[Federal Register Volume 70, Number 57 (Friday, March 25, 2005)]
[Rules and Regulations]
[Pages 15229-15239]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-5919]


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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-IFC]
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: Interim final rule with comment period.

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SUMMARY: This interim final rule with comment period adopts the 
substance of the April 15, 2004 temporary 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 will allow certain health 
care facilities to place alcohol-based hand rub dispensers in egress 
corridors under specified conditions. This interim final rule with 
comment period also requires that nursing facilities install smoke 
detectors in resident rooms and public areas if they do not have a 
sprinkler system installed throughout the facility or a hard-wired 
smoke detection system in those areas.

DATES: Effective date: These regulations are effective on May 24, 2005.
    Comments date: To be assured consideration, comments must be 
received at one of the addresses provided below, no later than 5 p.m. 
on May 24, 2005.

ADDRESSES: In commenting, please refer to file code CMS-3145-IFC. 
Because of staff and resource limitations, we cannot accept comments by 
facsimile (FAX) transmission.
    You may submit comments in one of three ways (no duplicates, 
please):
    1. Electronically. You may submit electronic comments on specific 
issues in this regulation to http://www.cms.hhs.gov/regulations/ecomments. (Attachments should be in Microsoft Word, WordPerfect, or 
Excel; however, we prefer Microsoft Word.)
    2. By mail. You may mail written comments (one original and two 
copies) to the following address ONLY:

Centers for Medicare & Medicaid Services, Department of Health and 
Human Services, Attention: CMS-3145-IFC, P.O. Box 8018, Baltimore, MD 
21244-8018.

    Please allow sufficient time for mailed comments to be received 
before the close of the comment period.
    3. By hand or courier. If you prefer, you may deliver (by hand or 
courier) your written comments (one original and two copies) before the 
close of the comment period to one of the following addresses. If you 
intend to deliver your comments to the Baltimore address, please call 
telephone number (410) 786-9994 in advance to schedule your arrival 
with one of our staff members.

Room 445-G, Hubert H. Humphrey Building, 200 Independence Avenue, SW., 
Washington, DC 20201; or 7500 Security Boulevard, Baltimore, MD 21244-
1850.

    (Because access to the interior of the HHH Building is not readily 
available to persons without Federal Government identification, 
commenters are encouraged to leave their comments in the CMS drop slots 
located in the main lobby of the building. A stamp-in clock is 
available for persons wishing to retain a proof of filing by stamping 
in and retaining an extra copy of the comments being filed.)
    Comments mailed to the addresses indicated as appropriate for hand 
or courier delivery may be delayed and received after the comment 
period.
    Submission of comments on paperwork requirements. You may submit 
comments on this document's paperwork requirements by mailing your 
comments to the addresses provided at the end of the ``Collection of 
Information Requirements'' section in this document.
    For information on viewing public comments, see the beginning of 
the SUPPLEMENTARY INFORMATION section.

FOR FURTHER INFORMATION CONTACT: Danielle Shearer, (410) 786-6617; 
James Merrill, (410) 786-6998; or Mayer Zimmerman, (410) 786-6839.

SUPPLEMENTARY INFORMATION: Submitting Comments: We welcome comments 
from the public on all issues set forth in this rule to assist us in 
fully considering issues and developing policies. You can assist us by 
referencing the file code CMS-3145-IFC and the specific ``issue 
identifier'' that precedes the section on which you choose to comment.
    Inspection of Public Comments: Comments received timely will be 
available for public inspection as they are received, generally 
beginning approximately 3 weeks after publication of a document, at the 
headquarters of the Centers for Medicare & Medicaid Services, 7500 
Security Boulevard, Baltimore, Maryland 21244, Monday through Friday of 
each week from 8:30 a.m. to 4 p.m. To schedule an appointment to view 
public comments, phone (410) 786-9994.

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 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

[[Page 15230]]

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. We did not receive any public comments 
contesting this prohibition during the rulemaking process.
    [If you choose to comment on issues in this section, please include 
the caption ``ABHR RESEARCH'' at the beginning of your comments.]
    The ABHRs have become an increasingly common infection control 
method. The issue of 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 website (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 after the introduction of ABHRs. Each category 
of health care provider, 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 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 health 
care 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).
    [If you choose to comment on issues in this section, please include 
the caption ``ABHR SAFETY'' at the beginning of your comments.]
    The benefits of using ABHRs have been well demonstrated. However, 
until a short time ago there were 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

[[Page 15231]]

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 
temporary 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. During a meeting of the NFPA's Standards Council on April 15, 
2004, 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 is 
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. Anything in the 
non-amended version of the 2000 edition of the LSC that is contrary to 
the amended policy will not apply.
    Chapters 18 and 19 will 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 (ASC) are not covered under chapters 18 
or 19 of the LSC; but are rather covered under chapter 21 of the LSC. 
Many ASCs are interested in installing ABHR dispensers in corridors. 
However, chapter 21 of the LSC has 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 interim final rule with 
comment period. 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:
     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 Detectors

