CMS SOM App. X, Tag X-100

The transplant program’s QAPI program must use objective measures to evaluate the

center’s performance with regard to transplantation activities and outcomes.

Outcome measures may include, but are not limited to, patient and donor selection criteria,

accuracy of the waiting list in accordance with the OPTN waiting list requirements,

accuracy of donor and recipient matching, patient and donor management, techniques for

organ recovery, consent practices, patient education, patient satisfaction, and patient

rights....

Guideline §482.96(a)

This standard requires transplant QAPI programs to identify, implement, assess and re-assess

objective measures to evaluate and improve both their transplantation outcomes as well as the

quality, safety and performance of their transplantation activities, across all phases of transplant

and living donation.

Transplantation and living donor care - including but not limited to the potential areas for

measurement listed in this standard – involve multiple phases, activities and potential outcomes,

each with various aspects that may be amenable to objective measurement. Objective measures

can mean that a transplant program will select some measures for routine monitoring on an

ongoing basis; others will be identified and implemented in order to address, evaluate and

monitor a particular problem or opportunity for improvement. Each transplant QAPI program

should identify and implement multiple objective measures that are relevant and meaningful for

evaluating its own performance with regard to both transplantation activities and outcomes to:

• Collect and analyze data to assess its baseline performance and to track performance on

the selected measures over time; and

• Use the information gained to evaluate and improve performance and to ensure that

improvements are sustained over time.

Measuring an outcome means measuring the health status of a patient resulting from health care.

For example, the SRTR reports contain a number of objective outcome measures useful for

performance monitoring and improvement (such as patient and graft survival), but additional

patient outcomes not reported by the SRTR may also be important for a program to measure (for

example, rates of specific intra- and post- operative complications for transplant recipients and

living donors).

In addition to measuring relevant outcomes, other types of clinical quality measures are needed

to evaluate transplantation activities. Each program must critically examine its own services and

performance to determine which activities (and which aspects of the activity) within each phase

of transplantation or donation should be evaluated and monitored using objective measures.