E-Tag E-0008

§486.360(a)(3) Condition for Participation:

This regulation requires Organ Procurement Organizations (OPOs) to include in their emergency preparedness plans the types of hospitals with which they have agreements, the services the OPO can provide during an emergency, and continuity of operations provisions such as succession planning and delegations of authority. OPOs must designate a qualified person authorized in writing to act in the administrator's absence and consider elements like essential personnel, critical resources, and alternate facility identification. This is a federal Condition of Participation for OPOs, not a behavioral health, IDD, ABA, or foster care facility type.

E-0008
(Rev. 204, Issued: 04-16-21; Effective: 04-16-21, Implementation: 04-16-21) 
 
§486.360(a)(3) Condition for Participation: 
[(a) Emergency Plan. The OPO must develop and maintain an emergency 
preparedness plan that must be reviewed, and updated at least every 2 years. The 
plan must do the following:] 
 
(3) Address the type of hospitals with which the OPO has agreements; the type of 
services the OPO has the capacity to provide in an emergency; and continuity of 
operations, including delegations of authority and succession plans. 
 
Interpretive Guidelines for §486.360(a)(3). 

The emergency plan must address the type of hospitals with which the OPO has 
agreements and the types of services that the OPO would be able to provide in an 
emergency. The OPO’s emergency preparedness plan must address/include the type of 
hospitals in which the OPO has an agreement. However, the emergency preparedness 
plan is not required to be included as a part of each agreement that the OPO has with 
their hospitals. The emergency plan must also identify which staff would assume 
specific roles in another’s absence through succession planning and delegations of 
authority. Succession planning is a process for identifying and developing staff with the 
potential to fill key business leadership positions in the company. Succession planning 
increases the availability of experienced and capable employees that are prepared to 
assume these roles as they become necessary. During times of emergency, facilities must 
have internal employees who are capable of assuming various critical roles in the event 
that current staff and leaders are not available. At a minimum, facilities should designate 
a qualified person who is authorized in writing to act in the absence of the administrator 
or person legally responsible for the operations of the facility. 
 
In addition to the facility- and community-based risk assessment, continuity of operations 
planning generally considers elements such as: essential personnel, essential functions, 
critical resources, vital records and IT data protection, alternate facility identification and 
location, and financial resources. Facilities are encouraged to refer to and utilize 
resources from various agencies such as FEMA and ASPR when developing strategies 
for ensuring continuity of operations. 
 
Survey Procedures 
Interview leadership and ask them to describe the following: 
• Services the OPO would be able to provide during an emergency; 
• How the OPO plans to continue operations during an emergency; 
• Delegations of authority and succession plans. 
• How the OPO has included/addressed all of the hospitals with which it has 
agreements into its emergency plan. 
 
Verify that all of the above are included in the written emergency plan.