[Congressional Record Volume 151, Number 104 (Wednesday, July 27, 2005)]
[House]
[Pages H6673-H6679]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]
PATIENT SAFETY AND QUALITY IMPROVEMENT ACT OF 2005
Mr. DEAL of Georgia. Mr. Speaker, I move to suspend the rules and
pass the Senate bill (S. 544) 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 effect patient safety.
The Clerk read as follows:
S. 544
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 of 2005''.
(b) Table of Contents.--The table of contents for this Act
is as follows:
Sec. 1. Short title; table of contents.
Sec. 2. Amendments to Public Health Service Act.
``Part C--Patient Safety Improvement
``Sec. 921. Definitions.
``Sec. 922. Privilege and confidentiality protections.
``Sec. 923. Network of patient safety databases.
``Sec. 924. Patient safety organization certification and listing.
``Sec. 925. Technical assistance.
``Sec. 926. Severability.
SEC. 2. 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) HIPAA confidentiality regulations.--The term `HIPAA
confidentiality regulations' means regulations promulgated
under section 264(c) of the Health Insurance Portability and
Accountability Act of 1996 (Public Law 104-191; 110 Stat.
2033).
``(2) Identifiable patient safety work product.--The term
`identifiable patient safety work product' means patient
safety work product that--
``(A) is presented in a form and manner that allows the
identification of any provider that is a subject of the work
product, or any providers that participate in activities that
are a subject of the work product;
``(B) constitutes individually identifiable health
information as that term is defined in the HIPAA
confidentiality regulations; or
``(C) is presented in a form and manner that allows the
identification of an individual who reported information in
the manner specified in section 922(e).
``(3) Nonidentifiable patient safety work product.--The
term `nonidentifiable patient safety work product' means
patient safety work product that is not identifiable patient
safety work product (as defined in paragraph (2)).
``(4) Patient safety organization.--The term `patient
safety organization' means a private or public entity or
component thereof that is listed by the Secretary pursuant to
section 924(d).
``(5) Patient safety activities.--The term `patient safety
activities' means the following activities:
``(A) Efforts to improve patient safety and the quality of
health care delivery.
``(B) The collection and analysis of patient safety work
product.
``(C) The development and dissemination of information with
respect to improving patient safety, such as recommendations,
protocols, or information regarding best practices.
``(D) The utilization of patient safety work product for
the purposes of encouraging a culture of safety and of
providing feedback and assistance to effectively minimize
patient risk.
``(E) The maintenance of procedures to preserve
confidentiality with respect to patient safety work product.
``(F) The provision of appropriate security measures with
respect to patient safety work product.
``(G) The utilization of qualified staff.
``(H) Activities related to the operation of a patient
safety evaluation system and to the provision of feedback to
participants in a patient safety evaluation system.
``(6) Patient safety evaluation system.--The term `patient
safety evaluation system' means the collection, management,
or analysis of information for reporting to or by a patient
safety organization.
``(7) Patient safety work product.--
``(A) In general.--Except as provided in subparagraph (B),
the term `patient safety work product' means any data,
reports, records, memoranda, analyses (such as root cause
analyses), or written or oral statements--
``(i) which--
``(I) are assembled or developed by a provider for
reporting to a patient safety organization and are reported
to a patient safety organization; or
``(II) are developed by a patient safety organization for
the conduct of patient safety activities;
and which could result in improved patient safety, health
care quality, or health care outcomes; or
``(ii) which identify or constitute the deliberations or
analysis of, or identify the fact of reporting pursuant to, a
patient safety evaluation system.
``(B) Clarification.--
``(i) Information described in subparagraph (A) does not
include a patient's medical record, billing and discharge
information, or any other original patient or provider
record.
``(ii) Information described in subparagraph (A) does not
include information that is collected, maintained, or
developed separately, or exists separately, from a patient
safety evaluation system. Such separate information or a copy
thereof reported to a patient safety organization shall not
by reason of its reporting be considered patient safety work
product.
``(iii) Nothing in this part shall be construed to limit--
``(I) the discovery of or admissibility of information
described in this subparagraph in a criminal, civil, or
administrative proceeding;
``(II) the reporting of information described in this
subparagraph to a Federal, State, or local governmental
agency for public health surveillance, investigation, or
other public health purposes or health oversight purposes; or
``(III) a provider's recordkeeping obligation with respect
to information described in this subparagraph under Federal,
State, or local law.
``(8) 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,
hospice program, renal dialysis facility, ambulatory surgical
center, pharmacy, physician or health care practitioner's
office, long term care facility, behavior health residential
treatment facility, clinical laboratory, or health center; or
``(ii) a physician, physician assistant, nurse
practitioner, clinical nurse specialist, certified registered
nurse anesthetist, certified nurse midwife, psychologist,
certified social worker, registered dietitian or nutrition
professional, physical or occupational therapist, pharmacist,
or other individual health care practitioner; or
``(B) any other individual or entity specified in
regulations promulgated by the Secretary.
``SEC. 922. PRIVILEGE AND CONFIDENTIALITY PROTECTIONS.
