[Congressional Record Volume 151, Number 101 (Friday, July 22, 2005)]
[Senate]
[Pages S8741-S8744]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]
PATIENT SAFETY AND QUALITY IMPROVEMENT ACT OF 2005
Mr. ENZI. Mr. President, as chairman of the Health, Eduation, Labor,
and Pensions Committee, I would like to take the opportunity to comment
on a very important piece of legislation the Senate passed this week--a
managers' substitute for S. 544, the Patient Safety and Quality
Improvement Act of 2005, offered by myself, Senators Jeffords, Gregg,
Kennedy, Frist, Murray, and Bingaman.
More than 5 years in the making, this legislation is an important
step toward building a culture of safety and quality in our health care
system.
The language of this bill reflects a carefully negotiated bipartisan,
bicameral agreement between the chairmen and ranking members of the
Senate Health, Education, Labor, and Pensions Committee and the House
Energy and Commerce Committee. I want to thank my colleagues Senator
Kennedy, Chairman Barton, and Representative Dingell for their hard
work in bringing this agreement to fruition.
Tremendous credit also goes to the HELP Committee's previous
Chairman, Senator Gregg, whose tireless work on this issue was
invaluable in bringing us to where we are today, and to Senator
Jeffords, sponsor of the original legislation upon which this agreement
builds.
The Patient Safety and Quality Improvement Act will create a
framework through which hospitals, doctors, and other health care
providers can work to improve health care quality in a protected legal
environment.
More specifically, the bill will extend crucial legal privilege and
confidentiality protections to health care providers to allow them to
report health care errors and ``near misses'' to specially designated
patient safety organizations. In turn, these patient safety
organizations, some of which exist in limited form today, will be able
to collect and analyze patient safety data in a confidential manner.
After conducting this analysis, patient safety organizations will
report back to providers on trends in health care errors and will offer
guidance to them on how to eliminate or minimize these errors. Some of
this takes place today, but much more information could be collected
and analyzed if providers felt confident that reporting such errors
would not increase the likelihood that they could be sued.
It is not the intent of this legislation to establish a legal shield
for information that is already currently collected or maintained
separate from the new patient safety process, such as a patient's
medical record. That is, information which is currently available to
plaintiffs' attorneys or others will remain available just as it is
today. Rather, what this legislation does is create a new zone of
protection to assure that the assembly, deliberation, analysis, and
reporting by providers to patient safety organizations of what we are
calling ``Patient Safety Work Product'' will be treated as confidential
and will be legally privileged.
Errors in medical treatment take place far too often. Unfortunately,
however, providers live in fear of our unpredictable medical litigation
system. This fear, in turn, inhibits efforts to thoroughly analyze
medical errors and their causes. Without appropriate protections for
the collection and analysis of patient safety data, providers are
understandably loath to participate in medical error reporting systems.
I am pleased that the negotiated final version of this bill reflects
and upholds several of the key priorities of the bill the HELP
Committee marked up earlier this year, and which was also passed out of
the Senate last year.
For example, this agreement makes very clear that, in addition to
strong legal privilege provisions, patient safety work product will
also be subject to a clear and affirmative duty of confidentiality.
That is, not only will patient safety work product be subject to a
privilege in legal and related proceedings, but the bill will also
impose penalties of up to $10,000 per violation should such patient
safety work product be disclosed.
It was a key priority of the Senate bill that such information not
only be privileged in a legal proceeding, but also that serious
consequences will ensue if patient safety organizations, providers, or
anyone else divulges it in ways not permitted under the bill. I am very
pleased that the compromise agreement we are passing this week upholds
this commitment to an affirmative duty of confidentiality.
Also, we believed very strongly that the definition of patient safety
work product--that is, exactly what kind of information is to be
protected--be drawn broadly enough to assure that providers will feel
safe and secure in participating in a patient safety system--and that
they not be chilled from participating by fear that their efforts to
assemble, analyze, deliberate on, or report patient safety information
to patient safety organizations would somehow fall outside of a too-
narrow statutory definition of patient safety work product.
With this in mind, we negotiated a definition in the agreement which
takes great care to make clear to providers that the assembly of data,
its analysis, deliberations about it, and its reporting to a patient
safety organization will be firmly protected. We also clarified that
information that is collected, maintained, or developed separately from
the patient safety system will continue to be treated the same as it is
under current law.
