[Federal Register: December 8, 2006 (Volume 71, Number 236)]
[Rules and Regulations]
[Page 71377-71428]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr08de06-18]
[[Page 71377]]
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Part IV
Department of Health and Human Services
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Centers for Medicare & Medicaid Services
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42 CFR Part 482
Medicare and Medicaid Programs; Hospital Conditions of Participation:
Patients' Rights; Final Rule
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
42 CFR Part 482
[CMS-3018-F]
RIN 0938-AN30
Medicare and Medicaid Programs; Hospital Conditions of
Participation: Patients' Rights
AGENCY: Centers for Medicare & Medicaid Services (CMS), DHHS.
ACTION: Final rule.
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SUMMARY: This final rule finalizes the Patients' Rights Condition of
Participation (CoP) which is applicable to all Medicare- and Medicaid-
participating hospitals and contains standards that ensure minimum
protections of each patient's physical and emotional health and safety.
It responds to comments on the following standards presented in the
July 2, 1999 interim final rule: Notice of rights; exercise of rights;
privacy and safety; confidentiality of patient records; restraint for
acute medical and surgical care; and seclusion and restraints for
behavior management. As a result of comments received, we have revised
the standards regarding restraint and seclusion and set forth standards
regarding staff training and death reporting.
DATES: Effective Date: These regulations are effective on January 8,
2007.
FOR FURTHER INFORMATION CONTACT: Patricia Chmielewski, RN, MS (410)
786-6899, Janice Graham, RN, MS (410) 786-8020, Monique Howard, OTR/L
(410) 786-3869, Jeannie Miller, RN, MPH (410) 786-3164, Rachael
Weinstein, RN, MPA (410) 786-6775.
SUPPLEMENTARY INFORMATION:
Table of Contents
I. Background
A. Overview
B. Key Statutory Provisions
C. Regulatory Background
D. Requirements for Issuance of Regulations
E. Restraint and Seclusion in Other Settings
II. Provisions of the Proposed and Interim Final Rules Regarding
Patients' Rights
III. Comments on and Responses to the Provisions of the Interim
Final Rule With Comment Period
A. General Comments on the Requirements for Use of Restraint and
Seclusion
1. Is There Cause for Concern?
2. The Difference Between Standards (e) and (f)
3. The Roles of CMS and JCAHO
4. Applicability of the Patients' Rights CoP
5. Debriefing After the Use of Restraint/Seclusion
B. Comments Received on Specific Provisions
1. The Right to Be Free From Restraint (Sec. Sec. 482.13(e)(1)
and (f)(1))
2. Definition of ``Restraint'' and ``Physical Restraint''
(Sec. Sec. 482.13(e)(1) and (f)(1))
3. Definition of a ``Drug Used as a Restraint'' (Sec. Sec.
482.13(e)(1) and (f)(1))
4. Use of Restraints (Sec. Sec. 482.13(e)(2) and (e)(3)(i))
5. Ordering of Restraint/Seclusion (Sec. Sec. 482.13(e)(3)(ii)
and (f)(3)(ii))
a. Definition of Licensed Independent Practitioner (LIP)
(Sec. Sec. 482.13(e)(3)(ii) and (f)(3)(ii))
b. Physician Only
c. Elimination of Protocols
d. Initiate versus Order
6. Prohibition on Standing and PRN Orders (Sec. Sec.
482.13(e)(3)(ii)(A) and (f)(3)(ii)(A))
7. Consultation with the Treating Physician (Sec. Sec.
482.13(e)(3)(ii)(B) and (f)(3)(ii)(B))
8. Written Modification of the Plan of Care (Sec. Sec.
482.13(e)(3)(iii) and (f)(3)(iii))
9. Implementation of and Appropriate Use of Restraint/Seclusion
(Sec. Sec. 482.13(e)(3)(iv), (e)(3)(v), (f)(3)(iv), and (f)(3)(v))
10. Discontinuing the Use of Restraint/Seclusion (Sec. Sec.
482.13(e)(3)(vi) and(f)(3)(vi))
11. Assessment, Monitoring, and Evaluation of the Restrained/
Secluded Patient (Sec. Sec. 482.13(e)(4) and (f)(5))
12. Staff Training in the Use of Restraints/Seclusion
(Sec. Sec. 482.13(e)(5) and (f)(6))
13. Definition of Seclusion (Sec. 482.13(f)(1))
14. Use of Restraint/Seclusion for Behavior Management (Sec.
482.13(f)(2))
15. One Hour Rule (Sec. 482.13(f)(3)(ii)(C))
a. Comments Objecting to a Physician or LIP Seeing the Patient
Within 1 Hour
b. Comments Supporting Telephone Consultation with a Nurse
Onsite Performing the Patient Assessment
c. Comments Opposing Telephone Orders, Nurse Evaluation, and LIP
Involvement
d. Comments Stating that the 1-Hour Rule Did Not Address the
Problem
16. Limits for Restraint/Seclusion Orders (Sec.
482.13(f)(3)(ii)(D))
17. Simultaneous Use of Restraint and Seclusion (Sec.
482.13(f)(4))
18. The Use of Video and Audio Monitoring
19. Reporting of Death(s) Related to Restraint/Seclusion (Sec.
482.13(f)(7))
IV. Provisions of the Final Rule
V. Collection of Information Requirements
VI. Regulatory Impact Analysis
A. Overall Impact
B. Anticipated Effects
1. Effects on Providers
a. Section 482.13(e) Standard: Restraint or Seclusion
b. Section 482.13(f) Standard: Restraint or Seclusion: Staff
Training Requirements
c. Section 482.13(g) Standard: Death Reporting Requirements
2. Effect on Beneficiaries
3. Effect on the Medicare and Medicaid Programs
C. Alternatives Considered
Regulations Text
I. Background
A. Overview
This rule set forth final requirements for Patients' Rights in
hospitals, provides strong patient protections, provides flexibility to
providers, and is responsive to comments. This regulation focuses on
patient safety and the protection of patients from abuse. These
standards support and protect patients' rights in the hospital setting;
specifically, the right to be free from the inappropriate use of
restraint and seclusion with requirements that protect the patient when
use of either intervention is necessary. It recognizes the legitimate
use of restraint for acute medical and surgical care as a measure to
prevent patient injury, as well as the use of restraint or seclusion to
manage violent or self-destructive behavior that jeopardizes the
immediate physical safety of the patient, a staff member, or others. In
addition, this rule finalizes, without modification, the standards for
Notice of Rights, Exercise of Rights, Privacy and Safety, and
Confidentiality of Patient Records.
B. Key Statutory Provisions
Sections 1861(e) (1) through (8) of the Social Security Act (the
Act) define the term ``hospital'' and list the requirements that a
hospital must meet to be eligible for Medicare participation. Section
1861(e)(9) of the Act specifies that a hospital must also meet such
other requirements as the Secretary finds necessary in the interest of
the health and safety of the hospital's patients. Under this authority,
the Secretary has established in regulations at 42 CFR part 482 the
requirements that a hospital must meet to participate in the Medicare
program.
Section 1905(a) of the Act provides that Medicaid payments may be
applied to hospital services. Regulations at Sec. 440.10(a)(3)(iii)
require hospitals to meet the Medicare CoPs to qualify for
participation in Medicaid.
The Children's Health Act of 2000 (CHA) (Pub. L. 106-310) was
enacted October 17, 2000. Section 3207 of the CHA amended Title V of
the Public Health Service Act (PHSA) by adding a new part H, which
contains requirements relating to the rights of residents of certain
facilities. Specifically, section 591 of the PHS Act, as added by the
CHA (42 U.S.C. 290ii), establishes certain minimum requirements with
regard to the use of restraint and seclusion in facilities that receive
support in any form from any program supported in whole or in part
[[Page 71379]]
with funds appropriated to any Federal department or agency. In
addition, Sections 592 and 593 of the PHS Act (42 U.S.C. 290ii and
290ii-3) establish minimum mandatory death reporting and staff training
requirements. This final rule conforms to the requirements of the CHA.
As implementing regulations are issued, a critical point for
consideration is that Title V, part H of the PHS Act is not an isolated
enactment, but part of a trend of legislation and regulations aimed at
protecting and promoting resident, patient, and client rights. Part H,
section 591(c) of the PHS Act states ``This part shall not be construed
to affect or impede any Federal or State law or regulations that
provide greater protections than this part regarding seclusion and
restraint.'' The value of preserving existing law and regulations is
recognized while extending protections to those facilities that are
currently without the protection intended by the Congress.
C. Regulatory Background
In the December 19, 1997 Federal Register (62 FR 66726), we
published a proposed rule entitled ``Medicare and Medicaid Programs;
Hospital Conditions of Participation; Provider Agreements and Supplier
Approval'' to revise the entire set of CoPs for hospitals found at 42
CFR part 482. This proposed rule included a CoP for patients' rights.
In the July 2, 1999 Federal Register (64 FR 36070), we published the
Patients' Rights CoP as an interim final rule with comment. This CoP
was separated from the other proposed hospital CoPs in response to
Congressional and public interest. Although we have modified some of
the provisions to address public comments, these modifications do not
lessen protections afforded patients who are restricted or secluded. We
note that we have revised the regulation to expand training
requirements and have added a requirement that the attending physician
or other licensed independent practitioner (LIP) responsible for the
care of the patient be consulted as soon as possible when the ``one
hour'' evaluation of a patient in restraint or seclusion is conducted
by a trained registered nurse (RN) or physician assistant (PA).
D. Requirements for Issuance of Regulations
Section 902 of the Medicare Prescription Drug, Improvement, and
Modernization Act of 2003 (MMA) amended section 1871(a) of the Act and
requires the Secretary, in consultation with the Director of the Office
of Management and Budget, to establish and publish timelines for the
publication of Medicare final regulations based on the previous
publication of a Medicare proposed or interim final regulation. Section
902 of the MMA also states that the timelines for these regulations may
vary but shall not exceed 3 years after publication of the preceding
proposed or interim final regulation except under exceptional
circumstances. In a notice published December 30, 2004 (69 FR 78442),
we implemented section 902 of the Act by announcing that all
outstanding interim final rules as of December 8, 2003 would be
finalized by December 8, 2006 or expire.
This final rule finalizes provisions set forth in the July 2, 1999
interim final rule with comment. In accordance with section 902 and our
notice of 2004, this final rule is being published within 3 years of
the date of enactment of the MMA, which was December 8, 2003, in order
to finalize the 1999 interim final rule with comment.
E. Restraint and Seclusion in Other Settings
In the preamble of the July 2, 1999 interim final rule with comment
period, we explained that we were considering the advisability of
adopting a consistent restraint and seclusion standard that would apply
not only to hospitals but to other kinds of health care entities with
which CMS has provider agreements, including those that provide
inpatient psychiatric services for individuals under 21 years of age (a
program under Medicaid). We asked the public whether we should adopt
the same standards that appeared in the July 2, 1999 interim final rule
with comment period, or whether we should adopt more stringent
standards.
Consumer advocacy groups that commented on extending these
requirements to other settings generally argued for more stringent
expectations for the care of children, citing special hazards and
concerns that arise when children and adolescents are restrained. Some
commenters encouraged CMS to apply the restraints and seclusion
standards of the interim final rule with comment period to all other
Medicaid-funded facilities, particularly residential treatment centers
for children and adolescents.
Other commenters did not agree with this approach, arguing that the
fields of mental health and developmental disabilities are very
different and that similarities between the two should not be assumed.
For example, some commenters stated that little research exists on the
use of restraint/seclusion in mental health, but that in contrast, a
considerable amount of research in the developmental disabilities field
supports the effectiveness of restraint and seclusion for severe
behavior problems. Thus, the field of developmental disabilities
already has extensive guidelines, standards, and rules governing the
use of restraint and seclusion.
Some of those commenters who supported uniform restraint and
seclusion standards across settings offered detailed suggestions for
what those standards should require. For example, commenters suggested
that the regulation forbid the use of mechanical restraints for
children under a certain age (these commenters offered varying
suggestions regarding the threshold age (17 and 21 years of age were
two of these suggestions)), or permit therapeutic holding for periods
no longer than 15 minutes. Some of the commenters expressed concern
about proposing requirements that paralleled existing requirements for
hospitals because of the differences in patient acuity and
characteristics and treatment.
