Responding To Disruptive Patients, 30306-30309 [2010-13048]
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Federal Register / Vol. 75, No. 104 / Tuesday, June 1, 2010 / Proposed Rules
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SUPPLEMENTARY INFORMATION:
RIN 2900–AN45
Department of Veterans Affairs.
Proposed rule.
AGENCY:
On March 13, 2009, we published a
notice of proposed rulemaking (NPRM)
entitled ‘‘Drawbridge Operation
Regulations; Perquimans River,
Hertford, NC’’ in the Federal Register (74
FR 10850–10853). The rulemaking
would have allowed the drawbridge to
operate on an advance notice basis
during specific times of the year.
Officials from the Town of Hertford
commented that not maintaining a
tender during peak boating times would
have an adverse impact on public safety.
Withdrawal
The North Carolina Department of
Transportation (NCDOT), responsible
for the operation of the US17 Bridge,
had requested advance notification of
vessel openings during specific times of
the year due to the infrequency of
requests for vessel openings of the
drawbridge.
The Coast Guard received several
comments opposing changes to the
proposed rulemaking. We conducted a
lengthy and thorough investigation that
included a site visit and a meeting with
officials of the Town of Hertford. The
Coast Guard met with the Mayor, Town
Manager, Town Planner and a
representative from NCDOT. We also
met separately with a marina owner and
the Chief of the Water Rescue team.
Our investigation along with the
majority of the comments revealed that
the rulemaking could impose critical
service delays to commercial and
recreational boaters and impede the
ability of rescue boats to arrive promptly
on scene. The withdrawal is based on
the reason that this change would not
improve the schedule for roadway and
waterway users.
Authority
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38 CFR Part 17
Responding To Disruptive Patients
Background
This action is taken under the
authority of 33 U.S.C. 499; 33 CFR 1.05–
1; Department of Homeland Security
Delegation No. 0170.1.
Dated: May 11, 2010.
Wayne E. Justice,
Real Admiral, U.S. Coast Guard, Commander,
Fifth Coast Guard District.
[FR Doc. 2010–12980 Filed 5–28–10; 8:45 am]
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ACTION:
SUMMARY: This document proposes to
amend the Department of Veterans
Affairs (VA) regulation that authorizes
appropriate action when a patient
engages in disruptive behavior at a VA
medical facility. VA needs to update its
current regulation to reflect modern
medical care and ethical practices. The
proposed rule would authorize VA to
modify the time, place, and/or manner
in which VA provides treatment to a
patient, in order to ensure the safety of
others at VA medical facilities, and to
prevent any interference with the
provision of medical care.
DATES: Comment Date: Comments on
the proposed rule must be received by
VA on or before August 2, 2010.
ADDRESSES: Written comments may be
submitted through https://
www.Regulations.gov; by mail or handdelivery to the Director, Regulations
Management (02REG), Department of
Veterans Affairs, 810 Vermont Avenue,
NW., Room 1068, Washington, DC
20420; or by fax to (202) 273–9026.
Comments should indicate that they are
submitted in response to ‘‘RIN 2900–
AN45—Responding To Disruptive
Patients.’’ Copies of comments received
will be available for public inspection in
the Office of Regulation Policy and
Management, Room 1063B, between the
hours of 8 a.m. and 4:30 p.m., Monday
through Friday (except holidays). Please
call (202) 461–4902 for an appointment.
This is not a toll free number. In
addition, during the comment period,
comments may be viewed online at
https://www.Regulations.gov through the
Federal Docket Management System
(FDMS).
FOR FURTHER INFORMATION CONTACT:
Roscoe Butler, Deputy Director,
Business Policy, Chief Business Office
(163), Veterans Health Administration,
Department of Veterans Affairs, 810
Vermont Avenue, NW., Washington, DC
20420, (202) 461–1586. (This is not a
toll free number.)
SUPPLEMENTARY INFORMATION: Under 38
U.S.C. chapters 17 and 18, VA has
authority to provide medical care to
certain veterans and nonveterans. VA is
required, per 38 U.S.C. 1721, to
prescribe rules and regulations to
promote good conduct on the part of VA
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patients. VA has implemented this
authority in 38 CFR part 17.
Regarding the rights of patients
receiving VA care, 38 CFR 17.33(a)
prescribes, in part, that patients have ‘‘a
right to be treated with dignity in a
humane environment that affords them
both reasonable protection from harm
and appropriate privacy with regard to
their personal needs.’’ Patients also have
‘‘a right to receive, to the extent of
eligibility therefor under the law,
prompt and appropriate treatment for
any physical or emotional disability.’’
Section 17.33(b) also prescribes rights
with respect to visitations and
communications, clothing, personal
possessions, money, social interaction,
exercise, and worship for VA residents
and inpatients. These rights may be
restricted by the appropriate health care
professional in certain circumstances.
See 38 CFR 17.33(c). The restrictions
authorized by § 17.33(c), however, do
not apply to outpatients and only cover
restrictions on the listed rights. In
certain cases, VA must restrict the
provision of medical care to a patient in
order to prevent harm to other patients
and VA staff and disruptions in VA’s
provision of medical care due to the
patient’s behavior.
