
Database.
``(5) Patient safety work product.--
``(A) The term `patient safety work product' means any
document or communication (including any information, report,
record, memorandum, analysis, deliberative work, statement,
or root cause analysis) that--
``(i) except as provided in subparagraph (B), is developed
by a provider for the purpose of reporting to a patient
safety organization, and is reported to a patient safety
organization;
``(ii) is created by a patient safety organization; or
``(iii) would reveal the deliberations or analytic process
of a patient safety evaluation system (as defined in
paragraph (3)).
``(B)(i) Patient safety work product described in
subparagraph (A)(i)--
``(I) does not include any separate information described
in clause (ii); and
``(II) shall not be construed to include such separate
information merely by reason of inclusion of a copy of the
document or communication involved in a submission to, or the
fact of submission of such a copy to, a patient safety
organization.
``(ii) Separate information described in this clause is a
document or communication (including a patient's medical
record or any other patient or hospital record) that is
developed or maintained, or exists, separately from any
patient safety evaluation system.
``(C) Information available from sources other than a
patient safety work product under this section may be
discovered or admitted in a civil or administrative
proceeding, if discoverable or admissible under applicable
law.
``(6) Provider.--The term `provider' means--
``(A) an individual or entity licensed or otherwise
authorized under State law to provide health care services,
including--
``(i) a hospital, nursing facility, comprehensive
outpatient rehabilitation facility, home health agency, and
hospice program;
``(ii) a physician, physician assistant, nurse
practitioner, clinical nurse specialist, certified nurse
midwife, nurse anesthetist, psychologist, certified social
worker, registered dietitian or nutrition professional,
physical or occupational therapist, or other individual
health care practitioner;
``(iii) a pharmacist; and
``(iv) a renal dialysis facility, ambulatory surgical
center, pharmacy, physician or health care practitioner's
office, long-term care facility, behavioral health
residential treatment facility, clinical laboratory, or
community health center; or
``(B) any other person or entity specified in regulations
by the Secretary after public notice and comment.
[[Page H1768]]
``SEC. 922. PRIVILEGE FOR PATIENT SAFETY WORK PRODUCT.
``(a) Privilege.--Notwithstanding any other provision of
law and subject to subsection (c), patient safety work
product shall not be--
``(1) subject to a civil or administrative subpoena or
order;
``(2) subject to discovery in connection with a civil or
administrative proceeding;
``(3) subject to disclosure 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;
``(4) required to be admitted as evidence or otherwise
disclosed in any State or Federal civil or administrative
proceeding; or
``(5) if the patient safety work product is identifiable
information and is received by a national accreditation
organization in its capacity as a patient safety
organization--
``(A) used by a national accreditation organization in an
accreditation action against the provider that reported the
information;
``(B) shared by such organization with its survey team; or
``(C) required as a condition of accreditation by a
national accreditation association.
``(b) Reporter Protection.--
``(1) In general.--A 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 information--
``(A) to the provider with the intention of having the
information reported to a patient safety organization; or
``(B) directly to a patient safety organization.
``(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 adverse 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.--Any provider that violates this subsection
shall be subject to a civil monetary penalty of not more than
$20,000 for each such violation involved. Such penalty shall
be imposed and collected in the same manner as civil money
penalties under subsection (a) of section 1128A of the Social
Security Act are imposed and collected.
``(c) Disclosures.--Nothing in this section prohibits any
of the following disclosures:
``(1) Voluntary disclosure of nonidentifiable information.
``(2) Voluntary disclosure of identifiable information by a
provider or patient safety organization, if such disclosure--
``(A) is authorized by the provider for the purposes of
improving quality and safety;
``(B) is to an entity or person subject to the requirements
of section 264(c) of the Health Insurance Portability and
Accountability Act of 1996 (Public Law 104-191; 110 Stat.
2033), or any regulation promulgated under such section; and
``(C) is not in conflict with such section or any
regulation promulgated under such section.
``(3) Disclosure as required by law by a provider to the
Food and Drug Administration, or on a voluntary basis by a
provider to a federally established patient safety program,
with respect to an Administration-regulated product or
activity for which that entity has responsibility, for the
purposes of activities related to the quality, safety, or
effectiveness of such Administration-regulated product or
activity.
``(4) Disclosures of patient safety work product in
accordance with this part by a provider to a patient safety
organization.
``(d) Effect of Transfer, Disclosure.--The following shall
not be treated as a waiver of any privilege or protection
established under this part:
``(1) The transfer of any patient safety work product
between a provider and a patient safety organization.
``(2) Disclosure of patient safety work product as
described in subsection (c).
``(3) The unauthorized disclosure of patient safety work
product.
``(e) Penalty.--
``(1) Prohibition.--Except as provided in this part, and
subject to paragraphs (2) and (4), it shall be unlawful for
any person to disclose patient safety work product in
violation of this section, if such disclosure constitutes a
negligent or knowing breach of confidentiality.
``(2) Relation to hipaa.--The penalty under paragraph (3)
for a disclosure in violation of paragraph (1) does not apply
if the person would be subject to a penalty under section
264(c) of the Health Insurance Portability and Accountability
Act of 1996 (Public Law 104-191; 110 Stat. 2033), or any
regulation promulgated under such section, for the same
disclosure.
``(3) Amount.--Any person who violates paragraph (1) shall
be subject to a civil monetary penalty of not more than
$10,000 for each such violation involved. Such penalty shall
be imposed and collected in the same manner as civil money
penalties under subsection (a) of section 1128A of the Social
Security Act are imposed and collected.
