CMS SOM App. X, Tag X-102

A transplant program must establish and implement written policies to address and

document adverse events that occur during any phase of an organ transplantation case.

(1) The policies must address, at a minimum, the process for the identification, reporting,

analysis, and prevention of adverse events.

Guideline §482.96(b)(1)

An adverse event is defined at 42 CFR §482.70 as “an untoward, undesirable, and usually

unanticipated event that causes death or serious injury, or the risk thereof.”

The facility policies should include:

• A clear definition of what the transplant program considers an adverse event

incorporating the CMS regulatory definition;

• The procedures for internal reporting of adverse events in all phases of transplant

recipient or living donor care within the hospital;

• The process(es) used for analyzing adverse events in the transplant program;

• The process for developing, evaluating and tracking actions to prevent recurrence; and

• The required timeframe for reporting, investigating and analyzing adverse events.

The policies should also address any external adverse event reporting obligations, such as:

• External reporting of events to the OPTN, ESRD Network, etc. as required and

applicable;

• Reporting to other federal or state survey/health agencies as required by law (e.g., for

suspected medical device-related deaths or serious injury, transmission of an infectious

disease, etc.); and

• Reporting to the OPO if a transplant recipient infection is related to an infectious disease

present in a transplanted organ to ensure that other recipients who received organs from

the same donor can be notified.