I
106TH CONGRESS
1ST SESSION
H. R. 3010
To amend titles XVIII and XIX of the Social Security Act to ensure that
individuals enjoy the right to be free from restraint, and for other purposes.
IN THE HOUSE OF REPRESENTATIVES
OCTOBER 4, 1999
Mr. SHAYS (for himself, Ms. DELAURO, Mr. GEJDENSON, Mr. LARSON, and
Mr. MALONEY of Connecticut) introduced the following bill; which was re-
ferred to the Committee on Commerce, and in addition to the Committee
on Ways and Means, for a period to be subsequently determined by the
Speaker, in each case for consideration of such provisions as fall within
the jurisdiction of the committee concerned
A BILL
To amend titles XVIII and XIX of the Social Security Act
to ensure that individuals enjoy the right to be free
from restraint, and for other purposes.
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ‘‘Restraint Safety Act
of 1999’’.
SEC. 2. INDIVIDUALS’ RIGHT TO FREEDOM FROM RE-
STRAINT 
AND 
REPORTING 
OF 
SENTINEL
EVENTS UNDER MEDICARE.
(a) AMENDMENT TO SOCIAL SECURITY ACT.—
(1) IN GENERAL.—Part D of title XVIII of the
Social Security Act (42 U.S.C. 1395x et seq.) is
amended by adding at the end the following:
‘‘INDIVIDUALS’ FREEDOM FROM RESTRAINT AND
REPORTING OF SENTINEL EVENTS
‘‘SEC. 1897. (a) DEFINITIONS.—In this section:
‘‘(1) CHEMICAL RESTRAINT.—The term ‘chem-
ical restraint’ means the non-therapeutic use of a
medication that—
‘‘(A) is unrelated to the patient’s medical
condition; and
‘‘(B) is imposed for disciplinary purposes
or the convenience of staff.
‘‘(2) PHYSICAL RESTRAINT.—The term ‘phys-
ical restraint’ means any mechanical or personal re-
striction that immobilizes or reduces the ability of
an individual to move his or her arms, legs, or head
freely. Such term does not include devices, such as
orthopedically prescribed devices, surgical dressings
or bandages, protective helmets, and other methods
involving the physical holding of a resident for the
purpose of conducting routine physical examinations
or tests or to protect the patient from falling out of
bed or to permit a patient to participate in activities
without the risk of physical harm to the patient.
‘‘(3) PROVIDER OF SERVICES.—The term ‘pro-
vider of services’ has the meaning given that term
in section 1861(u), except that for purposes of this
section the term includes a psychiatric hospital but
does not include a home health agency.
‘‘(4) SECLUSION.—The term ‘seclusion’ means
any separation of the resident from the general pop-
ulation of the facility that prevents the resident from
returning to such population when he or she desires.
‘‘(5) SENTINEL
EVENT.—The term ‘sentinel
event’ means an unexpected occurrence involving an
individual in the care of a provider of services for
treatment for a psychiatric or psychological illness
that results in death or serious physical or psycho-
logical injury that is unrelated to the natural course
of the individual’s illness or underlying condition.
‘‘(b) PROTECTION OF RIGHT TO BE FREE FROM RE-
STRAINTS.—A provider of services eligible to be paid
under this title for providing services to an individual enti-
tled to benefits under part A or enrolled under part B
(including an individual provided with a Medicare+Choice
plan offered by a Medicare+Choice organization under
part C) shall—
‘‘(1) protect and promote the right of each such
individual to be free from physical or mental abuse,
corporal punishment, and any physical or chemical
restraints or involuntary seclusion imposed for pur-
poses of discipline or convenience;
‘‘(2) impose restraints—
‘‘(A) only to ensure the physical safety of
the individual or other individuals in the care or
custody of the provider, a staff member, or oth-
ers; and
‘‘(B) only upon the written order of a phy-
sician or other licensed independent practitioner
permitted by the State and the facility to order
such restaint or seclusion that specifies the du-
ration and circumstances under which the re-
straints are to be used (except in emergency
circumstances specified by the Secretary until
such an order could reasonably be obtained);
and
‘‘(3) submit the reports required under sub-
section (d).