``(4) Subsequent disclosure.--Paragraph (1) applies only to
the first person that breaches confidentiality with respect
to particular patient safety work product.
``(f) Relation to HIPAA.--
``(1) In general.--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)--
``(A) patient safety organizations shall be treated as
business associates; and
``(B) activities of such organizations described in section
921(4) in relation to a provider are deemed to be health care
operations (as defined in such regulations) of the provider.
``(2) Rule of construction.--Nothing in this section shall
be construed to alter or affect the implementation of such
regulations or such section 264(c).
``(g) No Limitation of Other Privileges.--Nothing in this
section shall be construed to affect privileges, including
peer review and confidentiality protections, that are
otherwise available under Federal or State laws.
``(h) No Limitation on Contracts.--Nothing in this section
shall be construed to limit the power of a provider and a
patient safety organization, or a patient safety organization
and the Agency or any National Patient Safety Database,
consistent with the provisions of this Act and other
applicable law, to enter into a contract requiring greater
confidentiality or delegating authority to make an authorized
disclosure.
``(i) Relation to State Reporting Requirements.--Nothing in
this part shall be construed as preempting or otherwise
affecting any State law requiring a provider to report
information, including information described in section
921(5)(B), that is not patient safety work product.
``(j) Continuation of Privilege.--Patient safety work
product 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.
``(k) Reports on Strategies To Improve Patient Safety.--
``(1) Draft report.--Not later than the date that is 18
months after any National Patient Safety Database is
operational, the Secretary, in consultation with the
Director, shall prepare a draft report on effective
strategies for reducing medical errors and increasing patient
safety. The draft report shall include any measure determined
appropriate by the Secretary to encourage the appropriate use
of such strategies, including use in any federally funded
programs. The Secretary shall make the draft report available
for public comment and submit the draft report to the
Institute of Medicine for review.
``(2) Final report.--Not later than 1 year after the date
described in paragraph (1), the Secretary shall submit a
final report to the Congress that includes, in an appendix,
any findings by the Institute of Medicine concerning research
on the strategies discussed in the draft report and any
modifications made by the Secretary based on such findings.
``SEC. 923. NATIONAL PATIENT SAFETY DATABASE.
``(a) Authority.--
``(1) In general.--In conducting activities under this
part, the Secretary shall provide for the establishment and
maintenance of a database to receive relevant nonidentifiable
patient safety work product, and may designate entities to
collect relevant nonidentifiable patient safety work product
that is voluntarily reported by patient safety organizations
upon the request of the Secretary. Any database established
or designated under this paragraph may be referred to as a
`National Patient Safety Database'.
``(2) Use of information.--Information reported to any
National Patient Safety Database shall be used to analyze
national and regional statistics, including trends and
patterns of health care errors. The information resulting
from such analyses may be included in the annual quality
reports prepared under section 913(b)(2).
``(3) Advisory role.--The Secretary shall provide
scientific support to patient safety organizations, including
the dissemination of methodologies and evidence-based
information related to root causes and quality improvement.
``(b) Standards.--In establishing or designating a database
under subsection (a)(1), the Secretary shall, in consultation
with representatives of patient safety organizations, the
provider community, and the health information technology
industry, determine common formats for the voluntary
reporting of nonidentifiable patient safety work product,
including necessary elements, common and consistent
definitions, and a standardized computer interface for the
processing of the work product. To the extent practicable,
such standards shall be consistent with the administrative
simplification provisions of part C of title XI of the Social
Security Act.
``(c) Certain Methodologies for Collection.--The Secretary
shall ensure that the methodologies for the collection of
nonidentifiable patient safety work product for any National
Patient Safety Database include the methodologies developed
or recommended by the Patient Safety Task Force of the
Department of Health and Human Services.
``(d) Facilitation of Information Exchange.--To the extent
practicable, the Secretary may facilitate the direct link of
information between providers and patient safety
[[Page H1769]]
organizations and between patient safety organizations and
any National Patient Safety Database.
``(e) Restriction on Transfer.--Only nonidentifiable
information may be transferred to any National Patient Safety
Database.
``SEC. 924. TECHNICAL ASSISTANCE.
``(a) In General.--The Secretary, acting through the
Director, may--
``(1) provide technical assistance to patient safety
organizations, and to States with reporting systems for
health care errors; and
``(2) provide guidance on the type of data to be
voluntarily submitted to any National Patient Safety
Database.
``(b) Annual Meetings.--Assistance provided under
subsection (a) may include annual meetings for patient safety
organizations to discuss methodology, communication,
information collection, or privacy concerns.
``SEC. 925. CERTIFICATION OF PATIENT SAFETY ORGANIZATIONS.
``(a) In General.--Not later than 6 months after the date
of enactment of the Patient Safety and Quality Improvement
Act, the Secretary shall establish a process for certifying
patient safety organizations.
``(b) Process.--The process established under subsection
(a) shall include the following:
``(1) Certification of patient safety organizations by the
Secretary or by such other national or State governmental
organizations as the Secretary determines appropriate.
``(2) If the Secretary allows other governmental
organizations to certify patient safety organizations under
paragraph (1), the Secretary shall establish a process for
approving such organizations. Any such approved organization
shall conduct certifications and reviews in accordance with
this section.
``(3) A review of each certification under paragraph (1)
(including a review of compliance with each criterion in this
section and any related implementing standards as determined
by the Secretary through rulemaking) not less often than
every 3 years, as determined by the Secretary.
``(4) Revocation of any such certification by the Secretary
or other such governmental organization that issued the
certification, upon a showing of cause.
