100-07 State Operations Manual: Chapter 5 - Complaint Procedures

State
Operations Manual
Chapter 5 - Complaint Procedures
Table of Contents
(Rev. 243; Issued: 06-12-26)
Transmittals for Chapter 5
Sections 5000 to 5080.1 relate to all Medicare/Medicaid-certified
provider/supplier types.
5000 - Management of Complaints and Incidents
5000.1 - Purpose of the Complaint/Incident Process
5000.2 - Overview
5010 - General Intake Process
5010.1 - Information to Collect From Complainant
5010.2 - Information to Provide to Complainant
5010.3 - Notification to the CMS location
5050 - CMS Regional Office Responsibility for Monitoring SA Management of
Complaints and Incidents
5060 - ASPEN Complaints/Incidents Tracking System (ACTS)
5060.1-Data Entry
5060.2-Reports
5070 - Priority Assignment for Nursing Homes, Deemed and Non-Deemed Non-Long
Term Care Providers/Suppliers, and EMTALA
5075 - Priority Definitions for Nursing Homes, Deemed and Non-Deemed Non-Long
Term Care Providers/Suppliers, and EMTALA
5075.1 - Immediate Jeopardy (for Nursing Homes, Deemed and Non-
Deemed Non-Long Term Care Providers/Suppliers, and EMTALA)
5075.2 - Non-Immediate Jeopardy - High (for Nursing Homes and
Deemed and Non-Deemed Non-Long Term Care Providers/Suppliers, and
EMTALA)
5075.3 - Non-Immediate Jeopardy - Medium (for Nursing Homes and
Deemed and Non-Deemed Non-Long Term Care Providers/Suppliers)
5075.4 - Non-Immediate Jeopardy – Low (for Nursing Homes and
Deemed and Non-Deemed Non-Long Term Care Providers/Suppliers)
5075.5 - Administrative Review/Offsite Investigation (for Nursing Homes
and Deemed and Non-Deemed Non-Long Term Care Providers/Suppliers)
5075.6 - Referral – Immediate (for Nursing Homes, Deemed and Non-
Deemed Non-Long Term Care Providers/Suppliers, and EMTALA)

5075.7 - Referral – Other (for Nursing Homes, Deemed and Non-Deemed
Non-Long Term Care Providers/Suppliers, and EMTALA)
5075.8 - No Action Necessary (for Nursing Homes, Deemed and Non-
Deemed Non-Long Term Care Providers/Suppliers, and EMTALA)
5075.9 - Maximum Timeframes Related to the Federal Onsite
Investigation of Complaints/Incidents
5077 - State Monitoring Visits
5078 - Pre-survey Activities
5079 - Entrance Conference - Non-Long Term Care
5080 - Investigation Findings and Reports
5080.1 - Report to the Complainant
5080.2 - Survey Exit Conference and Report to the Provider/Supplier
Sections 5100 to 5170 relate to deemed providers/suppliers.
5100 - Investigation of Complaints for Deemed Providers/Suppliers
5100.1 - Basis for Investigation
5100.2 - Initial Response to Complainant
5110 - Post-Survey Procedures
5110.1 - Substantial Compliance
5110.2 - Condition-Level, IJ
5110.3 - Condition-Level, Non-IJ
5110.4 - Full Survey after Complaint Survey with Condition-level Deficiencies,
When Authorized by the CMS location
5120 - Life Safety Code Guidance for Deemed Providers/Suppliers
5130 - Deemed Provider/ Supplier Hospital Refusal of Complaint Investigation Surveys
5140 - Complaints Involving HIV-Infected Individuals
5150 - Investigating Complaints Involving ESRD Services Provided by Deemed
Hospitals or CAHs
5160 - Investigating Complaints Against ESRD Suppliers
Section 5170 Relates to Hospital Restraint/Seclusion Death Reporting
and Investigation
5170 - Hospital Restraints/Seclusion Death Reporting and Investigation
5170.1 - Background
5170.2 - Responsibilities
5170.3 - Process
Sections 5200 to 5240 relate to all non-deemed provider/supplier types,
excluding nursing homes (SNFs/NFs).

5200 - Investigating Complaints for Non-Deemed Providers/Suppliers, Excluding
Nursing Homes (SNFs/NFs)
5200.1 - General Procedures
5200.2 - Special Procedures for Psychiatric Hospitals
5210- Processing of Complaints Originating with or Investigated by the CMS location
5220 - Investigation Conducted Directly by the CMS location
5230- Special CMS location Processing
5240 - Complaints - HHA Hotline
Sections 5300 to 5390 relate to nursing homes.
5300 - Investigation of Complaints for Nursing Homes
5300.1 - Task 1: Offsite Survey Preparation
5300.2 - Task 2: Entrance Conference/Onsite Preparatory Activities
5300.3 - Task 5: Information Gathering
5300.4 - Task 6: Information Analysis
5300.5 - Task 7: Exit Conference
5310 - Action on Allegations of Resident Neglect and Abuse, and Misappropriation of
Resident Property for Nursing Homes
5310.1 - Written Procedures
5310.2 - Review and Triage of Allegation
5310.2 A-Immediate Jeopardy Priority
5310.3 - Investigating Allegations
5310.4 - Factors Beyond the Control of the Individual
5320 - Reporting Findings of Abuse, Neglect, or Misappropriation of Property to the
Nurse Aide Registry
5320.1 - Notification Procedures- Preliminary Determinations
5320.2 - Conduct of Hearing for Nurse Aides
5320.3 - Reporting Findings
5330 - Reporting Abuse to Law Enforcement and the Medicaid Fraud Control Unit for
Nursing Homes
5340 - Post-Survey Certification Actions for Nursing Homes
5350 - Data Entry
5360 - Processing of Complaints Originating with or Investigated by the CMS location
5370 - Pre-Investigation Actions on Allegations Originating Through the CMS location
5380 - CMS location Processing of CMS location Investigated Complaints
5390 - CMS location Oversight of Complaint-Related Processes
Sections 5400 to 5480.2 relate to alleged EMTALA violations

