CMS SOM App. B, Tag G646

(1) The HHA’s performance improvement activities must—

(i) Focus on high risk, high volume, or problem-prone areas;

(ii) Consider incidence, prevalence, and severity of problems in those areas; and

(iii) Lead to an immediate correction of any identified problem that directly or

potentially threaten the health and safety of patients.

Interpretive Guidelines §484.65(c)(1)

“High risk” areas may include global concerns such as a type of service (e.g., pediatrics),

geographic concerns (e.g., safety of a neighborhood served); or specific patient care

services (e.g., administration of intravenous medications or tracheostomy care). All

factors would be associated with significant risk to the health or safety of patients.

“High volume” areas refers to care or service areas that are frequently provided by the

HHA to a large patient population, thus possibly increasing the scope of the problem (e.g.

laboratory testing, physical therapy, infusion therapy, diabetes management).

“Problem-prone” areas refer to care or service areas that have the potential for negative

outcomes and that are associated with a diagnosis or condition for a particular patient

group or a particular component of the HHA operation or historical problem areas.