Programs of All-Inclusive Care for the 
Elderly (PACE) 
 
Chapter 7  Service Delivery Settings 
Table of Contents 
(Rev. 2, Issued: 06-09-11) 
 
Transmittals for Chapter 7 
 
10 - Introduction 
 
20 - PACE Center 
 
20.1 - Physical Environment 
 
20.2 - Frequency of Attendance at the PACE Center 
 
20.3 - Equipment 
 
20.4 - Equipment Maintenance 
 
20.5 - Emergency Procedures 
 
20.6 - Fire Safety 
 
20.7 - Emergency and Disaster Preparedness 
 
20.8 - Participant Safety and Comfort 
 
20.9 - Infection Control 
 
30 - Alternative Care Settings 
 
40 - Institutional Settings  10 - Introduction 
(Rev. 2, Issued: 06-09-11; Effective: 06-03-11; Implementation: 06-03-11) 
 
The PACE organization will have a written plan and procedure specifying how the 
organization meets the individualized needs of each participant in all care settings 24-
hours a day, every day of the year.  
 
20 - PACE Center 
(Rev. 2, Issued: 06-09-11; Effective: 06-03-11; Implementation: 06-03-11) 
 
20.1 - Physical Environment 
(Rev. 2, Issued: 06-09-11; Effective: 06-03-11; Implementation: 06-03-11) 
 
The PACE organizations physical environment must be designed, constructed, equipped 
and maintained to provide for the physical safety of participants, personnel and 
caregivers, and visitors. The PACE organization is required to ensure a safe, sanitary, 
functional, accessible and comfortable environment for the delivery of services that 
protects the dignity and privacy of the participant. The PACE center must include: 
 
  Suitable space and equipment to provide primary medical care and suitable 
space for treatment, restorative therapies, therapeutic recreation, socialization, 
dining and personal care. Examples include, but arent limited to, food and 
nutritional supplement storage, meal preparation and serving and participant 
laundry; 
 
  Suitable meeting space for personnel to conduct team meetings and for 
participants/caregivers, and visitors; 
 
  Protecting the participants privacy and dignity during the delivery of 
services. 
 
The PACE organization must provide evidence that there are life safety code inspection 
results of fire marshal inspections, public health inspections, and other required state 
agency inspections. 
 
The PACE organization must provide evidence of a federal Clinical Laboratory 
Improvement Amendment (CLIA) exemption if the center is performing waived 
laboratory services on site or in the home, e.g., glucose meter testing, urine testing, fecal 
occult blood testing, blood testing, cholesterol screening or hemoglobin or hematocrit 
testing. 
 
In addition, the PACE organization must meet all applicable Federal, State, and local 
laws and regulations, which include the Americans with Disabilities Act and Section 504 
of the Rehabilitation Act. 
 
[42 CFR  460.72(a)(1) and (2), and (b)(1); PACE State Readiness Review Guide]   
20.2 - Frequency of Attendance at the PACE Center 
(Rev. 2, Issued: 06-09-11; Effective: 06-03-11; Implementation: 06-03-11) 
 
The PACE center provides a point of service where the primary care clinic is located, 
where services are provided, and socialization occurs with staff that is consistent and 
familiar. Attendance at the center is an important aspect of the PACE model, which helps 
to differentiate it from home health care or institutional care. 
 
The frequency of a participants attendance at the center is determined by the IDT based 
on the needs and preferences of each participant. The PACE organization is required to 
maintain a written plan specifying the criteria used to determine frequency a participant 
attends the center. These criteria should take into account the participants medical 
condition, behavioral, psychosocial and personnel care needs, caregiver support and 
preferences. 
 
[42 CFR  460.98(e); 460.106] 
 
20.3 - Equipment 
(Rev. 2, Issued: 06-09-11; Effective: 06-03-11; Implementation: 06-03-11) 
 
20.4 - Equipment Maintenance 
(Rev. 2, Issued: 06-09-11; Effective: 06-03-11; Implementation: 06-03-11) 
 
A PACE organization must perform the manufacturers recommended maintenance on all 
equipment as indicated in the manufacturers written recommendations. This 
maintenance may be performed by PACE staff or contracted entities and in compliance 
with the contract. 
 
A PACE organization must establish, implement and maintain a written plan to ensure 
that all equipment is maintained in accordance with the manufacturers 
recommendations. 
 
[42 CFR  460.72(a)(3)] 
 
20.5 - Emergency Procedures 
(Rev. 2, Issued: 06-09-11; Effective: 06-03-11; Implementation: 06-03-11) 
 
The PACE organization is required to have trained personnel, drugs, and emergency 
equipment immediately available at every PACE center at all times to adequately support 
participants until Emergency Medical Services (EMS) responds to the PACE center. Each 
PACE center is required to have at least one staff member who has been trained in 
cardio-pulmonary resuscitation (CPR) and will be on site during the hours that 
participants are in attendance. 
  The minimum emergency equipment that must be on the premises and immediately 
available includes: portable oxygen, airways, suction, and emergency drugs. 
 
The PACE organization must have a written plan and procedure for handling emergency 
situations that may arise including, but not limited to, cardiac arrest, choking and seizure 
activity. 
 
In addition, the PACE center must have a documented plan to obtain Emergency Medical 
Services from sources outside the PACE center when needed. At least annually, a PACE 
organization must test, evaluate, and document the effectiveness of its emergency and 
disaster plans to ensure and maintain appropriate responses to the situations and needs 
that may arise from both medical and nonmedical emergencies. 
 
[42 CFR  460.72(c); 71 FR 71275 (Dec. 8, 2006)] 
 
20.6 - Fire Safety 
(Rev. 2, Issued: 06-09-11; Effective: 06-03-11; Implementation: 06-03-11) 
 
A PACE center must meet the applicable provisions of the 2000 edition of the Life Safety 
Code (LSC) of the National Fire Protection Association that apply to the type of setting 
in which the center is located. Copies of the code may be obtained from the National Fire 
Protection Association, 1 Batterymarch Park, Quincy, MA 02269  
(http://www.nfpa.org/index.asp?cookie%5Ftest=1). CMS will publish any changes in the 
Federal Register to announce any changes in this edition. 
 
The LSC provisions do not apply in a state in which CMS determines that a fire and 
safety code imposed by state law adequately protects participants and staff and CMS may 
waive specific provisions of the LSC that, if rigidly applied, would result in unreasonable 
hardship on the center, but only if the waiver does not adversely affect the health and 
safety of participants and staff. 
 
Although there is specific waiver authority under the PACE statute, CMS PACE staff do 
not have the authority to approve waivers of the LSC. Rather, CMS staff responsible for 
Life Safety Code compliance would have to approve LSC waivers. Since PACE centers 
are often licensed as adult day health centers or clinics, they are not among the types of 
Medicare providers that CMS typically surveys for compliance with the LSC. As a result, 
CMS will accept State licensure requirements related to fire and safety as meeting the 
LSC. 
 
The SAA assures that LSC requirements are met for facilities in which the PACE 
organization furnishes services to PACE participants in accordance with 42 CFR  
460.72(b). 
 
CMS recognizes that the responsibility for certifying compliance with state licensure 
laws concerning fire safety may not be a direct function of the State Administering  Agency. For example, the clinical and building code expertise associated with this 
function may lend itself to a separate branch or State office. 
 
However, CMS depends on the State Administering Agency as the single point of contact 
on all State-related requirements regardless of whether the functions are housed directly 
within the State Administering Agency. In the case of fire and safety codes imposed by 
State law, the State Administering Agency may find it necessary to secure appropriate 
documentation from the entity with jurisdiction over these areas.  
 
Beginning March 13, 2006 a PACE center must be in compliance with the 2000 LSC 
Edition (Chapter 9.2.9) which states that Emergency Lighting must provide illumination 
for at least a 90-minute duration. 
 
Notwithstanding any provisions of the 2000 edition of the Life Safety Code to the 
contrary, a PACE center may install alcohol-based hand rub dispensers if: 
 
  The use of alcohol-based hand rub dispensers does not conflict with any State 
or local codes that prohibit or otherwise restrict the placement of alcohol-
based hand rub facilities in health care facilities; 
 
  The dispensers are installed in such a manner that minimizes leaks and spills 
that could lead to falls; 
 
  The dispensers are installed in a manner that adequately protects against 
inappropriate access; 
 
  The dispensers are installed in accordance with Chapter 18.3.2.7 or Chapter 
19.3.2.7 of the 2000 edition of the Life Safety Code, as amended by National 
Fire Protection Association Temporary Interim Amendment; and 
 
  The dispensers are maintained in accordance with dispenser manufacturer 
guidelines. 
 
[42 CFR  460.72(b); 71 FR 71275 (Dec. 8, 2006) and the PACE Program Agreement] 
 
20.7 - Emergency and Disaster Preparedness 
(Rev. 2, Issued: 06-09-11; Effective: 06-03-11; Implementation: 06-03-11) 
 
Emergencies include, but are not limited to, the following: 
 
  Fire; 
 
  Equipment, water or power failure; 
 
  Care-related emergencies; 
    Natural disasters likely to occur in the organizations geographic area (An 
organization is not required to develop emergency plans for disasters that 
typically do not affect its geographic location). 
 
The PACE organization must establish, implement and maintain documented procedures 
to manage medical and non-medical emergencies and disasters that are likely to threaten 
the health and safety of participants, staff or the public. The Disaster Plan must address 
the organizations arrangements for emergency food, nutritional supplements and potable 
water supplies. 
 