VA regulations also prescribe rules of
conduct for patients and other
individuals who have access to VA
facilities. See 38 CFR 1.218. In
particular, § 1.218(a)(5) prohibits
persons on VA property from causing a
wide variety of disturbances, including
creating ‘‘loud or unusual noise,’’
obstructing public areas, and impeding
or disrupting ‘‘the performance of
official duties by Government
employees.’’ The sole enforcement
mechanism provided by paragraph (a)(5)
is ‘‘arrest and removal from the
premises.’’ 38 CFR 1.218(a)(5). VA has
determined that arrest is generally not
an appropriate remedy in a situation
where the Department must balance the
rights and needs of a disruptive patient
against the need to protect other
patients, guests, and staff. Some patients
establish a pattern of disruptive
behavior when interacting with VA
personnel or when they are on VA
property, and we believe that by
understanding these patterns of
behavior, planning for such behavior in
advance, and setting safe conditions for
care delivery, we can intervene in ways
that can prevent subsequent episodes
requiring removal and arrest.
In addition to §§ 1.218 and 17.33, the
behavior of patients is specifically
governed by current 38 CFR 17.106. It
requires, in part, that VA maintain the
good conduct of patients through
‘‘corrective and disciplinary procedure.’’
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Federal Register / Vol. 75, No. 104 / Tuesday, June 1, 2010 / Proposed Rules
However, current § 17.106, which VA
promulgated in 1973 and last amended
over 10 years ago, does not adequately
reflect modern practice or VA’s policy
regarding disruptive patients in the
health care setting, which opposes the
use of punishment in the management
of disruptive patients. Instead, it reflects
the view that patients exhibiting
disruptive behavior must be punished.
For example, current § 17.106
emphasizes disciplining patients who
do not engage in ‘‘good conduct,’’ and
includes measures (such as withholding
pass privileges) that do not differentiate
between providing care and ensuring
the safety of others. Moreover, the
current rule could be viewed as
interfering with VA’s legal obligation to
provide medical care to certain veterans
and nonveterans. Accordingly, VA has
determined that amendments to current
regulations are necessary to implement
its policy regarding disruptive patients,
which emphasizes continuation of
treatment.
We propose to amend § 17.106 to
prescribe the remedial measures VA
will take when a patient is disruptive
and the procedures for implementing
those measures. VA intends that the
proposed rule would minimize the risk
of a particular patient jeopardizing the
health or safety of others, or disrupting
the safe provision of medical care to
another patient, in a VA medical
facility.
In proposed § 17.106(a), we would
define ‘‘VA medical facility’’ to mean
any VA medical center, outpatient
clinic, or domiciliary. We would not
include VA nursing homes (also referred
to as community living centers) because
the limitations on the time, place, and
manner for delivering care are not
applicable to patients in this residential
setting.
Proposed paragraph (b) would
authorize VA to restrict the time, place,
and/or manner of the provision of a
patient’s medical care if the patient’s
behavior at a VA medical facility has or
could jeopardize the health or safety of
other patients, VA staff, or guests at the
facility, or otherwise interfere with the
delivery of safe medical care to another
patient at the facility. Decisions
regarding these restrictions would be
made by the VA medical facility Chief
of Staff or his or her designee. An
appropriate designee might include, for
example, a Disruptive Behavior
Committee (DBC). VA has mandated
DBCs at all of the Department’s medical
centers, and these committees regularly
assess disruptive behavior. As such,
they have developed expertise in this
area.
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Proposed paragraph (b) would also set
forth procedures for implementing these
determinations. Thus, any order
restricting a patient’s care would need
to be in writing and signed by the Chief
of Staff or designee with a copy entered
into the patient’s VA medical record.
The Chief of Staff or designee would
provide the patient a copy of the order
and an explanation of the procedure for
an administrative review under
paragraph (e) as soon as possible after
issuance. Unless otherwise stated in the
order, these restrictions would take
effect upon the signature of the Chief of
Staff or designee. We have determined
that restrictions under this proposed
rule would be necessary in situations
where a patient’s behavior has or could
harm another person or interfere with
the delivery of medical care to another
patient at the facility. Accordingly, in
almost every case VA would need to
implement the restrictions immediately
to prevent the harm and meet its
obligation to provide safe medical care.
The proposed procedure would
emphasize addressing the disruptive
patient’s needs in order to advance VA’s
focus on patient care. We propose to
require that authorized officials making
determinations under this section
narrowly tailor restrictions to avoid
interfering with the disruptive patient’s
care. Ultimately, we expect that actions
under this proposed rule would increase
the likelihood that the disruptive
patient will engage, or re-engage (if it
has been necessary to terminate an
episode of care), in health care in a safe
and efficacious manner, without being
disruptive. Indeed, through our DBCs
and similar committees, we are already
seeing anecdotal evidence of such
results.
The standard for making
determinations under the proposed rule
is in paragraph (b)(1). Under this
standard, the Chief of Staff or designee
would evaluate whether the patient’s
behavior has or could jeopardize the
health or safety of patients or other
individuals who have access to VA
medical facilities. The Chief of Staff or
designee would also evaluate whether
the patient’s behavior has or could
interfere with the delivery of medical
care to another patient at a VA medical
facility. In making such determinations,
the Chief of Staff or designee would
consider, among other things, the
patient’s individual fears; VA’s
obligation to provide the patient with
high-quality medical care; and all of the
pertinent facts, such as any prior
counseling of the patient regarding his
or her inappropriate behavior. See
proposed paragraph (c).
