(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.