[Federal Register Volume 71, Number 236 (Friday, December 8, 2006)]
[Rules and Regulations]
[Pages 71378-71428]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 06-9559]
[[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
Federal Register / Vol. 71, No. 236 / Friday, December 8, 2006 /
Rules and Regulations
[[Page 71378]]
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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://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
[[Page 71393]]
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
[[Page 71394]]
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 to State laws.
Physicians are individually accountable for the care of their
patients. The physician has the discretion to delegate, or to withhold
the delegation of, tasks or responsibilities as he or she deems
appropriate. We believe that the physician is more than capable of
making the determination regarding whether his or her direct oversight
is necessary, or whether in some situations, as permitted by hospital
policy, these functions can be performed by another practitioner. The
continued physician accountability for actions taken under his or her
license provides a direct incentive for taking the decision to delegate
very seriously.
As commenters pointed out, clinical psychologists or other
practitioners who may be authorized by the State to order restraint or
seclusion may lack the technical medical skills and training to conduct
a comprehensive physical assessment. Therefore, the practitioner who
conducts the 1-hour face-to-face evaluation must be able to complete,
under their scope of practice, both a physical and psychological
assessment of the patient. To ensure physician oversight of restraint
and seclusion, we have retained the requirement that the attending
physician must be consulted as soon as possible if the attending
physician did not order the restraint or seclusion.
Comment: Some commenters representing independent residential
treatment centers, day programs, skilled nursing facilities, and other
non-hospital provider types mistakenly believed that the requirements
in these hospital CoPs were applicable to them. Accordingly, a number
of the commenters cited physician access as a problem.
Response: We reiterate that these requirements apply to Medicare-
and Medicaid-participating hospitals only, that is, short-term,
psychiatric, rehabilitation, long-term, children's and alcohol-drug
hospitals. The pending regulations based on the CHA will address the
use of restraint and seclusion in the other settings noted above.
[[Page 71395]]
Comment: Several commenters expressed concern that practitioners
without psychiatric training may be allowed to order seclusion or
restraint to manage aggressive, self-destructive or violent patient
behavior.
Response: We have revised combined standard (e) to specify that the
use of restraint or seclusion must be ordered by a physician or other
LIP who is responsible for the care of the patient and authorized to
order restraint or seclusion by hospital policy in accordance with
State law. We have also tied the order for restraint or seclusion to
the patient's attending physician. The attending physician must be
consulted as soon as possible if the attending physician did not order
the restraint or seclusion. We believe that this modification will
alleviate concerns about a practitioner who may not have psychiatric
training, or is unfamiliar with the patient's condition or diagnosis
providing orders for the patient's care.
Comment: One commenter wrote that when fewer staff at the hospital
are allowed to routinely approve seclusions or restraint, there is less
likelihood of a serious review and a reduction of their use.
Response: As part of a hospital's QAPI program, we would expect the
use of restraint and seclusion to be monitored and evaluated on an
ongoing basis. We believe that the number of staff permitted to order
restraint or seclusion is irrelevant to the QAPI process.
Comment: Several commenters were concerned that the regulation
could be interpreted as precluding physicians enrolled in residency
training programs from ordering restraints or seclusion, or from
evaluating the need for their continued use. For example, in Maryland,
residents generally do not hold a State medical license, but are
authorized to practice without completing the usual licensing process.
A commenter stated this is permitted because of the close supervision
that residents receive during their training, and because required
licensing is impractical since residents often move to another State to
complete their training or to set up permanent practice.
Response: In many States a resident is authorized by State law to
practice as a physician. Therefore, there is no question that a
resident can carry out the functions reserved for a physician or LIP by
this regulation in accordance with State law.
Comment: One commenter opined that psychologists and behavior
analysts, not just physicians, should assume responsibility for the
design and oversight of restraint and seclusion. Physicians should
regulate chemical restraint and assume principal responsibility for the
oversight of psychiatric problems and the design of pharmacological and
psychiatric interventions.
Response: We recognize the important role that psychologists and
other behavioral health professionals play as members of the
multidisciplinary team. We believe that these practitioners should
participate in the design and oversight of restraint and seclusion
practices, as well as participate in patient care. However, we do not
believe Congress gave us the authority to create ordering authority for
psychologists or other professionals in States that have not granted
them this authority. Wherever State law and hospital policy have
afforded ordering rights to these practitioners, we have honored that
decision.
Comment: One commenter stated that if the patient or the patient's
surrogate voluntarily consents to the use of the restraint in the
provision of acute medical and surgical care, an order from the
physician or other LIP is not required per JCAHO's requirements. The
commenter also stated that if restraints are clinically justified and
consent is obtained, the care of the patient is consistent with the
standards, and no order should be needed.
Response: The current JCAHO standard at PC.11.40 requires that
restraint use be based upon an individual order from an LIP. If an
intervention meets the definition of a restraint, the regulatory
requirements apply regardless of whether use of the restraint is
voluntary or involuntary. This would include the requirement for a
physician or other LIP order. The use of restraint is inherently risky.
The risks associated with any intervention must be considered within
the context of an ongoing process of assessment, intervention,
evaluation, and re-evaluation.
c. Elimination of Protocols
Many commenters discussed the key differences between acute medical
and psychiatric settings and the use of protocols in specified
situations in each of these settings. The more commonly cited examples
included the use of arm boards to protect an IV site, or the restraint
of a patient's arms to prevent the removal of an endotracheal tube.
Commenters argued that in these situations, the need for restraint
could be anticipated given the medical procedure or symptoms and
condition of the patient. Before publication of the interim final rule
with comment period, acute medical and postsurgical protocols were used
to handle such situations. Use was triggered by the existence of
specified criteria. Some commenters argued that disallowing acute
medical and postsurgical protocols increases the risk of needless
reintubating or replacement of IVs. Most hospitals use physician-
reviewed protocols to determine the need for restraint in the medical/
surgical context, a practice that is accepted by JCAHO. JCAHO affirmed
this, and recommended allowing the use of protocols in certain
situations with medical staff approval. JCAHO explained that during the
treatment of certain specific conditions (for example, post-traumatic
brain injury) or certain specific clinical procedures (for example,
intubation), restraints might often be necessary to prevent significant
harm to the patient. For those conditions or procedures, protocols for
the use of restraint may be established based upon the frequent
presentation of patient behavior that seriously endangers the patient
or compromises the effectiveness of the procedures. Such protocols
would include guidelines for assessing the patient, and criteria for
application, monitoring, reassessment, and termination of the
restraint. JCAHO stated that it was unaware of any evidence or studies
indicating that the use of protocols in this manner has in any way
diminished patient care. Some commenters expressed strong support for
these types of protocols.
One commenter stated that we should not prohibit the use of such
protocols and the use of PRN orders by LIPs or physicians, and asked
that we expressly state that those sorts of protocols are acceptable.
One commenter pointed to a passage in the interim final rule with
comment period (64 FR 36083) which discussed the initiation of
restraint/seclusion according to protocols developed by hospital and
medical staff, as permitting the use of acute medical and surgical
protocols.
Response: Protocols are not banned by the regulation. A protocol
may contain information that is helpful for staff, such as how a
restraint is to be applied and monitored. However, a protocol cannot
serve as a substitute for obtaining a physician or other LIP order
before initiating each episode of restraint or seclusion use, and the
requirements of the regulation must still be met. The philosophy that
serves as the foundation for the regulation is that restraint or
seclusion use is an exception, not a routine response to a certain
condition or behavior. Each patient should be thoroughly assessed.
Interventions should be tailored to meet the individual patient's
needs. The creation
[[Page 71396]]
of a protocol can run counter to this philosophy if it sets up the
expectation that restraint will be used as a normal part of care. The
use of restraint or seclusion is a last resort when less restrictive
measures have been determined ineffective to protect the patient or
others from harm, not a standard response to a behavior or patient
need.
As discussed previously, we have added language to combined
standard (e) that limits the application of the definition of
restraint. 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. This revision clarifies
the definition of a restraint and addresses many of the examples cited
by commenters.
When implementing a protocol that includes the use of an
intervention that meets the definition of a restraint, a separate order
must be obtained for the restraint. In addition, the patient's medical
record must include documentation of an individualized patient
assessment indicating that the patient's symptoms and diagnosis meet
use-triggering criteria listed in the protocol. Hospitals that utilize
protocols in the situations commenters described would be expected to
provide evidence that there has been medical staff involvement in the
development, review, and quality monitoring of their use.
d. Initiate versus Order
Comment: Many facilities stated that they do not have a physician
present 24 hours a day. One commenter suggested that the registered
nurse be given the ability to assess and respond to emergency life
threatening situations. Another commenter suggested that we should
permit an emergency protocol that could be initiated by a health care
professional if a physician or LIP was not present.
Several commenters questioned whether an order would have to be
obtained before initiating restraint or seclusion and requested
clarification regarding who may initiate seclusion or restraint. One
commenter suggested we require that, ``If an order cannot be obtained
prior to instituting restraint or seclusion, their use must be
authorized by a registered nurse, who shall document in the patient
record both the reasons for restraint or seclusion as well as the need
to use them prior to obtaining an order.'' One commenter stated that
given the unpredictable frequency of emergencies and the need for
intervention for certain conditions and populations, requiring a
physician's order for each intervention is impractical. Others
expressed concern that the regulations do not specifically say that a
registered nurse can initiate restraint in an emergency situation,
which is most often what happens.
Response: We understand that physicians are not always onsite when
an emergency occurs. Registered nurses play a vital role in ensuring
patient safety and well being. We do not expect staff to stand by and
let the patient injure himself or others without intervening simply
because a physician is not present. The hospital may develop emergency
procedures that staff follow before obtaining the order for restraint
or seclusion; however, an order must be obtained as soon as possible.
Many types of emergencies can occur, and staff are expected to
effectively respond. In some emergency situations, the need for a
restraint or seclusion intervention may occur so quickly that an
appropriate order cannot be obtained before the application of
restraints. In these emergency situations, the order must be obtained
either during the emergency application of the restraint or seclusion,
or immediately after the restraint has been applied. The hospital
should address this process in its restraint policies and procedures.
These hospital procedures should specify who could initiate the use of
restraint or seclusion in an emergency prior to obtaining an order from
a physician or other LIP.
6. Prohibition on Standing and PRN Orders (Sec. 482.13(e)(3)(ii)(A)
and (f)(3)(ii)(A))
We stated that an order for restraint must never be written as a
standing or on an as needed basis (that is, PRN). Section
482.13(f)(3)(ii)(A) contains a parallel provision for behavior
management that also applies to orders for seclusion.
Comment: We received many comments arguing that PRN orders for
medication should be permitted. Many commenters, who objected to the
PRN prohibition stated that it represents a departure from current
practice. Some commenters supported the use of PRN medications as
humane and efficacious, in that their administration may help the
patient retain self-control and avert escalation of behavior that would
require seclusion or physical restraint. These commenters argued that a
professional registered nurse is able to appropriately assess and
determine the need to administer a PRN. Other commenters argued that
PRN medications are not a form of chemical restraint. One such
commenter requested that we clarify that orders for PRN medications are
appropriate.
One commenter argued that the elimination of PRN medications could
inhibit a patient's efforts to manage his/her own behaviors. Another
commenter suggested that prohibiting PRN medications might backfire and
lead to more routine orders for behavior-controlling medications, with
some patients receiving more medication than they would have received
with a PRN order. Other commenters stated that they were unsure of how
the ban on PRN orders would effect the administration of medications
prescribed for agitation.
Conversely, several commenters stated that in their experience, PRN
orders are overused for the convenience of staff, and de-escalation
techniques are less likely to be attempted in any meaningful manner if
such orders are available.
Response: As discussed earlier, the use of PRN orders for
medications is only prohibited when a medication is being used as a
restraint. A drug is deemed to be a restraint only if it is not a
standard treatment or dosage for the patient's condition. Using a drug
to restrain the patient for staff convenience is expressly prohibited.
Comment: Several commenters recommended deleting the word,
``written'' from the provision, ``The order must never be written as a
standing or on an as needed basis (that is, PRN).''
Response: As we understand it, the commenters' objection to
``written'' is that it fails to acknowledge that orders may be given
verbally. Under Sec. 482.23(c)(2), all orders need to be documented in
the patient's medical record either manually or electronically. Verbal
orders need to be documented in the medical record by the person
accepting the verbal order. This regulation does not prohibit the use
of verbal orders for restraint or seclusion, but they must be used
infrequently. Regardless of whether the order is written by the
ordering practitioner or documented as a verbal order, the order may
not be written as a standing or on an as needed basis.
[[Page 71397]]
Comment: One commenter asked that we replace the word ``must'' with
``shall'' in this section as well as throughout the regulation.
Response: We currently use the word ``must'' rather than ``shall''
in regulations. Both terms mean that the action/activity is mandatory,
and as such, the use of ``must'' provides a solid legal basis for
enforcement. Therefore, we have maintained the use of ``must''.
Comment: Several commenters indicated that PRN orders for any type
of restraint or seclusion should never be used with children or
adolescents and that all orders for seclusion should be time-limited
based on the individual needs of the youth.
Response: We agree and have maintained these provisions. An order
for restraint or seclusion must never be written on a PRN basis. Orders
for restraint or seclusion to manage self-destructive or violent
behavior that jeopardizes the immediate physical safety of the patient,
a staff member, or others must be time limited and should be tailored
to the individual needs of the patient. An individualized assessment
that considers the patient's characteristics, such as age, history,
size, medical and mental condition, and preferences, should be the
basis of any intervention. The regulation identifies maximum time
limits on the length of order based on age. The physician or LIP has
the discretion to write the order for a shorter length of time. The
length-of-order requirement identifies critical points at which there
is mandatory contact with a physician or LIP responsible for the care
of the patient. In addition, the time limits do not dictate how long a
patient is in restraint or seclusion. Staff should be continually
assessing and monitoring the patient to ensure that the patient is
released from restraint or seclusion at the earliest possible time.
Restraint or seclusion may only be employed while the unsafe situation
continues. Once the unsafe situation ends, the use of restraint or
seclusion must be discontinued. In the final rule, combined standard
(e) explicitly states that the intervention must be discontinued at the
earliest possible time, regardless of the length of time identified in
the order.
7. Consultation With the Treating Physician (Sec. Sec.
482.13(e)(3)(ii)(B) and (f)(3)(ii)(B))
We stated that this order must be followed by consultation with the
patient's treating physician as soon as possible if the restraint is
not ordered by the patient's treating physician. Sec.
482.13(f)(3)(ii)(B) paralleled that requirement in the behavior
management standard, and imposed the same requirement on seclusion if
it is used.
Comment: A few commenters suggested that the requirement for
notifying the treating physician be deleted. Most comments on this
provision revolved around the question of who the treating physician
is, particularly when many physicians or specialists are involved in
the patient's care. One commenter suggested that the ``treating
physician'' should be the physician responsible for the part of care
that requires the use of restraint, for example, the pulmonologist
would write the order if the patient was on a ventilator. Another
commenter indicated that the treating physician for the purposes of an
emergency situation after hours is the medical officer on call. Other
commenters stated that each hospital should be permitted to determine
who the patient's treating physician is.
Response: We agree with the commenters who recommended that
hospital medical staff policies determine who is considered the
treating (attending) physician. In addition, we have revised combined
standard (e) to change the term ``treating physician'' to ``attending
physician.'' We do not believe restraint or seclusion use is the only
instance where the question of who is in charge of managing the overall
medical care of the patient is of concern. Our intent is to ensure that
the physician who has overall responsibility and authority for the
management and care of the patient is aware of and involved in the
intervention. The attending physician information regarding the
patient's history may have significant impact on selection of a
restraint or seclusion intervention.
Comment: Several commenters asked what was meant by notification of
the treating physician ``as soon as possible.'' Most of those who
commented on this provision were not in favor of our use of ``as soon
as possible.'' One commenter noted that when a restraint or seclusion
incident occurs in the middle of the night, it is not realistic to
request a consultation with the treating physician. In such a case, the
consultation might be delayed 8 hours, possibly longer if ordered on a
Friday evening. The commenter was concerned that an oversight review
might not consider this standard practice as being ``as soon as
possible.'' To clarify this point, the commenter suggested the
following wording after ``as soon as possible': ``or the next working
day if after hours, if the restraint or seclusion is not ordered by the
patient's treating [that is, attending] physician(s).''
One commenter argued that the more familiar the physician present
at the time of the restraint or seclusion intervention is with the
individual and the treatment plan, the less urgency there would be to
obtain the required notification. One commenter suggested incorporating
parameters or standards for how quickly this communication must be
initiated and accomplished.
Response: The purpose of attending physician notification is to
promote continuity of care, to assure patient safety, and to elicit
information from the attending physician that might be relevant in
choosing the most appropriate intervention for the patient. Therefore,
consultation should occur as soon as possible. Hospital policies and
procedures should address the definition of ``as soon as possible''
based on the needs of their particular patient population. We have
retained the requirement that the attending physician must be consulted
as soon as possible if a restraint or seclusion is ordered by a
practitioner other than the patient's attending physician.
Comment: One commenter noted that primary physicians often have
another physician on call for their patients when they are unavailable,
such as during surgery or vacation. In these instances, the physician
on call should be considered the treating physician.
Response: We agree. When the attending physician is unavailable and
has delegated responsibility for a patient to another physician, then
the covering physician is considered the attending physician.
Comment: A commenter indicated that this provision is ``cumbersome
and can lead to problems, especially if the treating physician was
listed on the admission and does not come into the hospital for twenty-
four hours if the patient was admitted on the weekend.''
Response: This provision does not specify that consultation with
the attending physician be face-to-face. The consultation can occur via
telephone. In addition, when the attending physician is not available,
responsibility for the patient must be delegated to another physician
who would then be considered the attending physician.
Comment: One commenter asked that we clarify that the patient can
be under the care of a treating LIP other than a physician.
Response: The hospital CoPs do permit the patient to be under the
care of a treating LIP other than a physician. Section 482.12(c)(1)
requires every Medicare patient to be under the care of a doctor of
medicine or osteopathy; or
[[Page 71398]]
a doctor of dental surgery or dental medicine, a doctor of podiatry,
chiropractor, or clinical psychologist within the scope of their
license. The individual overseeing the patient's care may be the
attending physician or a health professional practicing with the
delegated authority or supervision of a doctor of medicine or
osteopathy as permitted by State law and hospital policy. As noted
earlier, we also defer to State laws that recognize the ordering rights
of other types of practitioners. For the purposes of the use of
restraint or seclusion, the attending practitioner must be able to
conduct both a physical and psychological assessment of the patient in
accordance with State law, their scope of practice, and hospital
policy.
Comment: One commenter stated that this requirement was highly
prescriptive and unusual to be included in a CoP. Another commenter
stated that this notification was unnecessary since the treating
physician has the opportunity before the need for restraint or
seclusion arises to alert hospital staff and other physicians or LIPs
that use of restraint or seclusion would be an inappropriate
intervention for the patient. These commenters recommended elimination
of this requirement.
Response: It is not the information in the medical record alone
that should determine the course of treatment for a patient. Decisions
about how best to manage a patient's care, engage the patient in
treatment, and ensure continued progress in recovery require the
oversight of the person with the authority and responsibility for the
patient--the patient's attending physician.
8. Written Modification of the Plan of Care (Sec. Sec.
482.13(e)(3)(iii) and (f)(3)(iii))
We stated in this provision that an order for a restraint must be
in accordance with a written modification to the patient's plan of
care. A parallel provision in Sec. 482.13(f)(3)(iii) extended this
provision into situations where restraint or seclusion is used to
manage violent, self-destructive behavior that jeopardizes the
immediate physical safety of the patient, a staff member, or others.
Comment: Several commenters found this provision confusing and
asked for clarification. One commenter was unsure of whether this
requirement entails having the nurse explain the patient's behavior in
a note, or having the nurse provide a more detailed, written plan. Some
of these commenters suggested that the use of seclusion and restraint
should not be stated in the patient's plan of care; instead, the
behavior(s) that caused the use of seclusion or restraint and other
interventions to address the behavior(s) should be documented.
One commenter suggested that as written, this provision indicates
that a modification to the plan of care would be required before the
order being written for seclusion or restraint. The commenter observed
that written modifications might not be possible prior to the renewal
of the order because the review and modification should be conducted by
the treating physician, while the on-call physician may be involved in
assessing an episode of dangerous behavior. This commenter preferred to
have a review of the patient's treatment plan within a certain
timeframe after the episode, such as the next business day or within 72
hours.
One commenter stated that because restraint and seclusion should be
exceptional rather than ordinary interventions, the regulation should
incorporate the requirement that multiple restraint and seclusion
orders trigger a re-evaluation of the plan of care. Another commenter
agreed, recommending that the following language be added at Sec.
482.13(f)(3)(ii)(D):
Because multiple restraint and seclusion orders may indicate a
need to evaluate and change the current placement and/or behavior
management plan, where there are two or more restraint and seclusion
orders within a one-week period, the chart shall indicate treatment
team actions in evaluating the current placement and plan of care
and the results of that evaluation.
Response: The regulation does not require that a modification to
the patient's plan of care be made before initiating or obtaining an
order for the use of restraint or seclusion. The use of a restraint or
seclusion intervention should be reflected in the patient's plan of
care or treatment plan based on an assessment and evaluation of the
patient. The plan of care or treatment plan should be reviewed and
updated in writing within a timeframe specified by hospital policy. We
have not required that multiple restraint and seclusion episodes
trigger a re-evaluation of a placement or behavior management plan. We
are retaining the language specified in the interim final rule with
comment.
In this final rule, we are specifying that the use of restraint or
seclusion be documented in the patient's medical record. In response to
comments, we have specified the required elements of documentation
under the combined standard. Such documentation is a usual and
customary recordkeeping practice. Therefore, we are retaining the
language as specified in the interim final rule with comment period.
Comment: Another commenter feared that much detail, such as a
description of the event, what led to it, and key data and information
typically available to anyone reading the patient's record, will be
lost because the provision only requires a written modification to the
plan of care. The commenter suggested that facilities would avoid
placing such information in the patient's record to assure that the
facilities are ``discovery protected.'' To remedy this, the commenter
suggested expanding the regulation to require that each instance of
seclusion or restraint and certain details must be entered into the
patient's record.
Response: We agree. We have revised combined standard (e) to
require that the use of restraint or seclusion be documented in the
patient's medical record and have specified the documentation elements.
Under combined standard (e), the patient's medical record must contain
documentation that includes: the 1-hour face-to-face medical and
behavioral evaluation if 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 other 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(s), including the rationale for continued use of the
intervention. This type of 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.
Comment: One commenter believed that restraint date, time, and
duration should be documented in the patient's record. Another
commenter stated that the name, title, and credentials of staff members
involved in the procedure should be included in the record.
Response: We have required that when restraint or seclusion is
used, certain elements must to be documented in the patient's medical
record. We believe that some of the information that the commenter has
suggested would indeed appear as part of the patient's medical record.
Additional elements of documentation, such as name, title, and
credentials of staff members involved in the procedure, should be
specified in hospital policy.
