[Congressional Record (Bound Edition), Volume 151 (2005), Part 12]
[Senate]
[Pages 17119-17123]
[From the U.S. 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

[[Page 17120]]

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 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

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     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 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

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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 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

[[Page 17123]]

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.

                          ____________________