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23 September 2006
[Federal Register: September 22, 2006 (Volume 71, Number 184)]
[Rules and Regulations]
[Page 55326-55341]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr22se06-11]
=======================================================================
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
42 CFR Parts 403, 416, 418, 460, 482, 483, and 485
[CMS-3145-F]
RIN 0938-AN36
Medicare and Medicaid Programs; Fire Safety Requirements for
Certain Health Care Facilities; Amendment
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This final rule adopts the substance of the April 15, 2004
tentative interim amendment (TIA) 00-1 (101), Alcohol Based Hand Rub
Solutions, an amendment to the 2000 edition of the Life Safety Code,
published by the National Fire Protection Association (NFPA). This
amendment allows certain health care facilities to place alcohol-based
hand rub dispensers in egress corridors under specified conditions.
This final rule also requires that nursing facilities at least install
battery-operated single station smoke alarms in resident rooms and
common areas if they are not fully sprinklered or they do not have
system-based smoke detectors in those areas. Finally, this final rule
confirms as final the provisions of the March 25, 2005 interim final
rule with changes and responds to public comments on that rule.
DATES: Effective Date: These regulations are effective on October 23,
2006. The incorporation by reference of certain
[[Page 55327]]
publications listed in the rule is approved by the Director of the
Federal Register as of October 23, 2006.
FOR FURTHER INFORMATION CONTACT: Danielle Shearer, (410) 786-6617;
James Merrill, (410) 786-6998; Jeannie Miller, (410) 786-3164; or Mayer
Zimmerman, (410) 786-6839.
SUPPLEMENTARY INFORMATION:
I. Background
A. Alcohol-Based Hand Rubs (ABHR)
The Life Safety Code (LSC) is a compilation of fire safety
requirements for new and existing buildings that is updated and
generally published every 3 years by the National Fire Protection
Association (NFPA), a private, nonprofit organization dedicated to
reducing loss of life due to fire. The Medicare and Medicaid
regulations have historically incorporated these requirements by
reference, while providing the opportunity for a Secretarial waiver of
a requirement under certain circumstances. The general statutory basis
for incorporating NFPA's LSC for our providers is under the Secretary's
general rulemaking authority at sections 1102 and 1871 of the Social
Security Act.
On January 10, 2003, we published a final rule in the Federal
Register, entitled ``Fire Safety Requirements for Certain Health Care
Facilities'' (68 FR 1374). In that final rule, we adopted the 2000
edition of the LSC provisions governing Medicare and Medicaid health
care facilities. The Office of the Federal Register's rules regarding
incorporation by reference state that the document so incorporated is
the one referred to as it exists on the date of publication of the
final rule. Among other things, the 2000 edition of the LSC prohibited
the placement of accelerants, including alcohol-based hand rub (ABHR)
dispensers, in egress corridors, but allowed their placement in patient
rooms and other appropriate areas.
On April 15, 2004 the NFPA adopted a tentative interim amendment
(TIA) 001 (101), Alcohol Based Hand Rub Solutions, to the 2000 edition
of the LSC. This amendment allows certain health care facilities to
install alcohol-based hand rub (ABHR) dispensers in egress corridors
under certain specified conditions.
On March 25, 2005 we published an interim final rule with comment
period in the Federal Register, entitled ``Fire Safety Requirements for
Certain Health Care Facilities; Amendment'' (70 FR 15229). In that
interim final rule, we adopted the substance of the April 15, 2004 TIA.
As stated in the preamble to the March 2005 interim final rule,
ABHRs have become an increasingly common infection control method.
Effective infection control has been a concern identified in numerous
research studies and reports.
The Centers for Disease Control and Prevention (CDC) reports that
there are more than 2 million health care acquired infections per year
(http://www.cdc.gov/handhygiene/firesafety/aha_meeting.htm). Many of
the microorganisms that cause these infections are transmitted to
patients because health care workers do not wash their hands or do so
improperly or inadequately. Improving hand hygiene is an important step
towards reducing the number of health care acquired infections. In
October 2002, the CDC posted hand hygiene guidelines for health care
settings on its Web site (http://www.cdc.gov/handhygiene/firesafety/default.htm
). The guidelines clearly recommended the use of ABHRs. The
CDC stated that--
Compared with soap and water hand washing, ABHRs are more
effective in reducing bacteria on hands, cause less skin irritation/
dermatitis, and save personnel time;
Use of ABHRs has been associated with improved adherence
to recommended hand hygiene practices;
Adherence is directly tied to access. The highest possible
adherence to hand hygiene practice is achieved when ABHR dispensers are
in readily accessible locations such as the corridor near the patient
room entrance and inside patient rooms; and
Improved hand hygiene practices have been associated with
reduced health care-associated infection rates.
Research from a variety of sources confirms the CDC's research and
statements about the usefulness and effectiveness of ABHRs in health
care facilities. For example, the study ``Improving adherence to hand
hygiene practice: A multidisciplinary approach'' (Pittet D. Emerging
Infectious Diseases. 2001 March-April; 7(2):243-40. Review) concludes
that, ``[a]lcohol-based hand rub, compared with traditional handwashing
with unmedicated soap and water or medicated hand antiseptic agents,
may be better because it requires less time, acts faster, and irritates
hands less often.''
The same study goes on to state that, ``[t]his method was used in
the only program that reported a sustained improvement in hand hygiene
compliance with decreased infection rates.'' The relationship between
ABHRs and improved adherence to recommended hand hygiene practices is
also found in other studies, including ``Availability of an alcohol
solution can improve hand disinfection compliance in an intensive care
unit'' (Maury E, et al. American Journal of Respiratory and Critical
Care Medicine, 2000; 162:324-327). This study saw compliance with hand
hygiene practice rates rise from 42.4 percent before the introduction
of ABHRs to 60.9 percent afterwards. Each category of health care
employer, from nurses to physicians, and even patients, increased
compliance with hand hygiene practices.
Another study, ``Effectiveness of a hospital-wide programme to
improve compliance with hand hygiene'' (Pittet D, Hugonnet S, Harbarth
S, et al. Lancet 356; 2000; 1307-1312), also demonstrated an increase
in compliance with hand hygiene practices that was directly related to
the use of ABHRs. In this study, compliance rates rose from 47.6
percent to 66.2 percent over a 3-year period. Handwashing rates
remained stable at 30 percent during this period while hand
disinfection rates rose from 13.6 percent to 37.0 percent. During this
time, the annual amount of ABHR use increased from 3.5L per 1,000
patients to 10.9L per 1,000 patients. The increase in hand disinfection
through ABHRs and related increase in compliance with hand hygiene
practices are directly tied to the increased availability and use of
ABHRs.
An important aspect of getting health care workers and others to
use ABHRs is their accessibility. In the study ``Handwashing compliance
by health care workers: The impact of introducing an accessible,
alcohol-based antiseptic'' (Bischoff WE, et al. Archives of Internal
Medicine, 2000; 160: 1017-1021), researchers assessed how the
accessibility of ABHRs impacted their use. The researchers found that
when one ABHR dispenser was available for every four patient beds, the
adherence rate for hand hygiene was 19 percent before patient contact
and 41 percent after patient contact. When one ABHR dispenser was
available for each bed, the rates rise to 23 percent before patient
contact and 48 percent after patient contact. Increased availability of
ABHR dispensers resulted in increased hand hygiene rates.
The relationship between increased availability and increased use
is likely the result of several factors. An increase in the number of
ABHR dispensers acts as a continuous reminder to workers and others
that they need to disinfect their hands. For example, each time an
individual approaches a patient area, he or she may see, right next to
the door, an ABHR dispenser. The dispenser
[[Page 55328]]
reminds an individual to disinfect his or her hands. In addition to
reminding an individual, the location of ABHR dispensers in obvious and
highly visible locations serves as a convenient way to disinfect hands.
Rather than repeatedly walking to a sink located in another area, a
worker can use the ABHR as he or she enters a patient's room as well as
while inside the room. Easy and immediate access to ABHR dispensers is
a key element in improving adherence to hand hygiene practices.
Improving hand hygiene has a direct effect on the number of
healthcare-acquired infections. Following the introduction of ABHRs in
one hospital, there was a reduction in the proportion of methicillin-
resistant S. aureus infections for each of the quarters of 2000-2001,
when ABHRs were utilized, compared with 1999-2000, when ABHRs were not
utilized. There was also a 17.4 percent reduction in the incidence of
Clostridium difficile-associated disease from 11.5 cases per 1,000
admissions before the introduction of ABHRs to 9.5 cases per 1000
admissions after the introduction of ABHRs (Gopal Rao G, Jeanes A,
Osman M, et al. Marketing hand hygiene in hospitals: A case study.
Journal of Hospital Infection 2002; 50:42-47).
The benefits of using ABHRs have been well demonstrated. However,
there have been previous concerns about placing ABHR dispensers in
egress corridors. The ABHRs are most commonly found in a gel form
contained in a single use disposable bag that is inserted into a wall-
mounted dispenser, similar in appearance to wall-mounted hand soap
dispensers. The dispenser compresses the bag to dispense the gel.
During normal operation and replacement, the dispenser remains a closed
system, meaning that vapors are not released into the atmosphere. In
addition, refilling is done using single-use disposable bags rather
than large bulk containers. The relatively small quantity of gel in
each dispenser combined with the absence of vapor release means that
these dispensers, when properly installed and used, pose little fire
risk in health care facilities.
In July 2003, the American Hospital Association (AHA), in
conjunction with the CDC, held a stakeholder meeting with
representatives from more than 20 governmental and non-governmental
agencies, including CMS, to discuss the issue of the placement and use
of ABHRs. During the meeting, the AHA presented a fire modeling study
that was conducted by Gage-Babcock & Associates, Inc. on behalf of the
AHA's sister organization, the American Society for Healthcare
Engineering (ASHE). This study demonstrated that placing ABHR
dispensers in egress corridors is safe, provided that certain
conditions are met (http://www.hospitalconnect.com/ashe/currentevent/alcohol_based_hand_rub/Final_Report_rev1.2_Part_1_2.pdf
).
In February 2004, the ASHE submitted and received approval for
tentative interim amendment (TIA) 00-1 (101), Alcohol Based Hand Rub
Solutions, to amend the 2003 edition of the LSC. This TIA permitted the
placement of ABHR dispensers in egress corridors if certain criteria
are met. At the April 15, 2004 meeting of the NFPA's Standards Council,
TIA 00-1 (101) was approved for the 2003 edition of the LSC. The TIA
was also approved for the 2000 edition of the LSC (the edition CMS
adopted). The TIA altered chapters 18.3.2.7 and 19.3.2.7 of the 2000
edition of the LSC. The change became effective May 5, 2004.
