CMS SOM App. A, Tag A-0309

§482.21(e) Standard: Executive Responsibilities

The hospital’s governing body (or organized group or individual who assumes full legal

authority and responsibility for operations of the hospital), medical staff, and

administrative officials are responsible and accountable for ensuring the following:

(1) That an ongoing program for quality improvement and patient safety, including the

reduction of medical errors, is defined, implemented, and maintained.

(2) That the hospital-wide quality assessment and performance improvement efforts

address priorities for improved quality of care and patient safety and that all

improvement actions are evaluated….

(5) That the determination of the number of distinct improvement projects is

conducted annually.

Interpretive Guidelines §482.21(e)(1), (2) & (5)

The hospital’s leadership, meaning the hospital’s governing body (or organized group or

individual who assumes full legal authority and responsibility for operations of the hospital),

medical staff, and administrative officials, are all responsible and accountable for the hospital’s

QAPI program. The medical staff may delegate this leadership responsibility and accountability

for the QAPI program to the medical staff executive committee if it has such a committee.

"Administrative officials" includes, at a minimum, the hospital’s chief executive officer, chief

operating officer, and the chief nurse executive (or equivalent), but would also include other

executives in the hospital’s administration.

Because the QAPI program is required to be a hospital-wide program, the governing body,

medical staff, and administrative officials are responsible for the QAPI requirements at all

locations of the hospital (onsite and off-site inpatient and outpatient services and departments)

and with regard to all services provided directly by the hospital as well as those services

provided under arrangement or contract. This means that the services at all locations of the

hospital must be taken into consideration when developing, defining, implementing, and

maintaining the QAPI program.

Together these hospital leaders are responsible for ensuring that the requirements identified in

this standard, as well as in the other standards of this CoP, are met. Therefore, the hospital

should be able to provide evidence that all such individuals are engaged in and fulfilling their

QAPI responsibilities. While these leaders are not expected to be directly involved in the day-to-day activities of the hospital’s QAPI program, they should be actively engaged in the oversight

of the QAPI program through their periodic review of the program, including, but not limited to,

the development of a plan to implement and maintain the QAPI program, the review of the

progress of QAPI projects, the determination of annual QAPI projects, the evaluation of the

effectiveness of improvement actions that the hospital has implemented, etc. Evidence may also

include, but is not limited to, the establishment of a QAPI plan, QAPI meeting minutes with

attendance rosters, signatures on annual QAPI project reviews and approvals, minutes from

annual budget meetings that incorporate planning for QAPI resources, etc.

Additionally, this group of leaders is responsible for ensuring that clear expectations for safety

are established and communicated hospital-wide. Establishing clear expectations for safety

should, at a minimum, include, but not be not limited to, informing all staff of their specific roles

and responsibilities in QAPI. Clear expectations for safety must also be set and communicated

to those providing services under arrangements or contracts and should be documented in the

contracts. It is expected that upon survey, all staff (including contractors) are able to articulate

their roles and responsibilities in supporting the hospital’s expectations for safety, such as what

safety risks or breaches they are expected to report and how they would be expected to report

them. Hospitals may communicate safety expectations through education and training, the use

of posters that are constant reminders of safety requirements, staff newsletters, etc.

Contracted Services or Services Under Arrangement

When hospitals choose to provide services under an arrangement or through a contract instead

of providing the services directly, it does not mean that the hospital is not responsible for the

quality and safety of the services provided by the contractor. Instead, in accordance with 42

CFR 482.12(e)(1), the hospital’s governing body must ensure that services performed under

contract are provided in a safe and effective manner and, under 482.21, must ensure that

services provided under contract or arrangement are included in the QAPI program. Therefore,

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

arrangement or contract in its QAPI program, Evidence of this inclusion would include, but not

be limited to, periodic assessment of contracted services, what resources the contractor has

allocated to QAPI activities, how the contractor actively participates in QAPI activities, such as

providing the governing body with periodic quality reports/data, attending QAPI planning

meetings, and, when appropriate, conducting performance improvement projects. For example,

a hospital that provides emergency services (and staffing) for its emergency department (ED)

under contract or arrangement must demonstrate that it routinely receives quality data from the

ED contractor, reviews the data, and takes necessary action based on the data. It is expected

that the hospital must be able to provide evidence that the contracted services are included in the

QAPI program in order to demonstrate compliance with the QAPI CoP.

Evidence of the executive leadership exercising its required QAPI program oversight would

include:

• budget or other documents that indicate the resources available to the QAPI program,

and

• minutes of governing body meetings that show QAPI as a standing agenda item, and

more specifically, that the executive leadership makes the required QAPI program

decisions related to planning, data collection, and projects, conducts regular reviews of

information on the performance of the QAPI program, and makes decisions based on that

review for the overall direction and management of the program.

Survey Procedures

• Ask to see evidence that the governing body, hospital CEO, Medical Staff (or its executive

committee), and other administrative officials are providing oversight in the QAPI

program

• Are there QAPI meeting minutes that document their attendance?

• Do the Governing Body meeting agendas provide evidence that the QAPI

program thas been addressed?

• Do the governing body meeting minutes include evidence of QAPI discussions?

• Are there documents such as annual QAPI program reviews that include their

signatures?

• Ask to see evidence that the governing body, medical staff (or its executive committee),

and administrative officials:

• Approve the number of distinct QAPI projects to be conducted annually.

• Review the results of QAPI data collection, analyses, activities, and projects, and

make decisions based on such review.

• For those services the hospital provides under arrangement or contract, ask to see

evidence that the contractor is actively involved in the QAPI program:

• Do the governing body, medical staff, and administrative officials periodically

receive and review quality data from the contractor?

• Is the contracted service involved in any current or past hospital QAPI projects?

• Does the contract or agreement include the hospital’s expectations regarding the

contractor’s roles and responsibilities regarding QAPI?

• Does the data from the contractor demonstrate positive outcomes related to the

services provided?