We considered the comments we received in developing specific
restraint and seclusion requirements for inpatient psychiatric services
for individuals under 21 years of age. These requirements were
published in an interim final rule with comment period entitled,
``Medicaid Program; Use of Restraint and Seclusion in Psychiatric
Residential Treatment Facilities Providing Services to Individuals
under Age 21'' in the January 22, 2001 Federal Register (66 FR 7148).
In the May 22, 2001 Federal Register (66 FR 28110), we published an
additional interim final rule with comment period to amend and further
clarify the January 22, 2001 interim final rule with comment period.
There was little comment on extending restraint and seclusion
requirements to specific non-behavioral or non-psychiatric types of
settings or providers, such as home health agencies, ambulatory
surgical centers, or providers of x-ray services. While a few
commenters gave blanket support to this idea, they did not supply a
rationale for applying one set of standards versus another. Several
commenters discussed their concern about extending the restraint and
seclusion requirements to the nursing home setting and strongly
disagreed with any adoption of the standards presented in the interim
final rule with comment period in that setting. One nursing home
industry association argued for consistency in terminology and
philosophy, but recognized that the settings where beneficiaries
receive services are diverse, as are the beneficiaries
[[Page 71380]]
themselves, and that adopting a blanket approach might not be practical
or appropriate.
After considering these comments and engaging in internal
deliberations, we have decided that it would not be appropriate to
adopt a detailed, technical approach that would create an identical
standard for all of the providers with which CMS has agreements.
Instead, the needs of specific treatment populations and settings
should drive the types of standards developed. Therefore, we do not
plan to adopt the hospital requirements verbatim for other provider
types.
However, we are concerned about beneficiaries receiving care in
settings where no regulatory protections regarding the use of restraint
or seclusion currently exist. The CHA provides statutory protection to
patients at any facility receiving Federal funding. While it is
impractical, in our view, to take the requirements for hospitals,
nursing homes, or intermediate care facilities for the mentally
retarded and adopt them as a whole in any other given setting, we can
instead develop any new requirements with the same philosophical
foundation that underlies the three existing sets of standards and
requirements. This foundation encompasses the belief that the patient
has the right to be free from unnecessary restraint or seclusion, that
using a restraint for convenience, punishment, retaliation, or coercion
is never acceptable, and that each patient should be treated with
respect and dignity. These beliefs are true in every care setting and
are legally enforceable in accordance with the CHA. As appropriate, we
will develop regulations that support these concepts. However, given
the variations in treatment populations and settings, the individual
case setting will drive the type of standards developed which will vary
as appropriate.
II. Provisions of the Proposed and Interim Final Rules Regarding
Patients' Rights
The December 19, 1997 hospital CoP proposed rule included a
patients' rights CoP that proposed to establish standards for the
following:
Notice of rights.
Exercise of rights regarding care.
Privacy and safety.
Confidentiality of patient records.
Seclusion and restraint.
With the exception of the standard for seclusion and restraint, we
received few comments in response to these proposed requirements.
In the July 2, 1999 Federal Register, we published an interim final
rule with comment period that separated the patients' rights CoP from
the other hospital CoPs and introduced modifications to proposed
standard (e) and added a new standard (f), governing the use of
restraint and seclusion. Because we received few comments on the other
provisions of the patients' rights section (standards a through d),
these four provisions were not reopened for public comment in the July
2, 1999 interim final rule with comment period.
In the 1997 proposed rule, standard (e) was entitled ``Seclusion
and restraint,'' and covered the patient's right to be free of
restraint or seclusion used as a means of coercion, convenience, or
retaliation by staff. The proposed language set forth several basic
ideas and expectations; namely, that restraint (including
psychopharmacological drugs used as restraints) and seclusion must be
used in accordance with the patient's plan of care; that restraints or
seclusion may be used only as a last resort and in the least
restrictive manner possible to protect the patient or others from harm;
and that restraint or seclusion must be removed or ended at the
earliest possible time.
The interim final rule with comment period introduced two standards
on restraint and seclusion--one governing the use of restraint in the
provision of acute medical and surgical care and the other governing
the use of seclusion and restraint for behavior management. The revised
standard (e) included definitions that had not specifically appeared in
the proposed rule and also included: (1) A prohibition on standing
orders or orders on an as needed basis (that is, PRN) for restraint;
(2) an emphasis on continual assessment and monitoring; and re-
evaluation of the condition of the restrained patient; (3) a
requirement that the hospital notify the patient's treating physician
if he/she did not issue the restraint order personally; and (4) a
training requirement for all staff with direct patient contact.
Standard (f) offered definitions and provided more prescriptive
requirements than the proposed or revised standard (e). The focus on
behavior management in standard (f) was intended to apply in situations
where the patient's aggressive or violent behavior creates an emergency
situation that places his or her safety or that of others at risk. The
more prescriptive elements, such as--(1) requiring a physician or
licensed independent practitioner (LIP) to see and evaluate the need
for restraint or seclusion within 1-hour of the initiation of the
intervention; (2) the limitation on the length of orders and required
re-evaluation; and (3) the requirement for continual face-to-face
monitoring or continual monitoring using both video and audio equipment
if restraint and seclusion are used simultaneously, were meant to be
commensurate with the increased risk to patient health and safety when
these interventions are used to address violent or aggressive patient
behavior.
In both standards (e) and (f) of the July 2, 1999 interim final
rule with comment period, the phrase ``psychopharmacological drugs used
as restraints'' was replaced with the phrase ``drug used as a
restraint,'' in recognition of the idea that singling out one type of
medication encourages the misperception that only one class of drugs is
used to restrain patients.
Concern for patient health and safety prompted us to make these
requirements effective on August 2, 1999. However, given the changes to
the proposed standard (e) and the addition of standard (f), we believed
that the public should have an opportunity to comment on the revised
restraint and seclusion provisions. For these reasons, we published the
July 2, 1999 rule as an interim final rule with comment period.
III. Comments on and Responses to the Provisions of the Interim Final
With Comment Period
We received approximately 4,200 timely comments on the interim
final rule with comment period. Comments were received from hospitals,
mental health treatment facilities, physicians, nurses, attorneys,
professional associations, accrediting bodies, state agencies, national
and State patient protection and advocacy groups, and members of the
general public. Many commenters applauded the addition of the restraint
and seclusion provisions in the Patients' Rights CoP, even if they
disagreed with specific requirements or concepts. A summary of the
comments received on these provisions (standards (e) and (f)) and our
responses follows.
We received comments on issues out of the scope of the interim
final rule with comment period; these comments will not be addressed in
this final rule.
A. General Comments on the Requirements for the Use of Restraint and
Seclusion
Some commenters suggested that the 1-hour physician or LIP visit
and assessment were not consistent with the goal of creating a
government that works better and costs less. A few commenters stated
that the rapid introduction of standards (e) and (f) was a ``knee-jerk
[[Page 71381]]
reaction'' to the lobbying of certain groups and the sensationalized
media coverage of a limited number of cases. One commenter stated, ``It
is time the legislature and administrative agencies stop reacting to
sensational headlines and layering the health care system with costly
and time consuming regulations to meet.'' Another commenter questioned
the validity of the 1998 Hartford Courant series of articles (cited in
the preamble to the interim final rule with comment period), asserting
that the articles did not clearly determine that the use of restraint
and seclusion were the proximate and sole cause of deaths in the cases
cited. The same commenter asked in which setting these deaths occurred,
stating that it makes no sense to regulate a hospital on this point if
there is no evidence that restraint-related deaths are problematic in
hospitals. Another commenter questioned the FDA's estimate of at least
100 deaths per year from improper use of restraints, specifically
noting that he believes that these are not cases where restraint use
was unmerited. Another commenter stated that while the abuse and deaths
that have occurred are unfortunate, they do not represent an emergency
situation meriting the actions that were taken by CMS. The commenter
made the following statement:
While 142 deaths in 10 years is unfortunate, the number pales
when compared to the 3 million people hospitalized per year for
adverse drug reactions and 150,000 deaths resulting from drugs taken
properly as prescribed by the physician.
A commenter stated that CMS has given too much credence to over-
dramatized accounts of restraint and seclusion use. Many hospitals
reported having no injuries or deaths associated with restraint or
seclusion use. A number of physicians also noted that none of their
patients have suffered serious injuries or died due to the use of
restraints. One commenter stated that it was unfair to subject the
industry as a whole to highly prescriptive requirements when the events
that triggered such concern occurred in a handful of facilities. The
commenter argued that only the hospitals where the deaths occurred
should be governed by these rules. Another commenter suggested that in
the situations where these deaths occurred, the practices used were out
of compliance with the hospitals' own policies and procedures.
Accordingly, the commenter stated that prescriptive regulations do not
represent the gateway to reduced injuries and deaths, and that
enforcement of existing requirements would be more effective. Still
other commenters have suggested that even if death and injury are of
concern, CMS has not yet hit upon the correct solution.
To balance these comments, we mention those received from advocacy
groups, patients, and hospital staff. Some of the anecdotal information
provided was clearly disturbing, including accounts of patients being
choked during takedowns even though staff had been trained in proper
procedures, and patients suffering broken limbs or other injuries.
Other commenters described situations where patients had been placed in
restraints for extended periods of time (up to 10 consecutive hours)
and staff did not take vital signs regularly, did not offer food,
fluids, or use of the toilet at all, or offered them only once while
the patient was restrained. Comments also related concerns about the
over use and inappropriate use of restraint or seclusion. One commenter
stated that a lawsuit was filed on behalf of a patient dually diagnosed
with mental retardation and organic brain syndrome who was placed in
restraints 48 times within a six month period. The commenter stated
that in the six months after the lawsuit was settled, the patient had
only been restrained twice.
Many commenters applauded the regulatory action. Commenters stated
that the action was long overdue and important for the safety of
vulnerable populations most in need of protection from abuse of
restraints and seclusion. Commenters see this rule as a major step
forward in addressing issues surrounding the use of restraint and
seclusion in inpatient facilities and support further movement toward
the goals of ultimately eliminating the use of seclusion and restraint,
and preserving patients' rights and dignity. In addition, many
commenters stated that they would like to see even more stringent
requirements for the use of restraint and seclusion for behavior
management.
1. Is There Cause for Concern?
Given the prevalence of restraint use, we believe that awareness
and vigilance are justified. On October 11, 1998, the Hartford Courant
reported that of the 142 deaths it confirmed, 59.6 percent occurred in
the hospital setting (including psychiatric hospitals and psychiatric
wards of general hospitals). The Courant further stated that 47.2
percent of the 142 deaths involved physical restraints or therapeutic
holds, while 44.1 percent involved mechanical restraint, 3.1 percent
involved a combination of the two, and the remaining 5.5 percent were
seclusion-related. Although the Courant did not claim that restraint
and seclusion use were the sole and proxmate cause of death in each
case, we question the usefulness of this criterion in determining
whether restraint and seclusion pose significant risk to health and
safety. Obviously, when a patient's trachea is crushed during a
takedown, restraint would constitute the ``sole and proximal'' cause of
death. However, a case cited by one commenter illustrates how this
characterization may fail to take into account the many times that
restraint or seclusion can play a part in injury. The commenter
reported that one young man died after suffering a severe asthma attack
soon after fighting with another patient and being restrained. The
death was ruled to be due to natural causes, even though the medical
examiner found that both the stress of the fight and the restraint
triggered the asthma attack. One cannot only consider whether restraint
or seclusion is the sole cause of death when examining whether the use
of restraint or seclusion poses a significant risk to the patient.
One commenter questioned the statistical significance of 142 deaths
over a 10-year period. This number may not reflect the actual number of
such deaths that occur each year. In explaining how it conducted its
investigation, the Courant noted, ``Throughout the reporting * * * it
became clear that many deaths go unreported.'' To better determine the
national annual death rate, the Courant hired statistician Roberta
Glass, a research specialist for the Harvard Center of Risk Analysis at
the Harvard School of Public Health. The Courant reported the
following:
Glass projected that the annual number of deaths could range as
high as 150. ``Admittedly, the estimates are only rough
approximations,'' Glass said. ``The data needed for precise
estimation are not collected in a systematic way nationwide.''
