H.R. 663 Text
3-12-03
House
Vote 418-6
7-22-04
Passed Senate With Amendment by
Unanimous Consent, now in Conference
108th CONGRESS
1st Session
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.
IN THE HOUSE OF REPRESENTATIVES
February 11, 2003
Mr. BILIRAKIS (for himself, Mr. BROWN of Ohio, Mr. TAUZIN, Mr. DINGELL, Mr.
BARTON of Texas, Mr. WAXMAN, Mr. UPTON, Mr. MARKEY, Mr. GREENWOOD, Mr. TOWNS,
Mr. BURR, Mr. PALLONE, Mr. WHITFIELD, Mr. GORDON, Mr. NORWOOD, Mr. DEUTSCH,
Mr. TERRY, Mr. RUSH, Mr. ROGERS of Michigan, Mr. ENGEL, Mr. WYNN, Ms. MCCARTHY
of Missouri, Mr. STRICKLAND, Mrs. CAPPS, Mr. JOHN, and Ms. HARMAN) introduced
the following bill; which was referred to the Committee on Energy and Commerce
A BILL
To amend title IX of the Public Health Service Act to provide for
the improvement of patient safety and to reduce the incidence of events that
adversely affect patient safety, and for other purposes.
Be it enacted by the Senate and House of Representatives of the United
States of America in Congress assembled,
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.
`(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;
`(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.
`(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.
`(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.
`(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 2013.'.
SEC. 4. PROMOTING THE DIFFUSION AND INTEROPERABILITY OF INFORMATION TECHNOLOGY
SYSTEMS INVOLVED WITH HEALTH CARE DELIVERY.
(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.'.
END
