CMS SOM App. L, Tag Q-0080

Improvement

The ASC must develop, implement and maintain an ongoing, data-driven quality

assessment and performance improvement (QAPI) program.

Interpretive Guidelines: §416.43

The QAPI CfC requires an ASC to take a proactive, comprehensive and ongoing

approach to improving the quality and safety of the surgical services it delivers. The

QAPI CfC presumes that ASCs employ a systems approach to evaluating their systems

and processes, identifying problems that have occurred or that potentially might result

from the ASC’s practices and getting to root causes of problems rather than just

superficially addressing one problem at a time.

From a survey perspective, the focus of the QAPI condition is not on whether an ASC

has any deficient practices, but rather on whether it has an effective, ongoing system in

place for identifying problematic events, policies, or practices and taking actions to

remedy them, and then following up on these remedial actions to determine if they were

effective in improving performance and quality. QAPI programs work best in an

environment that fixes problems rather than assigning blame.

For surveyors this can sometimes pose difficult challenges, because it requires a

balancing act. ASCs are not relieved of their obligation to comply with all Medicare

CfCs, and surveyors are obligated when they find evidence of violations of a CfC to cite

accordingly. However, surveyors generally should avoid using the ASC’s own QAPI

program data and analyses as evidence of violations of other CfCs. For example, an ASC

that identifies problems with infection control through its QAPI program and takes

effective actions to reduce the potential for transmission of infection would be taking

actions consistent with the QAPI CfC. Absent evidence independently collected by the

surveyors of current noncompliance with the infection control CfC, it would not be

appropriate for surveyors to use the infection control information in the ASC’s QAPI

program as evidence of violations of the infection control CfC. There can be egregious

cases under investigation where it might be appropriate to use QAPI program information

as evidence of a deficiency, but these cases should be the exception rather than the rule.

CMS does not prescribe a particular QAPI program; it provides each ASC with the

flexibility to develop its own program. Each program must, however, satisfy the

regulatory criteria:

• Ongoing – i.e., the program is a continuing one, not just a one-time effort.

Evidence of this would include, but is not limited to, things like collection by the

ASC of quality data at regular intervals; analysis of the updated data at regular

intervals; and updated records of actions taken to address quality problems

identified in the analyses, as well as new data collection to determine if the

corrective actions were effective.

• Data-driven – i.e., the program must identify in a systematic manner what data it

will collect to measure various aspects of quality of care; the frequency of data

collection; how the data will be collected and analyzed; and evidence that the

program uses the data collected to assess quality and stimulate performance

improvement.

Survey Procedures: §416.43

When there is a team surveying the ASC, survey of the QAPI Condition should be

coordinated by one surveyor.