On October 26, 1999, Associate Director Leslie Aronovitz of the
U.S. Government Accountability Office provided testimony before the
Senate Committee on Finance entitled, ``Extent of Risk from Improper
Restraint or Seclusion is Unknown.'' Aronovitz testified to the
following:
Neither the federal government nor the states comprehensively
track the use of restraint or seclusion or injuries related to them
across all types of facilities that serve individuals with mental
illness or mental retardation * * * Because reporting is so
piecemeal, the exact number of deaths in which restraint or
seclusion was a factor is not known. We contacted the P&As
[[Page 71382]]
[protection and advocacy agencies] for each state and the District
of Columbia and asked them to identify people in treatment settings
who died in fiscal year 1998 and for whom restraint or seclusion was
a factor in their death. The P&As identified 24, but this number is
likely to be an understatement, because many states do not require
all or some of their facilities to report such incidents to P&As.
The lack of systemic information collection is an important point.
The Joint Commission on Accreditation for Healthcare Organizations
(JCAHO), which accredits 80 percent of the hospitals that participate
in Medicare and Medicaid, does not require hospitals to report
``sentinel events'' such as injuries or deaths related to restraint or
seclusion use, but encourages voluntary reporting through its sentinel
event program. JCAHO defines a sentinel event as ``an unexpected
occurrence involving death or serious physical or psychological injury,
or the risk thereof.'' Even if each of the accredited hospitals
scrupulously and voluntarily reports sentinel events, the 20 percent of
Medicare- and Medicaid-participating hospitals that are non-accredited
do not provide this information to JCAHO. Since reporting is voluntary
rather than mandatory, accredited hospitals may choose not to inform
JCAHO. Hospitals may fear that reported information might be used
against them in court, which would provide a clear disincentive to
consistent and voluntary reporting.
Even if Glass' projection of up to 150 deaths per year is correct,
some may question its statistical significance when compared with the
number of deaths that result from other factors, such as medical
errors. We believe that while deaths are a focal point, it is important
not to discount patient injuries. If deaths are under-reported, injury
data are even more elusive. Estimating the psychological and social
impact of restraint or seclusion is more challenging still. We do not
imply that most of the nation's providers recklessly seclude or
restrain patients without regard to their emotional well-being. To the
contrary, many who commented on this regulation stated that restraint
or seclusion are measures of last resort and that they do not undertake
these interventions unless absolutely necessary. However, even when a
restraint or seclusion is needed, the patient may feel dehumanized,
isolated, or depressed as a result. Physical impact, although arguably
not simple to measure, is more easily monitored and reported than
impact on the spirit.
In summary, we suspect that patient deaths and injuries are
underreported, and, even if all parties voluntarily report incidents
involving restraint or seclusion or comply with State and local
reporting requirements, there are gaps in the system that thwart
conclusive calculation of the number of physical injuries and deaths
associated with restraint and seclusion use. Given the prevalence of
use, the potential for injury, death, or adverse psychological impact,
we maintain our original position--that this area deserves regulatory
attention to safeguard patient health and safety.
2. The Difference Between Standards (e) and (f)
Comment: Many commenters stated that it is unclear which standard
applies in any given situation. One commenter recommended that we
delineate a clear, objective explanation of when application of the
behavior management standard outside the psychiatric care setting is
expected. One commenter objected to the creation of separate
requirements for the care of psychiatric patients versus those
receiving acute medical treatment, and asserted that all patients
should be treated equally. However, most commenters agreed that
different requirements should apply to restraints used for violent,
aggressive patients as opposed to restraints used in the provision of
medical care; some suggested that setting-specific requirements are
more reasonable than behavior-specific ones.
Response: Based on public comment regarding the lack of clarity
between the application of standard (e) Restraint for acute medical and
surgical care, and the application of standard (f) Restraint and
seclusion for behavior management, we have revised and combined these
requirements into a single standard in the final rule. This combined
standard, entitled ``Restraint or seclusion,'' is subparagraph (e)
under Sec. 482.12 Patients' Rights in the final rule. This combined
standard (e) applies to all uses of restraint or seclusion regardless
of the patient's location. Although we have modified some of the
provisions to address public comments, these modifications do not
lessen protections afforded patients who are restricted or secluded. We
note that we have revised the regulation to expand training
requirements, and have added a requirement that the attending physician
or other licensed independent practitioner (LIP) responsible for the
care of the patient be consulted as soon as possible when the one-hour
restraint or seclusion evaluation of the violent or self-destructive
patient is conducted by a trained registered nurse (RN) or physician
assistant (PA).
Comment: A few commenters noted the challenge of making a
determination on the standard of care for a patient with multiple
diagnoses and behaviors.
Response: We agree that multiple diagnosis and behaviors can make
determination on the standard of care a challenge. Therefore, even
though several requirements were revised based on public comments, none
of the current requirements in standards (e) and (f) have been deleted.
All of the requirements contained in the current standard (e) are also
contained in the current standard (f). These requirements, in their
entirety, have been moved to the combined standard (e) in the final
rule. All of the requirements contained in the current standard (f),
have also been moved, in their entirety, to the combined standard (e)
in the final rule.
Comment: One commenter noted the difficulty in enforcing behavior-
specific standards. However, another commenter supported writing the
standards to focus on patient behavior or circumstances rather than on
the setting. Some commenters requested clarification on what ``behavior
management'' means.
Response: For the purpose of clarity we have eliminated the term
``behavior management'' and are using more specific language. The
management of violent or self-destructive behavior can occur as part of
medical and surgical care as well as part of psychiatric care. The use
of the language ``violent or self-destructive behavior'' is intended to
clarify the application of these requirements across all patient
populations. It is not intended to single out any particular patient
population. Based on public comments, we have eliminated the language
``behavior management,'' and have used clearer, more descriptive
language in the final rule. Specifically, we have revised the
regulations text at 482.13(e) to provide that restraint or seclusion
may only be imposed to ensure the immediate physical safety of the
patient, a staff member, or others, and must be discontinued at the
earliest possible time. This combined standard clearly outlines the
requirements any time restraint or seclusion is used, regardless of the
patient's location. We do not support a setting-based approach because
interventions and protections provided without considering the
patient's behavior and symptoms may fail to adequately safeguard the
health and safety of patients. In addition, this standard is not
targeted only at patients on psychiatric units or those with
behavioral/mental health care needs. The patient protections contained
in this standard apply to all patients when
[[Page 71383]]
the use of restraint or seclusion becomes necessary.
Although a patient's violent or self-destructive behavior may
jeopardize the immediate physical safety of the patient, a staff
member, or others more frequently in a psychiatric unit or in a
psychiatric hospital, this behavior also appears in the acute medical/
surgical care settings, including emergency and critical care settings.
Some examples follow. A patient may experience a severe medication
reaction that causes him or her to become violent. A patient may be
withdrawing from alcohol and having delirium tremors (DTs). The patient
is agitated, combative, verbally abusive, and attempting to hit staff.
Regardless of facility type, such emergencies generally pose a
significant risk for patients and others. For the safety of the patient
and others, the use of restraint or seclusion may be necessary to
manage the patient's violent or self-destructive behavior that
jeopardize the immediate physical safety of the patient, a staff
member, or others when less restrictive interventions have been
determined to be ineffective to protect the patient, staff, or others
from harm. It is not targeted only at patients on psychiatric units or
those with behavioral/mental health care needs. The patient protections
contained in this standard apply to all patients when the use of
restraint or seclusion becomes necessary.
Comment: One commenter suggested adding language in Sec.
482.13(f)(2) to indicate that standard (f) applies when a restraint or
seclusion is used, ``In an emergency situation to manage an
unanticipated outburst of severely aggressive or destructive behavior
that poses an imminent danger to the patient or others.'' Several
commenters suggested changing the title of standard (f), examples
include, ``Emergency behavior management'' and ``Seclusion/restraint
for patients with primary behavioral health care needs.''
Response: The current standard (e) contains two requirements that
are more stringent, if restraint or seclusion is used when a patient
jeopardizes the immediate physical safety of the patient, a staff
member, or others. They are: time limits on length of each order, and
the 1-hour face-to-face evaluation. The intent of these more stringent
requirements is to add additional patient protections when restraint or
seclusion is used for behavior management. We do not intend for these
two more stringent requirements to apply to all uses of restraint. We
have added clarifying language in the final rule that these
requirements apply when restraint or seclusion are used for the
management of violent or self-destructive behavior that jeopardizes the
immediate physical safety of the patient, a staff member, or others. We
have also specified that seclusion is only permitted to manage violent
or self-destructive behavior that jeopardizes the immediate physical
safety of the patient, a staff member, or others.
Since publication of the interim final rule with comment period, we
have repeatedly responded to inquiries regarding the criteria for
differentiating between emergency situations where the patient's
behavior is violent or self-destructive and jeopardizes the immediate
physical safety of the patient, a staff member, or others versus the
non-emergency use of restraint. Most of the individuals to whom we
spoke indicated that this distinction was clear and understandable.
Clinicians are adept at identifying behavior and symptoms, and can
readily recognize violent and self-destructive behavior that
jeopardizes the immediate physical safety of the patient, a staff
member, or others. Asking them to act based on evaluation of the
patient's behavior is no different than relying on the clinical
judgment that they use daily in assessing the needs of each patient and
taking actions to meet those individual needs.
In the final rule, we adopted the restraint definition contained in
the CHA. Because the requirements governing the use of restraint or
seclusion have been combined in a single standard, we also have a
single, consistent definition of restraint. A restraint is any manual
method, physical or mechanical device, material, or equipment that
immobilizes or reduces the ability of a patient to move his or her
arms, legs, body, or head freely; or a drug or medication when it is
used as a restriction to manage the patient's behavior or restrict the
patient's freedom of movement and is not a standard treatment or dosage
for the patient's condition. The final rule also clarifies that a
restraint does not include devices, such as orthopedically prescribed
devices, surgical dressings or bandages, protective helmets, or other
methods that involve the physical holding of a patient for the purpose
of conducting routine physical examinations or tests, or to protect the
patient from falling out of bed, or to permit the patient to
participate in activities without the risk of physical harm (this does
not include a physical escort). The devices and methods described above
are typically used in medical/surgical care, and would not be
considered restraints, and thus not subject to these requirements.
The final, combined standard (e) applies to the use of restraint,
the use of seclusion, as well as the simultaneous use of restraint and
seclusion. To clarify this point, we have adopted use of the word
``or'' in the final, combined standard for restraint and seclusion. The
use of ``or'' imports the ``and,'' whereas ``and'' standing alone
requires that both happen. It is not our intent that the requirements
in this standard only apply when both restraint and seclusion are used.
Therefore, throughout the regulation text, we have deleted ``and'' and
inserted ``or.'' The regulations apply to the use of restraint or
seclusion. This means they also apply when both restraint and seclusion
are used.
3. The Roles of CMS and JCAHO
Comment: Regarding any provision that was not identical to JCAHO's
policy, a host of commenters expressed concern that CMS's standards did
not parallel or actually ran counter to JCAHO's. One commenter stated
that these discrepancies would create an implementation burden for
hospitals. A number of commenters expressed concern that CMS was
straying from its stated intent of maintaining consistency between
Federal and accreditation standards.
Response: In the interim final rule with comment period (64 FR
36079), we stated, ``We believe it is appropriate to recognize JCAHO's
work in this area [regarding the length of physician or LIP orders] and
maintain consistency between Federal and accreditation standards when
possible.'' We adopted JCAHO's standard for time limited orders
because, upon examination, we found nothing to suggest that these
timeframes have been found faulty or that any more appropriate ones
have been scientifically determined. However, we did not intend to
suggest that we planned to follow JCAHO's standards in all respects.
Comment: One commenter suggested that the requirement that a
physician or LIP see a patient who is restrained or secluded for
behavior management within 1-hour is unnecessary because current
practice provides good patient care. The commenter cited JCAHO's
revision of its standards regarding restraints and seclusion and noted
that the hospital agreed with JCAHO and implemented those standards.
Further, the commenter reported that the hospital has an ongoing
improvement process, which has significantly decreased the use of
restraints and seclusion for its adult population.