5400 - Investigations Involving Alleged EMTALA Violations
5410 - EMTALA and Born-Alive Infants Protection Act of 2002
5410.1 - Interaction of the Born-Alive Infant Protection Act and
EMTALA
5410.3 - Conduct of Investigations
5420 - Basis for Investigation
5430 - CMS location Direction of Investigation
5430.1 - Evaluation of Allegation
5430.2 - Request for Investigation of Allegations
5440 - Conducting an Investigation
5440.1 - Selecting the Team
5440.2 - Scheduling the Investigation
5440.3 - Guidelines for Surveyors Conducting Investigations
5440.4 - Conducting the Investigation
5440.5 - Exit Conference
5450 - Forwarding Report of Investigation to the CMS location
5460 - CMS location Review of Investigation
5460.1 - Hospital Is In Compliance - No Past Violation
5460.2 - Hospital Is In Compliance - Past Violation, No Termination
5460.3 - Hospital Is Not in Compliance - Immediate Jeopardy to Patient
Health and Safety
5460.4 - Hospital Is Not in Compliance - Situation Does Not Pose an
Immediate Jeopardy to Patient Health and Safety
5465 - Procedures for the 5-day QIO Review of Alleged Violations of 42 CFR 489.24
5470 - Termination Procedures for EMTALA Violations
5470.1 - Procedures for Termination when the EMTALA Violation is an
Immediate Jeopardy to Patient Health and Safety
5470.2 - Procedures for Termination When the EMTALA Violation is Not
Immediate Jeopardy to Patient Health and Safety
5480 - Procedures for QIO Review of Confirmed EMTALA Violation
5480.1 - Procedures for Coordinating 60 day QIO Review
5480.2 - EMTALA Case Referral to OIG
5480.3 - Releasing QIO Assessment
Sections 5500 to 5590 relate to the Clinical Laboratory Improvement
Amendments of 1988 (CLIA).
5500 - Complaint Investigations in Non-Accredited, Non-Exempt Laboratories
5500.1 - Control
5500.2 - Acknowledgment

5500.3 - Evaluation
5500.4 - Scheduling Investigations
5510 - Conducting Complaint Investigations in Non-Accredited, Non-Exempt
Laboratories
5510.1 - Conducting Investigations in a Laboratory with a Certificate of Waiver
5510.2 - Conducting Investigations in a Laboratory with a Certificate for Provider-
performed Microscopy Procedures
5510.3 - Conducting Investigations in a Laboratory with a Certificate of
Compliance
5510.4 - Conducting Investigations in a Laboratory with a Certificate Registration
5510.5 - Conducting Investigations in a Laboratory with Temporary Testing Sites,
Regardless of Certificate Type
5520 - Post Complaint Investigation Actions in Non-Accredited, Non-Exempt
Laboratories
5530 - Post Complaint Investigation in Non-Accredited, Non-Exempt Laboratories
Resolution/Closeout
5540 - State Laboratory Licensing Program Laboratory Complaint Investigations -
General
5540.1 - Review of State Laboratory Licensing Program Laboratory Complaints
5540.2 - Conducting Complaint Investigations and Surveys for State Laboratory
Licensing Program
5550 - State Laboratory Licensing Program Complaint Post-Investigation Actions
5560 - State Laboratory Licensing Program Complaint Resolution/Closeout
5570 - Complaint Investigations and Surveys of Accredited Laboratories
5570.1 - CMS Direction of Complaint Investigation of an Accredited Laboratory
5570.2 - Conducting Complaint Survey of an Accredited Laboratory by CMS or
State Agency
5570.3 - Forwarding Investigation Report to CMS by the SA
5570.4 - Accredited Laboratory Found in Compliance Following a Complaint
Survey
5570.5 - Accredited Laboratory Found Not in Condition-level Compliance
Following a Complaint Survey
5580 - Accredited Laboratories Post Investigation Actions
5590 - Accredited Laboratories Resolution/Closeout

5000.1 – Purpose of the Complaint/Incident Process
(Rev. 212; Issued; 02-10-23; Effective: 10-21-22; Implementation: 10-24-22)
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.
5010 - General Intake Process
(Rev. 243; Issued: 06-12-26; Effective: 06-12-26; Implementation: 06-12-26)
A complaint is an allegation of noncompliance with Federal and/or State requirements. If
the SA determines that the allegation(s) falls within the authority of the SA, the SA
determines the severity and urgency of the allegations, so that appropriate and timely
action can be pursued. Each SA is expected to have written policies and procedures to
ensure that the appropriate response is taken for all allegations and is consistent with
Federal requirements as well as with procedures in the State Operations Manual. This
structure needs to include response timelines and a process to document actions taken by
the SA in response to allegations. If a State’s time frames for the investigation of a
complaint/incident are more stringent than the Federal time frames, the intake is
prioritized using the State’s timeframes. The SA is expected to be able to share the logic
and rationale that was utilized in prioritizing the complaint/incident for investigation.
The SA response must be designed to protect the health and safety of all residents,
patients, and clients.
Besides the SA, other public entities receive information and/or perform investigations.
These entities include the office of the coroner or medical examiner, end-stage renal
disease (ESRD) networks, quality improvement networks (QINs), law enforcement, the
ombudsman’s office, and protection and advocacy systems. At times, these public
entities will forward information to the SA if there are concerns about the health and
safety of residents, patients, and clients. The SAs are required to manage and investigate
these referrals as complaints.
An allegation is an assertion of noncompliance with Federal health and safety
regulations. The point of receipt of the allegation is a critical fact-finding and decision-
making point. The SA ensures that its complaint telephone number is listed in local
directories. Information regarding the care, treatment and services provided to
beneficiaries can come from a variety of sources, including beneficiaries themselves,
beneficiaries’ family members, health care providers, concerned citizens, public agencies,

or media reports. Report sources may be verbal or written. In some instances, the
complainant may request anonymity.
The SA and CMS location ensure the privacy and anonymity of every complainant.
Generally, the SA follows the disclosure procedures under chapter 3, §3308. The SA
discloses the complainant’s identity only to those individuals with a need to know who
are acting in an official capacity to investigate the complaint.
In addition to these Federal requirements, the SA abides by any State procedures not in
direct conflict with CMS instructions. The SA notifies the CMS location if State
regulations conflict directly with any part of these complaint procedures.
See also Section 5310.1 for information related to facility-reported incidents.
5010.1 - Information to Collect From Complainant
(Rev. 18, Issued: 03-17-06; Effective/Implementation Dates: 03-17-06)
The SA collects information necessary to make important decisions about the allegations.
In instances where written or verbal allegations are received, subsequent communication
may be necessary to obtain additional information.
Comprehensive information should be collected during the intake process to allow for
proper prioritization, including the following:
• 	Information about the complainant (e.g., name, address, telephone, etc.);
• 	Individuals involved and affected;
• 	Narrative/specifics of the complainant’s concerns including the date, and time of
the allegation;
• 	The complainant’s views about the frequency and pervasiveness of the allegation;
• 	Name of the provider/supplier including location (e.g., unit, room, floor) of the
allegation, if applicable;
• 	How/why the complainant believes the alleged event occurred;
• 	Whether the complainant initiated other courses of action, such as reporting to
other agencies, discussing issues with the provider, and obtaining a
response/resolution; and
• 	The complainant’s expectation/desire for resolution/remedy, if appropriate.
5010.2 - Information to Provide to Complainant
(Rev. 243; Issued: 06-12-26; Effective: 06-12-26; Implementation: 06-12-26)

