Federal Register / Vol. 70, No. 57 / Friday, March 25, 2005 / Rules and Regulations 15229

Junction, Kentucky northward to its 

confluence with the Salt River. Otter 

Creek from Point D (latitude 

37°51′31.77′′ N; longitude 86°00′03.79′′

W) located approximately 3.4 miles 

north of Vine Grove, Kentucky to Point 

E (latitude 37°55′21.95′′ N; longitude 

86°01′47.38′′ W) located approximately 

2.3 miles southwest of Muldraugh. 

(b) The regulation. All persons, 

swimmers, vessels and other craft, 

except those vessels under the 

supervision or contract to local military 

or Army authority, vessels of the United 

States Coast Guard, and federal, local or 

state law enforcement vessels, are 

prohibited from entering the danger 

zones without permission from the 

Commanding General, U.S. Army 

Garrison, Fort Knox Military 

Reservation, Fort Knox, Kentucky or 

his/her authorized representative. 

(c) Enforcement. The regulation in 

this section, promulgated by the United 

States Army Corps of Engineers, shall be 

enforced by the Commanding General, 

U.S. Army Garrison, Fort Knox Military 

Reservation, Fort Knox, Kentucky and/

or other persons or agencies as he/she 

may designate.

Dated: March 16, 2005. 

Michael B. White, 

Chief, Operations, Directorate of Civil Works.

[FR Doc. 05–5904 Filed 3–24–05; 8:45 am] 

BILLING CODE 3710–92–P

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. 

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 

15230 Federal Register / Vol. 70, No. 57 / Friday, March 25, 2005 / Rules and Regulations 

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 difficileassociated 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 

Federal Register / Vol. 70, No. 57 / Friday, March 25, 2005 / Rules and Regulations 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 allinclusive 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 

15232 Federal Register / Vol. 70, No. 57 / Friday, March 25, 2005 / Rules and Regulations 

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 nonpublic areas such as storage rooms, 

closets, and offices? 

Facilities that choose to install a hardwired 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 

§ 403.744(a)(4)). 

—Ambulatory Surgical Services (ASC) 

(new § 416.44(b)(5)). 

—Hospices (new § 418.100(d)(6)). 

—Programs of all-inclusive care for the 

elderly (PACE) (new § 460.72(b)(6)). 

—Hospitals (new § 482.41(b)(9)). 

—Long-term care (LTC) facilities (new 

§ 483.70(a)(6)). 

—Intermediate care facilities for the 

mentally retarded (ICFs/MR) (revised 

§ 483.470(j)(7)). 

—Critical access hospitals (CAHs) (new 

§ 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 

Federal Register / Vol. 70, No. 57 / Friday, March 25, 2005 / Rules and Regulations 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 GageBabcock 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 § 483.70(a)(7) that 

long-term care facilities will, at 

minimum, be required to install batteryoperated 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 batteryoperated 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 batteryoperated smoke detectors to do so as 

quickly as possible in order to increase 

fire safety. We believe that this phasein 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 

15234 Federal Register / Vol. 70, No. 57 / Friday, March 25, 2005 / Rules and Regulations 

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 belowaverage-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 

Federal Register / Vol. 70, No. 57 / Friday, March 25, 2005 / Rules and Regulations 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 longterm 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 batteryoperated smoke detectors in the 

specified areas will be $29,400,000. 

Following installation of batteryoperated 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 

15236 Federal Register / Vol. 70, No. 57 / Friday, March 25, 2005 / Rules and Regulations 

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 longterm 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 longterm 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 hardwired 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 batteryoperated 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 hardwired 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 longterm 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 batteryoperated 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. 

Federal Register / Vol. 70, No. 57 / Friday, March 25, 2005 / Rules and Regulations 15237

42 CFR Part 485

Grant programs—health, Health 

facilities, Medicaid, Medicare, 

Reporting and recordkeeping 

requirements

■ 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

■ 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

■ 2. Add new paragraphs (a)(3) and (a)(4) 

to § 403.744 to read as follows:

§ 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

■ 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

■ 4. Add new paragraph (b)(5) to 

§ 416.44 to read as follows:

§ 416.44 Conditions for coverageEnvironment.

* * * * *

(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

■ 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

■ 6. Add a new paragraph (d)(6) to 

§ 418.100 to read as follows:

§ 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 

15238 Federal Register / Vol. 70, No. 57 / Friday, March 25, 2005 / Rules and Regulations 

amendment, CMS will publish notice in 

the Federal Register to announce the 

changes.

* * * * *

PART 460—PROGRAMS OF ALLINCLUSIVE CARE FOR THE ELDERLY 

(PACE)

■ 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

■ 8. Add a new paragraph (b)(5) to 

§ 460.72 to read as follows:

§ 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

■ 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

■ 10. Add a new paragraph (b)(9) to 

§ 482.41 to read as follows:

§ 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

■ 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

■ 12. In § 483.70, add new paragraphs 

(a)(6) and (a)(7) to read as follows:

§ 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 

Federal Register / Vol. 70, No. 57 / Friday, March 25, 2005 / Rules and Regulations 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

■ 13. Revise paragraph (j)(7) to § 483.470 

to read as follows:

§ 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

■ 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)

■ 15. Add a new paragraph (d)(7) to 

§ 485.623 to read as follows:

§ 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

DEPARTMENT OF THE INTERIOR

Fish and Wildlife Service 

50 CFR Part 17

RIN 1018–AI20

Endangered and Threatened Wildlife 

and Plants; Final Designation of 

Critical Habitat for Topeka Shiner

AGENCY: Fish and Wildlife Service, 

Interior.

ACTION: Final rule; correction.

SUMMARY: We, the U.S. Fish and 

Wildlife Service (Service), announce 

corrections to the final rule designating 

critical habitat for the Topeka shiner 

(Notropis topeka), published in the 

Federal Register on July 27, 2004. In the 

final rule, the map legends incorrectly 

referred to stream segments as 

‘‘proposed’’ critical habitat rather than 

‘‘designated’’ critical habitat, and six 

transcription errors were included in 

legal descriptions of critical habitat from 

Unit 1 (Iowa) and Unit 4 (Minnesota). 

This document corrects these errors.

DATES: Effective August 26, 2004.

FOR FURTHER INFORMATION CONTACT:

Vernon Tabor, Kansas Ecological 

Services Field Office, 315 Houston 

Street, Suite E, Manhattan, Kansas 

66502 (telephone 785–539–3474; 

facsimile 785–539–8567). The complete 

file for this correction document and the 

rule are available for public inspection, 

by appointment, during normal business 

hours at the above address. Copies of 

the rule, draft economic analysis, and 

draft environmental assessment are 

available by writing to the above 

address or by connecting to the Service