Before I close, I want to take just a minute to thank the many Senate
staff members who worked very hard to bring this legislation to where
it is today. Among those who deserve special recognition and thanks are
Andrew Patzman and Stephen Northrup of my HELP Committee professional
staff, David Bowen of Senator Kennedy's Committee staff, Peggy Binzer
with Senator Gregg, Dean Rosen of Senator Frist's Leadership staff, and
Sean Donohue with Senator Jeffords. Much credit also goes to the hard
work of the staff of the House Energy and Commerce Committee, as well
as to the expert and very capable legislative staff at the Department
of Health and Human Services.
I ask unanimous consent that a section-by-section summary of the
legislation be printed in the Record.
There being no objection, the material was ordered to be printed in
the Record, as follows:
Section-by-Section Summary
``Patient Safety and Quality Improvement Act of 2005''
Managers Substitute Amendment
[July 2005]
Section 1. Short Title
The Patient Safety and Quality Improvement Act of 2005.
Section 2. Amendments to Public Health Service Act
Creates a new Part C of Title IX of the Public Health
Service Act, Entitled ``Patient Safety Improvement''
SECTION 921. DEFINITIONS
``Patient Safety Activities'' describes activities
involving providers and certified patient safety
organizations (see Sec. 924, below) which include the
following: (1) efforts to improve patient safety and the
quality of health care delivery, (2) collection and analysis
of patient safety work product, (3) development and
dissemination of information with respect to improving
patient safety, such as recommendations, protocols, or
information regarding best practices, (4) 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, (5) maintenance of
procedures to preserve confidentiality with respect to
patient safety
[[Page S8742]]
work product, (6) 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.
``Patient Safety Evaluation System'' means the collection,
management, or analysis of information for reporting to or by
a patient safety organization.
``Patient Safety Work Product'' is the data and other
information for which the bill provides legal privilege and
confidentiality protection. Patient safety work product
includes any data, reports, records, memoranda, analyses
(such as root cause analyses), or written or oral statements
which: (1) are assembled or developed by a provider for
reporting to a patient safety organization and are reported
to such an organization, (2) are developed by a patient
safety organization for the conduct of patient safety
activities, or, (3) identify or constitute the deliberations
or analyses of a patient safety evaluation system, or which
identify the fact of reporting pursuant to such a system.
Patient safety work product does not include a patient's
medical record, billing and discharge information, or any
other original patient or provider record, or information
that is collected, maintained, or developed separately, or
exists separately, from a patient safety evaluation system.
SECTION 922. PRIVILEGE AND CONFIDENTIALITY PROTECTIONS
Provides that patient safety work product is legally
privileged and as such is not subject to (1) Federal, State
or local civil, criminal, or administrative subpoena, (2)
discovery in connection with a Federal, State or local civil,
criminal, or administrative proceeding, (3) disclosure
pursuant to the Freedom of Information Act (FOIA), (4)
admitted as evidence in any Federal or State civil, criminal,
or administrative proceeding, (5) admitted in a professional
disciplinary proceeding.
Provides that patient safety work product is also
confidential and shall not be disclosed.
Provides a number of exceptions to the privilege and
confidentiality protections:
Exceptions to both privilege and confidentiality include
disclosure of patient safety work product in a criminal
proceeding after a court makes an in camera determination
that such work product contains evidence of a criminal act
and that it is material to the proceeding and not reasonably
available from another source, disclosure of patient safety
work product if authorized by the providers identified in it,
and disclosure of patient safety work product when such
disclosure is necessary in a proceeding against an employer
for an adverse employment action based on a person's having
made a good faith report to a patient safety organization.
Exceptions to the confidentiality rule but not to the
privilege protection include (1) disclosure of patient safety
work product to carry out patient safety activities, (2)
disclosure of non-identifiable patient safety work product,
(3) disclosure of patient safety work product for HHS-
sanctioned research, (4) disclosure by a provider of patient
safety work product to the FDA regarding products or
activities regulated by the FDA, (5) voluntary disclosure of
patient safety work product by a provider to an accrediting
body, (6) such disclosures as the Secretary may determine are
necessary to carry out business operations, (7) disclosure of
patient safety work product to law enforcement authorities
relating to the commission of a crime if the person making
the disclosure reasonably believes that the work product
being disclosed is necessary for criminal law enforcement
purposes, (8) with respect to persons who are not patient
safety organizations, the disclosure of patient safety work
product that does not include materials that assess the
quality of care of an identifiable provider or describe or
pertain to one or more actions or failures to act by an
identifiable provider.
Provides that in most cases, the disclosure of patient
safety work product pursuant to one of the exceptions above
does not constitute a waiver of privilege or confidentiality
with respect to subsequent disclosures of such work product.