[[Page 71384]]
To govern the use of restraint and seclusion for children, another
commenter suggested an approach similar to JCAHO's. The commenter
further suggested that national accreditation bodies could establish a
certification and approval process for nonviolent intervention regimes.
Additionally, the commenter suggested that accreditation surveys or
regulatory reviews could include thorough individual and aggregate
review of documentation of restraint and seclusion use.
Response: The hospital CoPs are minimum health and safety standards
that hospitals must meet to participate in the Medicare and Medicaid
programs. The CoPs are intended to protect patient health and safety
and to ensure that high quality care is provided to all patients. While
we applaud JCAHO's progress in the areas of examining restraint and
seclusion use, JCAHO accreditation is voluntary and not the only way
hospitals participate in the Medicare and Medicaid programs. Twenty
percent of the hospitals that participate in Medicare and Medicaid are
non-accredited. Non-accredited hospitals are surveyed by State survey
agencies to determine compliance with the CoPs. We have the
responsibility to ensure that all Medicare- and Medicaid-participating
hospitals have certain protections in place. Before July 2, 1999, the
CoPs contained no requirements concerning Patients' Rights.
Our minimum requirements need to exist in regulatory form in order
to carry the weight of the law and be enforceable. This final rule
informs the public and provider community of our minimum requirements
for the protection of patient health and safety while providing a sound
basis for legal action if we find that those requirements are not met.
While quality improvement initiatives and other internal efforts to
track restraints and seclusion use and eliminate inappropriate use are
important, we do not believe that they serve as a substitute for stated
minimum Federal requirements.
Comment: One commenter stated, ``Let's leave the seclusion and
restraint abusers to the civil courts and JCAHO, who are quite capable
of creating over-regulations without help from CMS.'' Conversely,
another commenter asserted,
``CMS bears a great deal of the blame for the deaths, injuries,
and serious long-term psychological harm which those aforementioned
patients and their families have endured because it did not amend
its CoPs to assure such desirable outcomes. The JCAHO standards were
available to CMS during those many years but it chose--for
unexplainable and unacceptable reasons--to maintain the status-
quo.''
Response: There were other such polarized responses to the interim
final rule with comment period. However, many commenters acknowledged
the appropriateness of regulation in this area even if they disagreed
with individual provisions of the interim final rule with comment
period.
The Congress has charged us with creating standards that protect
the nation's Medicare and Medicaid beneficiaries and ensure that these
beneficiaries receive high quality care. Many commenters came forward
with ideas about how the regulation could be changed and improved. Our
task is to reconcile these ideas when feasible, and determine the best,
most reasonable approach that promotes patient health and safety and
yet does not create a disincentive for providers to serve those
populations who most critically need their help.
Comment: A commenter stated that CMS's interest in alerting the
public to the potential dangers associated with the use of restraint
and seclusion is ``faddish.''
Response: This commenter's statement stood in stark contrast to
those of many of his contemporaries who wrote of their tireless efforts
to avert the potential hazards associated with the use of restraint and
seclusion, and of the seriousness with which they undertake such
interventions. While accounts of efforts to minimize use of restraint
and seclusion and assure patient safety were heartening, a few of the
letters we received were disturbing in their conceptualization of a
restraint or seclusion not only as wholly appropriate, but as a ``time-
honored'' standard of care. To that argument, we reply that standards
of care continually evolve. For example, at one time patient shackles
were considered a standard intervention. Habit does not justify the
continued use of an intervention when alternative methods that are
safer or more effective are available. The numerous training programs
that emphasize alternative techniques for handling violent or self-
destructive behavior and symptoms demonstrate that clinicians recognize
the risks inherent in the use of restraint and seclusion. Practitioners
in the field of medicine are constantly searching for better ways to
manage symptoms and conditions that have been traditionally treated
through the use of restraint or seclusion or both. We fully support
these efforts.
4. Applicability of the Patients' Rights CoP
Comment: One commenter stated that the preamble should explain the
application and effect of the new regulation on psychiatric hospitals.
If the regulation applies to psychiatric hospitals, the commenter
stated the requirements specified in standard (f) (among others) might
not be appropriate.
Response: In the summary of the interim final rule with comment
period (64 FR 36070), we explained, ``The Patients'' Rights CoP,
including the standard regarding seclusion and restraint, applies to
all Medicare- and Medicaid-participating hospitals, that is, short-
term, psychiatric, rehabilitation, long-term, children's, and alcohol-
drug.'' This final rule, including its provisions concerning the use of
restraint and seclusion, is explicitly intended to apply in the
psychiatric hospital setting.
We disagree with the opinion that the requirements in the current
standard (e) might not be appropriate for the psychiatric hospital
setting. While violent or self-destructive patient behavior that
jeopardizes the immediate physical safety of the patient, a staff
member, or others occasionally occurs on an acute care unit in a
hospital, it occurs more often on a psychiatric unit or in a
psychiatric hospital. When a patient's behavior becomes violent or
self-destructive, the immediate physical safety of the patient, a staff
member, or others is at risk. In such an emergency situation, it is
critical to ensure that staff is well trained in alternative
interventions and techniques; to ensure the safety and well being of
the patient and others; to manage the patient's behavior; and, to
competently apply restraints or use seclusion. Additionally, the
protections provided ensure that: the restrained or secluded patient is
appropriately monitored and that the patient's condition is reassessed;
the patient's medical and psychological conditions are evaluated; and,
the intervention is ended as quickly as possible. Therefore, we believe
that the protections in the current standard (f) that have been
relocated to the combined standard (e) in the final rule are
appropriate for the psychiatric care setting.
Comment: One commenter suggested that we need to develop a separate
category of patient rights for children that address their
developmental needs rights and other basic needs.
Response: The provisions contained in the Patients' Rights CoP
apply universally to all hospital patients,
[[Page 71385]]
including children. Although there is no separate category for
patient's rights on the basis of age, the regulations recognize
differences. Timeframes on orders for the use of restraints or
seclusion are different based on age. For example, for children and
adolescents 9 to 17 years of age, orders for restraint or seclusion are
limited to a maximum of 2 hours. When implementing these regulations,
we expect hospitals to develop and implement an approach that meets the
individualized needs of the patient populations that they serve.
Comment: One commenter stated that since there are no attending
physicians in religious non-medical facilities, amendments should be
made to incorporate the provisions of section 1861(ss) of the Act.
Response: Effective January 31, 2000, religious non-medical
facilities are not governed by the hospital CoPs, but by their own
requirements. The new requirements for religious non-medical facilities
do not permit the use of restraint or involuntary seclusion (Sec. Sec.
403.730(c)(4) and (5)). (For additional information, see the November
30, 1999 and November 28, 2003 Federal Registers (64 FR 67028) and (68
FR 66710), respectively).
5. Debriefing After the Use of Restraint/Seclusion
Comment: Many consumer advocates suggested creating a requirement
for debriefing staff and patients following each incident of restraint
or seclusion, and documenting the use of either procedure in the
patient's record. The debriefing's purpose would be to--(1) develop an
understanding of the factors that may have evoked the behaviors
necessitating the use of restraint or seclusion; (2) give the patient
time to verbalize his or her feelings and concerns; and (3) identify
strategies to avoid future use of seclusion or restraint. Another
commenter recommended that staff debriefing, followed by patient
debriefing, occur within 24 hours of each incident of restraint or
seclusion. One commenter noted that its hospital requires staff
debriefing as part of an approach that has dramatically reduced its
incidence of restraint and seclusion use.
Another commenter argued that debriefing is unnecessary in many
cases of restraint use. The commenter further stated that requiring
debriefing after each use of restraint or seclusion would create
unnecessary work.
``It is not uncommon for patients to require restraint or
seclusion for multiple episodes of aggression in a 24-hour time
period. The underlying rationale for debriefings, to avoid future
uses of restraint or seclusion, can be handled by other means,
including consultation with the physician or advance practice nurse
who authorizes restraint use. There could be debriefings when
incidents are critical in nature.''
Response: We agree that debriefing can be a useful, productive
exercise that helps both the patient and staff understand what has
happened and how such situations can be averted in the future. However,
we see the argument made by the opposing commenter as valid. The use of
restraint or seclusion is only permitted while the unsafe situation
persists, and must be discontinued at the earliest possible time. A
patient may have multiple uses of restraint or seclusion in a fairly
short timeframe. Requiring that a debriefing occur after each use may
be impractical or unnecessary. We believe that hospitals and clinicians
will use debriefing as a component of the treatment plan designed to
safely manage violent or self-destructive patient behavior that
jeopardizes the immediate physical safety of the patient, a staff
member, or others as necessary. Therefore, we are not requiring
debriefing.
Comment: One commenter suggested that a multidisciplinary team
should review each incident within 24 hours. Their review should be
part of the hospital's quality assurance and peer review procedures.
Response: We believe that hospitals will monitor restraint and
seclusion use through their Quality Assessment Performance Improvement
(QAPI) programs. Mandating that a multidisciplinary team review each
incident within 24 hours would be unnecessarily burdensome. Therefore,
we are not specifying that this must occur in this rule.
B. Comments Received on Specific Provisions
1. The Right To Be Free From Restraint (Sec. Sec. 482.13(e)(1) and
(f)(1))
We stated that the patient has the right to be free from restraints
of any form that are not medically necessary, or are used as a means of
coercion, discipline, convenience, or retaliation by staff. Section
482.13(f)(1) paralleled this requirement and stated that the patient
has the right to be free from seclusion and restraints, of any form,
imposed as a means of coercion, discipline, convenience, or retaliation
by staff.
Comment: Many commenters agreed with this general statement and
applauded our efforts to eliminate the inappropriate use of restraint.
However, some commenters stated that the procedural requirements
specified in the interim final rule for the appropriate use of
restraint were too idealistic.
Response: We appreciate the support expressed by many commenters.
Regarding concerns about the practicality of the current requirements,
we believe that some commenters have interpreted current standard to
require face-to-face monitoring in every clinical situation. Our intent
is that the restrained or secluded patient's condition be assessed and
monitored by a physician, other licensed independent practitioner or
trained staff at an interval determined by hospital policy. In this
final rule, we have amended the regulatory language at Sec.
482.13(e)(10) to reflect this. Hospital policies should address the
frequency of assessment and the assessment parameters (for example,
vital signs, circulation checks, hydration needs, elimination needs,
level of distress and agitation, mental status, cognitive functioning,
skin integrity). Hospital policies should guide staff in how to
determine an appropriate interval for assessment and monitoring based
on the individual needs of the patient, the patient's condition, and
the type of restraint used. It may be that a specific patient needs
continual face-to-face monitoring; or that the patient's safety,
comfort, and well-being are best assured by periodic checks. Continual
face-to-face monitoring is only required when restraint and seclusion
are used simultaneously to address violent or self-destructive behavior
that jeopardizes the immediate physical safety of the patient, a staff
member, or others. The hospital is responsible for providing the level
of monitoring and frequency of reassessment that will ensure the
patient's safety. In this final rule, we have also added language to
clarify that a restraint does not include devices, such as
orthopedically prescribed devices, surgical dressings or bandages,
protective helmets, or other methods that involve the physical holding
of a patient for the purpose of conducting routine physical
examinations or tests, or to protect the patient from falling out of
bed, or to permit the patient to participate in activities without the
risk of physical harm (this does not include a physical escort).
Comment: One commenter stated that he could not find legal
authority for health professionals to restrain their patients, absent
specific court orders. The commenter also noted that health
professionals might be excused for restraining patients only if the
purpose of restraint is to minimize an imminent risk of great bodily
harm, and only
[[Page 71386]]
when the need for restraint is not provoked by the health professional.
Response: We agree that consideration of the safety of the patient,
staff, or others is the basis for applying a restraint. We have
supported this approach in combined standard (e) by stating that all
patients have the right to be free from physical or mental abuse, and
corporal punishment, and have the right to be free from restraint or
seclusion, of any form, imposed as a means of coercion, discipline,
convenience, or retaliation by staff. Restraint or seclusion may only
be imposed to ensure the immediate physical safety of the patient,
staff or others and must be discontinued at the earliest possible time.