``(c) Criteria.--A patient safety organization must meet
the following criteria as conditions of certification:
``(1) The mission of the patient safety organization is to
conduct activities that are to improve patient safety and the
quality of health care delivery and is not in conflict of
interest with the providers that contract with the patient
safety organization.
``(2) The patient safety organization has appropriately
qualified staff, including licensed or certified medical
professionals.
``(3) The patient safety organization, within any 2 year
period, contracts with more than 1 provider for the purpose
of receiving and reviewing patient safety work product.
``(4) The patient safety organization is not a component of
a health insurer or other entity that offers a group health
plan or health insurance coverage.
``(5) The patient safety organization is managed,
controlled, and operated independently from any provider that
contracts with the patient safety organization for reporting
patient safety work product.
``(6) To the extent practical and appropriate, the patient
safety organization collects patient safety work product from
providers in a standardized manner that permits valid
comparisons of similar cases among similar providers.
``(d) Additional Criteria for Component Organizations.--If
a patient safety organization is a component of another
organization, the patient safety organization must, in
addition to meeting the criteria described in subsection (c),
meet the following criteria as conditions of certification:
``(1) The patient safety organization maintains patient
safety work product separately from the rest of the
organization, and establishes appropriate security measures
to maintain the confidentiality of the patient safety work
product.
``(2) The patient safety organization does not make an
unauthorized disclosure under this Act of patient safety work
product to the rest of the organization in breach of
confidentiality.
``(3) The mission of the patient safety organization does
not create a conflict of interest with the rest of the
organization.''.
(b) Authorization of Appropriations.--Section 937 of the
Public Health Service Act (as redesignated by subsection (a))
is amended by adding at the end the following:
``(e) Patient Safety and Quality Improvement.--For the
purpose of carrying out part C, there are authorized to be
appropriated such sums as may be necessary for each of the
fiscal years 2004 through 2008.''.
SEC. 102. PROMOTING THE DIFFUSION AND INTEROPERABILITY OF
INFORMATION TECHNOLOGY SYSTEMS INVOLVED WITH
HEALTH CARE DELIVERY.
(a) Voluntary Standards.--
(1) In general.--Not later than 18 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--
(A) develop or adopt voluntary national standards that
promote the interoperability of information technology
systems involved with health care delivery, including but not
limited to computerized physician order entry;
(B) in developing or adopting such standards, take into
account--
(i) the ability of such systems to capture and aggregate
clinically specific data to enable evidence-based medicine
and other applications that promote the electronic exchange
of patient medical record information; and
(ii) 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;
(C) in developing or adopting such standards and to the
extent practicable, test the efficacy, usability, and
scalability of proposed interoperability standards within a
variety of clinical settings, including an urban academic
medical center, a rural hospital, a community health center,
and a community hospital; and
(D) submit a report to the Congress containing
recommendations on such standards.
(2) Consultation.--In developing or adopting standards
under paragraph (1)(A), the Secretary shall consider the
recommendations of the National Committee on Vital Health
Statistics for the standardization of message formatting,
coding, and vocabulary for interoperability of information
technology systems involved with health care delivery. The
Secretary shall consult with representatives of the health
information technology industry and the provider community
who are involved with the development of interoperability
standards.
(b) Updates.--The Secretary shall provide for the ongoing
review and periodic updating of the standards developed under
subsection (a).
SEC. 103. REQUIRED USE OF PRODUCT IDENTIFICATION TECHNOLOGY.
The Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et
seq.) is amended--
(1) in section 502, by adding at the end the following:
``(w) If it is a drug or biological product, unless it
includes a unique product identifier for the drug or
biological product as required by regulations under section
510(q).''; and
(2) in section 510, by adding at the end the following:
``(q)(1) The Secretary shall issue, and may periodically
revise, regulations requiring the manufacturer of any drug or
biological product that is subject to regulation by the Food
and Drug Administration, or the packager or labeler of a drug
or biological product that is subject to regulation by the
Food and Drug Administration, to include a unique product
identifier on the packaging of the drug or biological
product.
``(2) For purposes of this subsection, the term `unique
product identifier' means an identification that--
``(A) is affixed by the manufacturer, labeler, or packager
to each drug or biological product described in paragraph (1)
at each packaging level;
``(B) uniquely identifies the item and meets the standards
required by this section; and
``(C) can be read by a scanning device or other technology
acceptable to the Secretary.
``(3) A unique product identifier required by regulations
issued or revised under paragraph (1) shall be based on--
``(A) the National Drug Code maintained by the Food and
Drug Administration;
``(B) commercially accepted standards established by
organizations that are accredited by the American National
Standards Institute, such as the Health Industry Business
Communication Council or the Uniform Code Council; or
``(C) other identification formats that the Secretary deems
appropriate.
``(4) The Secretary may, at the Secretary's discretion,
waive the requirements of this section, or add additional
provisions that are necessary to safeguard the public
health.''.
SEC. 104. GRANTS FOR ELECTRONIC PRESCRIPTION PROGRAMS.
(a) Grants.--
(1) In general.--The Secretary of Health and Human Services
(in this section referred to as the ``Secretary'') may make
grants to qualified practitioners for the purpose of
establishing electronic prescription programs.
(2) Matching funds.--
(A) In general.--With respect to the costs of establishing
an electronic prescription program, a condition for the
receipt of a grant under paragraph (1) is that the qualified
practitioner involved agree to make available (directly or
through donations from public or private entities) non-
Federal contributions toward such costs in an amount that is
not less than 50 percent of such costs.
(B) Determination of amount contributed.--Non-Federal
contributions required in subparagraph (A) may be in cash or
in kind, fairly evaluated, including equipment or services.
Amounts provided by the Federal Government, or services
assisted or subsidized to any significant extent by the
Federal Government, may not be included in determining the
amount of such non-Federal contributions.
(b) Study.--
(1) In general.--The Secretary, acting through the Director
of the Agency for Healthcare Research and Quality, shall
support a study to assess existing scientific evidence
regarding the effectiveness and cost-effectiveness of the use
of electronic prescription programs intended to improve the
efficiency of prescription ordering and the safe and
effective use of prescription drugs. The study shall address
the following:
[[Page H1770]]
(A) The ability of such programs to reduce medical errors
and improve the quality and safety of patient care.
(B) The impact of the use of such programs on physicians,
pharmacists, and patients, including such factors as direct
and indirect costs, changes in productivity, and
satisfaction.
(C) The effectiveness of strategies for overcoming barriers
to the use of electronic prescription programs.
(2) Report.--The Secretary shall ensure that, not later
than 18 months after the date of the enactment of this Act, a
report containing the findings of the study under paragraph
(1) is submitted to the appropriate committees of the
Congress.
(3) Dissemination of findings.--The Secretary shall
disseminate the findings of the study under paragraph (1) to
appropriate public and private entities.
(c) Development of Model.--The Secretary, acting through
the Director of the Agency for Healthcare Research and
Quality, may develop an Internet-based mathematical model
that simulates the cost and effectiveness of electronic
prescription programs for qualified practitioners. The model
may be designed to allow qualified practitioners to estimate,
through an interactive interface, the impact of electronic
prescribing on their practices, including the reduction in
drug-related health care errors.
(d) Definitions.--For purposes of this section:
(1) The term ``electronic prescription program''--
(A) means a program for the electronic submission and
processing of prescriptions; and
(B) includes the hardware (including computers and other
electronic devices) and software programs for the electronic
submission of prescriptions to pharmacies, the processing of
such submissions by pharmacies, and decision-support
programs.
(2) The term ``qualified practitioner'' means a
practitioner licensed by law to administer or dispense
prescription drugs.
SEC. 105. GRANTS TO HOSPITALS AND OTHER HEALTH CARE PROVIDERS
FOR INFORMATION TECHNOLOGIES.
(a) In General.--The Secretary of Health and Human Services
(in this section referred to as the ``Secretary'') shall make
grants to hospitals and other health care providers (but not
more than 1 grant to any 1 hospital or provider) to pay the
costs of acquiring or implementing information technologies
whose purposes are--
(1) to improve quality of care and patient safety; and
(2) to reduce adverse events and health care complications
resulting from medication errors.
(b) Special Consideration.--In making grants under
subsection (a), the Secretary shall give special
consideration to applicants who seek to promote the
following:
(1) Interoperability across hospital services or
departments using standards developed or adopted by the
Secretary under section 102.
(2) Electronic communication of patient data across the
spectrum of health care delivery.
(3) Computerized physician order entry or bar coding
applications.
(4) Electronic communication of patient data in hospitals
that provide services to underserved or low-income
populations.
(5) Improved clinical decisionmaking through acquisition
and implementation of decision-support technologies.
(c) Certain Grant Conditions.--A condition for the receipt
of a grant under subsection (a) is that the applicant
involved meet the following requirements:
(1) The applicant agrees to carry out a program to measure,
analyze, and report patient safety and medical errors at the
hospital or other health care provider involved, to submit to
the Secretary a description of the methodology that will be
used, and to have such program in effect as soon as
practicable after the application for the grant is approved,
without regard to whether information technologies under the
grant have been implemented.
(2) The applicant has arranged for an evaluation that
addresses the effectiveness and cost-effectiveness of the
information technology for which the grant is provided and
its impact on the quality and safety of patient care,
submitted the evaluation plan to the Secretary, and received
approval from the Secretary of the applicant's methodology.
(3) The applicant has or is developing a patient safety
evaluation system (as that term is defined in section 921 of
the Public Health Service Act (as amended by section 101))
for reporting health care errors to a patient safety
organization.
(4) The applicant agrees to provide the Secretary with such
information as the Secretary may require regarding the use of
funds under this program or its impact.
(5) The applicant provides assurances satisfactory to the
Secretary that any information technology planned, acquired,
or implemented with grant funds under this section will be
part of an information program that--
(A) carries out the purposes described in subsection (a);
and
(B) is comprehensive or will be expanded to become
comprehensive, regardless of whether Federal assistance is
available for such expansion.
(d) Technical Assistance to Grantees.--The Secretary,
acting through the Director of the Agency for Healthcare
Research and Quality, shall provide technical assistance to
applicants and grantees to ensure the appropriate evaluation
of the information technologies for which grants are awarded
under this section, such as--
(1) reviewing and providing technical assistance on the
applicant's proposed evaluation;
(2) developing mechanisms to ensure ongoing communications
between grantees and evaluators to facilitate the
identification and resolution of problems as they arise,
ensure mutual learning, and promote the rapid dissemination
of information;
(3) reviewing the interim and final reports required under
subsection (e); and
(4) disseminating evidence-based information in interim and
final reports to patient safety organizations, as
appropriate.
(e) Evaluation Reports by Grantee.--A condition for the
receipt of a grant under subsection (a) is that the applicant
agree to submit an interim and a final report to the
Secretary in accordance with this subsection.
