CMS SOM App. A, Tag A-0283

§§482.21(b)(2)(ii), 482.21(c)(1) & 482.21(c)(3)

§482.21(b)(2) Standard: Program Data

The hospital must use the data collected to--…

(ii) Identify opportunities for improvement and changes that will lead to improvement.

Interpretive Guidance §§482.21(b)(2)(ii)

As a component of the hospital’s QAPI program, the hospital should utilize the data collected to identify

opportunities of continuous and ongoing improvement as well as mechanisms for change to improve

safety and quality of care for the patients it serves.

§482.21(c) Standard: Program Activities

• The hospital must set priorities for its performance improvement activities that-

• Focus on high-risk, high-volume, or problem-prone areas;

• Consider the incidence, prevalence, and severity of problems in those areas; and

• Affect health outcomes, patient safety, and quality of care….

(3) The hospital must take actions aimed at performance improvement and, after

implementing those actions, the hospital must measure its success, and track performance to

ensure that improvements are sustained.

Interpretive Guidance §§482.21(c)(1) & 482.21 (c)(3)

Hospitals should evaluate their QAPI program data to ensure that they are considering the information

below in establishing priority areas where it will undertake specific actions to improve its performance.

The prioritization of quality of efforts should address the effect on health outcomes, patient safety, and

quality of care. Hospitals should determine these areas based on the complexity of the services they

provide.

• High-risk areas - where the opportunity for error is higher than in other areas, for example,

where there are complex processes, and/or where the consequences of poor quality or

medical errors are more likely to have a serious, adverse impact on patients. Examples may

include, but are not limited to, Emergency Departments, Labor and Delivery Units, ICUs,

and care areas treating immunocompromised patients.

• High volume areas - where the number of potential patients who could be adversely affected

is high due to common elements in their care. These areas may include, but are not limited

to, clinical staff hand hygiene, sanitary food preparation, and general medication

administration.

• Problem-prone areas - where the hospital’s own internal QAPI data shows a history of

problems, or where nationally available research or expert consensus has identified areas

especially prone to problems. These areas may include, but are not limited to, hospital-acquired infections, central-venous catheter use, patient hand-off communication processes

between members of the healthcare team, systems for identifying patients, and medication

administration.

• Incidence refers to the rate or frequency at which an event being measured occurs within a

specific timeframe.

• Prevalence refers to how widespread something is at a specific point in time in a particular

place or population.

• Severity refers to the degree of seriousness or significance of an event or issue in a hospital.

Survey Procedures §§482.21(b)(2)(ii), 482.21(c)(1) & 482.21(c)(3)

• Ask to see a list of current or recent performance improvement activities.

• Ask the governing body or the leadership staff who oversee the QAPI program to provide evidence

that its improvement activities are focused on high-risk, high-volume, or problem-prone areas. Does

it have any data (either derived from its own QAPI data col lection or public data) on incidence,

prevalence, or severity to support its choices? Does it have evidence that the activities affect health

outcomes through improving quality of care or patient safety?

• Ask the governing body or leadership staff who oversee the QAPI program to provide evidence of

QAPI activities that were initiated based on data reported through the medical error/adverse event

tracking system.

• Ask to see evidence that the hospital tracks data for the identified indicators, which may include, but

are not limited to blood product transfusion reactions, drug reactions, errors in medication

administration, and infection control-related errors and events.