In the final rule, we have also stated that restraint or seclusion may
only be used when less restrictive interventions have been determined
to be ineffective to protect the patient or others from harm. Finally,
we have stated that the type or technique of restraint or seclusion
used must be the least restrictive intervention that will be effective
to protect the patient or others from harm.
Comment: Several commenters argued that few effective means of
therapeutic intervention for significant behavioral problems exist, and
that disallowing the use of restraint or seclusion might result in a
denial of treatment for individuals with significant problems because
of the limitation on what providers can do to address symptoms. These
commenters argued that providers would be unwilling to jeopardize staff
and others' safety or incur any liability associated with untreated
behaviors. Some commenters suggested that this regulation would result
in the increased use of other interventions, such as psychotropic
medications, to address behavioral challenges. Some suggested that
without the use of restraint or seclusion, patients would remain
incapacitated by their problems. Several commenters said that CMS
inappropriately excluded ``therapeutic'' uses of restraint, such as
therapeutic holding and medications.
Response: This final rule does not ban the use of restraint or
seclusion. However, it does prohibit the use of restraint or seclusion
that are imposed as a means of coercion, discipline, convenience, or
retaliation by staff. This final rule also establishes parameters to
assure patient safety when less restrictive interventions have been
determined to be ineffective to protect the patient, staff, or others
from harm. In the final rule, a restraint is any manual method,
physical or mechanical device, material, or equipment that immobilizes
or reduces the ability of a patient to move his or her arms, legs,
body, or head freely; or a drug or medication when it is used as a
restriction to manage the patient's behavior or restrict the patient's
freedom of movement and is not a standard treatment or dosage for the
patient's condition. A restraint does not include devices, such as
orthopedically prescribed devices, surgical dressings or bandages,
protective helmets, or other methods that involve the physical holding
of a patient for the purpose of conducting routine physical
examinations or tests, or to protect the patient from falling out of
bed, or to permit the patient to participate in activities without the
risk of physical harm (this does not include a physical escort. The
devices and methods listed here that would not be considered
restraints, and thus not subject to these requirements, are typically
used in medical surgical care. Although physical holding of a patient
for the purpose of conducting routine physical exams or tests is not
considered a restraint, all patients have the right to refuse
treatment. This patient right is addressed at Sec. 482.13(b)(2). The
use of therapeutic holds to manage violent or self-destructive behavior
that jeopardizes the immediate physical safety of the patient, a staff
member, or others would be considered a form of restraint and
therefore, would be subject to the requirements contained in this final
rule. If the definition of restraint is met, then that practice or
device (whether it is therapeutic holding or a mechanical device) is
considered a form of restraint and may be employed so long as all of
the requirements for restraint use are met.
In the interim final rule with comment period, the definition of
``drug used as a restraint'' specifically exempted medications that are
used as a standard treatment for the patient's medical or psychiatric
condition. Some commenters criticized this definition as being too
broad and subjective. This regulation is not intended to interfere with
the clinical treatment of patients who are suffering from serious
mental illness and who need appropriate therapeutic doses of
medications to improve their level of functioning so that they can more
actively participate in their treatment. Similarly, the regulation is
not intended to interfere with appropriate doses of sleeping medication
prescribed for patients with insomnia or anti-anxiety medication
prescribed to calm a patient who is anxious. Thus, those medications
that are a standard treatment for a patient's condition are not subject
to the requirements of this regulation.
In this final rule, we have defined a drug used as a restraint as a
drug or medication that is used as a restriction to manage the
patient's behavior or restrict the patient's freedom of movement and is
not a standard treatment or dosage for the patient's condition. We
believe this revised definition more clearly supports the role of
medications that facilitate the patient's participation in their care
and maintenance of the patient's functional status.
Comment: A commenter suggested that the word ``discipline'' should
be replaced with ``punishment,'' since the two words are not the same
in meaning and there are situations where patient discipline is
necessary.
Response: The distinction between the word ``discipline'' and
``punishment'' is a more relevant issue in the developmental
disability/mental retardation setting, as opposed to the psychiatric
and acute care settings. Therefore, we have retained the use of the
word ``discipline.''
Comment: One commenter opined that this regulation provides the
``right to fall and break a hip'' or ``crack your head open.'' Another
commenter who provides care to patients with dementia who ``need a vest
restraint [commonly referred to as a Posey vest] at night to prevent
them from falling out of bed, or getting up and falling in the
bathroom,'' questioned whether allowing these patients to fall
unnecessarily is more humane than restraining them. The commenter also
stated that while some patients can be medicated and restrained briefly
on an occasional basis, others--those with dementia or Alzheimers or
both, for example, need some type of restraint most of the time on a
permanent basis for their own safety.
Response: The final regulation states that devices that protect the
patient from falling out of bed are not restraints. However, when the
clinician raises all four side rails in order to restrain a patient,
(defined in this regulation as immobilizing or reducing the ability of
a patient to move his or her arms, legs, body, or head freely) to
ensure the immediate physical safety of the patient then the rule
applies. Raising fewer than four side rails when the bed has more than
two side rails, would not necessarily immobilize or reduce the ability
of a patient to move as defined in this regulation.
Practitioners and hospitals utilize a variety of measures to ensure
patient safety. Use of a restraint is only one of the possible
interventions.
[[Page 71387]]
Comprehensive assessment of the patient and the environment, in
conjunction with individualized patient care planning, should be used
to determine those interventions that will best ensure the patient's
safety and well-being with the least risk. However, as part of
clinician's decision-making, we would expect such an assessment to be
conducted regardless of whether or not the intervention to ensure
patient safety is considered a restraint under this regulation.
Clinical decision making, which includes assessments, would govern the
use of restrictions that are not covered by these requirements.
Regarding the idea that some patients require permanent restraint,
we contend that every patient is entitled to an individualized
assessment and treatment that takes into account the patient's
individual strengths, weaknesses, choices, needs, and concerns. For
example, most adults sleep at home in their beds each night without
being tied down or otherwise protected from falling out of bed. All use
of restrictions, whether governed by these regulations or not, should
be based on an individualized patient assessment and the use of all
available innovative alternatives and approaches to address patient
care needs. Again, we have not prohibited the use of restraints; but we
do prohibit using restraints as a substitute for adequate staffing,
monitoring, assessment, or investigation of the reasons behind patient
behavior such as wandering or getting up in the night, which may be
indicative of unmet patient care needs. When the use of restraints is
necessary, the combined standard (e) applies.
Comment: One commenter suggested adding the words, ``Or as a
replacement for adequate levels of staff,'' to the statement that
restraint may not be used as a means of coercion, discipline,
convenience, or retaliation by staff.
Response: The final regulation language states that all patients
have the right to be free from restraint or seclusion, of any form,
imposed for convenience. This language precludes using restraint or
seclusion as a substitute for adequate staffing levels. Therefore, we
have not accepted this comment.
Comment: One commenter suggested removing the words, ``medically
necessary,'' from (e)(1), arguing that physicians would not order
treatments that were not medically necessary. Another commenter,
however, described just such a case; namely, interventions undertaken
at the voluntary request of the patient, such as a cognitively intact
patient asking to have his or her bed's side rails put up. This
commenter asked if a voluntary request would be exempted from meeting
the regulatory requirements.
Response: In the final rule, ``not medically necessary'' has been
removed from the definition of restraint. Restraint may only be used to
ensure the immediate physical safety of the patient, staff, or others.
In addition, a restraint does not include devices, such as
orthopedically prescribed devices, surgical dressings or bandages,
protective helmets, or other methods that involve the physical holding
of a patient for the purpose of conducting routine physical
examinations or tests, or to protect the patient from falling out of
bed, or to permit the patient to participate in activities without the
risk of physical harm (this does not include a physical escort).
Often with the best of intentions, a patient or the patient's
family may ask for a restraint to be applied. For example, a concerned
husband may ask that his frail elderly wife be tied into bed to prevent
her from wandering. In both examples, the concern may be valid, and a
responsive intervention may be appropriate. However, a patient or
family member may be unfamiliar with the many innovative, less
restrictive alternatives available to address a patient's needs. Such a
request, like any other patient or family request for an intervention,
should prompt a patient and situational assessment to determine whether
an intervention is needed. If a need is confirmed, the practitioner
must then determine the type of intervention that will meet the
patient's needs with the least risk and most benefit to the patient. A
request from a patient or family member for the application of a
restraint which they would consider to be beneficial is not a
sufficient basis for the use of a restraint intervention. Regardless of
whether restraint use is voluntary or involuntary, if restraint (as
defined by the regulation) is used, then the requirements of the
regulation must be met. Finally, this rule would not preclude a
patient, or a patient's family member from requesting that his or her
side rail be raised.
Comment: One commenter asked whether the rule requires adding the
rights provided by standards (e) and (f) to the hospital's patients'
rights policies and procedures and/or a written notification provided
to the patient. The commenter argued that specifically stating these
rights would require increased staff time, would be a risk management
``nightmare,'' and would require a patient/family member release form
to be signed authorizing the use of a restraint, even when a restraint
is medically necessary.
Response: Standard (a), Notice of rights, requires patient
notification of his or her rights. We are not convinced that notifying
the patient of the right to be free from restraint or seclusion imposed
as a means of coercion, discipline, convenience, or retaliation by
staff, will take significantly more time than informing the patient of
his or her other rights, particularly since the hospital retains
extreme flexibility in how and when this notice is provided. We are
also uncertain why informing the patient of his or her rights would
present a risk management ``nightmare.'' Concerning the commenter's
third point, the rule does not require that the patient or his or her
representative sign release forms. A hospital may choose to introduce
this policy; however, depending on the mechanism the hospital uses to
provide this notification (for example, as a standard part of each
admissions packet; in posted forms in the admissions office or
emergency room area; bundled with existing required notices) such a
step may be unnecessary.
2. Definition of ``Restraint'' and ``Physical Restraint'' (Sec. Sec.
482.13(e)(1) and (f)(1))
In the interim final rule with comment period, we stated that the
term ``restraint'' includes either a physical restraint or a drug that
is being used as a restraint. A physical restraint is any manual method
or physical or mechanical device, material, or equipment attached or
adjacent to the patient's body that he or she cannot easily remove that
restricts freedom of movement or normal access to one's body.
Comment: One commenter recommended uniform definitions of restraint
and physical restraint across care settings to avoid confusion. Another
commenter suggested defining restraint as, ``the forcible and
involuntary deprivation of the liberty to move about.'' The same
commenter recommended classifying restraints in three categories: least
restrictive (manual restraint or holding); intermediate (seclusion, to
be defined as ``restricting voluntary movement by locking a patient in
a room. If an individual cannot leave the room at will, the room is
considered locked, whether the door is actually locked or not''); and
most restrictive and intrusive (mechanical restraints such as belts,
cuffs, or soft ties). Several other commenters argued for similar
categorization, with corresponding monitoring and ordering requirements
[[Page 71388]]
(that is, with consideration for the differences between interventions
such as a four-point restraint and a restraint used for frail
patients). One commenter argued that physical and mechanical restraints
should be defined separately rather than lumped into one category.
Response: We agree that a uniform definition of restraint across
care settings is a good approach, adds clarity, and avoids confusion.
In the final rule, we have combined the regulations governing the use
of restraint or seclusion into a single standard, and have adopted a
single, consistent restraint definition. This definition applies to all
uses of restraint in all hospital care settings. A restraint is any
manual method, physical or mechanical device, material, or equipment
that immobilizes or reduces the ability of a patient to move his or her
arms, legs, body, or head freely; or a drug or medication when it is
used as a restriction to manage the patient's behavior or restrict the
patient's freedom of movement and is not a standard treatment or dosage
for the patient's condition. The final rule also clarifies that a
restraint does not include devices, such as orthopedically prescribed
devices, surgical dressings or bandages, protective helmets, or other
methods that involve the physical holding of a patient for the purpose
of conducting routine physical examinations or tests, or to protect the
patient from falling out of bed, or to permit the patient to
participate in activities without the risk of physical harm (this does
not include a physical escort). This definition renders unnecessary the
otherwise impossible task of naming each device and practices that can
inhibit a patient's movement.