``(a) Privilege.--Notwithstanding any other provision of
Federal, State, or local
[[Page H6674]]
law, and subject to subsection (c), patient safety work
product shall be privileged and shall not be--
``(1) subject to a Federal, State, or local civil,
criminal, or administrative subpoena or order, including in a
Federal, State, or local civil or administrative disciplinary
proceeding against a provider;
``(2) subject to discovery in connection with a Federal,
State, or local civil, criminal, or administrative
proceeding, including in a Federal, State, or local civil or
administrative disciplinary proceeding against a provider;
``(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, State, or
local law;
``(4) admitted as evidence in any Federal, State, or local
governmental civil proceeding, criminal proceeding,
administrative rulemaking proceeding, or administrative
adjudicatory proceeding, including any such proceeding
against a provider; or
``(5) admitted in a professional disciplinary proceeding of
a professional disciplinary body established or specifically
authorized under State law.
``(b) Confidentiality of Patient Safety Work Product.--
Notwithstanding any other provision of Federal, State, or
local law, and subject to subsection (c), patient safety work
product shall be confidential and shall not be disclosed.
``(c) Exceptions.--Except as provided in subsection
(g)(3)--
``(1) Exceptions from privilege and confidentiality.--
Subsections (a) and (b) shall not apply to (and shall not be
construed to prohibit) one or more of the following
disclosures:
``(A) Disclosure of relevant patient safety work product
for use in a criminal proceeding, but only after a court
makes an in camera determination that such patient safety
work product contains evidence of a criminal act and that
such patient safety work product is material to the
proceeding and not reasonably available from any other
source.
``(B) Disclosure of patient safety work product to the
extent required to carry out subsection (f)(4)(A).
``(C) Disclosure of identifiable patient safety work
product if authorized by each provider identified in such
work product.
``(2) Exceptions from confidentiality.--Subsection (b)
shall not apply to (and shall not be construed to prohibit)
one or more of the following disclosures:
``(A) Disclosure of patient safety work product to carry
out patient safety activities.
``(B) Disclosure of nonidentifiable patient safety work
product.
``(C) Disclosure of patient safety work product to
grantees, contractors, or other entities carrying out
research, evaluation, or demonstration projects authorized,
funded, certified, or otherwise sanctioned by rule or other
means by the Secretary, for the purpose of conducting
research to the extent that disclosure of protected health
information would be allowed for such purpose under the HIPAA
confidentiality regulations.
``(D) Disclosure by a provider to the Food and Drug
Administration with respect to a product or activity
regulated by the Food and Drug Administration.
``(E) Voluntary disclosure of patient safety work product
by a provider to an accrediting body that accredits that
provider.
``(F) Disclosures that the Secretary may determine, by rule
or other means, are necessary for business operations and are
consistent with the goals of this part.
``(G) Disclosure of patient safety work product to law
enforcement authorities relating to the commission of a crime
(or to an event reasonably believed to be a crime) if the
person making the disclosure believes, reasonably under the
circumstances, that the patient safety work product that is
disclosed is necessary for criminal law enforcement purposes.
``(H) With respect to a person other than a patient safety
organization, the disclosure of patient safety work product
that does not include materials that--
``(i) assess the quality of care of an identifiable
provider; or
``(ii) describe or pertain to one or more actions or
failures to act by an identifiable provider.
``(3) Exception from privilege.--Subsection (a) shall not
apply to (and shall not be construed to prohibit) voluntary
disclosure of nonidentifiable patient safety work product.
``(d) Continued Protection of Information After
Disclosure.--
``(1) In general.--Patient safety work product that is
disclosed under subsection (c) shall continue to be
privileged and confidential as provided for in subsections
(a) and (b), and such disclosure shall not be treated as a
waiver of privilege or confidentiality, and the privileged
and confidential nature of such work product shall also apply
to such work product in the possession or control of a person
to whom such work product was disclosed.
``(2) Exception.--Notwithstanding paragraph (1), and
subject to paragraph (3)--
``(A) if patient safety work product is disclosed in a
criminal proceeding, the confidentiality protections provided
for in subsection (b) shall no longer apply to the work
product so disclosed; and
``(B) if patient safety work product is disclosed as
provided for in subsection (c)(2)(B) (relating to disclosure
of nonidentifiable patient safety work product), the
privilege and confidentiality protections provided for in
subsections (a) and (b) shall no longer apply to such work
product.
``(3) Construction.--Paragraph (2) shall not be construed
as terminating or limiting the privilege or confidentiality
protections provided for in subsection (a) or (b) with
respect to patient safety work product other than the
specific patient safety work product disclosed as provided
for in subsection (c).
``(4) Limitations on actions.--
``(A) Patient safety organizations.--
``(i) In general.--A patient safety organization shall not
be compelled to disclose information collected or developed
under this part whether or not such information is patient
safety work product unless such information is identified, is
not patient safety work product, and is not reasonably
available from another source.
``(ii) Nonapplication.--The limitation contained in clause
(i) shall not apply in an action against a patient safety
organization or with respect to disclosures pursuant to
subsection (c)(1).
``(B) Providers.--An accrediting body shall not take an
accrediting action against a provider based on the good faith
participation of the provider in the collection, development,
reporting, or maintenance of patient safety work product in
accordance with this part. An accrediting body may not
require a provider to reveal its communications with any
patient safety organization established in accordance with
this part.