[[Page 71399]]
Comment: Several commenters recommended removing the word
``written'' from the provision, ``in accordance with a written
modification of the patient's plan of care.''
Response: We have retained the word ``written'' in the provision,
``in accordance with a written modification of the patient's plan of
care.'' The use of restraint or seclusion constitutes a change in a
patient's plan of care. Changes in a patient's plan of care must be
documented. Documentation in the patient's medical record can be
``written'' manually or electronically.
Comment: One commenter suggested that the regulations should
provide special protections for hearing impaired individuals who
communicate in sign language using their hands and arms. To this end,
this commenter recommended adding language to Sec. 482.13(f)(3): ``For
a person whose mode of communication is through sign language, designed
so that the person is able to effectively communicate in sign language
despite restraints and/or seclusion.''
Response: Providers are expected to meet the communication needs of
their atients, whether those patients speak another language, are
hearing or vision impaired, or have other conditions or characteristics
that merit special intervention to assure smooth communication.
However, there may be situations when it is necessary to place a
patient with special communication needs in restraint or seclusion. In
these situations, the hospital is expected to make reasonable efforts
to meet these needs.
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))
We stated that the use of restraint and seclusion must be
implemented in the least restrictive manner possible and must be in
accordance with safe and appropriate restraining techniques.
No comments were received on these provisions. However, based on
inquiries received after closure of the comment period, we have
determined that the phrase ``used in the least restrictive manner''
needed further clarification; for example, how would a four-point
restraint be used in ``the least restrictive manner''? Our intent is
that if a restraint is necessary, the least restrictive intervention
(which may vary, depending on the patient's history and condition) that
effectively protects the patient's safety or that of others must be
selected.
10. Discontinuing the Use of Restraint/Seclusion (Sec. Sec.
482.13(e)(3)(vi) and (f)(3)(vi))
We stated that restraint or seclusion, whether for acute medical
and surgical care or for behavior management, must be ended at the
earliest possible time.
Comment: While some commenters expressed support for this provision
as written, many hoped to clarify this language and offered either new
wording or guiding concepts to be used in developing new wording.
Several commenters recommended amending the regulatory text to read,
``Ended at the earliest possible time, namely when no longer needed to
ensure the patient's physical safety or whenever a less restrictive
measure would protect the patient or others from harm. If restraint and
seclusion are used simultaneously, the restraint and seclusion shall be
independently evaluated to determine when either or both may be
ended.'' A few commenters suggested that restraint use should be ended
when it is no longer justified or when the emergency situation has
subsided, rather than being dependent on an arbitrary timeframe. One
commenter noted that the patient's release from seclusion and his or
her rapid return to the therapeutic environment is desirable. Another
commenter stated that a patient should be restrained or secluded only
so long as necessary for the patient to regain self-control. One
commenter noted that if the patient is able to take a bathroom break or
eat a meal without incident, the restraint or seclusion should be
discontinued. These commenters believed that the regulation did not
clearly state that the intervention would end when the emergency was
over.
Response: These comments tended to be aimed at standard (f) rather
than (e); overall, they seemed to reflect the concern that what
constitutes ``at the earliest possible time'' may be subject to
interpretation. To address this concern, we have revised the
requirement in combined standard (e) to state that restraint or
seclusion must be discontinued at the earliest possible time,
regardless of the length of time identified in the order.
Comment: One group of commenters wanted to allow the patient a
trial period out of restraints, during which the patient would be
closely observed. If the patient again exhibited the symptoms that had
prompted the prior use of restraints, the patient would be placed in
restraint again and this episode would be considered as part of the
original episode/order.
Response: The approach suggested by these commenters is equivalent
to a PRN order, which is not permitted by combined standard (e). If
staff ends an ordered intervention, they have no authority to start it
again without the initiation of a new order. For example, a patient is
released from restraint or seclusion. If this patient later exhibits
violent or self-destructive behavior that jeopardizes the immediate
physical safety of the patient, a staff member, or others that can only
be handled through the use of restraint or seclusion, a new order would
be required. Staff cannot discontinue an order and then restart it
because that would constitute a PRN order. However, a temporary release
that occurs for the purpose of caring for a patient's needs, for
example, toileting, feeding, and range of motion, is not considered a
discontinuation of the intervention.
11. Assessment, Monitoring, and Evaluation of the Restrained/Secluded
Patient (Sec. Sec. 482.13(e)(4) and (f)(5))
We stated that the condition of the restrained patient must be
continually assessed, monitored, and reevaluated. Section 482.13(f)(5)
created a parallel requirement when a patient is restrained or secluded
for behavior management.
Comment: There was much confusion over the meaning of
``continually.'' One commenter pointed out that ``continually'' appears
to refer to constant face-to-face observation in one portion of the
interim final rule with comment period, while in another it seems to
mean ongoing, but not constant, monitoring. Several commenters
misinterpreted the requirement as forcing physicians and nurses to
remain in a restrained patient's room for the duration of the restraint
use, and argued that this would be a poor use of resources.
Response: Ongoing assessment and monitoring of the patient's
condition are crucial for prevention of patient injury or death. We are
still requiring these activities, but leave it to staff discretion how
frequently they are conducted based upon hospital policy and an
individualized patient assessment. In the final rule, monitoring and
assessment may occur periodically (for example, every 15 minutes) or
continually (that is, moment to moment), depending on the patient's
needs. With the exception of the simultaneous use of restraint and
seclusion, one-to-one observation with a staff member in constant
attendance is not required. To clarify this point, we have deleted the
word ``continually'' from the monitoring requirements in combined
standard (e) with one exception. We have retained the word
``continually'' in the monitoring
[[Page 71400]]
requirements for the simultaneous use of restraint and seclusion.
We expect hospital policies to guide staff in determining
appropriate intervals for assessment and monitoring based on the
individual needs of the patient, the patient's condition, and the type
of restraint used. For example, placing staff at the bedside of a
patient with wrist restraints may be unnecessary. However, for a more
restrictive or risky intervention and/or a patient who is suicidal,
self injurious, or combative, staff may determine that continual face-
to-face monitoring is needed. The hospital is responsible for providing
the level of monitoring and frequency of reassessment that will protect
the patient's safety. Based on public comments, we have revised
combined standard (e) to clarify that the condition of the patient who
is in restraint or seclusion must be monitored and assessed by a
physician, or other licensed independent practitioner or trained staff
at an interval determined by hospital policy. The criteria for staff to
be considered ``trained'' are specified under Sec. 482.13(f).
We have also added language to clarify that all requirements
specified under combined standard (e) apply in the simultaneous use of
restraint and seclusion, which is not permitted unless the patient is
continually monitored. If restraint and seclusion are used
simultaneously to manage self-destructive or violent patient behavior
that jeopardizes the immediate physical safety of the patient, a staff
member, or others, the patient must be continually monitored, face-to-
face, by an assigned, trained staff member; or continually monitored by
trained staff using both video and audio equipment. This monitoring
must be in close proximity to the patient. For the purposes of this
provision, ``continually'' means ongoing without interruption.
Comment: Some commenters requested clarification on the aspects of
the patient's physical condition that must be monitored when the
patient is in restraint or seclusion (indicators such as vital signs,
circulation, hydration, level of distress, agitation), when staff re-
evaluate the need for continued use of restraint or seclusion, and when
an LIP is deciding whether to renew the order for the intervention.
Some commenters also suggested that the patient should be permitted
bathroom breaks and the opportunity to eat meals.
Response: The importance of appropriate assessment and monitoring
of the patient's physical, emotional and behavioral condition when
restraint or seclusion is used cannot be overemphasized. As the interim
final rule with comment period stated, research indicates that the
potential for injury or harm with the use of restraint is a reality.
However, evaluation of the situation and each patient's individual
medical needs and health status should be paramount considerations in
choosing the intervention method, level of monitoring, and frequency of
assessment. Hospital policies should address frequency of assessment
and monitoring components of monitoring (for example, vital signs,
hydration and circulation, level of distress and agitation, mental
status, cognitive functioning, skin integrity), nutritional needs,
range of motion, elimination needs, and other care needs. We cannot
provide an exhaustive list of the items to be monitored because they
will vary with the type of intervention used and the patient's
condition. For example, the use of a restraint that keeps the patient
immobilized would require a check of the patient's skin integrity and
steps to prevent skin breakdown. Depending on the duration of the
intervention, range of motion exercises might be necessary. The
patient's mental status, as well as vital signs, should be assessed,
particularly when the restraint is initiated to manage self-destructive
or violent behavior that jeopardizes the immediate physical safety of
the patient, a staff member, or others. The patient should be provided
the opportunity for toileting, hydration, and eating if the
intervention used impedes these activities.
Reassessments of the patient's condition are essential to assure
that the intervention ends as soon as possible. Again, we expect
frequency of reassessments to be addressed by hospital policies. When
the patient's self-destructive or violent behavior presents an
immediate risk to the patient, a staff member, or others, frequent
reassessments ensure the intervention is used only while the unsafe
situation continues and is discontinued at the earliest possible time,
regardless of the length of time identified in the order.
The interim final rule with comment period did not, and this final
rule does not, require that the practitioner who ordered the
intervention be physically present to re-evaluate the need for
continuing the intervention. The patient's attending practitioner
should, however, be contacted with an update on the patient's status
and an evaluation of the patient's mental and physical condition when
the order for restraint or seclusion is about to expire if it appears
that the intervention is still necessary. In this final rule, we have
retained and revised the provision under combined standard (e)
requiring that after 24 hours, 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 must see and
assess the patient before writing a new order for the use of restraint
or seclusion 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 each order for restraint
used to ensure the physical safety of the non-violent or non-self-
destructive patient may be renewed as authorized by hospital policy.
Comment: A commenter asked what time frames were meant for
``continuously assessed'' (that is, every 5 minutes, every 30 minutes).
Some members of the public and one hospital argued that we should
incorporate required 15-minute checks for restrained and secluded
patients, as we had mentioned in the December 19, 1997 proposed rule.
One commenter suggested that vital signs be taken every 2 hours, with
written documentation of such checks in the medical record. Some
commenters urged retaining flexibility in allowing clinical judgment to
determine timeframes or intervals. Some commenters questioned the value
of continual monitoring for a restrained patient who is sleeping or
only awakening intermittently.
Response: As discussed previously, we expect hospital policies to
guide staff in determining appropriate intervals for assessment and
monitoring based on the individual needs of the patient, the patient's
condition, and the type of restraint used.
Regarding the sleeping patient scenario, a staff person may or may
not need to be permanently posted at a sleeping, restrained patient's
bedside. The fact that a patient is at one point asleep does not
guarantee that the patient will remain asleep hours on end and will
therefore need no reassessment or monitoring. The selection of an
intervention and determination of the necessary frequency of assessment
and monitoring should be individualized, taking into consideration
variables such as the patient's condition, cognitive status, risks
associated with the use of the chosen intervention, and other relevant
factors. In some cases, checks every 15 minutes or vital signs taken
every 2 hours may not be sufficient to ensure the patient's safety. In
others, it may be excessive or disruptive to patient care (for example,
mandating that a patient with wrist restraints who
[[Page 71401]]
is asleep be checked every 15 minutes and awakened every 2 hours to
take the patient's vital signs may be unnecessary). Similarly,
depending on the patient's needs and situational factors, seclusion may
require either periodic or constant monitoring. We expect staff to
determine the appropriate level of monitoring and frequency of
assessment based on hospital policy, an individualized patient
assessment, and type of intervention used.
Comment: Commenters discussed who should perform the assessment,
monitoring, and re-evaluation. Some mental health consumer advocacy
groups and their members suggested that a clinically licensed
registered nurse should perform these tasks; another commenter
suggested that they be performed by licensed professionals trained in
mental health procedures.
Response: We have revised combined standard (e) to provide
hospitals flexibility in determining which staff performs the
assessment and monitoring. This determination, of course, must be in
accordance with the practitioner's scope of practice and State law. For
example, assessment and monitoring are activities within a registered
nurse's scope of practice. However, some trained, unlicensed staff may
perform components of monitoring (for example, checking vital signs,
hydration and circulation; the patient's level of distress and
agitation; or skin integrity), and may also provide for general care
needs (for example, eating, hydration, toileting, range of motion).
Standard (f) requires that before applying restraints, implementing
seclusion, or performing associated monitoring and care tasks, staff be
trained and able to demonstrate competency in the performance of these
actions. Combined standard (e) has been amended to require that the
condition of the restrained patient be assessed and monitored by a
physician, other LIP or by trained staff.
Comment: One commenter suggested that a history of sexual
victimization should be considered when restraining a patient. The
commenter provided the following example: ``Most females who are raped
are raped in the supine position, and therefore supine position is more
likely to recreate the trauma. Similarly, it seems that most males who
are raped are raped in a prone position, therefore prone restraint
might well be contraindicated.''
Response: The hospital should conduct a thorough individualized
assessment of the patient that integrates the patient's salient history
into the treatment plan. However, we will not be mandating this
particular consideration in the regulation's text.
Comment: One commenter urged that children not be left alone for
long periods of time, as an hour can seem quite long when a child is
distressed. Another commenter argued that children in restraint or
seclusion should be monitored one-on-one.
Response: We agree that children, as well as adults, may become
distressed when left alone. We expect staff to determine the frequency
and level of monitoring necessary based on hospital policy, an
individualized patient assessment, and the type of intervention used.
Comment: One commenter suggested that because the lack of vigorous
physical activity may contribute to behaviors triggering restraint and
seclusion, the regulations should include a section requiring vigorous
physical activity for children.
Response: The multidisciplinary team that works with each patient
is able to create an individualized treatment plan that meets the
patient's needs. We do not believe that arbitrarily mandating vigorous
physical activity is wise or necessary.
Comment: One commenter asked how continual assessment, monitoring
and reevaluation would be documented.
Response: How this information is documented will vary with the
policies and practices of each hospital.
Comment: One commenter asked whether a patient restrained for
medical purposes could be monitored from a distance as long as the
patient is kept within eyesight.
Response: A patient restrained under combined standard (e) does not
have to be continually monitored face-to-face unless restraint and
seclusion are used simultaneously or continual face-to-face monitoring
is clinically indicated.
12. Staff Training in the Use of Restraints/Seclusion (Sec. Sec.
482.13(e)(5) and (f)(6))
We stated that all clinical staff that have direct patient contact
must have ongoing education and training in the proper and safe use of
restraints. Section 482.13(f)(6) contains a similar requirement that
specifies that all staff who have direct patient contact must have
ongoing education and training in the proper and safe use of seclusion
and restraint application and techniques and alternative methods for
handling behavior, symptoms, and situations that traditionally have
been treated through the use of restraints or seclusion.
Comment: These provisions enjoyed much support from commenters.
Several commenters quoted the Hartford Courant series (October 11,
1998) as naming better staff training as a low cost mechanism for
averting the situations described in the articles. Many hospitals
agreed that the key to patient safety is staff training and competency,
suggesting that this element more directly affects patient care than
other factors suggested by CMS. One commenter stated the following:
The death of a patient while in restraints or seclusion should
never occur. To that end, steps need to be taken to assure that
staff that initiate a restraint or seclusion intervention and those
who later monitor and evaluate the patient are appropriately
educated, trained, and demonstrate competencies in these practices.
We see these issues as key to the safety and well being of patients
and staff.
One commenter reported that it provides staff with a minimum of 16
hours of annual training that emphasizes verbal de-escalation
techniques. This step, in combination with others, has resulted in
dramatic reduction in restraint/seclusion use for that hospital in the
past 2 years. Many other commenters reported that their hospitals
employ extensive training for clinical staff; one commenter noted that
training direct care staff is a good investment of its resources.
Another commenter voiced its ``complete agreement'' with the training
and educational requirements.
One commenter expressed enthusiastic support for stringent and
appropriate training, noting that this area needs to be expanded and
enforced. This commenter stated, ``Until service providers are
adequately trained in the proper use of restraints, all the regulations
and rules in the world will not be able to ensure safety.'' Another
commenter suggested that CMS should focus on ensuring that restraint
and seclusion are used properly by monitoring training, education,
proper privileging, and proper/effective staff monitoring by
appropriate and available facility staff.
Response: We appreciate the support expressed by commenters and
share the belief that without adequate training and competency among
the direct care staff, patients, staff and others are placed at risk.
Patients have a right to the safe application of restraint or seclusion
by trained and competent staff. We recognize the important role that
staff training and education play in the reduction of restraint and
seclusion use in a hospital. We applaud hospitals that currently
provide extensive training and education for staff as part of a
comprehensive program to ensure patient safety and minimize the use of
restraint and seclusion.
[[Page 71402]]
Based on public comments, we have revised our regulatory language
to provide additional requirements for staff training that focus on
demonstrated competencies and building a skill set for working with
patients. We have also moved the training requirements from current
standards (e) and (f), and created a separate standard (standard (f))
that addresses staff training. This was done to emphasize the
importance of staff training in the safe use of restraint or seclusion.
Standard (f) requires that staff be trained and able to demonstrate
competency prior to applying restraints, implementing seclusion, or
performing associated monitoring and assessment of, or providing care
for a patient in restraint or seclusion. The hospital must require
appropriate staff to have education, training, and demonstrated
knowledge based on the specific needs of the patient population. Staff
must demonstrate competencies as outlined in standard (f) initially, as
part of orientation, and subsequently on a periodic basis. Individuals
providing staff training must be qualified as evidenced by education,
training, and experience in techniques used by hospitals to address
patients' behaviors. Successful completion of training and
demonstration of competency must be documented in staff personnel
records.
Comment: Many hospitals reported that they have instituted training
programs and have made efforts to carefully examine and review their
use of restraints. Some argued that such efforts, rather than
regulatory standards, are the answer to reducing restraint-related
injuries and deaths.
Response: Some of the commenting hospitals stated that they have
never had an injury or death related to restraints or seclusion use,
and it is appropriate to acknowledge this achievement. As its
appearance in our regulation affirms, we believe that a critical piece
of ensuring the health and safety of the patient, staff, and others is
comprehensive training. However, while training programs are a critical
step to assuring patient safety, they do not serve as a substitute for
a statement of basic performance expectations.
Comment: One commenter requested that we define, ``direct patient
contact.'' Several commenters questioned whether we intended that all
staff be trained, including nonclinical personnel or those who have no
part in the provision of care (that is, those who would be unlikely to
take part in a restraint or seclusion intervention). Some disagreed
with a broad training requirement, stating that it would be cost-
prohibitive. These commenters argued that the current wording could be
construed as including housekeeping staff, service staff, clerical
staff, administrative personnel, environmental services staff, dietary
staff, laboratory staff, and all clinical staff. Many commenters argued
that this level of education should be limited to clinical staff who
apply and remove restraints or who provide primary direct care to
patients who may require restraints. One commenter suggested that all
staff should be trained ``commensurate with the amount of contact with
patients'' rather than using direct contact alone as a criterion.
Response: We have accepted the suggestions of these commenters. We
have replaced the phrase, ``direct patient contact,'' with more
specific language to clarify this requirement. We have revised our
standards to require training for the staff who are involved with the
application of a restraint, implementation of seclusion, providing care
for a patient in restraint or seclusion, or with assessing and
monitoring the condition of the restrained or secluded patient.
Comment: One commenter asked whether training would be required for
house medical staff/covering psychiatrists.
Response: In the final rule, combined standard (e) specifies that
physician and other LIP training requirements must be specified in
hospital policy. At a minimum, physicians and other LIPs authorized to
order restraint or seclusion by hospital policy in accordance with
State law must have a working knowledge of hospital policy regarding
the use of restraint and seclusion. Hospitals have the flexibility to
identify training requirements above this minimum based on the
competency level of their physicians and other LIPs and the needs of
the patient population that they serve. Physicians receive training in
the assessment, monitoring and evaluation of a patient's condition as
part of their medical school education. However, physicians generally
do not receive training regarding application of restraint or
implementation of seclusion as part of their basic education. Depending
on the level and frequency of involvement that a physician has in the
performance of these activities, the physician or other LIP may or may
not require training. If house staff, hospitalists or covering
psychiatrists are the medical staff that are directly involved in the
care of a patient in restraint or seclusion, a hospital may determine
that training is necessary to insure competency of these individuals in
this area. We believe the hospital is in the best position to determine
if physician training is necessary based on the model of care, level of
physician competency, and the needs of the patient population(s) that
the hospital serves. Therefore, we have only mandated a minimum level
of physician and other LIP training. Instead, we have provided
hospitals with the flexibility to specify additional physician and
other LIP training requirements, if any, in hospital policy.
Comment: One commenter suggested that staff be required to talk to
the patient intermittently to assist the patient's efforts to regain
self-control and to explain what the patient needs to do for the
restraint or seclusion to end.
Response: The training requirements are intended to equip staff
with skills that can be used in this fashion.
Comment: One commenter suggested that there should be Federal
compensation for the added cost of providing such training.
Response: Staff training is generally included in administrative
costs and is recognized in calculating payments under the hospital
inpatient prospective payment system. Therefore, we are not providing
separate compensation to fund this training.
Comment: Several commenters asked about the frequency of training.
One commenter suggested that the term ``ongoing'' should be replaced
with ``annually.''
Response: We have modified the regulatory text to require staff to
demonstrate the competencies specified in standard (f) initially as
part of orientation and subsequently on a periodic basis consistent
with hospital policy. We believe the hospital is in the best position
to identify a timeframe for ongoing training based on the level of
staff competency, and the needs of the patient population(s) served.
Comment: Commenters had varying ideas about what topics training
should cover, and whether the regulation should specify training
content in detail. Several commenters asked whether training must be
obtained from Federally-specified programs.
One commenter urged that requirements for the training curriculum
be described in the regulations. A few commenters suggested that the
current standard (f) training requirement should not be limited to the
proper and safe use of restraints; one commenter suggested more
emphasis on positive behavioral supports and less on ``proper'' use.
One commenter supported education on alternatives to restraint use and
safe handling of a patient in restraints. Another commenter suggested
that the training should include personally experiencing being
restrained. One commenter argued that staff should be
[[Page 71403]]
trained in values clarification, cultural diversity, and counter-
transference since it is commonly acknowledged that patients become
more agitated and lose control when staff responds in a manner that
provokes the patient.
Response: We have adopted more detailed training requirements in
this final rule. In addition, we have moved the training requirements
from the current standards (e) and (f), and have created a separate
standard (f) that addresses staff training requirements.
Standard (f) states that the hospital must require appropriate
staff to have education, training, and demonstrated knowledge based on
the specific needs of the patient population in at least the following:
Techniques to identify staff and patient behaviors,
events, and environmental factors that may trigger circumstances that
require the use of restraint or seclusion;
The use of nonphysical intervention skills;
Choosing the least restrictive intervention based on an
individualized assessment of the patient's medical, or behavioral
status or condition;
The safe application and use of all types of restraint or
seclusion used in the hospital, including training in how to recognize
and respond to signs of physical and psychological distress (for
example, positional asphyxia);
Clinical identification of specific behavioral changes
that indicate that restraint or seclusion is no longer necessary;
Monitoring the physical and psychological well-being of
the patient who is restrained or secluded, including, but not limited
to, respiratory and circulatory status, skin integrity, vital signs,
and any special requirements specified by hospital policy associated
with the 1-hour face-to-face evaluation; and
The use of first aid techniques and certification in the
use of cardiopulmonary resuscitation, including required periodic
recertification.