Provides that in most cases a patient safety organization
shall not be compelled to disclose information collected or
developed under this act, unless such information is
identified, is not patient safety work product, and is not
available from another source.
Provides that an accrediting body shall not take an
accrediting action against a provider based on the provider's
participation in a patient safety process, and that an
accrediting body may not require a provider to reveal its
communications with a patient safety organization.
Provides that a provider may not take an adverse employment
action against an individual based on such individual's good
faith reporting of information to the provider or to a
patient safety organization.
Provides that civil monetary penalties of up to $10,000 per
violation shall apply to any person who knowingly or
recklessly violates the confidentiality or privilege
protections, as well as equitable relief to address a
wrongful employment action. Where a violation of this act
also constitutes a violation of the Health Insurance
Portability and Accountability Act (HIPAA), there shall be no
double penalty.
Provides for a number of rules of construction, including
that nothing in this act shall be construed: (1) to limit
other Federal, State, or local laws that may provide for
confidentiality or privilege provisions stronger than those
in this act, (2) to limit or affect current law pertaining to
information that is not confidential or privileged under this
act, (3) to alter or affect implementation of HIPAA, except
where specifically specified in this act, (4) to limit,
alter, or affect any requirement for reporting to the Food
and Drug Administration information regarding the safety of
an FDA-regulated product, (5) to prohibit 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.
Clarifies that for purposes of applying HIPAA
confidentiality regulations (regarding patient health
information), patient safety organizations shall be treated
as business associates, and patient safety activities of a
provider under this act are deemed to be health care
operations, as such terms are defined pursuant to HIPAA.
Directs the Secretary to prepare a report, based on
reporting to the Network of Patient Safety Databases (see
Sec. 923 below), on effective strategies for reducing medical
errors and increasing patient safety.
SECTION 923. PATIENT SAFETY NETWORK OF DATABASES
Directs the Secretary to facilitate the creation of a
network of patient safety databases to collect and analyze
relevant non-identifiable patient safety information
voluntarily reported by patient safety organizations,
providers, or other entities, and to provide an interactive
evidence-based management resource. The Secretary may also
establish common standards for the reporting of such data.
SECTION 924. PATIENT SAFETY ORGANIZATION CERTIFICATION AND LISTING
Provides for procedures to be used in the certification,
recertification, and (as necessary) revocation of
certification of patient safety organizations by HHS.
Criteria for certification as a patient safety organization
include the following: (1) 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, (2)
the entity has appropriately qualified staff as determined by
the Secretary, including medical professionals, (3) the
entity receives and reviews patient safety work product from
more than one provider, (4) the entity is not a health
insurance issuer (as defined in section 2791 (b)(2) of the
Public Health Service Act).
Where applicable, the entity shall fully disclose to the
Secretary any financial, reporting, or contractual
relationship between the entity and any provider that
contracts with the entity, and the fact that the entity is
not managed, controlled, and operated independently from any
provider than contracts with the entity.
The Secretary shall review such disclosures and make
findings whether the entity can fairly and accurately operate
as a patient safety organization, and shall consider such
findings in determining whether to accept, condition, deny,
or revoke such entity's certification.
SECTION 925. TECHNICAL ASSISTANCE
The. Secretary 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.
SECTION 926. SEVERABILITY
If any provision of this act is held to be
unconstitutional, the remainder of the act shall be
unaffected.
Authorization of Appropriations--for purposes of carrying
out this act, there are authorized such sums as may be
necessary for each of the fiscal years 2006 through 2010.
Mr. JEFFORDS. Mr. President, I came to the floor today to commend our
colleagues and extend my appreciation to them because last night the
Senate unanimously passed S. 544, the Patient Safety and Quality
Improvement Act of 2005. I do not believe it is too great an
exaggeration to say that this bill will be among the most significant
healthcare legislation the Senate will consider during this Congress. I
say that because I believe this legislation will contribute immensely
to the current efforts that are underway to save lives and reduce the
tragedy of needless medical errors.
This legislation starts with a simple premise. Let us set up a system
that helps our health care providers learn from each other. Let us set
up a system that promotes the reporting and analysis of medical errors.
Let us set up a system that engenders the trust of providers and the
patients they serve.
The passage of this legislation represents the successful culmination
of efforts, by many of our colleagues, that began with the publication
of a small but significant report about medical errors.
