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(1) NO ENROLLMENT RESTRICTION FOR GENETIC
SERVICES.—Section 9802(a)(1)(F) of the Internal
Revenue Code of 1986 is amended by inserting before
the period the following: ‘‘(including information
about a request for or receipt of genetic services)’’.
(2) NO
DISCRIMINATION
IN
GROUP
PREMIUMS
BASED ON PREDICTIVE GENETIC INFORMATION.—
(A) IN GENERAL.—Subchapter B of chapter
100 of the Internal Revenue Code of 1986, as
amended by section 2301(f), is further amended
by adding at the end the following:
‘‘SEC. 
9815. 
PROHIBITING 
PREMIUM 
DISCRIMINATION
AGAINST GROUPS ON THE BASIS OF PRE-
DICTIVE GENETIC INFORMATION.
‘‘A group health plan shall not adjust premium or con-
tribution amounts for a group on the basis of predictive
genetic information concerning any individual (including
a dependent) or a family member of the individual (includ-
ing information about a request for or receipt of genetic
services).’’.
(B) 
CONFORMING
AMENDMENT.—Section
9802(b) of the Internal Revenue Code of 1986 is
amended by adding at the end the following:
‘‘(3) REFERENCE TO RELATED PROVISION.—For
a provision prohibiting the adjustment of premium or
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contribution amounts for a group under a group
health plan on the basis of predictive genetic informa-
tion (including information about a request for or the
receipt of genetic services), see section 9815.’’.
(C) AMENDMENT TO TABLE OF SECTIONS.—
The table of sections for subchapter B of chapter
100 of the Internal Revenue Code of 1986, as
amended by section 2301(f), is further amended
by adding at the end the following:
‘‘Sec. 9815. Prohibiting premium discrimination against groups on the basis of
predictive genetic information.’’.
(b) LIMITATION ON COLLECTION OF PREDICTIVE GE-
NETIC INFORMATION.—Section 9802 of the Internal Rev-
enue Code of 1986 is amended by adding at the end the
following:
‘‘(d) COLLECTION OF PREDICTIVE GENETIC INFORMA-
TION.—
‘‘(1) LIMITATION ON REQUESTING OR REQUIRING
PREDICTIVE GENETIC INFORMATION.—Except as pro-
vided in paragraph (2), a group health plan shall not
request or require predictive genetic information con-
cerning any individual (including a dependent) or a
family member of the individual (including informa-
tion about a request for or receipt of genetic services).
‘‘(2) INFORMATION
NEEDED
FOR
DIAGNOSIS,
TREATMENT, OR PAYMENT.—
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‘‘(A) IN GENERAL.—Notwithstanding para-
graph (1), a group health plan that provides
health care items and services to an individual
or dependent may request (but may not require)
that such individual or dependent disclose, or
authorize the collection or disclosure of, pre-
dictive genetic information for purposes of diag-
nosis, treatment, or payment relating to the pro-
vision of health care items and services to such
individual or dependent.
‘‘(B) NOTICE
OF
CONFIDENTIALITY
PRAC-
TICES; DESCRIPTION
OF
SAFEGUARDS.—As a
part of a request under subparagraph (A), the
group health plan shall provide to the individual
or dependent a description of the procedures in
place to safeguard the confidentiality, as de-
scribed in subsection (e), of such predictive ge-
netic information.
‘‘(e) CONFIDENTIALITY WITH RESPECT TO PREDICTIVE
GENETIC INFORMATION.—
‘‘(1) NOTICE OF CONFIDENTIALITY PRACTICES.—
‘‘(A) PREPARATION OF WRITTEN NOTICE.—
A group health plan shall post or provide, in
writing and in a clear and conspicuous manner,
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notice of the plan’s confidentiality practices, that
shall include—
‘‘(i) a description of an individual’s
rights with respect to predictive genetic in-
formation;
‘‘(ii) the procedures established by the
plan for the exercise of the individual’s
rights; and
‘‘(iii) the right to obtain a copy of the
notice of the confidentiality practices re-
quired under this subsection.