Staff need to employ a broad range of clinical interventions to
maintain the safety of the patient and others in the provision care.
The hospital is expected to provide education and training at the
appropriate level to the appropriate staff based upon the specific
needs of the patient population being served. For example, staff
routinely providing care for violent or self-destructive behavior that
jeopardizes the immediate physical safety of the patient, a staff
member, or others (such as in an emergency department or on a
psychiatric unit) generally require more in-depth training in the areas
included in the regulation than staff routinely providing medical/
surgical care.
Lastly, we have not required that training be obtained from
Federally-specified programs. Hospitals may develop and implement their
own training programs or use an outside training program. However,
standard (f) specifies that individuals providing staff training must
be qualified as evidenced by education, training and experience in
techniques used to address patients' behaviors.
Comment: One commenter suggested that training should include
instruction on--(1) how to identify patients who may have conditions
that would require special attention, (for example, a history of
respiratory or cardiac problems); (2) how to monitor patients in
restraints; and (3) what conditions are necessary for a person to be
released from restraints. This commenter suggested that in standard
(f), the training requirement should include instructions on how to
screen patients for special problems that could affect the use, type,
or duration of restraints (for example, emotional problems associated
with a history of abuse or neglect).
Response: We agree and have incorporated the suggested elements in
standard (f).
Comment: One commenter suggested that staff that has not completed
training should be prohibited by regulation from initiating and
complying with orders for restraint or seclusion.
Response: We agree. In standard (f), we require that staff be
trained and able to demonstrate competency before applying restraints,
implementing seclusion, or performing associated monitoring and
assessment of, or providing care for, a patient in restraint or
seclusion. Application of restraint or seclusion by an untrained staff
member, including contract staff, would constitute a violation of this
requirement.
13. Definition of Seclusion (Sec. 482.13(f)(1))
We defined seclusion as the involuntary confinement of a person in
a room or an area where the person is physically prevented from
leaving.
Comment: Several commenters suggested adding the word ``alone'' to
the definition of seclusion. Several commenters pointed out that the
definition that appeared in the interim final rule with comment period
would define a patient confined involuntarily on a locked unit as being
secluded. Additionally, one commenter believed the word ``area'' was
too broad and might be read as including being on a unit or ward with
others.
Response: In the final rule, we have added the word ``alone'' to
this definition for clarity and retained the use of the word ``area''.
Seclusion does not include confinement on a locked unit, ward, or other
area where the patient is with others. Seclusion is not just confining
a patient to an area but involuntarily confining the patient alone in a
room or area where the patient is physically prevented from leaving. A
situation where a patient is restricted to a room or area alone and
staff are physically intervening to prevent the patient from leaving
the room or area is also considered seclusion. In addition, we have
clarified that seclusion may only be used for the management of violent
or self-destructive behavior that jeopardizes the immediate physical
safety of the patient, a staff member, or others.
Comment: One commenter stated that physical restraint is more
frequently associated with injury and death than is monitored
seclusion. This commenter argued against categorizing seclusion with
restraint, stating that its use should not be governed by the same
requirements. Another commenter said that linking the terms
``seclusion'' and ``restraint'' is misleading in that it creates the
inaccurate perception that the two interventions are equivalent in all
respects. This commenter could not imagine a death resulting from
seclusion, other than from self-inflicted injury (which would indicate
a possible need for restraint initially) or from the total and gross
neglect of an acutely ill patient, which no amount of regulation would
prevent, since this would represent unacceptable, deviant practice.
One commenter stated that seclusion is therapeutically different
from restraint. Seclusion is indicated when a patient's behavior poses
a significant threat to others or is profoundly disturbing in the
therapeutic environment (such as a patient disrobing in public). This
commenter suggested that while this behavior is not violent, it is
appropriately, humanely, and therapeutically addressed through
seclusion.
Response: The frequency and level of monitoring and assessment of
the condition of a patient who is in restraint or seclusion are
determined by staff based on hospital policy and an individualized
patient assessment. These parameters would differ based on the type of
intervention used. We would not necessarily expect these parameters to
be identical for all types of restraint and the use of seclusion.
[[Page 71404]]
In response to the comment about the therapeutic use of seclusion,
we note that the use of seclusion is a means to an end, not the end
itself. In the example given, simply secluding a patient who habitually
disrobes is not a long-term solution to eliminating this inappropriate
behavior. The patient should be assessed and engaged in an active,
individualized treatment program.
Comment: A commenter, concerned about the needs of students
receiving special education, asked whether this regulation would define
a child who has been restricted from attending a school program as
having been ``secluded,'' and requested that the regulation prohibit
this action except when the requirements of the regulation are met.
Response: Not allowing a patient to attend a school program or
removing a patient from a classroom setting would not meet the
definition of seclusion as defined in this rule, and also outside the
scope of this regulation which addresses restraint and seclusion in
hospitals.
Comment: One commenter stated that there should be minimum
standards for the cubic dimensions and ventilation of a seclusion room,
which were not provided in the interim final rule with comment period.
Response: We believe that setting these types of standards is
beyond the scope of this rule.
Comment: Commenters concerned with children's issues discussed the
use of ``time outs.'' Several commenters argued that CMS should
distinguish between seclusion (where a child is locked in a room) and a
time out, and that time outs should not be governed by the regulation.
These commenters believed that a ``time out'' should be defined as
actions to require the child or adolescent to retire to an alternative
setting, either in his or her room or in a separate quiet room, but
without restraining or locking up the child. Several commenters
expressed concern that the regulation prohibits so called ``open door''
and ``decreased stimulation'' time outs, which are used to prevent the
escalation of behavior leading to emergency situations. One commenter
asked whether a child voluntarily removing himself from a current
activity and spending 15 minutes calming his or her emotions
constitutes seclusion.
Response: For the purposes of this final rule, seclusion is the
involuntary confinement of a patient alone in a room or area from which
the patient is physically prevented from leaving. Seclusion may only be
used for the management of violent or self-destructive behavior. If a
patient is free to leave a time out area whenever the patient chooses,
this would not be considered seclusion based on this definition. The
key distinction in deciding whether an intervention is seclusion or a
time out is whether the patient is physically prevented from leaving a
room or area. Another distinction is the patient's level of personal
control. In the case of seclusion, boundaries are placed on the
patient's behavior based on the clinical determination that the
patient's behavior poses a risk to the safety of the patient or others.
In a time out, the patient is able to respond to staff direction
encouraging a time out or to independently decide that such action is
needed. In a time out, the staff and patient collaboratively determine
when the patient has regained self-control and is able to return to the
treatment milieu. In seclusion, this judgment is made by the
clinicians--that is, an agitated patient may feel that he or she should
be released, even though the patient's behavior continues to be violent
or self-destructive.
Comment: One commenter inquired whether seclusion requires a
physician's order and all related monitoring and documentation.
Response: The use of seclusion for the management of violent or
self-destructive behavior is regulated by combined standard (e). If an
intervention meets the definition of seclusion in standard (e), all of
the requirements under standard (e) would apply, including those
related to a physician or other LIP's order, the 1-hour face-to-face
evaluation, monitoring and documentation.
Comment: One commenter expressed concern that the definition of
``seclusion'' covers typical hospital practices, such as keeping
visitors and patients out of certain areas for purposes of infection
control, security, patient privacy, or prevention of disruption of
treatment.
Response: Our modification to the definition, that is, adding the
word ``alone,'' should alleviate this concern. In the cases cited, the
hospital is keeping patients or visitors out of an area versus
involuntarily confining the patient alone within a room or area from
which the patient is physically prevented from leaving for management
of violent or self-destructive behavior that jeopardizes the immediate
physical safety of the patient, a staff member, or others. It is not
the intent of this rule to interfere with hospital infection control
practices, security measures, patient privacy or measures intended to
prevent the disruption of treatment. Additionally, State law outlines
requirements for quarantining a patient. If the need to quarantine a
patient arises, the hospital would follow State law. Quarantining, as
governed by State law, would not be considered seclusion.
14. Use of Restraint/Seclusion for Behavior Management (Sec.
482.13(f)(2))
We stated that seclusion or restraint for behavior management can
only be used in emergency situations if needed to ensure the patient's,
a staff member, or others' physical safety and less restrictive
interventions have been determined to be ineffective.
Comment: Many commenters stated that the use of restraint or
seclusion is a treatment failure. In contrast, several commenters
argued that the regulation's requirements are not guided by solid
clinical information, nor do they take into account the realities of
inpatient psychiatric treatment. One commenter stated, ``While I am
aware of individuals who think that medications and/or restraints for
[violent, aggressive] patients should never be applied, such thinking
is naive, unrealistic, and idealistic.'' The commenter recommended that
we study how many deaths/injuries/assaults are prevented by appropriate
use of restraints.
Response: The role of restraint and seclusion for behavior
management was a point of fundamental disagreement among commenters.
While we believe that restraint and seclusion are not desirable
interventions, we recognize the diversity of patients and situations
that clinicians must address. In some of these situations, the patient
poses a real safety risk to self or others, and alternative, less
restrictive interventions are not sufficient to assure the safety of
the patient or others.
Comment: A few commenters strongly agreed that restraints should
only be used for emergency safety situations. Some physicians and
hospitals indicated that they view restraint as a last resort which is
only used when absolutely necessary to protect the safety of the
patient or others. One commenter indicated that seclusion and restraint
have a valuable place in treatment, but only when used minimally, such
as in cases of extreme violence or when needed to protect clients. One
commenter stated that the rule does not define the term ``emergency,''
and cited a Maryland regulation that defines an emergency as a
situation in which the patient's behavior poses a serious and imminent
danger to the physical safety of self or others.
In contrast, a commenter suggested removing ``in emergency
situations.'' Another commenter agreed with this
[[Page 71405]]
suggestion, arguing that the rule does not permit the use of seclusion
and restraint as therapeutic interventions as part of a treatment plan
for serious behavioral problems. The commenter argued that although
short-term, crisis-based use of seclusion and restraint is necessary,
it is not the only appropriate use of restraint, since short-term
behavioral restrictions can be the most humane way to prevent the
patient from self-injury and reduce the need for invasive medical
therapies that can have serious, long-term adverse consequences.
Response: The use of restraint or seclusion should not be a routine
response when a patient's behavior begins to escalate. Restraint or
seclusion may only be imposed to ensure the immediate physical safety
of the patient or others. Seclusion may only be used for the management
of violent or self-destructive behavior of patients when there is an
immediate danger of harm to the patient, a staff member, or others. We
recognize that there may be circumstances in which the use of restraint
or seclusion may be necessary to prevent a situation from escalating
into an emergency situation in which a patient is in immediate danger
of harming himself, staff, or others. In the therapeutic environment,
staff often skillfully intervene with alternative techniques that
redirect the patient, engage the patient in constructive discussion or
activity, or otherwise help the patient maintain self-control and avert
escalation. Therapy is a building process in which the patient gains
the skills necessary to appropriately handle daily stressors and
situations. The use of restraint or seclusion to manage violent or
self-destructive behavior is an emergency measure that temporarily
protects the safety of the patient, staff, and others. However, neither
restraint nor seclusion is a long-term solution for handling
problematic behavior.
Based on public comment, we have clarified this provision by
replacing the reference to emergency situations with more descriptive
language. Therefore, combined standard (e) states that restraint or
seclusion can only be imposed to ensure the immediate physical safety
of the patient, staff, or others, must be discontinued at the earliest
possible time, and less restrictive interventions have been determined
to be ineffective. Seclusion may only be used to manage violent or
self-destructive behavior of patients that jeopardizes the immediate
physical safety of the patient, a staff member, or others.
Comment: One commenter suggested permitting the use of restraints
to control anticipated catastrophic behavior associated with conditions
such as Lesch Nyhan Disease (manifested by self-mutilation) or other
self injurious or assaultive behaviors. The commenter argued that such
use would be appropriate to address intractable behaviors that have not
responded to medications or other treatment interventions. This type of
use would be part of an individualized plan of care addressing the
underlying cause of the behavior and would involve rigorous monitoring
and active treatment to allow for the removal of restraints.
Response: The regulation has not barred the use of restraint to
manage catastrophic behavior. If a patient has a diagnosed chronic
medical or psychiatric condition such as those associated with Lesch-
Nyhan Syndrome, and he or she engages in repetitive self-mutilating
behavior, the use of restraint would need to meet the requirements of
combined standard (e). In these situations where the patient exhibits
chronic self-injurious behavior, a PRN order that is applied in
accordance with the specific parameters established in the treatment
plan would be permitted (note that PRN application of restraint is not
otherwise permitted). Again, this use of restraint would need to be
integrated into the plan for the patient's care and treatment. As
always, the use of alternative interventions should be pursued when
feasible, and use of restraint should be discontinued as quickly as
possible. Since the use of restraints to prevent self-injury for these
types of rare, severe medical and psychiatric conditions have been
intergrated into the patient's care and treatment plan, the requirement
for the 1-hour face-to-face evaluation and the limitation of length of
orders (4, 2, or 1 hour(s) depending on the patient's age) are not
applicable.
Comment: One commenter suggested a series of steps for treating a
patient who has a known history of assault or who exhibits aggression.
First, the patient must have a treatment plan to address the problem.
Second, if the treatment plan does not work, a back-up plan must
provide the patient relief from whatever seems to be provoking the
attack. Third, if the back-up plan fails, staff should try to coach or
encourage some alternative to assault. The commenter suggested that
assault is almost always goal directed, and that staff's task is to
determine the goal and suggest an alternative to achieve it. If
alternatives are not accepted, staff should ``reduce their verbiage''
and ``exaggerate simple non-verbal messages.'' If an attack is
initiated, staff should continue the use of verbal de-escalation
techniques while physically evading attack. If all these interventions
fail and the attack continues, ``some form of bodily restraint may be
justified.''
Response: We appreciate the commenter's insights. However, the
level of detail provided is more typical of hospital policy on how to
handle assaultive behavior than of regulatory text. When a patient is
exhibiting violent or self-destructive behavior and the patient is in
danger of harming themselves or others, and less restrictive
interventions have been determined to be ineffective, we expect staff
to implement appropriate interventions to ensure the safety of the
patient and others. While the steps described by the commenter may be
appropriate in some situations, they may not be appropriate in others.
For example, a patient is attacking another patient. In this situation,
immediate intervention, that is, restraint or seclusion in conjunction
with ongoing verbal de-escalation and communication with the patient
may be necessary to ensure the safety of all involved. The use of less
restrictive interventions that are ineffective in this scenario may, in
fact, further jeopardize the safety of those involved. Therefore, it is
critical that staff employ the least restrictive interventions that
will be effective in ensuring the safety of the patient, other
patients, staff and others.
Comment: One commenter observed that insuring the safety of
patients (as required by the Patients' Rights CoP) will not be possible
unless restraining patients who endanger the safety of others is
permitted. The commenter stated that the interim final rule with
comment period precludes this type of use of restraint or seclusion. A
second commenter agreed, noting that provision (f)(2) of the interim
final rule with comment period contradicts (f)(3)(i) in that only
patient safety (not that of others as provided in (3)(i)) is mentioned
in (f)(2). One commenter suggested the following rewording for (f)(2)
to remedy this contradiction: ``Seclusion or restraint can only be used
in emergency situations if needed to ensure the patient's physical
safety or the safety of others and less restrictive interventions with
the patient have previously been determined to be ineffective.'' Other
commenters echoed the concern that the requirement should take the
safety of other patients and staff into account.
Response: The interim final rule with comment period stated that
the use of restraint or seclusion must be selected only when ``less
restrictive measures have been found ineffective to protect
[[Page 71406]]
the patient or others from harm.'' We have revised the final rule to
state 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. In addition, we have specified
the type or technique of restraint or seclusion used must be the least
restrictive that will be effective to protect the patient or others
from harm.
Comment: One commenter stated that ``absolute danger'' cannot be
the only qualifier for restraint or seclusion use in behavior
management. The hospital cited examples of highly agitated behavior
that disrupts the treatment milieu, such as a patient yelling
profanities, disrobing, or destroying property. In addition, another
commenter stated that Maryland regulation permits the use of seclusion
or restraint when an individual presents a serious disruption to a
therapeutic environment (behavior of such a grave or protracted nature
that it significantly interferes with the emotional well-being of other
patients or with their treatment).
Response: We recognize that situations do occur in which highly
agitated behaviors can disrupt the therapeutic environment. A
disruption to the therapeutic environment that jeopardizes the safety
of patients, staff, and others could be a situation where the use of
restraint or seclusion may be necessary. In these situations, there may
be no other intervention short of the use of restraint or seclusion
that will assure the safety of the patients, staff and others. Based on
these comments, we have revised combined standard (e) to state that
restraint or seclusion can only be used to manage violent or self-
destructive behavior of patients when they are in danger of harming
themselves or others, and less restrictive interventions have been
determined to be ineffective. However, we have not accepted the
commenter's recommendation regarding ``agitated behavior.'' A patient's
agitated behavior may or may not pose a physical safety threat to the
patient, staff or others. We caution against automatic responses, where
the situation is oversimplified and the intervention is not tailored to
the individual patient. For example, the fact that a patient is yelling
profanities is not an automatic trigger for restraint use. A patient
might yell because of pain or any number of factors, which could
perhaps be addressed by other types of intervention. In the examples
cited, the patient's behavior should prompt individualized assessment
and treatment. A patient who is shouting profanities may be calmed by
one-to-one interaction with a staff member. A patient who is trying to
destroy an object can, in some cases, be distracted or encouraged to
redirect his or her energies. Again, we emphasize that the decision of
how to handle any given situation will depend on the patient, the
patient's history, the patient's symptoms, and the seriousness and
immediate danger presented by the patient's behavior.
Comment: One commenter stated that each patient who is restrained
or secluded should be given a complaint form when the intervention
ends, with instructions on how to fill it out, and privacy and
protection in submitting it.
Response: The hospital is required by standard (a) to establish a
process for prompt resolution of patient grievances and must inform
each patient who to contact to file a grievance. If the patient or the
patient's representative wants to file a grievance, this can be done
verbally or in writing.
Comment: One commenter recommended sanctions against providers who
misuse or abuse any chemical or physical intervention be significant,
sure, and swiftly applied.
Response: We appreciate this commenter's support for vigorous
enforcement. Hospital noncompliance with these requirements is of the
same gravity as noncompliance with existing standards, and could result
in enforcement action.
Comment: A commenter stated that the regulation should reflect the
fact that to reduce the use of restraints, it is necessary for hospital
leadership to make clear that this is their policy and their goal. The
commenter also stated that leadership must create an atmosphere where
the use of restraints is not tolerated, unless absolutely necessary.
Response: We agree that hospital leadership plays a critical role
in the reduction of restraint and seclusion use. There are many
challenges associated with initiating and sustaining reduced use of
restraint and seclusion. Strong organizational leadership is essential
in creating the culture change necessary to minimize the use of
restraint and seclusion. The responsibilities of the governing body and
Medical staff are addressed in other CoPs.
15. One Hour Rule (Sec. 482.13(f)(3)(ii)(C))
We stated that a physician or other licensed independent
practitioner must see and evaluate the need for restraint or seclusion
within 1-hour after the initiation of this intervention.
This provision was the lightning rod for public comment. Almost
every commenting physician opposed the provision as written, and the
majority of commenters strenuously objected to it, with most asking
that the words, ``see and'' be eliminated to leave only the requirement
for a physician or LIP evaluation. A core of commenters from advocacy
groups and the general public stated that this provision should be
modified by shortening the timeframe to half an hour and eliminating
the recognition of an LIP's ability to perform this function.
Many commenters asked what the face-to-face requirement of the
interim final rule with comment period accomplished. In the preamble of
the July 2, 1999 interim final rule (64 FR 36079) we stated the
following:
In situations where a restraint must be used for behavior
management, increased vigilance is required because of the
heightened potential for harm or injury as the patient struggles or
resists. Furthermore, there is an immediate need for assessment of
what has triggered this behavior and for continuous monitoring of
the patient's condition. To address the need for quick assessment of
the condition, we are specifying that the physician or licensed
independent practitioner see the patient face-to-face within 1-hour
of the application of the restraint or the use of seclusion.
The one-hour requirement of the interim final rule with comment
period was intended to assure patient safety with a quick assessment by
a physician or other LIP to rule out possible underlying factors that
might be contributing to the patient's behavior, to assess the
patient's physical and psychiatric condition, and to decide whether
restraint or seclusion continue to be necessary.
Commenters were divided on whether this provision would promote
patient safety or address adequately the problems identified by the
media. While some commenters stated that deaths that occur during the
first hour of restraint or seclusion support the need for this mandated
onsite physician or LIP assessment within the first hour, a second
group stated that by the time the physician arrived in the 59th minute,
if staff were not properly trained, the patient might already be dead.
This latter group of commenters argued that our proposed ``fix'' did
not directly address the key problem and that we were essentially
adding a process without proof of an improved outcome for patients.
Some commenters referred us to a Pennsylvania policy used in its
ten State-operated psychiatric hospitals, which requires a physician's
face-to-face evaluation within half an hour, and accompanying data that
shows a reduction in restraint and seclusion use.
[[Page 71407]]
The Commonwealth's policy and data were cited as proof that a half-hour
physician face-to-face assessment improves patient care and assures
patient safety. In preparing the final rule, we were interested in the
Commonwealth's experience, including any outcomes data or research
related to its half-hour physician assessment policy. We asked for and
received a package of information from the Commonwealth that described
its policies regarding restraint and seclusion and data showing use
over time.
The Commonwealth's policies provide that--(1) only a physician may
order restraint or seclusion; (2) orders may not exceed 1 hour; (3) if
a verbal order is given, the physician must physically evaluate the
patient within 30 minutes; (4) persons in restraint must be kept under
constant observation; (5) each reorder may not exceed 1-hour and
requires physical examination; (6) each incident must be followed by
patient debriefing; and (7) each use triggers clinical, administrative,
and continuous quality improvement review, plus a revision to the
treatment plan.
After reviewing the information received, we did not find any
claims by the Commonwealth that physician assessment within half an
hour had directly contributed to reduced restraint and seclusion use.
Furthermore, to make such an attribution would be to ignore the fact
that the Commonwealth introduced a multi-pronged approach that embraces
many methods to address the issues of patient and staff safety. An
important aspect of the approach is that physicians are on staff around
the clock in the Commonwealth's psychiatric facilities. The
requirements referenced earlier do not exist in isolation, but are part
of the Commonwealth's integrated approach and ongoing efforts to work
collaboratively toward the goals of restraint and seclusion reduction
and patient and staff safety.
To summarize, given the comprehensive restraint and seclusion
policies instituted by the Commonwealth, it is simply unclear whether
one could point to the half-hour evaluation and demonstrate a direct,
causal effect on the reduction in restraint and seclusion initiation
and duration in Pennsylvania's State psychiatric hospitals.
