[House Report 108-28]
[From the U.S. Government Publishing Office]
108th Congress Report
HOUSE OF REPRESENTATIVES
1st Session 108-28
======================================================================
PATIENT SAFETY AND QUALITY IMPROVEMENT ACT
_______
March 6, 2003.--Committed to the Committee of the Whole House on the
State of the Union and ordered to be printed
_______
Mr. Tauzin, from the Committee on Energy and Commerce, submitted the
following
R E P O R T
[To accompany H.R. 663]
[Including cost estimate of the Congressional Budget Office]
The Committee on Energy and Commerce, to whom was referred
the bill (H.R. 663) to amend title IX of the Public Health
Service Act to provide for the improvement of patient safety
and to reduce the incidence of events that adversely affect
patient safety, and for other purposes, having considered the
same, report favorably thereon with an amendment and recommend
that the bill as amended do pass.
CONTENTS
Page
Amendment........................................................ 1
Purpose and Summary.............................................. 11
Background and Need for Legislation.............................. 11
Hearings......................................................... 12
Committee Consideration.......................................... 12
Committee Votes.................................................. 12
Committee Oversight Findings..................................... 12
Statement of General Performance Goals and Objectives............ 12
New Budget Authority, Entitlement Authority, and Tax Expenditures 13
Committee Cost Estimate.......................................... 13
Congressional Budget Office Estimate............................. 13
Federal Mandates Statement....................................... 17
Advisory Committee Statement..................................... 17
Constitutional Authority Statement............................... 17
Applicability to Legislative Branch.............................. 17
Section-by-Section Analysis of the Legislation................... 17
Changes in Existing Law Made by the Bill, as Reported............ 23
Amendment
The amendment is as follows:
Strike all after the enacting clause and insert the
following:
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Patient Safety and Quality Improvement
Act''.
SEC. 2. FINDINGS AND PURPOSES.
(a) Findings.--The Congress finds as follows:
(1) In 1999, the Institute of Medicine released a report
entitled ``To Err Is Human'' that described medical errors as
the 8th leading cause of death in the United States, with as
many as 98,000 people dying as a result of medical errors each
year.
(2) To address these deaths and injuries due to medical
errors, the health care system must identify and learn from
such errors so that systems of care can be improved.
(3) Myriad public and private patient safety initiatives have
begun. The Quality Interagency Coordination Task Force has
recommended steps to improve patient safety that may be taken
by each Federal agency involved in health care and activities
relating to these steps are ongoing.
(4) The Department of Health and Human Services has initiated
several patient safety projects. The Joint Commission on
Accreditation of Healthcare Organizations issued a patient
safety standard that went into effect on July 1, 2001, and the
peer review organizations are conducting ongoing studies of
clinical performance measurement of care delivered to
beneficiaries under the medicare program under title XVIII of
the Social Security Act.
(5) Several steps can be taken now to improve patient safety.
For example, according to the Centers for Disease Control and
Prevention, hand washing is the single most important means of
preventing the spread of infection. Repeated studies indicate
that lack of or improper hand washing still contributes
significantly to disease transmission in health care settings.
Working with experts from the private sector, the Centers for
Disease Control and Prevention has drafted ``Guidelines for
Hand Hygiene in Healthcare Settings'' setting forth
recommendations to promote improved hand hygiene practices and
reduce transmission of pathogenic microorganisms to patients
and personnel in health care settings.
(6) According to the Centers for Disease Control and
Prevention, nosocomial infections affect approximately 2
million patients annually in acute care facilities in the
United States at an estimated direct patient care cost of
approximately $3.5 billion each year.
(7) The Congress encourages the continuation and acceleration
of private sector efforts to take immediate steps to improve
patient safety and recognizes the need for action in the public
sector to complement these efforts.
(8) The research on patient safety unequivocally calls for a
learning environment, where providers will feel safe to report
health care errors, in order to improve patient safety.
(9) Voluntary data gathering systems are more supportive than
mandatory systems in creating the learning environment referred
to in paragraph (8) as stated in the Institute of Medicine's
report.
(10) Promising patient safety reporting systems have been
established throughout the United States, and the best ways to
structure and use these systems are currently being determined,
largely through projects funded by the Agency for Healthcare
Research and Quality.
(11) Many organizations currently collecting patient safety
information have expressed a need for protections that will
allow them to review protected information so that they may
collaborate in the development and implementation of patient
safety improvement strategies. Currently, the State peer review
protections provide inadequate conditions to allow the sharing
of information to promote patient safety.
(12) In 2001, the Institute of Medicine released a report
entitled ``Crossing the Quality Chasm'' that found that the
United States health care system does not consistently deliver
high-quality care to patients.
(b) Purposes.--The purposes of this Act are--
(1) to encourage a culture of safety and quality in the
United States health care system by providing for a health care
errors reporting system that both protects information and
improves patient safety and quality of health care; and
(2) to ensure accountability by raising standards and
expectations for continuous quality improvements in patient
safety through the actions of the Secretary of Health and Human
Services.
SEC. 3. AMENDMENTS TO PUBLIC HEALTH SERVICE ACT.
(a) In General.--Title IX of the Public Health Service Act (42 U.S.C.
299 et seq.) is amended--
(1) in section 912(c), by inserting ``, in accordance with
part C,'' after ``The Director shall'';
(2) by redesignating part C as part D;
(3) by redesignating sections 921 through 928, as sections
931 through 938, respectively;
(4) in section 938(1) (as so redesignated), by striking
``921'' and inserting ``931''; and
(5) by inserting after part B the following:
``PART C--PATIENT SAFETY IMPROVEMENT
``SEC. 921. DEFINITIONS.
``In this part:
``(1) Identifiable information.--The term `identifiable
information' means information that is presented in a form and
manner that allows the identification of any provider, patient,
or reporter of patient safety work product. With respect to
patients, such information includes any individually
identifiable health information as that term is defined in the
regulations promulgated pursuant to section 264(c) of the
Health Insurance Portability and Accountability Act of 1996
(Public Law 104-191; 110 Stat. 2033).
``(2) Nonidentifiable information.--The term `nonidentifiable
information' means information that is presented in a form and
manner that prevents the identification of any provider,
patient, or reporter of patient safety work product. With
respect to patients, such information must be de-identified
consistent with the regulations promulgated pursuant to section
264(c) of the Health Insurance Portability and Accountability
Act of 1996 (Public Law 104-191; 110 Stat. 2033).
``(3) Patient safety evaluation system.--The term `patient
safety evaluation system' means a process that involves the
collection, management, or analysis of information for
submission to or by a patient safety organization.
``(4) Patient safety organization.--The term `patient safety
organization' means a private or public organization or
component thereof that is certified, through a process to be
determined by the Secretary under section 925, to perform each
of the following activities:
``(A) The conduct, as the organization or component's
primary activity, of efforts to improve patient safety
and the quality of health care delivery.
``(B) The collection and analysis of patient safety
work product that is submitted by providers.
``(C) The development and dissemination of evidence-
based information to providers with respect to
improving patient safety, such as recommendations,
protocols, or information regarding best practices.
``(D) The utilization of patient safety work product
to carry out activities limited to those described
under this paragraph and for the purposes of
encouraging a culture of safety and of providing direct
feedback and assistance to providers to effectively
minimize patient risk.
``(E) The maintenance of confidentiality with respect
to identifiable information.
``(F) The provision of appropriate security measures
with respect to patient safety work product.
``(G) The submission of nonidentifiable information
to the Agency consistent with standards established by
the Secretary under section 923(b) for any National
Patient Safety Database.
``(5) Patient safety work product.--
``(A) The term `patient safety work product' means
any document or communication (including any
information, report, record, memorandum, analysis,
deliberative work, statement, or root cause analysis)
that--
``(i) except as provided in subparagraph (B),
is developed by a provider for the purpose of
reporting to a patient safety organization, and
is reported to a patient safety organization;
``(ii) is created by a patient safety
organization; or
``(iii) would reveal the deliberations or
analytic process of a patient safety evaluation
system (as defined in paragraph (3)).
``(B)(i) Patient safety work product described in
subparagraph (A)(i)--
``(I) does not include any separate
information described in clause (ii); and
``(II) shall not be construed to include such
separate information merely by reason of
inclusion of a copy of the document or
communication involved in a submission to, or
the fact of submission of such a copy to, a
patient safety organization.
``(ii) Separate information described in this clause
is a document or communication (including a patient's
medical record or any other patient or hospital record)
that is developed or maintained, or exists, separately
from any patient safety evaluation system.
``(C) Information available from sources other than a
patient safety work product under this section may be
discovered or admitted in a civil or administrative
proceeding, if discoverable or admissible under
applicable law.
``(6) Provider.--The term `provider' means--
``(A) an individual or entity licensed or otherwise
authorized under State law to provide health care
services, including--
``(i) a hospital, nursing facility,
comprehensive outpatient rehabilitation
facility, home health agency, and hospice
program;
``(ii) a physician, physician assistant,
nurse practitioner, clinical nurse specialist,
certified nurse midwife, psychologist,
certified social worker, registered dietitian
or nutrition professional, physical or
occupational therapist, or other individual
health care practitioner;
``(iii) a pharmacist; and
``(iv) a renal dialysis facility, ambulatory
surgical center, pharmacy, physician or health
care practitioner's office, long-term care
facility, behavioral health residential
treatment facility, clinical laboratory, or
community health center; or
``(B) any other person or entity specified in
regulations by the Secretary after public notice and
comment.
``SEC. 922. PRIVILEGE FOR PATIENT SAFETY WORK PRODUCT.
``(a) Privilege.--Notwithstanding any other provision of law and
subject to subsection (c), patient safety work product shall not be--
``(1) subject to a civil or administrative subpoena or order;
``(2) subject to discovery in connection with a civil or
administrative proceeding;
``(3) subject to disclosure pursuant to section 552 of title
5, United States Code (commonly known as the Freedom of
Information Act), or any other similar Federal or State law;
``(4) required to be admitted as evidence or otherwise
disclosed in any State or Federal civil or administrative
proceeding; or
``(5) if the patient safety work product is identifiable
information and is received by a national accreditation
organization in its capacity as a patient safety organization--
``(A) used by a national accreditation organization
in an accreditation action against the provider that
reported the information;
``(B) shared by such organization with its survey
team; or
``(C) required as a condition of accreditation by a
national accreditation association.