‘‘(B) MODEL
NOTICE.—The Secretary, in
consultation with the National Committee on
Vital and Health Statistics and the National As-
sociation of Insurance Commissioners, and after
notice and opportunity for public comment, shall
develop and disseminate model notices of con-
fidentiality practices. Use of the model notice
shall serve as a defense against claims of receiv-
ing inappropriate notice.
‘‘(2) 
ESTABLISHMENT
OF
SAFEGUARDS.—A
group health plan shall establish and maintain ap-
propriate administrative, technical, and physical
safeguards to protect the confidentiality, security, ac-
curacy, and integrity of predictive genetic informa-
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tion created, received, obtained, maintained, used,
transmitted, or disposed of by such plan.’’.
(c) DEFINITIONS.—Section 9832(d) of the Internal
Revenue Code of 1986 is amended by adding at the end
the following:
‘‘(6) FAMILY MEMBER.—The term ‘family mem-
ber’ means, with respect to an individual—
‘‘(A) the spouse of the individual;
‘‘(B) a dependent child of the individual,
including a child who is born to or placed for
adoption with the individual; and
‘‘(C) all other individuals related by blood
to the individual or the spouse or child described
in subparagraph (A) or (B).
‘‘(7) GENETIC INFORMATION.—The term ‘genetic
information’ means information about genes, gene
products, or inherited characteristics that may derive
from an individual or a family member (including
information about a request for or receipt of genetic
services).
‘‘(8) GENETIC
SERVICES.—The term ‘genetic
services’ means health services provided to obtain, as-
sess, or interpret genetic information for diagnostic
and therapeutic purposes, and for genetic education
and counseling.
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‘‘(9) PREDICTIVE GENETIC INFORMATION.—
‘‘(A) IN GENERAL.—The term ‘predictive ge-
netic information’ means, in the absence of
symptoms, clinical signs, or a diagnosis of the
condition related to such information—
‘‘(i) information about an individual’s
genetic tests;
‘‘(ii) information about genetic tests of
family members of the individual; or
‘‘(iii) information about the occurrence
of a disease or disorder in family members.
‘‘(B) EXCEPTIONS.—The term ‘predictive
genetic information’ shall not include—
‘‘(i) information about the sex or age of
the individual;
‘‘(ii) information derived from phys-
ical tests, such as the chemical, blood, or
urine analyses of the individual including
cholesterol tests; and
‘‘(iii) 
information 
about 
physical
exams of the individual.
‘‘(10) GENETIC TEST.—The term ‘genetic test’
means the analysis of human DNA, RNA, chro-
mosomes, proteins, and certain metabolites, including
analysis of genotypes, mutations, phenotypes, or
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karyotypes, for the purpose of predicting risk of dis-
ease in asymptomatic or undiagnosed individuals.
Such term does not include physical tests, such as the
chemical, blood, or urine analyses of the individual
including cholesterol tests, and physical exams of the
individual, in order to detect symptoms, clinical
signs, or a diagnosis of disease.’’.
(d) EFFECTIVE DATE.—Except as provided in this sec-
tion, this section and the amendments made by this section
shall apply with respect to group health plans for plan
years beginning after 1 year after the date of the enactment
of this Act.
TITLE XXV—PATIENT SAFETY
AND ERRORS REDUCTION
SEC. 2501. SHORT TITLE.
This title may be cited as the ‘‘Patient Safety and Er-
rors Reduction Act’’.
SEC. 2502. PURPOSES.
It is the purpose of this title to—
(1) promote the identification, evaluation, and
reporting of medical errors;
(2) raise standards and expectations for im-
provements in patient safety;
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(3) reduce deaths, serious injuries, and other
medical errors through the implementation of safe
practices at the delivery level;
(4) develop error reduction systems with legal
protections to support the collection of information
under such systems;
(5) extend existing confidentiality and peer re-
view protections to the reports relating to medical er-
rors that are reported under such systems that are de-
veloped for safety and quality improvement purposes;
and
(6) provide for the establishment of systems of
information collection, analysis, and dissemination to
enhance the knowledge base concerning patient safety.
SEC. 2503. AMENDMENT TO PUBLIC HEALTH SERVICE ACT.
Title IX of the Public Health Service Act (42 U.S.C.