‘‘(c) CONSTRUCTION.—Nothing in this section shall
be construed as prohibiting the use of restraints for med-
ical immobilization, adaptive support, or medical protec-
tion.
‘‘(d) REPORTS.—
‘‘(1) REPORTS TO AGENCIES OR ENTITIES WITH
OVERSIGHT AUTHORITY.—
‘‘(A) IN GENERAL.—A provider of services
shall report each sentinel event that occurs to
an individual while the individual is in the care
or custody of the provider to—
‘‘(i) in the case of a provider of serv-
ices participating in the program estab-
lished under this title or the medicaid pro-
gram under title XIX as a result of accred-
itation by a national accrediting body, the
national accrediting body for that provider;
and
‘‘(ii) in the case of all other providers
of services, the Secretary or, upon agree-
ment between the Secretary and the rel-
evant State, the State agency designated
by the Secretary.
‘‘(B) INVESTIGATION
AND
FURTHER
RE-
PORTING OF SENTINEL EVENTS.—Upon receipt
of a report made pursuant to subparagraph
(A), the agency or entity with oversight author-
ity shall—
‘‘(i) ensure that the provider—
‘‘(I) conducts an investigation of
the sentinel event reported;
‘‘(II) determines the root cause
or causes of the sentinel event; and
‘‘(III) establishes a time-limited
plan or strategy, that allows the agen-
cy or entity with oversight authority
to review and approve the analyses
and any corrective actions proposed or
made by the provider of services, to
correct the problem or problems that
resulted in the sentinel event, and to
lead to risk reduction; and
‘‘(ii) prepare and submit the reports
required under paragraph (2).
‘‘(2) REPORTS TO THE SECRETARY.—
‘‘(A) IN
GENERAL.—Subject to subpara-
graph (D), the agency or entity with oversight
authority shall submit a report containing the
information described in subparagraph (B) to
the Secretary in such form and manner, and by
such date, as the Secretary prescribes.
‘‘(B) INFORMATION TO BE REPORTED.—
‘‘(i) IN
GENERAL.—The report sub-
mitted under subparagraph (A) shall be
submitted to the Secretary at regular in-
tervals, but not less frequently than annu-
ally, and shall include—
‘‘(I) a description of the sentinel
events occurring during the period
covered by the report;
‘‘(II) a description of any correc-
tive action taken by the providers of
services with respect to the sentinel
events or any other measures nec-
essary to prevent similar sentinel
events from occurring in the future;
‘‘(III) proposed systems changes
identified as a result of analysis of
events from multiple providers; and
‘‘(IV) such additional information
as the Secretary determines to be es-
sential to ensure compliance with the
requirements of this section.
‘‘(ii) INFORMATION EXCLUDED.—The
report submitted under subparagraph (A)
shall not identify any individual provider of
services, practitioner, or individual.
‘‘(C) ADDITIONAL
REPORTING
REQUIRE-
MENTS WHEN A PROVIDER HAS BEEN IDENTI-
FIED AS HAVING A PATTERN OF POOR PER-
FORMANCE.—
‘‘(i) IN GENERAL.—In addition to the
report required under subparagraph (A),
the agency or entity with oversight author-
ity shall report to the Secretary the name
and address of any provider of services
with a pattern of poor performance.
‘‘(ii) DETERMINATION OF PATTERN.—
The agency or entity with oversight au-
thority shall determine if a pattern of poor
performance exists with respect to a pro-
vider of services in accordance with the
definition of pattern of poor performance
developed by the Secretary under clause
(iii).
‘‘(iii) 
DEVELOPMENT
OF
DEFINI-
TION.—The Secretary, in consultation with
national accrediting organizations and oth-
ers, shall develop a definition to identify a
provider of services with a pattern of poor
performance.
‘‘(D) AUTHORITY
TO
WAIVE
REPORTING
REQUIREMENT.—The Secretary may waive the
requirement to submit a report required under
this paragraph (but not a report regarding a
sentinel event that resulted in death required
under paragraph (3)) upon consideration of the
severity of the sentinel event.
‘‘(3) ADDITIONAL REPORTING REQUIREMENTS
FOR SENTINEL EVENTS RESULTING IN DEATH.—In
addition to the report required under paragraph (1),
a provider of services shall report any sentinel event
resulting in death to—
‘‘(A) the Secretary or the Secretary’s des-
ignee;
‘‘(B) the State Attorney General or, upon
agreement with the State Attorney General, to
the appropriate law enforcement agency;
‘‘(C) the State agency responsible for li-
censing the provider of services; and
‘‘(D) the State protection and advocacy
system established pursuant to part C of title I
of the Developmental Disabilities Assistance
and Bill of Rights Act (42 U.S.C. 6041 et seq.)
for the State in which the event occurred.
‘‘(4) RESPONSIBILITIES
OF
THE
AGENCY
OR
ENTITY
WITH
OVERSIGHT
AUTHORITY.—Upon re-
ceipt of a report of a sentinel event that resulted in
death, the agency or entity with oversight authority
shall, in addition to the requirements of paragraph
(2)—
‘‘(A) determine whether the death was re-
lated to the use of restraints or seclusion; and
‘‘(B) notify the Secretary of the determina-
tion.
‘‘(5) SANCTIONS FOR FAILURE TO REPORT.—
‘‘(A) IN
GENERAL.—The Secretary shall
establish sanctions, including intermediate sanc-
tions, as appropriate, for failure of a provider
of services or an agency or entity with oversight
authority to submit the reports and information
required under this subsection.
‘‘(B) REMOVAL
OF
AGENCY
OR
ENTITY
WITH OVERSIGHT AUTHORITY.—The Secretary,
after notice to an agency or entity with over-
sight authority of a provider of services, as de-
termined in paragraph (1), and opportunity to
comply, may remove the agency or entity of
such authority if the agency or entity refuses
to submit the reports and information required
under this subsection.
‘‘(6) LIABILITY
FOR
REPORTING.—An indi-
vidual, provider of services, agency, or entity shall be
liable with respect to any information contained in
a report required under this subsection if the indi-
vidual, provider of services, agency, or entity had
knowledge of the falsity of the information contained
in the report at the time the report was submitted
under this subsection. Nothing in the preceding sen-
tence shall be construed as limiting the liability of
an individual, provider of services, agency, or entity
for damages relating to the occurrence of a sentinel
event, including a sentinel event that results in
death.
‘‘(7) NONDISCLOSURE OF ANALYSIS.—Notwith-
standing any other provision of law or regulation,
the root cause analysis developed under this sub-
section shall be kept confidential and shall not be
subject to disclosure or discovery in a civil action.
‘‘(d) ESTABLISHMENT
OR DESIGNATION
OF SEN-
TINEL EVENTS DATABASE.—
‘‘(1) IN GENERAL.—Not later than 1 year after
the date of enactment of this section, the Secretary
shall establish or designate a database of informa-
tion using the reports submitted under paragraphs
(2) and (3) of subsection (d) (in this subsection re-
ferred to as the ‘Sentinel Events Database’).
‘‘(2) CONTENTS.—
‘‘(A) IN
GENERAL.—Subject to subpara-
graph (B), the Sentinel Events Database shall
include the following:
‘‘(i) The name and address of any
provider of services that is the subject of
a 
report 
submitted 
under 
subsection
(d)(3), if the agency or entity with over-
sight authority has determined that the
death was related to the use of restraints
or seclusion.
‘‘(ii) The information reported by the
agency or entity under subparagraphs (B)
and (C) of subsection (d)(2).
‘‘(B) CONFIDENTIALITY.—The Secretary
shall establish procedures to ensure that the
privacy of individuals whose treatment is the
subject of a report submitted under paragraph
(2) or (3) of subsection (d) is protected.