(1) Interim report.--Not later than 1 year after the
implementation of information technologies under the grant is
completed, the applicant will submit an interim report to the
Secretary describing the initial effectiveness of such
technologies in carrying out the purposes described in
subsection (a).
(2) Final report.--Not later than 3 years after the
implementation of information technologies under the grant is
completed, the applicant will submit a final report to the
Secretary describing the effectiveness and cost-effectiveness
of such technologies and addressing other issues determined
to be important in carrying out the purposes described in
subsection (a).
(3) Relation to disbursement of grant.--In disbursing a
grant under subsection (a), the Secretary shall withhold \1/
3\ of the grant until the grantee submits to the Secretary
the report required in paragraph (1).
(f) Reports by Secretary.--
(1) Interim reports.--
(A) In general.--Through the fiscal year preceding the
fiscal year in which the final report under paragraph (2) is
prepared, the Secretary shall submit to the Committee on
Energy and Commerce of the House of Representatives and the
Committee on Health, Education, Labor, and Pensions of the
Senate periodic reports on the grant program under subsection
(a). Such reports shall be submitted not less frequently than
once each fiscal year, beginning with fiscal year 2004.
(B) Contents.--A report under subparagraph (A) shall
include information on--
(i) the number of grants made;
(ii) the nature of the projects for which funding is
provided under the grant program;
(iii) the geographic distribution of grant recipients; and
(iv) such other matters as the Secretary determines
appropriate.
(2) Final report.--Not later than 180 days after the date
on which the last of the reports is due under subsection
(e)(2), the Secretary shall submit a final report to the
committees referred to in paragraph (1)(A) on the grant
program under subsection (a), together with such
recommendations for legislation and administrative action as
the Secretary determines appropriate.
(g) Definitions.--For purposes of this section:
(1) The term ``costs'', with respect to information
technologies referred to in subsection (a), includes total
expenditures incurred for--
(A) purchasing, leasing, and installing computer software
and hardware, including hand-held computer technologies;
(B) making improvements to existing computer software and
hardware; and
(C) purchasing or leasing communications capabilities
necessary for clinical data access, storage, and exchange.
(2) The term ``health care provider'' has the same meaning
given to the term ``provider'' in section 921 of the Public
Health Services Act (as amended by this Act).
(h) Termination of Grant Authorities.--The authority of the
Secretary to make grants under subsection (a) terminates upon
the expiration of fiscal year 2011.
(i) Matching Funds.--
(1) In general.--With respect to the costs of a grant to be
carried out under this section, such grant may be made only
if the applicant agrees to make available (directly or
through donations from public or private entities) non-
Federal contributions toward such costs in an amount that is
not less than 50 percent of such costs ($1 for each $1 of
Federal funds provided in the grant).
(2) Determination of amounts contributed.--Amounts provided
by the Federal Government, or services assisted or subsidized
to any significant extent by the Federal Government, may not
be included in determining the amount of such non-Federal
contributions.
SEC. 106. AUTHORIZATION OF APPROPRIATIONS FOR GRANTS UNDER
SECTIONS 104 AND 105.
For the purpose of carrying out sections 104 and 105, there
are authorized to be appropriated $25,000,000 for each of
fiscal years 2004 and 2005.
TITLE II--MEDICAL INFORMATION TECHNOLOGY ADVISORY BOARD.
SEC. 201. MEDICAL INFORMATION TECHNOLOGY ADVISORY BOARD.
Title XI of the Social Security Act is amended by adding at
the end the following new section:
[[Page H1771]]
``medical information technology advisory board
``Sec. 1180. (a) Establishment.--
``(1) In general.--Not later than 3 months after the date
of the enactment of this section, 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 section, 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 102 of the
Patient Safety and Quality Improvement 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) Funding.--There are authorized to be appropriated
such sums as are necessary for each fiscal year to carry out
this section.''.
The SPEAKER pro tempore. Pursuant to the rule, the gentleman from
Florida (Mr. Bilirakis) and the gentleman from Louisiana (Mr. John)
each will control 20 minutes.
The Chair recognizes the gentleman from Florida (Mr. Bilirakis).
General Leave
Mr. BILIRAKIS. Mr. Speaker, I ask unanimous consent that all Members
may have 5 legislative days within which to revise and extend their
remarks and to insert extraneous material on H.R. 663, the legislation
under consideration.
The SPEAKER pro tempore. Is there objection to the request of the
gentleman from Florida?
There was no objection.
Mr. BILIRAKIS. Mr. Speaker, I yield myself such time as I may
consume.
Mr. Speaker, I first commend the leadership of the gentleman from
Louisiana (Mr. Tauzin), chairman of the Committee on Energy and
Commerce, and the gentleman from Ohio (Mr. Brown) and the gentleman
from Michigan (Mr. Dingell), minority leaders on that committee, and
the gentleman from California (Mr. Thomas), chairman of the Committee
on Ways and Means, and the gentlewoman from Connecticut (Mrs. Johnson),
the subcommittee chairman of the Committee on Ways and Means, in
helping us bring forward this important bipartisan legislation.
[[Page H1772]]
Mr. Speaker, I rise in strong support of the bill. This is a
critically important bill which we refer to as the Patient Safety and
Quality Improvement Act, and I look forward to its favorable
consideration by the House today.
I know most Members are well acquainted with the disturbing frequency
and devastating impact of medical errors. Unfortunately, recent events
have once again attached a human face to the horrible reality that,
sometimes, even the best health care professionals make mistakes.