299 et seq.) is amended—
(1) by redesignating part C as part D;
(2) by redesignating sections 921 through 928, as
sections 931 through 938, respectively;
(3) in section 938(1) (as so redesignated), by
striking ‘‘921’’ and inserting ‘‘931’’; and
(4) by inserting after part B the following:
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‘‘PART C—REDUCING ERRORS IN HEALTH CARE
‘‘SEC. 921. DEFINITIONS.
‘‘In this part:
‘‘(1) ADVERSE EVENT.—The term ‘adverse event’
means, with respect to the patient of a provider of
services, an untoward incident, therapeutic misadven-
ture, or iatrogenic injury directly associated with the
provision of health care items and services by a health
care provider or provider of services.
‘‘(2) CENTER.—The term ‘Center’ means the
Center for Quality Improvement and Patient Safety
established under section 922(b).
‘‘(3) CLOSE CALL.—The term ‘close call’ means,
with respect to the patient of a provider of services,
any event or situation that—
‘‘(A) but for chance or a timely interven-
tion, could have resulted in an accident, injury,
or illness; and
‘‘(B) is directly associated with the provi-
sion of health care items and services by a pro-
vider of services.
‘‘(4) EXPERT ORGANIZATION.—The term ‘expert
organization’ means a third party acting on behalf of,
or in conjunction with, a provider of services to col-
lect information about, or evaluate, a medical event.
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‘‘(5) HEALTH CARE OVERSIGHT AGENCY.—The
term ‘health care oversight agency’ means an agency,
entity, or person, including the employees and agents
thereof, that performs or oversees the performance of
any activities necessary to ensure the safety of the
health care system.
‘‘(6) 
HEALTH
CARE
PROVIDER.—The 
term
‘health care provider’ means—
‘‘(A) any provider of services (as defined in
section 1861(u) of the Social Security Act); and
‘‘(B) any person furnishing any medical or
other health care services as defined in section
1861(s)(1) and (2) of such Act through, or under
the authority of, a provider of services described
in subparagraph (A).
‘‘(7) PROVIDER OF SERVICES.—The term ‘pro-
vider of services’ means a hospital, skilled nursing fa-
cility, comprehensive outpatient rehabilitation facil-
ity, home health agency, renal dialysis facility, ambu-
latory surgical center, or hospice program, and any
other entity specified in regulations promulgated by
the Secretary after public notice and comment.
‘‘(8) PUBLIC
HEALTH
AUTHORITY.—The term
‘public health authority’ means an agency or author-
ity of the United States, a State, a territory, a polit-
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ical subdivision of a State or territory, and an In-
dian tribe that is responsible for public health matters
as part of its official mandate.
‘‘(9) MEDICAL EVENT.—The term ‘medical event’
means, with respect to the patient of a provider of
services, any sentinel event, adverse event, or close
call.
‘‘(10) MEDICAL EVENT ANALYSIS ENTITY.—The
term ‘medical event analysis entity’ means an entity
certified under section 923(a).
‘‘(11) ROOT CAUSE ANALYSIS.—
‘‘(A) IN GENERAL.—The term ‘root cause
analysis’ means a process for identifying the
basic or contributing causal factors that underlie
variation in performance associated with med-
ical events that—
‘‘(i) has the characteristics described in
subparagraph (B);
‘‘(ii) includes participation by the
leadership of the provider of services and in-
dividuals most closely involved in the proc-
esses and systems under review;
‘‘(iii) is internally consistent; and
‘‘(iv) includes the consideration of rel-
evant literature.
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‘‘(B) CHARACTERISTICS.—The characteris-
tics described in this subparagraph include the
following:
‘‘(i) The analysis is interdisciplinary
in nature and involves those individuals
who are responsible for administering the
reporting systems.
‘‘(ii) The analysis focuses primarily on
systems and processes rather than indi-
vidual performance.
‘‘(iii) The analysis involves a thorough
review of all aspects of the process and all
contributing factors involved.
‘‘(iv) The analysis identifies changes
that could be made in systems and proc-
esses, through either redesign or development
of new processes or systems, that would im-
prove performance and reduce the risk of
medical events.