The concept of liberty of movement as proposed in this comment is
incorporated in the final rule at the beginning of combined standard
(e). All patients have the right to be free from restraint or
seclusion, of any form, imposed as a means of coercion, discipline,
convenience, or retaliation by staff. Restraint or seclusion may only
be imposed to insure the immediate physical safety of the patient,
staff, or others and must be discontinued at the earliest possible
time.
However, we did not break restraints into three classes or view
seclusion as a subset of restraint. We believe that the categorization
proposed by the commenter is somewhat arbitrary, particularly in light
of the fact that several of the deaths reported by the Hartford Courant
occurred during physical holds, which the commenter would have
categorized as ``least restrictive.'' This fact makes us wary of
suggesting, even implicitly, that physical holds are preferable to
mechanical restraint. The deaths resulting from other traditional
mechanical devices also persuade us of the hazards of using mechanical
restraints. The type of restraint used is not the defining hazard--
other variables, such as lack of patient assessment in choosing the
restraint, inappropriate application of the physical restraint
mechanism or technique, or inadequate patient monitoring could render
many interventions dangerous. Accordingly, given the unique
circumstances presented by each patient, we believe that it would be
inappropriate and would place patients at risk to arbitrarily suggest
that one form of restraint is categorically preferable to another.
Finally, we have streamlined and clarified monitoring requirements
in combined standard (e). The final rule states that the condition of
the patient who is restrained or secluded must be monitored by a
physician, other licensed independent practitioner or trained staff at
an interval determined by hospital policy. When restraint or seclusion
is used to manage violent or self-destructive behavior that jeopardizes
the immediate physical safety of the patient, a staff member, or
others, the patient must be seen and evaluated face-to-face within one
hour after the initiation of the intervention. This final rule provides
flexibility for trained staff to determine the monitoring parameters
necessary when a restraint or seclusion is used. The more stringent
continual monitoring requirements have been retained only for patients
who are simultaneously restrained and secluded for management of
violent or self-destructive behavior that jeopardizes the immediate
physical safety of the patient, a staff member, or others.
Comment: Some commenters asked whether the following constitute
restraint: therapeutic holding; comforting children through holding;
escorting or touching for de-escalation; virtually any type of
touching, like holding a patient's arm to prevent him from hitting the
wall; basket holds; or touching to encourage the patient to lie still
for a procedure. Many commenters argued that therapeutic holding is
necessary, and that the regulation should allow individualized
treatment.
Response: Several commenters mentioned different types of holding,
including therapeutic holding. For the purposes of this regulation, a
staff member picking up, redirecting, or holding an infant, toddler, or
preschool-aged child to comfort the patient is not considered
restraint. If an intervention meets the regulatory definition of
restraint, then that intervention constitutes a restraint and the
standards for restraint use must be followed. A restraint is any
method, physical or mechanical device, material, or equipment that
immobilizes or reduces the ability of a patient to move his or her
arms, legs, body, or head freely. A restraint does not include devices,
such as orthopedically prescribed devices, surgical dressings or
bandages, protective helmets, or other methods that involve the
physical holding of a patient for the purpose of conducting routine
physical examinations or tests, or to protect the patient from falling
out of bed, or to permit the patient to participate in activities
without the risk of physical harm (this does not include a physical
escort. The devices and methods listed here that would not be
considered restraints, and thus not subject to these requirements, are
typically used in medical surgical care.
The regulation permits the physical holding of a patient for the
purpose of conducting routine physical examinations or tests. However,
patients do have the right to refuse treatment. See Sec. 482.13(b)(2).
This includes the right to refuse physical examinations or tests.
Holding a patient in a manner that restricts the patient's movement
against his or her will would be considered a restraint. This includes
therapeutic holds. Many deaths have involved these practices and may be
just as restrictive and potentially dangerous as restraining methods
that involve devices. However, the opportunity for individualized
treatment of the patient is still available, since the regulation does
not prohibit the use of any particular type of restraint. This
regulation requires individualized patient assessment and use of the
least restrictive intervention when restraint is needed to protect the
patient, a staff member, or others from harm.
Comment: Several commenters asked whether a side rail was a
physical restraint. One commenter stated that ``the majority'' of
hospitals require that side rails be raised for safety reasons, and
that patients do not perceive this common safety practice as a
restraint. This commenter also cited a need for side rails to be raised
to protect patients who are confused or disoriented by narcotics or
controlled substances. Another commenter wanted to know if crib rails
are a restraint.
Response: The final rule states that a restraint does not include
methods that protect the patient from falling out of
[[Page 71389]]
bed. It is standard practice to raise the side rails when a patient is
on a stretcher, recovering from anesthesia, sedated, experiencing
involuntary movement, or on certain types of therapeutic beds to
prevent the patient from falling out of the bed. However, the use of
side rails to prevent a patient from exiting a hospital bed may pose
risk to the patient's safety, particularly for the frail elderly who
may be at risk for entrapment between the mattress and the bed frame. A
disoriented patient may see the side rail as a barrier to be climbed
over or may attempt to wriggle through split rails or to the end of the
bed to exit the bed. As a result, this patient may have an increased
risk for a fall or other injury by attempting to exit the bed with the
side rails raised. The risk presented by side rail use should be
weighed against the risk presented by the patient's behavior as
ascertained through individualized assessment. Clinical judgment
determines whether or not the use of siderails is governed by the rule.
When the clinician raises all four siderails in order to restrain a
patient, defined in this regulation as immobilizing or reducing the
ability of a patient to move his or her arms, legs, body, or head
freely to ensure the immediate physical safety of the patient, then the
rule applies. Raising fewer than four siderails when the bed has more
than two siderails, would not necessarily immobilize or reduce the
ability of a patient to move as defined in the regulation.
Regarding the question of whether crib rails are a restraint,
placement in a crib with raised rails is an age-appropriate standard
safety practice for every infant or toddler. Therefore, placement of an
infant or toddler in the crib with raised rails would not be regarded
as a restraint. Age or developmentally appropriate protective safety
interventions, such as stroller safety belts, swing safety belts, high
chair lap belts, raised crib rails, and crib covers, that a safety-
conscious child care provider outside a health care setting would
utilize to protect an infant, toddler, or preschool-aged child would
not be considered restraint or seclusion for the purposes of these
regulations. The use of these safety interventions should be addressed
in hospital policies or procedures.
Comment: Several commenters believed that mechanical restraints
should never be used in the mental health treatment of children and
adolescents. One commenter suggested banning both mechanical restraint
and seclusion for patients who are 17 years of age or younger. Several
commenters offered permutations of this suggestion, such as a ban on
the use of mechanical restraint for patients under 17 years of age.
Response: Situations exist where it may become necessary to
restrain or seclude a child or adolescent to ensure the safety of the
patient or others. Regardless of age, the selection of an intervention
must be individualized for each patient. When a restraint is used to
manage self-destructive or violent behavior that jeopardizes the
immediate physical safety of the patient, a staff member, or others, a
variety of factors, such as medical condition, disability, psychiatric
condition, history of abuse, height, and weight, as well as age, must
be assessed and evaluated to determine the least restrictive
intervention that will effectively ensure the safety of the patient and
others. In unique emergencies, a mechanical restraint may be necessary
for a patient under 17 years of age. For example, if a 250-pound 16-
year old male is physically attacking another patient, staff may have
limited options to stop the attack. At times, the child's size may
eliminate the ability to safely use a physical hold with the staff
available. The child's medical condition (for example, asthma or a
fractured limb) could also contraindicate the use of a physical hold.
However, we recognize that children and adolescents, as well as
adults, are vulnerable and at risk when restrained or secluded to
manage violent or self-destructive behavior that jeopardizes the
immediate physical safety of the patient, a staff member, or others.
Therefore, we have retained the time limits on each order for restraint
or seclusion to manage aggressive destructive in combined standard (e).
Orders are limited to 4 hours for adults 18 years of age or older; 2
hours for children and adolescents 9 to 17 years of age; and 1-hour for
children under 9 years of age. The restraint or seclusion order may
only be renewed in accordance with these limits for up to a total of 24
hours. Before writing a new order, a physician or licensed independent
practitioner must see and assess the patient.
Comment: Many commenters indicated that the restraint definition is
too broad and includes items that are typically used in the provision
of care, such as catheters, drainage tubes, plastic casts, and
bandages, which can restrict freedom of movement. Several commenters
asked whether adaptive or protective devices such as helmets, or
devices that are used for postural support, meet the definition of
restraint. One commenter asked whether CMS would permit the use of
devices to assist with chronic conditions or for physically frail
patients. One commenter asked that we address the use of restraint for
dental, diagnostic, and surgical procedures. The commenter stated that
devices used for medical immobilization are given an exemption by
JCAHO. The commenter asked if CMS would create a mirroring exemption.
Response: In response to comments, we have added language that
limits the application of this definition. In the final rule, a
restraint does not include devices, such as orthopedically prescribed
devices, surgical dressings or bandages, protective helmets, or other
methods that involve the physical holding of a patient for the purpose
of conducting routine physical examinations or tests, or to protect the
patient from falling out of bed, or to permit the patient to
participate in activities without the risk of physical harm (this does
not include a physical escort). The devices and methods listed here
that would not be considered restraints, and thus not subject to these
requirements, are typically used in medical surgical care. Adaptive
devices or mechanical supports used to achieve proper body position,
balance, or alignment to allow greater freedom of mobility than would
be possible without the use of such a mechanical support is not
considered a restraint. For example, some patients are unable to walk
without the use of leg braces, or are unable to sit upright without
neck, head or back braces. Such devices generally permit the patient to
participate more fully in activities without the risk of physical harm.
Comment: Several commenters suggested that devices used for
security purposes should be exempt from the regulatory requirements.
Another commenter argued that forensic hospitals or units should be
exempted from the regulatory requirements because they compromise the
hospital's ability to manage behavior.
Response: The use of handcuffs or other restrictive devices applied
by law enforcement officials who are not employees of the hospital for
custody, detention, and public safety reasons are not governed by this
rule. The law enforcement officers who maintain custody and direct
supervision of their prisoner (the hospital's patient) are responsible
for the use, application, and monitoring of these restrictive devices
in accordance with Federal and State law. However, the hospital is
still responsible for providing safe and appropriate care to the
patient.
Comment: One commenter argued for the need for ``programmatic'' use
of restraint for mentally retarded patients
[[Page 71390]]
in a psychiatric or an acute care unit and stated that the interim
final rule with comment period created a barrier to using a restraint
as part of a treatment plan.
Response: Our expectation is that restraint or seclusion will not
be a standard response to a particular behavior or situation. The use
of such interventions is a temporary measure that protects the safety
of patients and others, but is not a long-term solution for handling
problematic behavior.
3. Definition of ``Drug Used as a Restraint'' (Sec. Sec. 482.13(e)(1)
and (f)(1))
We stated that a drug used as a restraint is a medication used to
control behavior or restrict the patient's freedom of movement and is
not a standard treatment for the patient's medical or psychiatric
condition.
Comment: Some commenters indicated that the definition of ``drug
used as a restraint'' was too broad, subjective, and confusing. One
commenter suggested that we adopt the definition of chemical restraint
found in the long-term care interpretive guidelines--that is, ``A
medication used for discipline or convenience that is not required to
treat medical symptoms.''
Several commenters argued that the determination of what
constitutes a ``standard treatment'' for certain medical or psychiatric
conditions is too subjective. One commenter observed that physicians
may legitimately order nonstandard treatments for their patients.
Another commenter noted that problems present in mentally retarded
patients do not correspond closely to any medical or psychiatric
diagnosis and that the rule only discusses these two sorts of standard
uses of medication. One commenter explained that in acute care,
medications are changed based on the patient's medical condition and
symptoms. This commenter also stated that this regulation creates a
burden for the administrative staff that will have to distinguish a
drug used as ongoing medical management from a drug that, at some
point, has evolved into a restraint that is not part of standard
treatment.