The complaint intake process assists the complainant in resolving his/her conflicts. As
part of the intake process the SA provides the following:
• 	Policies and procedures for handling intakes including the scope of the SA’s
regulatory authority and any considerations pertaining to confidentiality;
• 	The course of action that the SA or CMS location will take and the anticipated
time frames;
• 	Information about other appropriate agencies that could provide assistance
including the name and telephone number of a contact person, if available; and
• 	A SA contact name and number for follow-up by the complainant.
NOTE FOR DEEMED PROVIDERS/SUPPLIERS: If a complaint does not allege
condition-level noncompliance, the SA may: 1) advise the complainant to file the
complaint to the accrediting organization (AO), or 2) ask for the complainant's
permission to release the information to the AO.
5010.3 – Notification to the CMS Location
(Rev. 243; Issued: 06-12-26; Effective: 06-12-26; Implementation: 06-12-26)
1 – Notification to the CMS location
The SA immediately forwards allegations involving the following to the CMS location:
• 	Deemed providers/suppliers;
• 	Hospital and psychiatric residential treatment facility (PRTF) restraint/seclusion-
related deaths;
• 	EMTALA complaints;
• 	Fires resulting in serious injury or death in a Medicare/Medicaid-certified facility;
• 	Federal facilities;
• 	Religious Non-medical Health Care Institutions (RNHCIs)(evaluation performed
by Region I, Boston, only);
• 	CLIA-certified laboratories holding a certificate of accreditation. (See Chapter 6).
• 	CLIA-exempt laboratory. (See Chapter 6);

• 	Blood transfusion-related fatalities (See Chapter 6 and Appendix C);
• 	Over-utilization or inappropriate utilization of services within the QIO’s
jurisdiction;
• 	Civil rights violations; or
• 	Medicare or Medicaid fraud
2 – Special Cases
The SA considers whether notification to the CMS location is appropriate. If a complaint
is especially significant, sensitive, or attracting broad public or media attention, the SA
informs the CMS location immediately. Additionally, the SA needs to consider any other
early notice requirements prescribed by other State or Federal policies or interagency
agreements.
5050 - CMS Regional Office Responsibility for Monitoring SA
Management of Complaints and Incidents
(Rev. 243; Issued: 06-12-26; Effective: 06-12-26; Implementation: 06-12-26)
CMS locations are responsible for monitoring the SAs’ management of complaints and
incidents to assure that the SAs are complying with the provisions set forth in Federal
regulations, the SOM, and CMS policy memoranda. As part of the monitoring process,
the SAs will be evaluated in accordance with the criteria set forth by the State
Performance Standard Review. Many States have State laws and regulations that specify
how to manage complaints and incidents. Whenever possible, State and Federal
requirements should be integrated to avoid unnecessary duplication. CMS locations
should accept State requirements that meet or exceed the intent of the Federal
requirements. At a minimum, it is expected that noncompliance with Federal
requirements resulting from a complaint or reported incident will receive follow-up and
be documented in the Aspen Complaints Tracking System (ACTS).
5060 – ASPEN Complaints/Incidents Tracking System (ACTS)
(Rev. 243; Issued: 06-12-26; Effective: 06-12-26; Implementation: 06-12-26)
The SA collects information related to complaints and facility-reported incidents and uses
a system to track and monitor the receipt and disposition of complaint and incident
intakes.
The ASPEN Complaints/Incidents Tracking System (ACTS) is designed to track,
process, and report on complaints and incidents reported against health care providers
and suppliers regulated by CMS. It is designed to manage all operations associated with
complaint/incident processing, from initial intake and investigation through the final
disposition.

The ACTS must be used for the intake of all allegations against Medicare/Medicaid-
certified providers/suppliers and CLIA. The ACTS is a Federal system and data entered
into ACTS is subject to Federal laws governing disclosure and the protection of an
individual’s right to privacy.
A complaint/incident record is created in ACTS based on how the allegation is received
by the SA or CMS location. For example, if one person calls with ten allegations about
one provider/supplier, this is counted as one complaint record. If six people call with the
same allegation, this is counted as six telephone calls and is counted as six complaint
records. If one letter is received with one or many allegations and is signed by 20 people,
this is counted as one complaint record.
5060.1 - Data Entry
(Rev. 243; Issued: 06-12-26; Effective: 06-12-26; Implementation: 06-12-26)
The SAs and CMS locations are required to enter into ACTS:
• 	All complaints gathered as part of Federal survey and certification
responsibilities, regardless if an onsite survey is conducted [i.e., complaints
related to noncompliance with the Federal condition(s) of participation (COPs),
condition(s) for coverage (CFCs), condition(s) for certification, requirement(s) for
participation (RFPs), or EMTALA requirement(s)]; and
• 	For nursing homes, all self-reported incidents that are reported under Federal law
and the requirements for participation [i.e., reporting to law enforcement of
crimes occurring in LTC facilities – §1150B of the Social Security Act and
§483.12(b)(5); alleged violations of abuse, neglect, exploitation or mistreatment,
including injuries of unknown source and misappropriation of resident property –
§483.12(c)(1) and (4)]. For non-long term care providers/suppliers, all self-
reported incidents that require a Federal onsite survey.
The information recorded in ACTS reflects the allegation furnished by the
complainant/provider/supplier at the time of the intake. At a minimum, if the intake
information requires an onsite survey and the allegation may involve both Federal and
State licensure requirements, a Federal onsite survey is completed and entered into
ACTS.
If an investigation finds one or more violations of Federal requirements, the findings
must be cited under the appropriate tags and entered into the Federal system even if the
information is entered into a State licensure data system. Since this information is
essential to the effective management of the survey and certification program, it is
important that SAs complete the required fields in ACTS in a timely manner.
Exhibit 23 defines the required fields in ACTS.