Based on our analysis of the information supplied by the
Commonwealth, and given the numerous public comments we received on
this requirement, we have revised the regulatory language to broaden
the types of practitioners who may conduct the 1-hour face-to-face
evaluation to include a trained RN or PA unless superseded by State law
that is more restrictive. We have also addressed the criteria by which
staff are to be considered ``trained'', and specify the components of
the 1-hour evaluation. In making these changes, we acknowledge the
comments of many psychiatrists and other physicians who noted that they
are appropriately consulted within 1-hour of the initiation of
restraint or seclusion by the onsite staff. Many such commenters argued
that a RN is entirely capable of assessing the patient's condition, and
that to suggest otherwise ignores RNs' training and high level of
expertise.
How quickly the patient needs to be seen by his or her attending
physician (or other practitioner, as noted in the regulation) is left
to the medical judgment of the physician or other LIP. We have revised
standard (f) to state that if the 1-hour face-to-face evaluation is
conducted by a trained RN or PA, the attending physician or other LIP
responsible for the care of the patient must be consulted as soon as
possible. The attending physician or other LIP is responsible for
assuring that the patient receives a timely and adequate face-to-face
assessment based on the clinical need presented by the individual
patient's case.
Comment: One commenter noted that in California, the contractual
relationship between a physician and hospital may affect the hospital's
ability to ask physicians to meet the 1-hour requirement.
Response: The comments submitted (some of which came from
physicians from California) indicated that a high level of physician
involvement in the patient's care already exists. Many reported routine
contact with hospital staff if a patient under their care becomes
violent or self-destructive and restraint or seclusion may be
indicated. Most of these physicians argued for the removal of the word
``see,'' noting that they are willing to be and indeed already are
involved with these sorts of decisions, but that their objection was to
the onsite visit. We have revised the requirements to permit a trained
RN or PA to conduct the 1-hour evaluation, and do not require the
physician to come to the hospital to see and evaluate the patient 1-
hour after the initiation of the restraint or seclusion. Because this
change permits more flexibility and clinical judgment on the
physician's part, we believe that the cause for physician objection is
largely removed.
a. Comments Objecting to a Physician or LIP Seeing the Patient Within 1
Hour
The majority of commenters objected to our requirement that a
physician or LIP see the patient within 1-hour of the initiation of
restraint or seclusion for behavior management. They provided the
following arguments regarding this requirement as written in the
interim final rule with comment period. The rule--
Is impractical. By the time the physician or LIP arrives,
the patient's episode may already be over, leaving some physicians
asking what they are supposed to evaluate when they arrive. One
physician asked whether he must awaken a patient to perform an
evaluation after the intervention has ended if the patient is asleep
afterward.
Forces free standing facilities to hire under qualified
and ill-prepared physicians to see and evaluate patients with whom they
are unfamiliar.
Pits the physician against staff.
Creates hesitation to use an intervention to address
violent or aggressive behavior that places the patient, the staff, and
other patients at risk. One commenter believed that psychiatrists will
tell nursing staff to tolerate aggression or violence until they find
time to come and see the patient, which also places those present at
the hospital at risk. To provide evidence of the risk to staff,
commenters referred to various data sources: the Occupational Safety
and Health Administration has named health care workers as one of the
most injured-on-the-job occupational groups; the National Institute for
Occupational Safety and Health has found that most non-fatal workplace
assaults occur in service settings such as hospitals, nursing homes,
and social service agencies. Forty-eight percent of nonfatal assaults
in the workplace are committed by health care patients; and the
Department of Justice has found that mental health professionals rank
sixth (behind taxi-drivers, police officers, security guards, prison
guards, and bartenders) on a list of occupations with the greatest risk
of attack. This requirement, commenters argued, will add risk of on-
the-job injury that could otherwise be avoided.
Inappropriately dictates medical practice. Requiring
timely and appropriate medical evaluation is reasonable, but it is not
feasible or clinically necessary to require a face-to-face evaluation
by a physician in each case. A physician assessment of the situation
should always be done, but whether face-to-face evaluation is necessary
should be left to the physician's discretion.
[[Page 71408]]
Nullifies the professional clinical decisions of
registered nurses and insults their professionalism and training.
Adversely impacts staff morale, recruitment, and
retention. One physician described getting good staff as a continuing
challenge since the job is inherently dangerous. He believed that he
will lose staff who decide that the increased hassle of inpatient work
is not worth the trouble when plenty of outpatient work is available.
Other commenters voiced similar concerns, noting that nurses must deal
with belligerent and uncontrollable patients, and limiting their
available options will make retaining nursing personnel difficult.
Will cause hospitals to place patients immediately in
restraint without trying seclusion (that is, move to the most
restrictive intervention first) so that the physician only has to make
one visit to assess the patient.
Will adversely affect patient access to care. Admitting
teams will refuse to accept any potentially violent or disruptive
patients because of this requirement and thereby increase the number of
patients routed to State hospitals, the criminal justice system, or
juvenile hall, and increase the number of patients who are put out on
the street. Persons with the most severe mental illness will be denied
a choice of physicians and hospitals although their treatment needs are
the greatest.
May be impossible to implement. Existing psychiatrist
shortages may thwart hospitals' attempts to hire coverage so that this
requirement can be met. One facility commented that it has tried to
recruit personnel, but was repeatedly told that psychiatrists can make
more money with considerably fewer disruptions in their lives by
choosing not to do inpatient psychiatry. As a result of these
regulations, three of that facility's current physicians are
questioning whether they will continue with their inpatient privileges.
The commenter also states that a nearby psychiatric unit may close its
inpatient services as a result of its entire psychiatric staff
resigning. Another hospital reported that no local physicians were
willing to be on call and onsite within 1 hour. Many physicians stated
that this provision has caused them to question whether they should
continue rendering inpatient services.
Cannot be implemented because of geographical/logistical
issues. While large organizations may have house staff and residents
with which to meet this requirement, it will be difficult to accomplish
in community or rural hospitals.
May require onsite physicians (usually emergency room
physicians) to leave less stable patients simply to comply with this
regulation.
In effect will require all hospitals to have physicians
present 24 hours a day, 7 days a week. One hospital noted that hiring
an onsite physician would be costly and impractical given the low
occurrence of restraint and seclusion.
Has no clear clinical rationale.
Will result in patient overmedication in an attempt to
avoid such situations. One physician cautioned that overuse of
antipsychotic medications can result in severe (sometimes irreversible)
neurologic side effects or Neuroleptic Malignant Syndrome, which is
potentially fatal. Increased use of psychotropic medications may lead
to excessive sedation and cognitive dulling, which could affect the
patient's ability to benefit from therapy and other interventions.
Will be disruptive of care provided to outpatients by
requiring that practitioners drop everything to come into the hospital
to meet the requirement. This disruptiveness will discourage
practitioners from providing inpatient services, and thereby adversely
impact patient care and access to good practitioners.
Is not based in any empirical evidence that suggests that
a face-to-face evaluation by a physician or LIP will improve the
outcomes of care for patients who are secluded or restrained; nor is it
based on any information that suggests that a telephone consultation is
less effective than a face-to-face evaluation.
Will cost too much. Various hospitals provided estimates
that ranged from a cost of $62,000 to $750,000 per year. One commenter
stated that the economics of small community facilities that provide
inpatient psychiatric care are tenuous at best. This regulation may
force these facilities to close or go bankrupt. The commenter alleged
that we have ``tolled the death knell of inpatient psychiatric services
across the country.'' Another commenter believed that most providers
will go out of business, and those that remain will have to pass the
increased costs on to the payors and patients. One hospital stated that
this requirement will force it to ``close its doors.'' One physician
reported that nearly all psychiatric facilities and programs operate on
a slim margin at best. Studies have shown that mental health program
budgets have been reduced by 54 percent over the past decade, compared
to 7 percent in non-psychiatric medical programs. Programs that
specialize in treating geriatric and juvenile patients will be severely
affected by this rule. It is likely, he argued, that administrators
will be forced to divert resources for staffing levels, equipment,
patient education, case management, and other critical patient care
activities to offset the cost of implementing the rule. One hospital
sent in a notice of closure as a comment.
Will be costly, both in time and resources. Each time the
physician is required to see a restrained/secluded patient, there will
be an additional fee for the visit. Most often, a physician who is
unfamiliar with the patient will have to spend time reading the chart
and examining the patient, and talking to staff. This may also result
in confusion about treatment.
May be used to manipulate the physician since the patient
can escalate his/her behavior, knowing that the physician will have to
appear within 1-hour as a response.
Will be ignored by the medical community. One physician
indicated that the unanimous response he has received from colleagues
is that ``it ain't gonna happen.''
Does not allow for treatment that is individualized and
based on medical necessity.
Is unreasonable. Physicians in independent private
practice have full out-patient office schedules after hospital rounds
and cannot be expected to cancel an entire schedule and ignore the
clinical needs of outpatients to drive to the hospital on an
unpredictable and irregular basis. Family practitioners and specialists
have a full daytime schedule and will not be able to provide quality
services if they are exhausted and unpredictable in their schedules.
b. Comments Supporting Telephone Consultation With a Nurse Onsite
Performing the Patient Assessment
Many of these commenters suggesting deleting the word ``see'' from
the requirement to allow staff consultation with the physician or LIP
by phone. A large number of these commenters agreed with the revised
language proposed by the American Hospital Association (AHA) and the
National Association of Psychiatric Health Systems (NAPHS), ``A
physician or other licensed independent practitioner must evaluate the
need for restraint or seclusion within one hour after the initiation of
this intervention.'' AHA and NAPHS believed that the evaluation may be
done by the physician or LIP in consultation with a registered nurse
who has demonstrated competency in the evaluation of a patient in
restraint or
[[Page 71409]]
seclusion and who is in face-to-face contact with the patient. Many
commenters argued that this change would be appropriate because
qualified registered nurses are more readily accessible in emergency
situations. Because of the RN's involvement at the earliest stages of
an event, the RN would be able to provide additional information about
the situation and provide the physician with rapid, appropriate
consultation. The RN would carry out the physician's order and direct
staff in the use of least restrictive methods and in the
discontinuation of restraint or seclusion at the earliest possible
time, as specified in the interim final rule with comment period.
The NAPHS further suggested that the content of the nurse/physician
consultation include the following elements in order to promote an
informed evaluation of the patient: (1) Consideration of organic causes
for the behavior; (2) known medical disorders; (3) the patient's
medications; (4) the patient's mental status; (5) a brief neurological
examination; and (6) vital signs. If data from this evaluation
supported the need for a face-to-face visit, then the physician would
come to see the patient.
Other commenters argued that by limiting the ability to assess the
patient to an LIP or physician, CMS is contradicting JCAHO standards
which permit a RN to assess and document the need for restraint. Many
commenters supported RN or psychiatric nurse assessment of the patient.
One commenter noted that the interim final rule with comment period
permitted the evaluation to be performed by ANY physician, even one
with no training in psychiatry and no direct knowledge of the
individual's medical and treatment history--but would not permit the
evaluation to be conducted by a psychiatric nurse or other licensed
professional who is an integral part of the patient's individual
treatment team. This organization urged CMS to ensure that orders for
these interventions and evaluations following initiation of the
interventions be conducted by licensed practitioners who are specially
trained and qualified to assess and monitor both the inherent medical
and the psychological risks. This may involve physicians or LIPs, or
nurses or psychologists who are more familiar with the individual's
psychological history. Another commenter echoed this concern, arguing
that non-psychiatric physicians do not necessarily have the
competencies for treating people with mental illness.
One commenter interpreted the rule to inappropriately devalue and
undermine the profession of psychiatry, as well as psychiatric care, by
requiring face-to-face assessment for psychiatrists, but not for other
physicians. This commenter asked whether physicians who are not
psychiatrists have greater reasoning ability and better judgment in
matters that involve assessing the appropriateness of restraint and
seclusion, or whether nurses in medical hospitals are somehow more
adept at reporting reliable and accurate information to treating
physicians than those nurses who work in psychiatric hospitals. The
commenter also supported the use of telephone consultation.
A commenter stated that the requirement would in all probability be
unproductive. The commenter also stated, ``Patients requiring seclusion
or restraint have shown behaviors potentially dangerous to themselves
or others; such behaviors are caused by impaired reasoning, distorted
thinking, or other irrational stimuli. It is extremely unlikely that
such an event would have resolved in an hour; either the patient would
continue to be irrational or would be sedated from concomitant
therapeutic use of medication so that an assessment would not be
possible.'' The commenter stated that telephone contact between staff
and physician is perfectly adequate. In addition, the commenter noted
that an appropriate review of the circumstances is much more likely
several hours (8 to 12) after the initiation of the intervention.
A few commenters' disagreements were based on the idea that
episodes requiring restraint and seclusion typically involve such gross
behavioral problems that they cannot be mistaken for anything other
than emergencies, so a physician's visit to assess the need for
restraint is not essential. A commenter who had experience in a
hospital with a 2-hour face-to-face rule reported that he has never
disagreed with a nurse's assessment that a given patient needed to be
restrained.
One commenter pointed out that the physician is always accountable
for the medical care his or her patient receives, as well as for what
actions are taken under his or her direction or license. Another
commenter noted that since the order has already been implemented, the
physician has already accepted responsibility, so requiring face-to-
face evaluation is unnecessary.
c. Comments Opposing Telephone Orders, Nurse Evaluation, and Other LIP
Involvement
Some commenters strongly disagreed with allowing telephone orders
for restraint and seclusion and with allowing anyone other than a
physician to perform the face-to-face evaluation of the patient. One
commenter, an RN/PhD, made the following statements:
This letter comes to urge members of the regulatory task force
to require that physicians complete a face-to-face assessment of the
patient within the hour after initiation of the restraint or
seclusion and every hour thereafter. There are many reasons for a
patient to become ``out of control,'' among which are reactions to
medications, delirium secondary to metabolic dysfunction, hypoxia,
and so forth. These need to be assessed thoroughly and with all due
respect to my own profession [the commenter is a RN and Ph.D.], most
practicing nurses are not educationally equipped to make such
evaluations. In my years of practice, I have seen patients placed in
restraints when they had akathesia and when they were confused as a
result of impending pulmonary edema with nurses labeling this as
``out of control.'' In fact, I had opportunity to render an expert
opinion in a lawsuit involving the death of a gentleman who died in
congestive heart failure--he was hypoxic, became confused, and the
nurses tied him down. It is not a pretty thought that he drowned in
his own fluid tied to a bed.
Similarly, another commenter wrote,
Sometimes it is important for us to do what is right instead of
what is convenient. For the last 40 years that I can remember, we
have looked for easy ways to restrain uncooperative patients without
infringing on our own time and effort. There is no proper way to do
it. One hour of restraint or seclusion is certainly a maximum that
should be allowed before personal examination and evaluation by
someone who is authorized to directly give such an order. Think of
the patient, a decent human being, not yet properly evaluated for
the patient's ``bad'' or ``uncontrollable'' behavior. One hour is a
long time to be physically restrained for no or improper reasons.
The time allotted to a temporary restraining order must be minimal.
The person providing the evaluation and giving the regular order
must do so very quickly thereafter and be able to accept
responsibility for doing it without proper indication. There will be
a lot of opposition to this position, as there has been continuously
ever since these treatments were first used. But that does not make
it right to use them improperly. There is no other way to treat our
fellow men and women.
d. Comments Stating That the 1-Hour Provision Did Not Address the
Problem
Other commenters took issue with the idea that the requirement for
a physician's onsite visit would prevent the sorts of situations
described in the Hartford Courant's series. A physician who serves as
an expert consultant to Protection and Advocacy, Inc. has reviewed
several cases of deaths occurring in chronic and acute care facilities.
He stated,
[[Page 71410]]
Several of these deaths occurred among patients who were at the
time of their death contained (or in the process of being contained)
in seclusion or restraints. These deaths were tragic and in some
cases due to serious, preventable errors. However, I do not believe
that the outcome in any of these cases that I have reviewed would
have been changed by the proposed rule that patients requiring
seclusion or restraint be evaluated face-to-face by a physician or
LIP within one hour after the initiation of these interventions.
Many facilities that opposed the provision reported having had no
injuries or deaths associated with restraints use. Many discussed their
use of training programs to assure staff competency and argued that
training and monitored staff competency, not the 1-hour requirement for
a physician's onsite visit, was the key to assuring patient safety.
Many commenters argued that better training in restraint use,
constant or frequent monitoring of patients in restraints, the banning
of dangerous techniques such as face-down floor holds, and CPR training
for all direct care workers could prevent the deaths associated with
restraint use. One hospital reported that during a recent three-month
period, it identified 94 patients who would have been covered by the 1-
hour provision. Of these 94 cases, no restraint-related injury
occurred.
Some commenters believed that this provision was excessive and
unnecessary, given that they had no problems with deaths or injuries
caused by restraint.
Another commenter argued that the problems that have caused the
reported deaths and injuries have been due to the administrative
policies of the problematic facilities. The commenter therefore
believed that it is unnecessary to develop new rules to cover a
``problem'' that for the most part does not exist. Another commenter
affirmed this point, stating,
Several years ago, the California Psychiatric Association
investigated the causes of deaths of persons who had died in
seclusion and/or restraint in California over a period of several
years. Our investigation found that in nearly every case, the
seclusion and/or restraint was in violation of the hospital's own
policies and procedures. The better answer to seclusion and
restraint deaths is enforcement of existing laws, not the enactment
of a law which will have the unintended consequence of denying the
sickest of the sick hospitalization.
One commenter characterized this requirement as, ``A very arbitrary
decision and obviously made without much thought at all.'' The
commenter further stated, ``While there have been instances of deaths,
to make an unreasonable demand upon all physicians because of a few
instances that can be corrected is extremely unreasonable and would
greatly change how psychiatrists and physicians practice medicine in a
negative way and would not add anything positive in terms of health
care. Hospitals and physicians will work hard with CMS to eradicate
such abuses as have been reported.'' Another commenter agreed, stating
the following:
While it is desirable to remedy the shortcomings of our current
restraint and seclusion practices, it is immediately apparent to me
that your new requirement will result in more patient injuries
because of the difficulty of compliance with the new standard. Since
you are demanding a new type of treatment protocol, I suggest that
the burden is yours to demonstrate in a controlled trial that your
solution will indeed be more effective than the existing policy.
This is the same process by which all proposed therapies are judged
in our field. To do less is to subject all patients to a cruel mass
experiment.
One hospital agreed with many of the points raised by CMS in the
interim final rule with comment period, and with the position of the
National Alliance for the Mentally Ill (NAMI), and supported standards
that protect people with mental illness from abuse or unnecessary risk.
The hospital noted that it has adopted most of NAMI's best practices
initiatives in their institution. However, the hospital stated this
provision provides no additional benefit to the patient and may cripple
its ability to provide a high standard of care to its patients.
Response: The revised requirement in no way prohibits a physician
from coming to the hospital to assess the patient in person. In the
final rule, combined standard (e) requires that if a trained RN or PA
conducts the 1-hour face-to-face evaluation, the attending physician or
other LIP responsible for the care of the patient must be consulted as
soon as possible after completion of the evaluation. As many commenters
noted, telephone consultation may be effective in this context. Other
steps may be critical in addressing the problems identified in the
Hartford Courant series. We are not persuaded that it is practical or
necessary in all cases for a physician to physically be present within
1-hour to assess the patient. We believe that the patient's attending
physician or other LIP responsible for the care of the patient is
sufficiently qualified to determine whether the patient's symptoms,
condition, and history indicate the need for an immediate onsite visit.
Based on the arguments and information submitted by the commenters,
we have revised these requirements. When restraint or seclusion is used
to manage violent or self-destructive behavior, a physician or other
LIP, or a RN or PA trained in accordance with the requirements
specified under Sec. 482.13(f), must see the patient face-to-face
within 1-hour after the initiation of the intervention to evaluate: (1)
The patient's immediate situation; (2) the patient's reaction to the
intervention; (3) the patient's medical and behavioral condition; and,
(4) the need to continue or terminate the restraint or seclusion. As is
the case with all CoPs, States are free to have requirements that are
more restrictive than these requirements. For example, States have the
flexibility to limit who may conduct the 1-hour face-to-face
evaluation, require that the evaluation be completed in less than an
hour, or require additional training. Finally, if the 1-hour face-to
face evaluation is conducted by a trained RN or PA, the attending
physician or other LIP who is responsible for the care of the patient
as specified under Sec. 482.12(c) must be consulted as soon as
possible after completion of the 1-hour face-to-face evaluation.
Comment: One commenter suggested that the psychiatrist be
thoroughly informed of the events that led to the need for an
intervention, vital signs, and other pertinent clinical information by
telephone, and be required to conduct the onsite evaluation ``within a
reasonable time, not to exceed two hours.'' This wording, the commenter
noted, will allow some flexibility without completely abandoning time
limits.
Response: We agree that the attending physician (psychiatrist)
should be kept informed about the patient's status. The final rule
specifies that the attending physician must be consulted as soon as
possible if the attending physician did not order the restraint or
seclusion. It also specifies that the attending physician or other LIP
responsible for the care of the patient must be consulted as soon as
possible after the completion of the 1-hour face-to-face evaluation if
this evaluation is completed by a trained RN or PA. During these
consultations, we would expect that the patient's status and areas
suggested by the commenter are discussed with the attending physician.
We do not believe that it is necessary to require that the attending
physician conduct an onsite evaluation within 2 hours. How quickly the
patient needs to be seen by his or her attending physician (or other
practitioner, as noted in the regulation)
[[Page 71411]]
is left to the medical judgment of the physician.
Comment: One commenter noted that under Commonwealth of Virginia
law, only physicians and licensed clinical psychologists are able to
order restraint and seclusion. The commenter stated that the
recognition of LIPs in this provision did nothing to lessen the
facility's burden.
Response: This regulatory provision is applicable unless superseded
by State law that is more restrictive. It is not our intent to
interfere with State laws governing who may order restraint and
seclusion.
Comment: Some commenters argued that licensed practitioners such as
social workers and psychologists (who may be recognized under some
State laws as being LIPs) do not have training in physiology or
pharmacology and therefore may not be able to assess the patient
appropriately in an emergency situation.
Response: In this final rule, we have specified that while these
types of practitioners may order restraint or seclusion if permitted to
do so by State law and hospital policy, the patient's attending
physician (or other practitioner) must be contacted to assure continued
medical oversight and continuity of care. The 1-hour face-to-face
evaluation includes both a physical and behavioral assessment of the
patient. Therefore, the practitioner who conducts this evaluation must
be able to complete both a physical and behavioral assessment of the
patient in accordance with State law, his or her scope of practice, and
hospital policy. Generally, practitioners such as social workers,
psychologists and other mental health workers are not qualified to
conduct a physical assessment, nor is it in their scope of practice.
Comment: One hospital association questioned why we distinguished
restraint and seclusion from other medical interventions initiated when
the patient undergoes a sudden change in condition.