``(b) Reporter Protection.--
``(1) In general.--A provider may not use against an
individual in an adverse employment action described in
paragraph (2) the fact that the individual in good faith
reported information--
``(A) to the provider with the intention of having
the information reported to a patient safety
organization; or
``(B) directly to a patient safety organization.
``(2) Adverse employment action.--For purposes of this
subsection, an `adverse employment action' includes--
``(A) the failure to promote an individual or provide
any other employment-related benefit for which the
individual would otherwise be eligible;
``(B) an adverse evaluation or decision made in
relation to accreditation, certification,
credentialing, or licensing of the individual; and
``(C) a personnel action that is adverse to the
individual concerned.
``(3) Remedies.--Any provider that violates this subsection
shall be subject to a civil monetary penalty of not more than
$20,000 for each such violation involved. Such penalty shall be
imposed and collected in the same manner as civil money
penalties under subsection (a) of section 1128A of the Social
Security Act are imposed and collected.
``(c) Disclosures.--Nothing in this section prohibits any of the
following disclosures:
``(1) Voluntary disclosure of nonidentifiable information.
``(2) Voluntary disclosure of identifiable information by a
provider or patient safety organization, if such disclosure--
``(A) is authorized by the provider for the purposes
of improving quality and safety;
``(B) is to an entity or person subject to the
requirements of section 264(c) of the Health Insurance
Portability and Accountability Act of 1996 (Public Law
104-191; 110 Stat. 2033), or any regulation promulgated
under such section; and
``(C) is not in conflict with such section or any
regulation promulgated under such section.
``(3) Disclosure as required by law by a provider to the Food
and Drug Administration, or on a voluntary basis by a provider
to a federally established patient safety program, with respect
to an Administration-regulated product or activity for which
that entity has responsibility, for the purposes of activities
related to the quality, safety, or effectiveness of such
Administration-regulated product or activity.
``(4) Disclosures of patient safety work product in
accordance with this part by a provider to a patient safety
organization.
``(d) Effect of Transfer, Disclosure.--The following shall not be
treated as a waiver of any privilege or protection established under
this part:
``(1) The transfer of any patient safety work product between
a provider and a patient safety organization.
``(2) Disclosure of patient safety work product as described
in subsection (c).
``(3) The unauthorized disclosure of patient safety work
product.
``(e) Penalty.--
``(1) Prohibition.--Except as provided in this part, and
subject to paragraphs (2) and (4), it shall be unlawful for any
person to disclose patient safety work product in violation of
this section, if such disclosure constitutes a negligent or
knowing breach of confidentiality.
``(2) Relation to HIPAA.--The penalty under paragraph (3) for
a disclosure in violation of paragraph (1) does not apply if
the person would be subject to a penalty under section 264(c)
of the Health Insurance Portability and Accountability Act of
1996 (Public Law 104-191; 110 Stat. 2033), or any regulation
promulgated under such section, for the same disclosure.
``(3) Amount.--Any person who violates paragraph (1) shall be
subject to a civil monetary penalty of not more than $10,000
for each such violation involved. Such penalty shall be imposed
and collected in the same manner as civil money penalties under
subsection (a) of section 1128A of the Social Security Act are
imposed and collected.
``(4) Subsequent disclosure.--Paragraph (1) applies only to
the first person that breaches confidentiality with respect to
particular patient safety work product.
``(f) Relation to HIPAA.--
``(1) In general.--For purposes of applying the regulations
promulgated pursuant to section 264(c) of the Health Insurance
Portability and Accountability Act of 1996 (Public Law 104-191;
110 Stat. 2033)--
``(A) patient safety organizations shall be treated
as business associates; and
``(B) activities of such organizations described in
section 921(4) in relation to a provider are deemed to
be health care operations (as defined in such
regulations) of the provider.
``(2) Rule of construction.--Nothing in this section shall be
construed to alter or affect the implementation of such
regulations or such section 264(c).
``(g) No Limitation of Other Privileges.--Nothing in this section
shall be construed to affect privileges, including peer review and
confidentiality protections, that are otherwise available under Federal
or State laws.
``(h) No Limitation on Contracts.--Nothing in this section shall be
construed to limit the power of a provider and a patient safety
organization, or a patient safety organization and the Agency or any
National Patient Safety Database, consistent with the provisions of
this Act and other applicable law, to enter into a contract requiring
greater confidentiality or delegating authority to make an authorized
disclosure.
``(i) Relation to State Reporting Requirements.--Nothing in this part
shall be construed as preempting or otherwise affecting any State law
requiring a provider to report information, including information
described in section 921(5)(B), that is not patient safety work
product.
``(j) Continuation of Privilege.--Patient safety work product of an
organization that is certified as a patient safety organization shall
continue to be privileged and confidential, in accordance with this
section, if the organization's certification is terminated or revoked
or if the organization otherwise ceases to qualify as a patient safety
organization.
``(k) Reports on Strategies To Improve Patient Safety.--
``(1) Draft report.--Not later than the date that is 18
months after any National Patient Safety Database is
operational, the Secretary, in consultation with the Director,
shall prepare a draft report on effective strategies for
reducing medical errors and increasing patient safety. The
draft report shall include any measure determined appropriate
by the Secretary to encourage the appropriate use of such
strategies, including use in any federally funded programs. The
Secretary shall make the draft report available for public
comment and submit the draft report to the Institute of
Medicine for review.
``(2) Final report.--Not later than 1 year after the date
described in paragraph (1), the Secretary shall submit a final
report to the Congress that includes, in an appendix, any
findings by the Institute of Medicine concerning research on
the strategies discussed in the draft report and any
modifications made by the Secretary based on such findings.
``SEC. 923. NATIONAL DATABASE.
``(a) Authority.--
``(1) In general.--In conducting activities under this part,
the Secretary shall provide for the establishment and
maintenance of a database to receive relevant nonidentifiable
patient safety work product, and may designate entities to
collect relevant nonidentifiable patient safety work product
that is voluntarily reported by patient safety organizations
upon the request of the Secretary. Any database established or
designated under this paragraph may be referred to as a
`National Patient Safety Database'.
``(2) Use of information.--Information reported to any
National Patient Safety Database shall be used to analyze
national and regional statistics, including trends and patterns
of health care errors. The information resulting from such
analyses may be included in the annual quality reports prepared
under section 913(b)(2).
``(3) Advisory role.--The Secretary shall provide scientific
support to patient safety organizations, including the
dissemination of methodologies and evidence-based information
related to root causes and quality improvement.
``(b) Standards.--In establishing or designating a database under
subsection (a)(1), the Secretary shall, in consultation with
representatives of patient safety organizations, the provider
community, and the health information technology industry, determine
common formats for the voluntary reporting of nonidentifiable patient
safety work product, including necessary elements, common and
consistent definitions, and a standardized computer interface for the
processing of the work product. To the extent practicable, such
standards shall be consistent with the administrative simplification
provisions of part C of title XI of the Social Security Act.
``(c) Certain Methodologies for Collection.--The Secretary shall
ensure that the methodologies for the collection of nonidentifiable
patient safety work product for any National Patient Safety Database
include the methodologies developed or recommended by the Patient
Safety Task Force of the Department of Health and Human Services.
``(d) Facilitation of Information Exchange.--To the extent
practicable, the Secretary may facilitate the direct link of
information between providers and patient safety organizations and
between patient safety organizations and any National Patient Safety
Database.
``(e) Restriction on Transfer.--Only nonidentifiable information may
be transferred to any National Patient Safety Database.
``SEC. 924. TECHNICAL ASSISTANCE.
``(a) In General.--The Secretary, acting through the Director, may--
``(1) provide technical assistance to patient safety
organizations, and to States with reporting systems for health
care errors; and
``(2) provide guidance on the type of data to be voluntarily
submitted to any National Patient Safety Database.
``(b) Annual Meetings.--Assistance provided under subsection (a) may
include annual meetings for patient safety organizations to discuss
methodology, communication, information collection, or privacy
concerns.
``SEC. 925. CERTIFICATION OF PATIENT SAFETY ORGANIZATIONS.
``(a) In General.--Not later than 6 months after the date of
enactment of the Patient Safety and Quality Improvement Act, the
Secretary shall establish a process for certifying patient safety
organizations.
``(b) Process.--The process established under subsection (a) shall
include the following:
``(1) Certification of patient safety organizations by the
Secretary or by such other national or State governmental
organizations as the Secretary determines appropriate.
``(2) If the Secretary allows other governmental
organizations to certify patient safety organizations under
paragraph (1), the Secretary shall establish a process for
approving such organizations. Any such approved organization
shall conduct certifications and reviews in accordance with
this section.
``(3) A review of each certification under paragraph (1)
(including a review of compliance with each criterion in this
section and any related implementing standards as determined by
the Secretary through rulemaking) not less often than every 3
years, as determined by the Secretary.
``(4) Revocation of any such certification by the Secretary
or other such governmental organization that issued the
certification, upon a showing of cause.
``(c) Criteria.--A patient safety organization must meet the
following criteria as conditions of certification:
``(1) The mission of the patient safety organization is to
conduct activities that are to improve patient safety and the
quality of health care delivery and is not in conflict of
interest with the providers that contract with the patient
safety organization.
``(2) The patient safety organization has appropriately
qualified staff, including licensed or certified medical
professionals.
``(3) The patient safety organization, within any 2 year
period, contracts with more than 1 provider for the purpose of
receiving and reviewing patient safety work product.
``(4) The patient safety organization is not a component of a
health insurer or other entity that offers a group health plan
or health insurance coverage.
``(5) The patient safety organization is managed, controlled,
and operated independently from any provider that contracts
with the patient safety organization for reporting patient
safety work product.
``(6) To the extent practical and appropriate, the patient
safety organization collects patient safety work product from
providers in a standardized manner that permits valid
comparisons of similar cases among similar providers.
``(d) Additional Criteria for Component Organizations.--If a patient
safety organization is a component of another organization, the patient
safety organization must, in addition to meeting the criteria described
in subsection (c), meet the following criteria as conditions of
certification:
``(1) The patient safety organization maintains patient
safety work product separately from the rest of the
organization, and establishes appropriate security measures to
maintain the confidentiality of the patient safety work
product.