‘‘(12) SENTINEL
EVENT.—The term ‘sentinel
event’ means, with respect to the patient of a provider
of services, an unexpected occurrence that—
‘‘(A) involves death or serious physical or
psychological injury (including loss of a limb);
and
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‘‘(B) is directly associated with the provi-
sion of health care items and services by a health
care provider or provider of services.
‘‘SEC. 922. RESEARCH TO IMPROVE THE QUALITY AND SAFE-
TY OF PATIENT CARE.
‘‘(a) IN GENERAL.—To improve the quality and safety
of patient care, the Director shall—
‘‘(1) conduct and support research, evaluations
and training, support demonstration projects, provide
technical assistance, and develop and support part-
nerships that will identify and determine the causes
of medical errors and other threats to the quality and
safety of patient care;
‘‘(2) identify and evaluate interventions and
strategies for preventing or reducing medical errors
and threats to the quality and safety of patient care;
‘‘(3) identify, in collaboration with experts from
the public and private sector, reporting parameters to
provide consistency throughout the errors reporting
system;
‘‘(4) identify approaches for the clinical manage-
ment of complications from medical errors; and
‘‘(5) establish mechanisms for the rapid dissemi-
nation of interventions and strategies identified under
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this section for which there is scientific evidence of ef-
fectiveness.
‘‘(b) CENTER FOR QUALITY IMPROVEMENT AND PA-
TIENT SAFETY.—
‘‘(1) ESTABLISHMENT.—The Director shall estab-
lish a center to be known as the Center for Quality
Improvement and Patient Safety to assist the Direc-
tor in carrying out the requirements of subsection (a).
‘‘(2) MISSION.—The Center shall—
‘‘(A) provide national leadership for re-
search and other initiatives to improve the qual-
ity and safety of patient care;
‘‘(B) build public-private sector partner-
ships to improve the quality and safety of pa-
tient care; and
‘‘(C) serve as a national resource for re-
search and learning from medical errors.
‘‘(3) DUTIES.—
‘‘(A) IN
GENERAL.—In carrying out this
section, the Director, acting through the Center,
shall consult and build partnerships, as appro-
priate, with all segments of the health care in-
dustry, including health care practitioners and
patients, those who manage health care facilities,
systems and plans, peer review organizations,
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health care purchasers and policymakers, and
other users of health care research.
‘‘(B) REQUIRED
DUTIES.—In addition to
the broad responsibilities that the Director may
assign to the Center for research and related ac-
tivities that are designed to improve the quality
of health care, the Director shall ensure that the
Center—
‘‘(i) builds scientific knowledge and
understanding of the causes of medical er-
rors in all health care settings and identi-
fies or develops and validates effective inter-
ventions and strategies to reduce errors and
improve the safety and quality of patient
care;
‘‘(ii) promotes public and private sec-
tor research on patient safety by—
‘‘(I) developing a national patient
safety research agenda;
‘‘(II) identifying promising op-
portunities for preventing or reducing
medical errors; and
‘‘(III) tracking the progress made
in addressing the highest priority re-
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search questions with respect to patient
safety;
‘‘(iii) facilitates the development of vol-
untary national patient safety goals by con-
vening all segments of the health care indus-
try and tracks the progress made in meeting
those goals;
‘‘(iv) analyzes national patient safety
data for inclusion in the annual report on
the quality of health care required under
section 913(b)(2);
‘‘(v) strengthens the ability of the
United States to learn from medical errors
by—
‘‘(I) developing the necessary tools
and advancing the scientific techniques
for analysis of errors;
‘‘(II) providing technical assist-
ance as appropriate to reporting sys-
tems; and
‘‘(III) entering into contracts to
receive and analyze aggregate data
from public and private sector report-
ing systems;
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‘‘(vi) supports dissemination and com-
munication activities to improve patient
safety, including the development of tools
and methods for educating consumers about
patient safety; and
‘‘(vii) undertakes related activities that
the Director determines are necessary to en-
able the Center to fulfill its mission.
‘‘(C) LIMITATION.—Aggregate data gathered
for the purposes described in this section shall
not include specific patient, health care provider,
or provider of service identifiers.