    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.
    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 detector, and the majority 
of victims died from smoke inhalation. The lack of smoke detectors 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 is a crucial 
aspect of the current facility fire safety requirements. Long-term care 
facilities are required by 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 detectors, a basic fire safety 
device, are only required by the 2000 edition of the Life Safety Code 
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 detectors 
were not in the resident sleeping rooms where the fires started and 
staff members were not aware of the fires until smoke reached the smoke 
detectors in the

[[Page 15232]]

corridors. This delay inhibited timely staff response and may have 
contributed to resident deaths.
    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. As with resident sleeping rooms, 
there is a possibility that no one will be aware of this fire until its 
smoke spread to a corridor where there are smoke detectors. By this 
time, smoke may have also begun filtering into other areas of the 
facility such as resident sleeping rooms and public 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 detectors in resident sleeping rooms and 
public areas. For these reasons, we are requiring that long-term care 
facilities that do not have sprinklers must at least install battery-
operated smoke detectors in patient rooms and public areas. We have 
discussed this issue in detail in section II.B of this interim final 
rule with comment period.
    We are specifically soliciting public comment on the placement of 
smoke detectors in long-term care facilities. Should detectors also be 
placed in non-public areas such as storage rooms, closets, and offices?
    Facilities that choose to install a hard-wired smoke detector 
system in accordance with NFPA 72, National Fire Alarm Code, in patient 
rooms and public areas within the 1 year phase-in period discussed in 
section II.B of this interim final rule with comment period will be 
exempt from this requirement. A hard-wired smoke detector system is a 
system that is wired to both a facility's electrical and fire alarm 
systems. The detectors draw their energy from a facility's electrical 
system and use batteries as back-ups in case of power failure. In 
addition, the detectors communicate with one another so that an alarm 
in one room would trigger an alarm in every room. The detectors also 
communicate with the facility's fire alarm system, thus notifying the 
fire department of the situation. If a facility chose to install a 
hard-wired system in resident rooms and public areas, then it will not 
have to install battery-operated smoke detectors because such a system 
will exceed the requirements of this interim final rule with comment 
period. Facilities that have installed sprinkler systems throughout in 
accordance with NFPA 13, Automatic Sprinklers, will also be exempt from 
the proposed requirement to install smoke detectors, because such a 
system will exceed this requirement.

C. Requirements for Issuance of Regulations

    Section 902 of the Medicare Prescription Drug, Improvement, and 
Modernization Act of 2003 (MMA) amended section 1871(a) of the Act and 
requires the Secretary, in consultation with the Director of the Office 
of Management and Budget, to establish and publish timelines for the 
publication of Medicare final regulations based on the previous 
publication of a Medicare proposed or interim final regulation. Section 
902 of the MMA also states that the timelines for these regulations may 
vary but shall not exceed 3 years after publication of the preceding 
proposed or interim final regulation except under exceptional 
circumstances. We intend to publish the final rule within the 3-year 
timeframe established under section 902 of the MMA.

II. Provisions of the Interim Final Rule

A. Alcohol-Based Hand Rubs

    [If you choose to comment on issues in this section, please include 
the caption ``PLACEMENT REQUIREMENTS'' at the beginning of your 
comments.]
    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)(6)).
--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)).

    The numbering that appears above corresponds to the most recent 
changes to the Life Safety Code regulations, published in the Federal 
Register as a final rule on August 11, 2004.
    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 met the following conditions:
     The use of ABHR dispensers could 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/or 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 were 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 necessitates the requirement that 
facilities take extra steps to ensure that ABHR dispensers do not leak 
or spill.
    In addition to any extra steps such as additional hardware 
installation, facilities should follow all manufacturer maintenance 
recommendations for ABHR dispensers. 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.
     The dispensers were installed in a manner that adequately 
protected against access by vulnerable populations, such as residents 
in psychiatric units. 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 misusing 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 misuse by 
these vulnerable populations.
     The dispensers were installed in accordance with chapters 
18.3.2.7 and

[[Page 15233]]

19.3.2.7 of the 2000 edition of the LSC. 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 study also showed that if 
those conditions are not met, there will be an increase in the risk of 
fire.

