CMS SOM App. Z, Tag E-0028

[(b) Policies and procedures. The dialysis facility 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 at least every 2 years. At a

minimum, the policies and procedures must address the following:]

(9) A process by which the staff can confirm that emergency equipment, including,

but not limited to, oxygen, airways, suction, defibrillator or automated external

defibrillator, artificial resuscitator, and emergency drugs, are on the premises at all

times and immediately available.

Interpretive Guidelines for §494.62(b)(9).

ESRD facilities must include policies and procedures in its emergency plan that address a

process that confirms that the specific requirements listed under this standard are on the

premises at all times and immediately available in the event of an emergency. The

process must be in writing. It is the facilities’ responsibility to determine what equipment

in addition to oxygen, airways, suction, defibrillator or automated external defibrillators,

artificial resuscitators, and emergency drugs should be on the premises and available

during an emergency to assist patients in an emergency. ESRD facilities may find that

additional emergency equipment should be maintained on the premises as well, such as

additional potable water for treatment; water treatment equipment (carbon filtration and

either reverse osmosis or deionization); or supplies (dialyzers, blood lines, saline,

medications, etc.) Additionally, it is the responsibility of the facility to ensure that all

necessary equipment identified in this standard

Should be in working order at all times in

accordance with the manufacturer instructions. Emergency drugs should not be out of

date and should be stored and maintained based on the manufacturer instructions,

however, in certain emergencies which may present shortages, such as during a

pandemic, the facility should monitor FDA’s website for Emergency Use Authorizations

which may include

extensions on shelf life for medications and other equipment and

supplies to help address shortages. The facility is in the best position to determine what

emergency equipment it needs to have available. In addition, dialysis facilities need to be

able to manage care-related emergencies during an emergency when other assistance,

emergency medical services systems, may not be immediately available to them.

ESRD facilities should also consider supply chain challenges and other planning

considerations in the event of large-scale emergencies, such as pandemics. During these

emergencies, timely and immediately available additional equipment may be dependent

on receipt through an agreement with a vendor, an alternate arrangement, or the state.

In the event of supply shortages, we recommend facilities have policies and procedures in

place for reviewing recommendations provided by the state and federal government to

procure supplies, or transfer patients to different care settings to provide continuity of

care based on the patient’s needs.

ESRD facilities experiencing a shortage should have a set process on how to engage their

local and state health and emergency management departments for assistance, including

processes on how to engage with the ESRD Networks. For additional information on

local health departments supporting preparedness and response activities, visit the

National Association for County and City Health Officials Directory of Local Health

Departments. ESRD facilities should also monitor the Food and Drug Administration

Emergency Use Authorization website (https://www.fda.gov/medical-devices/emergency-

situations-medical-devices/emergency-use-authorizations) that may list current and

terminated Emergency Use Authorizations that make available diagnostic and

therapeutic medical devices to diagnose and respond during declared public health

emergencies.

Survey Procedures

• Verify the dialysis facility has a process in place by which its staff can confirm that

emergency equipment is on the premises and immediately available.

• Verify that the process includes at least the listed emergency equipment within its

emergency plan by asking to see a copy of the written processes/ policy on

emergency equipment and medications.

• Check to see that all of the above equipment is available and in working order. Ask to

see procedures/checklist for ensuring equipment is checked

• Check to see that all emergency drugs are not out of date and request to see a

facility’s policy on emergency drugs in the event of shortages.

PACE - NON-CITABLE (No assigned tags)

Reference Only (PACE)

(Rev. 204, Issued: 04-16-21; Effective: 04-16-21, Implementation: 04-16-21)

§460.84(b)(10) Requirement:

[(b) Policies and procedures. The PACE organization 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 at least every 2 years.]

The policies and procedures must address management of medical and non-medical

emergencies, including, but not limited to: Fire; equipment, power, or water failure;

care-related emergencies; and natural disasters likely to threaten the health or

safety of the participants, staff, or the public. Policies and procedures must be

reviewed and updated at every 2 years. At a minimum, the policies and procedures

must address the following:

(10)(i) Emergency equipment, including easily portable oxygen, airways, suction,

and emergency drugs.

(ii) Staff who know how to use the equipment must be on the premises of every

center at all times and be immediately available.

(iii) A documented plan to obtain emergency medical assistance from outside

sources when needed.

Interpretive Guidelines for §460.84(b)(10).

PACE organizations must include policies and procedures in its emergency plan to

address the requirements of this standard.