[Federal Register Volume 71, Number 184 (Friday, September 22, 2006)]
[Rules and Regulations]
[Pages 55326-55341]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 06-7885]


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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.

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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