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Proposed paragraph (d) would also
suggest a range of possible restrictions
that could be imposed. We believe that
these suggestions would assist Chiefs of
Staff or their designees to narrowly
tailor restrictions imposed under the
proposed rule. We do not intend to limit
the remedial options available to the
officials making determinations under
this section. Rather, proposed paragraph
(d) would illustrate the types of
restrictions that might be appropriate in
a given situation and would authorize
any other restriction that the Chief of
Staff or designee deems appropriate
short of arrest and removal. Restrictions
could thus be tailored to consider the
needs of a particular situation or
patient.
Proposed paragraph (e) would
prescribe the procedures for obtaining
an administrative review of restrictions
imposed by order of the Chief of Staff
or designee under the proposed rule. VA
provides medical care through 21
networks of medical facilities known as
Veterans Integrated Service Networks.
We propose to allow one appeal of an
order restricting medical care under this
section to the Network Director of
jurisdiction. The patient would initiate
the Network Director’s review by
submitting a request to the Chief of Staff
within 30 days of the effective date of
the Chief of Staff’s or designee’s order.
However, in light of VA’s obligation to
provide safe medical care for all
patients, the order would be enforced
while under review by the Network
Director. The Chief of Staff would
provide the patient written notice of the
Network Director’s final decision.
At the end of the proposed rule, we
would include a note stating as follows:
‘‘Although VA may restrict the time,
place, and/or manner of care under this
section, VA will continue to offer the
full range of needed medical care to
which a patient is eligible under title 38
of the United States Code or Code of
Federal Regulations.’’ We do not intend
to prevent patients from accessing nonemergent VA medical care and will
work with veterans to try to find other
VA medical facilities that can provide
the care. However, we recognize that in
a few instances VA restrictions on the
time, place, or manner of care may make
it very difficult for a veteran to access
VA care if the veteran is unwilling to
accept the restrictions placed upon his
or her behavior by the local facility. We
also note that it has been our experience
that through creative case management
on the part of VA staff and other
involved parties, it is almost always
possible to find transportation, even for
veterans who must travel great distances
for routine appointments.
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We do not consider patients
disruptive if they merely do not comply
with a doctor’s orders, decline
recommended medical treatment, or
leave a facility against medical advice.
Such noncompliance can be, and is,
addressed most effectively through
clinical means. We propose to add a
second sentence to the note explicitly
stating that noncompliance with VA
medical treatment recommendations is
not disruptive under this section.
Unfunded Mandates
The Unfunded Mandates Reform Act
requires, at 2 U.S.C. 1532, that agencies
prepare an assessment of anticipated
costs and benefits before developing any
rule that may result in the expenditure
by State, local, or tribal governments, in
the aggregate, or by the private sector, of
$100 million or more (adjusted annually
for inflation) in any given year. This
proposed rule will have no such effect
on State, local, or tribal governments, or
the private sector.
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Paperwork Reduction Act of 1995
This document contains no provisions
constituting a collection of information
under the Paperwork Reduction Act of
1995 (44 U.S.C. 3501–3521).
Executive Order 12866
Executive Order 12866 directs
agencies to assess all costs and benefits
of available regulatory alternatives and,
when regulation is necessary, to select
regulatory approaches that maximize
net benefits (including potential
economic, environmental, public health
and safety, and other advantages;
distributive impacts; and equity). The
Executive Order classifies a ‘‘significant
regulatory action,’’ requiring review by
OMB unless OMB waives such review,
as any regulatory action that is likely to
result in a rule that may: (1) Have an
annual effect on the economy of $100
million or more or adversely affect in a
material way the economy, a sector of
the economy, productivity, competition,
jobs, the environment, public health or
safety, or State, local, or tribal
governments or communities; (2) create
a serious inconsistency or otherwise
interfere with an action taken or
planned by another agency; (3)
materially alter the budgetary impact of
entitlements, grants, user fees, or loan
programs or the rights and obligations of
recipients thereof; or (4) raise novel
legal or policy issues arising out of legal
mandates, the President’s priorities, or
the principles set forth in the Executive
Order.
The economic, interagency,
budgetary, legal, and policy
implications of this proposed rule have
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been examined and it has been
determined to be a significant regulatory
action under the Executive Order
because it is likely to result in a rule that
may raise novel legal or policy issues
arising out of legal mandates, the
President’s priorities, or the principles
set forth in the Executive Order.
Dated: May 26, 2010.
Robert C. McFetridge,
Director of Regulation Policy and
Management, Office of the General Counsel.
Regulatory Flexibility Act
PART 17—MEDICAL
The Secretary hereby certifies that
this proposed rule would not have a
significant economic impact on a
substantial number of small entities as
they are defined in the Regulatory
Flexibility Act, 5 U.S.C. 601–612. This
proposed rule would not cause a
significant economic impact on health
care providers, suppliers, or entities
since only a small portion of the
business of such entities concerns VA
beneficiaries. Therefore, pursuant to 5
U.S.C. 605(b), this proposed amendment
is exempt from the initial and final
regulatory flexibility analysis
requirements of sections 603 and 604.
1. The authority citation for part 17 is
revised to read as follows:
Catalog of Federal Domestic Assistance
The Catalog of Federal Domestic
Assistance numbers and titles for the
programs affected by this document are
64.007, Blind Rehabilitation Centers;
64.008, Veterans Domiciliary Care;
64.009, Veterans Medical Care Benefits;
64.010, Veterans Nursing Home Care;
64.011, Veterans Dental Care; 64.012,
Veterans Prescription Service; 64.013,
Veterans Prosthetic Appliances; 64.014,
64.015, Sharing Specialized Medical
Resources; 64.019, Veterans
Rehabilitation Alcohol and Drug
Dependence; and 64.022, Veterans
Home Based Primary Care.
