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Calendar No. 387
108th CONGRESS
1st Session
S. 720
[Report No. 108-196]
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.
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
March 26, 2003
Mr. Jeffords (for himself, Mr. Frist, Mr. Breaux, Mr. Gregg, Mr. Enzi,
Mr. Hagel, and Mr. Smith) introduced the following bill; which was read
twice and referred to the Committee on Health, Education, Labor, and
Pensions
November 17, 2003
Reported by Mr. Gregg, with an amendment
[Strike out all after the enacting clause and insert the part printed
in italic]
_______________________________________________________________________
A BILL
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.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
<DELETED>SECTION 1. SHORT TITLE.</DELETED>
<DELETED> This Act may be cited as the ``Patient Safety and Quality
Improvement Act''.</DELETED>
<DELETED>SEC. 2. FINDINGS AND PURPOSES.</DELETED>
<DELETED> (a) Findings.--Congress makes the following
findings:</DELETED>
<DELETED> (1) In 1999, the Institute of Medicine released a
report entitled To Err is Human that described medical errors
as the eighth leading cause of death in the United States, with
as many as 98,000 people dying as a result of medical errors
each year.</DELETED>
<DELETED> (2) To address these deaths and injuries due to
medical errors, the health care system must identify and learn
from such errors so that systems of care can be
improved.</DELETED>
<DELETED> (3) In their report, the Institute of Medicine
called on Congress to provide legal protections with respect to
information reported for the purposes of quality improvement
and patient safety.</DELETED>
<DELETED> (4) The Health, Education, Labor, and Pensions
Committee of the Senate held 4 hearings in the 106th Congress
and 1 hearing in the 107th Congress on patient safety where
experts in the field supported the recommendation of the
Institute of Medicine for congressional action.</DELETED>
<DELETED> (5) Myriad public and private patient safety
initiatives have begun. The Quality Interagency Coordination
Taskforce has recommended steps to improve patient safety that
may be taken by each Federal agency involved in health care and
activities relating to these steps are ongoing.</DELETED>
<DELETED> (6) The research on patient safety unequivocally
calls for a learning environment, rather than a punitive
environment, in order to improve patient safety.</DELETED>
<DELETED> (7) Voluntary data gathering systems are more
supportive than mandatory systems in creating the learning
environment referred to in paragraph (5) as stated in the
Institute of Medicine's report.</DELETED>
<DELETED> (8) Promising patient safety reporting systems
have been established throughout the United States and the best
ways to structure and use these systems are currently being
determined, largely through projects funded by the Agency for
Healthcare Research and Quality.</DELETED>
<DELETED> (9) The Department of Health and Human Services
has initiated several patient safety projects. The Joint
Commission on Accreditation of Healthcare Organizations issued
a patient safety standard that went into effect on July 1,
2001, and the peer review organizations are conducting ongoing
studies of clinical performance measurement of care delivered
to beneficiaries under the medicare program under title XVIII
of the Social Security Act.</DELETED>
<DELETED> (10) Many organizations currently collecting
patient safety data have expressed a 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. Currently, the State
peer review protections provide inadequate conditions to allow
the sharing of information to promote patient safety.</DELETED>
<DELETED> (11) In 2001, the Institute of Medicine released a
report entitled Crossing the Quality Chasm that found that the
United States health care system does not consistently deliver
high quality care to patients.</DELETED>
<DELETED> (b) Purposes.--It is the purpose of this Act to--
</DELETED>
<DELETED> (1) encourage a culture of safety and quality in
the United States health care system by providing for legal
protection of information reported voluntarily for the purposes
of quality improvement and patient safety; and</DELETED>
<DELETED> (2) ensure accountability by raising standards and
expectations for continuous quality improvements in patient
safety through the actions of the Secretary of Health and Human
Services.</DELETED>
<DELETED>SEC. 3. AMENDMENTS TO PUBLIC HEALTH SERVICE ACT.</DELETED>
<DELETED> Title IX of the Public Health Service Act (42 U.S.C. 299
et seq.) is amended--</DELETED>
<DELETED> (1) in section 912(c), by inserting ``, in
accordance with part C,'' after ``The Director
shall'';</DELETED>
<DELETED> (2) by redesignating part C as part D;</DELETED>
<DELETED> (3) by redesignating sections 921 through 928, as
sections 931 through 938, respectively;</DELETED>
<DELETED> (4) in section 938(1) (as so redesignated), by
striking ``921'' and inserting ``931''; and</DELETED>
<DELETED> (5) by inserting after part B the
following:</DELETED>
<DELETED>``PART C--PATIENT SAFETY IMPROVEMENT</DELETED>
<DELETED>``SEC. 921. DEFINITIONS.</DELETED>
<DELETED> ``In this part:</DELETED>
<DELETED> ``(1) Non-identifiable information.--The term
`non-identifiable information' means information that is
presented in a form and manner that prevents the identification
of any provider, patient, and the reporter of patient safety
data.</DELETED>
<DELETED> ``(2) Patient safety data.--The term `patient
safety data' means--</DELETED>
<DELETED> ``(A) any data, reports, records,
memoranda, analyses, deliberative work, statements,
root cause analyses, or quality improvement processes
that could result in improved patient safety or health
care quality, that are--</DELETED>
<DELETED> ``(i) collected or developed by a
provider for the purpose of reporting to a
patient safety organization;</DELETED>
<DELETED> ``(ii) reported to a patient
safety organization for patient safety or
quality improvement processes;</DELETED>
<DELETED> ``(iii) requested by a patient
safety organization (including the contents of
such request);</DELETED>
<DELETED> ``(iv) reported to a provider by a
patient safety organization;</DELETED>
<DELETED> ``(v) collected or developed by a
patient safety organization; or</DELETED>
<DELETED> ``(vi) reported among patient