``(e) Reporter Protection.--
``(1) In general.--A provider may not take an adverse
employment action, as described in paragraph (2), against an
individual based upon 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) loss of employment, the failure to promote an
individual, or the failure to provide any other employment-
related benefit for which the individual would otherwise be
eligible; or
``(B) an adverse evaluation or decision made in relation to
accreditation, certification, credentialing, or licensing of
the individual.
``(f) Enforcement.--
``(1) Civil monetary penalty.--Subject to paragraphs (2)
and (3), a person who discloses identifiable patient safety
work product in knowing or reckless violation of subsection
(b) shall be subject to a civil monetary penalty of not more
than $10,000 for each act constituting such violation.
``(2) Procedure.--The provisions of section 1128A of the
Social Security Act, other than subsections (a) and (b) and
the first sentence of subsection (c)(1), shall apply to civil
money penalties under this subsection in the same manner as
such provisions apply to a penalty or proceeding under
section 1128A of the Social Security Act.
``(3) Relation to hipaa.--Penalties shall not be imposed
both under this subsection and under the regulations issued
pursuant to section 264(c)(1) of the Health Insurance
Portability and Accountability Act of 1996 (42 U.S.C. 1320d-2
note) for a single act or omission.
``(4) Equitable relief.--
``(A) In general.--Without limiting remedies available to
other parties, a civil action may be brought by any aggrieved
individual to enjoin any act or practice that violates
subsection (e) and to obtain other appropriate equitable
relief (including reinstatement, back pay, and restoration of
benefits) to redress such violation.
``(B) Against state employees.--An entity that is a State
or an agency of a State government may not assert the
privilege described in subsection (a) unless before the time
of the assertion, the entity or, in the case of and with
respect to an agency, the State has consented to be subject
to an action described in subparagraph (A), and that consent
has remained in effect.
``(g) Rule of Construction.--Nothing in this section shall
be construed--
``(1) to limit the application of other Federal, State, or
local laws that provide greater privilege or confidentiality
protections than the privilege and confidentiality
protections provided for in this section;
``(2) to limit, alter, or affect the requirements of
Federal, State, or local law pertaining to information that
is not privileged or confidential under this section;
``(3) except as provided in subsection (i), to alter or
affect the implementation of any provision of the HIPAA
confidentiality regulations or section 1176 of the Social
Security Act (or regulations promulgated under such section);
``(4) to limit the authority of any provider, patient
safety organization, or other entity to enter into a contract
requiring greater confidentiality or delegating authority to
make a disclosure or use in accordance with this section;
``(5) as preempting or otherwise affecting any State law
requiring a provider to report information that is not
patient safety work product; or
[[Page H6675]]
``(6) to limit, alter, or affect any requirement for
reporting to the Food and Drug Administration information
regarding the safety of a product or activity regulated by
the Food and Drug Administration.
``(h) Clarification.--Nothing in this part prohibits any
person from conducting additional analysis for any purpose
regardless of whether such additional analysis involves
issues identical to or similar to those for which information
was reported to or assessed by a patient safety organization
or a patient safety evaluation system.
``(i) Clarification of Application of HIPAA Confidentiality
Regulations to Patient Safety Organizations.--For purposes of
applying the HIPAA confidentiality regulations--
``(1) patient safety organizations shall be treated as
business associates; and
``(2) patient safety activities of such organizations in
relation to a provider are deemed to be health care
operations (as defined in such regulations) of the provider.
``(j) Reports on Strategies To Improve Patient Safety.--
``(1) Draft report.--Not later than the date that is 18
months after any network of patient safety databases 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.
``SEC. 923. NETWORK OF PATIENT SAFETY DATABASES.
``(a) In General.--The Secretary shall facilitate the
creation of, and maintain, a network of patient safety
databases that provides an interactive evidence-based
management resource for providers, patient safety
organizations, and other entities. The network of databases
shall have the capacity to accept, aggregate across the
network, and analyze nonidentifiable patient safety work
product voluntarily reported by patient safety organizations,
providers, or other entities. The Secretary shall assess the
feasibility of providing for a single point of access to the
network for qualified researchers for information aggregated
across the network and, if feasible, provide for
implementation.
``(b) Data Standards.--The Secretary may determine common
formats for the reporting to and among the network of patient
safety databases maintained under subsection (a) of
nonidentifiable patient safety work product, including
necessary work product elements, common and consistent
definitions, and a standardized computer interface for the
processing of such 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) Use of Information.--Information reported to and
among the network of patient safety databases under
subsection (a) shall be used to analyze national and regional
statistics, including trends and patterns of health care
errors. The information resulting from such analyses shall be
made available to the public and included in the annual
quality reports prepared under section 913(b)(2).
``SEC. 924. PATIENT SAFETY ORGANIZATION CERTIFICATION AND
LISTING.
``(a) Certification.--
``(1) Initial certification.--An entity that seeks to be a
patient safety organization shall submit an initial
certification to the Secretary that the entity--
``(A) has policies and procedures in place to perform each
of the patient safety activities described in section 921(5);
and
``(B) upon being listed under subsection (d), will comply
with the criteria described in subsection (b).