Normally, when the NFPA amends the LSC, it amends the most recently
published edition of the code. The most recently published edition at
that time was the 2003 edition. However, when the NFPA amended the LSC
this time, it retroactively amended the 2000 edition of the LSC in
addition to the 2003 edition of the LSC. This is the first time that
the NFPA ever retroactively adopted an amendment for an earlier edition
of the LSC.
We are adopting the amendment to chapters 18 and 19 of the 2000
edition of the LSC, specifically the changes to chapters 18.3.2.7 and
19.3.2.7. Adopting the amended chapters will allow health care
facilities to place ABHR dispensers in egress corridors. We are not
adopting the entire revised 2000 edition of the LSC.
Chapters 18 and 19 of the Life Safety Code apply to hospitals,
long-term care facilities, religious non-medical health care
institutions, hospices, programs of all-inclusive care for the elderly,
hospitals, intermediate care facilities for the mentally retarded, and
critical access hospitals.
Ambulatory surgical centers (ASCs) are not covered under chapters
18 or 19 of the LSC; but are rather covered under chapters 20 (new
construction) and 21 (existing construction) of the LSC. Many ASCs are
interested in installing ABHR dispensers in corridors. However,
chapters 20 and 21 of the 2000 edition of the LSC have not been amended
thus far to permit the installation of ABHR dispensers in egress
corridors in ASCs. We are allowing ASCs to install ABHR dispensers in
egress corridors according to the same conditions identified for other
health care facilities.
We consider a health care facility to be in compliance with our
requirements if the placement of ABHR dispensers meets the specified
conditions listed in section II.A of this final rule. The ABHR
dispensers will also be required to meet the following criteria that
are listed in chapters 18.3.2.7 and 19.3.2.7 of the 2000 edition of the
LSC as amended:
Where dispensers are installed in a corridor, the corridor
shall have a minimum width of 6 ft (1.8m).
The maximum individual dispenser fluid capacity shall be:
--0.3 gallons (1.2 liters) for dispensers in rooms, corridors, and
areas open to corridors.
--0.5 gallons (2.0 liters) for dispensers in suites of rooms.
The dispensers shall have a minimum horizontal spacing of
4 ft (1.2m) from each other.
Not more than an aggregate 10 gallons (37.8 liters) of
ABHR solution shall be in use in a single smoke compartment outside of
a storage cabinet.
Storage of quantities greater than 5 gallons (18.9 liters)
in a single smoke compartment shall meet the requirements of NFPA 30,
Flammable and Combustible Liquids Code.
The dispensers shall not be installed over or directly
adjacent to an ignition source.
In locations with carpeted floor coverings, dispensers
installed directly over carpeted surfaces shall be permitted only in
sprinklered smoke compartments.
After careful and thorough consideration of the numerous studies
and recommendations presented above, we believe that placing ABHR
dispensers in all appropriate areas, including corridors, is safe and
appropriate for patients and providers alike.
B. Smoke Alarms
A recent Government Accountability Office (GAO) report entitled
``Nursing Home Fire Safety: Recent Fires Highlight Weaknesses in
Federal Standards and Oversight'' (GAO-04-660, July 16, 2004, http://www.gao.gov/new.items/d04660.pdf
) examined two long-term care facility
fires in 2003 that resulted in 31 resident deaths. The report examined
Federal fire safety standards and enforcement procedures, as well as
results from fire investigations of these two incidents. The report
recommended that fire safety standards for unsprinklered facilities be
strengthened. It specifically cited requiring smoke detectors in these
facilities as one way to strengthen the requirements.
[[Page 55329]]
On March 25, 2005, we published an interim final rule with comment
period in the Federal Register, entitled ``Fire Safety Requirements for
Certain Health Care Facilities; Amendment'' (70 FR 15229). In that
interim final rule, we required that long term care facilities at least
install battery operated smoke detectors in resident rooms and public
areas if they did not have sprinklers installed throughout or they did
not have a hard-wired smoke detection system in the specified areas.
This interim final regulation implemented the smoke detector
recommendation made by the GAO in the 2004 report. As we will discuss
in section III.B, Analysis of and Responses to Public Comments, Smoke
Alarms, of this document, we are altering the terminology used to
describe the smoke detector requirement. From this point forward, we
will refer to the following terms in the manner specified below unless
otherwise noted:
``Smoke detectors'' are now ``smoke alarms'';
``Public areas'' are now ``common areas'';
Having ``sprinklers installed throughout'' is now ``fully
sprinklered''; and
``A hard-wired smoke detection system'' is now ``system-
based smoke detectors''.
The fires, in Hartford, Connecticut and Nashville, Tennessee, had
several things in common. Each fire began in a resident sleeping room
at night, neither of those rooms had a smoke alarm, and the majority of
victims died from smoke inhalation. The lack of smoke alarms in
resident rooms, the report concludes, ``* * * may have delayed staff
response and activation of the buildings' fire alarms.''
Relying on an effective and timely staff response was, and still
is, a crucial aspect of facility fire safety requirements. Long-term
care facilities are required by the 2000 edition of the LSC (chapters
18.7.1.1 and 19.7.1.1) to have an emergency plan that will be
implemented in the event of a fire at the facility. As part of this
plan, staff members at Medicare-approved facilities are typically
expected to do things such as close resident room doors, turn off fans
and other air circulation devices, and evacuate residents.
However, battery-operated smoke alarms, a basic fire safety device,
are only required by the 2000 edition of the Life Safety Code (which
refers to them as smoke detectors) to be installed in existing non-
sprinklered resident rooms when those rooms contain furniture that the
resident has brought from his or her home. This was not the case in
either fire; therefore, smoke alarms were not in the resident sleeping
rooms where the fires started.
While resident rooms are the leading area of fire origin, fires can
and do originate in other areas. For example, a fire could originate in
an unoccupied resident activity room. There is a possibility that no
one will be aware of this fire until smoke spreads to a corridor where
there are smoke alarms. By this time, smoke may have also begun
filtering into other areas of the facility such as resident sleeping
rooms and common areas that are occupied, thus harming those residents.
In order to alert staff and residents in the earliest stages of a fire,
we believe that it is necessary to install smoke alarms in resident
sleeping rooms and common areas. For these reasons, we are requiring
that long-term care facilities that do not have sprinklers must at
least install battery-operated single station smoke alarms in resident
rooms and common areas. We have discussed this issue in detail in
section II.B of this final rule.
This rule requires facilities to at least install battery-operated
single station smoke alarms in the identified areas. We encourage
facilities to go beyond this minimum requirement by installing multiple
station smoke alarms that can be interconnected to other smoke alarms
so that the activation of one alarm causes the alarm signal in all
interconnected smoke alarms to sound. Installing and maintaining these
more advanced smoke alarms would meet and exceed the minimum
requirements of this regulation.
Facilities that chose to install system-based smoke detectors in
accordance with NFPA 72, National Fire Alarm Code, in resident rooms
and common areas would be deemed to have met this requirement. System-
based smoke detectors are connected to a building's general fire alarm
system and are designed to activate that system, thus alerting the
occupants of the entire building and notifying the fire department. If
a facility chose to install system-based smoke detectors in resident
rooms and common areas, then it does not have to install battery-
operated single station smoke alarms because such a system exceeds the
requirements of this final rule.
Facilities that are fully sprinklered in accordance with NFPA 13,
Standard for the Installation of Sprinkler Systems, would also be
considered to meet the requirement and would not have to install smoke
alarms, because such a system exceeds this requirement.
II. Provisions of the Proposed Regulations
A. Alcohol-Based Hand Rubs
For the reasons specified in the preamble, in sections I.A. and
I.B. above, we are modifying the conditions of participation for the
following facilities:
Religious non-medical health care institutions (RNHCI)
(new Sec. 403.744(a)(4)).
Ambulatory Surgical Services (ASC) (new Sec.
416.44(b)(5)).
Hospices (new Sec. 418.100(d)(6)).
Programs of all-inclusive care for the elderly (PACE) (new
Sec. 460.72(b)(5)).
Hospitals (new Sec. 482.41(b)(9)).
Long-term care (LTC) facilities (new Sec. 483.70(a)(6)).
Intermediate care facilities for the mentally retarded
(ICFs/MR) (revised Sec. 483.470(j)(7)).
Critical access hospitals (CAHs) (new Sec.
485.623(d)(7)).
Specifically, we are adding a new provision that will allow these
facilities to place ABHR dispensers in various locations, including
egress corridors, if the facilities meet the following conditions:
The use of ABHR dispensers does not conflict with any
State or local codes that prohibit or otherwise restrict the placement
of ABHR dispensers in health care facilities. Allowing ABHR dispensers
to be installed in egress corridors will be a significant lessening of
restrictions. States and local jurisdictions may choose to retain
stricter codes that prohibit or otherwise restrict the installation of
ABHR dispensers in health care facilities. Facilities will still be
required to comply with those stricter State and local codes.
Therefore, facilities could only install ABHR dispensers if the
dispensers were also permitted by State and local codes.
The dispensers are installed in a manner that minimized
leaks and spills that could lead to falls. Like soap, ABHRs are very
slick. As such, it is more likely for someone to slip and fall on a
surface that is covered by an ABHR solution than on a surface that is
clean.
The increased risk of falls posed by the presence of leaky or
spilled ABHR dispensers might be compounded by the medical conditions
of patients or residents. While a healthy individual may fall and only
suffer a bruise, a frail individual may suffer a broken hip. It is the
specific safety needs of the patient populations found in hospitals and
other health care facilities that necessitate the requirement that
facilities take extra steps to ensure that ABHR dispensers do not leak
or spill.
[[Page 55330]]
The dispensers are installed in a manner that adequately
protects against inappropriate access. There are certain patient or
resident populations, such as residents of dementia wards, who may
misuse ABHR solutions, which are both toxic and flammable. As a toxic
substance, ABHR solutions are very dangerous if they are ingested,
placed in the eyes, or otherwise misused. As a flammable substance,
ABHR solutions could be used to start fires that endanger the lives of
patients and destroy property.
Due to disability or disease, some patients are more likely to harm
themselves or others by inappropriately using ABHR solutions. In order
to avoid any and all dangerous situations, a facility will have to take
all appropriate precautions to secure the ABHR dispensers from
inappropriate access.