``(2) The patient safety organization does not make an
unauthorized disclosure under this Act of patient safety work
product to the rest of the organization in breach of
confidentiality.
``(3) The mission of the patient safety organization does not
create a conflict of interest with the rest of the
organization.''.
(b) Authorization of Appropriations.--Section 937 of the Public
Health Service Act (as redesignated by subsection (a)) is amended by
adding at the end the following:
``(e) Patient Safety and Quality Improvement.--For the purpose of
carrying out part C, there are authorized to be appropriated such sums
as may be necessary for each of the fiscal years 2004 through 2008.''.
SEC. 4. PROMOTING THE DIFFUSION AND INTEROPERABILITY OF INFORMATION
TECHNOLOGY SYSTEMS INVOLVED WITH HEALTH CARE
DELIVERY.
(a) Voluntary Standards.--
(1) In general.--Not later than 18 months after the date of
the enactment of this Act, the Secretary of Health and Human
Services (in this section referred to as the ``Secretary'')
shall--
(A) develop or adopt voluntary national standards
that promote the interoperability of information
technology systems involved with health care delivery,
including but not limited to computerized physician
order entry;
(B) in developing or adopting such standards, take
into account--
(i) the ability of such systems to capture
and aggregate clinically specific data to
enable evidence-based medicine and other
applications that promote the electronic
exchange of patient medical record information;
and
(ii) the cost that meeting such standards
would have on providing health care in the
United States and the increased efficiencies in
providing such care achieved under the
standards;
(C) in developing or adopting such standards and to
the extent practicable, test the efficacy, usability,
and scalability of proposed interoperability standards
within a variety of clinical settings, including an
urban academic medical center, a rural hospital, a
community health center, and a community hospital; and
(D) submit a report to the Congress containing
recommendations on such standards.
(2) Consultation.--In developing or adopting standards under
paragraph (1)(A), the Secretary shall consider the
recommendations of the National Committee on Vital Health
Statistics for the standardization of message formatting,
coding, and vocabulary for interoperability of information
technology systems involved with health care delivery. The
Secretary shall consult with representatives of the health
information technology industry and the provider community who
are involved with the development of interoperability
standards.
(b) Updates.--The Secretary shall provide for the ongoing review and
periodic updating of the standards developed under subsection (a).
SEC. 5. REQUIRED USE OF PRODUCT IDENTIFICATION TECHNOLOGY.
The Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) is
amended--
(1) in section 502, by adding at the end the following:
``(w) If it is a drug or biological product, unless it includes a
unique product identifier for the drug or biological product as
required by regulations under section 510(q).''; and
(2) in section 510, by adding at the end the following:
``(q)(1) The Secretary shall issue, and may periodically revise,
regulations requiring the manufacturer of any drug or biological
product that is subject to regulation by the Food and Drug
Administration, or the packager or labeler of a drug or biological
product that is subject to regulation by the Food and Drug
Administration, to include a unique product identifier on the packaging
of the drug or biological product.
``(2) For purposes of this subsection, the term `unique product
identifier' means an identification that--
``(A) is affixed by the manufacturer, labeler, or packager to
each drug or biological product described in paragraph (1) at
each packaging level;
``(B) uniquely identifies the item and meets the standards
required by this section; and
``(C) can be read by a scanning device or other technology
acceptable to the Secretary.
``(3) A unique product identifier required by regulations issued or
revised under paragraph (1) shall be based on--
``(A) the National Drug Code maintained by the Food and Drug
Administration;
``(B) commercially accepted standards established by
organizations that are accredited by the American National
Standards Institute, such as the Health Industry Business
Communication Council or the Uniform Code Council; or
``(C) other identification formats that the Secretary deems
appropriate.
``(4) The Secretary may, at the Secretary's discretion, waive the
requirements of this section, or add additional provisions that are
necessary to safeguard the public health.''.
SEC. 6. GRANTS FOR ELECTRONIC PRESCRIPTION PROGRAMS.
(a) Grants.--
(1) In general.--The Secretary of Health and Human Services
(in this section referred to as the ``Secretary'') may make
grants to qualified practitioners for the purpose of
establishing electronic prescription programs.
(2) Matching funds.--
(A) In general.--With respect to the costs of
establishing an electronic prescription program, a
condition for the receipt of a grant under paragraph
(1) is that the qualified practitioner involved agree
to make available (directly or through donations from
public or private entities) non-Federal contributions
toward such costs in an amount that is not less than 50
percent of such costs.
(B) Determination of amount contributed.--Non-Federal
contributions required in subparagraph (A) may be in
cash or in kind, fairly evaluated, including equipment
or services. Amounts provided by the Federal
Government, or services assisted or subsidized to any
significant extent by the Federal Government, may not
be included in determining the amount of such non-
Federal contributions.
(b) Study.--
(1) In general.--The Secretary, acting through the Director
of the Agency for Healthcare Research and Quality, shall
support a study to assess existing scientific evidence
regarding the effectiveness and cost-effectiveness of the use
of electronic prescription programs intended to improve the
efficiency of prescription ordering and the safe and effective
use of prescription drugs. The study shall address the
following:
(A) The ability of such programs to reduce medical
errors and improve the quality and safety of patient
care.
(B) The impact of the use of such programs on
physicians, pharmacists, and patients, including such
factors as direct and indirect costs, changes in
productivity, and satisfaction.
(C) The effectiveness of strategies for overcoming
barriers to the use of electronic prescription
programs.
(2) Report.--The Secretary shall ensure that, not later than
18 months after the date of the enactment of this Act, a report
containing the findings of the study under paragraph (1) is
submitted to the appropriate committees of the Congress.
(3) Dissemination of findings.--The Secretary shall
disseminate the findings of the study under paragraph (1) to
appropriate public and private entities.
(c) Development of Model.--The Secretary, acting through the Director
of the Agency for Healthcare Research and Quality, may develop an
Internet-based mathematical model that simulates the cost and
effectiveness of electronic prescription programs for qualified
practitioners. The model may be designed to allow qualified
practitioners to estimate, through an interactive interface, the impact
of electronic prescribing on their practices, including the reduction
in drug-related health care errors.
(d) Definitions.--For purposes of this section:
(1) The term ``electronic prescription program''--
(A) means a program for the electronic submission and
processing of prescriptions; and
(B) includes the hardware (including computers and
other electronic devices) and software programs for the
electronic submission of prescriptions to pharmacies,
the processing of such submissions by pharmacies, and
decision-support programs.
(2) The term ``qualified practitioner'' means a practitioner
licensed by law to administer or dispense prescription drugs.
SEC. 7. GRANTS TO HOSPITALS AND OTHER HEALTH CARE PROVIDERS FOR
INFORMATION TECHNOLOGIES.
(a) In General.--The Secretary of Health and Human Services (in this
section referred to as the ``Secretary'') shall make grants to
hospitals and other health care providers (but not more than 1 grant to
any 1 hospital or provider) to pay the costs of acquiring or
implementing information technologies whose purposes are--
(1) to improve quality of care and patient safety; and
(2) to reduce adverse events and health care complications
resulting from medication errors.
(b) Special Consideration.--In making grants under subsection (a),
the Secretary shall give special consideration to applicants who seek
to promote the following:
(1) Interoperability across hospital services or departments
using standards developed or adopted by the Secretary under
section 4.
(2) Electronic communication of patient data across the
spectrum of health care delivery.
(3) Computerized physician order entry or bar coding
applications.
(4) Electronic communication of patient data in hospitals
that provide services to underserved or low-income populations.
(5) Improved clinical decisionmaking through acquisition and
implementation of decision-support technologies.
(c) Certain Grant Conditions.--A condition for the receipt of a grant
under subsection (a) is that the applicant involved meet the following
requirements:
(1) The applicant agrees to carry out a program to measure,
analyze, and report patient safety and medical errors at the
hospital or other health care provider involved, to submit to
the Secretary a description of the methodology that will be
used, and to have such program in effect as soon as practicable
after the application for the grant is approved, without regard
to whether information technologies under the grant have been
implemented.
(2) The applicant has arranged for an evaluation that
addresses the effectiveness and cost-effectiveness of the
information technology for which the grant is provided and its
impact on the quality and safety of patient care, submitted the
evaluation plan to the Secretary, and received approval from
the Secretary of the applicant's methodology.
(3) The applicant has or is developing a patient safety
evaluation system (as that term is defined in section 921 of
the Public Health Service Act (as amended by section 3)) for
reporting health care errors to a patient safety organization.
(4) The applicant agrees to provide the Secretary with such
information as the Secretary may require regarding the use of
funds under this program or its impact.
(5) The applicant provides assurances satisfactory to the
Secretary that any information technology planned, acquired, or
implemented with grant funds under this section will be part of
an information program that--
(A) carries out the purposes described in subsection
(a); and
(B) is comprehensive or will be expanded to become
comprehensive, regardless of whether Federal assistance
is available for such expansion.
(d) Technical Assistance to Grantees.--The Secretary, acting through
the Director of the Agency for Healthcare Research and Quality, shall
provide technical assistance to applicants and grantees to ensure the
appropriate evaluation of the information technologies for which grants
are awarded under this section, such as--
(1) reviewing and providing technical assistance on the
applicant's proposed evaluation;
(2) developing mechanisms to ensure ongoing communications
between grantees and evaluators to facilitate the
identification and resolution of problems as they arise, ensure
mutual learning, and promote the rapid dissemination of
information;
(3) reviewing the interim and final reports required under
subsection (e); and
(4) disseminating evidence-based information in interim and
final reports to patient safety organizations, as appropriate.
(e) Evaluation Reports by Grantee.--A condition for the receipt of a
grant under subsection (a) is that the applicant agree to submit an
interim and a final report to the Secretary in accordance with this
subsection.
(1) Interim report.--Not later than 1 year after the
implementation of information technologies under the grant is
completed, the applicant will submit an interim report to the
Secretary describing the initial effectiveness of such
technologies in carrying out the purposes described in
subsection (a).
(2) Final report.--Not later than 3 years after the
implementation of information technologies under the grant is
completed, the applicant will submit a final report to the
Secretary describing the effectiveness and cost-effectiveness
of such technologies and addressing other issues determined to
be important in carrying out the purposes described in
subsection (a).
