55326 Federal Register / Vol. 71, No. 184 / Friday, September 22, 2006 / Rules and Regulations 

Restricted area Inspection description Frequency 

Building 39 .............................................. Inspect to ensure that use does not allow residential, daycare or school (children under 18 years old), hotel, motel, community center (children under 18 

years old), and/or recreational uses or activities uses.

Annually in June. 

Buildings 131, 117, & 313–S .................. Inspect area to ensure no excavation, drilling or otherwise disturbance of the 

building foundations and slabs that would likely result in human contact with 

underlying soils have occurred.

Annually in June. 

The second five-year review, 

completed in March 2006, concluded 

that the remedy at OU1 (the only site 

where hazardous materials remain onsite) is protective of human health and 

the environment in the short-term 

because there is no evidence of 

exposure. However, there was concern 

that some bank erosion occurred along 

the Charles River adjacent to Charles 

River Park (in areas where the Army 

was not required to remediate). In order 

for the remedy to remain protective in 

the long term, the Army must stabilize 

the riverbank adjacent to Areas P and Q 

before the next five-year review. While 

the integrity of the two-foot soil 

coverage required by the ROD and ESD 

remains intact along the riverbanks, the 

Army will undertake preventive 

measures to ensure long-term site 

integrity. This work began in September 

2006 and is expected to be completed 

before the end of the year. 

Community Involvement 

In addition to the regular community 

meetings discussed below, community 

relations activities for the Army 

Materials Testing Laboratory NPL Site 

have included the following: 

development of a community relations 

plan, public meetings and site tours 

during the RI and remedy selection 

process, public comment periods on 

proposed plans, and publication and 

distribution of fact sheets updating the 

status of site cleanup. 

In 1989, the Army established a 

Technical Review Committee (TRC) to 

enhance community involvement. In 

1993 the TRC transitioned into a 

Restoration Advisory Board (RAB). The 

purpose of the TRC and RAB was to 

serve as a forum where representatives 

of the community, regulators, and the 

Army could discuss and exchange 

information on environmental cleanup 

issues and progress at the Site. The TRC 

and RAB provided an opportunity for 

stakeholders to participate in the 

decision-making process by reviewing 

and commenting on documents and 

proposed remedial actions. Through the 

TRC and RAB, cleanup decisions were 

discussed and approved. 

During fiscal year 2006, a fact sheet 

that discussed the intention to delete 

the site from the NPL was distributed to 

the RAB. EPA will also announce the 

deletion of the Site from the NPL once 

the deletion has been completed with 

fact sheet and public notice. 

V. Deletion Action 

EPA, with concurrence from the 

Commonwealth of Massachusetts, has 

determined that all appropriate 

responses under CERCLA have been 

completed, and that no further response 

actions under CERCLA are necessary. 

Therefore, EPA is deleting the Site from 

the NPL. 

Because EPA considers this action to 

be non-controversial and routine, EPA is 

taking it without earlier publication of 

a notice of intent to delete. This action 

will become effective November 21, 

2006 unless EPA receives adverse 

comments by October 23, 2006 or a 

parallel notice of intent to delete is 

published in the Proposed Rule section 

of today’s Federal Register. If adverse 

comments are received, EPA will 

withdraw this direct final notice of 

deletion before the effective date of the 

deletion and it will not take effect. EPA 

will respond to comments, as 

appropriate, and continue with the 

traditional deletion process on the basis 

of the notice of intent to delete and the 

comments already received. There will 

be no additional opportunity to 

comment. If EPA receives no adverse 

comment(s), this deletion will become 

effective November 21, 2006. 

List of Subjects in 40 CFR Part 300 

Environmental protection, Air 

pollution control, Chemicals, Hazardous 

waste, Hazardous substances, 

Intergovernmental relations, Penalties, 

Reporting and recordkeeping 

requirements, Superfund, Water 

pollution control, Water supply. 

Dated: September 12, 2006. 

Robert W. Varney, 

Regional Administrator, U.S. EPA—New 

England. 

■ For the reasons set out in this 

document, 40 CFR part 300 is amended 

as follows: 

PART 300—[AMENDED] 

■ 1. The authority citation for part 300 

continues to read as follows: 

Authority: 33 U.S.C. 1321(c)(2); 42 U.S.C. 

9601–9657; E.O. 12777, 56 FR 54757, 3 CFR, 

1991 Comp.; p. 351; E.O. 12580, 52 FR 2923, 

3 CFR, 1987 Comp., p. 193. 

Appendix B—[Amended] 

■ 2. Table 2 of Appendix B to part 300 

is amended by removing the entry for 

‘‘Materials Technology Laboratory (US 

ARMY), Watertown, MA.’’

[FR Doc. 06–7966 Filed 9–21–06; 8:45 am] 

BILLING CODE 6560–50–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–F] 

RIN 0938–AN36 

Medicare and Medicaid Programs; Fire 

Safety Requirements for Certain Health 

Care Facilities; Amendment 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Final rule. 

SUMMARY: This final rule adopts the 

substance of the April 15, 2004 tentative 

interim amendment (TIA) 00–1 (101), 

Alcohol Based Hand Rub Solutions, an 

amendment to the 2000 edition of the 

Life Safety Code, published by the 

National Fire Protection Association 

(NFPA). This amendment allows certain 

health care facilities to place alcoholbased hand rub dispensers in egress 

corridors under specified conditions. 

This final rule also requires that nursing 

facilities at least install battery-operated 

single station smoke alarms in resident 

rooms and common areas if they are not 

fully sprinklered or they do not have 

system-based smoke detectors in those 

areas. Finally, this final rule confirms as 

final the provisions of the March 25, 

2005 interim final rule with changes 

and responds to public comments on 

that rule. 

DATES: Effective Date: These regulations 

are effective on October 23, 2006. The 

incorporation by reference of certain 


rwilkins on PROD1PC63 with RULES_1
Federal Register / Vol. 71, No. 184 / Friday, September 22, 2006 / Rules and Regulations 55327 

publications listed in the rule is 

approved by the Director of the Federal 

Register as of October 23, 2006. 

FOR FURTHER INFORMATION CONTACT: 

Danielle Shearer, (410) 786–6617; James 

Merrill, (410) 786–6998; Jeannie Miller, 

(410) 786–3164; or Mayer Zimmerman, 

(410) 786–6839. 

SUPPLEMENTARY INFORMATION: 

I. Background 

A. Alcohol-Based Hand Rubs (ABHR) 

The Life Safety Code (LSC) is a 

compilation of fire safety requirements 

for new and existing buildings that is 

updated and generally published every 

3 years by the National Fire Protection 

Association (NFPA), a private, nonprofit 

organization dedicated to reducing loss 

of life due to fire. The Medicare and 

Medicaid regulations have historically 

incorporated these requirements by 

reference, while providing the 

opportunity for a Secretarial waiver of a 

requirement under certain 

circumstances. The general statutory 

basis for incorporating NFPA’s LSC for 

our providers is under the Secretary’s 

general rulemaking authority at sections 

1102 and 1871 of the Social Security 

Act. 

On January 10, 2003, we published a 

final rule in the Federal Register, 

entitled ‘‘Fire Safety Requirements for 

Certain Health Care Facilities’’ (68 FR 

1374). In that final rule, we adopted the 

2000 edition of the LSC provisions 

governing Medicare and Medicaid 

health care facilities. The Office of the 

Federal Register’s rules regarding 

incorporation by reference state that the 

document so incorporated is the one 

referred to as it exists on the date of 

publication of the final rule. Among 

other things, the 2000 edition of the LSC 

prohibited the placement of accelerants, 

including alcohol-based hand rub 

(ABHR) dispensers, in egress corridors, 

but allowed their placement in patient 

rooms and other appropriate areas. 

On April 15, 2004 the NFPA adopted 

a tentative interim amendment (TIA) 

001 (101), Alcohol Based Hand Rub 

Solutions, to the 2000 edition of the 

LSC. This amendment allows certain 

health care facilities to install alcoholbased hand rub (ABHR) dispensers in 

egress corridors under certain specified 

conditions. 

On March 25, 2005 we published an 

interim final rule with comment period 

in the Federal Register, entitled ‘‘Fire 

Safety Requirements for Certain Health 

Care Facilities; Amendment’’ (70 FR 

15229). In that interim final rule, we 

adopted the substance of the April 15, 

2004 TIA. 

As stated in the preamble to the 

March 2005 interim final rule, ABHRs 

have become an increasingly common 

infection control method. Effective 

infection control has been a concern 

identified in numerous research studies 

and reports. 

The Centers for Disease Control and 

Prevention (CDC) reports that there are 

more than 2 million health care 

acquired infections per year (http:// 

www.cdc.gov/handhygiene/firesafety/ 

aha_meeting.htm). Many of the 

microorganisms that cause these 

infections are transmitted to patients 

because health care workers do not 

wash their hands or do so improperly or 

inadequately. Improving hand hygiene 

is an important step towards reducing 

the number of health care acquired 

infections. In October 2002, the CDC 

posted hand hygiene guidelines for 

health care settings on its Web site 

(http://www.cdc.gov/handhygiene/ 

firesafety/default.htm). The guidelines 

clearly recommended the use of ABHRs. 

The CDC stated that—

• Compared with soap and water 

hand washing, ABHRs are more 

effective in reducing bacteria on hands, 

cause less skin irritation/dermatitis, and 

save personnel time; 

• Use of ABHRs has been associated 

with improved adherence to 

recommended hand hygiene practices; 

• Adherence is directly tied to access. 

The highest possible adherence to hand 

hygiene practice is achieved when 

ABHR dispensers are in readily 

accessible locations such as the corridor 

near the patient room entrance and 

inside patient rooms; and 

• Improved hand hygiene practices 

have been associated with reduced 

health care-associated infection rates. 

Research from a variety of sources 

confirms the CDC’s research and 

statements about the usefulness and 

effectiveness of ABHRs in health care 

facilities. For example, the study 

‘‘Improving adherence to hand hygiene 

practice: A multidisciplinary approach’’

(Pittet D. Emerging Infectious Diseases. 

2001 March–April; 7(2):243–40. Review) 

concludes that, ‘‘[a]lcohol-based hand 

rub, compared with traditional 

handwashing with unmedicated soap 

and water or medicated hand antiseptic 

agents, may be better because it requires 

less time, acts faster, and irritates hands 

less often.’’

The same study goes on to state that, 

‘‘[t]his method was used in the only 

program that reported a sustained 

improvement in hand hygiene 

compliance with decreased infection 

rates.’’ The relationship between ABHRs 

and improved adherence to 

recommended hand hygiene practices is 

also found in other studies, including 

‘‘Availability of an alcohol solution can 

improve hand disinfection compliance 

in an intensive care unit’’ (Maury E, et 

al. American Journal of Respiratory and 

Critical Care Medicine, 2000; 162:324–

327). This study saw compliance with 

hand hygiene practice rates rise from 

42.4 percent before the introduction of 

ABHRs to 60.9 percent afterwards. Each 

category of health care employer, from 

nurses to physicians, and even patients, 

increased compliance with hand 

hygiene practices. 

Another study, ‘‘Effectiveness of a 

hospital-wide programme to improve 

compliance with hand hygiene’’ (Pittet 

D, Hugonnet S, Harbarth S, et al. Lancet 

356; 2000; 1307–1312), also 

demonstrated an increase in compliance 

with hand hygiene practices that was 

directly related to the use of ABHRs. In 

this study, compliance rates rose from 

47.6 percent to 66.2 percent over a 3- 

year period. Handwashing rates 

remained stable at 30 percent during 

this period while hand disinfection 

rates rose from 13.6 percent to 37.0 

percent. During this time, the annual 

amount of ABHR use increased from 

3.5L per 1,000 patients to 10.9L per 

1,000 patients. The increase in hand 

disinfection through ABHRs and related 

increase in compliance with hand 

hygiene practices are directly tied to the 

increased availability and use of 

ABHRs. 

An important aspect of getting health 

care workers and others to use ABHRs 

is their accessibility. In the study 

‘‘Handwashing compliance by health 

care workers: The impact of introducing 

an accessible, alcohol-based antiseptic’’

(Bischoff WE, et al. Archives of Internal 

Medicine, 2000; 160: 1017–1021), 

researchers assessed how the 

accessibility of ABHRs impacted their 

use. The researchers found that when 

one ABHR dispenser was available for 

every four patient beds, the adherence 

rate for hand hygiene was 19 percent 

before patient contact and 41 percent 

after patient contact. When one ABHR 

dispenser was available for each bed, 

the rates rise to 23 percent before 

patient contact and 48 percent after 

patient contact. Increased availability of 

ABHR dispensers resulted in increased 

hand hygiene rates. 