This may mean that facilities could choose to not install ABHR
dispensers in corridors in or near dementia or psychiatric units. It
may also mean that facilities could choose to install ABHR dispensers
only in areas that can be easily and frequently monitored, such as in
view of a nursing station or a continuously monitored security camera.
These are just a few of the many options that facilities may choose to
utilize in securing ABHR dispensers against inappropriate access.
The dispensers are installed in accordance with chapters
18.3.2.7 and 19.3.2.7 of the 2000 edition of the LSC as amended. The
revisions to the chapters were thoroughly examined by the NFPA's fire
safety experts and are based on the fire modeling study conducted by
Gage-Babcock for the ASHE. As noted above, the study demonstrated that
ABHR dispensers installed in egress corridors do not increase the risk
of fire if certain conditions, as outlined in chapters 18.3.2.7 and
19.3.2.7 of the 2000 edition of the LSC, are met.
The dispensers are maintained in accordance with dispenser
manufacturer guidelines. Regular maintenance of dispensers in
accordance with the directions of the manufacturer is a crucial step
towards ensuring that the dispensers do not leak or spill. Having a
maintenance program will help ensure that the dispensers are
functioning properly and that any malfunctions are addressed in a
timely manner. Following manufacturer guidelines will help ensure that
maintenance is properly performed and assure properly functioning
dispensers.
B. Smoke Alarms
We are requiring in Sec. 483.70(a)(7) that long-term care
facilities will, at minimum, be required to install battery-operated
single station smoke alarms in resident sleeping rooms and common
areas, unless they have system-based smoke detectors in those areas or
they are a fully sprinklered facility. Facilities may choose to use
more advanced smoke alarms such as dual sensor alarms or AC-powered
alarms. These devices are at least equivalent to battery-powered single
station smoke alarms and can be used in place of or in conjunction with
each other. We are also requiring that facilities that install battery-
operated single station smoke alarms have their own program for
inspection, testing, maintenance, and battery replacement that verifies
correct operation of the battery-operated single station smoke alarms.
Facilities should ensure that their testing, maintenance, and battery
replacement programs conform with manufacturer recommendations.
Battery-operated single station smoke alarms, when properly installed
and maintained in resident sleeping rooms and common areas, are a
basic, useful, and effective fire safety tool.
We believe that at least installing battery-operated single station
smoke alarms will provide earlier warning for facility residents and
staff. Fires that originate in these areas will be detected earlier
because the alarm will be located closer to the fire's origin. Earlier
detection, and thus earlier alarm, will allow residents and staff more
time to react to the situation and implement the facility's emergency
plan. Implementing the emergency plan typically includes notifying the
fire department, and this earlier notification will speed the arrival
of help. These factors would help to reduce the loss of life in a
nursing facility fire.
As discussed earlier, a facility will be required to have a program
for inspection, testing, maintenance, and battery replacement to ensure
the correct operation of the battery-operated single station smoke
alarms.
Battery-operated single station smoke alarms with standard
batteries require maintenance every 6 months to 1 year in order to
ensure that the batteries are operating at optimum power. We understand
that there are battery-operated single station smoke alarms that use
longer-lasting batteries. If a facility chooses to use such longer life
batteries, we would continue to expect that the maintenance plan would
reflect manufacturer recommendations. An alarm with a depleted battery
provides no protection. Thus, a regular maintenance program for the
alarms is crucial to ensuring that residents and staff are indeed
protected. Facilities will be expected to add maintenance of smoke
alarms that conforms to manufacturer recommendations to their existing
maintenance schedule.
The regulation has two exceptions, one for facilities that have
system-based smoke detectors in accordance with NFPA 72, National Fire
Alarm Code, and one for facilities that are fully sprinklered in
accordance with the requirements of NFPA 13, Standard for the
Installation of Sprinkler Systems. System-based smoke detectors
installed in resident rooms and common areas will protect the same
areas as the battery-operated alarms. Therefore, having both system-
based smoke detectors and battery-operated alarms in these areas will
be redundant, unnecessary, and overly burdensome. Facilities may still
choose to use battery-operated single station alarms along with system-
based smoke detectors as an additional layer of fire protection, but we
are not requiring the facilities to do so in this final rule.
Likewise, having both a fully sprinklered facility and battery-
operated smoke alarms in resident rooms and common areas will duplicate
fire safety efforts. Sprinklers are considered to be the best way to
protect building occupants in fires. Their response time and their
ability to extinguish fires before they become a significant hazard
will make battery-operated smoke alarms an unnecessary requirement.
Facilities may still choose to use smoke alarms as an additional layer
of fire protection beyond sprinklers, but they will not be required to
do so in this final rule.
III. Analysis of and Responses to Public Comments
We received 11 timely public comments in response to the March 2005
publication of the interim final rule with comment period. We received
comments from Federal government officials, State government officials,
health care providers and provider organizations, other national
organizations, and private industry. A summary of the comments and our
responses follows.
A. Alcohol-Based Hand Rubs
Comment: One commenter stated that chapters 18.3.2.7 and 19.3.2.7
of the 2000 edition of the LSC refer to rooftop heliports.
Response: The Tentative Interim Amendment (TIA) 00-1 (101) amended
the 2000 edition of the LSC. One result of this amendment was that
chapters 18 and 19 of the 2000 edition of the LSC were slightly
renumbered. Under the new numbering scheme, chapters
[[Page 55331]]
18.3.2.7 and 19.3.2.7 of the 2000 edition of the LSC now refer to the
placement of ABHRs in egress corridors.
Comment: Several commenters stated their support for CMS' adoption
of the TIA permitting ABHR dispensers to be installed in egress
corridors as a means of decreasing the risk of transmission of health
care associated infections, while one commenter disagreed with CMS'
decision. The commenter who disagreed considers ABHR dispensers to
potentially be a significant fire risk and stated that adopting the TIA
sets a dangerous precedent for allowing other flammable solutions to be
placed in exit corridors.
Response: We appreciate the support that we have received regarding
the placement of ABHR dispensers in egress corridors. We believe that
ABHRs are an important tool that health care facilities should have at
their disposal to help minimize the risk of the transmission of health
care associated infections. We agree that making ABHR dispensers
available in highly visible and convenient locations such as corridors
will likely increase their rate of usage.
At the same time, we understand that there are concerns regarding
the safety of placing ABHR dispensers in egress corridors. The fire
modeling study conducted by Gage-Babcock & Associates, Inc.
demonstrated that installing ABHR dispensers in egress corridors can be
done in a way that does not dramatically increase the threat of fire in
these areas. The manner in which the dispensers are installed (that is,
in a 6-feet-wide corridor and at least 4 feet apart) minimizes the
potential fire safety risk associated with the dispensers. We adopted
all of the technical installation requirements recommended by the NFPA,
and we added other installation requirements related to other non-fire
safety risks. We believe that all of these requirements will provide
for a safe patient care environment while allowing health care
providers the flexibility to address infection control concerns in a
manner they see fit.
Any lingering fire safety concerns are, we believe, outweighed by
the strong body of evidence that demonstrates that ABHRs are an
effective hand hygiene tool and that their use has a positive impact on
infection control practices. Healthcare-associated infections pose an
imminent threat to patient health and safety, and we believe that all
steps should be taken to prevent and control such infections.
Comment: A few commenters expressed their concern with the LSC TIA
language which states that, ``The dispensers shall not be installed
over or directly adjacent to an ignition source.'' The commenters
requested that we define the term ``adjacent to'' and that we describe
the ``adjacent to'' relationship between ABHR dispensers and palm
readers and time clocks.
Response: The NFPA does not define a specific distance for the term
``directly adjacent to'' when discussing flammable substances and
potential ignition sources. If the NFPA were to define this term at a
later date, we would consider using their definition. In the absence of
a clear definition from the NFPA, we believe that the term ``directly
adjacent to'' means that ABHR dispensers should not be placed in close
proximity to an electrical source. We would expect that facilities
would not install dispensers next to or directly over electrical
outlets or equipment. Rather than installing dispensers next to an
electrical device such as an employee palm reader or time punch clock
in order to encourage the use of ABHRs before or after touching these
devices, facilities may choose to install them on other walls, near
doorways, or other appropriate areas as permitted by this rule.
Comment: Several commenters stated that CMS should not defer to
State or local codes that prohibit or otherwise restrict the placement
of ABHR dispensers in health care facilities. One commenter agreed that
State and local jurisdictions have the right to retain stricter codes.
The commenters who disagreed with the deferral to State and local codes
indicated that the potential infection control benefits of ABHRs should
take precedence over any State or local codes that would prohibit or
restrict ABHR dispenser placement.
Response: Health care facilities that participate in the Medicare
and Medicaid programs are required to comply with Federal, State, and
local laws, regulations, and codes. For some facility types, this
requirement is explicitly stated in the applicable Conditions of
Participation. For other facility types, this requirement stems from
the requirement that facilities must be licensed by the State in which
they function if the State has such licensure requirements.
In this particular situation, we believe that whichever code is the
most stringent (with respect to fire protection) is the one that
facilities should be required to meet. States and local jurisdictions
are the most attuned to the particular needs of their populations and
have the right to decide how to best meet those needs. If State or
local jurisdictions have chosen to use codes that are more restrictive
in regards to the placement of ABHR dispensers, then facilities must
meet those codes.
Comment: One commenter stated that TIA stands for Tentative Interim
Amendment rather than Temporary Interim Amendment.
Response: We appreciate the correction and have adjusted our
terminology as needed throughout the preamble and regulation.
Comment: One commenter noted that ambulatory surgical centers
(ASCs) are covered under both chapters 20 and 21 of the LSC, rather
than only under chapter 21 as stated in the preamble of the interim
final rule. The same commenter also questioned whether or not ASCs are,
like other health care providers, required to have at least 6-feet-wide
corridors in order to install ABHR dispensers in those corridors.
Response: We appreciate the correction and have adjusted the
preamble discussion to reflect the fact that Chapter 20 applies to
newly constructed ASCs while Chapter 21 applies to existing ASCs.
In the interim final rule, we permitted ASCs to install ABHR
dispensers in egress corridors in accordance with the technical
specification of the TIA, even though the LSC chapters for ASCs were
not amended. We did this because the evidence supporting the safety and
effectiveness of ABHRs in corridors equally supports their installation
in health care occupancies and ASCs.
We understand that ASCs may not be able to meet all of the
technical specifications for installing ABHR dispensers in egress
corridors, particularly the requirement that corridors must be at least
6 feet wide. However, the 6-feet-wide minimum corridor requirement is
considered to be an essential fire safety precaution. Narrowing the
corridor requirement would, according to the fire modeling study
evidence presented by Gage-Babcock, likely increase the fire-related
risk of these dispensers. Chapters 20 and 21 of the 2006 edition of the
LSC allow ABHR dispensers in egress corridors, provided that those
dispensers and corridors meet the same technical specifications as for
health care occupancies, including having minimum 6-feet-wide
corridors.