Response: Our focus on restraint and seclusion is not to
distinguish these interventions from others initiated when a patient
suddenly undergoes a change in status; to the contrary, this focus only
serves to bring the use of these interventions the same level of
attention and concern. As we read through comments, we found that many
commenters use restraint or seclusion only when individualized
assessment for that particular patient indicates that one or both are
necessary as a last resort. However, some seemed to think that
restraining a patient was not only acceptable, but a standard, sound,
or unavoidable practice. Restraint and seclusion are not standard,
benign, or desirable interventions to address a patient's behavior. 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 is of the same gravity as other interventions
that require the physician's or other attending practitioner's (as
noted in the regulation) attention and concern.
Comment: One commenter argued for the onsite presence of the
attending physician, since it would introduce someone who did not
participate in the incidents leading up to the use of restraint or
seclusion who may be more objective in determining whether the
intervention is appropriate or whether the restraint or seclusion was
imposed as a means of coercion, discipline, retaliation, or
convenience.
Response: Including such a requirement would be unnecessarily
burdensome. The regulation requires that the attending physician be
notified as soon as possible if a restraint or seclusion has not been
ordered by the attending physician. The attending physician has a
vested interest in determining whether the intervention is appropriate
since the physician is ultimately responsible for oversight of the
patient's care. If the attending physician believes that the
intervention is not needed, he or she may instruct staff to release the
patient. If the attending physician wants to speak to the patient or
evaluate the patient in person to gather more information, he or she
can do so.
Comment: Several commenters suggested that this standard only be
applied to those hospitals where deaths or other sentinel events
related to restraints or seclusion have occurred.
Response: Once codified, this standard as well as the entire set of
existing hospital CoPs are the requirements that all hospitals must
meet to participate in the Medicare and Medicaid programs. The CoPs are
minimum health and safety standards. They are intended to protect
patient health and safety, and to ensure that high quality care is
provided to all patients. Although the majority of hospitals are in
compliance with the requirements, we cannot develop rules that only
apply to some participants or a particular provider group.
Comment: One commenter asked whether any physician who performs the
assessment can be any physician, or whether if it must be the patient's
attending physician.
Response: As revised in this final rule, standard (e) permits a
physician or other LIP, or a trained RN or PA to perform the 1-hour
face-to-face evaluation of the patient. We have not specified that the
evaluation must be completed by the patient's attending physician.
However, if the evaluation is conducted by a trained RN or PA, the
attending physician or other LIP responsible for the care of the
patient must be consulted as soon as possible. The physician may
determine, based on clinical need, how soon he or she should see the
patient.
Comment: One hospital stated that it is the facility's
responsibility to identify and provide the right number of competent
staff to meet the patients' needs. The hospital opposed the one-hour
provision as it has adequate, competent staff to assure patient safety
and well being.
Response: Based on public comment, we have amended the 1-hour face-
to-face evaluation requirement. We agree with the commenter's emphasis
on the importance of adequate levels of competent staff.
Comment: One commenter suggested moving away from the requirement
for an onsite physician visit, but suggested adding language requiring
that, ``If the evaluation is made by telephone, a physician or LIP must
personally sign, date, and note the time of the telephone order within
24 hours of the time the order was issued.''
Response: Signature and review of telephone orders arises for other
types of orders, not just those involving restraint or seclusion. We
see no need to establish separate requirements for how orders for these
interventions would be documented.
Comment: One commenter alleged that hospitals are dodging the 1-
hour requirement by releasing the patient from restraint or seclusion
and starting over with a new order before reaching the 1-hour point.
Response: Ending the intervention prior to the 1-hour point does
not mean that the mandated assessment and consultation are no longer
necessary. These steps are still required, even if the intervention
ends within one hour of initiation.
Comment: Many commenters pointed out that this provision was not in
the proposed revision of the hospital CoPs.
Response: Several organizations used this argument as a basis for
bringing suit against the Secretary to block implementation of this
provision, but the court upheld the validity of the regulation. (See
National Association of Psychiatric Health Systems v. Shalala, 120 F.
Supp. 2d 33 (D.D.C. 2000).) As we stated before the court, we believe
that this provision is a logical outgrowth
[[Page 71412]]
of the December 19, 1997 proposed rule. The court agreed with our
position.
Comment: One commenter asked whether the patient has to be released
from restraint or seclusion if the physician is unable to arrive within
1 hour.
Response: Since we have revised combined standard (e) to no longer
require a physician's onsite visit within 1 hour, this question is no
longer pertinent. However, if the face-to-face evaluation is not
completed by a physician, other LIP, or a trainer RN or PA, the
hospital would be out of compliance.
Comment: Several commenters were concerned that the onsite visit
would not be covered by Medicare, since additional visits on the same
day cannot be billed for as per the Medicare Claims Processing Internet
Only Manual (IOM) pub 100-04, chapter 12, section 30.6.9B.
Response: While multiple visits in the same day by the same
practitioner (or another practitioner within the same practice, with
the same specialty) cannot be separately billed, practitioners should
select a code that reflects all services provided during the date of
service (Medicare Claim Processing Internet Only Manual (10m) Pub. 100-
04, Chapter 12, section 30.6.9B).
Comment: One commenter asked that both children and adults be
monitored by a physician every 15-30 minutes and that documentation be
provided.
Response: We do not believe that this high degree of physician
involvement is necessarily merited, practical, or reasonable in every
case. Based on the patient's status and type of intervention used, more
frequent monitoring by a physician, LIP or other trained staff may be
necessary. The condition of the patient who is restrained or secluded
must be monitored by a physician, other LIP, or trained staffed at an
interval determined by hospital policy and based on assessed patient
needs.
Comment: Several commenters asked whether CMS will accept a
telemedicine evaluation in lieu of face-to-face evaluation.
Response: Since the requirement for face-to-face evaluation has
been changed to include a trained RN or PA, there would not necessarily
be any need to use telemedicine evaluation unless clinically indicated.
Telemedicine is an important developing field. We are looking at
the role of telemedicine in providing healthcare. However, telemedicine
is not addressed in this rule. Telemedicine will be addressed at a
future date.
Comment: One commenter asked whether an advanced registered nurse
practitioner can perform the 1-hour assessment.
Response: In the final rule, combined standard (e) permits an
advanced registered nurse practitioner (if recognized by State law and
hospital policy as having these abilities within the scope of the
individual's license and consistent with individually granted clinical
privileges) as being able to order the intervention as well as perform
the 1-hour face-to-face evaluation.
Comment: One commenter noted that managed care reimbursement for
psychiatric inpatient services is minimal, and the physician will
either have to demand that the hospital pay for the physician's time or
refuse to extend his or her time ``to unnecessarily observe a patient
who has been safely contained by competent mental health
professionals.''
Response: This final rule permits the attending physician or other
attending practitioner (as noted in the rule) to determine whether and
how quickly the physician's presence is merited without arbitrarily
requiring it.
16. Limits for Restraint/Seclusion Orders (Sec. 482.13(f)(3)(ii)(D))
We stated that each written order for a physical restraint or
seclusion is limited to 4 hours for adults, 2 hours for children and
adolescents ages 9 to 17; or 1-hour for patients under 9. The original
order may only be renewed in accordance with these limits for up to a
total of 24 hours. After the original order expires, a physician or
licensed independent practitioner (if allowed under State law) must see
and assess the patient before issuing a new order.
Although a few commenters agreed with the timeframes for length of
order specified in the interim final rule with comment period, the
majority of comments on this requirement were from advocacy
organizations wanting further restriction on the time limits and
seeking clarity on who can renew the order. However, one commenter did
object to the timeframes for length of order, arguing that they were
not based in research and were arbitrary.
Recommendations on this provision varied and included the
following:
Limiting the timeframes for length of order to no more
than one-half hour for children, 1-hour for adolescents, and 2 hours
for adults.
Making the timeframes for length of order different for
seclusion and restraint use.
Not using age as the determining criterion since it is an
arbitrary factor. Patients present with a variety of clinically
important indicators, such as size, weight, gender, history of abuse,
disability and medical conditions that should also be used to determine
the length of time a patient remains in restraint or seclusion.
Other commenters suggested that each renewal of the order should be
accompanied by another face-to-face examination of the patient by the
physician. A few commenters were uncertain of who would perform the
assessment of the patient prior to renewing the order for the
intervention. These commenters asked whether the interim final rule
with comment period required physician or LIP face-to-face re-
evaluation of the patient before renewal of the order.
Response: We conclude from the nature and number of comments that
we did not emphasize our intent for this standard strongly enough. The
regulation identifies maximum time limits on the length of each order
for restraint or seclusion used for the management of violent or self-
destructive behavior that jeopardizes the immediate physical safety of
the patient, a staff member, or others. The physician or LIP has the
discretion to write the order for a shorter length of time. The length-
of-order requirement identifies critical points at which there is
mandatory contact with a physician or LIP responsible for the care of
the patient. In addition, the time limits do not dictate how long a
patient is in restraint or seclusion. Staff should be continually
assessing and monitoring the patient to ensure that the patient is
released from restraint or seclusion at the earliest possible time.
Restraint or seclusion may only be employed while the unsafe situation
continues. Once the unsafe situation ends, the use of restraint or
seclusion should be discontinued. In the final rule, combined standard
(e) explicitly states that the intervention must be discontinued at the
earliest possible time, regardless of the length of time identified in
the order. For example, if a patient's behavior responds to the
intervention in 20 minutes, then the restraint or seclusion should be
discontinued, even if the order was given for up to 4 hours. If
restraint or seclusion is discontinued prior to the expiration of the
original order, a new order must be obtained prior to reinitiating the
use of restraint or seclusion.
We leave to the physician's or other LIP's discretion whether an
onsite assessment prior to renewing the order (for up to 4 hours, 2
hours, or 1 hour, as permitted by the regulation) is necessary. While
we agree that prompt physician involvement is important, requiring
face-to-face reassessment by a
[[Page 71413]]
physician prior to renewal of an order as proposed by the commenters
would be overly burdensome. Once the physician or other LIP has
assessed the patient's condition, the physician or other LIP chooses a
course of action to be followed and directs staff to implement it. We
believe that an RN can follow the physician's or other LIP's direction
and reassess the patient. Without evidence indicating that a
physician's own evaluation versus that of an RN, nurse practitioner,
physician's assistant, etc.) somehow better assures patient safety, we
cannot accept this suggestion. However, after 24 hours, a face-to-face
assessment by a physician or other LIP must occur before a new order is
written for restraints or seclusion for the violent or self-destructive
patient.
We are unaware of any research or data that suggest that limiting
orders to 1 hour is better than limiting them to 4 hours for adults 18
years of age or older, 2 hours for children and adolescents 9 to 17
years of age, or 1 hour for children under 9 years of age. We stress
that the timeframes outlined in the regulation are maximums. The
ordering practitioner has the discretion to provide an order for a
shorter timeframe based on the patient's condition and factors
suggested by commenters.
Comment: Some commenters were confused by the term ``renewal'' of
an order. We were asked to differentiate between the original order, a
renewal order, etc. One commenter stated that under policies in place
before the publication of the interim final rule with comment period,
continuation of a restraint order beyond the 4-hour time limit was a
decision that could be delegated to an RN. The commenter asked whether
this rule would require a repeat order from the physician, or whether a
4-hour continuation could be decided upon by other qualified staff,
such as an RN. Some commenters supported orders being renewed in this
manner for up to 24 hours without a new (physician's) order. One
commenter argued that not allowing nurses to evaluate the need to
continue the use of restraint or seclusion and, thus, the need to renew
an order would create a burden for hospitals.
Response: Each order for restraint or seclusion for the management
of violent or self-destructive behavior that jeopardizes the immediate
physical safety of the patient, a staff member, or others is limited to
the maximum timeframes in the regulation before the physician or other
LIP responsible for the care of the patient must be contacted again. At
the end of the timeframe, if the continued use of restraint or
seclusion is deemed necessary based on a patient assessment, another
order is needed. These limited timeframes apply regardless of whether
each order is considered a separate, distinct, original order, or
whether an order is considered a continuation or renewal of the
original order. Because the use of restraint or seclusion is considered
an intervention that can only be authorized by the order of a physician
or other LIP, it is consistent to require that the determination to
continue the intervention meet this standard as well. We believe that
it is reasonable to have a trained RN reassess the patient when the
original order is about to expire, and then contact the physician or
other LIP to obtain direction as to whether the intervention is to be
continued and whether other steps are to be taken. The key is the
continued medical oversight. There is no prohibition of telephone
renewals. We note, however, that at the 24-hour point, if the patient
is still in restraint or seclusion for the management of 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 assessed by a physician or other LIP before a new order can be
written. In the final rule, we have also specified that each order for
restraint used to ensure the physical safety of the non-violent or non-
self-destructive patient may be renewed as authorized by hospital
policy.
Comment: One commenter agreed that this provision is clinically
sound and warranted. However, the commenter believed that once
evaluated, the physician should have the right, based on years of
clinical training and supervision and board certification, to continue
seclusion or restraint with periodic nursing evaluation for 24 hours.
Response: We believe that the timeframes for length of order, as
established by the regulation, are reasonable. We note that the
regulatory timeframes do not mandate how long the intervention
continues; they only provide check points at which the ordering
practitioner, and subsequently the attending physician, must be
contacted with updated information regarding the patient.
Comment: One commenter suggested that the timeframes for seclusion
should be consistent with professional standards of practice, rather
than being regulated by this rule.
Response: We believe the timeframes for seclusion are consistent
with professional standards of practice. Seclusion should only be
employed while the unsafe situation persists. Once the unsafe situation
ends, the use of seclusion should be discontinued. The length-of-order
requirements identify intervals at which the ordering practitioner, and
subsequently the patient's attending physician, must be informed of the
patient's condition so that he or she can make a decision as to how
treatment should proceed.
Comment: One commenter suggested that a physician's review of the
documentation of the need for restraint [for the management of violent
or self-destructive behavior] should be done within 24 hours of the
order being issued.
Response: A documentation review alone may not adequately protect
the patient. We expect that a physician or other LIP will see the
patient if the patient is still restrained or secluded at the 24-hour
point. Twenty-four hours of restraint or seclusion for the management
of violent or self-destructive behavior that jeopardizes the immediate
physical safety of the patient, a staff member, or others is an extreme
measure which could potentially seriously harm the patient.
Comment: One commenter believed that allowing 24 hours to elapse
before the physician is required to physically see and reassess the
patient is too long an interval. If the patient remains extremely
agitated after 12 hours in restraint or seclusion, it is evident that
the intervention is not successful, and some other intervention is
needed. Another commenter argued that if the patient has been
restrained or secluded for 4 hours, but preferably 3, a physician
consultation is necessary. The medical director needs to be called in
to help chart a course of action that will get the patient out of
restraint or seclusion if it is proving ineffective.
Response: We agree with the commenter's concern that a patient's
continued agitation may indicate a need to consider another course of
treatment. However, the reason for the use of restraint or seclusion is
to protect the patient or others from harm. The use of these
interventions must not end efforts to treat the underlying cause of the
behavior; nor is it expected that treatment will come to a complete
halt. We expect that the use of restraint or seclusion will only last
while the unsafe situation persists. Certainly, trained staff should
work with the patient toward release as quickly as possible and use
other interventions to de-escalate the crisis behavior.
17. Simultaneous Use of Restraint and Seclusion (Sec. 482.13(f)(4))
We stated that restraint and seclusion may not be used
simultaneously unless
[[Page 71414]]
the patient is--(1) continually monitored face-to-face by an assigned
staff member; or (2) continually monitored by staff using both video
and audio equipment. This monitoring must be in close proximity to the
patient.
Comment: One commenter questioned whether our intent is that a
patient who has been medicated and placed in seclusion must be
continually monitored.
Response: The regulation only requires continual monitoring when
restraint and seclusion are used simultaneously. If the use of a drug
meets the definition of a restraint, and the patient is simultaneously
placed in seclusion, all the requirements related to the simultaneous
use of restraint and seclusion apply, including the requirement for
continual monitoring.
Comment: One commenter asked for definition of the word ``staff.''
Another commenter asked for more detail regarding the type of
monitoring and the level of expertise of the monitors. One commenter
argued that children should be monitored by a person who is trained to
interact and counsel.
Response: The word ``staff,'' as used in the regulation, has the
standard definition found in any dictionary and includes anyone
employed by the hospital directly or under a contract. Staff who
monitor the patient face-to-face should be trained not only in
restraint and seclusion techniques, but also in how to monitor physical
and emotional status (taking vital signs, checking physical well-being,
working with the patient to help the patient regain self-control,
recognizing when the emergency situation has abated and the
interventions (either one or both) can be ended). The components of
continual monitoring must be determined by staff based on hospital
policy, an individualized patient assessment, and the intervention
used. Standard (f) specifies the criteria CMS will apply to staff to
ascertain whether they have been ``trained''within the meaning of our
regulation.
Comment: Some commenters stated that the rule does not explain why
restraint and seclusion would be used simultaneously and argued that
restraint and seclusion should not be used simultaneously. Some
commenters asked to have simultaneous restraint and seclusion banned.
These commenters voiced their belief that there is no clinical
justification for subjecting a patient to both restraint and seclusion
at the same time, other than for convenience of staff, for discipline,
coercion, or retaliation. If simultaneous use continues to be
permitted, these commenters suggest that patients should be constantly
monitored by staff that is in the room or right outside the seclusion
room, but in direct visual sight.
Response: Although simultaneous use of restraint and seclusion may
be inappropriate in many cases, clinical situations exist where the
simultaneous use of restraint and seclusion may legitimately be needed
to protect the patient or others from harm. Staff must take extra care
to protect the safety of the patient when more restrictive
interventions are used. Restraint limits a patient's ability to move or
escape from harm. Seclusion of a restrained patient may be necessary to
protect a patient from possible abuse, assault or self injury during
the intervention. For example, a patient is restrained alone in a room
to maintain the patient's privacy. Shielding the patient from contact
with others may be more humane and supportive of personal dignity than
permitting everyone on the unit to witness what is happening to the
patient. In this situation, it may be necessary to lock the door and
seclude the patient if a staff member is not assigned to sit with the
patient one on one in order to protect the patient.
When the simultaneous use of restraint and seclusion is employed,
we would expect to see adequate documentation that justifies the
decision for simultaneous use as well as vigilance in continuously
monitoring the patient so that the patient's care needs are met. We
would expect that the simultaneous use of restraint or seclusion be
discontinued at the earliest possible time, regardless of the length of
time identified in the order.
We do not agree with the commenters' assertions that these uses
necessarily constitute patient abuse. However, there are risks
associated with the simultaneous use of restraint and seclusion.
Therefore in this final rule, we clarify that all requirements
specified under standard (e) apply in the simultaneous use of restraint
and seclusion, which is not permitted unless the patient is continually
monitored face-to-face by an assigned, trained staff member, or
continually monitored by trained staff using both video and audio
equipment. This monitoring must be in close proximity to the patient.
The hospital is responsible for providing the level of monitoring and
frequency of reassessment that will protect the patient's safety.
Comment: One commenter questioned whether the use of a restraint is
considered to be seclusion when the restraint prevents the patient from
leaving the room. The commenter further queried whether a patient
restrained in a seclusion room with the door open and unlocked would be
considered to be in seclusion, and whether a patient restrained in the
patient's room would be ``in seclusion.''
Response: In a situation where the patient is being restrained by a
technique or device that interferes with the patient's mobility, the
fact that the patient is confined in a room is a secondary effect. This
situation is not equivalent to the use of seclusion. It is important to
examine what would happen if the restraint were removed--if the patient
would be free to leave the room if the restraint were removed, the
patient is not being secluded. Conversely, if the restraint were
removed and the door is locked or the staff otherwise physically
prevent the patient from leaving the room, then the patient is being
secluded.
18. Use of Video and Audio Monitoring
The use of video and audio monitoring met with mixed response.
However, overall, the commenters viewed it negatively. Consumer
advocates tended to see it as inappropriately depriving the patient of
human contact when such contact would be beneficial to help the patient
regain self-control, and as not assuring that the patient's physical
and psychiatric status are adequately monitored.
Comment: One commenter stated that audio/video monitoring would be
``particularly odious to an individual already trussed up, tied down,
and left alone.'' The use of video and audio equipment further
alienates a patient who may be craving attention and engaging in the
only behavior that will bring about human contact.
Another commenter argued that there is no substitute for face-to-
face monitoring with periodic checks of patient's vital signs. The
commenter recounted two separate instances where patients died while in
restraints and seclusion. In both instances, the paramedics were unable
to ventilate the patients because they were unable to place a tube down
the throat of the patient. The onset of rigor mortis demonstrated that
these patients had been dead for several hours before hospital staff
discovered them and called the paramedics. The nursing logs for both
patients indicated that the patients had been checked every 15 minutes.
In these instances, ``checked'' meant looked at through a window into
the seclusion room.
Some commenters argued that audio and video monitoring is costly
and would result in financial burden to the hospitals. One commenter
explained
[[Page 71415]]
that his hospital does not have the financial resources to hire
additional nurses or nurse aides to perform one-to-one monitoring, nor
does it have the resources to buy video systems for monitoring. Another
commenter characterized electronic monitoring as costly and invasive of
privacy.
A commenter argued that face-to-face monitoring only increases
patient agitation and that both face-to-face and video/audio monitoring
confirm the misperceptions of psychotic patients who are paranoid or
delusional.
Other commenters did not object to alternative methods for
monitoring, but had suggestions about requiring both. One commenter
asked that we permit audio monitoring, but not require it. Another
commenter suggested that we reconsider the need for audio monitoring if
video monitoring is in place.
One commenter believed that video monitoring and taping was
appropriate to ensure proper patient monitoring and quality control;
however, this commenter believed that the regulations should also
require staff to be in the patient's room. One commenter recommended
ongoing audio/video monitoring to protect patient safety.
Another commenter asked for a more prescriptive definition of
``close proximity.'' The commenter understood that the intent of
requiring staff to be in close proximity is to assure that hospital
staff could quickly reach a patient should a safety issue arise.
Response: We agree that audio and video monitoring are not
substitutes for the therapeutic intervention that should be occurring
to help the patient regain self-control or for the level of monitoring
necessary to assure that the patient is safe and that the patient's
care needs are met. The use of video and audio monitoring equipment
does not eliminate the need for other therapeutic interventions or
frequent assessment of the patient's needs and status. For one patient,
continual monitoring face-to-face by an assigned staff member may be
appropriate and necessary. For another patient, the continual presence
of an assigned staff member may cause the patient to become more
agitated. In this situation, continual monitoring by trained staff
using both video and audio equipment with periodic in-room monitoring
may be more appropriate. In either situation, vigilant monitoring is
necessary to protect the patient from harm, and ensure that the
intervention is discontinued at the earliest possible time.
The hospital is responsible for providing the level of monitoring
and frequency of reassessment that will protect the patient's safety.
