CMS SOM App. A, Tag A-0297

§482.21(d) Standard: Performance Improvement Projects.

As part of its quality assessment and performance improvement program, the hospital

must conduct performance improvement projects.

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

proportional to the scope and complexity of the hospital’s services and operations.

(2) A hospital may, as one of its projects, develop and implement an information technology

system explicitly designed to improve patient safety and quality of care. This project, in its

initial stage of development, does not need to demonstrate measurable improvement in

indicators related to health outcomes.

(3) The hospital must document what quality improvement projects are being conducted, the

reasons for conducting these projects, and the measurable progress achieved on these

projects.

(4) A hospital is not required to participate in a QIO cooperative project, but its

own projects are required to be of comparable effort.

Interpretive Guidelines §482.21(d):

Performance improvement projects are differentiated from performance improvement activities under

482.21(b)(2) in that performance improvement projects require a significant amount of up-front

planning, include project objectives, and have a definitive beginning and end date (time-limited).

Whereas performance improvement activities make up the continuous, ongoing functions of a hospital

QAPI program, such as ongoing tracking of medical errors and adverse events, analysis of data,

implementation of changes with associated education and training, continuous monitoring of quality

and safety in all hospital departments and service areas, etc.

CMS does not prescribe the specific types of performance improvement projects to be conducted

annually. It is up to each hospital’s governing body to determine the number and types of annual

projects based on the complexity and scope of the services provided by the hospital. No fixed ratio is

required, but it is acceptable for smaller hospitals with a smaller number of distinct services to have

fewer projects than a large hospital with many different services.

Hospitals may choose to participate in Quality Improvement Organization (QIO) projects to fulfill the

annual project requirement, but are not required to do so to be compliant with the QAPI regulation.

QIOs are funded by CMS to promote, through cooperative projects, improvements in services provided

by Medicare-participating providers. If a hospital does not participate in a QIO project, it is expected to

implement its own annual projects that are comparable in effort to a QIO project. The hospital should

consider the number of patients affected, the range of services covered, and the projected magnitude of

the benefit to individual patients when developing annual projects. (68 FR at 3441)

Hospitals should keep records on each performance improvement project completed within the previous

six years, as well as a list of projects currently underway. The documentation for each project must, at

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

should indicate what data was collected in the hospital, or what publicly available data and/or

recommendations of nationally recognized organizations, leads the hospital to believe that the project

activities will result in improvements in patient health outcomes and safety in the hospital.

For projects that are in progress, the hospital should be able to explain what activities the

project entails and how the impact of the project is being monitored. The hospital should also be

able to provide evidence of baseline data it is collecting (or will be collecting, in the case of

projects just beginning) that will enable the hospital to assess whether the project achieved

measurable outcomes. For projects that are completed, the hospital should be able to

demonstrate that the project resulted in measurable progress toward improving the quality of

care or patient safety.

Survey Procedures

• Ask the hospital to provide a list of distinct performance improvement projects the

hospital is currently conducting and has conducted within the last three years to verify

the hospital is conducting annual QAPI projects.

• Ask to see the documentation of why each project was conducted and evidence to support

the progress being made on each project.

• Does the documentation include data to support “why” each project was

conducted (e.g., medical error and adverse event reports indicated a need for

improvement in a particular area)?

• Does the documentation include evidence of ongoing monitoring of the project's

progress, such as periodic data collection and analysis?

• Ask the Governing Body to explain how the selection (number and scope) of the specific

projects is in alignment with the hospital’s complexity and the scope of services it

provides.

• Consider the size of the facility and the intensity of its services, such as critical

care services/units, complex surgeries, transplant services, maternal/child health

services, and oncology services, including radiation and chemotherapy, etc.