B. Smoke Detectors

    [If you choose to comment on issues in this section, please include 
the caption ``LOCATION'' at the beginning of your comments.]
    We are requiring in Sec.  483.70(a)(7) that long-term care 
facilities will, at minimum, be required to install battery-operated 
smoke detectors in resident sleeping rooms and public areas, unless 
they have a hard-wired smoke detector system in resident rooms and 
public areas or a sprinkler system throughout the facility. We are also 
requiring that facilities that install battery-operated smoke detectors 
have a program for testing, maintenance, and battery replacement to 
ensure the reliability of the smoke detectors. Smoke detectors, when 
properly installed and maintained in resident sleeping rooms and public 
areas, are a basic, useful and effective fire safety tool.
    We believe that at least installing battery-operated smoke 
detectors will provide earlier warning for facility residents and 
staff. Fires that originate in these areas will be detected earlier 
because the detector will be located closer to the fire's origin than 
if it were only placed in the corridor. 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 
could help to reduce the loss of life in a nursing facility fire.
    [If you choose to comment on issues in this section, please include 
the caption ``MAINTENANCE'' at the beginning of your comments.]
    As discussed earlier, a facility will be required to have a program 
for testing, maintenance, and battery replacement to ensure the 
reliability of the smoke detectors. Detectors require maintenance every 
6 months to 1 year in order to ensure that the batteries are operating 
at optimum power. A detector with a depleted battery provides no 
protection. Thus, a regular maintenance program for the detectors is 
crucial to ensuring that residents and staff are indeed protected. 
Facilities will be expected to add maintenance of smoke detectors to 
their existing maintenance schedule.
    [If you choose to comment on issues in this section, please include 
the caption ``1 YEAR PHASE-IN'' at the beginning of your comments.]
    We are allowing facilities 1 year to comply with this regulation 
for two reasons. First, allowing facilities an extra year to comply 
with this regulation will also give interested facilities additional 
time to purchase and install a hard-wired smoke detector system or a 
sprinkler system. Purchasing and installing these systems is more 
complicated than purchasing and installing battery-operated detectors. 
Therefore, facilities that wanted to exercise this option would be 
prohibited from doing so if they were required to comply immediately. 
The 1-year phase-in will give facilities a chance to purchase and 
install a more advanced fire and smoke protection system than this 
regulation requires. We are strongly in favor of facilities taking 
advantage of this extended compliance period to install more advanced 
fire protection systems than the battery-operated smoke detectors that 
are required by this regulation.
    Second, some facilities might have difficulty obtaining and 
installing battery-operated smoke detectors within the typical 60-day 
period from the date of publication of a final rule to the rule's 
effective date. Therefore, we are allowing facilities to phase-in smoke 
detectors over a 1-year period from the effective date of a final 
regulation. Facilities could use this year to purchase and install 
battery-operated detectors, or they could do so on an abbreviated 
schedule. We encourage facilities that choose to install battery-
operated smoke detectors to do so as quickly as possible in order to 
increase fire safety. We believe that this phase-in period will give 
facilities more flexibility in meeting this requirement.
    [If you choose to comment on issues in this section, please include 
the caption ``EXCEPTIONS'' at the beginning of your comments.]
    The regulation will have two exceptions, one for facilities that 
have hard-wired smoke detection systems and one for facilities that 
have sprinkler systems. Hard-wired smoke detector systems installed in 
resident rooms and public areas will protect the same areas as the 
battery-operated detectors. Therefore, having both hard-wired and 
battery-operated detectors in these areas will be redundant, 
unnecessary, and overly burdensome. Facilities may still choose to use 
battery-operated detectors along with hard-wired detectors as an 
additional layer of fire protection, but we will not require the 
facilities to do so in this interim final rule with comment period.
    Likewise, having both a sprinkler system throughout and battery-
operated smoke detectors in resident rooms and public 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 detectors an unnecessary requirement. Facilities may 
still choose to use detectors as an additional layer of fire protection 
beyond sprinklers, but they will not be required to do so in this 
interim final rule with comment period.

III. Response to Comments

    Because of the large number of public comments we normally receive 
on Federal Register documents, we are not able to acknowledge or 
respond to them individually. We will consider all comments we receive 
by the date and time specified in the DATES section of this preamble, 
and, when we proceed with a subsequent document, we will respond to the 
comments in the preamble to that document.

IV. Waiver of Proposed Rulemaking

    We ordinarily publish a notice of proposed rulemaking in the 
Federal Register and invite public comment on the proposed rule. The 
notice of proposed rulemaking includes a reference to the legal 
authority under which the rule is proposed, and the terms and 
substances of the proposed rule or a description of the subjects and 
issues involved. This procedure can be waived, however, if an agency 
finds good cause that a notice-and-comment procedure is impracticable, 
unnecessary, or contrary to the public interest and incorporates a 
statement of the finding and its reasons in the rule issued.
    We believe that continuing to prohibit the placement of ABHR 
dispensers in all appropriate areas, including egress corridors, is 
contrary to the public interest because ABHRs are a safe and effective 
method for increasing hand hygiene compliance rates, and their use has 
been shown to help decrease health care-acquired infections. As the 
studies and recommendations described in section I.A of this document