‘‘(3) PROCEDURES
FOR
ENTRY
OF
INFORMA-
TION.—
‘‘(A) IN GENERAL.—The Secretary shall—
‘‘(i) prior to entry of information in
the Sentinel Events Database, disclose the
information to the provider of services that
is the subject of the information; and
‘‘(ii) establish procedures to—
‘‘(I) resolve disputes regarding
the accuracy of the information; and
‘‘(II) ensure the accuracy of the
information.
‘‘(B) NO
DELAY
OF
SANCTIONS.—Any
sanction to be imposed by the Secretary against
a provider of services or an agency or entity
with oversight authority in relation to a sentinel
event shall not be delayed as a result of a dis-
pute regarding the accuracy of information to
be entered into the database.
‘‘(4) ACCESS TO THE DATABASE.—
‘‘(A) AVAILABILITY.—The Secretary shall
establish procedures for making the information
maintained in the Sentinel Events Database re-
lated to a sentinel event resulting in death, and
any reports of sentinel injuries arising from
those providers of services with a pattern of
poor performance identified in accordance with
subsection (d)(2)(C), available to Federal and
State agencies, national accrediting bodies,
health care researchers, and the public.
‘‘(B) INTERNET ACCESS.—In addition to
any other procedures that the Secretary devel-
ops under subparagraph (A), the information in
the Sentinel Events Database shall be accessible
through the Internet.
‘‘(C) FEES FOR DISCLOSURE.—
‘‘(i) IN GENERAL.—Subject to clause
(ii), the Secretary may establish or approve
reasonable fees for disclosing information
maintained in the Sentinel Events Data-
base.
‘‘(ii) NO
FEE
FOR
FEDERAL
AGEN-
CIES.—No fee shall be charged to a Fed-
eral agency for access to the Sentinel
Events Database.
‘‘(iii) APPLICATION
OF
FEES.—Fees
collected under this clause shall be applied
by the Secretary toward the cost of main-
taining the Sentinel Events Database.’’.
(2) EFFECTIVE DATE.—
(A) IN
GENERAL.—Subject to subpara-
graph (B), the amendments made by this sub-
section take effect on the date of enactment of
this Act.
(B) REPORTING REQUIREMENTS.—The re-
porting requirements under section 1897(d) of
the Social Security Act, as added by paragraph
(1), shall apply to sentinel events occurring on
and after the date of enactment of this Act.
(b) INDIVIDUALS’ RIGHT TO FREEDOM FROM RE-
STRAINT AND REPORTING OF SENTINEL EVENTS UNDER
MEDICAID.—
(1) STATE PLANS FOR MEDICAL ASSISTANCE.—
Section 1902(a) of the Social Security Act (42
U.S.C. 1396a(a)) is amended—
(A) in paragraph (65), by striking the pe-
riod and inserting ‘‘; and’’; and
(B) by adding at the end the following:
‘‘(66) provide that the State will ensure that
any congregate care provider (as defined in section
1905(v)) that provides services to an individual for
which medical assistance is available shall—
‘‘(A) protect and promote the right of each
individual to be free from physical or mental
abuse, corporal punishment, involuntary seclu-
sion, and any physical or chemical restraints
imposed for purposes of discipline or conven-
ience;
‘‘(B) impose restraints only—
‘‘(i) to ensure the physical safety of
the individual or other individuals; and
‘‘(ii) upon the written order of a phy-
sician that specifies the duration and cir-
cumstances under which the restraints are
to be used (except in emergency cir-
cumstances specified by the Secretary until
such an order could reasonably be ob-
tained); and
‘‘(C) submit the reports required under
subsection (d) of section 1897 (relating to sen-
tinel events) in the same manner as a provider
of services under that section is required to
submit such reports.’’.
(2) DEFINITION OF CONGREGATE CARE PRO-
VIDER.—Section 1905 of the Social Security Act (42
U.S.C. 1396d) is amended by adding at the end the
following:
‘‘(v) The term ‘congregate care provider’ means an
entity that provides hospital services, nursing facility serv-
ices, services of intermediate care facilities for the men-
tally retarded, hospice care, residential treatment centers