CMS SOM App. A, Tag A-0263

Improvement Program

The hospital must develop, implement, and maintain an effective, ongoing, hospital-wide, data-driven quality assessment and performance improvement program. The hospital’s governing

body must ensure that the program reflects the complexity of the hospital’s organization and

services; involves all hospital departments and services (including those services furnished

under contract or arrangement); and focuses on indicators related to improved health outcomes

and the prevention and reduction of medical errors. The hospital must maintain and

demonstrate evidence of its QAPI program for review by CMS.

Interpretive Guidelines §482.21

A hospital is required to have a quality assessment and performance improvement (QAPI) program that

provides a mechanism to systematically examine the quality of care delivered and implement specific

improvement projects on an ongoing basis for all of the services provided by the hospital. The hospital

should also consider the complexity of those services when determining quality parameters of those

services. Hospitals are expected to continuously study and improve their processes and service delivery

and take a proactive approach to improve their performance and focus on improving patient outcomes

and the prevention of medical errors.

CMS does not prescribe a particular QAPI program that all hospitals must use. Rather, each hospital is

provided with the flexibility to develop its own program based on its unique needs, priorities, clinical

programs, as well as its own considerations for the health equity needs of its patient population. Each

hospital should have processes in place to continually identify opportunities for quality and safety

improvements and to implement changes that lead to improved outcomes that are sustained over time.

The hospital is expected to provide evidence of continuous data collection, data analysis (with identified

areas for improvement), and implementation of changes, including the ongoing monitoring of those

changes to determine their effectiveness. In addition, there should be evidence that the governing body

is engaged in the oversight of the QAPI program for all services provided by the hospital, including

those provided under contract or arrangement.

The hospital-wide program should include all locations and services and departments of the hospital,

whether on-campus or off-campus (i.e., other inpatient campuses, inpatient units located on another

hospital’s campus/buildings, off-campus EDs, etc.), covered under the hospital’s Medicare provider

agreement. While it is not expected that all departments and services be continuously engaged in large

scale or resource-intensive QAPI projects, all departments and services (including those provided under

arrangement or contract) should provide evidence that there is continuous monitoring of the quality and

safety of the services provided and take corrective actions as necessary to ensure patient safety and to

improve the quality of care provided.

For services under contract, in accordance with 42 CFR 482.12(e), the hospital’s governing body must

ensure that contractors provide services in a manner that allows the hospital to comply with all

applicable Conditions of Participation and standards for the contracted services. Furthermore, the

hospital must be able to demonstrate how it includes services provided under an arrangement or

contract in its QAPI program. This may be done by providing evidence of the evaluation of contracted

services and, when appropriate, conducting performance improvement activities or projects related to

services under arrangement or contract.

Survey Process

Surveyors are not expected to judge the performance and quality measures used by a hospital. Instead,

surveyors will evaluate the hospital’s success in its efforts to improve performance and quality. The

focus of the QAPI CoP assessment is to determine whether a hospital has an effective, ongoing system in

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

then following up on these remedial actions to determine if they were effective in improving

performance and quality. The survey focus will also include whether improvements are sustained over

time.

There may also be an evaluation of the QAPI program when surveyors identify non-compliance with

other regulatory requirements. For example, a surveyor may observe deficiencies in infection control or

medication administration practices. Citations should be made under the applicable portions of the

infection control, nursing, or pharmacy CoPs. However, surveyors should also investigate the tracking

of medical errors and adverse events related to healthcare-associated infections or medication errors,

what type of analyses and actions have been taken to reduce future errors, and what follow-up

evaluations are underway. If, during the course of the survey, such lapses in care and safety are found

to be very serious or widespread, surveyors should investigate the effectiveness of the QAPI program

related to the handling of medical errors and adverse events. If there is evidence that the hospital is

taking effective actions through its QAPI program to correct such deficiencies, then a citation of QAPI

CoP deficiencies generally would not be appropriate, despite the individual lapses surveyors might have

observed for other regulatory requirements.

Surveyors should avoid using the hospital’s own QAPI program data and analyses as evidence of

violations of other CoPs unless there is evidence of current non-compliance with the regulatory

requirements. However, surveyors may review additional records pertaining to the operation of the

hospital, including medical error reports and peer review information when these documents are

necessary to determine compliance with statutory and regulatory requirements. With rare exceptions,

surveyors must not use the information they have gathered from QAPI program records as the basis for

a deficiency citation under other CoPs. There may be cases where it might be appropriate to use QAPI

program information as evidence of a deficiency, but these cases would be the exception rather than the

rule. For example, a review of the QAPI program documents might show that a hospital identified

three incidents of wrong-site surgery over twelve months, and another five near misses, but that no

subsequent action was taken to analyze these incidents and implement any changes to its pre-surgical

verification procedures. Here, the QAPI documents would suggest there is current noncompliance with

the QAPI CoP since the hospital’s QAPI program did not take any action to address the problems it had

identified. In this circumstance, it would also be appropriate for surveyors to review the medical

records for the incidents identified in the QAPI system to assess compliance with the surgical services

CoP.

Surveyors should be aware of the sensitivity of the documents when reviewing QAPI program materials

furnished by a hospital that relate to peer review or other analyses of adverse events. Surveyors must:

• Avoid making copies of such information unless absolutely necessary to support a deficiency

citation; and

• Avoid making notes that could identify particular events-- e.g., do not write: “root cause

analysis of an adverse event in August, 20XX related to inadvertent disposal of an organ

recovered from a living donor showed that primary causes were Y and Z and that the process for

handling a recovered organ should be modified in XX manner. In December 20XX hospital

made the following changes to its process….” Instead write: “confirmed that hospital

conducted a root cause analysis of an adverse event related to the hospital’s transplant

program; reviewed analysis, which was systematic, detailed, and resulted in recommendations;

confirmed the hospital implemented recommendations and is monitoring for effectiveness.”

Ensure that the recommendations resulted in improvements to processes, outcomes, etc.,

resulting in positive patient outcomes.

Additionally, surveyors should:

• Verify the hospital has a formal QAPI program by asking for a copy of the program documents.

• Review program documentation and verify the program is:

• Based on, and reflects, the complexity of the hospital’s organization and services

• Is the size and complexity of the hospital reflected in the overall scope of the

QAPI program?

• Hospital-wide (including services under contract or arrangement)

• Is there evidence that all hospital departments and services are included in

the QAPI program?

• Does the documentation include participation by all contracted services?

• Do written contracts include QAPI requirements and roles and

responsibilities of the contractor?

• Data-driven (does the documentation indicate what data is used to make QAPI

program decisions?)

• Focused on quality indicators/measures related to improved health outcomes, as well

as the prevention and reduction of medical errors (does the program focus on non-clinical measures such as employee satisfaction data as opposed to clinical measures

such as infection control incidence rates and/or nationally recognized quality

indicators?)

• Verify that the hospital enables surveyors to assess its compliance with the QAPI requirements

by providing access to staff and program documentation as requested.

If the surveyor requests information that the hospital asserts is protected from review, ask the hospital if

it can provide alternative evidence of compliance that is not protected.

• If the hospital produces alternative evidence, it is within the sole discretion of the

surveyor to determine whether it provides sufficient evidence with which to assess

compliance with the QAPI requirements.

• If the hospital cannot produce alternative evidence or if the alternative evidence is

insufficient to determine compliance, a deficiency must be cited.