Other commenters grappled with how to characterize the appropriate
role of medications in a patient's care. For example, one commenter
expressed alarm at the apparent ban on PRN orders for medications that
might affect a patient's behavior or restrict a patient's movement. The
commenter argued that medications for behavioral health patients are
used precisely to affect behavior so that the patient can participate
more fully in his or her care, treatment, and therapy. The commenter
stated that they are administered in order to avoid the emergence or
escalation of specific behaviors that might prompt the use of more
restrictive physical restraints or seclusion. The commenter also stated
behavioral health providers recognize that the use of the same drug may
be therapeutic in one instance and not in another, and have indicated
that a drug used as a restraint should not be applied when its use
impedes a person's ability to participate in his or her care. Some
commenters noted that drug therapy should be part of an effective
treatment plan to manage behavior.
There was little agreement among commenters as to how drugs used to
restrain patients should be handled. While a few commenters agreed with
the concept that a drug used as a restraint is not a standard treatment
(one stating that ``prohibition is critical''), several recommended
deleting any reference to a drug used as a restraint. One commenter
argued that the use of medications is already closely scrutinized
through pharmacy oversight and the physician ordering process. The
requirements of the interim final rule with comment period add an
unnecessary layer of oversight.
Another commenter stated that the use of a drug as a restraint
should appear in its own standard, as the use of a medication differs
from physical interventions.
The idea of a medication ``controlling'' behavior garnered
considerable comments which included the following:
All psychotropic medications control behavior to the
extent that they reduce psychiatric symptoms;
The idea of a medication controlling behavior is not as
straightforward as it appears;
No medication ``controls'' behavior. A better word would
be ``directs,'' ``contains,'' or ``ameliorates;''
All drugs have effects as a restraint; and
The phrase ``control behavior'' should be removed, and a
drug used as a restraint should be defined as a drug used with the
intent to restrain or restrict the patient's freedom of movement.
One commenter asked for clarification regarding the classification
of paralytic drugs, sedatives, and analgesics, and how they would be
affected by the regulation.
A commenter suggested that if a patient has consented to the use of
a medication, it should not be classified as a drug used as a
restraint. Another commenter argued that if a drug is used as a one-
time dose to help aid in the plan of care but is not part of the care
plan, it is not a drug used as a restraint.
Many commenters characterized the use of a drug as possibly the
least restrictive alternative to deal with violent or aggressive
behavior, arguing that its use is more humane than allowing the patient
to escalate and lose self-control.
Response: Patients have a fundamental right to be free from
restraints that are imposed for coercion, discipline, convenience, or
retaliation by staff, including drugs that are used as restraints. In
the interim final rule with comment period, the definition of ``drug
used as a restraint'' was phrased so that medications that are used as
part of a patient's standard medical or psychiatric treatment would not
be subject to the requirements of standards (e) or (f). These
regulations are not intended to interfere with the clinical treatment
of patients who are suffering from serious mental illness and who need
therapeutic doses of medication to improve their level of functioning
so that they can more actively participate in their treatment.
Similarly, these regulations are not intended to interfere with
appropriate doses of sleeping medication prescribed for patients with
insomnia, anti-anxiety medication prescribed to calm a patient who is
anxious, or analgesics prescribed for pain management. This language
was intended to provide flexibility and recognize the variations in
patient conditions.
A standard treatment for a medication used to address a patient's
condition would include all of the following:
The medication is used within the pharmaceutical
parameters approved by the Food and Drug Administration (FDA) and the
manufacturer for the indications it is manufactured and labeled to
address, including listed dosage parameters.
The use of the medication follows national practice
standards established or recognized by the medical community and/or
professional medical association or organization.
The use of the medication to treat a specific patient s
clinical condition is based on that patient's symptoms, overall
clinical situation, and on the physician's or other LIP's knowledge of
that patient's expected and actual response to the medication.
An additional component of ``standard treatment'' for a medication
is the expectation that the standard use of a medication to treat the
patient's condition enables the patient to more effectively or
appropriately function in the world around them than would be
[[Page 71391]]
possible without the use of the medication. If the overall effect of a
medication is to reduce the patient's ability to effectively or
appropriately interact with the world around the patient, then the
medication is not being used as a standard treatment for the patient's
condition. We believe that trained practitioners possess the skills and
abilities necessary to identity when a drug or medication is being used
as a standard treatment for the patient's condition and when it is not.
Whether or not the use of a medication is voluntary, or even
whether the drug is administered as a one time dose or PRN are not
factors in determining if a drug is being used as a standard treatment.
The use of PRN medications is only prohibited if the drug is being used
as a restraint. The regulation supports existing State laws that
provide more vigorous promotion of the patient's choice and rights.
Of course, as with any use of restraint, staff must conduct a
patient assessment to determine the need for other types of
interventions before using a drug as a restraint. For example, a
patient may be agitated due to pain, an adverse reaction to an existing
medication, or other unmet care need or concern.
There are situations where the use of a medication is clearly
outside the standard for a patient or a situation, or a medication is
not medically necessary but is used for patient discipline or staff
convenience (neither of which is permitted by the regulation). In such
situations, the patient has the right to be free from the use of a drug
as a restraint.
For example, a patient has Sundowner's Syndrome, a syndrome in
which a patient's dementia becomes more apparent at the end of the day
than the beginning of the day. The patient may become agitated, angry,
or anxious at sundown. This may lead to wandering, pacing the floors,
or other nervous behaviors. The unit's staff find the patient's
behavior bothersome, and ask the physician to order a high dose of a
sedative to ``knock out'' the patient and keep him in bed. The patient
has no medical symptoms or condition that indicates that he needs a
sedative. In this case, for this patient, the sedative is being used as
a restraint for staff convenience. Such use is not permitted by the
regulation. The regulation does not allow a drug to be used to restrain
the patient for staff convenience, to coerce or discipline the patient,
or as a method of retaliation.
While the characterization of medications as more humane and less
invasive was quite common in comments on the interim final rule with
comment period, we put forth the caveat offered by one physician--that
overuse of antipsychotic medications can result in severe, sometimes
irreversible neurological side effects or Neuroleptic Malignant
Syndrome, which is potentially fatal. Also increased psychotropic
medication use may lead to excessive sedation and cognitive dulling
that impairs the patient's ability to benefit from therapy. While
medications can be a beneficial part of a carefully constructed,
individualized treatment plan for the patient, medication use should be
based on the assessed needs of the individual patient and the effects
of medications on the patient should be carefully monitored.
We agree with the many comments regarding the idea of a medication
``controlling'' behavior. To further clarify our intent and respond to
public comments, we have revised the definition of ``drugs used as a
restraint.'' In this final rule, a drug used as a restraint is now
defined as ``a drug or medication when it is used as a restriction to
manage the patient's behavior or restrict the patient's freedom of
movement and is not a standard treatment or dosage for the patient's
condition.''
Comment: One commenter asked whether the time-limited orders and
the assessment, documentation, and monitoring requirements of standards
(e) and (f) apply to a drug used as a restraint.
Response: Yes. If the use of the medication for the patient meets
the definition of a drug used as a restraint, the requirements of
combined standard (e) apply.
Comment: One commenter asked that orders for PRN medications be
deemed appropriate. Many commenters objected to the ban on PRN orders
for drugs used as a restraint.
Response: In the final rule, PRN orders for medications are not
prohibited. The use of PRN orders is only prohibited for drugs or
medications that are being used as restraints. We believe that ongoing
assessment, monitoring, and re-evaluation by the ordering practitioner
are even more critical when a patient is receiving treatment that is
not standard, or is administered in amounts or at a frequency greater
than recommended by the manufacturer or current standard of practice,
for the patient's condition. Therefore, we are retaining this
requirement.
4. Use of Restraints (Sec. Sec. 482.13(e)(2) and (e)(3)(i))
Section 482.13(e)(2) states that a restraint can only be used if
needed to improve the patient's well-being and less restrictive
interventions have been determined to be ineffective. Section
482.13(e)(3)(i) states that the use of a restraint must be selected
only when other less restrictive measures have been judged to be
ineffective to protect the patient or others from harm. These two
provisions are redundant, and in the final rule we have collapsed them
into one requirement. We will discuss them together, as the public
comments tended to apply to both.
Comment: One commenter believed that the regulation should include
illustrations of less restrictive interventions and alternative methods
for handling behavior, including a requirement that when there is a
history of a particular less restrictive intervention being
ineffective, other interventions must be tried.
Response: Including such illustrations in the regulation is not
feasible. Putting aside the fact that regulations generally provide
requirements rather than best practice suggestions, each care situation
consists of a unique combination of factors. What seems least
restrictive for one patient may not be an appropriate option for
another patient. The underpinning of this regulation is the concept
that good patient care hinges on looking at the patient as an
individual and assessing the patient's needs, strengths, weaknesses,
and preferences. Such an approach relies on caregivers who are skilled
in individualized assessment and in tailoring interventions to
individual patient's needs after weighing factors such as the patient's
condition, behaviors, and history. A list of progressive interventions
that should be taken would undermine the emphasis on individualized
care, and could discourage creativity in meeting patient needs.
However, there are resources available. For example, the American
Psychiatric Association (APA), American Psychiatric Nurses Association
(APNA), and the National Association of Psychiatric Health Systems
(NAPHS), with support from the American Hospital Association (AHA),
have sponsored the publication of a document entitled, ``Learning from
Each Other--Success Stories and Ideas for Reducing Restraint/Seclusion
in Behavioral Health.'' This document, published in 2003, was developed
through dialogue with the field and extensive input from behavioral
healthcare providers throughout the country who have been working to
reduce the use of restraint and seclusion, and to improve care within
their facilities. To access this document and other useful resources,
visit the web sites of the sponsoring organizations:
[[Page 71392]]
http://www.naphs.org; http://www.psych.org; http://www.apna.org; http:/
/http://www.aha.org.
Comment: One commenter argued that it would be impossible to comply
both with the Patients' Rights CoP standard (c), which protects patient
safety and the patient's right to be free from all forms of harassment,
and standard (f). The commenter included the following example, a manic
or psychotic patient may be verbally abusive to another patient or
destructive of that patient's property without actually being a
physical threat to the other patient. The commenter stated that such
behavior has often been handled by the use of seclusion until
medication can relieve the patient's agitation and abusiveness.
Response: Standard (c) provides that each patient has the right to
receive care in a safe setting, and the right to be free from all forms
of abuse or harassment. This standard clearly prohibits the behavior
described by this commenter, and some type of intervention would be
warranted. However, such behavior need not prompt the automatic use of
restraint or seclusion. The training requirements in standard (f) of
this final rule ensure that patients are attended to by staff that are
trained and skilled in utilizing an array of techniques and skills for
handling aggression. Depending on this situation, various interventions
(other than restraint or seclusion) may address the patient's behavior
and simultaneously promote the right of others to safety and freedom
from harassment and abuse.
Comment: One commenter suggested that seclusion and restraint
should be used only when less restrictive interventions, such as time-
outs and one-to-one staffing, are ineffective in preventing immediate
injury of the patient or others. Several commenters asked whether less
restrictive interventions actually had to be tried and shown to fail
before a more restrictive intervention was used. A number of these
commenters also questioned whether the patient or another person must
be injured before more restrictive intervention may be undertaken.
Response: Less restrictive interventions should be considered
before resorting to the use of restraint or seclusion. However, it is
not always appropriate for less restrictive alternatives to be
attempted prior to the use of restraint or seclusion. For example, when
a patient physically attacks another patient, immediate action is
needed. When a patient's behavior presents an immediate and serious
danger to the patient or others, immediate action is needed. While
staff should be mindful of using the least intrusive intervention, it
is critical that the intervention selected be effective in protecting
the patient or others from harm. Therefore, we have retained the
requirement that a restraint or seclusion can only be used when less
restrictive interventions have been determined to be ineffective to
protect the patient or others from harm.
Comment: One commenter suggested adding, ``The patient has the
right to be treated in a safe manner when special procedures are
required for the patient's care.''
Response: While we agree that the patient has the right to be
treated in a safe manner, we believe that this right exists regardless
of whether or not the patient is undergoing a special procedure.
Comment: One commenter suggested considering an issue raised by a
New England Journal of Medicine article; specifically, that the
regulation should state plainly that a competent patient may refuse the
use of physical restraint in the patient's acute care or treatment. The
commenter further suggested that an incompetent patient's
representative should be able to exercise this right to refuse physical
restraint on the patient's behalf. Similarly, another commenter stated
that the regulation should consider the individual's right to make
choices regarding their health care. The commenter further stated that
after complete information is provided about the method, risks, and
effects of these procedures, individuals and families should have the
right to either reject their use or select them as part of an overall
treatment regime.