The relationship between increased 

availability and increased use is likely 

the result of several factors. An increase 

in the number of ABHR dispensers acts 

as a continuous reminder to workers 

and others that they need to disinfect 

their hands. For example, each time an 

individual approaches a patient area, he 

or she may see, right next to the door, 

an ABHR dispenser. The dispenser 


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55328 Federal Register / Vol. 71, No. 184 / Friday, September 22, 2006 / Rules and Regulations 

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 healthcareacquired 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). 

The benefits of using ABHRs have 

been well demonstrated. However, there 

have been previous concerns about 

placing ABHR dispensers in egress 

corridors. The ABHRs are most 

commonly found in a gel form 

contained in a single use disposable bag 

that is inserted into a wall-mounted 

dispenser, similar in appearance to 

wall-mounted hand soap dispensers. 

The dispenser compresses the bag to 

dispense the gel. During normal 

operation and replacement, the 

dispenser remains a closed system, 

meaning that vapors are not released 

into the atmosphere. In addition, 

refilling is done using single-use 

disposable bags rather than large bulk 

containers. The relatively small quantity 

of gel in each dispenser combined with 

the absence of vapor release means that 

these dispensers, when properly 

installed and used, pose little fire risk 

in health care facilities. 

In July 2003, the American Hospital 

Association (AHA), in conjunction with 

the CDC, held a stakeholder meeting 

with representatives from more than 20 

governmental and non-governmental 

agencies, including CMS, to discuss the 

issue of the placement and use of 

ABHRs. During the meeting, the AHA 

presented a fire modeling study that was 

conducted by Gage-Babcock & 

Associates, Inc. on behalf of the AHA’s 

sister organization, the American 

Society for Healthcare Engineering 

(ASHE). This study demonstrated that 

placing ABHR dispensers in egress 

corridors is safe, provided that certain 

conditions are met (http:// 

www.hospitalconnect.com/ashe/ 

currentevent/alcohol_based_hand_rub/ 

Final_Report_rev1.2_Part_1_2.pdf). 

In February 2004, the ASHE 

submitted and received approval for 

tentative interim amendment (TIA) 00–

1 (101), Alcohol Based Hand Rub 

Solutions, to amend the 2003 edition of 

the LSC. This TIA permitted the 

placement of ABHR dispensers in egress 

corridors if certain criteria are met. At 

the April 15, 2004 meeting of the 

NFPA’s Standards Council, TIA 00–1 

(101) was approved for the 2003 edition 

of the LSC. The TIA was also approved 

for the 2000 edition of the LSC (the 

edition CMS adopted). The TIA altered 

chapters 18.3.2.7 and 19.3.2.7 of the 

2000 edition of the LSC. The change 

became effective May 5, 2004. 

Normally, when the NFPA amends 

the LSC, it amends the most recently 

published edition of the code. The most 

recently published edition at that time 

was the 2003 edition. However, when 

the NFPA amended the LSC this time, 

it retroactively amended the 2000 

edition of the LSC in addition to the 

2003 edition of the LSC. This is the first 

time that the NFPA ever retroactively 

adopted an amendment for an earlier 

edition of the LSC. 

We are adopting the amendment to 

chapters 18 and 19 of the 2000 edition 

of the LSC, specifically the changes to 

chapters 18.3.2.7 and 19.3.2.7. Adopting 

the amended chapters will allow health 

care facilities to place ABHR dispensers 

in egress corridors. We are not adopting 

the entire revised 2000 edition of the 

LSC. 

Chapters 18 and 19 of the Life Safety 

Code apply to hospitals, long-term care 

facilities, religious non-medical health 

care institutions, hospices, programs of 

all-inclusive care for the elderly, 

hospitals, intermediate care facilities for 

the mentally retarded, and critical 

access hospitals. 

Ambulatory surgical centers (ASCs) 

are not covered under chapters 18 or 19 

of the LSC; but are rather covered under 

chapters 20 (new construction) and 21 

(existing construction) of the LSC. Many 

ASCs are interested in installing ABHR 

dispensers in corridors. However, 

chapters 20 and 21 of the 2000 edition 

of the LSC have not been amended thus 

far to permit the installation of ABHR 

dispensers in egress corridors in ASCs. 

We are allowing ASCs to install ABHR 

dispensers in egress corridors according 

to the same conditions identified for 

other health care facilities. 

We consider a health care facility to 

be in compliance with our requirements 

if the placement of ABHR dispensers 

meets the specified conditions listed in 

section II.A of this final rule. The ABHR 

dispensers will also be required to meet 

the following criteria that are listed in 

chapters 18.3.2.7 and 19.3.2.7 of the 

2000 edition of the LSC as amended: 

• Where dispensers are installed in a 

corridor, the corridor shall have a 

minimum width of 6 ft (1.8m). 

• The maximum individual dispenser 

fluid capacity shall be: 

—0.3 gallons (1.2 liters) for dispensers 

in rooms, corridors, and areas open to 

corridors. 

—0.5 gallons (2.0 liters) for dispensers 

in suites of rooms. 

• The dispensers shall have a 

minimum horizontal spacing of 4 ft 

(1.2m) from each other. 

• Not more than an aggregate 10 

gallons (37.8 liters) of ABHR solution 

shall be in use in a single smoke 

compartment outside of a storage 

cabinet. 

• Storage of quantities greater than 5 

gallons (18.9 liters) in a single smoke 

compartment shall meet the 

requirements of NFPA 30, Flammable 

and Combustible Liquids Code. 

• The dispensers shall not be 

installed over or directly adjacent to an 

ignition source. 

• In locations with carpeted floor 

coverings, dispensers installed directly 

over carpeted surfaces shall be 

permitted only in sprinklered smoke 

compartments. 

After careful and thorough 

consideration of the numerous studies 

and recommendations presented above, 

we believe that placing ABHR 

dispensers in all appropriate areas, 

including corridors, is safe and 

appropriate for patients and providers 

alike. 

B. Smoke Alarms 

A recent Government Accountability 

Office (GAO) report entitled ‘‘Nursing 

Home Fire Safety: Recent Fires 

Highlight Weaknesses in Federal 

Standards and Oversight’’ (GAO–04–

660, July 16, 2004, http://www.gao.gov/ 

new.items/d04660.pdf) examined two 

long-term care facility fires in 2003 that 

resulted in 31 resident deaths. The 

report examined Federal fire safety 

standards and enforcement procedures, 

as well as results from fire 

investigations of these two incidents. 

The report recommended that fire safety 

standards for unsprinklered facilities be 

strengthened. It specifically cited 

requiring smoke detectors in these 

facilities as one way to strengthen the 

requirements. 


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Federal Register / Vol. 71, No. 184 / Friday, September 22, 2006 / Rules and Regulations 55329 

On March 25, 2005, we published an 

interim final rule with comment period 

in the Federal Register, entitled ‘‘Fire 

Safety Requirements for Certain Health 

Care Facilities; Amendment’’ (70 FR 

15229). In that interim final rule, we 

required that long term care facilities at 

least install battery operated smoke 

detectors in resident rooms and public 

areas if they did not have sprinklers 

installed throughout or they did not 

have a hard-wired smoke detection 

system in the specified areas. This 

interim final regulation implemented 

the smoke detector recommendation 

made by the GAO in the 2004 report. As 

we will discuss in section III.B, Analysis 

of and Responses to Public Comments, 

Smoke Alarms, of this document, we are 

altering the terminology used to 

describe the smoke detector 

requirement. From this point forward, 

we will refer to the following terms in 

the manner specified below unless 

otherwise noted: 

• ‘‘Smoke detectors’’ are now ‘‘smoke 

alarms’’; 

• ‘‘Public areas’’ are now ‘‘common 

areas’’; 

• Having ‘‘sprinklers installed 

throughout’’ is now ‘‘fully sprinklered’’; 

and 

• ‘‘A hard-wired smoke detection 

system’’ is now ‘‘system-based smoke 

detectors’’. 

The fires, in Hartford, Connecticut 

and Nashville, Tennessee, had several 

things in common. Each fire began in a 

resident sleeping room at night, neither 

of those rooms had a smoke alarm, and 

the majority of victims died from smoke 

inhalation. The lack of smoke alarms in 

resident rooms, the report concludes, 

‘‘* * * may have delayed staff response 

and activation of the buildings’ fire 

alarms.’’

Relying on an effective and timely 

staff response was, and still is, a crucial 

aspect of facility fire safety 

requirements. Long-term care facilities 

are required by the 2000 edition of the 

LSC (chapters 18.7.1.1 and 19.7.1.1) to 

have an emergency plan that will be 

implemented in the event of a fire at the 

facility. As part of this plan, staff 

members at Medicare-approved 

facilities are typically expected to do 

things such as close resident room 

doors, turn off fans and other air 

circulation devices, and evacuate 

residents. 

However, battery-operated smoke 

alarms, a basic fire safety device, are 

only required by the 2000 edition of the 

Life Safety Code (which refers to them 

as smoke detectors) to be installed in 

existing non-sprinklered resident rooms 

when those rooms contain furniture that 

the resident has brought from his or her 

home. This was not the case in either 

fire; therefore, smoke alarms were not in 

the resident sleeping rooms where the 

fires started. 

While resident rooms are the leading 

area of fire origin, fires can and do 

originate in other areas. For example, a 

fire could originate in an unoccupied 

resident activity room. There is a 

possibility that no one will be aware of 

this fire until smoke spreads to a 

corridor where there are smoke alarms. 

By this time, smoke may have also 

begun filtering into other areas of the 

facility such as resident sleeping rooms 

and common areas that are occupied, 

thus harming those residents. In order to 

alert staff and residents in the earliest 

stages of a fire, we believe that it is 

necessary to install smoke alarms in 

resident sleeping rooms and common 

areas. For these reasons, we are 

requiring that long-term care facilities 

that do not have sprinklers must at least 

install battery-operated single station 

smoke alarms in resident rooms and 

common areas. We have discussed this 

issue in detail in section II.B of this final 

rule. 

This rule requires facilities to at least 

install battery-operated single station 

smoke alarms in the identified areas. We 

encourage facilities to go beyond this 

minimum requirement by installing 

multiple station smoke alarms that can 

be interconnected to other smoke alarms 

so that the activation of one alarm 

causes the alarm signal in all 

interconnected smoke alarms to sound. 

Installing and maintaining these more 

advanced smoke alarms would meet and 

exceed the minimum requirements of 

this regulation. 

Facilities that chose to install systembased smoke detectors in accordance 

with NFPA 72, National Fire Alarm 

Code, in resident rooms and common 

areas would be deemed to have met this 

requirement. System-based smoke 

detectors are connected to a building’s 

general fire alarm system and are 

designed to activate that system, thus 

alerting the occupants of the entire 

building and notifying the fire 

department. If a facility chose to install 

system-based smoke detectors in 

resident rooms and common areas, then 

it does not have to install batteryoperated single station smoke alarms 

because such a system exceeds the 

requirements of this final rule. 

Facilities that are fully sprinklered in 

accordance with NFPA 13, Standard for 

the Installation of Sprinkler Systems, 

would also be considered to meet the 

requirement and would not have to 

install smoke alarms, because such a 

system exceeds this requirement. 

II. Provisions of the Proposed 

Regulations 

A. Alcohol-Based Hand Rubs 

For the reasons specified in the 

preamble, in sections I.A. and I.B. 

above, we are modifying the conditions 

of participation for the following 

facilities: 

• Religious non-medical health care 

institutions (RNHCI) (new 

§ 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)(5)). 

• 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)). 

Specifically, we are adding a new 

provision that will allow these facilities 

to place ABHR dispensers in various 

locations, including egress corridors, if 

the facilities meet the following 

conditions: 

• The use of ABHR dispensers does 

not conflict with any State or local 

codes that prohibit or otherwise restrict 

the placement of ABHR dispensers in 

health care facilities. Allowing ABHR 

dispensers to be installed in egress 

corridors will be a significant lessening 

of restrictions. States and local 

jurisdictions may choose to retain 

stricter codes that prohibit or otherwise 

restrict the installation of ABHR 

dispensers in health care facilities. 

Facilities will still be required to 

comply with those stricter State and 

local codes. Therefore, facilities could 

only install ABHR dispensers if the 

dispensers were also permitted by State 

and local codes. 

• The dispensers are installed in a 

manner that minimized leaks and spills 

that could lead to falls. Like soap, 

ABHRs are very slick. As such, it is 

more likely for someone to slip and fall 

on a surface that is covered by an ABHR 

solution than on a surface that is clean. 

