CMS SOM App. H, Tag V750

Interpretive Guidance § 494.180

This Condition addresses the overall management of the facility. It requires that an identifiable

governing body demonstrate responsibility for the operation of the facility, including fiscal

management, staff training and coverage, medical staff appointments and coverage, and the

QAPI program. This Condition also holds the governing body accountable for establishing an

internal grievance process; decreasing the potential for involuntary discharge of patients;

emergency coverage and backup plans for dialysis; electronic data submission; and the

relationship of the facility to the ESRD Network.

Compliance with this Condition is determined by patient and staff interview, observations, and

review of records. Because the governing body is responsible for the total operation of the

facility, the responsibility of the governing body must be considered when serious problems in

other Conditions are identified.

Examples of Condition-level noncompliance include but are not limited to:

• Major problems with care and safety of patients, patient rights, or operations;

• Failure to follow the requirements for involuntary patient discharge;

• Failure to respond to network requests for corrective action plans for problems identified

by the network;

• Failure to submit required data electronically; and,

• Noncompliance with another Condition for Coverage if the governing body has some

responsibility for the deficient practices.