[[Page 15234]]

demonstrate, ABHRs are a safe and effective method for cleansing hands.
    Although ABHR dispensers were once considered to be a fire safety 
risk when placed in egress corridors, they are no longer considered by 
fire safety experts to pose a significant risk to patient safety. 
According to the Gage-Babcock study, ABHR dispensers can be safely 
installed in egress corridors if they meet certain specifications, such 
as being placed at least 4 feet apart and not being placed over carpet 
in an unsprinklered smoke compartment. Fire safety experts believe that 
dispensers of ABHRs, when installed properly in egress corridors, do 
not decrease fire safety. We agree with this position.
    Any fire safety concerns are, we believe, more than offset by the 
potential for health care facilities to improve their infection control 
practices. As the availability of ABHRs increases in a facility, so 
does the rate of hand hygiene compliance. An increase in hand hygiene 
compliance rates results in a decrease in health care acquired 
infections. We believe that the public will benefit from more ABHR 
dispensers being available in more places because the increased 
availability of ABHR dispensers will likely decrease the number of 
health care acquired infections, thus improving public health and 
safety in health care facilities.
    We believe that allowing long-term care facilities to continue to 
care for residents in buildings that have neither sprinklers nor smoke 
detectors is contrary to the public interest because buildings that do 
not at least have smoke detectors present a greater risk of death or 
injury due to fire. In 2003, 31 long-term care facility residents died 
in two separate fires in buildings that did not have smoke detectors in 
patient rooms, where both fires started, or in public areas. Smoke 
detectors are basic and relatively inexpensive fire safety tools that 
have been proven to be effective at alerting residents and staff to 
fire, and that have been in use in homes and other buildings across the 
country for several decades. They provide early warning to occupants 
and have saved countless lives. Continuing to allow long-term care 
facilities that care for residents in buildings lacking smoke detectors 
risks the safety of all residents and staff in these buildings.
    Therefore, we find good cause to waive the notice of proposed 
rulemaking and to issue this final rule on an interim basis. We are 
providing a 60-day public comment period.

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 interim final rule with comment 
period, 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 interim final rule with comment period 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 
smoke detectors in resident rooms and public 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. In the first year, this interim final rule with 
comment period will cost, on average, approximately $9,800 per 
facility. In the following years, this interim final rule with comment 
period 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. Therefore, we certify that this 
interim final rule with comment period 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 603 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 interim final rule 
with comment period will not have a significant impact on small rural 
hospitals because the interim final rule with comment period 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 that may result in expenditure in any 1 year by State, 
local, or tribal governments, in the aggregate, or by the private 
sector, of $110 million. This interim final rule with comment period 
will not have an effect on State, local, or tribal governments, and the 
private sector costs will not be greater than the $110 million 
threshold.
    Executive Order 13132 establishes certain requirements that an 
agency must meet when it promulgates an interim final rule with comment 
period (and subsequent final rule) that imposes substantial direct 
requirement costs on

[[Page 15235]]

State and local 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 interim final rule with comment period 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 access to the dispensers by vulnerable 
populations. 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. 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 five 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 
three gallons of ABHR solution per smoke compartment. That same 
facility would be permitted to keep an additional two 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 decrease patient care costs.
2. Smoke Detectors
    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 a hard-wired 
smoke detector system in resident rooms and public 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, and that each room will require one 
battery-operated smoke detector. We estimated that each average 
facility will require 20 additional detectors for public areas, for a 
total of 70 detectors per facility. We estimated that the cost of each 
smoke detector and its installation will be approximately $100. 
Therefore, an average facility will expect to pay $7,000 to purchase 
and install battery-operated smoke detectors in resident sleeping rooms 
and public areas. The total industry cost for purchasing and installing 
battery-operated smoke detectors in the specified areas will be 
$29,400,000.
    Following installation of battery-operated smoke detectors in the 
specified areas, a long-term care facility will be required to have a 
program for testing, maintenance, and battery replacement to ensure the 
reliability of the smoke detectors. We estimate that a facility will 
conduct monthly tests of each detector by activating the test button. 
This will take approximately 5 minutes per smoke detector per test, or 
1 hour per smoke detector per year.
    In addition, we estimate that a facility will clean each detector 
and change its batteries two times per year. This will take 15 minutes 
per smoke detector per cleaning and replacement, or 30 minutes per 
smoke detector per year. We estimate that the total annual maintenance 
time per detector will be one 1.5 hours, for 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 detectors, based on a maintenance 
person earning $20 per hour and $5 for batteries per change, is $2,800. 
The annual industry total for this maintenance provision will thus be 
$11,760,000.
    The total cost for the first year of this regulation, including 
purchase, installation and maintenance costs, will be $9,800 per 
average facility, for a total of $41,160,000 industry wide. The cost 
for the following years of maintenance will be $2,800 per average 
facility annually, or $11,760,000 industry wide annually.