(3) Relation to disbursement of grant.--In disbursing a grant
under subsection (a), the Secretary shall withhold \1/3\ of the
grant until the grantee submits to the Secretary the report
required in paragraph (1).
(f) Reports by Secretary.--
(1) Interim reports.--
(A) In general.--Through the fiscal year preceding
the fiscal year in which the final report under
paragraph (2) is prepared, the Secretary shall submit
to the Committee on Energy and Commerce of the House of
Representatives and the Committee on Health, Education,
Labor, and Pensions of the Senate periodic reports on
the grant program under subsection (a). Such reports
shall be submitted not less frequently than once each
fiscal year, beginning with fiscal year 2004.
(B) Contents.--A report under subparagraph (A) shall
include information on--
(i) the number of grants made;
(ii) the nature of the projects for which
funding is provided under the grant program;
(iii) the geographic distribution of grant
recipients; and
(iv) such other matters as the Secretary
determines appropriate.
(2) Final report.--Not later than 180 days after the date on
which the last of the reports is due under subsection (e)(2),
the Secretary shall submit a final report to the committees
referred to in paragraph (1)(A) on the grant program under
subsection (a), together with such recommendations for
legislation and administrative action as the Secretary
determines appropriate.
(g) Definitions.--For purposes of this section:
(1) The term ``costs'', with respect to information
technologies referred to in subsection (a), includes total
expenditures incurred for--
(A) purchasing, leasing, and installing computer
software and hardware, including hand-held computer
technologies;
(B) making improvements to existing computer software
and hardware; and
(C) purchasing or leasing communications capabilities
necessary for clinical data access, storage, and
exchange.
(2) The term ``health care provider'' has the same meaning
given to the term ``provider'' in section 921 of the Public
Health Services Act (as amended by this Act).
(h) Termination of Grant Authorities.--The authority of the Secretary
to make grants under subsection (a) terminates upon the expiration of
fiscal year 2011.
(i) Matching Funds.--
(1) In general.--With respect to the costs of a grant to be
carried out under this section, such grant may be made only if
the applicant agrees to make available (directly or through
donations from public or private entities) non-Federal
contributions toward such costs in an amount that is not less
than 50 percent of such costs ($1 for each $1 of Federal funds
provided in the grant).
(2) Determination of amounts contributed.--Amounts provided
by the Federal Government, or services assisted or subsidized
to any significant extent by the Federal Government, may not be
included in determining the amount of such non-Federal
contributions.
SEC. 8. AUTHORIZATION OF APPROPRIATIONS FOR GRANTS UNDER SECTIONS 6 AND
7.
For the purpose of carrying out sections 6 and 7, there are
authorized to be appropriated $25,000,000 for each of fiscal years 2004
and 2005.
Purpose and Summary
H.R. 663 is intended to create a ``culture of safety'' by
providing peer review protections for information reported on
health care errors for the purpose of quality improvement and
patient safety.
Background and Need for Legislation
In its 1999 report, ``To Err Is Human,'' the Institute of
Medicine (IOM) estimated that 44,000 to 98,000 Americans die
each year as a result of medical errors; however, providers
have little to no incentive to report or analyze errors to
improve the quality of health care. The IOM offered several
recommendations to improve patient safety and reduce medical
errors, including that Congress pass legislation to extend peer
review protections to data related to patient safety and
quality improvement that are developed and analyzed by health
care organizations for internal use or share with others solely
for the purposes of improving safety and quality.
This bill is intended to encourage the reporting and
analysis of medical errors by providing peer review protection
of information reported to patient safety organizations for the
purposes of quality improvement and patient safety. These
protections will facilitate an environment in which health care
providers are able to discuss errors openly and learn from
them. The protections apply to certain categories of documents
and communications termed ``patient safety work product'' that
are developed in connection with newly created patient safety
organizations. This patient safety work product is considered
privileged and, therefore, cannot be subject to civil or
administrative proceedings, disclosed pursuant to the Freedom
of Information Act, or utilized to carry out an adverse
personnel action. Patient safety organizations will analyze
information reported from providers and disseminate information
back to providers in an effort to improve quality and patient
safety. It is intended that providers, with the assistance of
patient safety organizations, will determine the causes of
these errors, identify what changes need to be made in the
health care delivery system in order to prevent these errors,
and then implement these changes.
These new protections do not, however, prevent a provider
from complying with authorized requests for information that
has been developed, maintained, or which exists separately from
patient safety work product. In general, information that is
available to the public today will continue to be available;
only new information created for patient safety organizations
will be protected. Providers can also voluntarily disclose non-
identifiable information, and upon authorized request, they can
also disclose identifiable information for purposes of
improving safety and quality to entities required to comply
with the Health Insurance Portability and Accountability Act
(HIPAA). Violations of these provisions are subject to existing
penalties under the Public Health Service Act, including a
civil monetary penalty or penalties under HIPAA for violations
related to individually identifiable health information.
The Patient Safety and Quality Improvement Act requires the
Secretary of HHS to establish a national database to analyze
health care errors. The Secretary of HHS is also required to
develop and adopt voluntary national standards to promote the
compatibility of health information technology systems.
Finally, this bill creates grant programs for hospitals and
other health care providers for establishing electronic
prescribing programs and implementing information technologies.
These grants will allow physicians and other types of providers
who lack the necessary resources to adopt the latest
technologies that have been proven to significantly reduce the
incidence of medical errors.
Hearings
The Committee on Energy and Commerce has not held any
hearings on this legislation.
Committee Consideration
On Wednesday, February 12, 2003, the Full Committee on
Energy and Commerce met in open markup session and ordered H.R.
663 favorably reported to the House, as amended, by a voice
vote, a quorum being present.
Committee Votes
Clause 3(b) of rule XIII of the Rules of the House of
Representatives requires the Committee to list the record votes
on the motion to report legislation and amendments thereto.
There are no record votes taken in connection with ordering
H.R. 663 reported. A motion by Mr. Tauzin to order H.R. 663
reported to the House, as amended, was agreed to by a voice
vote.
Committee Oversight Findings
Pursuant to clause 3(c)(1) of rule XIII of the Rules of the
House of Representatives, the Committee has not held oversight
or legislative hearings on this legislation.
Statement of General Performance Goals and Objectives
The goal of H.R. 663 is to provide for a health care error
reporting system that both protects information and improves
patient safety and the quality of health care, and to ensure
accountability by raising standards and expectation for
continuous quality improvements in patient safety.
New Budget Authority, Entitlement Authority, and Tax Expenditures
In compliance with clause 3(c)(2) of rule XIII of the Rules
of the House of Representatives, the Committee finds that H.R.
663, the Patient Safety and Quality Improvement Act, would
result in no new or increased budget authority, or tax
expenditures or revenues.
Committee Cost Estimate
The Committee adopts as its own the cost estimate prepared
by the Director of the Congressional Budget Office pursuant to
section 402 of the Congressional Budget Act of 1974.
Congressional Budget Office Estimate
Pursuant to clause 3(c)(3) of rule XIII of the Rules of the
House of Representatives, the following is the cost estimate
provided by the Congressional Budget Office pursuant to section
402 of the Congressional Budget Act of 1974:
U.S. Congress,
Congressional Budget Office,
Washington, DC, March 3, 2003.
Hon. W.J. ``Billy'' Tauzin,
Chairman, Committee on Energy and Commerce,
House of Representatives, Washington, DC.
Dear Mr. Chairman: The Congressional Budget Office has
prepared the enclosed cost estimate for H.R. 663, the Patient
Safety and Quality Improvement Act.
If you wish further details on this estimate, we will be
pleased to provide them. The CBO staff contacts are Chris
Topoleski and Margaret Nowak.
Sincerely,
Douglas Holtz-Eakin.
Enclosure.
H.R 663--Patient Safety and Quality Improvement Act
Summary: H.R. 663 would require the Secretary of Health and
Human Services to establish credentialing procedures for
patient safety organizations (PSOs), which collect patient
safety data voluntarily submitted by health care providers for
inclusion in a patient safety database. The bill also would
establish privacy protections and impose civil monetary
penalties for violations of those protections. The Secretary
would be required to report to the Congress on effective
strategies for reducing medical errors and increasing patient
safety.
CBO estimates that implementing H.R. 663 would cost $20
million in 2004 and $104 million over the 2004-2008 period,
assuming the appropriation of the necessary amounts. CBO
estimates that receipts from fines for violation of the privacy
protections would amount to less than $500,000 a year.
The bill would require the Secretary of Health and Human
Services to develop methodologies for the collection of patient
safety data and provide technical assistance to PSOs and
states. In addition, the Secretary would, with the National
Committee for Vital and Health Statistics, develop voluntary
national standards that promote the comparability of medical
information technology systems.
H.R. 663 would authorize grants to qualified practitioners
for the purpose of establishing electronic prescription
programs, and would authorize the Health Resources and Services
Administration (HRSA) to make grants to hospitals and other
health care providers for acquiring or implementing information
technologies. The bill would require the inclusion of a unique
product identifier on packaging of a drug or biological product
that is subject to regulation by the Food and Drug
Administration (FDA). Drugs and biological products that do not
comply with FDA's labeling requirements would be deemed
misbranded, and their manufacturers and packagers would be
subject to civil penalties.
H.R. 663 would preempt state laws that would govern the
disclosure of information provided to patient safety
organizations, and it would prevent health care providers from
taking certain actions against employees because the employee
provided information to patient safety organizations. While
these provisions would be intergovernmental mandates as defined
in the Unfunded Mandates Reform Act (UMRA), they would impose
no requirements on states that would result in additional
spending; thus, the threshold as established by UMRA would not
be exceeded ($59 million in 2003, adjusted annually for
inflation).
The bill would impose private-sector mandates, as defined
in UMRA, on health care providers and on manufacturers,
packagers, and labelers of drugs and biological products.
Because the specific requirements of the bill would depend on
future actions by the Secretary of Health and Human Services,
however, CBO cannot determine whether the direct cost of the
mandates would exceed the annual threshold specified in UMRA
($117 million in 2003, adjusted annually for inflation).
Estimated cost to the federal government: The estimated
cost of H.R. 663 is shown in the following table. The bill
could also result in an increase in revenues from fines, but
CBO estimates that any such increase would be less than
$500,000 a year. The costs of this legislation fall within
budget function 550 (health).