Signing Authority
The Secretary of Veterans Affairs, or
designee, approved this document and
authorized the undersigned to sign and
submit the document to the Office of the
Federal Register for publication
electronically as an official document of
the Department of Veterans Affairs. John
R. Gingrich, Chief of Staff, approved this
document on March 22, 2010, for
publication.
List of Subjects in 38 CFR Part 17
Administrative practice and
procedure, Alcohol abuse, Alcoholism,
Day care, Dental health, Drug abuse,
Health care, Health facilities, Health
professions, Health records, Homeless,
Medical and dental schools, Medical
devices, Medical research, Mental
health programs, Nursing homes.
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For the reasons set forth in the
preamble, the Department of Veterans
Affairs proposes to amend 38 CFR part
17 as follows:
Authority: 38 U.S.C. 501, and as noted in
specific sections.
2. Section 17.106 is revised to read as
follows:
§ 17.106 VA response to disruptive
behavior of patients.
(a) Definition. For the purposes of this
section:
VA medical facility means VA
medical centers, outpatient clinics, and
domiciliaries.
(b) Response to disruptive patients.
The time, place, and/or manner of the
provision of a patient’s medical care
may be restricted by written order of the
Chief of Staff of the VA Medical Center
of jurisdiction or his or her designee if:
(1) The Chief of Staff or designee
determines pursuant to paragraph (c) of
this section that the patient’s behavior at
a VA medical facility has or could
jeopardize the health or safety of other
patients, VA staff, or guests at the
facility, or otherwise interfere with the
delivery of safe medical care to another
patient at the facility;
(2) The order is narrowly tailored to
address the patient’s disruptive
behavior and avoid undue interference
with the patient’s care;
(3) The order is signed by the Chief of
Staff or designee, and a copy is entered
into the patient’s permanent medical
record;
(4) The patient receives a copy of the
order and written notice of the
procedure for appealing the order to the
network director of jurisdiction as soon
as possible after issuance; and
(5) The order contains an effective
date and any appropriate limits on the
duration of or conditions for continuing
the restrictions. The Chief of Staff or
designee may order restrictions for a
definite period or until the conditions
for removing conditions specified in the
order are satisfied. Unless otherwise
stated, the restrictions imposed by an
order will take effect upon issuance by
the Chief of Staff or designee. Any order
issued by the Chief of Staff or designee
shall include a summary of the
pertinent facts and the bases for the
Chief of Staff’s or designee’s
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determination regarding the need for
restrictions.
(c) Evaluation of disruptive behavior.
In making determinations under
paragraph (b) of this section, the Chief
of Staff or designee must consider all
pertinent facts, including any prior
counseling of the patient regarding his
or her disruptive behavior or any
pattern of such behavior, and whether
the disruptive behavior is a result of the
patient’s individual fears, preferences,
or perceived needs. A patient’s
disruptive behavior must be assessed in
connection with VA’s duty to provide
good quality care, including care
designed to reduce or otherwise
clinically address the patient’s behavior.
(d) Restrictions. The restrictions on
care imposed under this section may
include but are not limited to:
(1) Specifying the hours in which
nonemergent outpatient care will be
provided;
(2) Arranging for medical and any
other services to be provided in a
particular patient care area (e.g., private
exam room near an exit);
(3) Arranging for medical and any
other services to be provided at a
specific site of care;
(4) Specifying the health care
provider, and related personnel, who
will be involved with the patient’s care;
(5) Requiring police escort; or
(6) Authorizing VA providers to
terminate an encounter immediately if
certain behaviors occur.
(e) Review of restrictions. The patient
may request the Network Director’s
review of any order issued under this
section within 30 days of the effective
date of the order by submitting a written
request to the Chief of Staff. The Chief
of Staff shall forward the order and the
patient’s request to the Network Director
for a final decision. The Network
Director shall issue a final decision on
this matter within 30 days. VA will
enforce the order while it is under
review by the network director. The
Chief of Staff will provide the patient
who made the request written notice of
the Network Director’s final decision.
Note: Although VA may restrict the time,
place, and/or manner of care under this
section, VA will continue to offer the full
range of needed medical care to which a
patient is eligible under title 38 of the United
States Code or Code of Federal Regulations.
Patients have the right to accept or refuse
treatments or procedures, and such refusal by
a patient is not a basis for restricting the
provision of care under this section.
(Authority: 38 U.S.C. 501, 901, 1721)
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POSTAL SERVICE
39 CFR Part 501
Revisions to the Requirements for
Authority To Manufacture and
Distribute Postage Evidencing
Systems
Postal ServiceTM.
ACTION: Proposed rule.
AGENCY:
In this proposed rule, the
Postal Service proposes to amend
regulations on Authorization to
Manufacture and Distribute Postage
Evidencing Systems. This proposed
revision clarifies the requirement for
examination by an independent audit
firm of a Postage Evidencing System
Provider’s Computerized Meter
Resetting System (CMRS) or PC
Postage® system internal controls.
DATES: Submit comments on or before
July 1, 2010.
Mail or deliver written
comments to the Manager, Postage
Technology Management, U.S. Postal
Service, 475 L’Enfant Plaza SW., Suite
4200 NB, Washington, DC 20260–4200.
Copies of all written comments will be
available for inspection and
photocopying between 9 a.m. and 4
p.m., Monday through Friday, at the
Postage Technology Management office.
