CMS SOM App. X, Tag X-103

any adverse event… .

Guideline §482.96(b)(2)

A thorough analysis is a planned, systematic investigative process that considers all of the phases

of transplantation/living donation in identifying the causes of and factors contributing to an

adverse event. The scope and depth of analysis, as well as the extent of multi-disciplinary

involvement, may be scaled in proportion to the scope and severity of the harm experienced

and/or the risk of harm involved.

A thorough analysis would include, but is not limited to:

• A description of the key facts of the event in enough detail so that one can clearly

understand the facts and chronology of what occurred, the severity of the event, and how

the potential recipient or potential living donor was affected;

• A review of whether similar events have occurred in the past;

• All of the information needed to identify factors that may have caused or contributed to

the outcome, directly or indirectly;

• Analysis of the information to identify actual and potential vulnerabilities and

opportunities to reduce risks and improve care;

• Use of the results of the analysis to design improvement actions to address the factors

that caused or contributed to the event’s occurrence, including factors and processes; and

• Specific plan for implementing, evaluating and monitoring improvement actions

(timeframes, responsible parties, measurement strategy to assess effectiveness, etc.).