With the publication of the Institute of Medicine, IOM, study, To Err
is Human in 1999, we were all reminded
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that Hippocrates' maxim to ``first, do no harm'' is as relevant to the
practice of medicine today as it was in 400 B.C. That IOM report was
among the first to galvanize national attention on the issue of patient
safety when it reported that medical errors contribute to approximately
100,000 patient deaths a year. This startling and troubling statistic
has been verified in subsequent studies and cited in peer reviewed
articles in the leading journals of biomedical research, including the
Journal of the American Medical Association, the Lancet, and the New
England Journal of Medicine.
When I was Chairman of the Senate Committee on Health, Education,
Labor, and Pensions in 1999, I undertook several hearings--5 in all--to
examine this issue and discuss the recommendations of the To Err is
Human report. The preponderance of testimony overwhelmingly agreed with
several of the original Institute of Medicine recommendations.
Perhaps the most important of these recommendations stresses that
improving patient safety requires a learning environment rather than a
punitive environment; voluntary data gathering systems as opposed to
mandatory systems; and appropriate legal protections--including
confidentiality and privilege from discovery--that allow for the review
and analysis of medical error information.
In response to this attention to patient safety issues, a myriad of
public and private patient safety initiatives have begun. The
Department of Health and Human Services has initiated several patient
safety projects, including project grants funded by the Agency for
Healthcare Research and Quality, AHRQ. The work of the Veterans'
Administration in developing and implementing innovative patient safety
systems--especially in the area of medication management--has drawn
attention from throughout the country. In addition, the Quality
Interagency Coordination Taskforce has recommended steps to improve
patient safety that can be taken by each Federal agency involved in
health care; and agency activities to implement these steps are
ongoing. Finally, efforts are well underway to bring the advanced
electronic technology of the information-age to bear on solving many of
the problems associated with medical errors.
Several non-governmental organizations and professional societies
have also ``stepped up to the plate'' on patient safety. The Joint
Commission on Accreditation of Healthcare Organizations, the U.S.
Pharmacopoeia, the American Medical Association, medical specialty
societies and other health care providers including the American
Hospital Association and the American Federation of Hospitals have
launched innovative efforts dedicated to improving patient safety.
Consumers of healthcare and academia are involved in reducing errors
in patient care as well. Examples of these include: ``The Leapfrog
Group'' an initiative driven by organizations that buy health care that
are working to initiate breakthrough improvements in the safety,
quality and affordability of healthcare; and the Institute for
Healthcare Improvement, led by an original IOM panel member, Dr. Don
Berwick, which has provided seminal work advancing the goals of patient
safety. All of these efforts deserve our gratitude because without them
deaths and injuries stemming from medical errors would continue to
increase.
However, many of the organizations currently collecting patient
safety data have expressed the need for legal protections that will
allow them to review protected information so that they may collaborate
in the development and implementation of patient safety improvement
strategies.
The work of Lucien Leape, another member of the IOM panel and adjunct
professor of health policy at Harvard University, has supported this
view. Dr. Leape has argued persuasively that we, as a society, will
continue to have difficulty reducing medical errors and improving
patient safety because our institutions are ``still locked into a blame
and punish approach to errors and a focus on individual culpability . .
.'' in turn, ``the fear of malpractice litigation thus becomes a major
barrier to openly discussing and reporting errors.''
To respond to these needs, I and several of our colleagues have for
many years introduced legislation that would promote the open
discussion of medical errors that is so needed to curb these needless
deaths and injuries. Last year, this legislation passed the Senate
unanimously, but unfortunately, a conference with our House colleagues
never occurred.
This Congress, I reintroduced S. 544, the Patient Safety and Quality
Improvement Act, with the bipartisan support of Senators Gregg,
Bingaman, Enzi, Frist, and Murray. Our group was soon joined in this
effort by Senators Sessions, Landrieu and Collins. Early in this
session, the Health, Education, Labor, and Pensions Committee
unanimously passed S. 544. To Chairman Enzi's great credit, he
recognized the significance of this legislation early-on and, enlisting
the support of Senator Kennedy, led the way to resolving differences
between S. 544 and language that was being considered by our colleagues
in the House of Representatives. Together, these Members worked
untiringly to hone and improve this legislation, which resulted in its
consideration by, and the unanimous support of, our colleagues last
night.
The legislation raises expectations for higher standards for
continuous patient safety improvement and it encourages a new and
needed culture of patient safety among health care providers and
American hospitals. The bill accomplishes these goals by establishing
appropriate legal protections for patient safety information
voluntarily shared among patient safety organizations and providers.