----------------------------------------------------------------------------------------------------------------
By fiscal year, in millions of dollars--
------------------------------------------------------
2004 2005 2006 2007 2008
----------------------------------------------------------------------------------------------------------------
CHANGES IN SPENDING SUBJECT TO APPROPRIATION
Estimated Authorization Level............................ 39 38 13 13 13
Estimated Outlays........................................ 20 39 20 13 13
----------------------------------------------------------------------------------------------------------------
Basis of estimate
Spending subject to appropriation
H.R. 663 would expand the current duties of the Agency for
Healthcare Research and Quality (AHRQ). Although not
specifically named, the AHRQ is the most likely and appropriate
agency within the Department of Health and Human Services to
carry out theprovisions of the bill. The new duties would
include providing technical assistance to states that have (or are
developing) systems for reporting medical errors. AHRQ also would
oversee the certification and recertification of PSOs, which collect
patient safety data from health care providers. (PSOs are private or
public organizations that conduct activities to improve patient safety
and the quality of health care delivery.) PSOs would not receive
funding under this bill.
In addition, the bill would require AHRQ to establish a
patient safety database to collect, support, and coordinate the
analysis of patient safety data that is reported on a voluntary
basis. AHRQ also would develop an Internet-based mathematical
model that simulates the cost and effectiveness of electronic
prescription programs. Based on information from AHRQ, CBO
expects that these tasks would require increased staff for
providing assistance to states, oversight of PSOs, and
collection and maintenance of the patient safety database. They
would also require additional computer resources for the
database. CBO estimates that the agency would need additional
appropriations of $14 million in 2004 and $64 million over the
2004-2008 period to carry out these responsibilities. We
estimate that outlays would total $54 million over the 2004-
2008 period, assuming the necessary amounts are appropriated.
In 2004, we estimate that the agency would spend about $5
million, primarily on developing and maintaining the patient
safety database.
The bill would require the Secretary to provide scientific
support to PSOs and to develop methodologies for collecting
data on patient safety. In addition, H.R. 663 would require the
Secretary to develop voluntary, national standards that promote
the compatibility of health care information technology systems
across all health care settings. CBO estimates that these
efforts would cost less than $500,000 a year.
H.R. 663 would allow the Secretary to make grants to
qualified practitioners for the purpose of establishing
electronic prescription programs. AHRQ would conduct a study
and report to the Congress on the effectiveness of electronic
prescription programs. HRSA would make grants available to
hospitals and other health care providers for acquisition or
implementation of information technology systems.
CBO assumes that grants would be awarded starting in 2004.
The bill would authorize appropriations for these grants at $25
million in fiscal year 2004 and $50 million over the 2004-2008
period. Based on historical spending patterns for similar
activities, CBO estimates that outlays would total $50 million
over the 2004-2008 period, assuming appropriation of the
authorized amounts.
The bill would require the inclusion of a unique product
identifier on packaging of a drug or biological product that is
subject to regulation by the Food and Drug Administration. This
provision would cost the FDA less than $500,000 per year to
implement.
Revenues
Because those prosecuted and convicted for violation of the
bill's privacy provisions could be subject to civil monetary
penalties, the federal government might collect additional
fines if the bill is enacted. Drugs and biological products
that do not comply with FDA's labeling requirements would be
deemed misbranded, and their manufacturers and packagers would
be subject to civil penalties. Collection of civil fines are
recorded in the budget as governmental receipts (i.e.,
revenues). CBO estimates that any additional receipts would be
less than $500,000 a year.
Estimated impact on state, local, and tribal governments:
H.R. 663 would preempt any state freedom of information law or
other laws governing civil or administrative procedure that
would require the disclosure of information provided by a
health care provider to a certified patient safety
organization. This preemption would be an intergovernmental
mandate as defined in UMRA because it would limit the
application of those state laws. Another intergovernmental
mandate in the bill would prohibit health care providers
(including public entities) from using the fact that an
employee reported patient safety data in an adverse employment
action against the employee. CBO estimates that these mandates
would impose no requirements on states that would result in
additional spending; thus, the threshold as established by UMRA
would not be exceeded ($59 million in 2003, adjusted annually
for inflation).
Estimated impact on the private sector: The bill contains
private-sector mandates, as defined in UMRA, on manufacturers,
packagers, and labelers of drugs and biological products and on
health care providers. Because the specific requirements of the
bill would depend on the future actions of the Secretary of
Health and Human Services, however, CBO cannot determine
whether the direct cost of the mandates would exceed the annual
threshold specified in UMRA ($117 million in 2003, adjusted
annually for inflation).
Under the bill, manufacturers, packagers, and labelers
would be required to include a computer-scannable unique
product identifier on the packaging of drugs and biological
products. Many drug products are currently labeled with such
identifiers, but many are not. Of the approximately 200,000
over-the-counter and prescription drug products currently on
the market, over one quarter are over-the-counter drugs--nearly
all of which already contain universal product codes at the
shelf-keeping unit level. In addition, a growing percentage of
prescription drugs administered in hospitals are labeled with
computer-scannable unique product identifiers. It is unclear
whether existing identifiers would meet the requirements of the
Secretary.
Adding unique product identifiers would impose costs for
products that do not now contain them, and potentially for
products that already contain similar information. Under the
bill, the Secretary would determine how much standardization of
identifiers would be required. The Secretary also would
determine what information would have to be included on the
identifiers. If identifiers were required to include only the
National Drug Code associated with that product, for example,
industry costs would be lower than if the identifiers also had
to include the lot number and expiration date of the product.
The specific details of the requirements imposed by the
Secretary, including how quickly the new requirements would
have to be implemented, would determine whether the cost of
this mandate would exceed the threshold specified in UMRA.
The bill also would impose a mandate on health care
providers, by not allowing them to use the fact that an
employee reported patient safety data in an adverse employment
action against the employee. This mandate would not have any
direct cost, however, because there are no activities that
health care providers would undertake under current law that
they would be prohibited from undertaking under the bill
(because patient safety data, as defined in the bill, do not
exist under current law).
Estimate prepared by: Federal revenues and outlays: Alexis
Ahlstrom, Julia Christensen, Margaret Nowak, and Chris
Topoleski; impact on state, local, and tribal governments: Leo
Lex; impact on the private sector: Dan Wilmoth.
Estimate approved by: Peter H. Fontaine, Deputy Assistant
Director for Budget Analysis.
Federal Mandates Statement
The Committee adopts as its own the estimate of Federal
mandates prepared by the Director of the Congressional Budget
Office pursuant to section 423 of the Unfunded Mandates Reform
Act.
Advisory Committee Statement
No advisory committees within the meaning of section 5(b)
of the Federal Advisory Committee Act were created by this
legislation.
Constitutional Authority Statement
Pursuant to clause 3(d)(1) of rule XIII of the Rules of the
House of Representatives, the Committee finds that the
Constitutional authority for this legislation is provided in
Article I, section 8, clause 3, which grants Congress the power
to regulate commerce with foreign nations, among the several
States, and with the Indian tribes.
Applicability to Legislative Branch
The Committee finds that the legislation does not relate to
the terms and conditions of employment or access to public
services or accommodations with the meaning of section
102(b)(3) of the Congressional Accountability Act.
Section-by-Section Analysis of the Legislation
Section 1. Short title
Section 1 establishes the short title as the Patient Safety
and Quality Improvement Act.
Section 2. Findings and purposes
Section 2. sets out a number of findings and purposes
related to patient safety and initiatives to improve patient
safety.
Section 3. Amendments to Public Health Service Act
Section 3 would establish a new Part C in Title IX of the
Public Health Service Act to encourage a voluntary reporting
system for patient safety data as set out below.
Section 921. Definitions
The bill would add a new section 921 to identify and define
the elements of a new voluntary reporting system, including the
terms ``identifiable information,'' ``non-identifiable
information,'' ``patient safety evaluation system,'' ``patient
safety organization,'' ``patient safety work product,'' and
``provider.''
Identifiable information is defined as information that
reveals the patient, individual provider, and/or the provider
organization. With respect to patients, the term includes
individually identifiable health information as defined in the
Health Insurance Portability and Accountability Act of 1996
(HIPAA). Non-identifiable information includes de-identified
patient level information as specified in HIPAA as well as
information that does not reveal the individual provider or
provider organization.
A patient safety organization is defined as requiring a
certification under new section 925. Once a certification of a
patient safety organization is provided by a state or federal
governmental organization, a provider may rely on that
certification with respect to privileges available for patient
safety work product. The activities listed in the definition
are general categories of activities or functions the patient
safety organization is required to perform in order to receive
a safety and quality; (2) the collection and analysis of
information submitted by providers; (3) the development and
dissemination of recommendations, protocols, or best practices;
(4) the utilization of reported information limited to the
activities described; (5) the maintenance of confidentially
with respect to individually-identifiable information; (6) the
provision of appropriate security measures with respect to
reported information; and, (7) the submission of non-
identifiable information to the Agency for Health Research and
Quality consistent with standard established by the Secretary
for any National Patient Safety Database.
The definition of patient safety work product contains
several parts, and a document or communication is patient
safety work product if it fall into any of the categories in
clauses (5)(A)(i)-(iii). A document may be patient safety work
product for multiple reasons. For example, a patient safety
organization may prepare a memorandum describing its request
for further collection of information from the reporting
provider. The memorandum of the patient safety organization is
both a document created by the patient safety organization and
a document that would reveal the deliberations or analytic
process of a patient safety evaluation system. Any memorandum
of the provider that reveals the deliberations or analytic
process of a patient safety evaluation system would also be
patient safety work product.
Subparagraph 5(B) explains documents or communications that
are not covered under clause (5)(A)(i). The Committee
understands that it is likely and appropriate for a provider to
keep a copy of documents and possible logs of communications
under (5)(A)(i) that are reported to the patient safety
organization. Generally, such copies are also patient safety
work product.
On the other hand, there may be documents or communications
that are part of traditional medical record keeping (such as
patients' medical records, billing records, guidance and
procedures, hospital policies, logs of operations, records of
drug deliveries, primary information on the time of events),
all of which may be sent to a patient safety organization, but
the originals or copies of such documents are developed
maintained or exist separately from any patient safety
evaluation system. These documents may be relevant to a patient
safety evaluation system but also are available for other
purposes and are not covered under 5(A)(i). In such
circumstances, such documents or communications at the provider
are not patient safety work product.