FOR FURTHER INFORMATION CONTACT:
Marlo Kay Ivey, Marketing Specialist,
Postage Technology Management, U.S.
Postal Service, at 202–268–7613.
SUPPLEMENTARY INFORMATION: Postage
Evidencing Systems are devices or
systems of components that a customer
uses to print evidence that the prepaid
postage required for mailing has been
paid. They include, but are not limited
to, postage meters and PC Postage
systems. The Postal Service regulates
these systems and their use in order to
protect postal revenue. Only Postal
Service–authorized product service
providers may design, produce, and
distribute Postage Evidencing Systems.
This proposed revision clarifies the
internal controls required in 39 CFR
501.15(i), Computerized Meter Resetting
system, and 501.16(f), PC Postage
Payment Methodology. This
requirement was added as part of a final
rule published in the Federal Register
on November 9, 2006, at 71 FR 65732.
Although exempt from the notice and
comment requirements of the
Administrative Procedure Act [39 U.S.C.
410(a)], the Postal Service invites public
comment on the following proposed
revisions to the Code of Federal
Regulations (see 39 CFR part 501).
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List of Subjects in 39 CFR Part 501
Postal Service.
Accordingly, 39 CFR part 501 is
proposed to be amended as follows:
PART 501—AUTHORIZATION TO
MANUFACTURE AND DISTRIBUTE
POSTAGE EVIDENCING SYSTEMS
1. The authority citation for 39 CFR
part 501 continues to read as follows:
SUMMARY:
ADDRESSES:
30309
Authority: 5 U.S.C. 552(a); 39 U.S.C. 101,
401, 403, 404, 410, 2601, 2605, Inspector
General Act of 1978, as amended (Pub. L. 95–
452, as amended); 5 U.S.C. App. 3.
2. Section 501.15 is amended by
revising paragraph (i) to read as follows:
§ 501.15 Computerized Meter Resetting
System.
*
*
*
*
*
(i) Security and Revenue Protection.
To receive Postal Service approval to
continue to operate systems in the
CMRS environment, the RC must submit
to a periodic examination of its CMRS
system and any other applications and
technology infrastructure that may have
a material impact on Postal Service
revenues, as determined by the Postal
Service. The examination shall be
performed by a qualified, independent
audit firm and conducted in accordance
with the Statement on Auditing
Standards (SAS) No. 70, Service
Organizations, developed by the
American Institute of Certified Public
Accountants (AICPA), as amended or
superseded. The examination shall
include testing of the operating
effectiveness of relevant RC internal
controls (Type II SAS 70 Report). If the
service organization uses another
service organization (sub-service
provider), Postal Service management
should consider the nature and
materiality of the transactions processed
by the sub-service organization and the
contribution of the sub-service
organization’s processes and controls in
the achievement of the Postal Service’s
information processing objectives. The
Postal Service should have access to the
sub-service organization’s SAS 70
report. The control objectives to be
covered by the SAS 70 report are subject
to Postal Service review and approval
and are to be provided to the Postal
Service 30 days prior to the initiation of
each examination period. As a result of
the examination, the auditor shall
provide the RC and the Postal Service
with an opinion on the design and
operating effectiveness of the RC’s
internal controls related to the CMRS
system and any other applications and
technology infrastructure considered
material to the services provided to the
Postal Service by the RC. Such
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Agencies
[Federal Register Volume 75, Number 104 (Tuesday, June 1, 2010)]
[Proposed Rules]
[Pages 30306-30309]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-13048]
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DEPARTMENT OF VETERANS AFFAIRS
38 CFR Part 17
RIN 2900-AN45
Responding To Disruptive Patients
AGENCY: Department of Veterans Affairs.
ACTION: Proposed rule.
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SUMMARY: This document proposes to amend the Department of Veterans
Affairs (VA) regulation that authorizes appropriate action when a
patient engages in disruptive behavior at a VA medical facility. VA
needs to update its current regulation to reflect modern medical care
and ethical practices. The proposed rule would authorize VA to modify
the time, place, and/or manner in which VA provides treatment to a
patient, in order to ensure the safety of others at VA medical
facilities, and to prevent any interference with the provision of
medical care.
DATES: Comment Date: Comments on the proposed rule must be received by
VA on or before August 2, 2010.
ADDRESSES: Written comments may be submitted through https://www.Regulations.gov; by mail or hand-delivery to the Director,
Regulations Management (02REG), Department of Veterans Affairs, 810
Vermont Avenue, NW., Room 1068, Washington, DC 20420; or by fax to
(202) 273-9026. Comments should indicate that they are submitted in
response to ``RIN 2900-AN45--Responding To Disruptive Patients.''
Copies of comments received will be available for public inspection in
the Office of Regulation Policy and Management, Room 1063B, between the
hours of 8 a.m. and 4:30 p.m., Monday through Friday (except holidays).
Please call (202) 461-4902 for an appointment. This is not a toll free
number. In addition, during the comment period, comments may be viewed
online at https://www.Regulations.gov through the Federal Docket
Management System (FDMS).
FOR FURTHER INFORMATION CONTACT: Roscoe Butler, Deputy Director,
Business Policy, Chief Business Office (163), Veterans Health
Administration, Department of Veterans Affairs, 810 Vermont Avenue,
NW., Washington, DC 20420, (202) 461-1586. (This is not a toll free
number.)