The increased risk of falls posed by 

the presence of leaky or spilled ABHR 

dispensers might be compounded by the 

medical conditions of patients or 

residents. While a healthy individual 

may fall and only suffer a bruise, a frail 

individual may suffer a broken hip. It is 

the specific safety needs of the patient 

populations found in hospitals and 

other health care facilities that 

necessitate the requirement that 

facilities take extra steps to ensure that 

ABHR dispensers do not leak or spill. 


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• The dispensers are installed in a 

manner that adequately protects against 

inappropriate access. There are certain 

patient or resident populations, such as 

residents of dementia wards, who may 

misuse ABHR solutions, which are both 

toxic and flammable. As a toxic 

substance, ABHR solutions are very 

dangerous if they are ingested, placed in 

the eyes, or otherwise misused. As a 

flammable substance, ABHR solutions 

could be used to start fires that endanger 

the lives of patients and destroy 

property. 

Due to disability or disease, some 

patients are more likely to harm 

themselves or others by inappropriately 

using ABHR solutions. In order to avoid 

any and all dangerous situations, a 

facility will have to take all appropriate 

precautions to secure the ABHR 

dispensers from inappropriate access. 

This may mean that facilities could 

choose to not install ABHR dispensers 

in corridors in or near dementia or 

psychiatric units. It may also mean that 

facilities could choose to install ABHR 

dispensers only in areas that can be 

easily and frequently monitored, such as 

in view of a nursing station or a 

continuously monitored security 

camera. These are just a few of the many 

options that facilities may choose to 

utilize in securing ABHR dispensers 

against inappropriate access. 

• The dispensers are installed in 

accordance with chapters 18.3.2.7 and 

19.3.2.7 of the 2000 edition of the LSC 

as amended. The revisions to the 

chapters were thoroughly examined by 

the NFPA’s fire safety experts and are 

based on the fire modeling study 

conducted by Gage-Babcock for the 

ASHE. As noted above, the study 

demonstrated that ABHR dispensers 

installed in egress corridors do not 

increase the risk of fire if certain 

conditions, as outlined in chapters 

18.3.2.7 and 19.3.2.7 of the 2000 edition 

of the LSC, are met. 

• The dispensers are maintained in 

accordance with dispenser 

manufacturer guidelines. Regular 

maintenance of dispensers in 

accordance with the directions of the 

manufacturer is a crucial step towards 

ensuring that the dispensers do not leak 

or spill. Having a maintenance program 

will help ensure that the dispensers are 

functioning properly and that any 

malfunctions are addressed in a timely 

manner. Following manufacturer 

guidelines will help ensure that 

maintenance is properly performed and 

assure properly functioning dispensers. 

B. Smoke Alarms 

We are requiring in § 483.70(a)(7) that 

long-term care facilities will, at 

minimum, be required to install batteryoperated single station smoke alarms in 

resident sleeping rooms and common 

areas, unless they have system-based 

smoke detectors in those areas or they 

are a fully sprinklered facility. Facilities 

may choose to use more advanced 

smoke alarms such as dual sensor 

alarms or AC-powered alarms. These 

devices are at least equivalent to batterypowered single station smoke alarms 

and can be used in place of or in 

conjunction with each other. We are 

also requiring that facilities that install 

battery-operated single station smoke 

alarms have their own program for 

inspection, testing, maintenance, and 

battery replacement that verifies correct 

operation of the battery-operated single 

station smoke alarms. Facilities should 

ensure that their testing, maintenance, 

and battery replacement programs 

conform with manufacturer 

recommendations. Battery-operated 

single station smoke alarms, when 

properly installed and maintained in 

resident sleeping rooms and common 

areas, are a basic, useful, and effective 

fire safety tool. 

We believe that at least installing 

battery-operated single station smoke 

alarms will provide earlier warning for 

facility residents and staff. Fires that 

originate in these areas will be detected 

earlier because the alarm will be located 

closer to the fire’s origin. Earlier 

detection, and thus earlier alarm, will 

allow residents and staff more time to 

react to the situation and implement the 

facility’s emergency plan. Implementing 

the emergency plan typically includes 

notifying the fire department, and this 

earlier notification will speed the arrival 

of help. These factors would help to 

reduce the loss of life in a nursing 

facility fire. 

As discussed earlier, a facility will be 

required to have a program for 

inspection, testing, maintenance, and 

battery replacement to ensure the 

correct operation of the battery-operated 

single station smoke alarms. 

Battery-operated single station smoke 

alarms with standard batteries require 

maintenance every 6 months to 1 year 

in order to ensure that the batteries are 

operating at optimum power. We 

understand that there are batteryoperated single station smoke alarms 

that use longer-lasting batteries. If a 

facility chooses to use such longer life 

batteries, we would continue to expect 

that the maintenance plan would reflect 

manufacturer recommendations. An 

alarm with a depleted battery provides 

no protection. Thus, a regular 

maintenance program for the alarms is 

crucial to ensuring that residents and 

staff are indeed protected. Facilities will 

be expected to add maintenance of 

smoke alarms that conforms to 

manufacturer recommendations to their 

existing maintenance schedule. 

The regulation has two exceptions, 

one for facilities that have system-based 

smoke detectors in accordance with 

NFPA 72, National Fire Alarm Code, 

and one for facilities that are fully 

sprinklered in accordance with the 

requirements of NFPA 13, Standard for 

the Installation of Sprinkler Systems. 

System-based smoke detectors installed 

in resident rooms and common areas 

will protect the same areas as the 

battery-operated alarms. Therefore, 

having both system-based smoke 

detectors and battery-operated alarms in 

these areas will be redundant, 

unnecessary, and overly burdensome. 

Facilities may still choose to use 

battery-operated single station alarms 

along with system-based smoke 

detectors as an additional layer of fire 

protection, but we are not requiring the 

facilities to do so in this final rule. 

Likewise, having both a fully 

sprinklered facility and battery-operated 

smoke alarms in resident rooms and 

common areas will duplicate fire safety 

efforts. Sprinklers are considered to be 

the best way to protect building 

occupants in fires. Their response time 

and their ability to extinguish fires 

before they become a significant hazard 

will make battery-operated smoke 

alarms an unnecessary requirement. 

Facilities may still choose to use smoke 

alarms as an additional layer of fire 

protection beyond sprinklers, but they 

will not be required to do so in this final 

rule. 

III. Analysis of and Responses to Public 

Comments 

We received 11 timely public 

comments in response to the March 

2005 publication of the interim final 

rule with comment period. We received 

comments from Federal government 

officials, State government officials, 

health care providers and provider 

organizations, other national 

organizations, and private industry. A 

summary of the comments and our 

responses follows. 

A. Alcohol-Based Hand Rubs 

Comment: One commenter stated that 

chapters 18.3.2.7 and 19.3.2.7 of the 

2000 edition of the LSC refer to rooftop 

heliports. 

Response: The Tentative Interim 

Amendment (TIA) 00–1 (101) amended 

the 2000 edition of the LSC. One result 

of this amendment was that chapters 18 

and 19 of the 2000 edition of the LSC 

were slightly renumbered. Under the 

new numbering scheme, chapters 


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18.3.2.7 and 19.3.2.7 of the 2000 edition 

of the LSC now refer to the placement 

of ABHRs in egress corridors. 

Comment: Several commenters stated 

their support for CMS’ adoption of the 

TIA permitting ABHR dispensers to be 

installed in egress corridors as a means 

of decreasing the risk of transmission of 

health care associated infections, while 

one commenter disagreed with CMS’

decision. The commenter who disagreed 

considers ABHR dispensers to 

potentially be a significant fire risk and 

stated that adopting the TIA sets a 

dangerous precedent for allowing other 

flammable solutions to be placed in exit 

corridors. 

Response: We appreciate the support 

that we have received regarding the 

placement of ABHR dispensers in egress 

corridors. We believe that ABHRs are an 

important tool that health care facilities 

should have at their disposal to help 

minimize the risk of the transmission of 

health care associated infections. We 

agree that making ABHR dispensers 

available in highly visible and 

convenient locations such as corridors 

will likely increase their rate of usage. 

At the same time, we understand that 

there are concerns regarding the safety 

of placing ABHR dispensers in egress 

corridors. The fire modeling study 

conducted by Gage-Babcock & 

Associates, Inc. demonstrated that 

installing ABHR dispensers in egress 

corridors can be done in a way that does 

not dramatically increase the threat of 

fire in these areas. The manner in which 

the dispensers are installed (that is, in 

a 6-feet-wide corridor and at least 4 feet 

apart) minimizes the potential fire safety 

risk associated with the dispensers. We 

adopted all of the technical installation 

requirements recommended by the 

NFPA, and we added other installation 

requirements related to other non-fire 

safety risks. We believe that all of these 

requirements will provide for a safe 

patient care environment while 

allowing health care providers the 

flexibility to address infection control 

concerns in a manner they see fit. 

Any lingering fire safety concerns are, 

we believe, outweighed by the strong 

body of evidence that demonstrates that 

ABHRs are an effective hand hygiene 

tool and that their use has a positive 

impact on infection control practices. 

Healthcare-associated infections pose an 

imminent threat to patient health and 

safety, and we believe that all steps 

should be taken to prevent and control 

such infections. 

Comment: A few commenters 

expressed their concern with the LSC 

TIA language which states that, ‘‘The 

dispensers shall not be installed over or 

directly adjacent to an ignition source.’’

The commenters requested that we 

define the term ‘‘adjacent to’’ and that 

we describe the ‘‘adjacent to’’

relationship between ABHR dispensers 

and palm readers and time clocks. 

Response: The NFPA does not define 

a specific distance for the term ‘‘directly 

adjacent to’’ when discussing flammable 

substances and potential ignition 

sources. If the NFPA were to define this 

term at a later date, we would consider 

using their definition. In the absence of 

a clear definition from the NFPA, we 

believe that the term ‘‘directly adjacent 

to’’ means that ABHR dispensers should 

not be placed in close proximity to an 

electrical source. We would expect that 

facilities would not install dispensers 

next to or directly over electrical outlets 

or equipment. Rather than installing 

dispensers next to an electrical device 

such as an employee palm reader or 

time punch clock in order to encourage 

the use of ABHRs before or after 

touching these devices, facilities may 

choose to install them on other walls, 

near doorways, or other appropriate 

areas as permitted by this rule. 

Comment: Several commenters stated 

that CMS should not defer to State or 

local codes that prohibit or otherwise 

restrict the placement of ABHR 

dispensers in health care facilities. One 

commenter agreed that State and local 

jurisdictions have the right to retain 

stricter codes. The commenters who 

disagreed with the deferral to State and 

local codes indicated that the potential 

infection control benefits of ABHRs 

should take precedence over any State 

or local codes that would prohibit or 

restrict ABHR dispenser placement. 

Response: Health care facilities that 

participate in the Medicare and 

Medicaid programs are required to 

comply with Federal, State, and local 

laws, regulations, and codes. For some 

facility types, this requirement is 

explicitly stated in the applicable 

Conditions of Participation. For other 

facility types, this requirement stems 

from the requirement that facilities must 

be licensed by the State in which they 

function if the State has such licensure 

requirements. 

In this particular situation, we believe 

that whichever code is the most 

stringent (with respect to fire protection) 

is the one that facilities should be 

required to meet. States and local 

jurisdictions are the most attuned to the 

particular needs of their populations 

and have the right to decide how to best 

meet those needs. If State or local 

jurisdictions have chosen to use codes 

that are more restrictive in regards to the 

placement of ABHR dispensers, then 

facilities must meet those codes. 

Comment: One commenter stated that 

TIA stands for Tentative Interim 

Amendment rather than Temporary 

Interim Amendment. 

Response: We appreciate the 

correction and have adjusted our 

terminology as needed throughout the 

preamble and regulation. 

Comment: One commenter noted that 

ambulatory surgical centers (ASCs) are 

covered under both chapters 20 and 21 

of the LSC, rather than only under 

chapter 21 as stated in the preamble of 

the interim final rule. The same 

commenter also questioned whether or 

not ASCs are, like other health care 

providers, required to have at least 6- 

feet-wide corridors in order to install 

ABHR dispensers in those corridors. 

Response: We appreciate the 

correction and have adjusted the 

preamble discussion to reflect the fact 

that Chapter 20 applies to newly 

constructed ASCs while Chapter 21 

applies to existing ASCs. 

In the interim final rule, we permitted 

ASCs to install ABHR dispensers in 

egress corridors in accordance with the 

technical specification of the TIA, even 

though the LSC chapters for ASCs were 

not amended. We did this because the 

evidence supporting the safety and 

effectiveness of ABHRs in corridors 

equally supports their installation in 

health care occupancies and ASCs. 

