CMS Pub. 100-11, ch. 10, § 30.3

When unusual incidents meet specified reporting thresholds, PACE organizations are

required to report them on a timely basis as Level Two Reporting Incidents to CMS

Central Office and Regional Offices and the State Administering Agency. Level Two

incidents require internal investigation and analysis of the occurrence by the PACE

organization with the goal of identifying system(s) failures and improvement

opportunities.

For example, Level Two reportable incidents may include:

• Deaths related to suicide or homicide (known or suspected), unexpected and

with active coroner investigation;

• Falls resulting in death or in injury requiring hospitalization of five days or

more, or resulting in injury for which the determination is made within 48

hours of the fall that permanent loss of function is expected;

• Infectious Disease Outbreak that meet the threshold of three or more cases

(or the respective State standard if more stringent) linked to the same

infectious agent within the same time frame;

• Pressure Ulcer acquired while enrolled in the PACE program;

• Traumatic Injuries which result in death or hospitalization of five days or

more, or result in injury for which the determination is made within 48 hours

of the injury that permanent loss of function is expected.

For a specific listing of reportable incidents and thresholds, refer to the Level Two

External Reporting Guidance, October 2010.