Regulation detail

E-Tag E-0015

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§403.748(b)(1), §418.113(b)(6)(iii), §441.184(b)(1), §460.84(b)(1), §482.15(b)(1),

Jurisdiction: CM Agency: Centers for Medicare & Medicaid Services
HOME_HEALTH (100%) HOSPICE (100%) PSYCH_FACILITY (40%) SNF (100%)
Plain-English summary

This federal emergency preparedness regulation requires inpatient facilities to develop and implement policies and procedures addressing subsistence needs (food, water, medical and pharmaceutical supplies) for staff and patients during emergencies, whether evacuating or sheltering in place. Facilities must also address alternate energy sources to maintain safe temperatures, emergency lighting, fire detection/alarm systems, and sewage and waste disposal. These policies must be reviewed and updated every two years (annually for long-term care facilities). The regulation explicitly excludes outpatient settings such as ASCs, outpatient hospice providers, CMHCs, HHAs, CORFs, RHCs/FQHCs, and ESRD facilities.

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Regulation text
E-0015
(Rev. 204, Issued: 04-16-21; Effective: 04-16-21, Implementation: 04-16-21) 
 
§403.748(b)(1), §418.113(b)(6)(iii), §441.184(b)(1), §460.84(b)(1), §482.15(b)(1), 
§483.73(b)(1), §483.475(b)(1), §485.625(b)(1) 
 
[(b) Policies and procedures. [Facilities] must develop and implement emergency 
preparedness policies and procedures, based on the emergency plan set forth in 
paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and 
the communication plan at paragraph (c) of this section. The policies and 
procedures must be reviewed and updated every 2 years [annually for LTC 
facilities]. At a minimum, the policies and procedures must address the following: 
 
(1) The provision of subsistence needs for staff and patients whether they evacuate 
or shelter in place, include, but are not limited to the following: 
(i) Food, water, medical and pharmaceutical supplies 
(ii) Alternate sources of energy to maintain the following: 
(A) Temperatures to protect patient health and safety and for the safe 
and sanitary storage of provisions. 
(B) Emergency lighting. 
(C) Fire detection, extinguishing, and alarm systems. 
(D) Sewage and waste disposal. 
 
*[For Inpatient Hospice at §418.113(b)(6)(iii):] Policies and procedures. 
(6) The following are additional requirements for hospice-operated inpatient care 
facilities only. The policies and procedures must address the following: 
(iii) The provision of subsistence needs for hospice employees and patients, 
whether they evacuate or shelter in place, include, but are not limited to the 
following: 
(A) Food, water, medical, and pharmaceutical supplies. 
(B) Alternate sources of energy to maintain the following: 
(1) Temperatures to protect patient health and safety and for the safe 
and sanitary storage of provisions. 
(2) Emergency lighting. 
(3) Fire detection, extinguishing, and alarm systems. 
(C) Sewage and waste disposal. 
Interpretive Guidelines applies to: §403.748(b)(1), §418.113(b)(6)(iii), 
§441.184(b)(1), §460.84(b)(1), §482.15(b)(1), §483.73(b)(1), §483.475(b)(1), 
§485.625(b)(1). 

NOTE: This does not apply to ASCs, Outpatient Hospice Providers [applies to 
inpatient hospices], Transplant Programs, HHA, CORFs, CMHCs, RHCs/FQHCs, 
ESRD facilities. 
 
Facilities must be able to provide for adequate subsistence for all patients and staff for the 
duration of an emergency or until all its patients have been evacuated and its operations 
cease. Facilities have flexibility in identifying their individual subsistence needs that 
would be required during an emergency. 
 
Provisions 
 
There are no requirements or standards establishing a set amount of provisions to be 
provided in facilities, for example ensuring availability of 72 hours’ worth of supplies. 
However, some states laws or accrediting organization requirements do specify a set 
amount or duration of subsistence items to have on hand, therefore facilities should check 
with their state agencies and accrediting organizations to determine if any additional 
requirements exist. Facilities also are required to continue to meet existing health and 
safety standards, such as physical environment at §482.41(a)(1) for hospitals, which 
address requirements like the
 emergency power and lighting in at least the operating, 
recovery, intensive care, and emergency rooms, and stairwells. In all other areas not 
serviced by the emergency supply source, battery lamps and flashlights must be 
available.. Provisions include, but are not limited to, food, pharmaceuticals and medical 
supplies. Provisions should be stored in an area which is less likely to be affected by 
disaster, such as storing these resources above ground-level to protect from possible 
flooding. Additionally, when inpatient facilities determine their supply needs, they are 
expected to consider the possibility that volunteers, visitors, and individuals from the 
community may arrive at the facility to offer assistance or seek shelter. 
 