Continual monitoring cannot happen solely from outside the seclusion
room. Staff must enter the seclusion room in order to--(1) monitor a
patient's vital signs, circulation, hydration needs, elimination needs,
level of distress and agitation, mental status, cognitive functioning,
etc., and assess and re-evaluate the patient; (2) provide for
nutritional needs; range of motion, and elimination needs; and (3)
provide other necessary therapeutic interventions and patient care. In
response to comments, we have therefore revised combined standard (e)
to clarify that all requirements specified under standard (e) apply in
the simultaneous use of restraint and seclusion.
In response to comments that requested that we reconsider requiring
both video and audio monitoring, we believe that neither video nor
audio monitoring alone adequately protect patient safety when restraint
and seclusion are used simultaneously. We do not require video and
audio monitoring; instead, it is one method the facility can use to
monitor its patients.
In response to the request for a more prescriptive definition of
``close proximity,'' the intent is to ensure that staff is immediately
available to intervene and render appropriate interventions to meet the
patient's needs. However, based on the number of possible unit
configurations, we believe an outcome-oriented requirement is more
appropriate than a more prescriptive one.
Comment: One commenter suggested that the regulations should
specify that under no circumstances should a restrained patient be left
unattended, as a patient in restraint is vulnerable to attack or
mistreatment from others.
Response: Including such a requirement would be unnecessarily
burdensome. As discussed earlier, we agree that a patient is more
vulnerable to possible abuse, assault, or self injury during a more
restrictive intervention. We expect staff to take extra care to protect
the safety of the patient when more restrictive interventions are used.
Regardless of the intervention used, the hospital is responsible for
providing the level of monitoring and frequency of assessment necessary
to protect the patient's safety. We believe hospitals should have the
flexibility to provide the level of monitoring and frequency of
assessment necessary to protect the patient's safety based on hospital
policy and an individualized patient assessment.
Comment: Due to nationwide staff shortages, one commenter stated
that his facility would be unable to meet the requirement.
Response: As one commenter offered earlier, it is the hospital's
responsibility to assure that it has adequate staff available to meet
the patients' needs. Given the acuity of a patient in restraint and
seclusion simultaneously, we believe that heightened monitoring and
intervention are merited.
Comment: One commenter stated that the requirement for face-to-face
monitoring places staff at higher risk for injury.
Response: We believe that the required training elements within
this regulation will promote staff awareness and expertise in handling
potentially hazardous situations.
Comment: One commenter suggested that a better approach for
increasing physician oversight and involvement would be to require a
log of restraint use to be kept by the hospital, along with quarterly
reports generated for local peer review organizations to track
restraint and seclusion use. Patterns of excessive use would emerge
more readily than they would otherwise under the current requirements.
Several commenters suggested requiring a restraint/seclusion log,
and included elements that should be part of this log, such as the time
initiated, discontinued, time physician was contacted, documentation of
physical exams, etc. Additionally, other commenters believed that
quality improvement efforts could more appropriately address the
concerns regarding patient safety and quality of care.
Response: We agree. Although not mandated in this rule, we expect a
hospital will address, as part of its quality assessment and
performance improvement (QAPI) program, patient safety and quality of
care issues. We also believe that this sort of tracking and monitoring
may be appropriate as part of a hospital's QAPI program. However,
including such a requirement would be unnecessarily burdensome.
Hospitals should have the flexibility to identify and monitor the
quality indicators that are most critical to the patient population(s)
that they serve.
Comment: One commenter questioned how face-to-face monitoring
should be documented.
Response: The regulation does not specify how face-to-face
monitoring will be documented. This should be addressed by hospital
policy.
19. Reporting of Death(s) Related to Restraint/Seclusion (Sec.
482.13(f)(7))
We stated that the hospital must report to CMS any death that
occurs
[[Page 71416]]
while a patient is restrained or in seclusion, or where it is
reasonable to assume that a patient's death is a result of restraint or
seclusion.
Comment: Several commenters noted that all deaths are routinely
reported to State authorities.
Response: As noted earlier in this preamble, while there may be
local mechanisms for reporting deaths, there is, at present, no
nationwide system for reporting these deaths. We have estimated that
the total number of deaths related to the use of restraint and
seclusion in hospitals will be less than 10 per year. Therefore, given
that the average number of reports per hospital is one or less, we do
not believe that it is burdensome to ask that the hospital notify the
CMS regional office if a patient dies while in restraint or seclusion,
or where it is reasonable to assume that restraint or seclusion
contributed directly or indirectly to the patient's death.
Comment: One commenter who supported the provision as written
opposed requiring more detailed reporting and expressed concern about
routine reporting to the Protection and Advocacy organizations (P&As).
(Providing the P&As with information was mentioned in the preamble of
the interim final rule with comment period.) Some commenters echoed
this concern, expressing serious reservations about CMS's ability to
maintain the confidentiality of the sensitive information provided in
accordance with the new rule. These commenters did not believe that
information provided to the P&As would be protected from disclosure or
legal discovery. One commenter asked whether CMS would maintain the
confidentiality of the information, or share it with outside entities.
Those commenters who opposed sharing the information with other
entities argued that forcing hospitals to report injuries and the
circumstances around them would in many cases require release of
information that hospitals gather through their own peer review
activities. Almost all 50 States protect information gathered in peer
review and other quality internal improvement processes from discovery
by lawyers. One commenter referred to Bredice v. Doctor's Hospital,
Inc. (50 FRD 249 (D.D.C. 1970)), citing it as a case in which the court
found that it was in the overwhelming public interest to maintain the
confidentiality of the minutes and reports of medical staff meetings
during which doctors critically analyze the hospital's medical care.
The commenter argued that self-critical analysis privilege is now
judicially recognized as a result of this case.
In contrast, a core of commenters from the public and the patient
advocacy community supported sharing this information with the P&As,
stressing the importance of partnering between CMS and P&As. These
commenters encouraged a mandatory, detailed system of reporting to the
P&As to ensure comprehensive investigations of incidents where patients
die or are injured during restraint or seclusion use.
Response: Since the publication of the interim final rule with
comment period, we have implemented a process for restraint or
seclusion death reporting. We centrally track reports of death from
restraints or seclusion occurring in hospitals. We use this information
to: Authorize onsite investigations and complaint surveys of these
hospitals, in accordance with the current complaint investigation
process; and to inform the Federally-mandated P&A entity in the
respective State or territory. P&A programs are congressionally
authorized (in accordance with 42 U.S.C. 10801 et seq.) to access
facilities and to investigate abuse and neglect complaints.
Comment: One commenter asked what information must be provided by
the hospital and the timeframe within which the hospital must report
the information to CMS. Some commenters proposed introducing timeframes
for reporting, such as contacting the CMS regional office within 4 days
of a patient death and the P&A within an additional 3 days. The
commenters who supported such timeframes cited proposed national
legislation, The Children's Health Act of 2000 (the CHA). The
commenters who asked for definite timeframes stated that delays in
reporting compromise the ability to investigate effectively (staff may
leave, medical/documentary evidence may be lost or concealed, and
potentially deadly practices continue). Other commenters suggested that
CMS require reporting to the P&A within 24 hours of an incident.
Response: The CHA was signed into law on October 17, 2000 (Pub. L.
106-310). Section 592 of the CHA establishes minimum death reporting
requirements. This final rule conforms to these requirements. We have
revised our requirements to specify that the hospital report each death
to the CMS regional office by telephone no later than the close of
business the next business day following knowledge of the patient's
death. This information will be relayed to CMS central office and the
State survey agency, inasmuch as it acts as a direct agent of CMS. Our
central office maintains a database to compile information related to
deaths associated with seclusion or restraint.
Comment: Some commenters suggested that the regulation excuses
hospitals from revealing many deaths precipitated by the misuse of
restraint or seclusion by allowing the hospital to make the
determination of whether a patient's death is reasonably assumed to
have resulted from restraint or seclusion. These commenters strongly
believed that providers tend to dismiss restraint-related deaths as
``unfortunate isolated incidents,'' not the manifestation of individual
abuse or systemic failures, and that hospitals can rationalize that
deaths were due to a patient's underlying condition or ``natural
causes.'' Several commenters cited an example of the death of a young
man who suffered a severe asthma attack soon after fighting with
another patient and being restrained. According to the commenters, the
death was ruled to be due to natural causes, even though the medical
examiner found that the stress of the fight and restraint triggered the
attack. Some commenters indicated that a complicating issue is that
death may occur after a patient has been restrained or secluded in an
originating facility, and is then transferred to another facility. The
receiving facility may be unaware of what has transpired at the
originating facility and may not report the death.
To address this issue, these commenters suggested that at a
minimum, CMS specify that any deaths that occur within one week of
restraint or seclusion use be assumed to be the result of restraint or
seclusion. Optimally, however, these commenters argued for reporting
all deaths of patients with a psychiatric diagnosis or mental
retardation. The commenters stated that in this way, CMS could remove
the subjectivity currently permitted by allowing the hospital to make a
determination that the death is ``reasonably assumed'' to be a result
of restraint or seclusion use.
These commenters also stated that a requirement for reporting the
deaths of all patients with a mental retardation or psychiatric
diagnosis would also permit CMS and the P&As to capture deaths that
occurred post-transfer, as a result of restraint and seclusion
practices at another facility.
Response: We have revised the reporting requirements. The hospital
must report to CMS each death that occurs while a patient is in
restraint or in seclusion or both at the hospital; and, each death
known to the hospital that occurs within 1 week after restraint
[[Page 71417]]
(whether physical restraint or drugs used as a restraint) or seclusion,
in cases in which it is reasonable to assume that use of restraint or
placement in seclusion contributed directly or indirectly to a
patient's death. We have also clarified the meaning of ``reasonable to
assume.'' As a result, ``reasonable to assume'' includes, but is not
limited to, deaths related to restrictions of movement for prolonged
periods of time, or deaths related to chest compression, restriction of
breathing, or asphyxiation. In addition, we have moved the reporting
requirements from standard (f) and created a separate standard
(standard (g)) that addresses these requirements. This was done to
clarify that all deaths associated with the use of seclusion or
restraint or both must be reported. The reporting requirements in
standard (g) are applicable to restraint and seclusion use.
We are not adopting the commenter's suggestion that all deaths of
patients with a psychiatric or mental retardation diagnosis be reported
to CMS; nor will we assume that all deaths that occur within 1 week of
the use of restraint or seclusion are the result of restraint or
seclusion.
Comment: A commenter stated that the reporting process is severely
deficient because inadequate information would be provided to CMS and
the P&As. The commenter suggested specific elements that should be
reported, including--
Identity of deceased/injured patient;
Patient's age;
Identity of patient's guardian, if applicable;
Identification of next of kin, in cases involving patient
death;
Date of death/injury;
Patient's home address;
Medications patient was taking/other medical services
provided;
Cause and circumstances of death/injury;
Whether/by whom death/injury is being investigated; and
Identity of person making report.
Some commenters believed that the report submitted to CMS should be
standardized and in writing.
Response: We agree that the suggested elements should be reported.
However, to allow some flexibility for hospitals, we are not specifying
these elements in the regulation text. In the final rule, standard (g),
we have specified that each death referenced in this section must be
reported to CMS by telephone no later than the close of business the
next business day following knowledge of the patient's death. In
addition, we have added a requirement that staff must document in the
patient's medical record the date and time the death was reported to
CMS.
Comment: One commenter suggested replacing the word ``assume'' with
``suspicion or belief.''
Response: We have retained use of the word ``assume'' and added
language to clarify the meaning of ``reasonable to assume.''
Comment: One commenter indicated that the accrediting organization
should also receive this information as deaths would be ``sentinel
events'' under JCAHO policy.
Response: We currently inform the hospital's accrediting
organization when we receive a death report from a hospital. In
addition, hospitals should report deaths to their accrediting
organization in accordance with their accreditation standards. JCAHO
instituted a sentinel events reporting policy (effective October 31,
1998) that encourages hospitals to voluntarily report such occurrences
within 7 days of the incident.
Comment: One commenter opposed the reporting requirement, stating
that there is no need to increase the number of people involved with
the monitoring and/or investigating patient deaths. Another commenter
echoed this sentiment, noting that this requirement is duplicative of
JCAHO's sentinel event reporting requirement, and that we should simply
share data with the JCAHO instead.
In contrast, a private psychiatric health system agreed with this
provision, saying it makes good sense. Many commenters supported this
provision, although they suggested measures that they believed would
strengthen it, such as requiring that serious injuries be reported and
specifying lists of elements to be provided to CMS.
Response: Section 592 of the CHA mandates death reporting and this
final rule incorporates/addresses these requirements. These
requirements address gaps in existing reporting systems that inhibit
the ability to conduct meaningful analysis of trends and target
problems. JCAHO's system is voluntary, not mandatory, and 20 percent of
the hospitals that participate in Medicare and Medicaid are not JCAHO
accredited. To adequately track deaths, mandatory reporting is needed
by all hospitals.
We believe that injury reporting is beyond the scope of the CHA;
and therefore, we are not incorporating injury reporting provisions in
this final rule. However, we would expect that serious injuries related
to the use of restraint or seclusion would be monitored through the
hospital's QAPI program.
Comment: Several commenters suggested that reporting should include
not only deaths of patients, but injuries to staff during the restraint
or seclusion procedure.
Response: We do not require reporting of staff injuries associated
with the use of seclusion or restraint. However, hospitals may
establish their own systems for tracking such information.
Comment: One commenter suggested requiring hospitals to report the
number of seclusion or restraint occurrences; the total number of
patients secluded or restrained; the average number of hours per
occurrence; and, the average number of hours in seclusion or restraint
per patient. The commenter also recommended that we protect patient
privacy by withholding of identifying information but otherwise
reporting demographic data.
Response: We believe that the burden of such an approach would have
the opposite effect; that is, it would most likely result in hospital
under-reporting of patients in restraint or seclusion. However,
although not mandated in this rule, we expect that a hospital will
address utilization of restraint and seclusion as part of their QAPI
program. Regarding the recommendation to this information is withheld
identifying information, required to investigate or otherwise follow-up
on a reported death, if necessary.
Comment: Some commenters believed that serious injuries, both
physical and psychological, must be reported to be proactive and to
prevent deaths. These commenters realized that there may be some
additional burden on hospitals, but believed that burden could be
minimized by limiting reports to more severe types of injuries. One
commenter asked that if we do add injury reporting, that it be limited
to injuries that require medical attention.
Some commenters offered a general argument that the P&As would be a
better entity than CMS to receive the information and investigate the
incidents. For example, commenters stated that the P&As have trained
investigators who are already a part of the Department of Health and
Human Services. Commenters also stated that the P&As need to be
involved to adequately perform the necessary investigations.
In contrast, several commenters questioned why the P&As should be
provided this information, since they have no authority to sanction a
hospital and are not able to act as CMS's agent. The commenters stated
that this
[[Page 71418]]
provision would expose the provider to two possible investigations
without any clear and convincing rationale.
Response: We are not adding any injury reporting requirement in
this rule. Aside from the issue of hospital burden and potential
disagreement on what constitutes a reportable event, a fundamental
problem in requiring injury reporting for this setting is the
administrative burden on the program itself. Many commenters seemed to
acknowledge this limitation, in that they used it as an argument for
the need for increased P&A involvement. So, these commenters may argue,
even if CMS cannot administratively handle injury reporting, this
information could be routed to the P&As for investigation or made
available to the public.
We believe that this points to a misperception of the roles of the
various agencies. A P&A cannot act as our agent. There is no statutory
connection between CMS and the P&As, as there is between CMS and the
State survey agencies. The P&A cannot take an enforcement action on our
behalf. While we support the role of the P&As, and we believe that a
coordinated effort between agencies is appropriate, we also believe
that the roles should not blur into each other. We have a distinct
interest in the health and safety of patients, which is shared by the
P&As. However, we also have a statutorily-governed relationship with
the providers of services. That relationship is built on the
expectation of confidentiality. We need information from the hospitals
inasmuch as we evaluate whether they are meeting the standards for care
we have set.
Comment: Mental health advocacy groups and P&A organizations
requested that the name, address, phone number, and brief description
of services provided by the P&A be required to be posted in each
hospital.
Response: We believe requiring that this information be posted
would be unnecessarily burdensome. Hospitals are already required to
provide patients with contact information if the patient wishes to file
a grievance.
Comment: One commenter stated that if serious injury or death
occurs, that event needs to be recorded and an independent auditor
needs to investigate the incident. The auditor should be clinically
oriented, not of an administrative background.
Response: We only require that deaths be reported. Upon receipt of
the information, we can initiate an independent investigation of the
death. We are not requiring that hospitals report serious injuries, but
this type of information could be reviewed while surveyors are onsite.
In addition, we will not require that the hospital hire an independent
auditor to investigate deaths and serious injuries.
Comment: One commenter charged that the reporting requirement is
not consistent with initiatives to create a government that works
better and costs less.
Response: We disagree. We do not believe that the revised reporting
requirements are overly burdensome. Furthermore, the reporting system
serves as an outcome indicator that can be used to target our
investigational efforts.
Comment: One P&A supported the reporting of serious injuries, but
argued for added resources for P&As so that meaningful and prompt
investigations can occur.
Response: We agree with the importance of P&A investigations.
However, we do not allocate funding for the P&A programs.
Comment: One commenter indicated that it is burdensome for a
hospital to have to review charts on all patient deaths to determine if
restraints or seclusion were used with the patient. The commenter
questioned whether only Medicare and Medicaid beneficiary deaths need
to be reported, or if all patient deaths related to restraint or
seclusion must be reported.
Response: The CoPs apply to all patients in a Medicare- and
Medicaid-participating hospital, not just Medicare/Medicaid
beneficiaries. Therefore, all patient deaths associated with the use of
restraint or seclusion or both must be reported. We do not view this as
particularly burdensome since these deaths should be infrequent.
Comment: A commenter stated that the regulation does not discuss a
penalty for failure to report.
Response: Noncompliance with this requirement, as with any of the
others in these standards, constitutes a violation of the CoPs that
would potentially be subject to termination of the hospital provider
agreement as described at 42 CFR 489.53.
IV. Provisions of the Final Rule
For reasons specified in section III of the preamble to this final
rule, we are codifying the Patients' Rights CoP within the current
hospital CoPs under Subpart B--Administration at Sec. 482.13. The
eight standards specified in this final rule establish minimum
protections and rights for patients. Any changes that have been made to
clarify or strengthen the provisions that appeared in the interim final
rule with comment period are noted in the following description of the
provisions.
The first standard, ``Notice of Rights,'' requires the patient or
the patient's representative, as permitted by State law, to be informed
of the patient's rights prior to furnishing or discontinuing care
whenever possible. The standard also requires that the hospital have a
grievance process, that the patient be informed of whom to contact to
file a grievance, and that the process include specific elements. This
standard has not been revised; and therefore, is being finalized
without change.
The second standard, ``Exercise of Rights,'' provides the patient
the right to participate in the development and implementation of his
or her plan of care, and to request or refuse treatment. This standard
supports the patient's right to make decisions regarding his or her
care and to formulate advance directives and have hospital staff and
practitioners who provide care in the hospital comply with these
directives, in accordance with Sec. 489.102 (Requirements for
providers). This standard also supports the patient's right to have a
family member or representative of his or her choice and his or her
physician notified promptly of the patient's admission to the hospital.
This standard has not been revised; and therefore is being finalized
without change.
The third standard, ``Privacy and Safety,'' which includes the
right to personal privacy, to receive care in a safe setting, and to be
free from all forms of abuse or harassment. This standard has not been
revised; and therefore is being finalized without change.
The fourth standard, ``Confidentiality of Patient Records,''
provides the patient's right to the confidentiality of his or her
records, and to access those records. This standard has not been
revised; and therefore is being finalized without change.
The fifth standard, ``Restraint or seclusion,'' differs both in
content and in application from the standard presented in the interim
final rule with comment period. We have revised and combined the
requirements contained in standards (e) and (f) in the interim final
rule into a single, combined standard in the final rule. 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
regardless of patient location.
The revised, combined standard (e) states that all patients have
the right to be free from physical or mental abuse, and corporal
punishment. It retains the patient's right to be free from restraint or
seclusion, of any form, imposed by staff as a means of coercion,
discipline,
[[Page 71419]]
convenience, or retaliation. It also states that 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.
A significant change from the interim final rule with comment
period to this final rule is that standard (e) provides a revised
definition of ``restraint.'' In the final rule, we adopted the
restraint definition contained in the CHA. 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 seclusion definition contained in
the interim final rule with comment period has been retained with minor
content revisions. Seclusion is the involuntary confinement of a
patient alone in a room or area from which the patient is physically
prevented from leaving. Standard (e) also clarifies that seclusion may
only be used for the management of violent or self-destructive behavior
that jeopardizes the immediate physical safety of the patient, a staff
member, or others.
All of the requirements contained in the current standard (e)
``Restraint for acute medical and surgical care'' are also contained in
the current standard (f) ``Seclusion and restraint for behavior
management.'' These requirements have been moved to the combined
standard (e) in the final rule. The more stringent requirements
contained in the current standard (f), but not in the current standard
(e) have also been moved to the combined standard (e) in the final
rule. These more stringent requirements are: Time limits on the length
of each order, and the 1-hour face-to-face evaluation. The final rule
clarifies that these two requirements only apply when restraint or
seclusion are used to manage violent or self-destructive behavior that
jeopardizes the immediate physical safety of the patient, a staff
member, or others. Requirements for the simultaneous use of restraint
and seclusion have also been retained in the final rule.
Standard (e) retains the following requirements: 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 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; and, the use of restraint or seclusion
must be in accordance with a written modification to the patient's plan
of care, and implemented in accordance with safe and appropriate
restraint and seclusion techniques as determined by hospital policy in
accordance with State law.
Standard (e) retains and clarifies the requirement that use of a
restraint or seclusion must be in accordance with the order of a
physician or other LIP who is responsible for the care of the patient
as specified under Sec. 482.12(c) and is authorized to order restraint
or seclusion by hospital policy in accordance with State law. The
standard also requires that the restraint or seclusion order never be
written as a standing order or on an as needed basis (PRN), and that
the attending physician must be consulted as soon as possible if
restraint or seclusion is not ordered by the patient's attending
physician. Standard (e) also sets limits on the length of each order
for restraint or seclusion used to manage violent or self-destructive
behavior that jeopardizes the immediate physical safety of the patient,
a staff member, or others based on the age of the patient, and states
that the order may only be renewed in accordance with these limits for
up to a total of 24 hours unless superseded by State law that is more
restrictive. After 24 hours, before writing a new order for the use of
restraint or seclusion for the management of violent or self-
destructive behavior that jeopardizes the immediate physical safety of
the patient, a staff member, or others, a physician or other LIP (if
allowed by State law) must see and assess the patient. Each order for
restraint used to ensure the physical safety of the non-violent or non-
self-destructive patient may be renewed as authorized by hospital
policy. Restraint or seclusion must be discontinued at the earliest
possible time, regardless of the length of time identified in the
order.
Further, standard (e) specifies that the condition of the patient
who is restrained or secluded must be monitored by a physician, other
LIP or by trained staff at an interval determined by hospital policy.