Tracking of Referrals in ACTS
The SAs are required to enter into ACTS all referrals from public entities that allege
noncompliance with the Federal requirements. For reporting purposes, the SAs should
enter these cases as complaints (i.e., Intake Type=Complaint, Intake Subtype=Federal
COPs, CFCs, RFPs, EMTALA). In order to more quickly identify which of these cases
stem from a referral, the SAs are expected to check the appropriate category under the
“Source” field. For example, for referrals from the coroner’s office, states would check
“Coroner” under the “Source” field for the intake.
Tracking of State Monitoring Visits (See Section 5077) in ACTS
When a State Monitoring Visit results in a Federal deficiency, the SA will identify the
survey in ASPEN as “complaint” and create an intake and survey record in ACTS. The
data should be entered into ACTS as follows:
• 	Intake Type = Complaint;
• 	Intake Subtype = Federal COPs, CFCs, RFPs, EMTALA;
• 	Source = State SA;
• 	Priority = can vary; and
• 	Allegation Type = State Monitoring.
5060.2 - Reports
(Rev. 212; Issued; 02-10-23; Effective: 10-21-22; Implementation: 10-24-22)
The ACTS produces a variety of reports that may be used for analysis and evaluation of
provider/supplier performance. Complaint/incident reports are generated and displayed
through menus that can be accessed in ACTS. Reports may be produced for one
provider/supplier, or reports may be combined and present information for multiple
providers/suppliers. Report filtering criteria is available through the Report
Customization window, which allows the user to select criteria for the report to meet the
user’s specifications. Refer to the ACTS Procedures Guide for a list and description of
the reports available in ACTS.
NOTE:
FOR ADDITIONAL INFORMATION ON SPECIFIC POLICIES RELATED TO:
• 	DEEMED PROVIDERS AND SUPPLIERS, EXCLUDING CLIA, SEE
SECTION 5100
• 	NON-DEEMED PROVIDERS AND SUPPLIERS, SEE SECTION 5200
• 	NURSING HOMES, SEE SECTION 5300

• 	EMTALA, SEE SECTION 5400
• 	CLIA LABORATORIES, SEE SECTION 5500
• 	ESRD, SEE SECTION 5160 AND SECTION 5170
5070 - Priority Assignment for Nursing Homes, Deemed and Non-
Deemed Non-Long Term Care Providers/Suppliers, and EMTALA
(Rev. 243; Issued: 06-12-26; Effective: 06-12-26; Implementation: 06-12-26)
This section does not apply to clinical laboratories subject to the Clinical
Laboratory Improvement Amendments of 1988 (CLIA). See Sections 5500 – 5590
for CLIA information.
An assessment of each complaint or incident intake must be made by an individual who
is professionally qualified to evaluate the nature of the problem based upon his/her
knowledge of Federal requirements and his/her knowledge of current clinical standards of
practice.
From a complainant’s allegation(s) or an allegation from a facility-reported incident, the
SA/CMS Location identifies potential concerns where the provider/supplier may not be
in compliance with Federal requirements. The SA/CMS Location must review the
allegation(s) for all requirements that apply and should be investigated. These
requirements will be specific to each health care entity. The surveyor then investigates
each of those areas of concern and health care entity type.
The role of the surveyor is not to validate whether the events contained in the allegation
had occurred, but it is to determine whether the facility is in compliance with the Federal
requirements for Medicare/Medicaid-certified providers/suppliers. If CMS or the SA
believes that the complaint or facility-reported incident should also be investigated under
the jurisdiction of another entity, referrals should be made as appropriate (e.g., law
enforcement for criminal activity, State licensing boards for health care practitioners, the
Medicare Administrative Contractor (MAC) for billing issues).
In the case of nursing homes, in situations where a determination is made that immediate
jeopardy may be present and ongoing, the SA must start the on-site investigation within
three business days of receipt of the initial complaint or incident report. Receipt of the
initial complaint or incident report means when the report is received by the SA, whether
it is received by the SA directly, or another State agency under arrangement or contractor
that is receiving the report on behalf of the SA from the complainant or facility. Also, if a
complaint or facility-reported incident is received after business hours, then it is
considered to be received on the next business day, for purposes of calculating the
investigation timeframe. For example, if a complaint is received on Saturday and the SA
office is closed during the weekend, then the following Monday will be used to calculate
the investigation timeframe.

For non-long term care providers/suppliers, in situations where a determination is made
that immediate jeopardy may be present and ongoing, the SA is required to start the on-
site investigation within two business days of receipt of the complaint or incident report,
or, in the case of a deemed provider or supplier, within two business days of CMS
location authorization for investigation. The same process applies to EMTALA
complaints or a survey related to a report of a hospital or CAH Distinct Part Unit patient
death associated with the use of restraint or seclusion. The SA’s investigation must be
initiated within two business days of CMS location authorization for investigation.
Generally, an alleged event occurring more than 12 months prior to the intake date would
not require a complaint investigation. However, the SA is not precluded from conducting
a Federal investigation (with appropriate CMS location authorization, where required) to
determine current compliance status based on the concerns identified in the complaint.
For nursing homes, an onsite survey may not be required if there is sufficient evidence
that the facility does not have continuing noncompliance and the alleged event occurred
before the last standard survey.
For all intakes concerning deemed status providers or suppliers where the intake involves
allegations of substantial noncompliance (in other words, the allegation would result in a
condition-level deficiency citation if found to be true and uncorrected), the SA must
submit a request for CMS location approval of a complaint validation survey (i.e.,
substantial allegation validation survey). The SA must obtain CMS location approval
before conducting a substantial allegation validation survey. The CMS location will
authorize the SA to conduct the survey by issuing electronically via iQIES a Form CMS-
2802, which will indicate the specific conditions for which the SA must assess
compliance. The CMS location must authorize assessment of compliance for a whole
condition and not just for particular standards within a condition, unless the Form CMS-
2802 for the applicable provider/supplier type permits selection of a specific standard,
e.g., Life Safety Code.
All allegations of EMTALA violations related to a hospital (which also includes cancer,
children’s, long term care, psychiatric and rehabilitation hospitals) or CAH, regardless of
whether the hospital or CAH is deemed, must be referred to the CMS location. The CMS
location will determine whether the SA will conduct an EMTALA investigation.
In cases where the SA or CMS location has noted a pattern of similar complaints about a
specific provider or supplier, each of which on its own merits would be triaged at a
medium or low level, the SA or CMS location has the discretion to assign a higher triage
level to a current intake based on the noted pattern, in order to ensure timely investigation
of the provider’s/supplier’s compliance with the applicable requirements or Conditions.
CMS expects SAs to prioritize complaints at the appropriate level that is warranted. The
timeframes in Section 5075 below represent maximum timeframes for investigation; the
SA is not precluded from investigating complaints and facility-reported incidents within a