SUPPLEMENTARY INFORMATION: Under 38 U.S.C. chapters 17 and 18, VA has
authority to provide medical care to certain veterans and nonveterans.
VA is required, per 38 U.S.C. 1721, to prescribe rules and regulations
to promote good conduct on the part of VA patients. VA has implemented
this authority in 38 CFR part 17.
Regarding the rights of patients receiving VA care, 38 CFR 17.33(a)
prescribes, in part, that patients have ``a right to be treated with
dignity in a humane environment that affords them both reasonable
protection from harm and appropriate privacy with regard to their
personal needs.'' Patients also have ``a right to receive, to the
extent of eligibility therefor under the law, prompt and appropriate
treatment for any physical or emotional disability.'' Section 17.33(b)
also prescribes rights with respect to visitations and communications,
clothing, personal possessions, money, social interaction, exercise,
and worship for VA residents and inpatients. These rights may be
restricted by the appropriate health care professional in certain
circumstances. See 38 CFR 17.33(c). The restrictions authorized by
Sec. 17.33(c), however, do not apply to outpatients and only cover
restrictions on the listed rights. In certain cases, VA must restrict
the provision of medical care to a patient in order to prevent harm to
other patients and VA staff and disruptions in VA's provision of
medical care due to the patient's behavior.
VA regulations also prescribe rules of conduct for patients and
other individuals who have access to VA facilities. See 38 CFR 1.218.
In particular, Sec. 1.218(a)(5) prohibits persons on VA property from
causing a wide variety of disturbances, including creating ``loud or
unusual noise,'' obstructing public areas, and impeding or disrupting
``the performance of official duties by Government employees.'' The
sole enforcement mechanism provided by paragraph (a)(5) is ``arrest and
removal from the premises.'' 38 CFR 1.218(a)(5). VA has determined that
arrest is generally not an appropriate remedy in a situation where the
Department must balance the rights and needs of a disruptive patient
against the need to protect other patients, guests, and staff. Some
patients establish a pattern of disruptive behavior when interacting
with VA personnel or when they are on VA property, and we believe that
by understanding these patterns of behavior, planning for such behavior
in advance, and setting safe conditions for care delivery, we can
intervene in ways that can prevent subsequent episodes requiring
removal and arrest.
In addition to Sec. Sec. 1.218 and 17.33, the behavior of patients
is specifically governed by current 38 CFR 17.106. It requires, in
part, that VA maintain the good conduct of patients through
``corrective and disciplinary procedure.''
[[Page 30307]]
However, current Sec. 17.106, which VA promulgated in 1973 and last
amended over 10 years ago, does not adequately reflect modern practice
or VA's policy regarding disruptive patients in the health care
setting, which opposes the use of punishment in the management of
disruptive patients. Instead, it reflects the view that patients
exhibiting disruptive behavior must be punished. For example, current
Sec. 17.106 emphasizes disciplining patients who do not engage in
``good conduct,'' and includes measures (such as withholding pass
privileges) that do not differentiate between providing care and
ensuring the safety of others. Moreover, the current rule could be
viewed as interfering with VA's legal obligation to provide medical
care to certain veterans and nonveterans. Accordingly, VA has
determined that amendments to current regulations are necessary to
implement its policy regarding disruptive patients, which emphasizes
continuation of treatment.
We propose to amend Sec. 17.106 to prescribe the remedial measures
VA will take when a patient is disruptive and the procedures for
implementing those measures. VA intends that the proposed rule would
minimize the risk of a particular patient jeopardizing the health or
safety of others, or disrupting the safe provision of medical care to
another patient, in a VA medical facility.
In proposed Sec. 17.106(a), we would define ``VA medical
facility'' to mean any VA medical center, outpatient clinic, or
domiciliary. We would not include VA nursing homes (also referred to as
community living centers) because the limitations on the time, place,
and manner for delivering care are not applicable to patients in this
residential setting.
Proposed paragraph (b) would authorize VA to restrict the time,
place, and/or manner of the provision of a patient's medical care if
the patient's behavior at a VA medical facility has or could jeopardize
the health or safety of other patients, VA staff, or guests at the
facility, or otherwise interfere with the delivery of safe medical care
to another patient at the facility. Decisions regarding these
restrictions would be made by the VA medical facility Chief of Staff or
his or her designee. An appropriate designee might include, for
example, a Disruptive Behavior Committee (DBC). VA has mandated DBCs at
all of the Department's medical centers, and these committees regularly
assess disruptive behavior. As such, they have developed expertise in
this area.
Proposed paragraph (b) would also set forth procedures for
implementing these determinations. Thus, any order restricting a
patient's care would need to be in writing and signed by the Chief of
Staff or designee with a copy entered into the patient's VA medical
record. The Chief of Staff or designee would provide the patient a copy
of the order and an explanation of the procedure for an administrative
review under paragraph (e) as soon as possible after issuance. Unless
otherwise stated in the order, these restrictions would take effect
upon the signature of the Chief of Staff or designee. We have
determined that restrictions under this proposed rule would be
necessary in situations where a patient's behavior has or could harm
another person or interfere with the delivery of medical care to
another patient at the facility. Accordingly, in almost every case VA
would need to implement the restrictions immediately to prevent the
harm and meet its obligation to provide safe medical care.