We understand that ASCs may not be 

able to meet all of the technical 

specifications for installing ABHR 

dispensers in egress corridors, 

particularly the requirement that 

corridors must be at least 6 feet wide. 

However, the 6-feet-wide minimum 

corridor requirement is considered to be 

an essential fire safety precaution. 

Narrowing the corridor requirement 

would, according to the fire modeling 

study evidence presented by GageBabcock, likely increase the fire-related 

risk of these dispensers. Chapters 20 

and 21 of the 2006 edition of the LSC 

allow ABHR dispensers in egress 

corridors, provided that those 

dispensers and corridors meet the same 

technical specifications as for health 

care occupancies, including having 

minimum 6-feet-wide corridors. 

Comment: A few commenters 

commended CMS for addressing the 

potential ‘‘slip/fall’’ and misuse hazard 

potentials of ABHRs. These commenters 

agreed that these hazard potentials are 

legitimate concerns that CMS should 

address since they were not the focus of 

the TIA. 

However, one commenter stated that, 

while addressing a necessary 

component of safety, CMS should delete 

the requirement that facilities must 

install ABHR dispensers in a manner 


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that minimizes leaks and spills that 

could lead to falls. The commenter 

stated that this requirement goes beyond 

the requirements of the LSC amendment 

and that installation would not 

necessarily ‘‘prevent leaks and spills.’’

The commenter went on to state that 

long term care facilities are already 

required in regulation to maintain an 

environment that is as free of accident 

hazards as is possible. The commenter 

did not cite similar regulations for other 

provider types. 

Response: We agree that addressing 

all aspects of ABHR dispenser 

placement is a necessary component of 

ensuring that patients and residents 

receive care in a safe environment. As 

stated in the preamble of the interim 

final rule, we believe that steps can and 

should be taken during the installation 

process to minimize leaks and spills 

that could lead to falls. Facilities may 

choose a variety of installation options 

such as drip cups or other devices and 

techniques to address this area of 

concern. We understand that taking the 

necessary steps to minimize leaks and 

spills, as required by the interim final 

rule, does not necessarily mean that 

ABHR-related falls will be completely 

prevented. 

We acknowledge that long term care 

facilities are already required in the 

Conditions of Participation to address 

accident hazards. Addressing leak and 

spill possibilities during the installation 

process should help these facilities meet 

the existing requirement that they 

maintain environments that are as free 

of accident hazards as is possible. 

Comment: One commenter questioned 

whether facilities that had already 

installed nonconforming ABHR 

dispensers in egress corridors would be 

allowed to keep those dispensers in 

place. 

Response: ABHR dispensers installed 

in corridors must be installed in 

accordance with the technical 

specifications of chapters 18.3.2.7 and 

19.3.2.7 as well as the additional 

specifications included in this final 

rule. If a facility were to have ABHR 

dispensers in its corridors that did not 

meet our specifications, then that 

facility would be out of compliance 

with the applicable fire safety standard. 

Such a facility would be expected to 

remove and/or relocate the improperly 

installed ABHR dispensers. The facility 

could choose to have ABHR dispensers 

in areas other than corridors or the 

facility could choose to re-install their 

dispensers in corridors in accordance 

with this rule. However, we do not 

anticipate that any Medicare or 

Medicaid participating facility will face 

this situation. Until March 25, 2005 

when the interim final rule was 

published, all Medicare and Medicaid 

participating facilities were prohibited 

from installing ABHR dispensers in 

egress corridors under any 

circumstances. Therefore, we would not 

expect that there would be many 

instances of facilities installing ABHR 

dispensers that were out of compliance 

with our rules. 

Comment: One commenter observed 

that the requirement that facilities 

install ABHR dispensers in a manner 

that adequately protects against access 

by vulnerable populations lacks 

specificity. The commenter suggested 

that language be added to the regulation 

stating that vulnerable populations are 

determined by the facility’s clinical 

staff. 

Response: We agree that the term 

‘‘vulnerable populations’’ is too general. 

We have removed this term. However, 

we continue to believe that protecting 

against inappropriate access to 

minimize the potential for misuse of 

ABHRs is an appropriate goal of the 

Conditions of Participation. Therefore, 

we have revised the regulatory text to 

read, ‘‘The dispensers are installed in a 

manner that adequately protects against 

inappropriate access.’’

Comment: One commenter noted that 

CMS did not require facilities to 

maintain their ABHR dispensers and 

noted that, without such maintenance, 

the devices may pose an increased risk. 

Response: We agree that proper 

maintenance of ABHR dispensers is an 

essential step toward ensuring that 

ABHR dispensers are, and continue to 

be, safe. To that end, we have added a 

new requirement at § 403.744(a)(4)(v), 

§ 416.44(b)(5)(v), § 418.100(d)(6)(v), 

§ 460.72(b)(5)(v), § 482.41(b)(9)(v), 

§ 483.70(a)(6)(v), § 483.470(j)(7)(ii)(E), 

and § 485.623(d)(7)(v) that facilities that 

choose to install ABHR dispensers must 

maintain those dispensers in accordance 

with dispenser manufacturer guidelines. 

If there were no manufacturer 

guidelines, we would expect facilities to 

have their own ABHR dispenser 

maintenance policies and procedures. 

Comment: One commenter noted that 

there are other products available that 

fulfill the same purpose as ABHRs, but 

do not pose the flammability risk that 

ABHRs do. The commenter contended 

that the availability of these other 

products makes the TIA unnecessary. 

Response: We support allowing health 

care facilities a wide variety of safe 

options to use in their efforts to improve 

infection control practices. Facilities 

can choose to use hand hygiene 

products based on their unique 

characteristics, and those products may 

or may not contain flammable 

substances like alcohol. Facilities are 

encouraged to examine all of the 

infection control options that are 

available to them. We believe that, as 

long as hand hygiene products like 

ABHRs can be safely used under certain 

specified conditions, the Conditions of 

Participation for Medicare and Medicaid 

providers should not unnecessarily 

impede their use. 

B. Smoke Alarms 

Comment: Many commenters noted 

that the proper term for the device that 

we described in the preamble is ‘‘single 

station smoke alarm’’ rather than 

‘‘smoke detector.’’ One commenter went 

on to note that the proper term for the 

smoke detection system that we 

described in exception one is ‘‘systembased smoke detectors’’ rather than 

‘‘hardwired smoke detection system.’’

Response: We agree with this 

comment that the proper terms are 

‘‘single station smoke alarm’’ and 

‘‘system-based smoke detectors,’’ and 

we have made the appropriate changes 

in both the preamble of this document 

and in the regulations text located at 

§ 483.70(a)(7). 

Comment: Several commenters 

expressed concern regarding the extent 

of the inspection, testing, and 

maintenance program that is expected. 

The commenters suggested that it may 

be difficult for CMS to judge compliance 

with this standard without further 

guidance. The commenters requested 

that CMS reference a specific edition of 

NFPA 72, National Fire Alarm Code, as 

the standard for installing, testing, and 

maintaining battery-operated single 

station smoke alarms and smoke 

detection systems in long term care 

facilities as discussed in § 483.70(a)(7). 

The commenters suggested that NFPA 

72 would establish the extent and 

frequency of the necessary inspection, 

testing, and maintenance activities for 

smoke alarms. 

Response: National Fire Protection 

Association publication 72, National 

Fire Alarm Code, has extensive 

installation, inspection, testing, and 

maintenance requirements for a variety 

of facility and system types. We agree 

that it is a very useful resource that 

facilities should consult when 

installing, inspecting, testing, and 

maintaining their smoke alarms. 

However, we do not believe that 

requiring facilities to comply with the 

many standards within NFPA 72 is 

appropriate in this regulation. The 

NFPA standards require significant 

amounts of documentation that may not 

all be necessary for this minimum 

requirement. In addition, NFPA 72 has 

very specific qualifications for those 


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individuals who are eligible to inspect, 

test, and maintain smoke alarms in 

health care facilities. General facility 

maintenance personnel may not meet 

these high qualifications, which may 

force such facilities to hire or contract 

with additional personnel. This would 

unnecessarily increase the burden of 

this minimum provision. 

Therefore, we will not require long 

term care facilities to comply with 

NFPA 72. At the same time, we 

encourage facilities to refer to NFPA 72 

for technical guidance when 

establishing their own policies and 

procedures for inspecting, testing, and 

maintaining battery-operated single 

station smoke alarms. We believe that 

NFPA 72 can be used in conjunction 

with manufacturer recommendations to 

develop a comprehensive, facilityspecific maintenance program. 

Comment: A few commenters 

questioned the role that AC powered 

single station smoke alarms may play in 

long term care facilities. Specifically, 

the commenters wanted CMS to clarify 

that AC powered (also known as hardwired) single station smoke alarms are 

acceptable in place of battery-operated 

smoke alarms. One commenter also 

wanted CMS to add a specific exception 

for facilities that have AC powered 

single station smoke alarms in resident 

rooms and common areas, similar to the 

exceptions for fully sprinklered 

buildings and buildings with systembased smoke detectors. 

Response: Battery-operated single 

station smoke alarms are, according to 

this regulation, the minimum fire safety 

devices that a facility must install in 

resident rooms and common areas. 

Facilities may choose to go beyond this 

minimum requirement by installing AC 

powered single station smoke alarms in 

the specified areas. We do not believe 

that it is necessary to add a specific 

exception for facilities that choose AC 

powered single station smoke alarms, 

because we state that battery-operated 

single station smoke alarms are the 

minimum requirement. Since AC 

powered single station smoke alarms are 

equivalent to, if not superior to, batteryoperated single station smoke alarms, 

they would meet the minimum 

requirement. 

If facilities choose to go beyond the 

minimum requirement by installing AC 

single station smoke alarms, they may 

choose to install AC powered single 

station smoke alarms in all areas, or 

they may choose to use a combination 

of AC powered and battery-operated 

single station smoke alarms. For 

example, a facility may have system 

based smoke detectors in corridors, AC 

single station smoke alarms in other 

common areas such as activity rooms 

and battery-operated single station 

smoke alarms in resident rooms. This 

combination of alarms and detectors is 

acceptable because all three fire safety 

device types meet the minimum 

requirement of at least having batteryoperated single station smoke alarms in 

all common areas and resident rooms. 

Regardless of the type of alarm or 

combination thereof that a facility 

chooses to use, the facility will still be 

required to ensure that at least batteryoperated single station smoke alarms are 

installed in all resident rooms and 

common areas. 

Comment: One commenter stated that 

battery-operated smoke alarms with 10- 

year batteries would not require the 

annual battery replacement schedule 

that we described in the regulatory 

impact statement section of the interim 

final rule. Another commenter stated 

that the bi-annual or annual battery 

replacement schedule that we described 

should be mandatory for all facilities. 

Response: In the interim final rule, 

§ 483.70(a)(7)(ii) requires facilities to 

have a program for testing, maintenance 

and battery replacement. In the 

preamble to this final rule, we state that 

this program should be in accordance 

with manufacturer recommendations. 

We expect that this program would be 

included in the facility’s own policies 

and procedures. Also in the preamble, 

we estimate that an average facility’s 

program would provide for annual 

battery replacement. 

However, as one commenter 

suggested, facilities may choose to use 

long life batteries. In that case, we 

would expect that the facility’s program 

for testing, maintenance, and battery 

replacement would be in accordance 

with the smoke alarm manufacturer and 

battery manufacturer recommendations 

for testing, maintenance, and battery 

replacement of long life batteries. If the 

program’s replacement schedule, as 

described in the facility’s own policies 

and procedures, was longer than our 

estimate of annual replacement because 

the manufacturers’ recommendations 

were longer, then the longer battery 

replacement schedule would be 

acceptable. 

Due to the variability of battery life 

and smoke alarm life, we believe that 

requiring facilities to conform their 

maintenance schedules to manufacturer 

recommendations rather than to 

imposed timeframes is the most 

effective and flexible regulatory option 

at this time. 

Comment: In response to our request 

for public comment, a few commenters 

recommended that long term care 

facilities not be required to install 

smoke alarms in areas other than 

resident rooms and common areas. The 

commenters cited two reasons for not 

installing smoke alarms in other areas 

such as storage rooms, closets and office 

spaces. Those reasons are: 

• No other national consensus codes 

or standards require smoke alarms in 

these areas; and 

• Since 1972 there has never been a 

multiple death fire that originated in 

one of these other areas. 

Another commenter, however, 

recommended that smoke alarms should 

be required in non-public areas as well 

as common areas and resident rooms. 