Comment: A few commenters commended CMS for addressing the
potential ``slip/fall'' and misuse hazard potentials of ABHRs. These
commenters agreed that these hazard potentials are legitimate concerns
that CMS should address since they were not the focus of the TIA.
However, one commenter stated that, while addressing a necessary
component of safety, CMS should delete the requirement that facilities
must install ABHR dispensers in a manner
[[Page 55332]]
that minimizes leaks and spills that could lead to falls. The commenter
stated that this requirement goes beyond the requirements of the LSC
amendment and that installation would not necessarily ``prevent leaks
and spills.'' The commenter went on to state that long term care
facilities are already required in regulation to maintain an
environment that is as free of accident hazards as is possible. The
commenter did not cite similar regulations for other provider types.
Response: We agree that addressing all aspects of ABHR dispenser
placement is a necessary component of ensuring that patients and
residents receive care in a safe environment. As stated in the preamble
of the interim final rule, we believe that steps can and should be
taken during the installation process to minimize leaks and spills that
could lead to falls. Facilities may choose a variety of installation
options such as drip cups or other devices and techniques to address
this area of concern. We understand that taking the necessary steps to
minimize leaks and spills, as required by the interim final rule, does
not necessarily mean that ABHR-related falls will be completely
prevented.
We acknowledge that long term care facilities are already required
in the Conditions of Participation to address accident hazards.
Addressing leak and spill possibilities during the installation process
should help these facilities meet the existing requirement that they
maintain environments that are as free of accident hazards as is
possible.
Comment: One commenter questioned whether facilities that had
already installed nonconforming ABHR dispensers in egress corridors
would be allowed to keep those dispensers in place.
Response: ABHR dispensers installed in corridors must be installed
in accordance with the technical specifications of chapters 18.3.2.7
and 19.3.2.7 as well as the additional specifications included in this
final rule. If a facility were to have ABHR dispensers in its corridors
that did not meet our specifications, then that facility would be out
of compliance with the applicable fire safety standard. Such a facility
would be expected to remove and/or relocate the improperly installed
ABHR dispensers. The facility could choose to have ABHR dispensers in
areas other than corridors or the facility could choose to re-install
their dispensers in corridors in accordance with this rule. However, we
do not anticipate that any Medicare or Medicaid participating facility
will face this situation. Until March 25, 2005 when the interim final
rule was published, all Medicare and Medicaid participating facilities
were prohibited from installing ABHR dispensers in egress corridors
under any circumstances. Therefore, we would not expect that there
would be many instances of facilities installing ABHR dispensers that
were out of compliance with our rules.
Comment: One commenter observed that the requirement that
facilities install ABHR dispensers in a manner that adequately protects
against access by vulnerable populations lacks specificity. The
commenter suggested that language be added to the regulation stating
that vulnerable populations are determined by the facility's clinical
staff.
Response: We agree that the term ``vulnerable populations'' is too
general. We have removed this term. However, we continue to believe
that protecting against inappropriate access to minimize the potential
for misuse of ABHRs is an appropriate goal of the Conditions of
Participation. Therefore, we have revised the regulatory text to read,
``The dispensers are installed in a manner that adequately protects
against inappropriate access.''
Comment: One commenter noted that CMS did not require facilities to
maintain their ABHR dispensers and noted that, without such
maintenance, the devices may pose an increased risk.
Response: We agree that proper maintenance of ABHR dispensers is an
essential step toward ensuring that ABHR dispensers are, and continue
to be, safe. To that end, we have added a new requirement at Sec.
403.744(a)(4)(v), Sec. 416.44(b)(5)(v), Sec. 418.100(d)(6)(v), Sec.
460.72(b)(5)(v), Sec. 482.41(b)(9)(v), Sec. 483.70(a)(6)(v), Sec.
483.470(j)(7)(ii)(E), and Sec. 485.623(d)(7)(v) that facilities that
choose to install ABHR dispensers must maintain those dispensers in
accordance with dispenser manufacturer guidelines. If there were no
manufacturer guidelines, we would expect facilities to have their own
ABHR dispenser maintenance policies and procedures.
Comment: One commenter noted that there are other products
available that fulfill the same purpose as ABHRs, but do not pose the
flammability risk that ABHRs do. The commenter contended that the
availability of these other products makes the TIA unnecessary.
Response: We support allowing health care facilities a wide variety
of safe options to use in their efforts to improve infection control
practices. Facilities can choose to use hand hygiene products based on
their unique characteristics, and those products may or may not contain
flammable substances like alcohol. Facilities are encouraged to examine
all of the infection control options that are available to them. We
believe that, as long as hand hygiene products like ABHRs can be safely
used under certain specified conditions, the Conditions of
Participation for Medicare and Medicaid providers should not
unnecessarily impede their use.
B. Smoke Alarms
Comment: Many commenters noted that the proper term for the device
that we described in the preamble is ``single station smoke alarm''
rather than ``smoke detector.'' One commenter went on to note that the
proper term for the smoke detection system that we described in
exception one is ``system-based smoke detectors'' rather than
``hardwired smoke detection system.''
Response: We agree with this comment that the proper terms are
``single station smoke alarm'' and ``system-based smoke detectors,''
and we have made the appropriate changes in both the preamble of this
document and in the regulations text located at Sec. 483.70(a)(7).
Comment: Several commenters expressed concern regarding the extent
of the inspection, testing, and maintenance program that is expected.
The commenters suggested that it may be difficult for CMS to judge
compliance with this standard without further guidance. The commenters
requested that CMS reference a specific edition of NFPA 72, National
Fire Alarm Code, as the standard for installing, testing, and
maintaining battery-operated single station smoke alarms and smoke
detection systems in long term care facilities as discussed in Sec.
483.70(a)(7). The commenters suggested that NFPA 72 would establish the
extent and frequency of the necessary inspection, testing, and
maintenance activities for smoke alarms.
Response: National Fire Protection Association publication 72,
National Fire Alarm Code, has extensive installation, inspection,
testing, and maintenance requirements for a variety of facility and
system types. We agree that it is a very useful resource that
facilities should consult when installing, inspecting, testing, and
maintaining their smoke alarms.
However, we do not believe that requiring facilities to comply with
the many standards within NFPA 72 is appropriate in this regulation.
The NFPA standards require significant amounts of documentation that
may not all be necessary for this minimum requirement. In addition,
NFPA 72 has very specific qualifications for those
[[Page 55333]]
individuals who are eligible to inspect, test, and maintain smoke
alarms in health care facilities. General facility maintenance
personnel may not meet these high qualifications, which may force such
facilities to hire or contract with additional personnel. This would
unnecessarily increase the burden of this minimum provision.
Therefore, we will not require long term care facilities to comply
with NFPA 72. At the same time, we encourage facilities to refer to
NFPA 72 for technical guidance when establishing their own policies and
procedures for inspecting, testing, and maintaining battery-operated
single station smoke alarms. We believe that NFPA 72 can be used in
conjunction with manufacturer recommendations to develop a
comprehensive, facility-specific maintenance program.
Comment: A few commenters questioned the role that AC powered
single station smoke alarms may play in long term care facilities.
Specifically, the commenters wanted CMS to clarify that AC powered
(also known as hard-wired) single station smoke alarms are acceptable
in place of battery-operated smoke alarms. One commenter also wanted
CMS to add a specific exception for facilities that have AC powered
single station smoke alarms in resident rooms and common areas, similar
to the exceptions for fully sprinklered buildings and buildings with
system-based smoke detectors.
Response: Battery-operated single station smoke alarms are,
according to this regulation, the minimum fire safety devices that a
facility must install in resident rooms and common areas. Facilities
may choose to go beyond this minimum requirement by installing AC
powered single station smoke alarms in the specified areas. We do not
believe that it is necessary to add a specific exception for facilities
that choose AC powered single station smoke alarms, because we state
that battery-operated single station smoke alarms are the minimum
requirement. Since AC powered single station smoke alarms are
equivalent to, if not superior to, battery-operated single station
smoke alarms, they would meet the minimum requirement.
If facilities choose to go beyond the minimum requirement by
installing AC single station smoke alarms, they may choose to install
AC powered single station smoke alarms in all areas, or they may choose
to use a combination of AC powered and battery-operated single station
smoke alarms. For example, a facility may have system based smoke
detectors in corridors, AC single station smoke alarms in other common
areas such as activity rooms and battery-operated single station smoke
alarms in resident rooms. This combination of alarms and detectors is
acceptable because all three fire safety device types meet the minimum
requirement of at least having battery-operated single station smoke
alarms in all common areas and resident rooms.
Regardless of the type of alarm or combination thereof that a
facility chooses to use, the facility will still be required to ensure
that at least battery-operated single station smoke alarms are
installed in all resident rooms and common areas.
Comment: One commenter stated that battery-operated smoke alarms
with 10-year batteries would not require the annual battery replacement
schedule that we described in the regulatory impact statement section
of the interim final rule. Another commenter stated that the bi-annual
or annual battery replacement schedule that we described should be
mandatory for all facilities.
Response: In the interim final rule, Sec. 483.70(a)(7)(ii)
requires facilities to have a program for testing, maintenance and
battery replacement. In the preamble to this final rule, we state that
this program should be in accordance with manufacturer recommendations.
We expect that this program would be included in the facility's own
policies and procedures. Also in the preamble, we estimate that an
average facility's program would provide for annual battery
replacement.
However, as one commenter suggested, facilities may choose to use
long life batteries. In that case, we would expect that the facility's
program for testing, maintenance, and battery replacement would be in
accordance with the smoke alarm manufacturer and battery manufacturer
recommendations for testing, maintenance, and battery replacement of
long life batteries. If the program's replacement schedule, as
described in the facility's own policies and procedures, was longer
than our estimate of annual replacement because the manufacturers'
recommendations were longer, then the longer battery replacement
schedule would be acceptable.
Due to the variability of battery life and smoke alarm life, we
believe that requiring facilities to conform their maintenance
schedules to manufacturer recommendations rather than to imposed
timeframes is the most effective and flexible regulatory option at this
time.
Comment: In response to our request for public comment, a few
commenters recommended that long term care facilities not be required
to install smoke alarms in areas other than resident rooms and common
areas. The commenters cited two reasons for not installing smoke alarms
in other areas such as storage rooms, closets and office spaces. Those
reasons are:
No other national consensus codes or standards require
smoke alarms in these areas; and
Since 1972 there has never been a multiple death fire that
originated in one of these other areas.
