State Operations Manual (Pub. 100-07), Ch. 5 § 5000.2
Overview
5000.2 – Overview
(Rev. 243; Issued: 06-12-26; Effective: 06-12-26; Implementation: 06-12-26)
All the procedures in this chapter are followed when complaints and reported incidents,
including referrals from public entities, involve Medicare-certified providers/suppliers,
Medicaid-certified providers/suppliers, or CLIA-certified laboratories. The investigation
and resolution of complaints are critical certification activities. The CMS, the State
Medicaid Agency (SMA), and the State survey agency (SA) are responsible for ensuring
that participating providers/suppliers of health care services continually meet Federal
requirements. This requires that the SA promptly reviews complaints/incidents, conducts
unannounced onsite investigations of reports alleging noncompliance, and informs the
CMS location and/or the SMA any time certification requirements are found to be out of
compliance.
Since there are multiple activities associated with the management of complaints and
incidents, responsibilities often cut across organizational lines. Thus, the SA must
demonstrate clear-cut accountability for each step of the process and a focal
coordinating/controlling responsibility to assure timely and appropriate action. The SA’s
responsibilities cannot be delegated.