The work of the Institute of Medicine in this area helped increase
the public's focus on this problem, as well as potential solutions. One
of the many recommendations that the IOM made in its 1999 report, which
they called ``To Err Is Human,'' was that Congress should enact laws to
protect the confidentiality of information collected as part of a
voluntary medical error reporting system. That IOM recommendation
represents the foundation of the Patient Safety and Quality Improvement
Act.
Specifically, H.R. 663 defines a new voluntary medical error
reporting system whereby the Secretary of Health and Human Services
will certify a number of private and public organizations to act as
patient safety organizations, PSOs. These patient safety organizations
will analyze data on medical errors, determine their causes, and
develop and disseminate evidence-based information to providers to help
them implement changes that will improve patient safety. H.R. 663
provides peer review protections to the documents and communications
providers will submit to patient safety organizations, which we hope
will encourage the exchange of this important information.
Mr. Speaker, I believe the bill will help us move from a ``culture of
blame'' to a ``culture of safety'' and ultimately increase patient
safety. The Patient Safety and Quality Improvement Act is the product
of excellent, bipartisan work. I urge Members to join me in supporting
it today.
Mr. Speaker, I reserve the balance of my time.
Mr. JOHN. Mr. Speaker, I yield myself such time as I may consume.
Mr. Speaker, I rise in support of H.R. 663, the Patient Safety and
Quality Improvement Act. This bill is a product of bipartisan
negotiations between not only the Committee on Energy and Commerce but
also includes key members from both sides of the aisle on the Committee
on Ways and Means; and I thank Members on both sides of the aisle for
their very hard work on this important piece of legislation.
{time} 1315
It has been more than 3 years since the Institute of Medicine
released the landmark study, ``To Err Is Human.'' The Institute of
Medicine stated that our health care system is plagued with an epidemic
of medical errors. However, many of these mistakes could be prevented
in the health care delivery system and the way that it is delivered.
With this bill, Congress is taking an important step towards reducing
medical errors. The Patient Safety and Quality Improvement Act creates
a voluntary reporting system that will enable providers to learn from
past mistakes. Providers could report information about medical errors
to patient safety organizations who would analyze the data in
confidence and recommend strategies to prevent future errors. These
organizations could share knowledge with each other and with the Agency
for Health Care Research and Quality so that all actors in the health
care system could benefit.
Congress intends for providers to take these lessons learned and
modify their operations to keep their patients safer. This bill
requires the Secretary of Health and Human Services to recommend which
strategies for reducing medical errors would be appropriate standards
for providers in Federal health care programs. No bill can prevent all
medical errors, but it is our hope that this legislation will result in
real differences that patients can see.
Mr. Speaker, I reserve the balance of my time.
Mr. BILIRAKIS. Mr. Speaker, I yield such time as he may consume to
the gentleman from Louisiana (Mr. Tauzin), the chairman of the full
committee, who is more responsible for this piece of legislation than
any of us.
Mr. TAUZIN. Mr. Speaker, actually I rise first to commend a Member of
the House who has done some extraordinary work, not even on our
committee but on the Committee on Ways and Means, and that is the
gentlewoman from Connecticut (Mrs. Johnson), who has really contributed
mightily to the understanding of this issue and has helped indeed frame
much of the solutions that this bill contains. I want to thank the
gentlewoman from Connecticut (Mrs. Johnson) and the gentleman from
California (Mr. Thomas) of the Committee on Ways and Means for that
vital process. I particularly also want to thank the gentleman from
Florida (Mr. Bilirakis), the chairman of the Subcommittee on Health,
and the gentleman from Ohio (Mr. Brown) and the gentleman from Michigan
(Mr. Dingell), the ranking members of the subcommittee and the full
committee, indeed for the fact that this is a bipartisan effort to do
something about medical errors which end up creating victims of a
health care system who should never have to suffer because of those
errors.
We are told in the project of 1999 that was done by the Institute of
Medicine, in that report entitled ``To Err Is Human,'' that as many as
98,000 people in this country die as a result of medical errors. In
fact, the news contains the story today of perhaps some errors in a
young child who received an organ transplant just this week again.
Those awful stories should come to an end. The first and most important
way of ending medical error damage and death in our health care system
is in fact to do what we are doing today, and that is to set up a
system whereby health care officials and doctors and nurses, clinics
and hospitals, can share information. One can learn from the other.
The impediments to sharing information today are many. The ability of
a doctor to share information about something that went wrong or a
hospital to share information with another hospital about something
that could go right in the case of a medical error prevented, those
inabilities are corrected in this act. The act creates not only the
incentive for information sharing but grants an assistance for the
technologies that are going to improve the transfer of information that
will make less error in the health care system a reality and,
therefore, again save human lives and human misery.
This act will not only improve the quality of our health care system,
it will immeasurably improve the safety of the health care facilities
and the safety net that surrounds someone who goes into one of those
facilities expecting to be healed rather than to come out with an
infection.
As the chairman of the Subcommittee on Health said, the effort here
is to create a culture of safety by providing a legal protection
framework for the information that is reported, that is provided, about
quality improvement and patient safety. The thrust is to provide the
opportunity for health care providers to submit information to a
patient safety organization and have an analysis done so that we can
learn from all the information coming in, what works, what does not
work, what errors are occurring and why they are occurring, and then to
have these same organizations have the benefit of that information in
preventing those errors and in improving the safety of their
procedures.
There are several provisions aimed at improving the diffusion and
functioning of important information technologies that help prevent
medical errors. This legislation is not the only one we will work on to
help improve patient safety and quality. There are other efforts being
undertaken in the States and in the local medical communities of all of
our homes. We want to support those efforts as well and will continue
to work in a bipartisan fashion as we have done here to help improve
the outcomes in our health care system.