shorter timeframe. In addition, the SA is not precluded from taking other factors into
consideration in its triage decision. For example, the SA may identify a trend in
allegations that indicates an increased risk of harm to residents or the SA may receive
corroborating information from other complainants regarding the allegation.
See also Section 5310.2 for requirements for nursing home facility-reported incidents.
5075 - Priority Definitions for Nursing Homes, Deemed and Non-
Deemed Non-Long Term Care Providers/Suppliers, and EMTALA
(Rev. 212; Issued; 02-10-23; Effective: 10-21-22; Implementation: 10-24-22)
5075.1 - Immediate Jeopardy (for Nursing Homes, Deemed and Non-
Deemed Non-Long Term Care Providers/Suppliers, and EMTALA)
(Rev. 243; Issued: 06-12-26; Effective: 06-12-26; Implementation: 06-12-26)
General Provisions
The regulations at 42 CFR 489.3 define immediate jeopardy as, “A situation in which the
provider’s noncompliance with one or more requirements of participation has caused, or
is likely to cause, serious injury, harm, impairment, or death to a resident.” Appendix Q
contains the Guidelines for Determining Immediate Jeopardy. Intakes are assigned this
priority if the alleged noncompliance indicates there was serious injury, harm,
impairment or death of a patient or resident, or the likelihood for such, and there
continues to be an immediate risk of serious injury, harm, impairment or death of a
patient or resident unless immediate corrective action is taken. In addition, for nursing
homes, facility-reported incidents are assigned this priority if immediate jeopardy may
have occurred, regardless of whether an immediate risk may continue to exist. Examples
of intakes that are assigned this priority include, but are not limited to, the following:
• 	All intakes alleging abuse of a resident/patient/client that involve serious injury,
harm, impairment, or death of a resident/patient/client or likelihood for such, and
it is uncertain that they are adequately protected.
• 	For nursing homes, all intakes where a resident was discharged to an unsafe
setting, or in a manner that place the resident at risk for serious harm (e.g. the
resident still has medical needs but they cannot be supported in the setting they
were discharged to).
• 	Intakes alleging EMTALA noncompliance may also be assigned this priority.
• 	Any hospital self-reported incident of patient death associated with use of
restraint or seclusion which the CMS location determines requires an on-site
investigation is also assigned this priority.
When the SA or CMS location makes the determination that a complaint or incident
report suggests an immediate jeopardy may be present, the investigation is to be initiated
in accordance with Section 5075.9.

See also Section 5310.2A for additional guidance related to nursing home facility-
reported incidents. (Note: Please see Section 5075.9 for maximum time frames related to
Federal onsite investigation of complaints/incidents.)
Fires Resulting in Serious Injury or Death
Fires resulting in serious injury or death are prioritized as “immediate jeopardy”. The
following actions are taken when a report of a fire resulting in serious injury or death in a
Medicare/Medicaid certified facility is received from any source:
The SA
• 	Enters the complaint or self-reported incident into the CMS system
(Priority = IJ, Allegation Category = Life Safety Code);
• 	Informs the appropriate CMS location of fire resulting in serious injury or
death no later than one working day after receipt of the intake;
• 	Compiles information as needed to present a comprehensive picture of the
situation surrounding the fire;
• 	Takes appropriate action necessary to assist the Medicare/Medicaid-
certified provider/supplier to protect and/or relocate residents or patients
from further harm; and
• 	Performs the Life Safety Code investigation.
The CMS location
• 	Informs CMS Central Office (CO) Division of Emergency Preparedness
and Life Safety Code (DEPL) of the fire and planned actions, sending a
copy of the alert to the Life Safety Code specialist;
• 	Consults with the CO DEPL to determine whether there is an indication
for CO DEPL participation in the survey for program evaluation purposes;
• 	Reports any findings and actions taken by the SA to the CO DEPL at the
end of the on-site survey; and
• 	At its discretion, may accompany the SA during the on-site survey.
The CO
• 	Consults with the CMS location to determine whether or not issues are
present that indicate further investigation to determine the adequacy of
current standards and their application; and

• 	In certain cases, CO DEPL staff may accompany CMS location and/or
state personnel on the on-site survey.
5075.2 - Non-Immediate Jeopardy - High Priority (for Nursing Homes
and Deemed and Non-Deemed Non-Long Term Care
Providers/Suppliers, and EMTALA)
(Rev. 243; Issued: 06-12-26; Effective: 06-12-26; Implementation: 06-12-26)
Nursing Homes:
Intakes are assigned a “high” priority if the alleged noncompliance with one or more
requirements may have caused harm that negatively impacts the individual’s mental,
physical and/or psychosocial status and are of such consequence to the person’s well-
being that a rapid response by the SA is indicated. Usually, specific rather than general
information (such as: descriptive identifiers, individual names, date/time/location of
occurrence, description of harm, etc.) factors into the assignment of this level of priority.
Note: Please see Section 5075.9 for maximum time frames related to Federal onsite
investigation of complaints/incidents.
NOTE: 	Exhibit 22 provides additional guidance to distinguish between the priorities of
“immediate jeopardy” and “non-immediate jeopardy - high” for nursing home
complaints/incidents.
NOTE: Please refer to Tag F610 in Appendix PP of the State Operations Manual for
information related to facility responses to alleged violations, including facility
investigation, resident protection, and corrective actions.
Non-Long Term Care Providers/Suppliers
Intakes are assigned this priority if the alleged noncompliance with the applicable
Conditions of Participation, Coverage or Certification, or EMTALA requirements, if
found to be true and uncorrected, would not represent an IJ, but would result in a
determination of substantial noncompliance, i.e., at least one condition-level deficiency.
Intakes assigned this priority require an onsite survey to be initiated within 45 calendar
days after intake prioritization for non-deemed providers/suppliers, and within 45
calendar days after authorization of the investigation by the CMS location for deemed
status providers/suppliers. The CMS location has the discretion to request the onsite
survey be initiated in less than 45 calendar days.
5075.3 - Non-Immediate Jeopardy - Medium Priority (for Nursing
Homes and Deemed and Non-Deemed Non-Long Term Care
Providers/Suppliers)