Section 922. Privilege for patient safety work product
New section 922 creates a privilege for patient safety work
product. The owner of the privilege may not be coerced into
waiving such privilege.
New paragraph 922(a)(5) sets out some points with respect
to the possibility that a patient safety organization is a
component of a national accreditation organization. This
paragraph is essentially a clarification of some general rules
elsewhere in the Act that require patient safety organizations
that are components to maintain patient safety work product
separately from the rest of the organization. The paragraph
also clarifies that no one may coerce a provider into
contracting with or reporting to a patient safety organization.
Contracting with a patient safety organization must at all
times be a voluntary decision on the part of a provider.
Subsection 922(b) sets out protections for individuals who
report information to providers, with the intent that the
information is reported to a patient safety organization, or
who report directly to a patient safety organization. A
provider may not use the fact that an individual reported
against the individual in any adverse employment action. An
adverse employment action includes traditional actions such as
firing the individual. The term also includes other adverse
actions, such as a failure to promote an individual, an adverse
evaluation, or any adverse accreditation, licensing, or
certification decision.
Subsection 922(c) states that nothing in this section
prohibits any of a number of categories of disclosures. Under
new paragraph 922(c)(2), nothing in the section prohibits the
voluntary disclosure of identifiable information by a provider
or patient safety organization provided such disclosure meets 3
tests. First, the provider must authorize the disclosure for
the purposes of improving quality and safety. The term
improving quality and safety can also include voluntarily
providing useful information for improving quality and safety
through accreditation systems. Second, under subparagraph
922(c)(2), such voluntary disclosure must be an entity or
person subject to the requirements of section 264(c) of HIPAA,
or any regulations promulgated under that section. Finally, the
disclosure must not be in conflict with such section or any
regulation promulgated under such section of HIPAA.
The Committee intends this approach to ensure that
individually identifiable health information as that term is
used under regulations under section 264(c) of HIPAA remain
subject to those provisions and that nothing in the new law
removes any confidentiality protection otherwise available for
individually identifiable health information of patients.
Voluntary disclosure of non-identifiable information in
patient safety work product is always allowable and does not
itself, under subsection 992(d), waive any privilege.
Subsection 922(d) sets out that the privilege is not waived
based on disclosures listed in the subsection. The Committee
understands that non-identifiable information may be
voluntarily disclosed and subsequently incorporated in other
publicly available documents or studies. Those subsequent
documents or studied are not the subject of the privilege under
this section because they are publicly available and involve
voluntary disclosure.
Subsection (e) sets out a penalty for disclosures of
patient safety work product in violation of section 922, if
such disclosure constitutes a negligent or knowing breach of
confidentiality.
The protections of enforcement provisions of HIPAA and
ensuring regulations continue to apply. Where a party would be
subject to sanctions under the HIPAA scheme, those sanctions
are exclusive for the same disclosure. The new penalty
provisions in new section 992(e) would not apply. In addition,
the new penalty only applies to the first person who breaches
confidentiality with respect to particular patient safety work
product.
New subsection 922(f) deems that a patient safety
organization shall be treated as a business associate for
purposes of section 264(c) of HIPAA. The activities of such
organization described in section 921(4) are deemed to be
health care operations of the provider. Other than on these two
points, nothing alters or effects the implementation of section
264(c) of HIPAA or regulations under section 264(c).
New subsection 922(g) is a savings clause for privileges,
including peer-review and confidentiality protections that are
otherwise available under Federal or State laws.
New subsection 922(h) is also a savings clause. Providers
and patient safety organizations can enter contracts that
increase confidentiality or restrict the use of information for
purposes of the relationship between the contracting parties,
so long as the contracts do not conflict with this Act or any
other laws. Parties may, by contract, delegate the authority to
make an authorized disclosure that is otherwise permissible
under the Act.
New subsection 922(i) is a savings clause concerning state
reporting requirements. State reporting requirements cannot
require reporting of patient safety work product but can
require reporting of primary medical information and other
documents or communications that are not patient safety work
product. Such reporting requirements may even require providers
to produce reports that are similar in basic function to
reports being provided to a patient safety organization.
However, patient safety work product itself, as defined in this
Act, remains privileged.
New subsection 922(j) explains that patient safety work
product remains privileged and confidential, in accordance with
this section, even where a patient safety organization has its
certification terminated or revoked or otherwise ceases to
qualify as a patient safety organization.
New subsection 922(k) requires the Secretary to provide a
report on effective strategies for reducing medical errors and
increasing patient safety, including any appropriate measures
to encourage the use of these strategies in federally funded
programs.
Section 923. National database
New section 923 requires the Secretary to: (1) establish a
National Patient Safety Database to collect reported, non-
identifiable information concerning patient safety; (2) analyze
national and regional statistics on health care errors; (3)
offer technical assistance to patient safety organizations
including dissemination of methodologies and evidence-based
information on quality improvement; and, (4) establish
commonformats for reporting data to the National Patient Safety
Database in consultation with representatives from patient safety
organizations, the provider community, and health care information
technology industry. The Secretary would also be permitted to enter
into contracts with private and public entities to administer the
Database. The database will contain only non-identifiable information
that precludes the identification of any provider, patient, or reporter
of the information. Identifiable information will not be transferred to
the database. The Secretary will ensure that methods of data collection
recommended by the interagency Patient Safety Task Force in the
Department of Health and Human Services are utilized in effort to
maximize the efficiency and utility of common data collection efforts
across agencies. If feasible, the Secretary will also facilitate a
direct link between patient safety organizations and the National
Patient Safety Database to allow for real time exchange of non-
identifiable information. There are authorized to be appropriated such
sums as may be necessary for each fiscal year to carry out this
section.
Section 924. Technical assistance
New section 924 states that the Secretary may provide
technical assistance to patient safety organizations and states
with reporting systems and may provide guidance on the type of
data to submit to the National Patient Safety Database. This
assistance may include annual meetings to share methods and any
concerns regarding confidentiality.
Section 925. Certification of patient safety organizations
New section 925 requires the Secretary to set up a process
for certification of patient safety organizations that includes
a number of elements. Certifications must be performed by the
Secretary or by state or federal governmental organizations
that have been approved by the Secretary. Certifications must
be reviewed by the appropriate certifying organization every
three years. The certifying organization has the authority to
revoke certifications upon a showing of cause.
New subsection 925(c) sets out criteria a patient safety
organization must meet as conditions of certification.
Paragraph 925(c)(5) states that the mission of a patient safety
organization must be to conduct activities to improve quality
and safety and must not create a conflict of interest with the
providers contracting with it. A patient safety organization
must be managed, controlled, and operated independently from
any provider that contracts with the patient safety
organization for reporting patient safety work product. Patient
safety organizations may not, for example, be subsidiaries or
partners of providers that contract with them. The contract
hiring the patient safety organization, terms therein, or
requests for analyses do not form a basis for a violation of
this paragraph. It is not the intent of the Committee to
disqualify a patient safety organization that meets the
independence requirements and is established by a broader-based
alliance or organization of providers in which no single or
subset of providers can influence (through ownership or other
interest) the policies or activities of the alliance or
organization or of the patient safety organization.
New paragraph 925(d) sets out certain additional
requirements for patient safety organizations that are
components of other organizations. For example, the patient
safety component must maintain patient safety work product
separately from the rest of the organization and establish
appropriate security measures to safeguard the confidentiality
of the patient safety work product. Also, the mission of the
patient safety component must not create a conflict of interest
with the rest of the organization.
Section 4. Promoting the diffusion and interoperability of health care
information technology systems involved with health care
delivery
Section 4 requires the Secretary within 18 months of
enactment to develop or adopt (and periodically review and
update) voluntary, national standards that promote the
interoperability of health care information technology systems
across all health care settings, including but not limited to
computer physician order entry. The Secretary must take into
account (1) the ability of the standards to promote the
aggregation of clinical data, electronic exchange of medical
records, and evidence based medicine and (2) the costs to the
health care system and any efficiencies that result from the
adoption of these standards. These standards would be developed
with consideration of reports and opinions of the National
Committee for Vital and Health Statistics and in consultation
with health information technology industry and providers. The
Secretary is required to report to Congress on the
interoperability standards but there is no requirement to issue
regulations. The Secretary, to the extent practicable, shall
test the efficiency, usability, and scalability of proposed
interoperability standards within a variety of clinical
settings, including an urban academic medical center, a rural
hospital, a community health center, and a community hospital.
It is the intent of the Committee that this testing would
demonstrate the effectiveness of the voluntary national
standards and encourage industry to comply with them.
Section 5. Required use of product identification technology
Section 5 amends the Federal Food, Drug, and Cosmetic Act
by adding to section 510 a requirement for the Secretary to
issue regulations for unique product identification for drug
and biological products. These regulations would require
manufacturers and entities that label and package drugs and
biological products to use unique product identifiers on the
packaging of each product. This includes bar codes that can be
read by scanners and other unique identifiers that can be read
through other technologies as deemed acceptable by the
Secretary. Identifiers will be based on the national Drug Code
or other standards that are either commercially acceptable or
deemed appropriate by the Secretary. The Secretary will have
the authority to waive these regulatory requirements or add
provisions in order to safeguard the public health.
Under this section, the FFDCA is also amended by adding to
section 502 that a drug or biological product without a unique
product identifier, as required by regulations under section
510, is considered misbranded.
Section 6. Grants for electronic prescribing
Section 6 would make grants available to physicians and
other health care professionals licensed to prescribe
prescription drugs for technology or services necessary to
establish electronic prescription programs in their practices.
Grantees would have to fund 50 percent of the cost of the
electronic prescription program in order to receive a grant.
Under this section, the Agency for Healthcare Research and
Quality would conduct a study of the cost-effectiveness of
electronic prescription programs based on the available
scientific evidence. the study would evaluate (1) effectiveness
of electronic prescribing in reducing medical errors, (2)
strategies used to overcome barriers to electronic prescribing,
and, (3) the impact of electronic prescribing on physicians,
pharmacists, and patients. A report would be presented to
Congress within 18 months of enactment and made available to
relevant public and private entities.