In short, today we begin a very aggressive campaign to root out
errors within the health care delivery system and to save lives and
injury that result from those errors. Tomorrow we will take up the
liability questions, the questions of how liability and malpractice
cases are pursued in this country. But today we focus on this set of
victims as our committee continues to put patients first, as we try to
focus all
[[Page H1773]]
our health care policy and decision-making on how we can better help
patients receive good, quality, safe health care when they go to a
health care facility in this country or they seek the services of a
health care provider.
This is extremely important stuff we do today. I hope this House
understands that while this is a bipartisan effort, while it passed
committee on a voice vote, while we are all very supportive of it and
very grateful for the work of not only the members of our committee but
other committees who have assisted us, I want everyone to know that
this is really serious stuff. If this works, we could save nearly
100,000 American citizens who die yearly from these errors. This is
important stuff. I urge the House to agree with this important
legislation.
Mr. BILIRAKIS. Mr. Speaker, I yield such time as she may consume to
the gentlewoman from New York (Mrs. Kelly).
Mrs. KELLY. Mr. Speaker, I rise today in strong support of the
Patient Safety and Quality Improvement Act, legislation which will
strengthen our health care system and improve patient care. Today we
are considering a bill that creates a structured process for reporting
errors made during the course of medical treatment. Voluntary and
confidential disclosure can help reduce injuries and death due to
medical errors. What we have here is the creation of patient safety
organizations that are created to conduct comprehensive analyses of
what went wrong following a medical mistake. The people who provide
health care are given feedback that way so that they can make changes
and prevent future occurrences. Compiling this information in a central
database will allow providers nationwide to benefit from lessons
learned.
The simple message is that we need to learn from our mistakes. For
this legislation to be effective, it is essential that practitioners
feel comfortable in coming forward with information. I met with a group
of doctors and providers in my district and they suggested strongly
that we encourage some kind of indemnification so that they could
report accurate figures. I am glad to report that this bill contains
strong legal protections and provisions to ensure that information
reported is treated as confidential, such as whistleblower-type
protections. I think that is a very good piece in this bill. Creating a
culture of safety surrounding the reporting of medical errors will
encourage health care practitioners to report these mistakes.
The Institute of Medicine reported in 1999 that medical errors are
the eighth leading cause of death among Americans. I believe this bill
will go a long way toward preventing many of these tragic deaths and
injuries. Mr. Speaker, the bill makes great sense for patients and for
health care providers. I applaud the committee for putting this bill
forward, and I urge my colleagues to support this legislation.
Mr. STARK. Mr. Speaker, reducing medical errors is an important goal,
and this legislation takes a small step in that direction. But don't be
fooled by the rhetoric.
While the legislation offers a glimmer of hope that action will be
taken, it does nothing to actually prevent any future medical errors or
improve patient safety.
Unfortunately, the timing of the consideration of this bill is driven
by crass political motives to provide cover for the anti-patient
legislation that will be considered tomorrow.
I personally think one of our goals should be to first do no harm,
and I believe this bill accomplishes that. But it doesn't do much good
either.
Federal agencies, states, and the private sector are making strides
in this area. But there are certain things that only Congress can do.
The legislation before us is not the best example of what that role
should be.
This legislation reflects a tenuously and delicately crafted
compromise that assures that information which is discoverable today
will remain discoverable if this bill becomes law. While the bill
creates a new federal privilege for the data created for this new
voluntary reporting system, it does not erode a patient's right to
access information that is currently available and would be available
but for this new system. I am satisfied that--as currently written--it
seems to accomplish that goal. But I am concerned about how it will be
used and intend to keep an eye on it.
The bill establishes a voluntary system under which patient safety
organizations may be created, providers may report their mistakes and
the Secretary may act to improve patient safety practices.
But let's talk about what this bill does not do.
It does not reflect the Institute of Medicine's recommendations from
the landmark 1999 report.
It does not ensure that providers change their practices to prevent
medical errors, based on the insight that might be gained from the
system created under this bill.
It does not require a rigorous evaluation of this new voluntary
system, which may be ineffective.
The IOM report estimated that as many as 98,000 hospital deaths each
year may be attributable to preventable medical errors, yet this
legislation fails to assure any reduction in this tragic statistic. It
certainly doesn't address the recent organ transplant tragedies.
There are a number of steps that can be taken today to reduce errors
and improve patient safety, but too few providers have implemented
these policies.
For example, only one percent of hospitals require use of
computerized order-entry systems to reduce pharmaceutical prescribing,
dispensing and administration errors.
Similarly, last year the American Nurses Association testified that a
significant portion of hospital errors are the result of fatigued and
overworked staff. Around the country, nurses are regularly forced to
work more hours than are believed to be safe to provide quality care. I
introduced legislation (H.R. 745) to prohibit this unsafe practice.
Without assurances that the system will use this newly protected data
to improve practice, this lop-sided exercise benefits the providers at
the expense of patients, and the trade-off may not be worth it.
Finally, let's not forget that the timing of this legislation is not
accidental. This legislation is being brought up today in an effort to
distract from the anti-patient legislation that Congress will take up
tomorrow. Don't be fooled by the rhetoric.
I intend to vote for this bill because it does no harm and lays the
groundwork for future action. But we have missed an opportunity to do
more.