This standard does not apply to outpatient facilities such as ASCs, Outpatient Hospice 
providers, transplant programs, HHAs, CORFs, CMHCs, RHCs/FQHCs, and ESRD 
facilities as it is expected that such outpatient providers would close and evacuate their 
patients to a safer setting during the emergency. However, per subsection (b)(1), 
inpatient providers must ensure that they have policies and procedures that address food, 
water, medical/pharmaceutical needs for both staff and patients during an emergency, 
regardless of whether they evacuate or not. Evacuation efforts may be delayed, therefore 
facilities affected by this provision should account for patient and staff needs leading up 
to or during an evacuation. 
 
NOTE: Facilities should also consider subsistence needs of volunteers, visitors and other 
individuals who are sheltering in the facility during an event. See subsection (b)(4). 
 
Alternate Energy Sources & Temperatures 
It is up to each individual facility, based on its risk assessment, to determine the 
most appropriate alternate energy sources to maintain temperatures to protect 
patient health and safety and for the safe and sanitary storage of provisions, 

emergency lighting, fire detection, extinguishing, and alarm systems, and sewage 
and waste disposal and continuity of treatments. 
 
Facilities are not required to upgrade their alternate energy source or electrical systems, 
but after review of their risk assessment may find it prudent to make modifications. 
Regardless of the alternate sources of energy a facility chooses to utilize, it must be in 
accordance with local and state laws, manufacturer requirements, as well as applicable 
LSC requirements (for example, hospitals are required to have an essential electric 
system with a generator that complies with NFPA 99 – Health Care Facilities Code and 
associate reference documents). 
 
Facilities must establish policies and procedures that determine how required heating and 
cooling of their facility will be maintained during an emergency situation, as necessary, if 
there were a loss of the primary power source. Facilities are not required to heat and cool 
the entire building evenly, but must ensure safe temperatures are maintained in those 
areas deemed necessary to protect patients,
 other people who are in the facility, and for 
provisions stored in the facility during the course of an emergency, as determined by the 
facility risk assessment. If unable to meet the temperature needs, a facility should have a 
relocation/evacuation plan (that may include internal relocation, relocation to other 
buildings on the campus or full evacuation). The relocation/evacuation should take place 
in a timely manner so as not to expose patients and residents to unsafe temperatures. 
 
NOTE: For LTC facilities under 483.10(i)(6), there are additional requirements for 
facilities who were initially certified after October 1, 1990 who must maintain a 
temperature range of 71 (min) to 81 °F (max).
 Facilities should include their Medicare 
[and Medicaid, as applicable] certification date[s] in the front of their plan. 
 
If used, portable generators should be connected to a facility’s electrical circuits via a 
power transfer system as recommended by the generators’ manufacturer. A power 
transfer system typically consists of a transfer switch, generator power cord and power 
inlet box In accordance with manufacturer instructions and NFPA 70, Article 400.8, 
individual extension cords should not to be run from portable generator outlet 
receptacles to electrical appliances. If a facility’s risk assessment determines the best 
way to maintain temperatures, emergency lighting, fire detection and extinguishing 
systems and sewage and waste disposal would be through the use of a portable and 
mobile generator, rather than a permanent generator, then the LSC provisions such as 
generator testing, maintenance, etc. outlined under the NFPA guidelines requirements 
would not be applicable, except for NFPA 70 - National Electrical Code. 
 
Per NFPA 70, portable and mobile generators should: 
• Have all wiring to each unit installed in accordance with the requirements of any 
of the wiring methods in Chapter 3. 
• Be designed and located to minimize the hazards that might cause complete 
failure due to flooding, fires, icing, and vandalism. 
• Be located so that adequate ventilation is provided. Typically, this may be 
accomplished by locating a portable or mobile generator outside of the building. 