``(2) Subsequent certifications.--An entity that is a
patient safety organization shall submit every 3 years after
the date of its initial listing under subsection (d) a
subsequent certification to the Secretary that the entity--
``(A) is performing each of the patient safety activities
described in section 921(5); and
``(B) is complying with the criteria described in
subsection (b).
``(b) Criteria.--
``(1) In general.--The following are criteria for the
initial and subsequent certification of an entity as a
patient safety organization:
``(A) The mission and primary activity of the entity are to
conduct activities that are to improve patient safety and the
quality of health care delivery.
``(B) The entity has appropriately qualified staff (whether
directly or through contract), including licensed or
certified medical professionals.
``(C) The entity, within each 24-month period that begins
after the date of the initial listing under subsection (d),
has bona fide contracts, each of a reasonable period of time,
with more than 1 provider for the purpose of receiving and
reviewing patient safety work product.
``(D) The entity is not, and is not a component of, a
health insurance issuer (as defined in section 2791(b)(2)).
``(E) The entity shall fully disclose--
``(i) any financial, reporting, or contractual relationship
between the entity and any provider that contracts with the
entity; and
``(ii) if applicable, the fact that the entity is not
managed, controlled, and operated independently from any
provider that contracts with the entity.
``(F) To the extent practical and appropriate, the entity
collects patient safety work product from providers in a
standardized manner that permits valid comparisons of similar
cases among similar providers.
``(G) The utilization of patient safety work product for
the purpose of providing direct feedback and assistance to
providers to effectively minimize patient risk.
``(2) Additional criteria for component organizations.--If
an entity that seeks to be a patient safety organization is a
component of another organization, the following are
additional criteria for the initial and subsequent
certification of the entity as a patient safety organization:
``(A) The entity 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.
``(B) The entity does not make an unauthorized disclosure
under this part of patient safety work product to the rest of
the organization in breach of confidentiality.
``(C) The mission of the entity does not create a conflict
of interest with the rest of the organization.
``(c) Review of Certification.--
``(1) In general.--
``(A) Initial certification.--Upon the submission by an
entity of an initial certification under subsection (a)(1),
the Secretary shall determine if the certification meets the
requirements of subparagraphs (A) and (B) of such subsection.
``(B) Subsequent certification.--Upon the submission by an
entity of a subsequent certification under subsection (a)(2),
the Secretary shall review the certification with respect to
requirements of subparagraphs (A) and (B) of such subsection.
``(2) Notice of acceptance or non-acceptance.--If the
Secretary determines that--
``(A) an entity's initial certification meets requirements
referred to in paragraph (1)(A), the Secretary shall notify
the entity of the acceptance of such certification; or
``(B) an entity's initial certification does not meet such
requirements, the Secretary shall notify the entity that such
certification is not accepted and the reasons therefor.
``(3) Disclosures regarding relationship to providers.--The
Secretary shall consider any disclosures under subsection
(b)(1)(E) by an entity and shall make public findings on
whether the entity can fairly and accurately perform the
patient safety activities of a patient safety organization.
The Secretary shall take those findings into consideration in
determining whether to accept the entity's initial
certification and any subsequent certification submitted
under subsection (a) and, based on those findings, may deny,
condition, or revoke acceptance of the entity's
certification.
``(d) Listing.--The Secretary shall compile and maintain a
listing of entities with respect to which there is an
acceptance of a certification pursuant to subsection
(c)(2)(A) that has not been revoked under subsection (e) or
voluntarily relinquished.
``(e) Revocation of Acceptance of Certification.--
``(1) In general.--If, after notice of deficiency, an
opportunity for a hearing, and a reasonable opportunity for
correction, the Secretary determines that a patient safety
organization does not meet the certification requirements
under subsection (a)(2), including subparagraphs (A) and (B)
of such subsection, the Secretary shall revoke the
Secretary's acceptance of the certification of such
organization.
``(2) Supplying confirmation of notification to
providers.--Within 15 days of a revocation under paragraph
(1), a patient safety organization shall submit to the
Secretary a confirmation that the organization has taken all
reasonable actions to notify each provider whose patient
safety work product is collected or analyzed by the
organization of such revocation.
``(3) Publication of decision.--If the Secretary revokes
the certification of an organization under paragraph (1), the
Secretary shall--
``(A) remove the organization from the listing maintained
under subsection (d); and
``(B) publish notice of the revocation in the Federal
Register.
``(f) Status of Data After Removal from Listing.--
``(1) New data.--With respect to the privilege and
confidentiality protections described in section 922, data
submitted to an entity within 30 days after the entity is
removed from the listing under subsection (e)(3)(A) shall
have the same status as data submitted while the entity was
still listed.
``(2) Protection to continue to apply.--If the privilege
and confidentiality protections described in section 922
applied to patient safety work product while an entity was
listed, or to data described in paragraph (1), such
protections shall continue to apply to such work product or
data after the entity is removed from the listing under
subsection (e)(3)(A).
