CMS SOM App. H, Tag V640

immediately correct any identified problems that threaten the health and safety of patients.

Interpretive Guidance § 494.110(c):

Page 254 of 420

Examples of conditions which could pose a threat to the health and safety of dialysis patients and

require immediate correction include, but are not limited to:

• Dangerous levels of contaminants in product water;

• Unsafe levels of electrolytes in dialysate;

• Failure to conduct an accurate pre-assessment;

• Setting an inaccurate fluid removal rate;

• Failure to provide adequate observation of patient, patient vascular access, patient

equipment;

• Defective clinical equipment;

• Failure to adequately disinfect reprocessed dialyzers; Failure to reduce residual

germicides in reprocessed dialyzers to safe levels;

• Lack of qualified staff to perform crucial tests or to meet critical patient needs;

• Evidence that staff assigned to perform crucial tests or to meet critical patient needs are

not competent;

• Potential for cross-contamination between infected and non-infected patients; and,

• Failure to use machine-provided safety devices (muting machine alarms, bypassing the

air detector, etc.).

The facility must take immediate, appropriate actions to address any serious threats and ensure

patient health and safety.