(Rev. 243; Issued: 06-12-26; Effective: 06-12-26; Implementation: 06-12-26)
Nursing Homes:
Complaints are assigned a “medium” priority if the alleged noncompliance with one or
more requirements caused no actual physical and/or psychosocial harm but there is the
potential for more than minimal harm to the resident(s) (Severity Level 2). Facility-
reported incidents are assigned a “medium” priority if the alleged noncompliance with
one or more requirements caused no actual physical and/or psychosocial harm but there is
the potential for more than minimal harm to the resident(s) (Severity Level 2) and the
facility has not provided an adequate response to the allegation or it is not known whether
the facility provided an adequate response. 	Please see Section 5075.9 for maximum time
frames related to Federal onsite investigation of complaints/incidents.
NOTE: Please refer to Tag F610 in Appendix PP of the State Operations Manual for
surveyor guidance related to facility responses to alleged violations, including facility
investigation, resident protection, and corrective actions.
Non-Long Term Care Providers/Suppliers
Intakes are assigned this priority if the alleged noncompliance with one or more standards
within a Condition of Participation, Condition for Coverage or Condition for Certification
is limited in manner and degree and/or caused, or may cause, harm that is of limited
consequence and does not impair the individual’s mental, physical and/or psychosocial
status or function. In other words, the incident or complaint, if found to be true and
uncorrected, would not result in a determination of substantial non-compliance, i.e., there
would not be any condition-level deficiency.
For non-deemed providers/suppliers, intakes assigned this priority are scheduled in
accordance with section 5075.9 for investigation no later than when the next on-site
survey occurs.
For deemed providers/suppliers, the SA (or CMS location, if the CMS location
handled the intake) advises the complainant that the allegation does not meet the
criteria for a Federal investigation and refers the complainant to the applicable
accrediting organization(s)(AOs) in accordance with the provisions of section 5100.2.
5075.4 - Non-Immediate Jeopardy – Low Priority (for Nursing Homes
and Deemed and Non-Deemed Non-Long Term Care
Providers/Suppliers)
(Rev. 243; Issued: 06-12-26; Effective: 06-12-26; Implementation: 06-12-26)
Nursing Homes
Intakes are assigned a “low” priority if the alleged noncompliance with one or more
requirements may have caused no actual harm with a potential for minimal harm

(Severity Level 1). 	Please see Section 5075.9 for maximum time frames related to
Federal onsite investigation of complaints/incidents.
In addition, facility-reported incidents are assigned a “low” priority if the alleged
noncompliance with one or more requirements may have caused no actual physical
and/or psychosocial harm but there is the potential for more than minimal harm to the
resident(s)(Severity Level 2) and the facility has provided a potentially adequate response
to the allegation.
NOTE: Please refer to Tag F610 in Appendix PP of the State Operations Manual for
information related to facility responses to alleged violations, including facility
investigation, resident protection, and corrective actions.
The SA reviews these intakes for tracking of possible trends in order to determine if there
are common themes that suggest areas for focused attention when the next on-site survey
occurs. If the SA identifies a trend that suggests similar concerns, the SA either
investigates the concerns during the next standard or complaint survey or initiates a
complaint survey.
Non-Long Term Care Providers/Suppliers
Intakes are assigned this priority if the alleged noncompliance with one or more standards
within a Condition of Participation, Coverage or Certification may have caused physical,
mental and/or psychosocial discomfort that does not constitute injury or damage.
For non-deemed providers/suppliers, the SA reviews these intakes for tracking of
possible trends in the nature of complaints in order to determine if there are common
themes that suggest areas for focused attention when the next on-site survey occurs.
Individual investigations of each intake are not required, although the SA has the
discretion to conduct a complaint survey if trending suggests a number of similar
problems that might warrant an on-site investigation.
For deemed providers/suppliers, the SA (or CMS location, if the CMS location handled
the intake) advises the complainant that the allegation does not meet the criteria for a
Federal investigation and refers the complainant to the applicable accreditation
organization(s)(AOs) in accordance with the provisions of section 5100.2.
5075.5 - Administrative Review/Offsite Investigation (for Nursing
Homes and Deemed and Non-Deemed Non-Long Term Care
Providers/Suppliers)
(Rev. 243; Issued: 06-12-26; Effective: 06-12-26; Implementation: 06-12-26)
Nursing Homes

The SA conducts the review/offsite investigation and may confirm the findings at the next
on-site survey.
Offsite investigations are rare and are not permitted unless approved in advance by
CMS. For example, if a complaint is received related to arbitration agreements,
prohibition on third party guarantee of payment, or prohibition on charges for services
covered under Medicaid, CMS may approve an offsite review of these or other documents
to assess compliance and cite noncompliance and require corrections, as necessary.
Non-long Term Care Providers/Suppliers
For non-long term care providers/suppliers, both deemed and non-deemed, administrative
review or offsite investigation is generally not permitted. Exceptions are usually limited
to the following types of cases:
• 	CMS location review of alleged noncompliance with provider agreement
requirements found in 42 CFR Part 489, such as:
• 	Alleged discrimination against Medicare beneficiaries, or
• 	Failure of a hospital to accept Medicare-like payment rates for treatment
provided to a patient referred by an Indian Health Service or tribal facility.
• 	CMS location review in the case of a CAH:
• 	Of a notice by the MAC of failure of a CAH to maintain an average annual
per patient length of stay not exceeding 96 hours, or
• 	Whether a relocating CAH or an existing hospital seeking to convert to CAH
status satisfies the CAH location requirements.
The CMS location documents in the provider/supplier file the results of such
administrative review or offsite investigation. Note: depending on CMS location
practice, such administrative review cases may or may not be entered into iQIES.
5075.6 - Referral – Immediate (for Nursing Homes, Deemed and Non-
Deemed Non-Long Term Care Providers/Suppliers, and EMTALA)
(Rev. 243; Issued: 06-12-26; Effective: 06-12-26; Implementation: 06-12-26)
Intakes are assigned a “Referral – Immediate” priority if the nature and seriousness of a
complaint/incident or State procedures requires the referral or reporting of this
information for investigation to another agency, board, or ESRD network without delay.
For example, if a complaint has criminal implications and the complainant has not
reported the incident to law enforcement, the SA must report the suspected crime to law
enforcement immediately (NOTE: In such cases, the referral is recorded in the