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, such as ABHR dispensers, increase. 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 they see fit. 
Providers are aware of the

[[Page 15236]]

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, 
and 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 by vulnerable 
populations such as patients in ICFs/MR or dementia units. Due to 
disability or illness, these populations require additional protection 
from substances that are toxic and/or 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 Detectors
    We considered not requiring long-term care facilities to install 
smoke detectors; however, we believe that installation of the smoke 
detectors will help save lives. The July 2004 GAO report clearly 
outlined the role that smoke detectors, one of the most basic and 
effective fire safety devices available, played in the Nashville and 
Hartford fires. The report also outlined the wider role that detectors 
can and should play in long-term care facility fire safety. The 
positive impact of smoke detectors on resident safety, we believe, 
warrants their installation.
    We also considered requiring long-term care facilities to 
immediately install battery-operated smoke detectors, rather than 
allowing facilities to phase them in over a 1-year period. We strongly 
support a facility's choice to install a fire safety system that 
exceeds the requirements of this regulation. It would have been 
extremely difficult for facilities that wanted to install hard-wired 
smoke detector systems or sprinkler systems to complete their tasks in 
60 days. The 1-year phase-in period will allow those facilities more 
time to complete these systems, which would go beyond what we are 
requiring in this rule.
    In addition, requiring facilities to, at a minimum, install 
battery-operated smoke detectors in 60 days would have posed a 
significant time and financial burden to facilities. Had we chosen this 
option, we would have required facilities to purchase and install a 
fairly large volume of detectors in a fairly short period of time, 60 
days. This may have been very difficult for some facilities due to the 
initial cost of purchasing and installing the detectors. We estimate 
that it will cost facilities $7,000 to purchase and install battery-
operated smoke detectors. There may be facilities that do not have the 
full amount of funds immediately available, and therefore would not be 
able to comply with this regulation within the standard 60-day time 
period. The 1-year phase-in period allows these facilities to 
distribute the cost over 12 months, for an average monthly cost of 
$584. Distributing the cost of smoke detectors over a 1-year period 
ensures that all facilities are able to afford the cost of complying 
with this rule.
    Furthermore, we considered requiring long-term care facilities to 
install a hard-wired smoke detector system in accordance with NFPA 72, 
National Fire Alarm Code, for hard-wired alternating current smoke 
detector systems. This option would have posed a significant burden to 
some long-term care facilities because of the cost and time associated 
with purchasing and installing these devices. Hard-wired detectors must 
be wired directly into the facility's electrical and fire alarm system. 
We believe that the costs associated with purchasing this system and 
the time required to install it would have placed this option out of 
reach for some nursing facilities.
    Therefore, we are requiring only the less expensive and less time 
consuming battery-operated detector. Facilities may still choose to 
install a hard-wired smoke detector system, and we encourage them to do 
so. Installation of such a system in patient rooms and public areas 
will exempt a facility from installing battery-operated detectors 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 believe that this 
issue warrants further examination, and are committed to working with 
NFPA, the long-term care facility industry, and advocates to develop a 
consensus position. Any new sprinkler requirements would be discussed 
in a separate regulatory document and would be published in the Federal 
Register. Facilities may still choose to install a sprinkler system 
throughout the facility in accordance with NFPA 13. Installation of 
such a system will exempt a facility from installing battery-operated 
detectors in patient rooms and public 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, 
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, Medicare, Reporting and 
recordkeeping requirements.

42 CFR Part 460

    Aged, Health care, Health records, Medicaid, Medicare, Reporting 
and recordkeeping requirements.

42 CFR Part 482

    Grant programs--health, Hospitals, Medicaid, Medicare, Reporting 
and recordkeeping requirements.

42 CFR Part 483

    Grant programs--health, Health facilities, Health professions, 
Health records, Medicaid, Medicare, Nursing homes, Nutrition, Reporting 
and recordkeeping requirements, Safety.

[[Page 15237]]

42 CFR Part 485

    Grant programs--health, Health facilities, Medicaid, Medicare, 
Reporting and recordkeeping requirements

0
For the reasons set forth in the preamble, the Centers for Medicare and 
Medicaid Services amends 42 CFR chapter IV as set forth below:

PART 403--SPECIAL PROGRAMS AND PROJECTS

0
1. The authority citation for part 403 is amended 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. Add new paragraphs (a)(3) and (a)(4) to Sec.  403.744 to read as 
follows:


Sec.  403.744  Condition of participation: Life safety from fire.