``(g) Disposition of Work Product and Data.--If the
Secretary removes a patient safety organization from the
listing as provided for in subsection (e)(3)(A), with respect
[[Page H6676]]
to the patient safety work product or data described in
subsection (f)(1) that the patient safety organization
received from another entity, such former patient safety
organization shall--
``(1) with the approval of the other entity and a patient
safety organization, transfer such work product or data to
such patient safety organization;
``(2) return such work product or data to the entity that
submitted the work product or data; or
``(3) if returning such work product or data to such entity
is not practicable, destroy such work product or data.
``SEC. 925. TECHNICAL ASSISTANCE.
``The Secretary, acting through the Director, may provide
technical assistance to patient safety organizations,
including convening annual meetings for patient safety
organizations to discuss methodology, communication, data
collection, or privacy concerns.
``SEC. 926. SEVERABILITY.
``If any provision of this part is held to be
unconstitutional, the remainder of this part shall not be
affected.''.
(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 2006 through 2010.''.
(c) GAO Study on Implementation.--
(1) Study.--The Comptroller General of the United States
shall conduct a study on the effectiveness of part C of title
IX of the Public Health Service Act (as added by subsection
(a)) in accomplishing the purposes of such part.
(2) Report.--Not later than February 1, 2010, the
Comptroller General shall submit a report on the study
conducted under paragraph (1). Such report shall include such
recommendations for changes in such part as the Comptroller
General deems appropriate.
The SPEAKER pro tempore. Pursuant to the rule, the gentleman from
Georgia (Mr. Deal) and the gentleman from Ohio (Mr. Brown) each will
control 20 minutes.
The Chair recognizes the gentleman from Georgia (Mr. Deal).
General Leave
Mr. DEAL of Georgia. Mr. Speaker, I ask unanimous consent that all
Members may have 5 legislative days within which to revise and extend
their remarks and include extraneous material on S. 544, the Senate
bill now under consideration.
The SPEAKER pro tempore. Is there objection to the request of the
gentleman from Georgia?
There was no objection.
Mr. DEAL of Georgia. Mr. Speaker, I yield myself such time as I may
consume, and I rise today in support of S. 544, the Patient Safety and
Quality Improvement Act of 2005.
This bill reflects the bipartisan and bicameral agreement of the
leadership of the Committee on Energy and Commerce and the Senate
Committee on Health, Education, Labor, and Pensions. The bill is
identical to H.R. 3205, which was passed by the Committee on Energy and
Commerce last week.
In 1999, the Institute of Medicine first identified that up to 98,000
Americans die every year as a result of preventable medical errors. In
the report, entitled ``To Err is Human,'' the IOM recommended that
Congress pass legislation to protect the development and analysis of
information related to improving safety and quality. The Patient Safety
and Quality Improvement Act of 2005 codifies the principal
recommendations made in the IOM report.
This bill will assist in promoting a culture of safety and quality;
and, more important, it will save lives. The bill encourages providers,
such as hospitals and physicians, to share information with HHS-
certified patient safety organizations to assess ways in which to
improve the delivery of health care and reduce medical errors.
Information regarding patients, providers, and reporters, called
patient safety work product, would now remain confidential and
protected.
Mr. Speaker, the bill fosters open and honest communications among
providers and patient safety organizations to achieve an environment
where providers are able to discuss errors openly and learn from them.
The bill also provides a privilege from disclosing patient safety work
product in most court or administrative proceedings.
In addition to enjoying bipartisan support, this bill is also
supported by providers and consumer groups. These include the American
Medical Association, the American Hospital Association, the American
College of Surgeons, and the AARP.
This new language builds directly on the work of our colleague, the
gentleman from Florida (Mr. Bilirakis), who worked to develop a
bipartisan patient safety bill that passed by over 400 votes in the
last Congress.
I also want to recognize Senators Enzi and Kennedy; our House ranking
member, the gentleman from Michigan (Mr. Dingell); and the ranking
member of the Subcommittee on Health, the gentleman from Ohio (Mr.
Brown), for their leadership in this effort. They, along with the
staffs of the House Committee on Energy and Commerce and the Senate
HELP Committee, deserve our thanks for producing this important
bipartisan bill.
I also specifically would like to recognize Andrew Patzman and David
Bowen from the Senate HELP Committee, along with Bridgett Taylor,
Purvee Kempf, Nandan Kenkermath, Melissa Bartlett, and Brandon Clark
for their important help on this bill.
Mr. Speaker, I yield 5 minutes to the gentleman from Florida (Mr.
Bilirakis), the original sponsor of this legislation in the past
Congress and one who has continued to work on it.
Mr. BILIRAKIS. Mr. Speaker, I thank the gentleman for yielding me
this time; and I, too, obviously, support S. 544, which is the exact
Senate counterpart to H.R. 3205, the legislation on which I and so many
others have worked for several years to reduce medical errors and save
lives.
The landmark 1999 Institute of Medicine report entitled ``To Err is
Human,'' found that as many as 98,000 people die each year from
preventable medical errors. The IOM report noted these errors may cost
taxpayers as much as $29 billion each year, in addition to the
incalculable pain and suffering experienced by those who lose loved
ones as a result of them.
The Patient Safety and Quality Improvement Act will implement many of
the IOM's recommendations for reducing medical errors. This legislation
would establish a framework within which providers can voluntarily
report medical errors to patient safety organizations, which in turn
would analyze the data and recommend steps providers could take to
prevent such errors from occurring in the future.