Response: For the reasons cited by the 

commenters, we agree that installing 

moke alarms in other areas such as 

closets and offices in long term care 

facilities is not necessary. Therefore, we 

are not requiring facilities to install 

smoke alarms beyond resident rooms 

and common areas. However, if a long 

term care facility chose to install smoke 

alarms in these additional areas, there is 

nothing in this regulation to prohibit 

this practice. 

Comment: One commenter contested 

a statement in the preamble to the 

interim final rule that said, ‘‘The lack of 

smoke detectors in resident rooms, the 

report concludes, ‘* * * may have 

delayed staff response and activation of 

the building’s fire alarms.’ ’’ The 

commenter stated that there was no 

evidence of a delayed staff response in 

the Hartford fire and that the resident 

accused of setting the fire summoned 

the nurse to the room of origin before 

smoke reached the corridor. 

Response: We appreciate the 

information provided by the 

commenter. However, the information 

that we cited on both the Hartford and 

Nashville fires came directly from the 

2004 GAO report. The report states that, 

‘‘In the Hartford fire, it is unclear 

whether the alarm was first activated by 

the corridor smoke detector or manually 

by the staff member who first attempted 

to extinguish the fire. According to the 

Hartford fire department, the absence of 

smoke detectors in resident rooms 

contributed to a delay of up to 5 

minutes or more.’’

We understand that there has been 

some disagreement regarding the exact 

timeline of events in the Hartford fire. 

None of this disagreement negates the 

fact that smoke alarms would have 

likely been helpful in both the Hartford 

and Nashville fires. 

Comment: A few commenters 

suggested that CMS either remove or 

define the term ‘‘public areas’’ in 

relationship to the requirement that long 

term care facilities must install smoke 

alarms in ‘‘public areas.’’ Suggested 


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definitions included areas such as 

cafeterias, waiting rooms, lobby areas, 

treatment rooms, activity rooms, and 

other meeting rooms. One commenter 

suggested that the need to place smoke 

alarms in ‘‘public areas’’ be addressed in 

the interpretive guidelines rather than 

in the regulations. In addition, a few 

commenters suggested that CMS use the 

term ‘‘common areas,’’ the term used in 

a Survey & Certification letter (S&C–05–

25) that further elaborated on this 

requirement, rather than ‘‘public areas’’

to describe these spaces. 

Response: We believe that installing, 

at a minimum, single station batteryoperated smoke alarms in areas other 

than resident rooms is a good idea. As 

stated in the preamble, fires can and do 

develop in other areas. Having the 

minimum smoke alarms in these areas 

would provide facility staff and 

residents earlier notice about the 

existence of the fire, thus giving them 

more time to respond to the situation 

and enabling earlier notification of local 

fire responders. 

At the same time, we agree that the 

term ‘‘common areas’’ is a more 

appropriate term for resident gathering 

areas as used in this regulation, and we 

have made the appropriate changes 

throughout this document. 

We also agree that it would be helpful 

to include a definition of this term in 

the definitions section of the long term 

care regulations. Therefore, in the 

definitions section at § 483.5, we have 

added the following definition, 

‘‘Common area. Common areas are 

dining rooms, activity rooms, meeting 

rooms where residents are located on a 

regular basis, and other areas in the 

facility where residents may gather 

together with other residents, visitors, 

and staff.’’ This definition is in 

accordance with the description of 

‘‘common areas’’ in the Survey & 

Certification letter cited above. 

Comment: A few commenters 

suggested that CMS should require 

facilities to install system-based smoke 

detectors in corridors that directly serve 

resident sleeping and treatment rooms 

and one commenter suggested that 

system-based smoke detectors should be 

installed in resident rooms as well. The 

commenters indicated that it was 

important that an alarm in one area of 

the building should notify staff at the 

nursing station. 

Response: The Medicare and 

Medicaid Conditions of Participation 

are the minimum standards that 

providers must meet in order to 

participate in the Medicare and 

Medicaid programs. We added the 

single station battery-operated smoke 

alarm requirement on top of the 

requirements of the 2000 edition of the 

Life Safety Code because we believe that 

these smoke alarms are necessary in 

order to achieve an acceptable level of 

fire safety. We specifically required 

smoke alarm installation in resident 

rooms and common areas because these 

areas can be closed off, thus impeding 

the ability of other residents or facility 

staff to detect a fire situation. Behind 

closed doors fires can grow undetected. 

Corridors, however, are highly trafficked 

areas that are open to other areas and do 

not pose the same risk of undetected fire 

development and growth. In addition, 

corridors are already protected by 

having smoke detectors at smoke 

barriers to control the doors and activate 

a facility’s alarm system. Requiring 

facilities to secure additional funds and 

undergo the construction process to 

install system-based smoke detectors in 

corridors without the benefit of any 

significant fire safety gains is, we 

believe, not the best option for long term 

care facilities or their residents. 

While we are not requiring facilities 

to do so, they are encouraged to go 

beyond the minimum requirements of 

this rule by installing system-based 

smoke detectors in resident rooms and 

common areas, either as a stand-alone 

fire safety feature or in combination 

with battery-operated single station 

smoke alarms. However, due to 

concerns about the increased cost and 

time associated with installing systembased smoke detectors in resident rooms 

and common areas, we are not, at this 

time, requiring facilities to install 

system-based smoke detectors in any 

section of their building. 

Comment: One commenter stated that 

CMS incorrectly described the way that 

system-based smoke detectors function. 

The commenter stated that system-based 

smoke detectors, rather that causing 

each other to sound, cause the facility’s 

general building fire alarm system to 

sound. The commenter also stated that 

the detectors themselves are not 

equipped with a battery to use as a backup power supply. Rather, the detectors 

are connected to the fire alarm control 

panel, which has a back-up power 

supply. 

Response: We appreciate this 

clarification of the mechanics of systembased smoke detectors and have 

clarified our description of their 

function in the preamble of this rule. 

Comment: One commenter suggested 

that CMS clarify in the preamble text 

that, in order to be exempt from 

installing, at a minimum, batteryoperated single station smoke alarms, a 

facility’s sprinkler system must meet the 

requirements of the publication NFPA 

13, Standard for the Installation of 

Sprinkler Systems. 

Response: We agree that the preamble 

should be clear that in order for a 

facility to qualify for an exception to 

this rule it must be fully sprinklered in 

accordance with NFPA 13, as stated in 

the regulation. We thank the commenter 

for suggesting this area for further 

clarification of our intent. 

Comment: A few commenters 

expressed support for installing smoke 

alarms in resident rooms and common 

areas and one commenter indicated that 

long term care facilities required 

financial assistance from CMS in order 

to install these minimum devices. 

Response: We appreciate the 

commenters’ support of these minimum 

fire safety requirements and understand 

that there is a cost associated with 

installing smoke alarms. We estimated 

in the interim final rule that an average 

size facility would spend $7,000 to 

purchase and install battery-operated 

single station smoke alarms in resident 

rooms and common areas. This is less 

than one half of one percent of the total 

revenue for an average or small facility. 

In light of this information, we believe 

that purchasing and installing batteryoperated single station smoke alarms is 

of minimal cost to affected facilities. 

To mitigate even this minimal cost, 

we also allowed affected facilities one 

year from the effective date of the 

interim final rule to comply with the 

installation requirement. We believe 

that these two factors make it 

unnecessary for us to provide financial 

assistance to aid in the purchase and 

installation of smoke alarms in affected 

facilities. 

Comment: A few commenters stated 

that the one year phase-in period for 

installing at least battery-operated single 

station smoke alarms was unnecessarily 

long. The commenter suggested that a 

90-day phase-in period would be a more 

appropriate length of time due to low 

purchase costs and easy installation. 

Another commenter requested that CMS 

allow long term care facilities an 

additional 180 days to comply with the 

smoke alarm requirement if they have 

signed contracts and funding in place to 

fully sprinkler their buildings in 

accordance with NFPA 13. 

Response: We agree that facilities that 

choose to comply with the minimum 

requirement, which is installing batteryoperated single station smoke alarms, 

should be able to purchase and install 

the alarms in less that one year’s time. 

These devices increase the level of fire 

safety above what is required in the 

2000 edition of the LSC. Alarms can be 

a primary fire safety goal or they can be 

an interim part of a facility’s long term 


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Federal Register / Vol. 71, No. 184 / Friday, September 22, 2006 / Rules and Regulations 55335 

plan to upgrade to sprinklers. That is, 

facilities that anticipate that fully 

upgrading to a more sophisticated fire 

protection system such as sprinklers 

would take more than one year would 

use smoke alarms during the installation 

period as an immediate fire safety 

improvement. Since we have already 

provided for a one year phase-in period, 

extending this phase-in period for an 

additional 180 days does not seem 

prudent. 

Comment: One commenter requested 

that CMS choose either the term ‘‘fully 

sprinklered’’ or the term ‘‘sprinklered 

throughout the facility’’ to describe the 

type of facility that is exempt from 

having to install at least battery operated 

single station smoke alarms in resident 

rooms and common areas. The 

commenter also requested that CMS 

define whichever term we choose to use 

in the regulation. 

Response: We agree that a single term 

should be used to describe a facility’s 

sprinkler status. Therefore, we are using 

the term ‘‘fully sprinklered’’ from the 

Survey & Certification memo discussed 

above (S&C–05–25). In addition, we 

have added the definition of ‘‘fully 

sprinklered’’ from the memo to the 

definitions section on the long term care 

regulations at new § 483.5(e). The 

definition is, ‘‘Fully sprinklered. A fully 

sprinklered long term care facility is one 

that has all areas sprinklered in 

accordance with National Fire 

Protection Association 13 ‘Standard for 

the Installation of Sprinkler Systems’

without the use of waivers or the Fire 

Safety Evaluation System.’’

Comment: One commenter 

recommended that facilities should be 

encouraged or required to use dual 

sensor smoke alarms that can quickly 

detect slow burning smoldering fires as 

well as fast burning flaming fires. The 

commenter stated that these detectors 

would enhance fire safety with only a 

small increase in cost. 

Response: The Medicare and 

Medicaid Conditions of Participation 

are the minimum standards that 

providers must meet in order to 

participate in the Medicare and 

Medicaid programs. We added the 

single station battery-operated smoke 

alarm requirement on top of the 

requirements of the 2000 edition of the 

Life Safety Code because we believe that 

these smoke alarms are necessary in 

order to achieve an acceptable level of 

fire safety. Therefore, we have decided 

not to require dual sensor alarms in this 

rule, but would consider requiring them 

in the future. 

However, facilities are free to go 

beyond the minimum requirements of 

this rule by installing dual sensor 

alarms. We agree that these alarms 

would enhance fire safety, potentially 

saving lives and reducing the loss of 

property by notifying staff and residents 

of a fire situation at the earliest possible 

time. 

Comment: A few commenters stated 

that CMS should require long term care 

facilities to have both smoke alarms and 

sprinklers. The commenters indicated 

that smoke alarms and sprinklers serve 

different fire safety functions, and that 

smoke alarms respond sooner than 

sprinklers. However, another 

commenter suggested that CMS should 

insert language into the regulation that 

would explicitly allow the removal of 

smoke alarms in long term care facilities 

once those facilities are fully 

sprinklered. 

Response: Facilities that are fully 

sprinklered would qualify for exception 

from this rule; fully sprinklered 

facilities may forgo having and 

maintaining battery-operated single 

station smoke alarms. This means that 

once a facility becomes fully sprinklered 

in accordance with NFPA 13, it is no 

longer required by this regulation to 

keep its smoke alarms. 

The 2004 GAO report only indicated 

that we should strengthen the fire safety 

requirements for long term care facilities 

that do not have sprinklers. The purpose 

of this rule is to implement this GAO 

recommendation. 

C. Other Areas of Comment 

Comment: A few commenters 

expressed support for CMS requiring all 

long term care facilities to be fully 

sprinklered with an appropriate (3- to 5- 

year) phase-in period. One commenter 

indicated that the 2006 edition of the 

LSC is slated to require the installation 

of automatic sprinkler systems in all 

existing nursing homes. According to 

the commenters, major constituency 

groups such as the American Healthcare 

Association, the National Citizens’

Coalition for Nursing Home Reform, and 

the International Fire Marshals 

Association are supporting this change. 

Response: We appreciate the support 

and the information that the commenter 

provided. We are carefully examining 

the sprinkler requirement and phase-in 

period issues and expect to issue a 

proposed rule in the near future. 

Comment: One commenter suggested 

that CMS should incorporate the 

International Fire Code, published by 

the International Code Council, into the 

long term care facility regulations. 

Response: We continue to specifically 

cite the LSC because under sections 

1819(d)(2)(B) and 1919(d)(2)(B) of the 

Social Security Act, nursing homes 

must meet the provisions of ‘‘such 

edition (as specified by the Secretary in 

regulation) of the Life Safety Code of the 

National Fire Protection Association 

* * *.’’ However, if a State’s own fire 

and safety code would ‘‘adequately 

protect patients’’ and the State code is 

imposed by State law, the State may 

submit a request in writing to substitute 

its fire safety code for the LSC to its 

CMS regional office. The CMS regional 

office will forward the request to CMS 

central office. The CMS central office 

will make a final decision on whether 

the State code may be used in place of 

the LSC. 

IV. Provisions of the Final Regulations 

For the most part, this final rule 

confirms the provisions of the March 25, 

2005 interim final rule. Those 

provisions of this final rule that differ 

from the interim final rule are as 

follows: 

A. Alcohol-Based Hand Rubs 

1. In response to public comments, we 

are revising the third requirement in the 

list of specifications that a facility must 

meet in order to install ABHR 

dispensers in egress corridors. In the 

interim final rule we required, ‘‘The 

dispensers are installed in a manner that 

adequately protects against access by 

vulnerable populations.’’ In this final 

rule, we require ‘‘The dispensers are 

installed in a manner that adequately 

protects against inappropriate access.’’

The revised requirement eliminates the 

unclear term ‘‘vulnerable populations’’

while achieving the same goal of 

ensuring that ABHRs are not misused in 

a manner that may cause harm to 

individuals or property. 

2. Also in response to public 

comments, we are adding a requirement 

that ‘‘The dispensers are maintained in 

accordance with dispenser 

manufacturer guidelines.’’ If there were 

no manufacturer guidelines, we expect 

facilities to have their own ABHR 

dispenser maintenance policies and 

procedures. Regular maintenance is a 

crucial step towards ensuring that the 

dispensers do not leak or spill. Having 

a maintenance program will help ensure 

that the dispensers are functioning 

properly and that any malfunctions are 

addressed in a timely manner. 

Following manufacturer guidelines will 

help ensure that maintenance is 

properly performed in a manner that 

will help, rather than hinder, the 

facility’s goal of having properly 

functioning dispensers. 

3. We have removed the statement ‘‘If 

any additional changes are made to this 

amendment, CMS will publish notice in 

the Federal Register to announce the 

changes’’ because we believe that this 


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55336 Federal Register / Vol. 71, No. 184 / Friday, September 22, 2006 / Rules and Regulations 

statement is not necessary. The term 

‘‘notice’’ refers to the notice-andcomment rulemaking process that CMS 

undergoes to amend the conditions of 

participation for health care providers. 

Any substantive changes to the 

conditions of participation are already 

required to go through the normal 

notice-and-comment rulemaking 

procedures. Since notice-and-comment 

rulemaking is the standard procedure 

for amending regulations, we do not 

believe that this statement is needed. 

B. Smoke Alarms 

1. We are altering the terminology 

used to describe the smoke detector 

requirement. Throughout this 

document, we are referring to the 

following terms in the manner specified 

below unless otherwise noted: 

• ‘‘Smoke detectors’’ are now ‘‘smoke 

alarms’’; 

• ‘‘Public areas’’ are now ‘‘common 

areas’’; 

• Having ‘‘sprinklers installed 

throughout’’ is now ‘‘fully sprinklered’’; 

and 

• ‘‘A hard-wired smoke detection 

system’’ is now ‘‘system-based smoke 

detectors.’’

All of these terminology changes were 

made in response to public comments. 

2. In addition to altering the 

terminology used to describe the smoke 

alarm requirement, we are adding 

definitions for the terms ‘‘common 

areas’’ and ‘‘fully sprinklered’’ to the 

definitions section of the regulation. 

New § 483.5(d) and (e) will provide 

facilities with more explicit guidance 

about where smoke alarms must be 

installed and about what requirements 

their buildings must meet in order to 

qualify for exception B of the smoke 

alarm requirement. 

3. In the interim final rule, in 

§ 483.70(a)(7)(ii), we required facilities 

to have a program for testing, 

maintenance, and battery replacement 

to ensure the reliability of the smoke 

alarms. We are modifying this 

requirement to be more specific about 

the contents of the inspection, testing, 

maintenance, and battery replacement 

program. The revised requirement states 

that facilities must ‘‘[h]ave a program for 

inspection, testing, maintenance, and 

battery replacement that conforms to the 

manufacturer’s recommendations and 

that verifies correct operation of the 

smoke alarms.’’ Conforming to 

manufacturer guidelines, coupled with 

our strong recommendation that 

facilities should also incorporate, to the 

extent possible, the requirements of 

NFPA 72, should help ensure that 

smoke alarms are consistently 

functioning in top working order. We 

expect that this program would be 

included in the facility’s own policies 

and procedures. 

V. Collection of Information 

Requirements 

This document does not impose 

information collection and 

recordkeeping requirements. 

Consequently, it need not be reviewed 

by the Office of Management and 

Budget under the authority of the 

Paperwork Reduction Act of 1995. 

VI. Regulatory Impact Statement 

A. Overall Impact 

We have examined the impact of this 

rule as required by Executive Order 

12866 (September 1993, Regulatory 

Planning and Review), the Regulatory 

Flexibility Act (RFA) (September 19, 

1980, Pub. L. 96–354), section 1102(b) of 

the Social Security Act, the Unfunded 

Mandates Reform Act of 1995 (Pub. L. 

104–4), and Executive Order 13132. 

Executive Order 12866 (as amended 

by Executive Order 13258, which 

merely reassigns responsibility of 

duties) directs agencies to assess all 

costs and benefits of available regulatory 

alternatives and, if regulation is 

necessary, to select regulatory 

approaches that maximize net benefits 

(including potential economic, 

environmental, public health and safety 

effects, distributive impacts, and 

equity). A regulatory impact analysis 

(RIA) must be prepared for major rules 

with economically significant effects 

($100 million or more in any 1 year). We 

have examined the impact of this final 

rule, and we have determined that this 

rule is neither expected to meet the 

criteria to be considered economically 

significant, nor do we believe it will 

meet the criteria for a major rule. 

The RFA requires agencies to analyze 

options for regulatory relief of small 

businesses. For purposes of the RFA, 

small entities include small businesses, 

nonprofit organizations, and small 

government jurisdictions. Most 

hospitals and most other providers and 

suppliers are small entities, either by 

nonprofit status or by having revenues 

of $6 million to $29 million in any 1 

year. For purposes of the RFA, most 

entities affected by this final rule are 

considered small businesses according 

to the Small Business Administration’s 

size standards, with total revenues of 

$29 million or less in any 1 year (for 

details, see 65 FR 69432). Individuals 

and States are not included in the 

definition of a small entity. According 

to CMS statistics, nursing facilities, 

which we require to install at least 

battery-operated single station smoke 

alarms in resident rooms and common 

areas, earned a total of $89.6 billion in 

1999 (http://www.cms.hhs.gov/ 

statistics/nhe/historical/t7.asp). 

According to the National Nursing 

Home Survey: 1999 Summary (http:// 

www.cdc.gov/nchs/data/series/sr_13/ 

sr13_152.pdf), there were 18,000 

nursing facilities in operation at that 

time. An average facility at this time 

thus had revenue of approximately 

$4,977,778. A facility with revenue 50 

percent below this average still earned 

$2,488,889. This final rule will cost 

$2,800 annually for maintenance. This 

amount will be less than one half of one 

percent of the total revenue for an 

average- or below-average-revenue 

facility. There is no installation cost 

associated with this final rule because, 

upon its effective date, facilities will 

have already installed their smoke 

alarms in accordance with the interim 

final rule. Therefore, we certify that this 

final rule will not have a significant 

impact on a substantial number of small 

entities. We are not considering 

hospitals or other facilities affected by 

the alcohol-based hand rub regulation in 

this regulatory flexibility analysis 

because we do not require those 

facilities to take any action. We are 

requiring that, if those facilities choose 

to install ABHR dispensers in egress 

corridors, then they will have to do so 

in accordance with the regulation. 

In addition, section 1102(b) of the Act 

requires us to prepare a regulatory 

impact analysis if a rule may have a 

significant impact on the operations of 

a substantial number of small rural 

hospitals. This analysis must conform to 

the provisions of section 604 of the 

RFA. For purposes of section 1102(b) of 

the Act, we define a small rural hospital 

as a hospital that is located outside of 

a Metropolitan Statistical Area and has 

fewer than 100 beds. This final rule will 

not have a significant impact on small 

rural hospitals because the final rule 

will not impose requirements on small 

rural hospitals. 

Section 202 of the Unfunded 

Mandates Reform Act of 1995 also 

requires that agencies assess anticipated 

costs and benefits before issuing any 

rule whose mandates require spending 

in any 1 year of $100 million in 1995 

dollars, updated annually for inflation. 

That threshold level is currently 

approximately $120 million. This rule 

will have no consequential effect on 

State, local, or tribal governments or on 

the private sector. 

Executive Order 13132 establishes 

certain requirements that an agency 

must meet when it promulgates a final 

rule that imposes substantial direct 

requirement costs on State and local 


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Federal Register / Vol. 71, No. 184 / Friday, September 22, 2006 / Rules and Regulations 55337 

governments, preempts State law, or 

otherwise has Federalism implications. 

This regulation does not have any 

Federalism implications. 

B. Anticipated Effects 

1. Alcohol-Based Hand Rubs 

This final rule does not require an 

affected facility to install ABHR 

dispensers; thus, the facility will not be 

mandated with a burden associated with 

this provision of the regulation. 

We, however, will require facilities 

that choose to install ABHR dispensers 

to do so in accordance with chapters 

18.3.2.7 and 19.3.2.7 of the 2000 edition 

of the LSC as amended by the TIA. 

Facilities will have to install them in 

accordance with the LSC, and in a way 

that minimized leaks and spills and 

inappropriate access. Installing 

dispensers according to the 

specifications of the LSC and this 

regulation may increase installation 

costs. Facilities that choose to install 

dispensers are required by this 

regulation to take additional steps to 

minimize dispenser leaks and spills. 

While this regulation does not require a 

specific method for minimizing leaks 

and spills, facilities may decide to 

install additional hardware to ensure 

compliance with this regulation. 

Additional hardware, such as a device 

below the dispenser to catch drips, 

could increase purchasing and 

installation costs. The leak and spill 

minimization requirement is new; 

therefore, we have no data to estimate 

the cost of the provision. We believe 

that any additional costs are small when 

compared to the costs of caring for a 

frail patient who fell on a slippery, 

ABHR-covered floor. 

In addition, the installation of these 

dispensers in egress corridors was 

previously prohibited. Therefore, no 

facility should have improperly 

installed ABHR dispensers in a manner 

that conflicts with the provisions of this 

final rule. The requirements for locating 

dispensers in other areas will not 

change. Therefore, a facility will not 

have to relocate or modify existing 

dispensers to conform to the 

specifications. 

Facilities that choose to install ABHR 

dispensers in any area, including 

corridors and patient rooms, are 

required by the LSC to store large 

quantities of ABHR solution in a 

flammable liquids cabinet. Facilities are 

required to use these cabinets if they 

choose to store 5 gallons or more of 

ABHR solution in a single smoke 

compartment. This LSC requirement 

helps ensure that large amounts of 

ABHR solution do not accelerate health 

care facility fires. 

Most hospitals already have these 

cabinets to store other alcohol products 

or flammables, and would therefore not 

need to purchase a special storage 

container for ABHR solutions. Other 

facilities that may choose to install 

ABHR dispensers are typically smaller 

than hospitals and would not need to 

store more than 5 gallons of ABHR 

solution in a single smoke compartment. 

A facility with 20 rooms per smoke 

compartment will likely install 10 

ABHR dispensers, for a total of 3 gallons 

of ABHR solution per smoke 

compartment. That same facility would 

be permitted to keep an additional 2 

gallons of ABHR solution for refilling in 

that same compartment without using a 

flammable liquids cabinet. Therefore, 

we do not believe that this LSC 

provision will pose a significant burden 

to facilities that choose to install ABHR 

dispensers. 

Facilities that choose to install ABHR 

dispensers may expect to see a decrease 

in health care acquired infections due to 

an increase in hand hygiene practices by 

clinicians and non-clinicians. While we 

cannot quantify the potential benefit of 

this decrease in infections, we do know 

that decreasing infection rates lead to 

better patient care outcomes and 

decreased patient care costs. 