A PACE organization must provide appropriate training and periodic orientation to all 
employees and contracted staff and participants to ensure that all staff demonstrate a 
knowledge of emergency procedures, including information on what to do, where to go, 
and whom to contact in case of emergency. 
 
At least annually, a PACE organization must actually test and evaluate the effectiveness 
of its emergency and disaster plans. Documentation must be maintained for all fire and 
disaster plan drills conducted by the PACE organization, along with records of all 
training conducted for employed and contracted staff. 
 
[42 CFR  460.72(c)] 
 
20.8 - Participant Safety and Comfort 
(Rev. 2, Issued: 06-09-11; Effective: 06-03-11; Implementation: 06-03-11) 
 
The PACE organizations physical environment must be designed, constructed, equipped 
and maintained to provide for the physical safety of participants, personnel caregivers, 
and visitors. The PACE organization is responsible for maintaining a safe, sanitary, 
functional, accessible and comfortable environment for the delivery of services that meet 
the physical needs and protects the dignity and privacy of the participant. 
 
In order for the environment to be considered safe and comfortable, the PACE center, 
along with alternative care settings, must: 
 
  Be accessible for the wheel chair bound person; 
 
  Have entries and hallways wide enough to accommodate a stretcher; 
 
  Ensure any handrails affixed to corridors are intact and free of splinters; 
 
  Have a functioning call system in all bathing areas and participant toilets; 
 
  Have water temperatures safe and comfortable;  
 
  Have well-ventilated participant areas; 
    Keep housekeeping compounds and other chemicals stored to prevent 
participant or visitor access; 
 
  Be as free of accident hazards as possible; 
 
  Be clean and pest free; and 
 
  Be free of objectionable odors.  
 
The PACE organization is expected to have a plan and procedure to address building 
security while open and after hours, including preventing participants from wandering 
offsite and a process for identifying participants and visitors. 
 
[42 CFR  460.72(a)(1); State Readiness Review Guide] 
 
20.9 - Infection Control 
(Rev. 2, Issued: 06-09-11; Effective: 06-03-11; Implementation: 06-03-11) 
 
The PACE organization must establish, implement, and maintain a documented infection 
control plan that ensures a safe and sanitary environment and prevents and controls the 
transmission of disease and infection. An infection control plan must include, but is not 
limited to: (1) procedures to identify, investigate, control, and prevent infections in every 
PACE center and in each participants place of residence; (2) procedures to record any 
incidents of infection; and (3) procedures to analyze the incidents of infection, to identify 
trends and develop corrective actions related to the reduction of future incidents. PACE 
organizations are required to follow accepted policies and standard procedures with 
respect to infection control, including, at the least, the standard precautions developed by 
the Center for Disease Control and Prevention (CDC). 
 
PACE organizations are expected to establish written policies and procedures for the 
investigation, control, and prevention of infections including: 
 
  An OSHA Exposure Control Plan which includes the Universal Precautions and 
Bloodborne Pathogen exposure procedures for staff; 
 
  Vaccinating participants and staff against diseases of particular concern for the 
PACE participant and the centers geographic location, e.g., influenza and 
pneumonia; 
 
  Initial and ongoing health screening and vaccinations for staff and participants in 
accordance with OSHA regulations (staff) and CDC guidelines for tuberculosis, 
Hepatitis B and other communicable diseases; 
 
  Written plans and procedures for the investigation, evaluation, resolution, and 
reporting of all incidences of staff and participant infection; 
    Written plans and procedures for maintaining records of staff and participant 
infections to include post-exposure evaluation, training records, and participant 
and staff surveillance reports. Written plans and procedures for reporting required 
communicable diseases to the appropriate state and local officials; 
 
  Plans and procedures for staff providing direct care to patients with infection(s); 
 
  Provision of adequate facilities and supplies necessary for infection control to 
include: 
 
  Hand washing facilities and supplies;  
 
  Laundry facilities and supplies; 
 
  Isolation facilities and supplies; 
 
  Written plans and procedures for addressing how laundry will be handled. If the 
service is contracted out, written agreements to comply with the requirements; 
 
  Written plans and procedures for the ongoing monitoring of the contractual 
agreement provisions for laundry and waste disposal; 
 
  Written plans and procedures for the appropriate handling and disposal of all 
waste products including blood and urine specimens for outside lab tests and other 
biohazardous wastes. 
 
The CDC Guidelines for Environmental Infection Control in Health Care Facilities can 
be found at http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5210a1.htm. The OSHA 
Guidelines for the handling of laundry and labeling of bio-hazardous waste can be found 
at http://www.osha.gov/pls/oshaweb/owadisp.show_document?p_table=STANDARDS&
p_id=10051#1910.1030(d)(4)(iv) . Should the State requirements be more stringent than 
those listed above, it is expected that the PACE organization will follow those 
requirements. Check with the State Administering Agency for the Guidelines for 
Environmental Infection Control in Health Care Facilities established by the State in 
which the PACE organization resides. 
 