The criteria for staff to be considered ``trained'' are specified under
Sec. 482.13(f). In addition, physician and other LIP training
requirements must be specified in hospital policy. At a minimum,
physicians and other LIPs authorized to order restraint or seclusion by
hospital policy in accordance with State law must have a working
knowledge of hospital policy regarding the use of restraint or
seclusion.
A significant change from the interim final rule with comment
period to this final rule is that standard (e) has been revised to
expand the type of practitioners permitted to conduct the 1-hour face-
to-face evaluation. When restraint or seclusion is used for the
management of violent or self-destructive behavior that jeopardizes the
immediate physical safety of the patient, a staff member, or others, a
physician or other LIP, or a RN or PA trained in accordance with the
requirements specified under Sec. 482.13(f), must see the patient
face-to-face within 1-hour after the initiation of the intervention.
This practitioner must evaluate the patient's immediate situation, the
patient's reaction to the intervention, the patient's medical and
behavioral condition, and the need to continue or terminate the
restraint or seclusion. As specified at Sec. 482.13(e)(13), State law
(by statute or regulation) regarding the 1-hour face-to-face evaluation
may be more restrictive than these requirements. If the 1-hour face-to-
face evaluation is conducted by a trained RN or PA, the attending
physician or other LIP who is responsible for the care of the patient
as specified under Sec. 482.12(c) must be consulted as soon as
possible after completion of the evaluation.
Standard (e) clarifies requirements related to the simultaneous use
of restraint and seclusion. All requirements specified under standard
(e) apply in the simultaneous use of restraint and seclusion, which is
not permitted unless the patient is continually monitored face-to-face
by an assigned, trained staff member, or continually monitored by
trained staff using both video and audio equipment. This monitoring
must be in close proximity to the patient.
Finally, standard (e) has been amended to specify elements of
documentation. When restraint or seclusion is used, there must be
documentation in the patient's medical record of the following: The 1-
hour face-to-face medical and behavioral evaluation if restraint or
seclusion is used to manage violent or self-destructive behavior that
jeopardizes the
[[Page 71420]]
immediate physical safety of the patient, a staff member, or others;
alternatives or other 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(s) used, including the rationale for continued use of the
intervention. When restraint or seclusion is used for violent or self-
destructive behavior, documentation must also include findings from the
1-hour face-to-face assessment.
Standard (f) is a new standard that addresses staff training
requirements. A patient has a right to the safe implementation of
restraint or seclusion by trained staff. Staff must be trained and able
to demonstrate competency in the application of restraints,
implementation of seclusion, monitoring, assessment, and providing care
for a patient in restraint or seclusion before performing any of these
actions, as part of orientation, and subsequently on a periodic basis
consistent with hospital policy.
In addition, standard (f) states that the hospital must require
appropriate staff to have education, training, and demonstrated
knowledge based on the specific needs of the patient population in at
least the following:
Techniques to identify staff and patient behaviors,
events, and environmental factors that may trigger circumstances that
require restraint or seclusion;
The use of non-physical intervention skills;
Choosing the least restrictive intervention based on an
individualized assessment of the patient's medical, or behavioral
status or condition;
The safe application and use of all types of restraint or
seclusion used in the hospital, including training in how to recognize
and respond to signs of physical and psychological distress (for
example, positional asphyxia);
Clinical identification of specific behavioral changes
that indicate that restraint or seclusion is no longer necessary;
Monitoring the physical and psychological well-being of
the patient who is restrained or secluded, including but not limited
to, respiratory and circulatory status, skin integrity, vital signs,
and any special requirements specified by hospital policy associated
with the 1-hour face-to-face evaluation; and,
The use of first aid techniques and certification in the
use of cardiopulmonary resuscitation, including required periodic
recertification.
Individuals providing staff training must be qualified as evidenced
by education, training, and experience in techniques used to address
patients' behaviors. The hospital must document in the staff personnel
records that the training and demonstration of competency were
successfully completed.
Standard (g) is a new standard that addresses reporting
requirements for deaths associated with the use of restraint or
seclusion. The hospital must report to CMS each death that: occurs
while a patient is in restraint or in seclusion at the hospital; occurs
within 24 hours after the patient has been removed from restraint or
seclusion; and, each death known to the hospital that occurs within 1
week after restraint or seclusion where it is reasonable to assume that
use of restraint or placement in seclusion contributed directly or
indirectly to a patient's death. For the purposes of this regulation,
``reasonable to assume'' includes, but is not limited to deaths related
to restrictions of movement for prolonged periods of time, or death
related to chest compression, restriction of breathing or asphyxiation.
Each death referenced in this section must be reported to CMS by
telephone no later than the close of business the next business day
following knowledge of the patient's death. Staff must document in the
patient's medical record the date and time the death was reported to
CMS. Although we have modified some of the provisions to address public
comments, these modifications do not lessen protections afforded
patients who are restrained or secluded.
V. Collection of Information Requirements
Under the Paperwork Reduction Act of 1995, we are required to
provide 30-day notice in the Federal Register and solicit public
comment before a collection of information requirement is submitted to
the Office of Management and Budget (OMB) for review and approval. In
order to fairly evaluate whether an information collection should be
approved by OMB, section 3506(c)(2)(A) of the Paperwork Reduction Act
of 1995 requires that we solicit comment on the following issues:
The need for the information collection and its usefulness
in carrying out the proper functions of our agency.
The accuracy of our estimate of the information collection
burden.
The quality, utility, and clarity of the information to be
collected.
Recommendations to minimize the information collection
burden on the affected public, including automated collection
techniques.
Section 482.13 of this document contains information collection
requirements; however, these information collection requirements are
currently approved under OMB control number 0938-0328, ``Hospital
Conditions of Participation'' with a current expiration date of January
31, 2008.
This document makes changes to the requirements in the following
paragraphs within Sec. 482.13 that contain information collection
requirements. In this final rule, we have combined the requirements
that were set forth in the interim final rule under standard Sec.
482.13(e) Standard: Restraint or Seclusion used in the provision of
acute medical, pre and post surgical care and Sec. 482.13(f) Standard:
Seclusion and restraint for management of violent, self destructive or
aggressive behavior into a single standard, Sec. 482.13(e) Standard:
Restraint and seclusion. This change is designed to address restraint
and seclusion use regardless of the treatment setting in which it
occurs.
Section 482.13(e) Standard: Restraint or Seclusion
Although we believe many hospitals are already complying with the
requirements in this standard through usual and customary practices,
the revisions, reformatting, and additions to the existing regulatory
text may result in increased burden. However, we believe this increased
burden should be offset by reduced burden upon the physicians and LIPs
since the need to assess the patient within 1-hour of the initiation of
restraint or seclusion can be performed by other qualified LIPS as
well.
Section 482.13(f) Standard: Restraint or Seclusion: Staff Training
Requirements
As we have discussed in greater detail in sections III. and IV. of
the preamble to this final rule, revisions have been made to the
proposed Sec. 482.13(e). Paragraph (e)(15) has been added to address
the documentation requirements when restraint and seclusion are used
simultaneously. We believe the majority of hospitals already maintain
such documentation. Therefore, the burden associated with this
requirement will not impose undue hardship on most hospitals. We
believe that compliance with these standards constitutes a usual and
customary business practice and the burden associated with the
requirements is exempt from the PRA as stipulated under 5 CFR
1320.3(b)(2).
[[Page 71421]]
Section 482.13(g) Standard: Death Reporting Requirements
The requirements contained in this section were previously
contained in paragraph (f)(7) of this section and are currently
approved under OMB control number 0938-0328. See section VI. of the
preamble to this final rule for a summary of the estimated burden hours
associated with this section.
If you comment on these information collection and recordkeeping
requirements, please mail copies directly to the following: Centers for
Medicare and Medicaid Services, Office of Strategic Operations and
Regulatory Affairs, Regulations Development Group, Room C4-26-05, 7500
Security Boulevard, Baltimore, MD 21244-1850; and Office of Information
and Regulatory Affairs, Office of Management and Budget, Room 10235,
New Executive Office Building, Washington, DC 20503, Attn: Carolyn
Lovett, CMS Desk Officer. Fax (202) 395-6974.
VI. Regulatory Impact Analysis
A. Overall Impact
We have examined the impact of this rule as required by Executive
Order 12866 (September 1993, Regulatory Planning and Review), the
Regulatory Flexibility Act (RFA) (September 19, 1980, Pub. L. 96-354),
section 1102(b) of the Social Security Act (the Act), the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4), and Executive Order 13132.
Executive Order 12866 directs agencies to assess all costs and
benefits of available regulatory alternatives and, if regulation is
necessary, to select regulatory approaches that maximize net benefits
(including potential economic, environmental, public health and safety
effects, distributive impacts, and equity). A regulatory impact
analysis (RIA) must be prepared for major rules with economically
significant effects ($100 million or more in any 1 year). This final
rule revises the restraints and seclusion provisions of the Patients'
Rights CoP that were published in the July 2, 1999 interim final rule
with comment period. The CoPs are the basic health and safety
requirements that a hospital must meet in order to participate in the
Medicare program. This rule will implement regulations that are
intended to reduce the use of restraint and seclusion, eliminate the
potential for adverse outcomes when restraint, seclusion or both are
implemented, and minimize the burden associated with compliance with
the rule. While it is not possible at this point to determine
definitively the additional costs to the Medicare program resulting
from this rule, we estimate that the impact will be below $100 million;
and therefore, we have determined that this final rule is not a major
rule.
The RFA requires agencies to analyze options for regulatory relief
of small entities. For purposes of the RFA, small entities include
small businesses, nonprofit organizations and government jurisdictions.
Individuals and States are not included in the definition of small
entity. We are not preparing analyses for either the RFA or section
1102(b) of the Act because we have determined, and we certify, that
this rule will not have a significant economic impact on a substantial
number of small entities or a significant impact on the operations of a
substantial number of small rural facilities. In addition, section
1102(b) of the Act requires us to prepare a regulatory impact analysis
if a rule may have a significant impact on the operations of a
substantial number of small rural hospitals. That analysis must conform
to the provisions of section 604 of the RFA. For purposes of section
1102(b) of the Act, we define a small rural hospital as a hospital that
is located outside of a Metropolitan Statistical Area since superseded
by ``core based statistical areas'' and has fewer than 100 beds.
Section 202 of the Unfunded Mandates Reform Act of 1995 also
requires that agencies assess anticipated costs and benefits before
issuing any rule that may result in expenditures in any one year by
State, local, or tribal governments, in the aggregate, or by the
private sector, of $120 million. This rule has no impact on the
expenditures of State, local, or tribal governments, and the impact on
the private sector is estimated to be less than $120 million.
Executive Order 13132 establishes certain requirements that an
agency must meet when it promulgates a proposed rule (and subsequent
final rule) that imposes substantial direct requirement costs on State
and local governments, preempts State law, or otherwise has Federalism
implications. Thus rule will not have any effect on State and local
governments.
In the December 19, 1997 Federal Register, we issued a proposed
rule that detailed our plans to revise all of the hospital CoPs which
emphasized lessening Federal regulation to eliminate unnecessary
structural and process requirements, focus on outcomes of care, allow
greater flexibility to hospitals and practitioners to meet quality
standards, and place a stronger emphasis on quality assessment and
performance improvement. The proposed rule indicated our intent to
include a new Patients' Rights CoP for hospitals that contained rights
not addressed in the then current CoPs. We solicited comments on the
Patients' Rights CoP and received strong support for its establishment
from the public, mental health advocacy groups, media, and the
Congress. These groups and individuals expressed serious concern about
improper care of patients in the hospital setting, particularly with
regard to the use of seclusion and restraint.
On July 2, 1999, we issued an interim final rule with comment
period that set forth requirements supporting and protecting patients'
rights in the hospital setting. It included four standards that were
finalized to ensure minimum protections of each patient's physical and
emotional health and safety. These standards address each patient's
right to: Notification of his or her rights; the exercise of his or her
rights in regard to his or her care; privacy and safety; and
confidentiality of patient's records.
Additionally, this interim final rule specifically addressed the
right to be free from the use of seclusion and restraint and included
various requirements to protect the patient when use of these
interventions is necessary.
B. Anticipated Effects
1. Effects on Providers
We anticipate the impact of these finalized standards will vary
widely among hospitals. However, we do not have the benefit of several
key pieces of information. For example, we do not have reliable data on
the prevalence of restraint and seclusion use, data on the volume of
staff in hospitals, or data on the varying levels and qualifications of
hospital staff who may be involved in restraint and seclusion use.
Given these and a variety of other factors, it would be unfair to
calculate an estimate based on the average of the limited available
data. In another example, with respect to training, this rule will have
significantly less impact on a hospital that already has a proactive
training program in place and has significantly reduced its restraint
and seclusion use than it will in a hospital that has not independently
taken such an approach.
Factors such as size, services rendered, staffing, and patient
populations vary as well. An additional consideration was noted when
one caller who telephoned for clarification on the provisions of the
interim final rule with comment period complained that some hospitals
specifically screen out patients with potentially violent,
[[Page 71422]]
self-destructive behavior, so that this population is diverted to State
systems, in turn, resulting in these State systems potentially bearing
the brunt of this burden. We are hesitant to make impact estimates in
this final rule that may not account for these and other unforeseen
variations. Thus, we reserve the right to provide estimates when
feasible. Below we discuss the anticipated effects on providers of the
standards related to restraints and seclusion.
a. Section 482.13(e) Standard: Restraint or Seclusion
Standard 482.13(e), previously entitled ``Restraint for acute
medical and surgical care'' in the interim final rule with comment
period, is now entitled ``Restraint or seclusion'' in this final rule.
The existing regulation sets out the patient's rights in the event he
or she is restrained or secluded, and limits when and by whom restraint
or seclusion can be implemented. We have combined the existing
standards 482.13(e) and 482.13(f) for clarity since it is our goal to
have the use of restraint or seclusion reduced in all settings of the
hospital. The revisions, reformatting, and additions to the existing
regulatory language will not result in additional impact upon hospitals
associated with their efforts to comply with this regulation. Instead,
since we have provided more clarity in the definition of a restraint
with respect to medical and surgical services, burdens on hospitals
should decrease.
In previous Sec. 482.13(e)(3)(B), we stated the patient's
``treating'' physician be consulted in the event of restraint or
seclusion. However, based on comments we have revised the requirement
at Sec. 482.13(e)(7) to reflect the need to consult the ``attending''
physician instead of the ``treating'' physician as soon as possible if
the attending physician did not order the restraint or seclusion.
We have revised and expanded Sec. 482.13(e)(4) to specify, at
Sec. 482.13(e)(10), that a physician, other licensed independent
practitioner or trained staff meet the training criteria specified in
paragraph (f) of this section at an interval determined by hospital
policy. We also recognize there will be some impact associated with
performing patient assessment and monitoring. However, we view patient
assessment and monitoring as a standard component of patient care.
Section 482.13(f)(3)(ii)(c), now Sec. 482.13(e)(7), clarifies that
the ``attending'' physician must be consulted as soon as possible if
the attending physician did not order the restraint or seclusion.
Although this may minimally increase burden to hospitals, we believe it
is a best practice for patient safety.
We have added elements at Sec. 482.13(e)(15) that monitoring must
occur face-to-face by trained staff or by using both video and audio
equipment, when there is simultaneous use of restraint and seclusion.
We have added elements at Sec. 482.13(e)(16) regarding the
documentation that must be included in the patient's medical record
when the patient is restrained or secluded, including the 1-hour face-
to-face medical and behavioral evaluation if restraint or seclusion is
used to manage violent or self-destructive behavior, the patient's
behavior and intervention used, alternatives or other less restrictive
interventions attempted (as applicable), the patient's condition or
symptom(s) that warranted restraint or seclusion use, and the patient's
response to the use of the restraint or seclusion intervention,
including the need for continued use of restraint or seclusion. We do
not believe additional burdens are imposed by this requirement since it
is a routine and customary practice to document the circumstances
surrounding such an event for comprehensiveness of patient care.
In the interim final rule with comment period at Sec.
482.13(f)(3)(ii)(c), we required that the physician or other LIP must
see and evaluate the patient's need for restraint or seclusion within
1-hour after the initiation of restraint or seclusion. This 1-hour on-
site physician or LIP evaluation was the most controversial provision
of the interim final rule with comment period.
Limited data has been gathered in the industry to date regarding
the prevalence of restraint and seclusion use. However, among the
limited data that is available, it reflects the use of restraint or
seclusion for behavior management only per the current requirement at
482.13(f).
For example, based on information provided to us by the National
Association of Psychiatric Health Systems (NAPHS), fifty NAPHS members
supplied data for the cost of complying with the CMS requirements that
a physician or LIP evaluate a patient face-to-face within 1 hour of the
initiation of restraint or seclusion. The data that was supplied
combined: (1) The cost of maintaining a physician or LIP on call to be
available in case there is an event of a restraint or seclusion and (2)
the cost of having a physician or LIP come to the facility to evaluate
a patient within 1 hour when a restraint or seclusion episode occurs.
The average cost was $80,789 per facility per year.
The NAPHS further discussed that there are approximately 250
freestanding specialty hospitals in the United States. This number does
not include the approximately 1,400 behavioral health units of general
hospitals or government (state and county) psychiatric specialty
hospitals. The 1 hour rule applies to all these facilities.
An average NAPHS member hospital is a 60-80 bed community-based
specialty hospital. The NAPHS stated the average total budget of such
facilities is approximately $10-$15 million hence the NAPHS views this
$80,000 to be a very significant portion of its operating budget.
We heard from many hospitals that this requirement was impossible
to fulfill because of the lack of available personnel, geographic
challenges, and the high costs associated with maintaining this degree
of coverage. This was particularly noted among rural hospitals.
Furthermore, these commenters stated that a required onsite visit is
costly with no demonstrable benefit in many cases.
We determined that the heightened degree of intervention and
restriction of who can perform this assessment was excessive and would
not be feasible in many rural or remote areas. In response to industry
concerns, we have expanded who may perform the 1-hour face-to-face
evaluation. Conversely, some commenters requested on-site mandatory
physician presence within half an hour of initiation of restraint or
seclusion. Again, we believe this would be too burdensome for hospitals
in rural or remote areas to comply.
Thus, we anticipate the expansion of who may perform the 1-hour
face-to-face evaluation will be less burdensome to hospitals. We
believe the training required by this rule will equip staff with
appropriate skills for handling escalating or aggressive patient
behavior and should reduce overall use of restraints. However, we are
aware that the facility's size, progress in reducing the use of
restraint or seclusion, and other characteristics will have a varying
impact upon each facility's performance of this requirement.
Again, the NAPHS stated their respondents reported it took an
estimated 30 minutes to 1 hour to document all the specific elements
required by CMS after a restraint or seclusion episode. This included
several elements unique to the rule such as notifying the attending
physician if the restraint was ordered by someone other than the
patient's attending physician.
[[Page 71423]]
Thus, our burden estimate is based on a median timeframe (that is, 45
minutes) that we believe it takes to complete the required
documentation in the patient's medical record. However, since we are
unable to estimate the prevalence of restraint and seclusion, we can
not apply this estimate to assess the associated burden across
behavioral health and medical surgical settings.
b. Section 482.13(f) Standard: Staff Training Requirements
Standard 482.13(f), previously entitled ``Restraint or seclusion:
Seclusion and restraint for behavior management,'' has been revised to
read ``Staff training requirements.'' This standard will specifically
address the requirements that have been significantly changed or are
new regarding staff training.
In section 482.13(f) Standard: Staff training requirements. Staff
training requirements have been expanded to include various training
specifications. While we have tried to minimize the burden which will
be placed on hospitals in order to meet this requirement, we believe it
is important for the provision of safe and effective restraint or
seclusion use.
We require that before staff apply restraints, implement seclusion,
perform associated monitoring and assessment of the restrained or
secluded patient, or provide care for a restrained or secluded patient,
the staff must be trained and able to demonstrate competency in the
performance of these actions. We have revised the staff training
requirements to address the following broad areas: Training intervals,
training contents, trainer requirements, and trainer documentation.
When developing this final rule, we considered public comments
regarding the impact associated with the requirement that all staff
with direct patient contact be trained in the use of restraint or
seclusion. Some argued that this broad requirement would entail
training dietary, administrative, housekeeping, and other types of
nonprofessional staff who are not direct care providers and not
involved in the application or use of restraint or seclusion. To reduce
burden and create a more reasonable requirement while assuring patient
safety, we have mandated that only those staff who are involved in the
application of restraint or seclusion or performing associated
monitoring and assessment of, or providing care for restrained or
secluded patients have this training. While we expect physicians and
LIPs to be trained in the proper use of restraint or seclusion, we do
not expect that they will be trained with the other hospital staff.
Thus, we have not included physicians and LIPs in the burden associated
with these requirements. Instead, we require the remaining hospital
staff who have direct contact with patients must be trained in
restraint or seclusion use.
We also considered commenters'suggestions that training be provided
by a nationally-recognized training program, such as the Crisis
Training Institute. Others asked that we provide a list of criteria to
be covered in this training. In this final rule, we have specified
broad topics to be covered in training, and have not required that
staff be trained by an outside organization. We believe that in-house
training may be more economical than sending staff off-site for
instruction. However, hospitals would still have the option of sending
either selected or all staff to outside training if they believe that
this is warranted.
Thus, we have based our burden estimate on having the actual number
of trainers attend such training from an outside organization one time.
We believe that most facilities would, in turn, have these trained
individuals function as program developers and trainers of the
appropriate hospital staff. We believe in most instances this
professional will be a registered nurse. Thus, we used $38.88 as the
nursing hourly rate in this estimate.
Train-the trainer programs are the way many facilities provide
staff instruction. The four day instructor certification program given
by the Crisis Prevention Institute (CPI, INC.) costs $1,200 dollars in
tuition plus travel, lodging, and participant salary (http://www.crisisprevention.com).
We estimate, on average, that roundtrip travel for each nurse will
cost approximately $400 to cover the need for either local or distant
travel, lodging for each nurse will costs approximately $120 per night
x 3 nights, and the meals and incidental expenses (M&IE) will be
approximately $50 per day depending upon the location within the
designated state. Thus, we anticipate the cost to train one nurse per
the 6,200 hospitals to be $1,200 for the course, an estimated $400
airfare based on location, $360 for 3 days lodging, $150 for 3 days
M&IE, $112.50 for partial day M&IE, and $1,244.16 for the nurse's
salarysat $38.88 per hour x 8 hours per day x 4 days. These expenses
would total $466.66 per nurse per hospital. If all 6,200 hospitals were
to send one nurse to such training, the total cost for the 6,200
hospitals would be $21,493,292.00.
------------------------------------------------------------------------
Annual burden Annual costs
Hours/est. salary/ of hospitals hours estimate
------------------------------------------------------------------------
Off-site training of the trainer:
Cost of course x 1 nurse............ .............. $1,200.00
Airfare x 1 nurse................... .............. 400.00
Lodging x 1 nurse................... .............. 360.00
M&IE x 1 nurse...................... .............. 262.50
Salary for 1 nurse x $38.88 per hr. 32 1,244.16
x 8 hrs. day x 4 days each for a
one time training..................
