CMS SOM App. L, Tag Q-0083

(1) The number and scope of distinct improvement projects conducted annually

must reflect the scope and complexity of the ASC’s services and operations.

(2) The ASC must document the projects that are being conducted. The

documentation, at a minimum, must include the reason(s) for implementing

the project, and a description of the project’s results.

Interpretive Guidelines: §416.43(d)

Every ASC must undertake one or more specific quality improvement projects each year.

Larger ASCs with multiple ORs or procedure rooms, multiple types of surgical

procedures offered, or high volume of cases are expected to undertake more or more

complex projects. Furthermore, a highly complex improvement project might be of such

scope that it could reasonably be the only project an ASC undertakes in a given year.

CMS does not specify particular projects that each ASC must undertake, but instead

expects the projects to be based on the types of services the ASC furnishes, as well as

other aspects of the ASC’s operations. The requirement for annual projects does not

mean that an ASC may not undertake a complex project that is expected to require more

than 1 year in order to be completed.

The ASC must keep records on its performance improvement projects. Each project

must, at a minimum, include an explanation of why the project was undertaken. The

explanation must indicate what data collected in the ASC or based on recommendations

of nationally recognized organizations leads the ASC to believe that the project’s

activities will actually result in improvements in patient health outcomes and safety in the

ASC. For projects that are still underway, the ASC must be able to explain what

activities the project entails, and how the impact of the project is being monitored.

Unless the project has just begun, the ASC must be able to provide evidence that it is

collecting data that will enable it to assess the project’s effectiveness. For projects that

are completed, the ASC must be able to show documentation that explains what the

results of the project were, and what actions, if any, the ASC took in response to those

results.

Survey Procedures: §416.43(d)

• Ask the ASC to show you documentation for performance improvement projects

currently underway, as well as those completed in the prior year.

• If a large, complex, or high volume ASC has only one project underway, is the

scope of that project such that it is likely to have a significant impact on the

ASC’s quality of care or patient safety?

• Does the ASC’s documentation indicate the rationale for undertaking each

project? Does the ASC have data indicating it had a problem in the area targeted

for improvement, or could the ASC point to recommendations from a nationally

recognized expert organization suggesting the activities?

• Does the documentation for the completed project(s) include the project’s results?

If a project was unsuccessful, ask the ASC what actions it took as a result of that

information. If the project was successful, ask the ASC how it is sustaining the

improvement.