    (a) * * *
    (3) [Reserved]
    (4) Notwithstanding any provisions of the 2000 edition of the Life 
Safety Code to the contrary, the RNHCI may place alcohol-based hand rub 
dispensers in its facility if--
    (i) Use of alcohol-based hand rub dispensers does not conflict with 
any State or local codes that prohibit or otherwise restrict the 
placement of alcohol-based hand rub dispensers in health care 
facilities;
    (ii) The dispensers are installed in a manner that minimizes leaks 
and spills that could lead to falls;
    (iii) The dispensers are installed in a manner that adequately 
protects against access by vulnerable populations; and
    (iv) The dispensers are installed in accordance with chapter 
18.3.2.7 or chapter 19.3.2.7 of the 2000 edition of the Life Safety 
Code, as amended by NFPA Temporary Interim Amendment 00-1(101), issued 
by the Standards Council of the National Fire Protection Association on 
April 15, 2004. The Director of the Office of the Federal Register has 
approved NFPA Temporary Interim Amendment 00-1(101) for incorporation 
by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. A 
copy of the amendment is available for inspection at the CMS 
Information Resource Center, 7500 Security Boulevard, Baltimore, MD and 
at the Office of the Federal Register, 800 North Capitol Street NW., 
Suite 700, Washington, DC. Copies may be obtained from the National 
Fire Protection Association, 1 Batterymarch Park, Quincy, MA 02269. If 
any additional changes are made to this amendment, CMS will publish 
notice in the Federal Register to announce the changes.
* * * * *

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. Add new paragraph (b)(5) to Sec.  416.44 to read as follows:


Sec.  416.44  Conditions for coverage-Environment.

* * * * *
    (b) * * *
    (5) Notwithstanding any provisions of the 2000 edition of the Life 
Safety Code to the contrary, an ASC may place alcohol-based hand rub 
dispensers in its facility if--
    (i) Use of alcohol-based hand rub dispensers does not conflict with 
any State or local codes that prohibit or otherwise restrict the 
placement of alcohol-based hand rub dispensers in health care 
facilities;
    (ii) The dispensers are installed in a manner that minimizes leaks 
and spills that could lead to falls;
    (iii) The dispensers are installed in a manner that adequately 
protects against access by vulnerable populations; and
    (iv) The dispensers are installed in accordance with the following 
provisions:
    (A) Where dispensers are installed in a corridor, the corridor 
shall have a minimum width of 6 ft (1.8m);
    (B) The maximum individual dispenser fluid capacity shall be:
    (1) 0.3 gallons (1.2 liters) for dispensers in rooms, corridors, 
and areas open to corridors.
    (2) 0.5 gallons (2.0 liters) for dispensers in suites of rooms;
    (C) The dispensers shall have a minimum horizontal spacing of 4 ft 
(1.2m) from each other;
    (D) 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;
    (E) 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;
    (F) The dispensers shall not be installed over or directly adjacent 
to an ignition source; and
    (G) In locations with carpeted floor coverings, dispensers 
installed directly over carpeted surfaces shall be permitted only in 
sprinklered smoke compartments.
* * * * *

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. Add a new paragraph (d)(6) to Sec.  418.100 to read as follows:


Sec.  418.100  Condition of participation: Hospices that provide 
inpatient care directly.

* * * * *
    (d) * * *
    (6) Notwithstanding any provisions of the 2000 edition of the Life 
Safety Code to the contrary, a hospice may place alcohol-based hand rub 
dispensers in its facility if--
    (i) Use of alcohol-based hand rub dispensers does not conflict with 
any State or local codes that prohibit or otherwise restrict the 
placement of alcohol-based hand rub dispensers in health care 
facilities;
    (ii) The dispensers are installed in a manner that minimizes leaks 
and spills that could lead to falls;
    (iii) The dispensers are installed in a manner that adequately 
protects against access by vulnerable populations; and
    (iv) The dispensers are installed in accordance with chapter 
18.3.2.7 or chapter 19.3.2.7 of the 2000 edition of the Life Safety 
Code, as amended by NFPA Temporary Interim Amendment 00-1(101), issued 
by the Standards Council of the National Fire Protection Association on 
April 15, 2004. The Director of the Office of the Federal Register has 
approved NFPA Temporary Interim Amendment 00-1(101) for incorporation 
by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. A 
copy of the amendment is available for inspection at the CMS 
Information Resource Center, 7500 Security Boulevard, Baltimore, MD and 
at the Office of the Federal Register, 800 North Capitol Street NW., 
Suite 700, Washington, DC. Copies may be obtained from the National 
Fire Protection Association, 1 Batterymarch Park, Quincy, MA 02269. If 
any additional changes are made to this

[[Page 15238]]

amendment, CMS will publish notice in the Federal Register to announce 
the changes.
* * * * *

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. Add a new paragraph (b)(5) to Sec.  460.72 to read as follows:


Sec.  460.72  Physical environment.