These patient safety organizations will be empowered to compile
reports on errors and near-misses, determine the causes of these errors
or near-errors, identify the changes that need to be made to the health
care delivery system to prevent these errors in the future, and
implement needed changes. Their work will be invaluable in identifying
national trends on medical errors and recommending how to prevent them.
The legislation encourages providers to share information about
medical mistakes by preventing the information that they have created
specifically to report to patient safety organizations from being used
against them. The bill would preclude this information, termed patient
safety work product, from being used against providers in civil and
administrative proceedings, disclosed pursuant to Freedom of
Information Act requests, or used to carry out adverse personnel
actions.
The bill does not shield other information outside this patient
safety work product from use in court cases. I believe it strikes an
appropriate balance between encouraging the reporting of valuable
information, which will be used to save lives, and safeguarding the
ability of individuals to access necessary information to seek judicial
redress when appropriate.
I believe that Congress must pass the Patient Safety and Quality
Improvement Act to encourage the voluntary reporting of information on
medical errors. Doing so will help create a culture of awareness to
expose and address the systemic causes of medical errors instead of
continuing the culture of blame which hides and perpetuates them.
Mr. Speaker, I want to thank several individuals: Chairman of the
Committee on Energy and Commerce, the gentleman from Texas (Mr.
Barton); and the chairman of the Subcommittee on Health, the gentleman
from Georgia (Mr. Deal). They have shared my commitment to making
medical errors as rare as possible and minimizing the hurt they cause
their families, as have the ranking member, the gentleman from Michigan
(Mr. Dingell), and the subcommittee ranking member, the
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gentleman from Ohio (Mr. Brown). This indeed has been a true bipartisan
effort.
I also want to thank members of the staff, though the gentleman from
Georgia (Mr. Deal) already has done so: Nandan Kenkermath and Melissa
Bartlett, as well as chief counsel Chuck Clapton and health policy
coordinator Brandon Clark.
Mr. Speaker, I also want to thank Jeanne Haggerty, Jeremy Allen, and
Steve Tilton, several former members of my staff, whose previous work
on this legislation laid the groundwork for its enactment here today.
All of these individuals, all should be proud their contributions to
this legislation will ultimately save the lives of many they will never
know.
Mr. Speaker, I urge all our colleagues to support the Patient Safety
and Quality Improvement Act.
Mr. BROWN of Ohio. Mr. Speaker, I yield myself 3 minutes.
It is tragic when Americans die prematurely despite modern medicine.
It is heartbreaking when Americans die because of modern medicine.
Medical errors take lives, medical errors waste money, and medical
errors are largely preventable.
Based on available data, medical errors kill up to 100,000 Americans
every year. That number, for sure, is a ballpark estimate because we
know that medical errors are underreported. That is disturbing, but
hardly surprising. The reality is that the consequences of reporting
medical errors can be onerous, which deters some who commit or witness
medical errors from documenting them.
This legislation is intended to overcome that obstacle. To reduce the
number of medical errors, we need to understand what causes them and
address those causes. Accurate and complete information on medical
errors is the first step. H.R. 3205, or S. 544, creates a secure
voluntary medical error reporting system. The system is carefully
crafted to encourage information-sharing without undermining the
ability of patients to obtain justice when they are harmed and to help
the health care system identify the root causes of medical errors
without hindering the prosecution of criminal acts.
My friend, the gentleman from Florida (Mr. Bilirakis), and I have
been working on this legislation for several years. I appreciate his
leadership on this issue, as well as that of the subcommittee chairman,
the gentleman from Georgia (Mr. Deal), and our ranking member on the
full committee, the gentleman from Michigan (Mr. Dingell), along with
the chairman of the full committee, the gentleman from Texas (Mr.
Barton).
I would also like to commend committee staff on both sides of the
aisle for their hard work to reach a solid bipartisan, bicameral
compromise on this bill. H.R. 3205/S. 544 will strengthen our health
care system and save lives, and I urge my colleagues' support of this
measure.
Mr. Speaker, I reserve the balance of my time.
Mr. DEAL of Georgia. Mr. Speaker, I yield 3 minutes to the gentleman
from Georgia (Mr. Norwood).
Mr. NORWOOD. Mr. Speaker, I thank the gentleman for yielding me this
time, and I rise in support of the Patient Safety and Quality
Improvement Act of 2005. I am a proud cosponsor of this bill, and I
know that this is a bill that my good friend, the gentleman from
Florida (Mr. Bilirakis), has been working on for at least 5 years. And
so now I am happy to see it finally come to the floor and will become
law, hopefully.
Americans have the best doctors and technology in the world; yet it
is reported every day that more than 250 Americans die because of
preventable medical errors in hospitals alone. The cost of preventable
medical errors is estimated between $17 billion and $29 billion
annually.
Mr. Speaker, we must acknowledge that any error that causes harm to a
patient is one too many. While our health care system may never be
perfect, we must strive for the best care for our Nation's patients. I
am happy that this legislation begins to improve the ability to connect
information about errors and near-errors between doctors, researchers,
and patients.