safety organizations, after obtaining
authorization; or</DELETED>
<DELETED> ``(B) information related to corrective
actions taken in response to patient safety
data;</DELETED>
<DELETED>for the purpose of improving patient safety, health
care quality, or health care outcomes.</DELETED>
<DELETED> ``(3) Patient safety organization.--The term
`patient safety organization' means a private or public
organization or component thereof that performs the following
activities (which are deemed to be necessary for the proper
management and administration of such organization or component
thereof):</DELETED>
<DELETED> ``(A) The conduct, as its primary
activity, of efforts to improve patient safety and the
quality of health care delivery.</DELETED>
<DELETED> ``(B) The collection and analysis of
patient safety data that are voluntarily submitted by a
provider.</DELETED>
<DELETED> ``(C) The development and dissemination of
information to providers with respect to improving
patient safety, such as recommendations, protocols, or
information regarding best practices.</DELETED>
<DELETED> ``(D) The utilization of patient safety
data to carry out activities under this paragraph and
for the purposes of encouraging a culture of safety and
of providing direct feedback and assistance to
providers to effectively minimize patient
risk.</DELETED>
<DELETED> ``(E) The maintenance of confidentiality
with respect to individually identifiable health
information.</DELETED>
<DELETED> ``(F) The provision of appropriate
security measures with respect to patient safety
data.</DELETED>
<DELETED> ``(G) The certification to the Agency that
the patient safety organization satisfies the criteria
of this paragraph for the period in which the
organization is carrying out such duties.</DELETED>
<DELETED> ``(4) Provider.--The term `provider' means--
</DELETED>
<DELETED> ``(A) a provider of services (as defined
in section 1861(u) of the Social Security Act) and a
person furnishing any medical or other health care
services (as defined in section 1861(s)(1) and (2) of
such Act) through, or under the authority of, such a
provider of services;</DELETED>
<DELETED> ``(B) a physician (as defined in section
1861(r) of such Act);</DELETED>
<DELETED> ``(C) any other person, including a
pharmacist, who is engaged in the delivery of medical
or other health services (as defined in section
1861(s)(1) and (2) of such Act) in a State and who is
required by State law or regulation to be licensed or
certified by the State to engage in the delivery of
such services in the State;</DELETED>
<DELETED> ``(D) a renal dialysis facility,
ambulatory surgical center, pharmacy, physician or
health care practitioner's office, long term care
facility, behavioral health residential treatment
facility, or clinical laboratory; or</DELETED>
<DELETED> ``(E) any other person or entity specified
in regulations by the Secretary after public notice and
comment.</DELETED>
<DELETED>``SEC. 922. CONFIDENTIALITY AND PEER REVIEW
PROTECTIONS.</DELETED>
<DELETED> ``(a) In General.--Notwithstanding any other provision of
law, and subject to this section, patient safety data shall be
privileged and confidential.</DELETED>
<DELETED> ``(b) Scope of Privilege.--Subject to the provisions of
subsection (c), patient safety data to which subsection (a) applies
shall not be--</DELETED>
<DELETED> ``(1) subject to a civil, criminal, or
administrative subpoena;</DELETED>
<DELETED> ``(2) subject to discovery in connection with a
civil, criminal, or administrative proceeding;</DELETED>
<DELETED> ``(3) disclosed pursuant to section 552 of title
5, United States Code (commonly known as the Freedom of
Information Act) or any other similar Federal or State
law;</DELETED>
<DELETED> ``(4) admitted as evidence or otherwise disclosed
in any civil, criminal, or administrative proceeding;
or</DELETED>
<DELETED> ``(5) utilized in an adverse employment action or
in the evaluation of decisions made in relation to
accreditation, certification, credentialing or licensing of an
individual, that is based on such individual's participation in
the development, collection, reporting, or storage of patient
safety data in accordance with this part.</DELETED>
<DELETED> ``(c) Disclosure Requirements.--Nothing in this section
shall be construed to prohibit one or more of the following disclosures
(which are deemed to be necessary for the proper management and
administration of the patient safety organization):</DELETED>
<DELETED> ``(1) Disclosures by a provider in complying with
authorized requests for the provision of information to which
subsection (a) applies (such as a patient's medical record or
other relevant information) that is in the control of such a
provider and that has been developed, maintained, or exists
separately from the process by which the provider collects or
develops information for reporting to a patient safety
organization.</DELETED>
<DELETED> ``(2) Disclosures by a provider or patient safety
organization of patient safety data as part of a disciplinary
proceeding relating to a provider, or a criminal proceeding, if
such a disclosure of such patient safety data is--</DELETED>
<DELETED> ``(A) material to the
proceeding;</DELETED>
<DELETED> ``(B) within the public interest;
and</DELETED>
<DELETED> ``(C) not available from any other
source.</DELETED>
<DELETED> ``(3) Disclosures by a provider or patient safety
organization of relevant information to the Food and Drug
Administration, or to a person that is subject to the
jurisdiction of such Administration, with respect to an
Administration-regulated product or activity for which that
entity has responsibility, for the purposes of activities
related to the quality, safety, or effectiveness of such
Administration-regulated product or activity, subject to
section 520(c) of the Federal Food, Drug, and Cosmetic
Act.</DELETED>
<DELETED> ``(4) Disclosures by a provider or patient safety
organization of information to which subsection (a) applies to
carry out activities described in paragraph (2)(A) (i) through
(vi) or (3) of section 921.</DELETED>
<DELETED> ``(d) Transfer of Information.--The transfer of any
patient safety data by a provider to a patient safety organization
shall not be treated as a waiver of any privilege or protection
established under this part or established under State law.</DELETED>
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