[Code of Federal Regulations]

[Title 42, Volume 4]

[Revised as of October 1, 2006]

From the U.S. Government Printing Office via GPO Access

[CITE: 42CFR482.21]



[Page 500-501]

 

                         TITLE 42--PUBLIC HEALTH

 

  CHAPTER IV--CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF 

                  HEALTH AND HUMAN SERVICES (CONTINUED)

 

PART 482_CONDITIONS OF PARTICIPATION FOR HOSPITALS--Table of Contents

 

                   Subpart C_Basic Hospital Functions

 

Sec.  482.21  Condition of participation: Quality assessment and 





performance 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.

    (a) Standard: Program scope. (1) The program must include, but not 

be limited to, an ongoing program that shows measurable improvement in 

indicators for which there is evidence that it will improve health 

outcomes and identify and reduce medical errors.

    (2) The hospital must measure, analyze, and track quality 

indicators, including adverse patient events, and other aspects of 

performance that assess processes of care, hospital service and 

operations.

    (b) Standard: Program data. (1) The program must incorporate quality 

indicator data including patient care data, and other relevant data, for 

example, information submitted to, or received from, the hospital's 

Quality Improvement Organization.

    (2) The hospital must use the data collected to--

    (i) Monitor the effectiveness and safety of services and quality of 

care; and

    (ii) Identify opportunities for improvement and changes that will 

lead to improvement.

    (3) The frequency and detail of data collection must be specified by 

the hospital's governing body.

    (c) Standard: Program activities. (1) The hospital must set 

priorities for its performance improvement activities that--

    (i) Focus on high-risk, high-volume, or problem-prone areas;

    (ii) Consider the incidence, prevalence, and severity of problems in 

those areas; and

    (iii) Affect health outcomes, patient safety, and quality of care.

    (2) Performance improvement activities must track medical errors and 

adverse patient events, analyze their causes, and implement preventive 

actions and mechanisms that include feedback and learning throughout the 

hospital.

    (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.

    (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.

    (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,



[[Page 501]]



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.

    (3) That clear expectations for safety are established.

    (4) That adequate resources are allocated for measuring, assessing, 

improving, and sustaining the hospital's performance and reducing risk 

to patients.

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

projects is conducted annually.



[68 FR 3454, Jan. 24, 2003]