2. Smoke Alarms 

As discussed in section VI.A of this 

section, Overall Impact, affected 

facilities were required by the interim 

final rule to install, at a minimum, 

battery-operated single station smoke 

alarms in resident rooms and common 

areas by May 24, 2006. Since this date 

is close to the date of publication of this 

rule, there is not an installation burden 

associated with this final rule. There is, 

however, a maintenance burden 

associated with this final rule. That 

burden is described below. 

The July 2004 GAO report estimated 

that 20 to 30 percent of long-term care 

facilities do not have sprinklers 

throughout the facility and will 

therefore be subject to the provisions of 

this regulation. We do not have 

information on the number of facilities 

that have system-based smoke detectors 

in resident rooms and common areas. 

For the purposes of our analysis, we 

estimated that 25 percent of long-term 

care facilities, or 4,200, will be subject 

to the provisions of this regulation. We 

estimate that an average long-term care 

facility in a building that does not have 

sprinklers has 100 residents in 50 twoperson resident sleeping rooms, based 

on data from our Online Survey 

Certification and Reporting System. In 

addition, we estimate that each room 

will require one battery-operated single 

station smoke alarm. We estimate that 

each average facility requires 20 

additional alarms for common areas, for 

a total of 70 alarms per facility. 

TABLE 1.—NUMBER OF SMOKE

ALARMS

Number of 

alarms 

Per Facility ................................ 70 

Nationwide ................................ 378,000 

Formulas: 

• 50 alarms in resident rooms + 20 

alarms in common areas = 70 total 

alarms per average facility × 4,200 

affected facilities = 378,000 total alarms 

nationwide 

Following installation of batteryoperated single station smoke alarms in 

the specified areas, a long-term care 

facility will be required to have a 

program that conforms to manufacturer 

recommendations for testing, 

maintenance, and battery replacement 

that verifies the correct operation of the 

smoke alarms. We estimate that a 

facility will conduct monthly tests of 

each smoke alarm by activating the test 

button. This will take approximately 5 

minutes per smoke alarm per test, or 1 

hour per smoke alarm per year. 

In addition, we estimate that a facility 

will clean each smoke alarm and change 

its batteries two times per year. Based 

on the time necessary to remove dust 

and debris from the smoke alarm, as 

well as the time necessary to remove old 

batteries and properly insert new ones, 

we estimate that this maintenance task 

will take 15 minutes per smoke alarm 

per cleaning and replacement, or 30 

minutes per smoke alarm per year. We 

estimate that the total annual 

maintenance time per smoke alarm will 

be 1.5 hours, for a total of 105 hours per 

average facility. 

We estimate that the cost for this 

provision for an average long-term care 

facility with 70 smoke alarms, based on 

a maintenance person earning $20 per 

hour (salary from May 2003 National 

Occupational Employment and Wage 

Estimates, http://www.bls.gov/oes/2003/ 

may/oes_37Bu.htm plus 30 percent 

fringe benefits) and $5 for batteries per 

change, is $2,800. The annual industry 

total for this maintenance provision will 

thus be $11,760,000. 


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55338 Federal Register / Vol. 71, No. 184 / Friday, September 22, 2006 / Rules and Regulations 

TABLE 2.—SMOKE ALARM MAINTENANCE TIME AND COSTS

Time (hours) Cost 

Maintenance per detector ........................................................................................................................................ 1.5 $40 

Maintenance per facility ........................................................................................................................................... 105 2,800 

Maintenance nationwide .......................................................................................................................................... 441,000 11,760,000 

Formulas: 

• 5 minutes per test per alarm × 12 

tests per year per alarm = 1 hour per 

year per alarm for testing × 70 alarms 

per facility = 70 hours per year per 

facility for tests × 4,200 affected 

facilities = 294,000 hours per year 

nationwide for tests 

• 15 minutes per cleaning and battery 

change per alarm × 2 cleanings and 

battery changes per year = 30 minutes 

per alarm for cleaning and battery 

changes × 70 alarms = 35 hours per 

facility for cleaning and battery changes 

× 4,200 affected facilities = 147,000 

hours nationwide for cleaning and 

battery changes 

• 1 hour per year per alarm for testing 

+ 30 minutes per alarm for cleaning and 

battery changes (sum of the two 15- 

minute cleaning and battery changes 

described above) = 1.5 hours per year 

per detector for maintenance and testing 

× 70 detectors per facility = 105 hours 

per year per facility for maintenance 

and testing × 4,200 affected facilities = 

441,000 hours nationwide for 

maintenance and testing 

• 1.5 hours per year per detector for 

maintenance and testing × $20 per hour 

= $30 per alarm + $10 for battery 

replacement = $40 per alarm for 

maintenance, testing and battery 

replacement per alarm × 70 alarms per 

facility = $2,800 per facility for 

maintenance, testing and battery 

replacement of alarms × 4,200 affected 

facilities = $11,760,000 nationwide for 

maintenance, testing and battery 

replacement of alarms 

C. Alternatives Considered 

1. Alcohol-Based Hand Rubs 

We considered not adopting chapters 

18.3.2.7 and 19.3.2.7 of the 2000 edition 

of the LSC as amended by the TIA, 

thereby continuing to prohibit the 

placement of ABHR dispensers in egress 

corridors. However, continuing this 

prohibition was not acceptable for two 

reasons. First, we want to improve hand 

hygiene practices in order to reduce 

health-care-acquired infections. Hand 

hygiene levels increase when the 

availability of hygiene stations 

increases, including stations that 

dispense ABHRs. It is helpful to have 

these stations in areas that are highly 

visible and easily accessed, as they are 

in corridors. Therefore, the potential to 

increase hand hygiene and thus 

decrease health care acquired infections 

by placing ABHR dispensers in all 

appropriate locations warranted this 

regulation. 

Second, continuing to prohibit ABHR 

dispensers in egress corridors is 

contrary to our goal of increasing 

provider flexibility. We believe that, 

wherever possible, providers should be 

allowed the flexibility to meet the needs 

of their patients/residents in the manner 

that meets the facility’s needs. Providers 

are aware of the hazards posed by 

infections and have developed many 

methods for addressing those hazards. 

The ABHR dispensers are one method, 

and we believe that providers should be 

allowed to utilize the ABHR dispensers 

to the fullest extent within the context 

of patient safety. 

We also considered adopting chapters 

18.3.2.7 and 19.3.2.7 of the 2000 edition 

of the LSC without the additional 

requirements. However, the chapters do 

not address several important areas of 

patient safety such as the potential for 

slips and falls on slippery, ABHR-coated 

floors and the potential for the misuse 

of ABHR solutions. We believe that not 

addressing these areas may put patient 

safety at risk. The NFPA is dedicated to 

reducing loss of life due to fires. As 

such, it concerned itself solely with the 

fire safety implications of installing 

ABHR dispensers in egress corridors. 

Chapters 18.3.2.7 and 19.3.2.7 of the 

2000 edition of the LSC did not address 

leaks and spills that will result in 

people slipping and falling, nor did they 

address the potential for inappropriate 

use of ABHRs. Due to disability or 

illness, certain populations require 

additional protection from substances 

that are toxic and flammable. The 

ABHRs are both toxic and flammable. 

Chapters 18.3.2.7 and 19.3.2.7 of the 

2000 edition of the LSC did not address 

these non-fire safety issues. Therefore, 

we believe that it is necessary to add 

other installation requirements in 

addition to chapters 18.3.2.7 and 

19.3.2.7 of the 2000 edition of the LSC. 

2. Smoke Alarms 

We considered not requiring longterm care facilities to install smoke 

alarms, thus maintaining the existing 

fire safety regulations that required 

facilities to only meet the standards of 

the 2000 edition of the Life Safety Code. 

Maintaining the existing requirements 

would have left decisions regarding 

more stringent fire safety measures in 

the hands of State and local 

governments. State and local 

governments have, in the past, made 

very different decisions about fire safety 

requirements in long-term care facilities. 

For example, some States, such as 

Tennessee and Virginia, already require 

all long-term care facilities to have 

sprinklers throughout their buildings. In 

contrast, other states, such as Arkansas 

and Nebraska, do not have such 

requirements, resulting in 25 percent or 

more of their long-term care facilities 

completely lacking sprinklers. The same 

State-to-State variability that is seen in 

sprinkler requirements would likely be 

seen in smoke alarm requirements. This 

level of variability is not acceptable to 

us because we believe that residents of 

long-term care facilities should be 

assured the same minimum level of fire 

safety regardless of what State or 

locality they reside in. Federal 

regulation is the most efficient and 

expedient manner for achieving the goal 

of uniform nationwide minimum fire 

safety standards; therefore, we chose to 

pursue Federal regulation rather than 

depending on State and local 

governments. 

In addition to pursuing Federal 

regulation in this area, we chose to 

require smoke alarms because we 

believe that their installation will help 

save lives. The July 2004 GAO report 

clearly outlined the role that smoke 

alarms, one of the most basic and 

effective fire safety devices available, 

did or did not play in the Nashville and 

Hartford fires. The report also outlined 

the wider role that alarms can and 

should play in long-term care facility 

fire safety. The positive impact of smoke 

alarms on resident safety, we believe, 

warrants their installation. 

We also considered requiring longterm care facilities to install systembased smoke detectors in accordance 

with NFPA 72, National Fire Alarm 

Code, for system-based smoke detectors. 

System-based detectors must be wired 

directly into the facility’s electrical and 

fire alarm system. This option would 

have likely required a longer phase-in 

period to accommodate the increased 


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Federal Register / Vol. 71, No. 184 / Friday, September 22, 2006 / Rules and Regulations 55339 

time and cost associated with installing 

this type of system. A longer phase-in 

period would have delayed our ability 

to quickly increase the level of fire 

safety in long term care facilities. 

Therefore, in order to quickly increase 

the level of fire safety in long term care 

facilities, we are requiring only the less 

expensive and less time consuming 

battery-operated single station smoke 

alarm. Facilities may still choose to 

install system-based smoke detectors, 

and we encourage them to do so. 

Installation of such a system in resident 

rooms and common areas will exempt a 

facility from installing battery-operated 

single station smoke alarms in those 

areas. 

Finally, we considered requiring 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 are currently examining 

this issue. We are committed to working 

with NFPA, the long-term care facility 

industry, and advocates to develop a 

consensus position. Facilities may still 

choose to become fully sprinklered in 

accordance with NFPA 13. Installation 

of sprinklers will exempt a facility from 

installing battery-operated single station 

smoke alarms in resident rooms and 

common areas. We encourage all 

facilities to fully explore this option, as 

it provides the highest level of fire 

protection currently available. 

D. Conclusion 

For these reasons, we are not 

preparing analyses for either the RFA or 

section 1102(b) of the Act because we 

have determined that this rule will not 

have a significant economic impact on 

a substantial number of small entities or 

a significant impact on the operations of 

a substantial number of small rural 

hospitals. 

In accordance with the provisions of 

Executive Order 12866, this regulation 

was reviewed by the Office of 

Management and Budget. 

List of Subjects 

42 CFR Part 403 

Grant programs—health, Health 

insurance, Hospitals, Incorporation by 

reference, Intergovernmental relations, 

Medicare, Reporting and recordkeeping 

requirements. 

42 CFR Part 416 

Health facilities, Incorporation by 

reference, Kidney diseases, Medicare, 

Reporting and recordkeeping 

requirements. 

42 CFR Part 418 

Health facilities, Hospice care, 

Incorporation by reference, Medicare, 

Reporting and recordkeeping 

requirements. 

42 CFR Part 460 

Aged, Health care, Health records, 

Incorporation by reference, Medicaid, 

Medicare, Reporting and recordkeeping 

requirements. 

42 CFR Part 482 

Grant programs—health, Hospitals, 

Incorporation by reference, Medicaid, 

Medicare, Reporting and recordkeeping 

requirements. 

42 CFR Part 483 

Grant programs—health, Health 

facilities, Health professions, Health 

records, Incorporation by reference, 

Medicaid, Medicare, Nursing homes, 

Nutrition, Reporting and recordkeeping 

requirements, Safety. 

42 CFR Part 485 

Grant programs—health, Health 

facilities, Incorporation by reference, 

Medicaid, Medicare, Reporting and 

recordkeeping requirements. 

■ For the reasons set forth in the 

preamble, the interim final rule 

amending 42 CFR parts 403, 416, 418, 

460, 482, 483, and 485, which was 

published on March 25, 2005 (70 FR 

15229) is adopted as final with the 

following changes: 

PART 403—SPECIAL PROGRAMS AND 

PROJECTS 

■ 1. The authority citation for part 403 

continues to read as follows: 

Authority: 42 U.S.C. 1395b–3 and Secs. 