However, as I have stated for years, a key step to improving care
should be also the passage of meaningful patient protections under
Federal law. When insurers and employees are concerned about the cost
of health care, the quality of patient care can be jeopardized for the
bottom line. This breeds improper care, and it breeds medical error.
{time} 1230
In this light, this legislation is an important first step. This bill
will encourage the creation of patient safety organizations that
providers will contract with to provide patient safety information to a
national patient safety database. While I will concede that I wish we
were mandating more in this legislation about reporting errors and
getting that information to patients, I stress that this is an
essential, important first step.
The bill helps develop a culture of safety that encourages
information sharing. When an error occurs, it is important to learn
from it so as to not repeat it. We need to get everyone comfortable
with reporting errors and near errors, and this bill begins to do just
that.
This bill presents us with an opportunity to stand up for patients,
and I urge all of my colleagues to join us in supporting it.
Mr. BROWN of Ohio. Mr. Speaker, I yield 5 minutes to the gentleman
from Rhode Island (Mr. Kennedy) who has been a strong advocate during
his several terms in Congress for patient safety and for patients
generally.
Mr. KENNEDY of Rhode Island. Mr. Speaker, I would like to thank the
gentleman from Ohio (Mr. Brown) for his leadership in this area, as
well as the gentleman from Florida (Mr. Bilirakis) for his, in addition
to the committee chairman, the gentleman from Texas (Mr. Barton), and
the ranking member, the gentleman from Michigan (Mr. Dingell).
Of the many bills we are talking about on the floor this week, this
is the only one that is really addressing the root problem in our
health care system. We stand here in the well of the House, all of us
from both sides of the aisle, pontificating about the high cost of
care, malpractice rates, access to prescription drugs, or the
uninsured. All of these are serious problems with big negative impacts
on people, but these issues are all symptomatic of a real problem in
health care. Our system is not set up to get the right care at the
right time to the right people.
Hundreds of our constituents will die today, tomorrow, and every day
until we get this right. Millions will be priced out of care until we
get this right. My friends just mentioned the statistics; the
equivalent of a jumbo jet crashing every 3 days is how many people we
lose in our health care system due to inadequate information because
there is inadequate information technology to make the information
intraoperable and transparent for all to see so there are not those
medications that one is being prescribed by one doctor contravening the
medications that are prescribed by another doctor because no one has an
electronic medical record.
This bill is a step in the right direction. It aligns the incentives
in health care to promote outcomes we want: higher quality, higher
safety and higher efficiency. We have seen studies where Medicare has
had a single procedure. That procedure has been done all around the
country, and even in the markets where it costs us the most, we often
see where we have the worst outcomes. We have to ask ourselves why is
it that we are paying for more care and getting less results? This bill
does a lot to address that problem. We need to learn from our mistakes
and use them to make better decisions in the future.
This is a bill that is carefully designed to compromise so we do not
have a situation where we close down people's right to seek redress for
those that are seriously and grievously injured in the course of their
health care.
I hope this patient safety bill is the tip of the iceberg in what we
will do to transform health care. We need to pass a strong health care
information technology bill. This bill was reported out of the
committee and I think it will go a long way to getting us on that road,
but I hope that we continue in this legislative session to move us even
further, where we begin as a country to make our health care system
come up to the same level of technology as every other area in our
country is right now.
It is inconceivable that people can have an ATM card and get
information
[[Page H6678]]
or dollars anywhere in the country, and yet they cannot get their
medical record to the doctor that they need to have that medical record
so that physician can make the right decision based upon all of the
information that is there about their background, and that we are not
having situations where there are drug overdoses because of lack of
being able to read the orders. As is too often the case, we not only
have people die, but also seriously injured.
One instance, a little girl named Josie King in Baltimore was
seriously scalded when she went into the bathtub and the tub was too
hot. Her mother took her to the hospital, and she got the best care
because this country has the best health care in the world. She had the
best professionals because this country has the best professionals in
the world. But when it came to the system, the system is what is
broken, and this system let Josie King down to the point where she was
given the wrong medication because her physician did not have the right
information before him. As a result, Josie King was in a coma and
eventually had to be removed from life support.
Mr. Speaker, we need to learn from these tragedies if we are to
prevent them in the future. This legislation moves us down that path. I
ask my colleagues to support this legislation.
Mr. DEAL of Georgia. Mr. Speaker, I yield 2 minutes to the gentleman
from Texas (Mr. Burgess), a member of the Subcommittee on Health.
Mr. BURGESS. Mr. Speaker, I thank the gentleman for yielding me this
time, and thank the gentleman from Florida (Mr. Bilirakis) for his
leadership, and the gentleman from Texas (Chairman Barton), who is
always evenhanded, played a big role in us finally getting this bill to
the floor. I thank the ranking member, the gentleman from Ohio (Mr.
Brown), for his work on this bill as well.
Mr. Speaker, this is an important bill before us today. As a
physician, I know that in order to improve safety, we have got to
report errors. The gentleman from Georgia (Mr. Norwood) just pointed
out how if you do not report the error, you cannot learn from the
mistake and never prevent it from happening again.
We have an environment right now that punishes doctors for perceived
or actual mistakes by lawsuits and regulation, and it has become nearly
impossible to encourage true transparency in the practice of medicine.