The proposed procedure would emphasize addressing the disruptive
patient's needs in order to advance VA's focus on patient care. We
propose to require that authorized officials making determinations
under this section narrowly tailor restrictions to avoid interfering
with the disruptive patient's care. Ultimately, we expect that actions
under this proposed rule would increase the likelihood that the
disruptive patient will engage, or re-engage (if it has been necessary
to terminate an episode of care), in health care in a safe and
efficacious manner, without being disruptive. Indeed, through our DBCs
and similar committees, we are already seeing anecdotal evidence of
such results.
The standard for making determinations under the proposed rule is
in paragraph (b)(1). Under this standard, the Chief of Staff or
designee would evaluate whether the patient's behavior has or could
jeopardize the health or safety of patients or other individuals who
have access to VA medical facilities. The Chief of Staff or designee
would also evaluate whether the patient's behavior has or could
interfere with the delivery of medical care to another patient at a VA
medical facility. In making such determinations, the Chief of Staff or
designee would consider, among other things, the patient's individual
fears; VA's obligation to provide the patient with high-quality medical
care; and all of the pertinent facts, such as any prior counseling of
the patient regarding his or her inappropriate behavior. See proposed
paragraph (c).
Proposed paragraph (d) would also suggest a range of possible
restrictions that could be imposed. We believe that these suggestions
would assist Chiefs of Staff or their designees to narrowly tailor
restrictions imposed under the proposed rule. We do not intend to limit
the remedial options available to the officials making determinations
under this section. Rather, proposed paragraph (d) would illustrate the
types of restrictions that might be appropriate in a given situation
and would authorize any other restriction that the Chief of Staff or
designee deems appropriate short of arrest and removal. Restrictions
could thus be tailored to consider the needs of a particular situation
or patient.
Proposed paragraph (e) would prescribe the procedures for obtaining
an administrative review of restrictions imposed by order of the Chief
of Staff or designee under the proposed rule. VA provides medical care
through 21 networks of medical facilities known as Veterans Integrated
Service Networks. We propose to allow one appeal of an order
restricting medical care under this section to the Network Director of
jurisdiction. The patient would initiate the Network Director's review
by submitting a request to the Chief of Staff within 30 days of the
effective date of the Chief of Staff's or designee's order. However, in
light of VA's obligation to provide safe medical care for all patients,
the order would be enforced while under review by the Network Director.
The Chief of Staff would provide the patient written notice of the
Network Director's final decision.
At the end of the proposed rule, we would include a note stating as
follows: ``Although VA may restrict the time, place, and/or manner of
care under this section, VA will continue to offer the full range of
needed medical care to which a patient is eligible under title 38 of
the United States Code or Code of Federal Regulations.'' We do not
intend to prevent patients from accessing non-emergent VA medical care
and will work with veterans to try to find other VA medical facilities
that can provide the care. However, we recognize that in a few
instances VA restrictions on the time, place, or manner of care may
make it very difficult for a veteran to access VA care if the veteran
is unwilling to accept the restrictions placed upon his or her behavior
by the local facility. We also note that it has been our experience
that through creative case management on the part of VA staff and other
involved parties, it is almost always possible to find transportation,
even for veterans who must travel great distances for routine
appointments.
[[Page 30308]]
We do not consider patients disruptive if they merely do not comply
with a doctor's orders, decline recommended medical treatment, or leave
a facility against medical advice. Such noncompliance can be, and is,
addressed most effectively through clinical means. We propose to add a
second sentence to the note explicitly stating that noncompliance with
VA medical treatment recommendations is not disruptive under this
section.
Unfunded Mandates
The Unfunded Mandates Reform Act requires, at 2 U.S.C. 1532, that
agencies prepare an assessment of anticipated costs and benefits before
developing any rule that may result in the expenditure by State, local,
or tribal governments, in the aggregate, or by the private sector, of
$100 million or more (adjusted annually for inflation) in any given
year. This proposed rule will have no such effect on State, local, or
tribal governments, or the private sector.
Paperwork Reduction Act of 1995
This document contains no provisions constituting a collection of
information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-
3521).
Executive Order 12866
Executive Order 12866 directs agencies to assess all costs and
benefits of available regulatory alternatives and, when regulation is
necessary, to select regulatory approaches that maximize net benefits
(including potential economic, environmental, public health and safety,
and other advantages; distributive impacts; and equity). The Executive
Order classifies a ``significant regulatory action,'' requiring review
by OMB unless OMB waives such review, as any regulatory action that is
likely to result in a rule that may: (1) Have an annual effect on the
economy of $100 million or more or adversely affect in a material way
the economy, a sector of the economy, productivity, competition, jobs,
the environment, public health or safety, or State, local, or tribal
governments or communities; (2) create a serious inconsistency or
otherwise interfere with an action taken or planned by another agency;
(3) materially alter the budgetary impact of entitlements, grants, user
fees, or loan programs or the rights and obligations of recipients
thereof; or (4) raise novel legal or policy issues arising out of legal
mandates, the President's priorities, or the principles set forth in
the Executive Order.
The economic, interagency, budgetary, legal, and policy
implications of this proposed rule have been examined and it has been
determined to be a significant regulatory action under the Executive
Order because it is likely to result in a rule that may raise novel
legal or policy issues arising out of legal mandates, the President's
priorities, or the principles set forth in the Executive Order.
Regulatory Flexibility Act
The Secretary hereby certifies that this proposed rule would not
have a significant economic impact on a substantial number of small
entities as they are defined in the Regulatory Flexibility Act, 5
U.S.C. 601-612. This proposed rule would not cause a significant
economic impact on health care providers, suppliers, or entities since
only a small portion of the business of such entities concerns VA
beneficiaries. Therefore, pursuant to 5 U.S.C. 605(b), this proposed
amendment is exempt from the initial and final regulatory flexibility
analysis requirements of sections 603 and 604.
