CMS Pub. 100-11, ch. 10, § 30.5

A root cause analysis must be completed for events for which the PACE organization’s

staff, or PACE organization staff in consultation with the CMS Regional Office,

determines the identified event is sufficiently serious that an in-depth understanding of

how it could occur is essential, and/or multiple fail-safe measures are required as part of

the organization’s improvement plan. As described above, PACE organizations are to

consult with their CMS Regional Office Account Manager in cases where the PACE

organization believes a root cause analysis is not necessary.

There are many print and web-based resources to guide PACE personnel in conducting a

root cause analysis. Several essential elements are outlined below:

• Describe the details of what happened. The description will help define the

underlying problem. Who was involved? What were the circumstances of the

event? When did it occur? Where did it happen?

• Identify the immediate factors that contributed to the event. This step

enables the team to gather evidence. CMS recommends that the team ask why

the event occurred and what relationships were associated with the defined

problem. Specify factors that, if removed or changed, could prevent a

recurrence;

ο What were the human factors? (Staffing levels, knowledge, training,

competency, fatigue, distractions, etc.);

ο Was the risk identified, adequately assessed, and a reduction strategy

put in place prior to the incident? (Timely, comprehensive, documented,

communicated to pertinent persons, etc.);

ο What were the equipment-related factors? (Maintenance, mechanical

failure, age, operational history, etc.);

ο What were the environmental factors? (Lighting, noise, clutter,

cleanliness, temperature, inspections, security, etc.);

ο What were the communication factors? (Adequate tools in place, in-service training, documented policies and procedures, reciprocal flow

from/to management, information readily available, technical support,

etc.);

• Develop a risk reduction strategy for each identified problem that

differentiates effective solutions that meet team goals:

ο Discuss the rationale if the team determines that no action should be taken;

ο Develop and implement a corrective action if the team determines that a

policy, procedure, system, training, or process should be improved;

ο Design a performance measure to assess if the team’s corrective action is

effective and sustained over time;

ο Define the period during which progress will be monitored for

improvement;

• Evaluate the effectiveness of corrective action:

ο Assess the improvement in performance;

ο Revise the action plan accordingly.