Contact/Refer tab under the iQIES intake). This priority may be assigned in addition to
one of the priorities in sections 5075.1 through 5075.5.
When the SA refers the complaint/incident to another agency or entity (e.g., law
enforcement, Ombudsman, licensure agency, etc.) for action, the SA must request a
written report on the results of the investigation by the outside entity. Referral to an
outside entity does not relieve the SA of the responsibility to assess compliance with
Federal conditions or requirements, when applicable. The timeframes for investigation
are not altered by the referral. (Expressed requests by law enforcement that the SA defer
an onsite investigation should be discussed with the CMS location, as appropriate.)
5075.7 - Referral – Other (for Nursing Homes, Deemed and Non-
Deemed Non-Long Term Care Providers/Suppliers, and EMTALA)
(Rev. 243; Issued: 06-12-26; Effective: 06-12-26; Implementation: 06-12-26)
Intakes are assigned a “Referral – Other” priority when they are referred to another
agency, board, or ESRD network for investigation or for informational purposes. This
priority may be assigned in addition to one of the priorities in sections 5075.1 through
5075.5.
When the SA refers the complaint/incident to another agency or entity (e.g., law
enforcement, Ombudsman, licensure agency, etc.) for action, the SA must request a
written report on the results of the investigation by the outside entity. Referral to an
outside entity does not relieve the SA of the responsibility to assess compliance with
Federal conditions or requirements, when applicable. The time frames for investigation
are not altered by the referral. (Expressed requests by law enforcement that the SA defer
an onsite investigation should be discussed with the CMS location, as appropriate.)
5075.8 - No Action Necessary (for Nursing Homes, Deemed and Non-
Deemed Non-Long Term Care Providers/Suppliers, and EMTALA)
(Rev. 243; Issued: 06-12-26; Effective: 06-12-26; Implementation: 06-12-26)
Intakes are assigned a “No Action Necessary” priority if the SA or CMS location determines
with certainty that no further investigation, analysis, or action is necessary.
For example, no action is necessary if the allegation is not related to any Federal COPs,
CFCs, conditions for certification, RFPs, or EMTALA requirement(s); or situations in which
a previous survey investigated the exact same event(s) and either did not find noncompliance,
or noncompliance was previously identified and subsequently corrected by the
provider/supplier.
This category would also be used for intakes concerning an event that occurred more than 12
months in the past, unless the SA (or the CMS location, in the case of a deemed status
provider/supplier) determines that a complaint investigation is nevertheless warranted.

Nursing Homes
The following are examples of reports that require no further action or investigation by
the SA/CMS location:
1) 	Facility-reported incidents that are not reportable events under Federal law or
regulations;
2) 	Facility-reported incidents involving lost items, which are found and no theft is
suspected; and
3) 	The alleged event occurred before the last standard survey and there is sufficient
evidence that the facility does not have continuing noncompliance since the last
standard survey.
NOTE: Sufficient evidence that the facility does not have continuing noncompliance may
be indicated by a recent survey that reviewed the concern, no additional complaints or
facility reported incidents have been received regarding the same issue, and interview
with the Long-term Care Ombudsman which reveal no concerns.

5075.9 - Maximum Time Frames Related to the Federal Onsite Investigation of Complaints/Incidents
(Rev. 243; Issued: 06-12-26; Effective: 06-12-26; Implementation: 06-12-26)
Intake Prioritization
Provider Type 	Immediate Jeopardy (IJ) 	Non-IJ High 	Non-IJ Medium 	Non-IJ Low
Nursing home
complaints
SA must initiate an onsite
survey within 3 business
days of receipt of the initial
report.
SA must initiate an
onsite survey within
an annual average of
15 business days of
receipt of the initial
report, not to exceed
18 business days.
SA must initiate an
onsite survey within
45 calendar days of
receipt of the initial
report.
SA must track/trend
for potential focus
areas during the next
onsite survey, or
initiate a new
complaint survey.
Nursing home
incidents
With inadequate resident
protection, SA must initiate
an onsite survey within 3
business days of receipt of
the initial report.
With potentially adequate
resident protection, SA
must initiate an onsite
survey within 7 business
days of receipt of the initial
report.
See Section 5310.2A.
SA must initiate an
onsite survey within
an annual average of
15 business days of
receipt of the initial
report, not to exceed
18 business days.
With an inadequate
facility response, SA
must initiate an onsite
survey within 45
calendar days of
receipt of the initial
report.
With a potentially
adequate facility
response, SA must
track/trend for
potential focus areas
during the next onsite
survey, or initiate a
new complaint
survey.
Non-deemed
non-long term
care
providers/suppli
ers
SA must initiate an onsite
survey within 2 business
days of receipt.
SA must initiate an
onsite survey within
45 calendar days of
prioritization
SA must investigate
no later than when the
next onsite survey
occurs
SA must track/trend
for potential focus
areas during the next
onsite survey.
Deemed
providers/suppli
ers
SA must initiate an onsite
survey within 2 business
days of receipt of CMS
location authorization
SA must initiate an
onsite survey within
45 calendar days of
receipt of CMS
location
authorization.
Complainant is
referred to the
applicable accrediting
organization(s)
Complainant is
referred to the
applicable accrediting
organization(s)

EMTALA 	SA must initiate an onsite
survey within 2 business
days of receipt of CMS
location authorization.
SA must initiate an
onsite survey within
45 calendar days of
receipt of CMS
location authorization
N/A 	N/A
Death associated
with
restraint/seclusio
n-Hospitals
SA must initiate an onsite
survey within 2 business
days of receipt of CMS
location authorization.
N/A 	N/A 	N/A
Fires resulting in
serious injury or
death
SA must initiate an onsite
survey within 2 business
days of receipt.
N/A 	N/A 	N/A
Investigating nursing home complaints and facility-reported incidents according to section 5075.9 will be implemented no later than
October 1, 2023, to provide time for the SAs to prepare given the resource constraints in the SAs.

