42 CFR § 488.1040 - Onsite observations of home infusion therapy accrediting organization operations.

---
identifier: "/us/cfr/t42/s488.1040"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "42 CFR § 488.1040 - Onsite observations of home infusion therapy accrediting organization operations."
title_number: 42
title_name: "Public Health"
section_number: "488.1040"
section_name: "Onsite observations of home infusion therapy accrediting organization operations."
chapter_name: "CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "G"
subchapter_name: "STANDARDS AND CERTIFICATION"
part_number: "488"
part_name: "SURVEY, CERTIFICATION, AND ENFORCEMENT PROCEDURES"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "42 U.S.C 1302 and 1395hh."
regulatory_source: "53 FR 22859, June 17, 1988, unless otherwise noted."
cfr_part: "488"
---


# 488.1040 Onsite observations of home infusion therapy accrediting organization operations.

(a) As part of the application review process, the ongoing review process, or the continuing oversight of a home infusion therapy accrediting organization's performance, CMS may conduct onsite inspections of the home infusion therapy accrediting organization's operations and offices at any time to verify the home infusion therapy accrediting organization's representations and to assess the home infusion therapy accrediting organization's compliance with its own policies and procedures.

(b) Activities to be performed by CMS staff during the onsite inspections may include, but are not limited to the following:

(1) Interviews with various accrediting organization staff.

(2) Review of documents, survey files, audit tools, and related records.

(3) Observation of meetings concerning the home infusion therapy accreditation process.

(4) Auditing meetings concerning the accreditation process.

(5) Observation of in-progress surveys and audits.

(6) Evaluation of the accrediting organization's survey results and accreditation decision-making process.