‘‘(c) LEARNING FROM MEDICAL ERRORS.—
‘‘(1) IN GENERAL.—To enhance the ability of the
health care community in the United States to learn
from medical events, the Director shall—
‘‘(A) carry out activities to increase sci-
entific knowledge and understanding regarding
medical error reporting systems;
‘‘(B) carry out activities to advance the sci-
entific knowledge regarding the tools and tech-
niques for analyzing medical events and deter-
mining their root causes;
‘‘(C) carry out activities in partnership
with experts in the field to increase the capacity
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of the health care community in the United
States to analyze patient safety data;
‘‘(D) develop a confidential national safety
database of medical event reports;
‘‘(E) conduct and support research, using
the database developed under subparagraph (D),
into the causes and potential interventions to de-
crease the incidence of medical errors and close
calls; and
‘‘(F) ensure that information contained in
the national database developed under subpara-
graph (D) does not include specific patient,
health care provider, or provider of service iden-
tifiers.
‘‘(2) NATIONAL
PATIENT
SAFETY
DATABASE.—
The Director shall, in accordance with paragraph
(1)(D), establish a confidential national safety data-
base (to be known as the National Patient Safety
Database) of reports of medical events that can be
used only for research to improve the quality and
safety of patient care. In developing and managing
the National Patient Safety Database, the Director
shall—
‘‘(A) ensure that the database is only used
for its intended purpose;
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‘‘(B) ensure that the database is only used
by the Agency, medical event analysis entities,
and other qualified entities or individuals as de-
termined appropriate by the Director and in ac-
cordance with paragraph (3) or other criteria
applied by the Director;
‘‘(C) ensure that the database is as com-
prehensive as possible by aggregating data from
Federal, State, and private sector patient safety
reporting systems;
‘‘(D) conduct and support research on the
most common medical errors and close calls,
their causes, and potential interventions to re-
duce medical errors and improve the quality and
safety of patient care;
‘‘(E) disseminate findings made by the Di-
rector, based on the data in the database, to cli-
nicians, individuals who manage health care fa-
cilities, systems, and plans, patients, and other
individuals who can act appropriately to im-
prove patient safety; and
‘‘(F) develop a rapid response capacity to
provide alerts when specific health care practices
pose an imminent threat to patients or health
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care practitioners, or other providers of health
care items or services.
‘‘(3) CONFIDENTIALITY AND PEER REVIEW PRO-
TECTIONS.—Notwithstanding any other provision of
law any information (including any data, reports,
records, memoranda, analyses, statements, and other
communications) developed by or on behalf of a health
care provider or provider of services with respect to
a medical event, that is contained in the National Pa-
tient Safety Database shall be confidential in accord-
ance with section 925.
‘‘(4) PATIENT SAFETY REPORTING SYSTEMS.—
The Director shall identify public and private sector
patient safety reporting systems and build scientific
knowledge and understanding regarding the most
effective—
‘‘(A) components of patient safety reporting
systems;
‘‘(B) incentives intended to increase the rate
of error reporting;
‘‘(C) approaches for undertaking root cause
analyses;
‘‘(D) ways to provide feedback to those fil-
ing error reports;
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‘‘(E) techniques and tools for collecting, in-
tegrating, and analyzing patient safety data;
and
‘‘(F) ways to provide meaningful informa-
tion to patients, consumers, and purchasers that
will enhance their understanding of patient safe-
ty issues.
‘‘(5) TRAINING.—The Director shall support
training initiatives to build the capacity of the health
care community in the United States to analyze pa-
tient safety data and to act on that data to improve
patient safety.
‘‘(d) EVALUATION.—The Director shall recommend
strategies for measuring and evaluating the national
progress made in implementing safe practices identified by
the Center through the research and analysis required under
subsection (b) and through the voluntary reporting system
established under subsection (c).
‘‘(e) IMPLEMENTATION.—In implementing strategies to
carry out the functions described in subsections (b), (c), and
(d), the Director may contract with public or private enti-
ties on a national or local level with appropriate expertise.
‘‘SEC. 923. MEDICAL EVENT ANALYSIS ENTITIES.