Response: The Patients' Rights CoP promotes the patient's right to
be involved in and make decision about the patient's health care.
Standard (b)(2) states that the patient or his or her representative
(as allowed under State law) has the right to make informed decisions
regarding his or her care. The patient's rights include being informed
of his or her health status, being involved in care planning and
treatment, and being able to request or refuse treatment. This right
must not be construed as a mechanism to demand the provision of
treatment or services deemed medically unnecessary. In this context,
the use of a restraint would be considered a ``treatment.'' Before the
patient decides to request or refuse the use of restraint or seclusion,
the patient must be informed of the risks associated with refusing the
use of a restraint. While the hospital should work with the patient
regarding preferences as much as possible, the hospital is not
obligated to come up with a menu of alternative options because of the
patient's refusal. The hospital may refuse to perform a procedure or
render care if it believes that it is unable to safely and
appropriately do so because of the patient's refusal to allow certain
aspects of the prescribed treatment. In addition, if the patient's
violent or self-destructive behavior jeopardizes the immediate physical
safety of the patient, a staff member, or others, the patient does not
have the right to refuse the use of restraint or seclusion. In this
situation, the use of restraint or seclusion is an emergency measure to
protect the safety of the patient, staff, or others. If the patient or
the patient's representative requests the use of restraint or
seclusion, the attending practitioner would need to decide whether the
intervention is appropriate.
In conclusion, the restraint or seclusion requirements do not
prevent the patient from making informed decisions or participating in
the patient's healthcare. The rule establishes the patient's right to
be free from inappropriate restraint or seclusion, and lays out basic
protections in the event that these interventions are needed.
Comment: One commenter questioned whether, because of the
``Patients'' Rights'' provisions regarding patient privacy and safety,
a restrained patient must be restrained in a separate, private room,
and not in the day room.
Response: A hazard of restraining a patient is the damage that may
be done to the patient's dignity. The patient may feel dehumanized or
humiliated, which could be exacerbated by having peers witness the
experience. Certainly, we would not expect that a patient put in four-
point restraint would be placed in the midst of the day room in a
psychiatric facility since this would be humiliating to the patient.
The restrained patient should be afforded as much privacy as possible.
Since an underlying therapeutic goal for any psychiatric patient is the
development of a strong sense of self-worth and dignity, the hospital
should take steps to protect the privacy of the restrained patient.
However, an individual wearing mitts to prevent self-mutilating
behaviors is also being restricted. These individuals may desire
socialization and group activity notwithstanding these restraints that
a patient in the midst of a psychiatric crisis would not. We provide
these examples to stress that it is critical for the hospital to use an
individualized approach that is in the best interest of the patient and
promotes
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the patient's health, safety, dignity, self-respect, and self-worth.
Comment: Several commenters believed that the documentation of
clinical justification for the use of seclusion and restraint, the
alternative methods used, and the reasons for their ineffectiveness
should be included in the patient's record. Another commenter was
concerned that staff's time for direct patient care would be diverted
into creating documentation if we require demonstration that less
restrictive interventions were proven ineffective in cases that involve
medical immobilization.
Response: We agree with the commenters. In the final rule under
combined standard (e), we have specified that when restraint or
seclusion is used, the following must be documented in the patient s
medical record:
The 1-hour face-to-face medical and behavioral evaluation
when restraint or seclusion is used to manage violent or self-
destructive behavior that jeopardizes the immediate physical safety of
the patient, a staff member, or others;
A description of the patient's behavior and the
intervention used;
Alternatives or less restrictive interventions attempted
(as applicable);
The patient's condition or symptom(s) that warranted the
use of the restraint or seclusion; and
The patient's response to the intervention used, including
the need for continued use of the intervention.
We believe that such documentation is a usual and customary
recordkeeping practice. This information will provide a valuable tool
for charting the patient's course of treatment as well as examining
trends of use.
In response to comments, we have added language that limits the
application of the restraint definition. In the final rule, a restraint
does not include devices, such as orthopedically prescribed devices,
surgical dressings or bandages, protective helmets, or other methods
that involve the physical holding of a patient for the purpose of
conducting routine physical examinations or tests, or to protect the
patient from falling out of bed, or to permit the patient to
participate in activities without the risk of physical harm (this does
not include a physical escort). The devices and methods listed here,
typically used in medical/surgical care, would not be considered
restraints and, therefore, not subject to these requirements. We
believe that this addresses the commenter's concern regarding the
burden of documentation in such cases.
Comment: Several commenters asked that the word ``determined'' be
replaced with the word ``found.''
Response: We consulted the dictionary to determine whether there
was some significant difference between these two words. We found none.
When we combined the two requirements, we retained the word
``determined.''
Comment: One commenter suggested moving the sentence, ``A restraint
can only be used if needed to improve the patient's well-being and less
restrictive interventions have been determined ineffective,'' from
paragraph (e)(2) to paragraph (e)(1). The commenter stated that this
would place a greater emphasis on the fact that less restrictive
measures must be demonstrated to be ineffective first.
Response: Although we agree that the language in paragraph (e)(2)
is an essential component of standard (e), we do not believe that it is
necessary to relocate this language to paragraph (e)(1). We also note
that we have revised the regulatory text in the final rule to state
that ``a restraint can only be used when less restrictive interventions
have been determined to be ineffective to protect the patient or others
from harm.'' We deleted the language ``to enhance the patient's well-
being'' for clarity.
Comment: One commenter asked which individual(s) would be
responsible for making the determination that a less restrictive
intervention was ineffective, and suggested that we use the phrase
``clinically determined'' to indicate that this decision would be made
by the nursing staff.
Response: Since any trained clinical staff could make such
decisions, we have decided not to specify further who should determine
that a less restrictive intervention is ineffective for a particular
patient.
Comment: One commenter stated that positive reinforcement should be
used prior to restraint or seclusion.
Response: Combined standard (e) specifies that restraint or
seclusion may only be used when less restrictive interventions have
been determined to be ineffective to protect the patient or others from
harm. The intent, as suggested by the commenter, is to encourage staff
to use alternative, less restrictive methods, such as positive
reinforcement, in the patient's treatment.
5. Ordering of Restraint/Seclusion (Sec. 482.13(e)(3)(ii) and
(f)(3)(ii))
In this section, we stated that the use of a restraint must be in
accordance with the order of a physician or other licensed independent
practitioner (LIP) permitted by the State and hospital to order a
restraint. Section 482.13(f)(3)(ii) reiterated this requirement when a
restraint is used for behavior management, but added that the use of
seclusion must also be in accordance with such an order.
a. Definition of Licensed Independent Practitioner (LIP) (Sec. Sec.
482.13(e)(3)(ii) and (f)(3)(ii))
Comment: Many commenters stated that the definition of LIP was
unclear and open to interpretation. These commenters were unsure of how
delegated authority affected whether a practitioner was considered an
LIP, of which ``independent'' practitioners qualify as LIPs, and of how
the counter-signing of orders affected the determination of whether a
practitioner is independent.
Several independently licensed health professionals, such as nurse
practitioners and physician assistants, applauded our inclusion of the
LIP as recognition of highly trained individuals with strong patient
assessment skills. These commenters stated that it was important to
recognize the contribution of the multidisciplinary team in today's
health care settings.
Many commenters asked for an explanation of who would be considered
an LIP. Some commenters wanted explicit recognition of registered
nurses as LIPs; one commenter suggested replacing ``LIP'' with the term
``health care professional,'' so that registered nurses would clearly
be included. Many licensed professionals such as physician assistants,
nurse practitioners and advanced practice registered nurses were
concerned that narrow interpretation of the term ``LIP'' might limit
their ability to be fully involved in patient care. One organization
stated that ``LIP'' is the most problematic language in JCAHO's
standards and argued that use of this term might result in
inappropriate limits on its constituents' scope of practice. This
organization explained that the phrase is given wide and varied
interpretations by both hospitals and JCAHO surveyors.
Another concern expressed by commenters was that this regulation
marked the first appearance of this term in the CoPs. Several
commenters questioned how LIPs might be introduced in the remaining
hospital CoPs.
One commenter viewed the term ``LIP,'' with its requirement that
the practitioner be able to independently order restraint or seclusion,
as restricting existing practice. This
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commenter argued that such a restriction should only occur after a
finding that the existing practice has had an adverse effect on patient
care or that limiting this authority to physicians would improve
patient care. The commenter believed that neither the former nor the
latter point have been demonstrated or proven. This commenter also
noted that State law usually addresses when an LIP may order
restraints.
Response: The introduction of an alternative practitioner who could
order interventions, assess patients, and renew orders was an attempt
to accommodate existing State laws that acknowledge the role of non-
physicians in patient care and treatment. We originally used the term
``LIP'' to describe these practitioners to be consistent with existing
JCAHO standards.
For the purposes of this rule, a LIP is any individual permitted by
State law and hospital policy to order restraints and seclusion for
patients independently, within the scope of the individual's license
and consistent with the individually granted clinical privileges. This
provision is not to be construed to limit the authority of a physician
to delegate tasks to other qualified healthcare personnel, that is,
physician assistants and advanced practice nurses, to the extent
recognized under State law or a State's regulatory mechanism, and
hospital policy. It is not our intent to interfere with State laws
governing the role of physician assistants, advanced practice
registered nurses, or other groups that in some States have been
authorized to order restraint and seclusion or, more broadly, medical
interventions or treatments.
Each State faces the issue of how to best provide its citizens with
access to needed health care services. The issue is complex, as some
States have special considerations such as geographic barriers to care
delivery, medically underserved areas, and special population needs,
all of which would affect how a State resolves this issue. To disregard
a State's decision about who is qualified to order medical treatments
and interventions and render patient care would be unproductive and
arbitrary.
To clarify this, in combined standard (e), we have revised the
standard to state that the use of a restraint or seclusion must be in
accordance with the order of a physician or other licensed independent
practitioner who is responsible for the care of the patient as
specified under Sec. 482.12(c) and authorized to order restraint or
seclusion by hospital policy in accordance with State law.
b. Physician Only
Comment: While some commenters supported deferring to the States'
determination of which health professionals are allowed to order
seclusion or restraint, one contingent opposed allowing anyone other
than a physician to order restraint or seclusion, evaluate the patient,
or renew an order for restraint or seclusion. This group pushed for the
rule to override existing State laws that would allow these functions
to be performed by anyone other than a physician. Several of these
commenters stated that the clinical skills and qualifications of some
licensed therapists are not necessarily indicative of an understanding
and knowledge of the medical needs or risks of patients in seclusion or
restraint. Without this understanding or knowledge, there continues to
be risk to patients if other medical symptoms are overlooked.
Some commenters cited national legislation pending at the time that
would permit only a physician to order restraint/seclusion. Advocacy
organizations charged that by permitting someone other than a physician
to order restraint or seclusion, CMS would be allowing any 1 of over
600,000 mental health professionals to authorize the use of restraint
and seclusion, effectively undermining the purpose of the rule. Many
commenters reminded us that the motivation behind the promulgation of
this rule is the increasing concern regarding injuries, deaths or harm
associated with the use of restraint and seclusion. One commenter
maintained that by significantly narrowing the categories of clinicians
permitted to authorize the use, the risk of misuse or overuse of
restraint and seclusion would be minimized.
Several commenters cited the importance of physicians' clinical
training, the fact that they are individually accountable, and the fact
that they are distanced from the daily stress and conflicts that arise
between non-physician staff members and patients. Other commenters
asserted that it is reasonable to require that only a physician
authorize the use of procedures that can have serious and dangerous
consequences for patients. A number of factors may lead to a patient
displaying violent or agitated behavior, including inappropriate
medication, which often times can be corrected immediately. One
national organization representing physicians also opposed the
recognition of non-physicians as being able to order restraints and
seclusion.
Response: Some States have issues such as geographic barriers to
care delivery, medically underserved areas, and special population
needs. States have handled these difficult issues through a variety of
mechanisms. If a State has decided that a group of practitioners may
order medications or treatments exclusively, we defer