[Federal Register: March 25, 2005 (Volume 70, Number 57)]
[Rules and Regulations]
[Page 15229-15239]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr25mr05-7]
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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