Another commenter, however, recommended that smoke alarms should be
required in non-public areas as well as common areas and resident
rooms.
Response: For the reasons cited by the commenters, we agree that
installing moke alarms in other areas such as closets and offices in
long term care facilities is not necessary. Therefore, we are not
requiring facilities to install smoke alarms beyond resident rooms and
common areas. However, if a long term care facility chose to install
smoke alarms in these additional areas, there is nothing in this
regulation to prohibit this practice.
Comment: One commenter contested a statement in the preamble to the
interim final rule that said, ``The lack of smoke detectors in resident
rooms, the report concludes, `* * * may have delayed staff response and
activation of the building's fire alarms.' '' The commenter stated that
there was no evidence of a delayed staff response in the Hartford fire
and that the resident accused of setting the fire summoned the nurse to
the room of origin before smoke reached the corridor.
Response: We appreciate the information provided by the commenter.
However, the information that we cited on both the Hartford and
Nashville fires came directly from the 2004 GAO report. The report
states that, ``In the Hartford fire, it is unclear whether the alarm
was first activated by the corridor smoke detector or manually by the
staff member who first attempted to extinguish the fire. According to
the Hartford fire department, the absence of smoke detectors in
resident rooms contributed to a delay of up to 5 minutes or more.''
We understand that there has been some disagreement regarding the
exact timeline of events in the Hartford fire. None of this
disagreement negates the fact that smoke alarms would have likely been
helpful in both the Hartford and Nashville fires.
Comment: A few commenters suggested that CMS either remove or
define the term ``public areas'' in relationship to the requirement
that long term care facilities must install smoke alarms in ``public
areas.'' Suggested
[[Page 55334]]
definitions included areas such as cafeterias, waiting rooms, lobby
areas, treatment rooms, activity rooms, and other meeting rooms. One
commenter suggested that the need to place smoke alarms in ``public
areas'' be addressed in the interpretive guidelines rather than in the
regulations. In addition, a few commenters suggested that CMS use the
term ``common areas,'' the term used in a Survey & Certification letter
(S&C-05-25) that further elaborated on this requirement, rather than
``public areas'' to describe these spaces.
Response: We believe that installing, at a minimum, single station
battery-operated smoke alarms in areas other than resident rooms is a
good idea. As stated in the preamble, fires can and do develop in other
areas. Having the minimum smoke alarms in these areas would provide
facility staff and residents earlier notice about the existence of the
fire, thus giving them more time to respond to the situation and
enabling earlier notification of local fire responders.
At the same time, we agree that the term ``common areas'' is a more
appropriate term for resident gathering areas as used in this
regulation, and we have made the appropriate changes throughout this
document.
We also agree that it would be helpful to include a definition of
this term in the definitions section of the long term care regulations.
Therefore, in the definitions section at Sec. 483.5, we have added the
following definition, ``Common area. Common areas are dining rooms,
activity rooms, meeting rooms where residents are located on a regular
basis, and other areas in the facility where residents may gather
together with other residents, visitors, and staff.'' This definition
is in accordance with the description of ``common areas'' in the Survey
& Certification letter cited above.
Comment: A few commenters suggested that CMS should require
facilities to install system-based smoke detectors in corridors that
directly serve resident sleeping and treatment rooms and one commenter
suggested that system-based smoke detectors should be installed in
resident rooms as well. The commenters indicated that it was important
that an alarm in one area of the building should notify staff at the
nursing station.
Response: The Medicare and Medicaid Conditions of Participation are
the minimum standards that providers must meet in order to participate
in the Medicare and Medicaid programs. We added the single station
battery-operated smoke alarm requirement on top of the requirements of
the 2000 edition of the Life Safety Code because we believe that these
smoke alarms are necessary in order to achieve an acceptable level of
fire safety. We specifically required smoke alarm installation in
resident rooms and common areas because these areas can be closed off,
thus impeding the ability of other residents or facility staff to
detect a fire situation. Behind closed doors fires can grow undetected.
Corridors, however, are highly trafficked areas that are open to other
areas and do not pose the same risk of undetected fire development and
growth. In addition, corridors are already protected by having smoke
detectors at smoke barriers to control the doors and activate a
facility's alarm system. Requiring facilities to secure additional
funds and undergo the construction process to install system-based
smoke detectors in corridors without the benefit of any significant
fire safety gains is, we believe, not the best option for long term
care facilities or their residents.
While we are not requiring facilities to do so, they are encouraged
to go beyond the minimum requirements of this rule by installing
system-based smoke detectors in resident rooms and common areas, either
as a stand-alone fire safety feature or in combination with battery-
operated single station smoke alarms. However, due to concerns about
the increased cost and time associated with installing system-based
smoke detectors in resident rooms and common areas, we are not, at this
time, requiring facilities to install system-based smoke detectors in
any section of their building.
Comment: One commenter stated that CMS incorrectly described the
way that system-based smoke detectors function. The commenter stated
that system-based smoke detectors, rather that causing each other to
sound, cause the facility's general building fire alarm system to
sound. The commenter also stated that the detectors themselves are not
equipped with a battery to use as a back-up power supply. Rather, the
detectors are connected to the fire alarm control panel, which has a
back-up power supply.
Response: We appreciate this clarification of the mechanics of
system-based smoke detectors and have clarified our description of
their function in the preamble of this rule.
Comment: One commenter suggested that CMS clarify in the preamble
text that, in order to be exempt from installing, at a minimum,
battery-operated single station smoke alarms, a facility's sprinkler
system must meet the requirements of the publication NFPA 13, Standard
for the Installation of Sprinkler Systems.
Response: We agree that the preamble should be clear that in order
for a facility to qualify for an exception to this rule it must be
fully sprinklered in accordance with NFPA 13, as stated in the
regulation. We thank the commenter for suggesting this area for further
clarification of our intent.
Comment: A few commenters expressed support for installing smoke
alarms in resident rooms and common areas and one commenter indicated
that long term care facilities required financial assistance from CMS
in order to install these minimum devices.
Response: We appreciate the commenters' support of these minimum
fire safety requirements and understand that there is a cost associated
with installing smoke alarms. We estimated in the interim final rule
that an average size facility would spend $7,000 to purchase and
install battery-operated single station smoke alarms in resident rooms
and common areas. This is less than one half of one percent of the
total revenue for an average or small facility. In light of this
information, we believe that purchasing and installing battery-operated
single station smoke alarms is of minimal cost to affected facilities.
To mitigate even this minimal cost, we also allowed affected
facilities one year from the effective date of the interim final rule
to comply with the installation requirement. We believe that these two
factors make it unnecessary for us to provide financial assistance to
aid in the purchase and installation of smoke alarms in affected
facilities.
Comment: A few commenters stated that the one year phase-in period
for installing at least battery-operated single station smoke alarms
was unnecessarily long. The commenter suggested that a 90-day phase-in
period would be a more appropriate length of time due to low purchase
costs and easy installation. Another commenter requested that CMS allow
long term care facilities an additional 180 days to comply with the
smoke alarm requirement if they have signed contracts and funding in
place to fully sprinkler their buildings in accordance with NFPA 13.
Response: We agree that facilities that choose to comply with the
minimum requirement, which is installing battery-operated single
station smoke alarms, should be able to purchase and install the alarms
in less that one year's time. These devices increase the level of fire
safety above what is required in the 2000 edition of the LSC. Alarms
can be a primary fire safety goal or they can be an interim part of a
facility's long term
[[Page 55335]]
plan to upgrade to sprinklers. That is, facilities that anticipate that
fully upgrading to a more sophisticated fire protection system such as
sprinklers would take more than one year would use smoke alarms during
the installation period as an immediate fire safety improvement. Since
we have already provided for a one year phase-in period, extending this
phase-in period for an additional 180 days does not seem prudent.
Comment: One commenter requested that CMS choose either the term
``fully sprinklered'' or the term ``sprinklered throughout the
facility'' to describe the type of facility that is exempt from having
to install at least battery operated single station smoke alarms in
resident rooms and common areas. The commenter also requested that CMS
define whichever term we choose to use in the regulation.
Response: We agree that a single term should be used to describe a
facility's sprinkler status. Therefore, we are using the term ``fully
sprinklered'' from the Survey & Certification memo discussed above
(S&C-05-25). In addition, we have added the definition of ``fully
sprinklered'' from the memo to the definitions section on the long term
care regulations at new Sec. 483.5(e). The definition is, ``Fully
sprinklered. A fully sprinklered long term care facility is one that
has all areas sprinklered in accordance with National Fire Protection
Association 13 `Standard for the Installation of Sprinkler Systems'
without the use of waivers or the Fire Safety Evaluation System.''
Comment: One commenter recommended that facilities should be
encouraged or required to use dual sensor smoke alarms that can quickly
detect slow burning smoldering fires as well as fast burning flaming
fires. The commenter stated that these detectors would enhance fire
safety with only a small increase in cost.
Response: The Medicare and Medicaid Conditions of Participation are
the minimum standards that providers must meet in order to participate
in the Medicare and Medicaid programs. We added the single station
battery-operated smoke alarm requirement on top of the requirements of
the 2000 edition of the Life Safety Code because we believe that these
smoke alarms are necessary in order to achieve an acceptable level of
fire safety. Therefore, we have decided not to require dual sensor
alarms in this rule, but would consider requiring them in the future.
However, facilities are free to go beyond the minimum requirements
of this rule by installing dual sensor alarms. We agree that these
alarms would enhance fire safety, potentially saving lives and reducing
the loss of property by notifying staff and residents of a fire
situation at the earliest possible time.
Comment: A few commenters stated that CMS should require long term
care facilities to have both smoke alarms and sprinklers. The
commenters indicated that smoke alarms and sprinklers serve different
fire safety functions, and that smoke alarms respond sooner than
sprinklers. However, another commenter suggested that CMS should insert
language into the regulation that would explicitly allow the removal of
smoke alarms in long term care facilities once those facilities are
fully sprinklered.
Response: Facilities that are fully sprinklered would qualify for
exception from this rule; fully sprinklered facilities may forgo having
and maintaining battery-operated single station smoke alarms. This
means that once a facility becomes fully sprinklered in accordance with
NFPA 13, it is no longer required by this regulation to keep its smoke
alarms.
The 2004 GAO report only indicated that we should strengthen the
fire safety requirements for long term care facilities that do not have
sprinklers. The purpose of this rule is to implement this GAO
recommendation.
C. Other Areas of Comment
Comment: A few commenters expressed support for CMS requiring all
long term care facilities to be fully sprinklered with an appropriate
(3- to 5-year) phase-in period. One commenter indicated that the 2006
edition of the LSC is slated to require the installation of automatic
sprinkler systems in all existing nursing homes. According to the
commenters, major constituency groups such as the American Healthcare
Association, the National Citizens' Coalition for Nursing Home Reform,
and the International Fire Marshals Association are supporting this
change.
Response: We appreciate the support and the information that the
commenter provided. We are carefully examining the sprinkler
requirement and phase-in period issues and expect to issue a proposed
rule in the near future.
Comment: One commenter suggested that CMS should incorporate the
International Fire Code, published by the International Code Council,
into the long term care facility regulations.
Response: We continue to specifically cite the LSC because under
sections 1819(d)(2)(B) and 1919(d)(2)(B) of the Social Security Act,
nursing homes must meet the provisions of ``such edition (as specified
by the Secretary in regulation) of the Life Safety Code of the National
Fire Protection Association * * *.'' However, if a State's own fire and
safety code would ``adequately protect patients'' and the State code is
imposed by State law, the State may submit a request in writing to
substitute its fire safety code for the LSC to its CMS regional office.
The CMS regional office will forward the request to CMS central office.
The CMS central office will make a final decision on whether the State
code may be used in place of the LSC.
IV. Provisions of the Final Regulations
For the most part, this final rule confirms the provisions of the
March 25, 2005 interim final rule. Those provisions of this final rule
that differ from the interim final rule are as follows:
A. Alcohol-Based Hand Rubs
1. In response to public comments, we are revising the third
requirement in the list of specifications that a facility must meet in
order to install ABHR dispensers in egress corridors. In the interim
final rule we required, ``The dispensers are installed in a manner that
adequately protects against access by vulnerable populations.'' In this
final rule, we require ``The dispensers are installed in a manner that
adequately protects against inappropriate access.'' The revised
requirement eliminates the unclear term ``vulnerable populations''
while achieving the same goal of ensuring that ABHRs are not misused in
a manner that may cause harm to individuals or property.
2. Also in response to public comments, we are adding a requirement
that ``The dispensers are maintained in accordance with dispenser
manufacturer guidelines.'' If there were no manufacturer guidelines, we
expect facilities to have their own ABHR dispenser maintenance policies
and procedures. Regular maintenance is a crucial step towards ensuring
that the dispensers do not leak or spill. Having a maintenance program
will help ensure that the dispensers are functioning properly and that
any malfunctions are addressed in a timely manner. Following
manufacturer guidelines will help ensure that maintenance is properly
performed in a manner that will help, rather than hinder, the
facility's goal of having properly functioning dispensers.
3. We have removed the statement ``If any additional changes are
made to this amendment, CMS will publish notice in the Federal Register
to announce the changes'' because we believe that this
[[Page 55336]]
statement is not necessary. The term ``notice'' refers to the notice-
and-comment rulemaking process that CMS undergoes to amend the
conditions of participation for health care providers. Any substantive
changes to the conditions of participation are already required to go
through the normal notice-and-comment rulemaking procedures. Since
notice-and-comment rulemaking is the standard procedure for amending
regulations, we do not believe that this statement is needed.
B. Smoke Alarms
1. We are altering the terminology used to describe the smoke
detector requirement. Throughout this document, we are referring to the
following terms in the manner specified below unless otherwise noted:
``Smoke detectors'' are now ``smoke alarms'';
``Public areas'' are now ``common areas'';
Having ``sprinklers installed throughout'' is now ``fully
sprinklered''; and
``A hard-wired smoke detection system'' is now ``system-
based smoke detectors.''
All of these terminology changes were made in response to public
comments.
2. In addition to altering the terminology used to describe the
smoke alarm requirement, we are adding definitions for the terms
``common areas'' and ``fully sprinklered'' to the definitions section
of the regulation. New Sec. 483.5(d) and (e) will provide facilities
with more explicit guidance about where smoke alarms must be installed
and about what requirements their buildings must meet in order to
qualify for exception B of the smoke alarm requirement.
3. In the interim final rule, in Sec. 483.70(a)(7)(ii), we
required facilities to have a program for testing, maintenance, and
battery replacement to ensure the reliability of the smoke alarms. We
are modifying this requirement to be more specific about the contents
of the inspection, testing, maintenance, and battery replacement
program. The revised requirement states that facilities must ``[h]ave a
program for inspection, testing, maintenance, and battery replacement
that conforms to the manufacturer's recommendations and that verifies
correct operation of the smoke alarms.'' Conforming to manufacturer
guidelines, coupled with our strong recommendation that facilities
should also incorporate, to the extent possible, the requirements of
NFPA 72, should help ensure that smoke alarms are consistently
functioning in top working order. We expect that this program would be
included in the facility's own policies and procedures.
V. Collection of Information Requirements
This document does not impose information collection and
recordkeeping requirements. Consequently, it need not be reviewed by
the Office of Management and Budget under the authority of the
Paperwork Reduction Act of 1995.
VI. Regulatory Impact Statement
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 Unfunded Mandates
Reform Act of 1995 (Pub. L. 104-4), and Executive Order 13132.
Executive Order 12866 (as amended by Executive Order 13258, which
merely reassigns responsibility of duties) 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).
We have examined the impact of this final rule, and we have determined
that this rule is neither expected to meet the criteria to be
considered economically significant, nor do we believe it will meet the
criteria for a major rule.
The RFA requires agencies to analyze options for regulatory relief
of small businesses. For purposes of the RFA, small entities include
small businesses, nonprofit organizations, and small government
jurisdictions. Most hospitals and most other providers and suppliers
are small entities, either by nonprofit status or by having revenues of
$6 million to $29 million in any 1 year. For purposes of the RFA, most
entities affected by this final rule are considered small businesses
according to the Small Business Administration's size standards, with
total revenues of $29 million or less in any 1 year (for details, see
65 FR 69432). Individuals and States are not included in the definition
of a small entity. According to CMS statistics, nursing facilities,
which we require to install at least battery-operated single station
smoke alarms in resident rooms and common areas, earned a total of
$89.6 billion in 1999 (http://www.cms.hhs.gov/statistics/nhe/historical/t7.asp
).
According to the National Nursing Home Survey: 1999 Summary (http://www.cdc.gov/nchs/data/series/sr_13/sr13_152.pdf
), there were 18,000
nursing facilities in operation at that time. An average facility at
this time thus had revenue of approximately $4,977,778. A facility with
revenue 50 percent below this average still earned $2,488,889. This
final rule will cost $2,800 annually for maintenance. This amount will
be less than one half of one percent of the total revenue for an
average- or below-average-revenue facility. There is no installation
cost associated with this final rule because, upon its effective date,
facilities will have already installed their smoke alarms in accordance
with the interim final rule. Therefore, we certify that this final rule
will not have a significant impact on a substantial number of small
entities. We are not considering hospitals or other facilities affected
by the alcohol-based hand rub regulation in this regulatory flexibility
analysis because we do not require those facilities to take any action.
We are requiring that, if those facilities choose to install ABHR
dispensers in egress corridors, then they will have to do so in
accordance with the regulation.
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. This
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 and has fewer than 100 beds. This final rule will not
have a significant impact on small rural hospitals because the final
rule will not impose requirements on small rural hospitals.
Section 202 of the Unfunded Mandates Reform Act of 1995 also
requires that agencies assess anticipated costs and benefits before
issuing any rule whose mandates require spending in any 1 year of $100
million in 1995 dollars, updated annually for inflation. That threshold
level is currently approximately $120 million. This rule will have no
consequential effect on State, local, or tribal governments or on the
private sector.
Executive Order 13132 establishes certain requirements that an
agency must meet when it promulgates a final rule that imposes
substantial direct requirement costs on State and local
[[Page 55337]]
governments, preempts State law, or otherwise has Federalism
implications. This regulation does not have any Federalism
implications.
B. Anticipated Effects
1. Alcohol-Based Hand Rubs
This final rule does not require an affected facility to install
ABHR dispensers; thus, the facility will not be mandated with a burden
associated with this provision of the regulation.
We, however, will require facilities that choose to install ABHR
dispensers to do so in accordance with chapters 18.3.2.7 and 19.3.2.7
of the 2000 edition of the LSC as amended by the TIA. Facilities will
have to install them in accordance with the LSC, and in a way that
minimized leaks and spills and inappropriate access. Installing
dispensers according to the specifications of the LSC and this
regulation may increase installation costs. Facilities that choose to
install dispensers are required by this regulation to take additional
steps to minimize dispenser leaks and spills. While this regulation
does not require a specific method for minimizing leaks and spills,
facilities may decide to install additional hardware to ensure
compliance with this regulation. Additional hardware, such as a device
below the dispenser to catch drips, could increase purchasing and
installation costs. The leak and spill minimization requirement is new;
therefore, we have no data to estimate the cost of the provision. We
believe that any additional costs are small when compared to the costs
of caring for a frail patient who fell on a slippery, ABHR-covered
floor.
In addition, the installation of these dispensers in egress
corridors was previously prohibited. Therefore, no facility should have
improperly installed ABHR dispensers in a manner that conflicts with
the provisions of this final rule. The requirements for locating
dispensers in other areas will not change. Therefore, a facility will
not have to relocate or modify existing dispensers to conform to the
specifications.
Facilities that choose to install ABHR dispensers in any area,
including corridors and patient rooms, are required by the LSC to store
large quantities of ABHR solution in a flammable liquids cabinet.
Facilities are required to use these cabinets if they choose to store 5
gallons or more of ABHR solution in a single smoke compartment. This
LSC requirement helps ensure that large amounts of ABHR solution do not
accelerate health care facility fires.
Most hospitals already have these cabinets to store other alcohol
products or flammables, and would therefore not need to purchase a
special storage container for ABHR solutions. Other facilities that may
choose to install ABHR dispensers are typically smaller than hospitals
and would not need to store more than 5 gallons of ABHR solution in a
single smoke compartment. A facility with 20 rooms per smoke
compartment will likely install 10 ABHR dispensers, for a total of 3
gallons of ABHR solution per smoke compartment. That same facility
would be permitted to keep an additional 2 gallons of ABHR solution for
refilling in that same compartment without using a flammable liquids
cabinet. Therefore, we do not believe that this LSC provision will pose
a significant burden to facilities that choose to install ABHR
dispensers.
Facilities that choose to install ABHR dispensers may expect to see
a decrease in health care acquired infections due to an increase in
hand hygiene practices by clinicians and non-clinicians. While we
cannot quantify the potential benefit of this decrease in infections,
we do know that decreasing infection rates lead to better patient care
outcomes and decreased patient care costs.
2. Smoke Alarms
As discussed in section VI.A of this section, Overall Impact,
affected facilities were required by the interim final rule to install,
at a minimum, battery-operated single station smoke alarms in resident
rooms and common areas by May 24, 2006. Since this date is close to the
date of publication of this rule, there is not an installation burden
associated with this final rule. There is, however, a maintenance
burden associated with this final rule. That burden is described below.
The July 2004 GAO report estimated that 20 to 30 percent of long-
term care facilities do not have sprinklers throughout the facility and
will therefore be subject to the provisions of this regulation. We do
not have information on the number of facilities that have system-based
smoke detectors in resident rooms and common areas. For the purposes of
our analysis, we estimated that 25 percent of long-term care
facilities, or 4,200, will be subject to the provisions of this
regulation. We estimate that an average long-term care facility in a
building that does not have sprinklers has 100 residents in 50 two-
person resident sleeping rooms, based on data from our Online Survey
Certification and Reporting System. In addition, we estimate that each
room will require one battery-operated single station smoke alarm. We
estimate that each average facility requires 20 additional alarms for
common areas, for a total of 70 alarms per facility.
Table 1.--Number of Smoke Alarms
------------------------------------------------------------------------
Number of
alarms
------------------------------------------------------------------------
Per Facility............................................... 70
Nationwide................................................. 378,000
------------------------------------------------------------------------
Formulas:
50 alarms in resident rooms + 20 alarms in common areas =
70 total alarms per average facility x 4,200 affected facilities =
378,000 total alarms nationwide
Following installation of battery-operated single station smoke
alarms in the specified areas, a long-term care facility will be
required to have a program that conforms to manufacturer
recommendations for testing, maintenance, and battery replacement that
verifies the correct operation of the smoke alarms. We estimate that a
facility will conduct monthly tests of each smoke alarm by activating
the test button. This will take approximately 5 minutes per smoke alarm
per test, or 1 hour per smoke alarm per year.
In addition, we estimate that a facility will clean each smoke
alarm and change its batteries two times per year. Based on the time
necessary to remove dust and debris from the smoke alarm, as well as
the time necessary to remove old batteries and properly insert new
ones, we estimate that this maintenance task will take 15 minutes per
smoke alarm per cleaning and replacement, or 30 minutes per smoke alarm
per year. We estimate that the total annual maintenance time per smoke
alarm will be 1.5 hours, for a total of 105 hours per average facility.
We estimate that the cost for this provision for an average long-
term care facility with 70 smoke alarms, based on a maintenance person
earning $20 per hour (salary from May 2003 National Occupational
Employment and Wage Estimates, http://www.bls.gov/oes/2003/may/oes_37Bu.htm
plus 30 percent fringe benefits) and $5 for batteries per
change, is $2,800. The annual industry total for this maintenance
provision will thus be $11,760,000.
[[Page 55338]]
Table 2.--Smoke Alarm Maintenance Time and Costs
------------------------------------------------------------------------
Time (hours) Cost
------------------------------------------------------------------------
Maintenance per detector................ 1.5 $40
Maintenance per facility................ 105 2,800
Maintenance nationwide.................. 441,000 11,760,000
------------------------------------------------------------------------
Formulas:
5 minutes per test per alarm x 12 tests per year per alarm
= 1 hour per year per alarm for testing x 70 alarms per facility = 70
hours per year per facility for tests x 4,200 affected facilities =
294,000 hours per year nationwide for tests
15 minutes per cleaning and battery change per alarm x 2
cleanings and battery changes per year = 30 minutes per alarm for
cleaning and battery changes x 70 alarms = 35 hours per facility for
cleaning and battery changes x 4,200 affected facilities = 147,000
hours nationwide for cleaning and battery changes
1 hour per year per alarm for testing + 30 minutes per
alarm for cleaning and battery changes (sum of the two 15-minute
cleaning and battery changes described above) = 1.5 hours per year per
detector for maintenance and testing x 70 detectors per facility = 105
hours per year per facility for maintenance and testing x 4,200
affected facilities = 441,000 hours nationwide for maintenance and
testing
1.5 hours per year per detector for maintenance and
testing x $20 per hour = $30 per alarm + $10 for battery replacement =
$40 per alarm for maintenance, testing and battery replacement per
alarm x 70 alarms per facility = $2,800 per facility for maintenance,
testing and battery replacement of alarms x 4,200 affected facilities =
$11,760,000 nationwide for maintenance, testing and battery replacement
of alarms
C. Alternatives Considered
1. Alcohol-Based Hand Rubs
We considered not adopting chapters 18.3.2.7 and 19.3.2.7 of the
2000 edition of the LSC as amended by the TIA, thereby continuing to
prohibit the placement of ABHR dispensers in egress corridors. However,
continuing this prohibition was not acceptable for two reasons. First,
we want to improve hand hygiene practices in order to reduce health-
care-acquired infections. Hand hygiene levels increase when the
availability of hygiene stations increases, including stations that
dispense ABHRs. It is helpful to have these stations in areas that are
highly visible and easily accessed, as they are in corridors.
Therefore, the potential to increase hand hygiene and thus decrease
health care acquired infections by placing ABHR dispensers in all
appropriate locations warranted this regulation.
Second, continuing to prohibit ABHR dispensers in egress corridors
is contrary to our goal of increasing provider flexibility. We believe
that, wherever possible, providers should be allowed the flexibility to
meet the needs of their patients/residents in the manner that meets the
facility's needs. Providers are aware of the hazards posed by
infections and have developed many methods for addressing those
hazards. The ABHR dispensers are one method, and we believe that
providers should be allowed to utilize the ABHR dispensers to the
fullest extent within the context of patient safety.
We also considered adopting chapters 18.3.2.7 and 19.3.2.7 of the
2000 edition of the LSC without the additional requirements. However,
the chapters do not address several important areas of patient safety
such as the potential for slips and falls on slippery, ABHR-coated
floors and the potential for the misuse of ABHR solutions. We believe
that not addressing these areas may put patient safety at risk. The
NFPA is dedicated to reducing loss of life due to fires. As such, it
concerned itself solely with the fire safety implications of installing
ABHR dispensers in egress corridors. Chapters 18.3.2.7 and 19.3.2.7 of
the 2000 edition of the LSC did not address leaks and spills that will
result in people slipping and falling, nor did they address the
potential for inappropriate use of ABHRs. Due to disability or illness,
certain populations require additional protection from substances that
are toxic and flammable. The ABHRs are both toxic and flammable.
Chapters 18.3.2.7 and 19.3.2.7 of the 2000 edition of the LSC did not
address these non-fire safety issues. Therefore, we believe that it is
necessary to add other installation requirements in addition to
chapters 18.3.2.7 and 19.3.2.7 of the 2000 edition of the LSC.
2. Smoke Alarms
We considered not requiring long-term care facilities to install
smoke alarms, thus maintaining the existing fire safety regulations
that required facilities to only meet the standards of the 2000 edition
of the Life Safety Code. Maintaining the existing requirements would
have left decisions regarding more stringent fire safety measures in
the hands of State and local governments. State and local governments
have, in the past, made very different decisions about fire safety
requirements in long-term care facilities. For example, some States,
such as Tennessee and Virginia, already require all long-term care
facilities to have sprinklers throughout their buildings. In contrast,
other states, such as Arkansas and Nebraska, do not have such
requirements, resulting in 25 percent or more of their long-term care
facilities completely lacking sprinklers. The same State-to-State
variability that is seen in sprinkler requirements would likely be seen
in smoke alarm requirements. This level of variability is not
acceptable to us because we believe that residents of long-term care
facilities should be assured the same minimum level of fire safety
regardless of what State or locality they reside in. Federal regulation
is the most efficient and expedient manner for achieving the goal of
uniform nationwide minimum fire safety standards; therefore, we chose
to pursue Federal regulation rather than depending on State and local
governments.
In addition to pursuing Federal regulation in this area, we chose
to require smoke alarms because we believe that their installation will
help save lives. The July 2004 GAO report clearly outlined the role
that smoke alarms, one of the most basic and effective fire safety
devices available, did or did not play in the Nashville and Hartford
fires. The report also outlined the wider role that alarms can and
should play in long-term care facility fire safety. The positive impact
of smoke alarms on resident safety, we believe, warrants their
installation.
We also considered requiring long-term care facilities to install
system-based smoke detectors in accordance with NFPA 72, National Fire
Alarm Code, for system-based smoke detectors. System-based detectors
must be wired directly into the facility's electrical and fire alarm
system. This option would have likely required a longer phase-in period
to accommodate the increased
[[Page 55339]]
time and cost associated with installing this type of system. A longer
phase-in period would have delayed our ability to quickly increase the
level of fire safety in long term care facilities.
Therefore, in order to quickly increase the level of fire safety in
long term care facilities, we are requiring only the less expensive and
less time consuming battery-operated single station smoke alarm.
Facilities may still choose to install system-based smoke detectors,
and we encourage them to do so. Installation of such a system in
resident rooms and common areas will exempt a facility from installing
battery-operated single station smoke alarms in those areas.
Finally, we considered requiring long-term care facilities that do
not have sprinklers to install them. We are aware that the NFPA and
long-term care industry are carefully examining this issue in light of
the recent fires. We are also aware that installing sprinklers in
existing facilities is an expensive proposition. We are currently
examining this issue. We are committed to working with NFPA, the long-
term care facility industry, and advocates to develop a consensus
position. Facilities may still choose to become fully sprinklered in
accordance with NFPA 13. Installation of sprinklers will exempt a
facility from installing battery-operated single station smoke alarms
in resident rooms and common areas. We encourage all facilities to
fully explore this option, as it provides the highest level of fire
protection currently available.
D. Conclusion
For these reasons, we are not preparing analyses for either the RFA
or section 1102(b) of the Act because we have determined 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 hospitals.
In accordance with the provisions of Executive Order 12866, this
regulation was reviewed by the Office of Management and Budget.
List of Subjects
42 CFR Part 403
Grant programs--health, Health insurance, Hospitals, Incorporation
by reference, Intergovernmental relations, Medicare, Reporting and
recordkeeping requirements.
42 CFR Part 416
Health facilities, Incorporation by reference, Kidney diseases,
Medicare, Reporting and recordkeeping requirements.