Under this section, the Agency would also be allowed to
develop an Internet-based decision analytic model to allow
prescribing clinicians to simulate the health and economic
impact of electronic prescribing on their individual practices.
This model would assist clinicians in making informed decisions
regarding the use of electronic prescription programs.
Section 7. Grants for hospitals and other health care providers for
information technologies
Under section 7, matching grants would be available to
hospitals and other health care providers who apply to obtain
new or improved computer hardware and software for the purposes
of improving patient safety, health care quality, and reducing
adverse events and health care complications resulting from
medication errors. Grants would cover 50 percent of the costs
of information technologies and would only be available once to
grantees. Grantees would be required to measure, analyze, and
report the effect of the information technologies on medical
errors. Interim and final reports would be required at 1 and 3
years, respectively. The final \1/3\ of each grant would not be
disbursed until the grantee submitted the interim report at 1
year. Any sums necessary for this grant program would be
authorized for appropriations until 2011.
Section 8. Grants for hospitals and other health care providers for
information technologies
Section 8 authorizes $25,000,000 to be appropriated for
each of fiscal years 2004 and 2005 for the purpose of carrying
out sections 6 and 7.
Changes in Existing Law Made by the Bill, as Reported
In compliance with clause 3(e) of rule XIII of the Rules of
the House of Representatives, changes in existing law made by
the bill, as reported, are shown as follows (existing law
proposed to be omitted is enclosed in black brackets, new
matter is printed in italic, existing law in which no change is
proposed is shown in roman):
TITLE IX OF THE PUBLIC HEALTH SERVICE ACT
TITLE IX--AGENCY FOR HEALTHCARE RESEARCH AND QUALITY
* * * * * * *
PART B--HEALTH CARE IMPROVEMENT RESEARCH
* * * * * * *
SEC. 912. PRIVATE-PUBLIC PARTNERSHIPS TO IMPROVE ORGANIZATION AND
DELIVERY.
(a) * * *
* * * * * * *
(c) Reducing Errors in Medicine.--The Director shall, in
accordance with part C, conduct and support research and build
private-public partnerships to--
(1) * * *
* * * * * * *
PART C--PATIENT SAFETY IMPROVEMENT
SEC. 921. DEFINITIONS.
In this part:
(1) Identifiable information.--The term
``identifiable information'' means information that is
presented in a form and manner that allows the
identification of any provider, patient, or reporter of
patient safety work product. With respect to patients,
such information includes any individually identifiable
health information as that term is defined in the
regulations promulgated pursuant to section 264(c) of
the Health Insurance Portability and Accountability Act
of 1996 (Public Law 104-191; 110 Stat. 2033).
(2) Nonidentifiable information.--The term
``nonidentifiable information'' means information that
is presented in a form and manner that prevents the
identification of any provider, patient, or reporter of
patient safety work product. With respect to patients,
such information must be de-identified consistent with
the regulations promulgated pursuant to section 264(c)
of the Health Insurance Portability and Accountability
Act of 1996 (Public Law 104-191; 110 Stat. 2033).
(3) Patient safety evaluation system.--The term
``patient safety evaluation system'' means a process
that involves the collection, management, or analysis
of information for submission to or by a patient safety
organization.
(4) Patient safety organization.--The term ``patient
safety organization'' means a private or public
organization or component thereof that is certified,
through a process to be determined by the Secretary
under section 925, to perform each of the following
activities:
(A) The conduct, as the organization or
component's primary activity, of efforts to
improve patient safety and the quality of
health care delivery.
(B) The collection and analysis of patient
safety work product that is submitted by
providers.
(C) The development and dissemination of
evidence-based information to providers with
respect to improving patient safety, such as
recommendations, protocols, or information
regarding best practices.
(D) The utilization of patient safety work
product to carry out activities limited to
those described under this paragraph and for
the purposes of encouraging a culture of safety
and of providing direct feedback and assistance
to providers to effectively minimize patient
risk.
(E) The maintenance of confidentiality with
respect to identifiable information.
(F) The provision of appropriate security
measures with respect to patient safety work
product.
(G) The submission of nonidentifiable
information to the Agency consistent with
standards established by the Secretary under
section 923(b) for any National Patient Safety
Database.
(5) Patient safety work product.--
(A) The term ``patient safety work product''
means any document or communication (including
any information, report, record, memorandum,
analysis, deliberative work, statement, or root
cause analysis) that--
(i) except as provided in
subparagraph (B), is developed by a
provider for the purpose of reporting
to a patient safety organization, and
is reported to a patient safety
organization;
(ii) is created by a patient safety
organization; or
(iii) would reveal the deliberations
or analytic process of a patient safety
evaluation system (as defined in
paragraph (3)).
(B)(i) Patient safety work product described
in subparagraph (A)(i)--
(I) does not include any separate
information described in clause (ii);
and
(II) shall not be construed to
include such separate information
merely by reason of inclusion of a copy
of the document or communication
involved in a submission to, or the
fact of submission of such a copy to, a
patient safety organization.
(ii) Separate information described in this
clause is a document or communication
(including a patient's medical record or any
other patient or hospital record) that is
developed or maintained, or exists, separately
from any patient safety evaluation system.
(C) Information available from sources other
than a patient safety work product under this
section may be discovered or admitted in a
civil or administrative proceeding, if
discoverable or admissible under applicable
law.
(6) Provider.--The term ``provider'' means--
(A) an individual or entity licensed or
otherwise authorized under State law to provide
health care services, including--
(i) a hospital, nursing facility,
comprehensive outpatient rehabilitation
facility, home health agency, and
hospice program;
(ii) a physician, physician
assistant, nurse practitioner, clinical
nurse specialist, certified nurse
midwife, psychologist, certified social
worker, registered dietitian or
nutrition professional, physical or
occupational therapist, or other
individual health care practitioner;
(iii) a pharmacist; and
(iv) a renal dialysis facility,
ambulatory surgical center, pharmacy,
physician or health care practitioner's
office, long-term care facility,
behavioral health residential treatment
facility, clinical laboratory, or
community health center; or
(B) any other person or entity specified in
regulations by the Secretary after public
notice and comment.
SEC. 922. PRIVILEGE FOR PATIENT SAFETY WORK PRODUCT.
(a) Privilege.--Notwithstanding any other provision of law
and subject to subsection (c), patient safety work product
shall not be--
(1) subject to a civil or administrative subpoena or
order;
(2) subject to discovery in connection with a civil
or administrative proceeding;
(3) subject to disclosure pursuant to section 552 of
title 5, United States Code (commonly known as the
Freedom of Information Act), or any other similar
Federal or State law;
(4) required to be admitted as evidence or otherwise
disclosed in any State or Federal civil or
administrative proceeding; or
(5) if the patient safety work product is
identifiable information and is received by a national
accreditation organization in its capacity as a patient
safety organization--
(A) used by a national accreditation
organization in an accreditation action against
the provider that reported the information;
(B) shared by such organization with its
survey team; or
(C) required as a condition of accreditation
by a national accreditation association.
(b) Reporter Protection.--
(1) In general.--A provider may not use against an
individual in an adverse employment action described in
paragraph (2) the fact that the individual in good
faith reported information--
(A) to the provider with the intention of
having the information reported to a patient
safety organization; or
(B) directly to a patient safety
organization.
(2) Adverse employment action.--For purposes of this
subsection, an ``adverse employment action'' includes--
(A) the failure to promote an individual or
provide any other employment-related benefit
for which the individual would otherwise be
eligible;
(B) an adverse evaluation or decision made in
relation to accreditation, certification,
credentialing, or licensing of the individual;
and
(C) a personnel action that is adverse to the
individual concerned.
(3) Remedies.--Any provider that violates this
subsection shall be subject to a civil monetary penalty
of not more than $20,000 for each such violation
involved. Such penalty shall be imposed and collected
in the same manner as civil money penalties under
subsection (a) of section 1128A of the Social Security
Act are imposed and collected.
(c) Disclosures.--Nothing in this section prohibits any of
the following disclosures:
(1) Voluntary disclosure of nonidentifiable
information.
(2) Voluntary disclosure of identifiable information
by a provider or patient safety organization, if such
disclosure--
(A) is authorized by the provider for the
purposes of improving quality and safety;
(B) is to an entity or person subject to the
requirements of section 264(c) of the Health
Insurance Portability and Accountability Act of
1996 (Public Law 104-191; 110 Stat. 2033), or
any regulation promulgated under such section;
and
(C) is not in conflict with such section or
any regulation promulgated under such section.
(3) Disclosure as required by law by a provider to
the Food and Drug Administration, or on a voluntary
basis by a provider to a federally established patient
safety program, with respect to an Administration-
regulated product or activity for which that entity has
responsibility, for the purposes of activities related
to the quality, safety, or effectiveness of such
Administration-regulated product or activity.
(4) Disclosures of patient safety work product in
accordance with this part by a provider to a patient
safety organization.
(d) Effect of Transfer, Disclosure.--The following shall not
be treated as a waiver of any privilege or protection
established under this part:
(1) The transfer of any patient safety work product
between a provider and a patient safety organization.
(2) Disclosure of patient safety work product as
described in subsection (c).
(3) The unauthorized disclosure of patient safety
work product.
(e) Penalty.--
(1) Prohibition.--Except as provided in this part,
and subject to paragraphs (2) and (4), it shall be
unlawful for any person to disclose patient safety work
product in violation of this section, if such
disclosure constitutes a negligent or knowing breach of
confidentiality.
(2) Relation to HIPAA.--The penalty under paragraph
(3) for a disclosure in violation of paragraph (1) does
not apply if the person would be subject to a penalty
under section 264(c) of the Health Insurance
Portability and Accountability Act of 1996 (Public Law
104-191; 110 Stat. 2033), or any regulation promulgated
under such section, for the same disclosure.
(3) Amount.--Any person who violates paragraph (1)
shall be subject to a civil monetary penalty of not
more than $10,000 for each such violation involved.
Such penalty shall be imposed and collected in the same
manner as civil money penalties under subsection (a) of
section 1128A of the Social Security Act are imposed
and collected.
(4) Subsequent disclosure.--Paragraph (1) applies
only to the first person that breaches confidentiality
with respect to particular patient safety work product.
(f) Relation to HIPAA.--
(1) In general.--For purposes of applying the
regulations promulgated pursuant to section 264(c) of
the Health Insurance Portability and Accountability Act
of 1996 (Public Law 104-191; 110 Stat. 2033)--
(A) patient safety organizations shall be
treated as business associates; and
(B) activities of such organizations
described in section 921(4) in relation to a
provider are deemed to be health care
operations (as defined in such regulations) of
the provider.
(2) Rule of construction.--Nothing in this section
shall be construed to alter or affect the
implementation of such regulations or such section
264(c).
(g) No Limitation of Other Privileges.--Nothing in this
section shall be construed to affect privileges, including peer
review and confidentiality protections, that are otherwise
available under Federal or State laws.
(h) No Limitation on Contracts.--Nothing in this section
shall be construed to limit the power of a provider and a
patient safety organization, or a patient safety organization
and the Agency or any National Patient Safety Database,
consistent with the provisions of this Act and other applicable
law, to enter into a contract requiring greater confidentiality
or delegating authority to make an authorized disclosure.
(i) Relation to State Reporting Requirements.--Nothing in
this part shall be construed as preempting or otherwise
affecting any State law requiring a provider to report
information, including information described in section
921(5)(B), that is not patient safety work product.
(j) Continuation of Privilege.--Patient safety work product
of an organization that is certified as a patient safety
organization shall continue to be privileged and confidential,
in accordance with this section, if the organization's
certification is terminated or revoked or if the organization
otherwise ceases to qualify as a patient safety organization.
(k) Reports on Strategies To Improve Patient Safety.--
(1) Draft report.--Not later than the date that is 18
months after any National Patient Safety Database is
operational, the Secretary, in consultation with the
Director, shall prepare a draft report on effective
strategies for reducing medical errors and increasing
patient safety. The draft report shall include any
measure determined appropriate by the Secretary to
encourage the appropriate use of such strategies,
including use in any federally funded programs. The
Secretary shall make the draft report available for
public comment and submit the draft report to the
Institute of Medicine for review.
(2) Final report.--Not later than 1 year after the
date described in paragraph (1), the Secretary shall
submit a final report to the Congress that includes, in
an appendix, any findings by the Institute of Medicine
concerning research on the strategies discussed in the
draft report and any modifications made by the
Secretary based on such findings.
SEC. 923. NATIONAL DATABASE.
(a) Authority.--
(1) In general.--In conducting activities under this
part, the Secretary shall provide for the establishment
and maintenance of a database to receive relevant
nonidentifiable patient safety work product, and may
designate entities to collect relevant nonidentifiable
patient safety work product that is voluntarily
reported by patient safety organizations upon the
request of the Secretary. Any database established or
designated under this paragraph may be referred to as a
``National Patient Safety Database''.
(2) Use of information.--Information reported to any
National Patient Safety Database shall be used to
analyze national and regional statistics, including
trends and patterns of health care errors. The
information resulting from such analyses may be
included in the annual quality reports prepared under
section 913(b)(2).
(3) Advisory role.--The Secretary shall provide
scientific support to patient safety organizations,
including the dissemination of methodologies and
evidence-based information related to root causes and
quality improvement.
(b) Standards.--In establishing or designating a database
under subsection (a)(1), the Secretary shall, in consultation
with representatives of patient safety organizations, the
provider community, and the health information technology
industry, determine common formats for the voluntary reporting
of nonidentifiable patient safety work product, including
necessary elements, common and consistent definitions, and a
standardized computer interface for the processing of the work
product. To the extent practicable, such standards shall be
consistent with the administrative simplification provisions of
part C of title XI of the Social Security Act.
(c) Certain Methodologies for Collection.--The Secretary
shall ensure that the methodologies for the collection of
nonidentifiable patient safety work product for any National
Patient Safety Database include the methodologies developed or
recommended by the Patient Safety Task Force of the Department
of Health and Human Services.
(d) Facilitation of Information Exchange.--To the extent
practicable, the Secretary may facilitate the direct link of
information between providers and patient safety organizations
and between patient safety organizations and any National
Patient Safety Database.
(e) Restriction on Transfer.--Only nonidentifiable
information may be transferred to any National Patient Safety
Database.
SEC. 924. TECHNICAL ASSISTANCE.
(a) In General.--The Secretary, acting through the Director,
may--
(1) provide technical assistance to patient safety
organizations, and to States with reporting systems for
health care errors; and
(2) provide guidance on the type of data to be
voluntarily submitted to any National Patient Safety
Database.
(b) Annual Meetings.--Assistance provided under subsection
(a) may include annual meetings for patient safety
organizations to discuss methodology, communication,
information collection, or privacy concerns.
SEC. 925. CERTIFICATION OF PATIENT SAFETY ORGANIZATIONS.
(a) In General.--Not later than 6 months after the date of
enactment of the Patient Safety and Quality Improvement Act,
the Secretary shall establish a process for certifying patient
safety organizations.
(b) Process.--The process established under subsection (a)
shall include the following:
(1) Certification of patient safety organizations by
the Secretary or by such other national or State
governmental organizations as the Secretary determines
appropriate.
(2) If the Secretary allows other governmental
organizations to certify patient safety organizations
under paragraph (1), the Secretary shall establish a
process for approving such organizations. Any such
approved organization shall conduct certifications and
reviews in accordance with this section.
(3) A review of each certification under paragraph
(1) (including a review of compliance with each
criterion in this section and any related implementing
standards as determined by the Secretary through
rulemaking) not less often than every 3 years, as
determined by the Secretary.
(4) Revocation of any such certification by the
Secretary or other such governmental organization that
issued the certification, upon a showing of cause.
(c) Criteria.--A patient safety organization must meet the
following criteria as conditions of certification:
(1) The mission of the patient safety organization is
to conduct activities that are to improve patient
safety and the quality of health care delivery and is
not in conflict of interest with the providers that
contract with the patient safety organization.
(2) The patient safety organization has appropriately
qualified staff, including licensed or certified
medical professionals.
(3) The patient safety organization, within any 2
year period, contracts with more than 1 provider for
the purpose of receiving and reviewing patient safety
work product.
(4) The patient safety organization is not a
component of a health insurer or other entity that
offers a group health plan or health insurance
coverage.
(5) The patient safety organization is managed,
controlled, and operated independently from any
provider that contracts with the patient safety
organization for reporting patient safety work product.
(6) To the extent practical and appropriate, the
patient safety organization collects patient safety
work product from providers in a standardized manner
that permits valid comparisons of similar cases among
similar providers.
(d) Additional Criteria for Component Organizations.--If a
patient safety organization is a component of another
organization, the patient safety organization must, in addition
to meeting the criteria described in subsection (c), meet the
following criteria as conditions of certification:
(1) The patient safety organization maintains patient
safety work product separately from the rest of the
organization, and establishes appropriate security
measures to maintain the confidentiality of the patient
safety work product.
(2) The patient safety organization does not make an
unauthorized disclosure under this Act of patient
safety work product to the rest of the organization in
breach of confidentiality.
(3) The mission of the patient safety organization
does not create a conflict of interest with the rest of
the organization.
PART [C] D--GENERAL PROVISIONS
SEC. [921] 931. ADVISORY COUNCIL FOR HEALTHCARE RESEARCH AND QUALITY.
(a) * * *
* * * * * * *
SEC. [922] 932. PEER REVIEW WITH RESPECT TO GRANTS AND CONTRACTS.
(a) * * *
* * * * * * *
SEC. [923] 933. CERTAIN PROVISIONS WITH RESPECT TO DEVELOPMENT,
COLLECTION, AND DISSEMINATION OF DATA.
(a) * * *
* * * * * * *
SEC. [924] 934. DISSEMINATION OF INFORMATION.
(a) * * *
* * * * * * *
SEC. [925] 935. ADDITIONAL PROVISIONS WITH RESPECT TO GRANTS AND
CONTRACTS.
(a) * * *
* * * * * * *
SEC. [926] 936. CERTAIN ADMINISTRATIVE AUTHORITIES.
(a) * * *
* * * * * * *
SEC. [927] 937. FUNDING.
(a) * * *
* * * * * * *
(e) Patient Safety and Quality Improvement.--For the purpose
of carrying out part C, there are authorized to be appropriated
such sums as may be necessary for each of the fiscal years 2004
through 2008.
SEC. [928] 938. DEFINITIONS.
In this title:
(1) Advisory council.--The term ``Advisory Council''
means the National Advisory Council on Healthcare
Research and Quality established under section [921]
931.
* * * * * * *
----------
FEDERAL FOOD, DRUG, AND COSMETIC ACT
* * * * * * *
CHAPTER V--DRUGS AND DEVICES
Subchapter A--Drugs and Devices
* * * * * * *
misbranded drugs and devices
Sec. 502. A drug or device shall be deemed to be misbranded--
(a) * * *
* * * * * * *
(w) If it is a drug or biological product, unless it includes
a unique product identifier for the drug or biological product
as required by regulations under section 510(q).
* * * * * * *
registration of producers of drugs and devices
Sec. 510. (a) * * *
* * * * * * *
(q)(1) The Secretary shall issue, and may periodically
revise, regulations requiring the manufacturer of any drug or
biological product that is subject to regulation by the Food
and Drug Administration, or the packager or labeler of a drug
or biological product that is subject to regulation by the Food
and Drug Administration, to include a unique product identifier
on the packaging of the drug or biological product.
(2) For purposes of this subsection, the term ``unique
product identifier'' means an identification that--
(A) is affixed by the manufacturer, labeler, or
packager to each drug or biological product described
in paragraph (1) at each packaging level;
(B) uniquely identifies the item and meets the
standards required by this section; and
(C) can be read by a scanning device or other
technology acceptable to the Secretary.
(3) A unique product identifier required by regulations
issued or revised under paragraph (1) shall be based on--
(A) the National Drug Code maintained by the Food and
Drug Administration;
(B) commercially accepted standards established by
organizations that are accredited by the American
National Standards Institute, such as the Health
Industry Business Communication Council or the Uniform
Code Council; or
(C) other identification formats that the Secretary
deems appropriate.
(4) The Secretary may, at the Secretary's discretion, waive
the requirements of this section, or add additional provisions
that are necessary to safeguard the public health.
* * * * * * *