‘‘(a) IN GENERAL.—The Director, based on informa-
tion collected under section 922(c), shall provide for the cer-
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tification of entities to collect and analyze information on
medical errors, and to collaborate with health care providers
or providers of services in collecting information about, or
evaluating, certain medical events.
‘‘(b) COMPATIBILITY OF COLLECTED DATA.—To en-
sure that data reported to the National Patient Safety
Database under section 922(c)(2) concerning medical errors
and close calls are comparable and useful on an analytic
basis, the Director shall require that the entities described
in subsection (c) follow the recommendations regarding a
common set of core measures for reporting that are devel-
oped by the National Forum for Health Care Quality Meas-
urement and Reporting, or other voluntary private stand-
ard-setting organization that is designated by the Director
taking into account existing measurement systems and in
collaboration with experts from the public and private sec-
tor.
‘‘(c) DUTIES OF CERTIFIED ENTITIES.—
‘‘(1) IN GENERAL.—An entity that is certified
under subsection (a) shall collect and analyze infor-
mation, consistent with the requirement of subsection
(b), provided to the entity under section 924(a)(4) to
improve patient safety.
‘‘(2) INFORMATION TO BE REPORTED TO THE EN-
TITY.—A medical event analysis entity shall, on a
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periodic basis and in a format that is specified by the
Director, submit to the Director a report that
contains—
‘‘(A) a description of the medical events
that were reported to the entity during the pe-
riod covered under the report;
‘‘(B) a description of any corrective action
taken by providers of services with respect to
such medical events or any other measures that
are necessary to prevent similar events from oc-
curring in the future; and
‘‘(C) a description of the systemic changes
that entities have identified, through an analysis
of the medical events included in the report, as
being needed to improve patient safety.
‘‘(3) COLLABORATION.—A medical event analysis
entity that is collaborating with a health care pro-
vider or provider of services to address close calls and
adverse events may, at the request of the health care
provider or provider of services—
‘‘(A) provide expertise in the development of
root cause analyses and corrective action plan
relating to such close calls and adverse events; or
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‘‘(B) collaborate with such provider of serv-
ices to identify on-going risk reduction activities
that may enhance patient safety.
‘‘(d) CONFIDENTIALITY AND PEER REVIEW PROTEC-
TIONS.—Notwithstanding any other provision of law, any
information (including any data, reports, records, memo-
randa, analyses, statements, and other communications)
collected by a medical event analysis entity or developed
by or on behalf of such an entity under this part shall be
confidential in accordance with section 925.
‘‘(e) TERMINATION AND RENEWAL.—
‘‘(1) IN GENERAL.—The certification of an entity
under this section shall terminate on the date that is
3 years after the date on which such certification was
provided. Such certification may be renewed at the
discretion of the Director.
‘‘(2) NONCOMPLIANCE.—The Director may ter-
minate the certification of a medical event analysis
entity if the Director determines that such entity has
failed to comply with this section.
‘‘(f) IMPLEMENTATION.—In implementing strategies to
carry out the functions described in subsection (c), the Di-
rector may contract with public or private entities on a
national or local level with appropriate expertise.
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‘‘SEC. 924. PROVIDER OF SERVICES SYSTEMS FOR REPORT-
ING MEDICAL EVENTS.
‘‘(a) INTERNAL MEDICAL EVENT REPORTING SYS-
TEMS.—Each provider of services that elects to participate
in a medical error reporting system under this part shall—
‘‘(1) establish a system for—
‘‘(A) identifying, collecting information
about, and evaluating medical events that occur
with respect to a patient in the care of the pro-
vider of services or a practitioner employed by
the provider of services, that may include—
‘‘(i) the provision of a medically coher-
ent description of each event so identified;
‘‘(ii) the provision of a clear and thor-
ough accounting of the results of the inves-
tigation of such event under the system; and
‘‘(iii) a description of all corrective
measures taken in response to the event; and
‘‘(B) determining appropriate follow-up ac-
tions to be taken with respect to such events;
‘‘(2) establish policies and procedures with re-
spect to when and to whom such events are to be re-
ported;
‘‘(3) take appropriate follow-up action with re-
spect to such events; and