This opacity has not served anyone well with the possible exception of
the plaintiff's bar.
I am pleased the United States Congress has finally come to an
agreement on a level-headed approach to error reporting and will set
quality standards in medicine. I believe this bill will be the first
assault on the culture of fear that has permeated medicine for years
now; doctors afraid of making a mistake, or doctors afraid of saying I
am sorry for fear of being sued no matter how small the mistake, and
this may lead to underreporting, overtreatment, and repetition of the
same error again.
By permitting reporting, this bill takes a critical first step in
improving the quality of care in this country. The research on patient
safety unequivocally calls for a learning environment rather than the
punitive environment that is present in this country.
Many organizations are currently collecting patient safety data, and
this bill will give them the legal protections that will allow them to
review protected information and collaborate on the development and
implementation of patient safety and improvement strategies.
Mr. Speaker, this bill is long overdue. I agree with the gentleman
from Georgia (Mr. Norwood) it is but a first step, but it is an
important first step, and I am happy to put my support behind this bill
that will improve the medical profession and improve the quality and
safety of medical care for all Americans.
Mr. BROWN of Ohio. Mr. Speaker, I yield myself such time as I may
consume.
Mr. Speaker, S. 544 is identical to the bill passed out of the
Committee on Emergency and Commerce, H.R. 3205. Therefore, the
committee report we will be filing based on H.R. 3205 is directly
relevant to S. 544. I wanted that part of the Record.
Mr. DINGELL. Mr. Speaker, in 1999, the Institute of Medicine (IOM)
reported that as many as 98,000 people are estimated to die annually as
a result of medical errors. The IOM recommended several changes,
including the creation of a patient safety reporting system that would
allow health care service providers to report information about medical
errors in a non-punitive environment. This information would be
reviewed by a patient safety organization that would then help
providers learn from their mistakes without fear of reprisal.
The Committee has been working for many years on legislation to bring
forward the building blocks of this system, and in the 108th Congress,
we successfully passed bipartisan legislation in the House. Only this
Congress, however, did we successfully reach a compromise with our
colleagues in the Senate. I am pleased that today we will finally pass
the Patient Safety and Quality Improvement Act of 2005, with the
expectation that it will be enacted into law.
S. 544, the Senate companion bill to H.R. 3205, contains the same
language as the House bill approved unanimously by the Committee on
Energy and Commerce last week. The goal of H.R. 3205 is to set up an
error reporting system for health care providers that brings real
improvements in patient safety and the quality of health care. It will
also help ensure accountability by raising standards and creating the
expectation for continuous quality improvements in patient safety. This
bill achieves these goals by creating a helpful and non-punitive
atmosphere for health care providers to share information with entities
specialized in patient safety and quality improvement. Yet, it
continues to allow public access to information that is available
today. Patient safety organizations will receive information about
medical errors and then evaluate trends, such as infection rates and
other quality measures, within provider organizations. This will help
providers learn to avoid such errors in the future.
This is excellent and important legislation, and I urge its adoption.
Mr. DOOLITTLE. Mr. Speaker, I rise today to support the legislation
introduced by my colleague from Vermont which, understandably, enjoys
bipartisan support.
Last, year, President Bush called for the majority of Americans to
have electronic health records within 10 years and established the role
of the National Coordinator for Health Information Technology to help
realize this target. The Patient Safety and Quality Improvement Act
2005 is a critical step toward this important goal and the nation's
overall vision of providing safer, efficient healthcare for all
Americans.
I am proud to report that a healthcare leader in my district is ahead
of the curve in pursuit of this vision. In response to the need for
leadership in the area of healthcare information technology, Adventist
Health--a not-for-profit health care system headquartered in Roseville,
California--made the decision to invest over $120,000,000 to implement
a new state-of-the-art Clinical Information System for all their
hospitals. Project IntelliCare is a ground-breaking, historical
initiative and an important first step toward fulfilling patients'
aspirations for safe, effective health care.
Long before the concept of healthcare information technology was
being discussed nationally, Adventist Health committed to implementing
this system-- one of the largest single capital investments the health
care system has ever made. I think it is extremely important that we
support this legislation today. By establishing the refining our goals
in this area with legislation like this, we allow health care providers
like Adventist Health to easily adapt programs and projects that
support patient safety and quality.
It would be my hope--and good public policy--that officials at the
Department of Health and Human Services reach out to Adventist Health
officers and solicit their guidance. This guidance would be based on
the experience of a half a decade of success and challenges. I am proud
of what Adventist Health is accomplishing in California. I look forward
working with secretary Leavitt and the Department of Health and Human
Services to assist in the implementation of Health Information
Technology on a national level.
Mr. BROWN of Ohio. Mr. Speaker, I yield back the balance of my time.
Mr. DEAL of Georgia. Mr. Speaker, I urge the adoption of this bill,
and I yield back the balance of my time.
The SPEAKER pro tempore (Mr. Culberson). The question is on the
motion offered by the gentleman from Georgia (Mr. Deal) that the House
suspend the rules and pass the Senate bill, S. 544.
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. DEAL of Georgia. Mr. Speaker, on that I demand the yeas and nays.
The yeas and nays were ordered.
[[Page H6679]]
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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