Catalog of Federal Domestic Assistance
The Catalog of Federal Domestic Assistance numbers and titles for
the programs affected by this document are 64.007, Blind Rehabilitation
Centers; 64.008, Veterans Domiciliary Care; 64.009, Veterans Medical
Care Benefits; 64.010, Veterans Nursing Home Care; 64.011, Veterans
Dental Care; 64.012, Veterans Prescription Service; 64.013, Veterans
Prosthetic Appliances; 64.014, 64.015, Sharing Specialized Medical
Resources; 64.019, Veterans Rehabilitation Alcohol and Drug Dependence;
and 64.022, Veterans Home Based Primary Care.
Signing Authority
The Secretary of Veterans Affairs, or designee, approved this
document and authorized the undersigned to sign and submit the document
to the Office of the Federal Register for publication electronically as
an official document of the Department of Veterans Affairs. John R.
Gingrich, Chief of Staff, approved this document on March 22, 2010, for
publication.
List of Subjects in 38 CFR Part 17
Administrative practice and procedure, Alcohol abuse, Alcoholism,
Day care, Dental health, Drug abuse, Health care, Health facilities,
Health professions, Health records, Homeless, Medical and dental
schools, Medical devices, Medical research, Mental health programs,
Nursing homes.
Dated: May 26, 2010.
Robert C. McFetridge,
Director of Regulation Policy and Management, Office of the General
Counsel.
For the reasons set forth in the preamble, the Department of
Veterans Affairs proposes to amend 38 CFR part 17 as follows:
PART 17--MEDICAL
1. The authority citation for part 17 is revised to read as
follows:
Authority: 38 U.S.C. 501, and as noted in specific sections.
2. Section 17.106 is revised to read as follows:
Sec. 17.106 VA response to disruptive behavior of patients.
(a) Definition. For the purposes of this section:
VA medical facility means VA medical centers, outpatient clinics,
and domiciliaries.
(b) Response to disruptive patients. The time, place, and/or manner
of the provision of a patient's medical care may be restricted by
written order of the Chief of Staff of the VA Medical Center of
jurisdiction or his or her designee if:
(1) The Chief of Staff or designee determines pursuant to paragraph
(c) of this section that the patient's behavior at a VA medical
facility has or could jeopardize the health or safety of other
patients, VA staff, or guests at the facility, or otherwise interfere
with the delivery of safe medical care to another patient at the
facility;
(2) The order is narrowly tailored to address the patient's
disruptive behavior and avoid undue interference with the patient's
care;
(3) The order is signed by the Chief of Staff or designee, and a
copy is entered into the patient's permanent medical record;
(4) The patient receives a copy of the order and written notice of
the procedure for appealing the order to the network director of
jurisdiction as soon as possible after issuance; and
(5) The order contains an effective date and any appropriate limits
on the duration of or conditions for continuing the restrictions. The
Chief of Staff or designee may order restrictions for a definite period
or until the conditions for removing conditions specified in the order
are satisfied. Unless otherwise stated, the restrictions imposed by an
order will take effect upon issuance by the Chief of Staff or designee.
Any order issued by the Chief of Staff or designee shall include a
summary of the pertinent facts and the bases for the Chief of Staff's
or designee's
[[Page 30309]]
determination regarding the need for restrictions.
(c) Evaluation of disruptive behavior. In making determinations
under paragraph (b) of this section, the Chief of Staff or designee
must consider all pertinent facts, including any prior counseling of
the patient regarding his or her disruptive behavior or any pattern of
such behavior, and whether the disruptive behavior is a result of the
patient's individual fears, preferences, or perceived needs. A
patient's disruptive behavior must be assessed in connection with VA's
duty to provide good quality care, including care designed to reduce or
otherwise clinically address the patient's behavior.
(d) Restrictions. The restrictions on care imposed under this
section may include but are not limited to:
(1) Specifying the hours in which nonemergent outpatient care will
be provided;
(2) Arranging for medical and any other services to be provided in
a particular patient care area (e.g., private exam room near an exit);
(3) Arranging for medical and any other services to be provided at
a specific site of care;
(4) Specifying the health care provider, and related personnel, who
will be involved with the patient's care;
(5) Requiring police escort; or
(6) Authorizing VA providers to terminate an encounter immediately
if certain behaviors occur.
(e) Review of restrictions. The patient may request the Network
Director's review of any order issued under this section within 30 days
of the effective date of the order by submitting a written request to
the Chief of Staff. The Chief of Staff shall forward the order and the
patient's request to the Network Director for a final decision. The
Network Director shall issue a final decision on this matter within 30
days. VA will enforce the order while it is under review by the network
director. The Chief of Staff will provide the patient who made the
request written notice of the Network Director's final decision.
Note: Although VA may restrict the time, place, and/or manner
of care under this section, VA will continue to offer the full range
of needed medical care to which a patient is eligible under title 38
of the United States Code or Code of Federal Regulations. Patients
have the right to accept or refuse treatments or procedures, and
such refusal by a patient is not a basis for restricting the
provision of care under this section.
(Authority: 38 U.S.C. 501, 901, 1721)
[FR Doc. 2010-13048 Filed 5-28-10; 8:45 am]
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