CMS SOM App. H, Tag V110

Interpretive Guidance §494.30

This Condition incorporates, as regulation, two documents from the Centers for Disease

Control and Prevention (CDC) and also includes CMS-developed regulations. These infection

control requirements apply to both the chronic dialysis in-center facility and any home

dialysis program(s).

Survey of this Condition requires observations of care delivery, interviews with staff and

patients, and review of medical records, facility logs, policies and procedures and quality

assessment and performance improvement (QAPI) documentation. Direct care staff are

observed and interviewed regarding their adherence to infection control practices.

Administrative and supervisory staff, as well as the medical director, may be interviewed to

clarify issues. Medical and administrative records must demonstrate recognition of any

potential infection and the actions taken to prevent its transmission within the dialysis facility.

If deficient practices noted in infection control techniques are multiple, pervasive, or to an

extent that present a risk to patient health and safety, condition-level noncompliance should

be considered. Per 42 C.F.R. §488.24(b), condition level noncompliance should be

considered when the deficiencies are of such character as to substantially limit the provider’s

or supplier’s capacity to furnish adequate care or which adversely affect the health and

safety of patients.