Mr. DINGELL. Mr. Speaker, I rise in support of H.R. 663, the
``Patient Safety and Quality Improvement Act.'' This bipartisan bill is
the product of collaboration with my colleagues on the Committee on
Energy and Commerce, particularly Chairmen Tauzin and Bilirakis, and
Subcommittee Ranking Member Brown. I also note that this legislation
builds on the work of my colleagues on the Committee on Ways and Means,
including Representatives Johnson, Stark, Thomas, and Rangel. I thank
all who have made important contributions to this bill.
The Patient Safety and Quality Improvement Act addresses a problem
that many of us are familiar with. According to a December 2003 survey
by the Harvard School of Public Health and the Kaiser Family
Foundation, 42 percent of the public says that they or a family member
have experienced a medical error.
This bill contains one piece of the puzzle that must be completed in
order to reduce medical errors. It would create a voluntary reporting
system for the purpose of learning from medical mistakes.
Under this voluntary reporting system, health care providers could
report information on medical errors to Patient Safety Organizations.
These organizations would help providers analyze what went wrong and
identify what strategies could prevent future mistakes. It is our
intent that providers would take this knowledge and make changes in the
health care delivery system to improve care for patients.
I also hope that the Secretary of Health and Human Services would use
this knowledge to set some basic guidelines that all providers would be
required to follow. Patients should be able to expect that providers
are adhering to certain safety standards before they seek treatment
from a doctor, hospital, or other facility.
The best patient safety bill, however, cannot prevent all medical
errors. Unfortunately, there will be cases where a medical mistake is
made and a patient suffers injury or death as a result. If medical
malpractice was involved in these cases, patients and their families
should be entitled to seek compensation under a fair and accessible
legal system. It would be disingenuous to suggest that the limited
legislation before us today could supplant the vital role of legal
remedies for medical malpractice.
Again, I thank my colleagues for their cooperation in writing this
patient safety bill, and I look forward to seeing the improvements that
will result when it is implemented.
Mr. ENGEL. Mr. Speaker, HR 663, the Patient Safety and Quality
Improvement Act, is important legislation that holds great promise to
reduce medical errors. This legislation will allow medical errors to be
reported so we can learn from mistakes and hopefully prevent future
errors from occurring. By allowing errors or near misses to be reported
anonymously it takes away the fear many providers have in regards to
reporting errors.
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I am particularly pleased that the legislation creates the Medical
Information Technology Assessment Board which will work in conjunction
with the Department of Health and Human Services to develop national
interoperability standards. I was pleased to work with the Committee to
get this provision included in the bill. These national standards will
allow all aspects of health care technology to become compatible. Thus,
computers, hand held electronic charts and other new devices that hold
a variety of medical information, including laboratory and radiology
results, pharmacy orders, etc, will all be compatible. This
compatibility will greatly reduce medical errors. Further, the
legislation authorizes grants to test the interoperability standards.
This is vitally important as it will prove the efficacy, usability, and
scalability of interoperability standards, thus encouraging hospitals
and other health care facilities and providers to adopt the standards
and invest in medical informatics.
Mr. Speaker, I am proud to be a cosponsor of the Patient Safety and
Quality Improvement Act, and I thank both the Energy and Commerce and
Ways and Means Committees for working in a bipartisan fashion to
produce good legislation on such an important issue.
Mr. GREEN of Texas. Mr. Speaker, I am pleased to rise in support of
the Patient Safety and Quality Improvement Act. This important
legislation takes a number of steps to reduce medical errors.
In November of 1999, the Institute of Medicine released its
groundbreaking report, To Err is Human, which raises serious concerns
about shortcomings in the area of patient safety.
According to some estimates, as many as 98,000 people die in any
given year from medical errors that occur in hospitals. That's more
than die from motor vehicle accidents, breast cancer, or AIDS.
The costs of preventable adverse events are staggering. The direct
and indirect costs of medical errors range from $17 billion to $29
billion. By any standard, that is far too much.
The Institute of Medicine recommended a number of options to help
reduce medical errors, such as the creation of a Center for Patient
Safety within the Agency for Health Quality and Research.
They also suggested a new system of reporting, and better use of
technological advancements.
The legislation we are considering today incorporates many of the
suggestions made by IOM, and will go a long way to help health care
providers improve patient safety and prevent medical errors.
This legislation creates a ``culture of safety'' by encouraging
providers to report medical mistakes. By reporting these problems,
physicians and other providers are able to learn from their mistakes
and prevent them from happening in the future.
This legislation also permits the Secretary of the Department of
Health and Human Services to provide to patient safety organizations
and to States technical assistance with reporting systems for health
care errors, to establish a process to certify patient safety
organizations, and to develop or adopt voluntary national standards
promoting the interoperability of information technology systems
involved with health care delivery.
These provisions will go a long way in helping our hospitals and
physicians offices a safer place. I urge my colleagues to support this
legislation and hope to see it signed by the President this year.
Mr. JOHN. Mr. Speaker, I yield back the balance of my time.
Mr. BILIRAKIS. Mr. Speaker, I yield back the balance of my time.
The SPEAKER pro tempore (Mr. LaHood). The question is on the motion
offered by the gentleman from Florida (Mr. Bilirakis) that the House
suspend the rules and pass the bill, H.R. 663, as amended.
The question was taken.
The SPEAKER pro tempore. In the opinion of the Chair, two-thirds of
those present have voted in the affirmative.
Mr. BILIRAKIS. Mr. Speaker, on that I demand the yeas and nays.
The yeas and nays were ordered.
The SPEAKER pro tempore. Pursuant to clause 8 of rule XX and the
Chair's prior announcement, further proceedings on this motion will be
postponed.
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