1102 and 1871 of the Social Security Act (42 

U.S.C. 1302 and 1395hh). 

Subpart G—Religious Nonmedical 

Health Care Institutions—Benefits, 

Conditions of Participation, and 

Payment 

■ 2. Section 403.744 is amended as 

follows: 

■ A. Paragraph (a)(4)(iii) is revised. 

■ B. Paragraph (a)(4)(iv) is amended by 

removing the last sentence. 

■ C. Paragraph (a)(4)(iv) is further 

amended by removing the period at the 

end of the paragraph and adding in its 

place ‘‘; and’’. 

■ D. New paragraph (a)(4)(v) is added. 

The revisions read as follows: 

§ 403.744 Condition of participation: Life 

safety from fire. 

(a) * * * 

(4) * * * 

(iii) The dispensers are installed in a 

manner that adequately protects against 

inappropriate access; 

* * * * * 

(v) The dispensers are maintained in 

accordance with dispenser 

manufacturer guidelines. 

* * * * * 

PART 416—AMBULATORY SURGICAL 

SERVICES 

■ 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. Section 416.44 is amended as 

follows: 

■ A. Paragraph (b)(5)(iii) is revised. 

■ B. Paragraphs (b)(5)(iv)(F) and (G) are 

revised. 

■ C. Paragraph (b)(5)(v) is added. 

The revisions read as follows. 

§ 416.44 Conditions for coverageEnvironment. 

* * * * * 

(b) * * * 

(5) * * * 

(iii) The dispensers are installed in a 

manner that adequately protects against 

inappropriate access; 

(iv) * * * 

(F) The dispensers shall not be 

installed over or directly adjacent to an 

ignition source; 

(G) In locations with carpeted floor 

coverings, dispensers installed directly 

over carpeted surfaces shall be 

permitted only in sprinklered smoke 

compartments; and 

(v) The dispensers are maintained in 

accordance with dispenser 

manufacturer guidelines. 

* * * * * 

PART 418—HOSPICE CARE 

■ 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. Section 418.100 is amended as 

follows: 

■ A. Paragraph (d)(6)(iii) is revised. 

■ B. Paragraph (d)(6)(iv) is amended by 

removing the last sentence. 

■ C. Paragraph (d)(6)(iv) is further 

amended by removing the period at the 

end of the paragraph and adding in its 

place ‘‘; and’’. 


rwilkins on PROD1PC63 with RULES_1
55340 Federal Register / Vol. 71, No. 184 / Friday, September 22, 2006 / Rules and Regulations 

■ D. Paragraph (d)(6)(v) is added. 

The revisions read as follows: 

§ 418.100 Condition of participation: 

Hospices that provide inpatient care 

directly. 

* * * * * 

(d) * * * 

(6) * * * 

(iii) The dispensers are installed in a 

manner that adequately protects against 

inappropriate access; 

* * * * * 

(v) The dispensers are maintained in 

accordance with dispenser 

manufacturer guidelines. 

* * * * * 

PART 460—PROGRAMS OF 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. Section 460.72 is amended as 

follows: 

■ A. Paragraph (b)(5)(iii) is revised. 

■ B. Paragraph (b)(5)(iv) is amended by 

removing the last sentence. 

■ C. Paragraph (b)(5)(iv) is further 

amended by removing the period at the 

end of the paragraph and adding in its 

place ‘‘; and’’. 

■ D. Paragraph (b)(5)(v) is added. 

The revisions read as follows: 

§ 460.72 Physical environment. 

* * * * * 

(b) * * * 

(5) * * * 

(iii) The dispensers are installed in a 

manner that adequately protects against 

inappropriate access; 

* * * * * 

(v) The dispensers are maintained in 

accordance with dispenser 

manufacturer guidelines. 

* * * * * 

PART 482—CONDITIONS OF 

PARTICIPATION FOR HOSPITALS 

■ 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. Section 482.41 is amended as 

follows: 

■ A. Paragraph (b)(9)(iii) is revised. 

■ B. Paragraph (b)(9)(iv) is amended by 

removing the last sentence. 

■ C. Paragraph (b)(9)(iv) is further 

amended by removing the period at the 

end of the paragraph and adding in its 

place ‘‘; and’’. 

■ D. Paragraph (b)(9)(v) is added. 

The revisions read as follows: 

§ 482.41 Condition of participation: 

Physical environment. 

* * * * * 

(b) * * * 

(9) * * * 

(iii) The dispensers are installed in a 

manner that adequately protects against 

inappropriate access; 

* * * * * 

(v) The dispensers are maintained in 

accordance with dispenser 

manufacturer guidelines. 

* * * * * 

PART 483—REQUIREMENTS FOR 

STATES AND LONG TERM CARE 

FACILITIES 

■ 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 § 483.5, add new paragraphs (d) 

and (e) to read as follows: 

§ 483.5 Definitions. 

* * * * * 

(d) Common area. Common areas are 

dining rooms, activity rooms, meeting 

rooms where residents are located on a 

regular basis, and other areas in the 

facility where residents may gather 

together with other residents, visitors, 

and staff. 

(e) Fully sprinklered. A fully 

sprinklered long term care facility is one 

that has all areas sprinklered in 

accordance with National Fire 

Protection Association 13 ‘‘Standard for 

the Installation of Sprinkler Systems’’

without the use of waivers or the Fire 

Safety Evaluation System. 

■ 13. Section 483.70 is amended as 

follows: 

■ A. Paragraph (a)(6)(iii) is revised. 

■ B. Paragraph (a)(6)(iv) is amended by 

removing the last sentence. 

■ C. Paragraph (a)(6)(iv) is further 

amended by removing the period at the 

end of the paragraph and adding in its 

place ‘‘; and’’. 

■ D. Paragraph (a)(6)(v) is added. 

■ E. Paragraph (a)(7) is revised. 

The revisions read as follows: 

§ 483.70 Physical environment. 

(a) * * * 

(6) * * * 

(iii) The dispensers are installed in a 

manner that adequately protects against 

inappropriate access; 

* * * * * 

(v) The dispensers are maintained in 

accordance with dispenser 

manufacturer guidelines. 

(7) A long term care facility must: 

(i) Install, at least, battery-operated 

single station smoke alarms in 

accordance with the manufacturer’s 

recommendations in resident sleeping 

rooms and common areas. 

(ii) Have a program for inspection, 

testing, maintenance, and battery 

replacement that conforms to the 

manufacturer’s recommendations and 

that verifies correct operation of the 

smoke alarms. 

(iii) Exception: 

(A) The facility has system-based 

smoke detectors in patient rooms and 

common areas that are installed, tested, 

and maintained in accordance with 

NFPA 72, National Fire Alarm Code, for 

system-based smoke detectors; or 

(B) The facility is fully sprinklered in 

accordance with NFPA 13, Standard for 

the Installation of Sprinkler Systems. 

* * * * * 

Subpart I—Conditions of Participation 

for Intermediate Care Facilities for the 

Mentally Retarded 

■ 14. Section 483.470 is amended as 

follows: 

■ A. Paragraph (j)(7)(ii)(C) is revised. 

■ B. Paragraph (j)(7)(ii)(D) is amended 

by removing the last sentence. 

■ C. Paragraph (j)(7)(ii)(D) is further 

amended by removing the period at the 

end of the paragraph and adding in its 

place ‘‘; and’’. 

■ D. Paragraph (j)(7)(ii)(E) is added. 

The revisions read as follows: 

§ 483.470 Condition of participation: 

Physical environment. 

* * * * * 

(j) * * * 

(7) * * * 

(ii) * * * 

(C) The dispensers are installed in a 

manner that adequately protects against 

inappropriate access; 

* * * * * 

(E) The dispensers are maintained in 

accordance with dispenser 

manufacturer guidelines. 

* * * * * 

PART 485—CONDITIONS OF 

PARTICIPATION: SPECIALIZED 

PROVIDERS 

■ 15. The authority citation for part 485 

continues to read as follows: 


rwilkins on PROD1PC63 with RULES_1
Federal Register / Vol. 71, No. 184 / Friday, September 22, 2006 / Rules and Regulations 55341 

Authority: Secs. 1102 and 1871 of the 

Social Security Act (42 U.S.C. 1302 and 

1395(hh)). 

Subpart F—Conditions of 

Participation: Critical Access Hospitals 

(CAHs) 

■ 16. Section 485.623 is amended as 

follows: 

■ A. Paragraph (d)(7)(iii) is revised. 

■ B. Paragraph (d)(7)(iv) is amended by 

removing the last sentence. 

■ C. Paragraph (d)(7)(iv) is further 

amended by removing the period at the 

end of the paragraph and adding in its 

place ‘‘; and’’. 

■ D. Paragraph (d)(7)(v) is added. 

The revisions read as follows: 

§ 485.623 Condition of participation: 

Physical plant and environment. 

* * * * * 

(d) * * * 

(7) * * * 

(iii) The dispensers are installed in a 

manner that adequately protects against 

inappropriate access; 

* * * * * 

(v) The dispensers are maintained in 

accordance with dispenser 

manufacturer guidelines. 

(Catalog of Federal Domestic Assistance 

Program No. 93.778, Medical Assistance 

Program) 

(Catalog of Federal Domestic Assistance 

Program No. 93.773, Medicare—Hospital 

Insurance; and Program No. 93.774, 

Medicare—Supplementary Medical 

Insurance Program) 

Dated: February 8, 2006. 

Mark B. McClellan, 

Administrator, Centers for Medicare & 

Medicaid Services. 

Approved: May 31, 2006. 

Michael O. Leavitt, 

Secretary. 

[FR Doc. 06–7885 Filed 9–21–06; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

42 CFR Parts 405 and 491 

[CMS–1910–IFC] 

RIN 0938–AJ17 

Medicare Program; Rural Health 

Clinics: Amendments to Participation 

Requirements and Payment 

Provisions; and Establishment of a 

Quality Assessment and Performance 

Improvement Program; Suspension of 

Effectiveness 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Interim final rule with comment 

period; partial suspension of 

effectiveness. 

SUMMARY: This interim final rule with 

comment period revises the rural health 

clinic (RHC) regulations to revert to 

those provisions set forth in regulations 

before publication of the December 24, 

2003 RHC final rule. That final rule 

implemented certain provisions of the 

Balanced Budget Act (BBA) of 1997 to 

establish a process and criteria for 

disqualifying from the RHC program 

clinics that no longer meet basic 

location requirements (rural and 

medically underserved), and to require 

RHCs to establish quality assessment 

and performance improvement 

programs. That rule also prohibited 

‘‘commingling’’ (the use of the space, 

professional staff, equipment, and other 

resources) of an RHC with another 

entity. [In addition, it addressed 

comments on the February 28, 2000 

proposed rule. Since the publication of 

the RHC final rule exceeded the 3-year 

timeline for finalizing proposed rules 

set by the Medicare Prescription Drug, 

Improvement, and Modernization Act of 

2003, we are suspending the 

effectiveness of the current provisions 

by removing the RHC provisions set 

forth in the December 2003 final rule 

and reverting to those RHC provisions 

previously in effect.] We intend to 

reissue new proposed and final RHC 

rules to reinstate the current provisions. 

However, these revisions do not impact 

the effectiveness of the selfimplementing provisions of the BBA or 

any provisions we had previously 

implemented or enforced through 

program memoranda. 

DATES: Effective date: These regulations 

are effective on September 22, 2006. 

Comment date: To be assured 

consideration, comments must be 

received at one of the addresses 

provided below, no later than 5 p.m. on 

November 21, 2006. 

ADDRESSES: In commenting, please refer 

to file code CMS–1910–IFC. Because of 

staff and resource limitations, we cannot 

accept comments by facsimile (FAX) 

transmission. 

You may submit comments in one of 

four ways (no duplicates, please): 

1. Electronically. You may submit 

electronic comments on specific issues 

in this regulation to http:// 

www.cms.hhs.gov/eRulemaking. Click 

on the link ‘‘Submit electronic 

comments on CMS regulations with an 

open comment period.’’ (Attachments 

should be in Microsoft Word, 

WordPerfect, or Excel; however, we 

prefer Microsoft Word.) 

2. By regular 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–1910–

IFC, P.O. Box 8016, Baltimore, MD 

21244–8016. 

Please allow sufficient time for mailed 

comments to be received before the 

close of the comment period. 

3. By express or overnight mail. You 

may send 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–1910–IFC, Mail Stop C4–26–05, 

7500 Security Boulevard, Baltimore, MD 

21244–1850. 

4. 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–

7195 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 


rwilkins on PROD1PC63 with RULES_1