Our legislation reflects the belief that a culture of patient safety
can flourish best in an environment where information, data, processes,
and recommendations enjoy legal protection and privilege.
Because it appropriately addresses an obvious need and concern, the
Patient Safety and Quality Improvement Act has enjoyed widespread
endorsement by hospital, patient, doctor, and consumer advocacy
organizations. This degree of support underscores the broad appeal and
essential nature of this proposed legislation.
In the time since the release of To Err is Human, the Congress has
been unable to enact sensible legislation to reduce medical errors and
increase patient safety. In that time, assuming that the IOM data are
accurate, approximately one-half million more individuals have died and
countless others have experienced significant injuries through medical
errors.
With the leadership of Chairman Enzi and Senator Kennedy we have met
to work out differences with our colleagues in the House and it too
will soon consider legislation. I am encouraged that we have reconciled
disagreements that have previously stopped this legislation from moving
forward and I hope the House will act favorably so that this
legislation can become law.
We need to apply Hippocrates' admonition to ``first, do no harm''
beyond the medical community to the legislative community. We need to
pass legislation now that will help the health care community stop the
needless injury caused by unintentional medical errors.
Of course, we also live in a complex society--one in which medical
errors that may have harmed a patient might also be the basis for
litigation. It is a right under our laws to seek a remedy when harmed,
and we need to preserve access to certain information for this redress
of grievances.
However, an unfortunate consequence of living in a litigious society
is that hospitals and providers often feel that it's not in their best
interests to share information openly and honestly. We know, in fact,
that their attorneys and risk managers often advise them not to do so.
So, in order for our system to work, it needs to balance these
sometimes competing demands.
I believe the Patient Safety and Quality Improvement Act strikes this
balance. It calls for the creation of new entities we call Patient
Safety Organizations that would collect voluntarily reported data in
the form of patient safety workproducts. This bill provides the
protections of confidentiality and privilege to that patient safety
data--but this bill also sets definite limitations on what can be
considered confidential and privileged.
This legislation does nothing to reduce or affect other Federal,
State or
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local legal requirements pertaining to health related information. Nor
does this bill alter any existing rights or remedies available to
injured patients. The bottom line is that this legislation neither
strengthens nor weakens the existing system of tort and liability law.
Instead, the legislation before us creates a new, parallel system of
information collection and analysis, designed to educate our doctors
and protect patients' safety everywhere. This bill reflects difficult
negotiations and many compromises over almost 5 years of consideration.
Through the contributions of Members on both sides of the aisle, this
legislation has been greatly strengthened since I first introduced it
back in the 106th Congress.
I offer my appreciation to the many contributions from several
colleagues who have worked to reach an agreement on this legislation.
But I believe Chairman Enzi and Ranking Member Kennedy deserve special
recognition in their efforts to reach a consensus and so I commend them
once again. I also want to commend the work of Chairman Barton and that
of the Dean of the House, Representative Dingell, for their work to
address our differences. It is my true hope that they can persuade
their colleagues to favorably consider this bill.
When a significant bill makes its way through the many hoops of the
legislative process and is destined to be signed into law, as I believe
this one is, we have a custom in the Senate that we take a moment to
acknowledge those whose work on that measure often has made difference
between success and failure.
Chainnan Enzi's staff, Katherine McGuire, Steve Northrup, and
especially Andrew Patzman deserve many thanks for their contributions
and for reflecting so well the leadership of the Chairman. From Senator
Kennedy's office Michael Myers' commitment to this effort over the many
years has often served to keep discussions going and David Bowen has
once again demonstrated his ability to find common ground on difficult
issues. Vince Ventimiglia and Peggy Binzer of Senator Gregg's office
deserve special acknowledgement, not only for ``advancing the ball''
throughout the last Congress, but also for the legal expertise and
insights they brought to the process.
The majority leader has been a partner in this effort from the very
beginning and Dean Rosen and Liz Hall have contributed both their
subject expertise and their legislative navigational skills. Bruce
Lesley of Senator Bingaman's office and Anne Grady with Senator Murray
led the way with improvements to the bill that helped start its way
down the bipartisan path to success. Finally, I want to commend Sean
Donohue, of my staff, for his contributions to the bill and also to his
tenacious commitment over several years to get this legislation
enacted.
We legislate on many issues in the Congress, but it is not often we
can say that what we do makes a difference as a matter of life and
death. Patient safety, however, is one of those issues. When this
legislation is signed into law, everyone that has worked to improve it
can know that, in this instance, they have made that difference.
____________________