42 CFR Part 418
Health facilities, Hospice care, Incorporation by reference,
Medicare, Reporting and recordkeeping requirements.
42 CFR Part 460
Aged, Health care, Health records, Incorporation by reference,
Medicaid, Medicare, Reporting and recordkeeping requirements.
42 CFR Part 482
Grant programs--health, Hospitals, Incorporation by reference,
Medicaid, Medicare, Reporting and recordkeeping requirements.
42 CFR Part 483
Grant programs--health, Health facilities, Health professions,
Health records, Incorporation by reference, Medicaid, Medicare, Nursing
homes, Nutrition, Reporting and recordkeeping requirements, Safety.
42 CFR Part 485
Grant programs--health, Health facilities, Incorporation by
reference, Medicaid, Medicare, Reporting and recordkeeping
requirements.
0
For the reasons set forth in the preamble, the interim final rule
amending 42 CFR parts 403, 416, 418, 460, 482, 483, and 485, which was
published on March 25, 2005 (70 FR 15229) is adopted as final with the
following changes:
PART 403--SPECIAL PROGRAMS AND PROJECTS
0
1. The authority citation for part 403 continues to read as follows:
Authority: 42 U.S.C. 1395b-3 and Secs. 1102 and 1871 of the
Social Security Act (42 U.S.C. 1302 and 1395hh).
Subpart G--Religious Nonmedical Health Care Institutions--Benefits,
Conditions of Participation, and Payment
0
2. Section 403.744 is amended as follows:
0
A. Paragraph (a)(4)(iii) is revised.
0
B. Paragraph (a)(4)(iv) is amended by removing the last sentence.
0
C. Paragraph (a)(4)(iv) is further amended by removing the period at
the end of the paragraph and adding in its place ``; and''.
0
D. New paragraph (a)(4)(v) is added.
The revisions read as follows:
Sec. 403.744 Condition of participation: Life safety from fire.
(a) * * *
(4) * * *
(iii) The dispensers are installed in a manner that adequately
protects against inappropriate access;
* * * * *
(v) The dispensers are maintained in accordance with dispenser
manufacturer guidelines.
* * * * *
PART 416--AMBULATORY SURGICAL SERVICES
0
3. The authority citation for part 416 continues to read as follows:
Authority: Secs. 1102 and 1871 of the Social Security Act (42
U.S.C. 1302 and 1395hh).
Subpart C--Specific Conditions for Coverage
0
4. Section 416.44 is amended as follows:
0
A. Paragraph (b)(5)(iii) is revised.
0
B. Paragraphs (b)(5)(iv)(F) and (G) are revised.
0
C. Paragraph (b)(5)(v) is added.
The revisions read as follows.
Sec. 416.44 Conditions for coverage-Environment.
* * * * *
(b) * * *
(5) * * *
(iii) The dispensers are installed in a manner that adequately
protects against inappropriate access;
(iv) * * *
(F) The dispensers shall not be installed over or directly adjacent
to an ignition source;
(G) In locations with carpeted floor coverings, dispensers
installed directly over carpeted surfaces shall be permitted only in
sprinklered smoke compartments; and
(v) The dispensers are maintained in accordance with dispenser
manufacturer guidelines.
* * * * *
PART 418--HOSPICE CARE
0
5. The authority citation for part 418 continues to read as follows:
Authority: Secs. 1102 and 1871 of the Social Security Act (42
U.S.C. 1302 and 1395hh).
Subpart E--Conditions of Participation: Other Services
0
6. Section 418.100 is amended as follows:
0
A. Paragraph (d)(6)(iii) is revised.
0
B. Paragraph (d)(6)(iv) is amended by removing the last sentence.
0
C. Paragraph (d)(6)(iv) is further amended by removing the period at
the end of the paragraph and adding in its place ``; and''.
[[Page 55340]]
0
D. Paragraph (d)(6)(v) is added.
The revisions read as follows:
Sec. 418.100 Condition of participation: Hospices that provide
inpatient care directly.
* * * * *
(d) * * *
(6) * * *
(iii) The dispensers are installed in a manner that adequately
protects against inappropriate access;
* * * * *
(v) The dispensers are maintained in accordance with dispenser
manufacturer guidelines.
* * * * *
PART 460--PROGRAMS OF ALL-INCLUSIVE CARE FOR THE ELDERLY (PACE)
0
7. The authority citation for part 460 continues to read as follows:
Authority: Secs. 1102 and 1871 of the Social Security Act (42
U.S.C. 1302 and 1395).
Subpart E--PACE Administrative Requirements
0
8. Section 460.72 is amended as follows:
0
A. Paragraph (b)(5)(iii) is revised.
0
B. Paragraph (b)(5)(iv) is amended by removing the last sentence.
0
C. Paragraph (b)(5)(iv) is further amended by removing the period at
the end of the paragraph and adding in its place ``; and''.
0
D. Paragraph (b)(5)(v) is added.
The revisions read as follows:
Sec. 460.72 Physical environment.
* * * * *
(b) * * *
(5) * * *
(iii) The dispensers are installed in a manner that adequately
protects against inappropriate access;
* * * * *
(v) The dispensers are maintained in accordance with dispenser
manufacturer guidelines.
* * * * *
PART 482--CONDITIONS OF PARTICIPATION FOR HOSPITALS
0
9. The authority citation for part 482 continues to read as follows:
Authority: Secs. 1102 and 1871 of the Social Security Act (42
U.S.C. 1302 and 1395hh).
Subpart C--Basic Hospital Functions
0
10. Section 482.41 is amended as follows:
0
A. Paragraph (b)(9)(iii) is revised.
0
B. Paragraph (b)(9)(iv) is amended by removing the last sentence.
0
C. Paragraph (b)(9)(iv) is further amended by removing the period at
the end of the paragraph and adding in its place ``; and''.
0
D. Paragraph (b)(9)(v) is added.
The revisions read as follows:
Sec. 482.41 Condition of participation: Physical environment.
* * * * *
(b) * * *
(9) * * *
(iii) The dispensers are installed in a manner that adequately
protects against inappropriate access;
* * * * *
(v) The dispensers are maintained in accordance with dispenser
manufacturer guidelines.
* * * * *
PART 483--REQUIREMENTS FOR STATES AND LONG TERM CARE FACILITIES
0
11. The authority citation for part 483 continues to read as follows:
Authority: Secs. 1102 and 1871 of the Social Security Act (42
U.S.C. 1302 and 1395hh).
Subpart B--Requirements for Long Term Care Facilities
0
12. In Sec. 483.5, add new paragraphs (d) and (e) to read as follows:
Sec. 483.5 Definitions.
* * * * *
(d) Common area. Common areas are dining rooms, activity rooms,
meeting rooms where residents are located on a regular basis, and other
areas in the facility where residents may gather together with other
residents, visitors, and staff.
(e) Fully sprinklered. A fully sprinklered long term care facility
is one that has all areas sprinklered in accordance with National Fire
Protection Association 13 ``Standard for the Installation of Sprinkler
Systems'' without the use of waivers or the Fire Safety Evaluation
System.
0
13. Section 483.70 is amended as follows:
0
A. Paragraph (a)(6)(iii) is revised.
0
B. Paragraph (a)(6)(iv) is amended by removing the last sentence.
0
C. Paragraph (a)(6)(iv) is further amended by removing the period at
the end of the paragraph and adding in its place ``; and''.
0
D. Paragraph (a)(6)(v) is added.
0
E. Paragraph (a)(7) is revised.
The revisions read as follows:
Sec. 483.70 Physical environment.
(a) * * *
(6) * * *
(iii) The dispensers are installed in a manner that adequately
protects against inappropriate access;
* * * * *
(v) The dispensers are maintained in accordance with dispenser
manufacturer guidelines.
(7) A long term care facility must:
(i) Install, at least, battery-operated single station smoke alarms
in accordance with the manufacturer's recommendations in resident
sleeping rooms and common areas.
(ii) Have a program for inspection, testing, maintenance, and
battery replacement that conforms to the manufacturer's recommendations
and that verifies correct operation of the smoke alarms.
(iii) Exception:
(A) The facility has system-based smoke detectors in patient rooms
and common areas that are installed, tested, and maintained in
accordance with NFPA 72, National Fire Alarm Code, for system-based
smoke detectors; or
(B) The facility is fully sprinklered in accordance with NFPA 13,
Standard for the Installation of Sprinkler Systems.
* * * * *
Subpart I--Conditions of Participation for Intermediate Care
Facilities for the Mentally Retarded
0
14. Section 483.470 is amended as follows:
0
A. Paragraph (j)(7)(ii)(C) is revised.
0
B. Paragraph (j)(7)(ii)(D) is amended by removing the last sentence.
0
C. Paragraph (j)(7)(ii)(D) is further amended by removing the period at
the end of the paragraph and adding in its place ``; and''.
0
D. Paragraph (j)(7)(ii)(E) is added.
The revisions read as follows:
Sec. 483.470 Condition of participation: Physical environment.
* * * * *
(j) * * *
(7) * * *
(ii) * * *
(C) The dispensers are installed in a manner that adequately
protects against inappropriate access;
* * * * *
(E) The dispensers are maintained in accordance with dispenser
manufacturer guidelines.
* * * * *
PART 485--CONDITIONS OF PARTICIPATION: SPECIALIZED PROVIDERS
0
15. The authority citation for part 485 continues to read as follows:
[[Page 55341]]
Authority: Secs. 1102 and 1871 of the Social Security Act (42
U.S.C. 1302 and 1395(hh)).
Subpart F--Conditions of Participation: Critical Access Hospitals
(CAHs)
0
16. Section 485.623 is amended as follows:
0
A. Paragraph (d)(7)(iii) is revised.
0
B. Paragraph (d)(7)(iv) is amended by removing the last sentence.
0
C. Paragraph (d)(7)(iv) is further amended by removing the period at
the end of the paragraph and adding in its place ``; and''.
0
D. Paragraph (d)(7)(v) is added.
The revisions read as follows:
Sec. 485.623 Condition of participation: Physical plant and
environment.
* * * * *
(d) * * *
(7) * * *
(iii) The dispensers are installed in a manner that adequately
protects against inappropriate access;
* * * * *
(v) The dispensers are maintained in accordance with dispenser
manufacturer guidelines.
(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: February 8, 2006.
Mark B. McClellan,
Administrator, Centers for Medicare & Medicaid Services.
Approved: May 31, 2006.
Michael O. Leavitt,
Secretary.
[FR Doc. 06-7885 Filed 9-21-06; 8:45 am]
BILLING CODE 4120-01-P