§ 485.641 Condition of participation: Quality assessment and performance improvement program.

The CAH must develop, implement, and maintain an effective, ongoing, CAH-wide, data-driven quality assessment and performance improvement (QAPI) program. The CAH must maintain and demonstrate evidence of the effectiveness of its QAPI program.

(a) Definitions. For the purposes of this section—

Adverse event means an untoward, undesirable, and usually unanticipated event that causes death or serious injury or the risk thereof.

Error means the failure of a planned action to be completed as intended or the use of a wrong plan to achieve an aim. Errors can include problems in practice, products, procedures, and systems; and

Medical error means an error that occurs in the delivery of healthcare services.

(b) Standard: QAPI Program Design and scope. The CAH's QAPI program must: