CMS Pub. 100-11, ch. 10, § 30

An essential component of an effective quality improvement program is risk assessment

and management. Risk management entails identifying and systematically reducing

potential risks to the safety of PACE participants and the healthcare environment. Risk

assessment ideally is conducted prospectively to prevent occurrences that result in

adverse health outcomes to participants or staff, or harm to the organization’s physical

plant/equipment or fiscal status. In reality, risk assessment is most often conducted in

response to an event that results in medical, psychosocial, cognitive, or functional harm

to a participant or staff. Every person employed or contracted by the PACE organization

has responsibility for risk assessment and management.

External monitoring activities refer to both:

• The submission of the aggregated monitoring data elements via the PACE

monitoring module of the Health Plan Management System (HPMS) Level One

Reporting; and

• The reporting of events resulting in significant harm to participants, or negative

national or regional notoriety related to the PACE program (Level Two

Reporting).

This manual and the PACE Level Two External Reporting Guidance (the “Level Two

Guidance”) clarify the Level Two reporting events that must be expeditiously reported to

CMS.

[42 CFR § 460.140; Level Two Guidance, October 2010]