-------------------------------
Total for 1 nurse per hospital x 198,400 21,493,292.00
6,200 hospitals................
------------------------------------------------------------------------
To be responsive to requests for more detail regarding our
expectations and to assure staff competency, we have described the
content to be covered during training. Given that most facilities
already have some type of training program, as noted in many comments
from hospitals, we believe that these requirements will only serve to
refine existing programs, not mandate new ones. The current JCAHO
standards which apply to approximately 80 percent of the Medicare- and
Medicaid-participating hospitals address staff training and competence
with respect to the use of restraint or seclusion at PC.12.30. The
current JCAHO standard which applies to the hospital leadership's
approach to the use of restraint for acute medical and surgical (non-
psychiatric) care at PC.11.10 refers to staff orientation and
education. In effect, these JCAHO standards already require training of
this kind for staff involved with the application of restraint or
seclusion. Thus, there may be some initial cost for revising
[[Page 71424]]
programs' materials to incorporate the elements specified in the
regulation.
------------------------------------------------------------------------
Annual burden Annual costs
Hours/est. salary/ of hospitals hours estimate
------------------------------------------------------------------------
Developing a new training program (20%
of hospitals = 6,200 / 20% = 1,240):
1 clinical trainer @ $38.88 hr. x 40 49,600 $1,928,448.00
hrs. on average one-time x 1,240
hospitals..........................
-------------------------------
Total........................... 49,600 1,928,448.00
------------------------------------------------------------------------
Note: Salary data used in this estimate is based on the salary estimates
reported on-line at http://www.salary com. Estimates based on median
annual salary ($80,867.00 including benefits) for a Staff nurse-RN
divided by 2,080 hours per year worked by a full-time employed Staff
RN.
We require that each individual who will potentially be involved in
restraint and seclusion of a patient have training in the proper
techniques. According to the National Association of Psychiatric Health
Systems (NAPHS), initial training in de-escalation techniques,
restraint and seclusion policies and procedures, and restraint and
seclusion techniques range from 7 to 16 hours of staff and instructor
time.
Using data from the American Hospital Association's (AHA) 2004
Annual Survey, the average number of total full-time and part-time
clinical employees per hospital are 248 and 113 respectively. Clinical
employees include physicians and dentists, medical and dental residents
and interns, other trainees, registered nurses, licensed practical
(vocational Nurses), and nursing assistants. While we recognize this
does not include clinical staff in such areas as rehabilitation
services, this total of 361 persons per hospital should provide an
estimate on which to base this analysis. We realize that some hospitals
will have more or less employees in which to train.
Additionally, the CMS' OSCAR data, reveals the average number of
beds per hospital is 160. We estimate that an average size hospital may
have 361 staff persons who will require this training.
------------------------------------------------------------------------
Annual
Hours/est. salary/ of hospitals burden Annual costs
hours estimate
------------------------------------------------------------------------
Attendance in the training program:
1 clinical trainer @ $38.88 hr. x 8 49,600 $1,928,448.00
hrs. x 6,200 hospitals.............
361 trainees x 16 hours per hospital 17,905,600 .................
x 6,200 hospitals..................
-------------------------------
Total........................... 17,955,200 1,928,448.00
------------------------------------------------------------------------
We require that each individual will receive annual updates to the
training and that the annual training will also be documented. Again,
according to NAPHS, annual updates are about 7 hours of staff and
instructor time per each employee who has direct patient contact.
Again, an average size hospital has 361 employees who have direct
patient contact that must be trained in de-escalation techniques.
------------------------------------------------------------------------
Annual
Hours/est. salary/ of hospitals burden Annual costs
hours estimate
------------------------------------------------------------------------
Annual updates in the training program:
1 clinical trainer @ $.38.88 hr. x 4 24,800 964,224.00
hrs. on average annually x 6,200
hospitals..........................
361 trainees x 4 hours per hospital x 8,952,800 .................
6,200 hospitals........................
-------------------------------
Total........................... 8,977,600 964,224.00
------------------------------------------------------------------------
Additionally, we required recordkeeping for documenting in each
trained individual's personnel record that he or she has successfully
completed training as discussed in Section V. of the preamble to this
final rule. As noted there, we believe that such records are kept by
the hospital in the normal course of business. Therefore, we do not
believe that these requirements would have a significant economic
impact on hospitals.
------------------------------------------------------------------------
Annual
Hours/est. salary/ of hospitals burden Annual costs
hours estimate
------------------------------------------------------------------------
Documenting attendance in the training
program:
1 clinical trainer @ $38.88 hr. x 5 179,056 6,691,697.20
minutes on average x 361 trainees
annually x 6,200 hospitals.........
-------------------------------
Total........................... 179,056 6,961,697.20
------------------------------------------------------------------------
Finally, we require that each hospital revise its training program
annually as needed. We estimate this task to take approximately 4 hours
annually per hospitals.
[[Page 71425]]
------------------------------------------------------------------------
Annual
Hours/est. salary/ of hospitals burden Annual costs
hours estimate
------------------------------------------------------------------------
Revising the training program:
1 clinical trainer @ $38.88 hr. x 4 24,800 964,224.00
hours per average size hospital x
6,200 hospitals....................
-------------------------------
Total........................... 24,800 964,224.00
------------------------------------------------------------------------
c. Section 482.13(g) Standard: Death Reporting Requirements
This requirement, previously an element in the interim final rule
with comment period, has been revised to be a separate standard. In
revising this to form a separate standard, we have made it applicable
to all deaths associated with the use of restraint or seclusion
throughout the hospital. We have added the requirements at Sec.
482.13(g)(1)(i) that a hospital must report to CMS each death that
occurs while a patient is in restraint or seclusion at the hospital, at
Sec. 482.13(g)(1)(ii) each death that occurs within 24 hours after the
patient has been removed from restraint or seclusion, and at Sec.
482.13(g)(1)(iii) that the hospital must report each death known to the
hospital that occurs within 1 week after restraint or seclusion where
it is reasonable to assume that the use of restraint seclusion
contributed directly or indirectly to a patient's death.
At Sec. 482.13(g)(2) and Sec. 481.13(g)(3), we require that each
death referenced in this section must be reported to CMS by telephone
no later than the close of business the next business day following
knowledge of the patient's death. We believe that the number of deaths
related to restraint or seclusion use are still under-reported. In
October 1998, the Hartford Courant cited the results of a study that
identified 142 deaths from seclusion and restraint use in behavioral
health treatment facilities over the past 10 years. Since the Patients
Rights CoP became effective in 1999, the annual total of patient deaths
related to restraint and seclusion use has been reported to CMS as
follows: 1999 (14), 2000 (34), 2001 (22), 2002 (19), 2003 (17), 2004
(24), 2005 (30), and 2006 (5) year-to-date respectively as of June 19,
2006. These numbers include deaths from seclusion or restraint use in
behavioral health settings not the medical-surgical settings in the
hospital.
Although our goal is to reduce the utilization of restraint or
seclusion and associated deaths, we are aware that the actual number of
deaths from seclusion and restraint use may increase due to the
increased reporting requirements of deaths due to seclusion and
restraint use in all treatment settings in the hospital. Thus, we
anticipate there will be burden associated with this requirement due to
the increased number of deaths that will be reported by the various
units within the hospital. For the purposes of calculating burden, we
are assuming the number of deaths based on current levels and are not
considering the reduction in the number of deaths we expect to result
from this regulation.
Given this historical data, we believe the number of reports
certainly should average less than one per hospital per year (that is,
the total number of deaths in 8 years (165) divided by the total number
of hospitals 6,200 divided by 8 years equals .0033). Thus, we believe
the impact associated with this provision (that is, making a telephone
call and filling in a written form to report a death to the CMS) to be
negligible.
We estimate that one clerical person would report the death to CMS
and document the death in the patient's medical record. The burden
associated with the completion of this task would be .25 (15 minutes
divided by 60 minutes in one hour) x an average of 20 occurrences per
year throughout the 6,200 hospitals, .25 x 20 = 5 hours. The estimated
cost associated would be 5 hours x $.31 (that is, $18.88 hour divided
by 60minutes per hour x 15 minutes = 4.71 x 20 occurrences per year =
$94.20 annually).
------------------------------------------------------------------------
Annual burden Annual costs
Hours/est. salary/ of hospitals hours estimate
------------------------------------------------------------------------
Reporting death to CMS and documenting
in medical record:
1 clerical person @ $18.88 hr. x 15 5 $94.20
min. x average of 20 occurrences in
hospital annually..................
-------------------------------
Total........................... 5 94.20
------------------------------------------------------------------------
Note: Salary data used in this estimate is based on salary estimates
reported on-line at http://www.salary com. Estimates based on median
annual salary ($39,190.00 including benefits) for an admitting clerk
divided by 2,080 hours per year worked by a full-time employed
admitting clerk.
2. Effect on Beneficiaries
The implementation of the Patients Rights CoP will serve to protect
not only Medicare and Medicaid beneficiaries but all patients receiving
care in all Medicare-participating hospitals (that is, short-term,
psychiatric, rehabilitation, long-term, children's, and alcohol-drug),
including small rural hospitals. With the finalization of standards a-g
of the Patient's Rights CoP, we forsee better protection regarding
notification of the patient's rights, exercise of the patient's rights
with regard to his or her care, privacy and safety, confidentiality of
the patient's records, and restraint and seclusion use. Thus, all
patients will benefit from the hospital's focus on patients' rights.
Through these protections, patient care can be delivered in an
atmosphere of respect for an individual patient's comfort, dignity, and
privacy. We also believe that implementation of this final rule will
lead to a reduction in the numbers of restraint or seclusion related
injuries and deaths in hospitals.
3. Effect on Medicare and Medicaid Programs
Given that hospitals have been required to comply with the
regulations at Sec. 482.13(a) through Sec. 482.13(f) since 1999, we
do not expect the implementation of the finalized Patients' Rights
provisions to generate significant cost to the Medicare or Medicaid
programs. We do not believe there will be any additional costs to the
survey and certification program as compliance with this CoP will
either be reviewed through a routine, nonaccredited hospital survey,
[[Page 71426]]
validation survey or as part of the existing complaint survey process
for hospitals.
C. Alternatives Considered
We originally considered developing one set of very general
requirements regulating restraint or seclusion use in all hospitals for
all situations. However, based on public comments and recent concerns
about restraint or seclusion use for behavior management situations, we
concluded that one set of requirements did not afford patients with
adequate protections. In addition, we noted that JCAHO has more
prescriptive standards for behavioral health care accreditation than
for hospital accreditation.
We considered recognizing only physicians as the individuals able
to order restraints or seclusion. However, in recognizing that other
types of practitioners provide a great deal of care in rural and
frontier areas, we did not adopt that approach.
We considered keeping standards e and f separate as originally
proposed. However, due to public comment we found it to be more prudent
to address the use of restraint or seclusion in either medical-surgical
or behavioral treatment contexts in a single standard.
We considered finalizing the training section as proposed. In turn,
we planned to let hospitals establish, implement, and monitor their own
training programs. However, industry concerns were the impetus for
providing further direction regarding training. Additionally, we
considered mandating training for physicians and other LIPs; however,
the industry believed this was too prescriptive.
Regarding the timeframes in which a patient must be evaluated if
restraint or seclusion is used to manage violent or self-destructive
behavior, we considered more restrictive options including adopting the
Pennsylvania Office of Mental Health policy that requires an onsite
evaluation by a physician within half an hour of initiation of the
intervention. However, we rejected this idea on the basis that it is
unrealistic for rural areas because of geographical barriers and
practitioner shortages, cost (as noted by commenters).
We considered adopting more restrictive requirements for the
maximum time frames for the length of an order for restraint or
seclusion. However, since there was no supporting literature or
studies, we decided to adopt the approach and timeframes developed and
articulated by JCAHO for its hospital accreditation and behavioral
health care accreditation programs. These standards were developed by
experts from the health care field and represent consensus on the
approach and time frames for uses of seclusion or restraints. In
addition, approximately 80 percent of the Medicare- and Medicaid-
participating hospitals are already subject to these requirements
through accreditation. Therefore, we believe it is reasonable to adopt
requirements similar to those of JCAHO.
In accordance with the provisions of Executive Order 12866, this
regulation was reviewed by the Office of Management and Budget.
List of Subjects in 42 CFR Part 482
Grants programs--health, Hospitals, Medicaid, Medicare, Reporting
and recordkeeping requirements.
0
For the reasons set forth in the preamble, the interim rule amending 42
CFR chapter IV published on July 2, 1999 Federal Register (64 FR 36070)
is adopted as final with the following changes:
PART 482--CONDITIONS OF PARTICIPATION FOR HOSPITALS
0
1. The authority citation for part 482 continues to read as follows:
Authority: Secs. 1102 and 1871 of the Social Security Act,
unless otherwise noted (42 U.S.C. 1302 and 1395hh).
0
2. Section 482.13 is revised to read as follows:
Sec. 482.13 Condition of participation: Patient's rights.
A hospital must protect and promote each patient's rights.
(a) Standard: Notice of rights. (1) A hospital must inform each
patient, or when appropriate, the patient's representative (as allowed
under State law), of the patient's rights, in advance of furnishing or
discontinuing patient care whenever possible.
(2) The hospital must establish a process for prompt resolution of
patient grievances and must inform each patient whom to contact to file
a grievance. The hospital's governing body must approve and be
responsible for the effective operation of the grievance process and
must review and resolve grievances, unless it delegates the
responsibility in writing to a grievance committee. The grievance
process must include a mechanism for timely referral of patient
concerns regarding quality of care or premature discharge to the
appropriate Utilization and Quality Control Quality Improvement
Organization. At a minimum:
(i) The hospital must establish a clearly explained procedure for
the submission of a patient's written or verbal grievance to the
hospital.
(ii) The grievance process must specify time frames for review of
the grievance and the provision of a response.
(iii) In its resolution of the grievance, the hospital must provide
the patient with written notice of its decision that contains the name
of the hospital contact person, the steps taken on behalf of the
patient to investigate the grievance, the results of the grievance
process, and the date of completion.
(b) Standard: Exercise of rights. (1) The patient has the right to
participate in the development and implementation of his or her plan of
care.
(2) 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 or inappropriate.
(3) The patient has the right to formulate advance directives and
to have hospital staff and practitioners who provide care in the
hospital comply with these directives, in accordance with Sec. 489.100
of this part (Definition), Sec. 489.102 of this part (Requirements for
providers), and Sec. 489.104 of this part (Effective dates).
(4) The patient has the right to have a family member or
representative of his or her choice and his or her own physician
notified promptly of his or her admission to the hospital.
(c) Standard: Privacy and safety. (1) The patient has the right to
personal privacy.
(2) The patient has the right to receive care in a safe setting.
(3) The patient has the right to be free from all forms of abuse or
harassment.
(d) Standard: Confidentiality of patient records. (1) The patient
has the right to the confidentiality of his or her clinical records.
(2) The patient has the right to access information contained in
his or her clinical records within a reasonable time frame. The
hospital must not frustrate the legitimate efforts of individuals to
gain access to their own medical records and must actively seek to meet
these requests as quickly as its record keeping system permits.
(e) Standard: Restraint or seclusion. All patients have the right
to be free from physical or mental abuse, and corporal punishment. All
patients have the right to be free from restraint or seclusion, of any
form, imposed as a
[[Page 71427]]
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, a staff member, or others and must be
discontinued at the earliest possible time.
(1) Definitions. (i) A restraint is--
(A) 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
(B) 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.
(C) 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).
(ii) Seclusion is the involuntary confinement of a patient alone in
a room or area from which the patient is physically prevented from
leaving. Seclusion may only be used for the management of violent or
self-destructive behavior.
(2) Restraint or seclusion may only be used when less restrictive
interventions have been determined to be ineffective to protect the
patient a staff member or others from harm.
(3) The type or technique of restraint or seclusion used must be
the least restrictive intervention that will be effective to protect
the patient, a staff member, or others from harm.
(4) The use of restraint or seclusion must be--
(i) In accordance with a written modification to the patient's plan
of care; and
(ii) Implemented in accordance with safe and appropriate restraint
and seclusion techniques as determined by hospital policy in accordance
with State law.
(5) The use of 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.
(6) Orders for the use of restraint or seclusion must never be
written as a standing order or on an as needed basis (PRN).
(7) The attending physician must be consulted as soon as possible
if the attending physician did not order the restraint or seclusion.
(8) Unless superseded by State law that is more restrictive--
(i) Each order for restraint or seclusion used for the management
of violent or self-destructive behavior that jeopardizes the immediate
physical safety of the patient, a staff member, or others may only be
renewed in accordance with the following limits for up to a total of 24
hours:
(A) 4 hours for adults 18 years of age or older;
(B) 2 hours for children and adolescents 9 to 17 years of age; or
(C) 1 hour for children under 9 years of age; and
(ii) After 24 hours, before writing a new order for the use of
restraint or seclusion for the management of violent or self-
destructive behavior, a physician or other licensed independent
practitioner who is responsible for the care of the patient as
specified under Sec. 482.12(c) of this part and authorized to order
restraint or seclusion by hospital policy in accordance with State law
must see and assess the patient.
(iii) Each order for restraint used to ensure the physical safety
of the non-violent or non-self-destructive patient may be renewed as
authorized by hospital policy.
(9) Restraint or seclusion must be discontinued at the earliest
possible time, regardless of the length of time identified in the
order.
(10) The condition of the patient who is restrained or secluded
must be monitored by a physician, other licensed independent
practitioner or trained staff that have completed the training criteria
specified in paragraph (f) of this section at an interval determined by
hospital policy.
(11) Physician and other licensed independent practitioner training
requirements must be specified in hospital policy. At a minimum,
physicians and other licensed independent practitioners authorized to
order restraint or seclusion by hospital policy in accordance with
State law must have a working knowledge of hospital policy regarding
the use of restraint or seclusion.
(12) When restraint or seclusion is used for the management of
violent or self-destructive behavior that jeopardizes the immediate
physical safety of the patient, a staff member, or others, the patient
must be seen face-to-face within 1 hour after the initiation of the
intervention--
(i) By a--
(A) Physician or other licensed independent practitioner; or
(B) Registered nurse or physician assistant who has been trained in
accordance with the requirements specified in paragraph (f) of this
section.
(ii) To evaluate--
(A) The patient's immediate situation;
(B) The patient's reaction to the intervention;
(C) The patient's medical and behavioral condition; and
(D) The need to continue or terminate the restraint or seclusion.
(13) States are free to have requirements by statute or regulation
that are more restrictive than those contained in paragraph (e)(12)(i)
of this section.
(14) If the face-to-face evaluation specified in paragraph (e)(12)
of this section is conducted by a trained registered nurse or physician
assistant, the trained registered nurse or physician assistant must
consult the attending physician or other licensed independent
practitioner who is responsible for the care of the patient as
specified under Sec. 482.12(c) as soon as possible after the
completion of the 1-hour face-to-face evaluation.
(15) All requirements specified under this paragraph are applicable
to the simultaneous use of restraint and seclusion. Simultaneous
restraint and seclusion use is only permitted if the patient is
continually monitored--
(i) Face-to-face by an assigned, trained staff member; or
(ii) By trained staff using both video and audio equipment. This
monitoring must be in close proximity to the patient.
(16) When restraint or seclusion is used, there must be
documentation in the patient's medical record of the following:
(i) The 1-hour face-to-face medical and behavioral evaluation if
restraint or seclusion is used to manage violent or self-destructive
behavior;
(ii) A description of the patient's behavior and the intervention
used;
(iii) Alternatives or other less restrictive interventions
attempted (as applicable);
(iv) The patient's condition or symptom(s) that warranted the use
of the restraint or seclusion; and
(v) The patient's response to the intervention(s) used, including
the rationale for continued use of the intervention.
(f) Standard: Restraint or seclusion: Staff training requirements.
The patient has the right to safe implementation of restraint or
seclusion by trained staff.
[[Page 71428]]
(1) Training intervals. Staff must be trained and able to
demonstrate competency in the application of restraints, implementation
of seclusion, monitoring, assessment, and providing care for a patient
in restraint or seclusion--
(i) Before performing any of the actions specified in this
paragraph;
(ii) As part of orientation; and
(iii) Subsequently on a periodic basis consistent with hospital
policy.
(2) Training content. The hospital must require appropriate staff
to have education, training, and demonstrated knowledge based on the
specific needs of the patient population in at least the following:
(i) Techniques to identify staff and patient behaviors, events, and
environmental factors that may trigger circumstances that require the
use of a restraint or seclusion.
(ii) The use of nonphysical intervention skills.
(iii) Choosing the least restrictive intervention based on an
individualized assessment of the patient's medical, or behavioral
status or condition.
(iv) The safe application and use of all types of restraint or
seclusion used in the hospital, including training in how to recognize
and respond to signs of physical and psychological distress (for
example, positional asphyxia);
(v) Clinical identification of specific behavioral changes that
indicate that restraint or seclusion is no longer necessary.
(vi) Monitoring the physical and psychological well-being of the
patient who is restrained or secluded, including but not limited to,
respiratory and circulatory status, skin integrity, vital signs, and
any special requirements specified by hospital policy associated with
the 1-hour face-to-face evaluation.
(vii) The use of first aid techniques and certification in the use
of cardiopulmonary resuscitation, including required periodic
recertification.
(3) Trainer requirements. Individuals providing staff training must
be qualified as evidenced by education, training, and experience in
techniques used to address patients' behaviors.
(4) Training documentation. The hospital must document in the staff
personnel records that the training and demonstration of competency
were successfully completed.
(g) Standard: Death reporting requirements: Hospitals must report
deaths associated with the use of seclusion or restraint.
(1) The hospital must report the following information to CMS:
(i) Each death that occurs while a patient is in restraint or
seclusion.
(ii) Each death that occurs within 24 hours after the patient has
been removed from restraint or seclusion.
(iii) Each death known to the hospital that occurs within 1 week
after restraint or seclusion where it is reasonable to assume that use
of restraint or placement in seclusion contributed directly or
indirectly to a patient's death. ``Reasonable to assume'' in this
context includes, but is not limited to, deaths related to restrictions
of movement for prolonged periods of time, or death related to chest
compression, restriction of breathing or asphyxiation.
(2) Each death referenced in this paragraph must be reported to CMS
by telephone no later than the close of business the next business day
following knowledge of the patient's death.
(3) Staff must document in the patient's medical record the date
and time the death was reported to CMS.
(Catalog of Federal Domestic Assistance Program No. 93.778, Medical
Assistance Program)
(Catalog of Federal Domestic Assistance Program No. 93.773,
Medicare--Hospital Insurance; and Program No. 93.774, Medicare--
Supplementary Medical Insurance Program)
Dated: December 14, 2005.
Mark B. McClellan,
Administrator, Centers for Medicare & Medicaid Services.
Approved: November 16, 2006.
Michael O. Leavitt,
Secretary.
[FR Doc. 06-9559 Filed 12-7-06; 8:45 am]
BILLING CODE 4120-01-P