• Be located or protected so that sparks cannot reach adjacent combustible material. 
• Be operated, tested and maintained in accordance with manufacturer, local and/or 
State requirements. 
 
For requirements regarding permanently installed generators, please refer to applicable 
NFPA Codes and Standards. If a health surveyor is unclear whether the facility is 
complying with the alternate sources of energy and temperature requirements, the health 
surveyor must consult with their LSC surveyors. 

Extension cords or other temporary wiring devices may not be used to connect electrical 
equipment in the facility to a portable and mobile generator due to the potential for shock, 
fire, and tripping hazards when using such devices. For portable generators, they must 
be connected and provide emergency power to a facility’s electrical system circuits via a 
power transfer system as recommended by the generator manufacturer. A power transfer 
system typically consists of a generator power supply cord, power inlet box mounted 
outside, and transfer switch connected to the facility electrical panel. 
 
The type of protection needed for the fuel stored by the facility for use by the portable 
and mobile generator will depend on the amount of fuel stored and the location of the 
storage, as per the appropriate NFPA standard. 
 
If a facility has a permanent generator to maintain emergency power, LSC and NFPA 110 
provisions such as generator location, testing, fuel storage and maintenance, etc. will 
apply and the facility may be subject to LSC surveys to ensure compliance is met. Please 
also refer to Tag E0041 Emergency and Standby Power Systems for additional 
requirements for LTC facilities, CAHs and Hospitals. 
 
As an example, some facilities have contracted services with companies who maintain 
portable emergency generators for the facilities off-site. In the event of an emergency 
where the facility is unable to reschedule patients or evacuate, the generators are brought 
to the location in advance to assist in the event of loss of power. Facilities which are not 
specifically required by the EP Final Rule to have a generator, but are required to meet 
the provision for alternate sources of energy, may consider this approach for their facility. 
 
Sewage & Waste Disposal 
 
Facilities are not required to provide onsite treatment of sewage or waste, but must make 
provisions for maintaining necessary services. In addition, we are not specifying 
necessary services for sewage or waste management; however, facilities are required to 
follow their current facility-type requirements (e.g., CoPs/CfCs) which may address these 
areas. For example, LTC facilities are already required to meet Food Receiving and 
Storage provisions at §483.35(i) Sanitary Conditions, which contain requirements for 
keeping food off the floor and clear of ceiling sprinklers, sewer/waste disposal pipes, and 
vents can also help maintain food quality and prevent contamination. Additionally, 
ESRD facilities under current CfCs at §494.40(a)(4) are also required to have policies 
and procedures for handling, storage and disposal of potentially infectious waste. 

Additionally, we would expect facilities under this requirement to ensure current 
practices are followed, such as those outlined by the Environmental Protection Agency 
(EPA) and under State-specific laws. Maintaining necessary services may include, but 
are not limited to, access to medical gases; treatment of soiled linens; disposal of bio-
hazard materials for different infectious diseases; and may require additional assistance 
from transportation companies for safe and appropriate disposal in accordance with 
nationally accepted industry guidelines for emergency preparedness. 
 
Additional General Guidance 
 
As part of the cooperation and collaboration with emergency preparedness officials 
required under subsection (a) (for example, §482.15(a)(4), facilities should also confer 
with health department and emergency management officials to determine the types and 
duration of energy sources that could be available to assist them in providing care to their 
patient population during an emergency. As part of the risk assessment planning, 
facilities should determine the feasibility of relying on these sources and plan 
accordingly. 
 
NOTE: This policy and procedure is required to be reviewed and updated annually for 
LTC facilities only. 
 
Survey Procedures 
• Verify the emergency plan includes policies and procedures for the provision of 
subsistence needs including, but not limited to, food, water and pharmaceutical 
supplies for patients and staff. 
• Verify the emergency plan includes policies and procedures to ensure adequate 
alternate energy sources, including emergency power necessary to maintain: 
o Temperatures to protect patient health and safety and for the safe and sanitary 
storage of provisions; 
o Emergency lighting; and, 
o Fire detection, extinguishing, and alarm systems. 
• Verify the emergency plan includes policies and procedures to provide for sewage 
and waste disposal.