* * * * *
    (b) * * *
    (5) Notwithstanding any provisions of the 2000 edition of the Life 
Safety Code to the contrary, a PACE center may install alcohol-based 
hand rub dispensers in its facility if--
    (i) Use of alcohol-based hand rub dispensers does not conflict with 
any State or local codes that prohibit or otherwise restrict the 
placement of alcohol-based hand rub dispensers in health care 
facilities;
    (ii) The dispensers are installed in a manner that minimizes leaks 
and spills that could lead to falls;
    (iii) The dispensers are installed in a manner that adequately 
protects against access by vulnerable populations; and
    (iv) The dispensers are installed in accordance with chapter 
18.3.2.7 or chapter 19.3.2.7 of the 2000 edition of the Life Safety 
Code, as amended by NFPA Temporary Interim Amendment 00-1(101), issued 
by the Standards Council of the National Fire Protection Association on 
April 15, 2004. The Director of the Office of the Federal Register has 
approved NFPA Temporary Interim Amendment 00-1(101) for incorporation 
by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. A 
copy of the amendment is available for inspection at the CMS 
Information Resource Center, 7500 Security Boulevard, Baltimore, MD and 
at the Office of the Federal Register, 800 North Capitol Street NW., 
Suite 700, Washington, DC. Copies may be obtained from the National 
Fire Protection Association, 1 Batterymarch Park, Quincy, MA 02269. If 
any additional changes are made to this amendment, CMS will publish 
notice in the Federal Register to announce the changes.
* * * * *

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. Add a new paragraph (b)(9) to Sec.  482.41 to read as follows:


Sec.  482.41  Condition of participation: Physical environment.

* * * * *
    (b) * * *
    (9) Notwithstanding any provisions of the 2000 edition of the Life 
Safety Code to the contrary, a hospital may install alcohol-based hand 
rub dispensers in its facility if--
    (i) Use of alcohol-based hand rub dispensers does not conflict with 
any State or local codes that prohibit or otherwise restrict the 
placement of alcohol-based hand rub dispensers in health care 
facilities;
    (ii) The dispensers are installed in a manner that minimizes leaks 
and spills that could lead to falls;
    (iii) The dispensers are installed in a manner that adequately 
protects against access by vulnerable populations; and
    (iv) The dispensers are installed in accordance with chapter 
18.3.2.7 or chapter 19.3.2.7 of the 2000 edition of the Life Safety 
Code, as amended by NFPA Temporary Interim Amendment 00-1(101), issued 
by the Standards Council of the National Fire Protection Association on 
April 15, 2004. The Director of the Office of the Federal Register has 
approved NFPA Temporary Interim Amendment 00-1(101) for incorporation 
by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. A 
copy of the amendment is available for inspection at the CMS 
Information Resource Center, 7500 Security Boulevard, Baltimore, MD and 
at the Office of the Federal Register, 800 North Capitol Street NW., 
Suite 700, Washington, DC. Copies may be obtained from the National 
Fire Protection Association, 1 Batterymarch Park, Quincy, MA 02269. If 
any additional changes are made to this amendment, CMS will publish 
notice in the Federal Register to announce the changes.
* * * * *

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.  483.70, add new paragraphs (a)(6) and (a)(7) to read as 
follows:


Sec.  483.70  Physical environment.

    (a) * * *
    (6) Notwithstanding any provisions of the 2000 edition of the Life 
Safety Code to the contrary, a long-term care facility may install 
alcohol-based hand rub dispensers in its facility if--
    (i) Use of alcohol-based hand rub dispensers does not conflict with 
any State or local codes that prohibit or otherwise restrict the 
placement of alcohol-based hand rub dispensers in health care 
facilities;
    (ii) The dispensers are installed in a manner that minimizes leaks 
and spills that could lead to falls;
    (iii) The dispensers are installed in a manner that adequately 
protects against access by vulnerable populations; and
    (iv) The dispensers are installed in accordance with chapter 
18.3.2.7 or chapter 19.3.2.7 of the 2000 edition of the Life Safety 
Code, as amended by NFPA Temporary Interim Amendment 00-1(101), issued 
by the Standards Council of the National Fire Protection Association on 
April 15, 2004. The Director of the Office of the Federal Register has 
approved NFPA Temporary Interim Amendment 00-1(101) for incorporation 
by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. A 
copy of the amendment is available for inspection at the CMS 
Information Resource Center, 7500 Security Boulevard, Baltimore, MD and 
at the Office of the Federal Register, 800 North Capitol Street NW., 
Suite 700, Washington, DC. Copies may be obtained from the National 
Fire Protection Association, 1 Batterymarch Park, Quincy, MA 02269. If 
any additional changes are made to this amendment, CMS will publish 
notice in the Federal Register to announce the changes.
    (7) A long-term care facility must:
    (i) Install battery-operated smoke detectors in resident sleeping 
rooms and public areas by May 24, 2006.
    (ii) Have a program for testing, maintenance, and battery 
replacement to ensure the reliability of the smoke detectors.
    (iii) Exception:
    (A) The facility has a hard-wired AC smoke detection system in 
patient rooms and public areas that is installed, tested, and 
maintained in accordance

[[Page 15239]]

with NFPA 72, National Fire Alarm Code, for hard-wired AC systems; or
    (B) The facility has a sprinkler system throughout that is 
installed, tested, and maintained in accordance with NFPA 13, Automatic 
Sprinklers.
* * * * *

Subpart I--Conditions of Participation for Intermediate Care 
Facilities for the Mentally Retarded

0
13. Revise paragraph (j)(7) to Sec.  483.470 to read as follows:


Sec.  483.470  Condition of participation: Physical environment.

* * * * *
    (j) * * *
    (7) Facilities that meet the LSC definition of a health care 
occupancy. (i) After consideration of State survey agency 
recommendations, CMS may waive, for appropriate periods, specific 
provisions of the Life Safety Code if the following requirements are 
met:
    (A) The waiver would not adversely affect the health and safety of 
the clients.
    (B) Rigid application of specific provisions would result in an 
unreasonable hardship for the facility.
    (ii) Notwithstanding any provisions of the 2000 edition of the Life 
Safety Code to the contrary, a facility may install alcohol-based hand 
rub dispensers if--
    (A) Use of alcohol-based hand rub dispensers does not conflict with 
any State or local codes that prohibit or otherwise restrict the 
placement of alcohol-based hand rub dispensers in health care 
facilities;
    (B) The dispensers are installed in a manner that minimizes leaks 
and spills that could lead to falls;
    (C) The dispensers are installed in a manner that adequately 
protects against access by vulnerable populations; and
    (D) The dispensers are installed in accordance with chapter 
18.3.2.7 or chapter 19.3.2.7 of the 2000 edition of the Life Safety 
Code, as amended by NFPA Temporary Interim Amendment 00-1(101), issued 
by the Standards Council of the National Fire Protection Association on 
April 15, 2004. The Director of the Office of the Federal Register has 
approved NFPA Temporary Interim Amendment 00-1(101) for incorporation 
by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. A 
copy of the amendment is available for inspection at the CMS 
Information Resource Center, 7500 Security Boulevard, Baltimore, MD and 
at the Office of the Federal Register, 800 North Capitol Street NW., 
Suite 700, Washington, DC. Copies may be obtained from the National 
Fire Protection Association, 1 Batterymarch Park, Quincy, MA 02269. If 
any additional changes are made to this amendment, CMS will publish 
notice in the Federal Register to announce the changes.
* * * * *

PART 485--CONDITIONS OF PARTICIPATION: SPECIALIZED PROVIDERS

0
14. The authority citation for part 485 continues to read as follows:

    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
15. Add a new paragraph (d)(7) to Sec.  485.623 to read as follows:


Sec.  485.623  Condition of participation: Physical plant and 
environment.

* * * * *
    (d) * * *
    (7) Notwithstanding any provisions of the 2000 edition of the Life 
Safety Code to the contrary, a critical access hospital may install 
alcohol-based hand rub dispensers in its facility if--
    (i) Use of alcohol-based hand rub dispensers does not conflict with 
any State or local codes that prohibit or otherwise restrict the 
placement of alcohol-based hand rub dispensers in health care 
facilities;
    (ii) The dispensers are installed in a manner that minimizes leaks 
and spills that could lead to falls;
    (iii) The dispensers are installed in a manner that adequately 
protects against access by vulnerable populations; and
    (iv) The dispensers are installed in accordance with chapter 
18.3.2.7 or chapter 19.3.2.7 of the 2000 edition of the Life Safety 
Code, as amended by NFPA Temporary Interim Amendment 00-1(101), issued 
by the Standards Council of the National Fire Protection Association on 
April 15, 2004. The Director of the Office of the Federal Register has 
approved NFPA Temporary Interim Amendment 00-1(101) for incorporation 
by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. A 
copy of the amendment is available for inspection at the CMS 
Information Resource Center, 7500 Security Boulevard, Baltimore, MD and 
at the Office of the Federal Register, 800 North Capitol Street NW., 
Suite 700, Washington, DC. Copies may be obtained from the National 
Fire Protection Association, 1 Batterymarch Park, Quincy, MA 02269. If 
any additional changes are made to this amendment, CMS will publish 
notice in the Federal Register to announce the change.

(Catalog of Federal Domestic Assistance Program No. 93.778, Medical 
Assistance Program).
(Catalog of Federal Domestic Assistance Program No. 93.778, 
Medicare--Hospital Insurance; and Program No. 93.774, Medicare--
Supplementary Medical Insurance Program).

    Dated: September 1, 2004.
Mark B. McClellan,
Administrator, Centers for Medicare & Medicaid Services.
    Approved: December 7, 2004.
Tommy G. Thompson,
Secretary.
[FR Doc. 05-5919 Filed 3-24-05; 8:45 am]
BILLING CODE 4120-01-P