[42 CFR  460.74] 
 
30 - Alternative Care Settings 
(Rev. 2, Issued: 06-09-11; Effective: 06-03-11; Implementation: 06-03-11) 
 
Alternative care settings are allowed when a limited number of services may be provided. 
An alternative care setting is a physical facility, other than the participants place of 
residence, where PACE participants receive any of the required services. An adult day 
center used on the weekends for a blind participant is an alternate care setting. 
  All PACE organizations must notify CMS in writing (US mail or email) of any new 
arrangements being proposed whereby participants are transported from their place of 
residence to an alternative care setting. The arrangement minimally must describe what 
services will be offered, how the services will be provided, the number of participants 
receiving services in this setting, the location of the new setting, the staffing at the 
proposed new location, transportation arrangement to the new setting, Interdisciplinary 
team members involved, PACE Organization oversight of care provided at the new 
setting, and participant communication (both written and oral) considerations. 
 
The following is an outlined procedure for the PACE organization: 
 
  The PACE organization must notify the CMS Central Office team leader prior 
to opening or contracting with a provider to use an alternative care setting; 
 
  The CMS Central Office team leader will contact the State Administering 
Agency to ascertain their knowledge of the new arrangement; 
 
  The CMS Central Office team leader will schedule a conference call with your 
organization, the State Administering Agency and the CMS Regional Office 
to discuss details of the proposed arrangement; 
 
  The CMS Central Office team leader will request additional written 
information from the PACE organization, if necessary, to ensure participants 
rights are upheld. 
 
Additional information that may be requested: 
 
  A listing of services offered at the alternative care setting; 
 
  A description of the business relationship between the alternative care setting 
and the PACE organization; 
 
  The location of the setting in relation to the approved service area; 
 
  A description of staffing at the new setting; 
 
  A description of transportation arrangements; 
 
  A description of the interaction of interdisciplinary team members who 
oversee the care of participants attending the alternative care setting; 
 
  PACE organization oversight of the alternative care setting; 
 
  A description of how the building/space fire and safety codes meet the 
National Fire Protection Association 2000 guidelines; 
    The proposed marketing strategy and material to be used to inform existing 
and new enrollees of the new setting. 
 
[71 FR 71283 (Dec. 8, 2006); CMS Call Letter (June 23, 2004) and February 2006 
Guidance] 
 
40 - Institutional Settings 
(Rev. 2, Issued: 06-09-11; Effective: 06-03-11; Implementation: 06-03-11) 
 
Institutional settings include, but are not limited to, acute care hospitals, rehabilitation 
hospitals and distinct part rehabilitation units of acute care hospitals, psychiatric hospitals 
and distinct part psychiatric units of acute care hospitals, and critical access hospitals, 
nursing facilities and skilled nursing facilities. The PACE organization must contract 
only with institutional entities that meet all applicable Federal and State requirements as 
well as meet the Medicare or Medicaid participation requirements. There are provider 
specific Conditions of Participation for institutions that participate in the Medicare 
program. Therefore, all institutional contractors must be in compliance with their 
respective Conditions of Participation. 
 
When a participants care needs cannot be accommodated in the PACE center clinic and 
the organization extends its care options by contracting providers to deliver specialized 
services, the IDT does not hand off the participants care; it expands the care team by 
collaborating with contracted specialists and placing participants in more appropriate 
healthcare settings to meet new needs. This concept is clearly supported by PACE 
regulations governing contracted services which require the PACE organization to 
maintain responsibility for the participants care whether the care is delivered by the 
PACE organization or contractors. For example, when the PACE organization solicits 
services by a contractor or contracted facility, it must specify in the contract that the 
contractor furnishes only those services authorized by the PACE IDT and agrees to be 
accountable to the PACE organization. Or, when participants are admitted to an 
acute/long term/rehab facility or transferred temporarily, during that time away and upon 
return to program the Registered Dietician is responsible for maintaining communications 
as to the management of any dietary care plan changes and alters the nutrition program 
accordingly to keep current with the participants health/medicinal/gastrointestinal 
changes. 
 
PACE organizations cannot be reticent about exerting their contractual and regulatory 
authority to actively engage in the care of PACE participants placed in contracted 
facilities. CMS expects the PACE organization to establish a good working relationship 
with the contracted facility staff. 
 
[42 CFR  460.70; 460.78]  Transmittals Issued for this Chapter 
 
Rev #  Issue Date  Subject  Impl Date  CR# 
R2PACE 06/09/2011  Initial Publication of Manual  06/03/2011 NA 
06/03/2011  Initial Publication of Manual - Rescinded and  06/03/2011 NA 
R1_SO 
replaced by Transmittal 2 
 
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