CMS SOM Ch. 5 § 5590

Complaint Survey

5000.1 – Purpose of the Complaint/Incident Process

Mission: To protect Medicare/Medicaid beneficiaries from abuse, neglect, exploitation,

inadequate care or supervision.

The goal of the Federal complaint/incident process is to establish a system that will assist

in promoting and protecting the health, safety, and welfare of residents, patients, and

clients receiving health care services. The complaint/incident management system has

three objectives.

1. The first objective and priority for the complaint/incident management system is

protective oversight. This is accomplished by analyzing the complaint allegations

and reported incidents received to identify and respond to those that appear to

pose the greatest potential for harming beneficiaries (has caused or is likely to

cause, serious injury, harm, impairment or death). Complaints/incidents of this

type that allege an immediate threat to the health, safety or welfare of individuals

are investigated immediately.

2. The second objective is prevention. Complaints/incidents that do not allege a

threat of serious harm are investigated to determine if a problem exists that could

have a negative impact on the healthcare services provided. The investigation of

these complaints/incidents is designed to identify and correct less serious

complaints/incident to prevent the escalation of these problems into more serious

situations that would threaten the health, safety and welfare of the individuals

receiving the service. These complaints/incidents are also prioritized and

investigated based on the seriousness of the allegations.

Numerous or more frequent complaints/incidents may indicate systemic problems

and therefore may be assigned a higher priority for investigation.

3. The third objective is to promote efficiency and quality within the health care

delivery system. Complaints/incidents that are not directly related to Federal

requirements are forwarded to the appropriate agency(ies) for follow-up and

investigation. Complaints/incidents in this category may include but are not

limited to Medicare/Medicaid fraud, complaints against individual licensed

practitioners, and billing issues.

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.