5077 - State Monitoring Visits
(Rev. 243; Issued: 06-12-26; Effective: 06-12-26; Implementation: 06-12-26)
“State monitoring visits” refers to visits by the SA to oversee a provider’s/supplier’s
compliance status:
• 	During bankruptcy, in those cases in which CMS has authorized such visits.
• 	After a change of ownership, as authorized by the CMS location.
• 	During or shortly after removal of immediate jeopardy when the purpose of the
visit is to ensure the welfare of the residents/clients/patients by providing an
oversight presence, rather than to perform a structured follow-up visit.
• 	In other circumstances, as authorized by the CMS location.
See Section 5060 for data entry requirements for this type of visit.
5078 – Pre-Survey Activities
(Rev. 120, Issued: 09-19-14, Effective: 09-19-14, Implementation: 09-19-14)
To assist in planning the complaint investigation, prior to going on-site the SA should
review the provider’s or supplier’s prior compliance record and, as applicable, quality
indicators, ESRD Outcome List and Data or supporting information received from other
programs, such as the Ombudsman program or Protection and Advocacy program. This
process may require additional contact with the complainant. 	More information on pre-
survey activities may be found in Section 5170 for ESRD facilities, Section 5300.1 for
long term care facilities, in the provider/supplier-specific SOM appendices and in
Appendix V concerning EMTALA of the SOM.)
5079 – Entrance Conference - Non-Long Term Care
Providers/Suppliers
(Rev. 120, Issued: 09-19-14, Effective: 09-19-14, Implementation: 09-19-14)
Onsite complaint investigations must always be unannounced. Upon entrance, advise the
provider/supplier CEO or other senior official on duty of the general purpose of the visit.
The SA explains the reason for the survey and avoids any impression that a
predetermination has been made as to the validity of the allegation. It is important to let
the facility know why you are there, but to also protect the confidentiality of those
involved in the complaint. Do not release information that will cause opportunities to be
lost for pertinent observations, interviews, and record reviews required for a thorough
investigation. For example, in the case of a hospital, critical access hospital or ambulatory
surgical center, if the complaint is that a patient developed a life-threatening infection in
a post-surgical wound, do not tell the facility the exact complaint. Rather, tell them it is a
situation related to infection control for surgical patients. 	Another example, in the case
of a long term care facility, would be when a complaint that food that is intended to be

served hot is always served cold. In this case, do not tell the provider the exact
complaint. Rather, tell them it is a situation related to dietary requirements.
(See Section 5300.2 for guidance on the entrance conference for long term care facilities
as well as the provider/supplier-specific appendices of the SOM, and Appendix V of the
SOM concerning EMTALA.)
5080 - Investigation Findings and Reports
(Rev. 18, Issued: 03-17-06; Effective/Implementation Dates: 03-17-06)
Each SA establishes reporting policies, procedures and formats including report language
targeted to specific audiences.
5080.1 - Report to the Complainant
(Rev. 243; Issued: 06-12-26; Effective: 06-12-26; Implementation: 06-12-26)
The SA/CMS location provides the complainant a written report of the investigation
findings as a summary record of the investigation.
The following principles guide preparation of the report to the complainant:
• 	Acknowledge the complainant’s concern(s);
• 	Identify the SA’s regulatory authority to investigate the complaint/incident and
any statutory or regulatory limits that may bear on the authority to conduct an
investigation;
• 	Provide a summary of investigation methods (e.g., on-site visit, written
correspondence, telephone inquiries, etc.);
• 	Provide date(s) of investigation;
• 	Provide an explanation of your SA’s decision-making process (NOTE: CMS and
the SA should avoid using terms such as “substantiated” and “unsubstantiated”);
• 	Provide the complainant with information regarding whether or not
noncompliance was identified during the complaint investigation. (NOTE: To
the extent possible, the summary should not compromise the anonymity of
individuals, or include specific situations that may be used to identify individuals,
when anonymity has been requested or is appropriate in the judgment of the SA);
• 	Identify where the complainant may find the Statement of Deficiencies and Plan
of Correction (e.g., posted at the nursing home, Nursing Home Care Compare,
request the CMS-2567 from the SA);

• 	Describe how the complainant may request a copy of the investigation report,
subject to Federal and State disclosure requirements (e.g., see 42 CFR §488.325
and FOIA requirements at 45 CFR Part 5); and
• 	Identify appropriate referral information (i.e., other agencies that may be
involved).
5080.2 - Survey Exit Conference and Report to the Provider/Supplier
(Rev. 243; Issued: 06-12-26; Effective: 06-12-26; Implementation: 06-12-26)
Generally, the SA conducts an exit conference with the provider/supplier at the
completion of the on-site portion of the complaint investigation survey. The SA informs
the provider/supplier of the survey findings, including a general description of any
deficiencies found. The description should be detailed enough to inform the
provider/supplier of the types of activities that require the provider’s/supplier’s corrective
action. However, the SA must not comment on the scope and severity of the deficiencies
identified for long term care facilities. For non-long term care providers/suppliers, the
SA must not comment on manner and degree, that is, whether the deficiencies identified
were condition- or standard-level. Surveyors must also not make reference to any “Tags”
related to deficiencies identified in non-long term care as this identifies condition- or
standard-level. Instead identify the regulatory grouping where concerns exist. See
Section 2724 for additional information about presenting findings during the Exit
Conference.
For non-long term care providers/suppliers, the SA must not provide a list of patients
interviewed, observed, or whose medical records were reviewed, and does not identify
specific patients whose cases are associated with specific deficiencies. (The
provider/supplier has the right to request a copy of any documentation the surveyors copy
to support deficiency findings; therefore the provider/supplier should have enough
information after the exit conference to begin corrective actions.)
The SA informs the provider/supplier that survey findings will be documented on Form
CMS 2567, which will be sent to the provider/supplier and subsequently will be made
available to the public under the disclosure of survey information provisions. For
deemed providers/suppliers, the SA informs the provider/supplier that the CMS location
will be consulted and (depending on CMS location practice), either the CMS location or
the SA will inform the facility of the results of the survey investigation via the Form
CMS 2567.
The SA/CMS location sends to the provider/supplier a written report of the investigation
findings as a summary record of the investigation. At a minimum, this would include the
Form CMS 2567 and applicable notices. For surveys of deemed providers/suppliers (not
including EMTALA surveys), the CMS location sends a copy of the written report to the
applicable accrediting organization(s), following the procedures specified in Section
5110. At the CMS location’s or SA’s discretion, the materials may be sent to the
accrediting organization via e-mail.

(See Section 5300.5 for guidance on the exit conference for long term care facilities,
Section 5440.5 for EMTALA investigations, as well as the provider/supplier-specific
appendices of the SOM, and Appendix V of the SOM concerning EMTALA.)
NOTE: Sections 5300 to 5390 relate to nursing homes.
5100 - Investigation of Complaints for Deemed Providers/Suppliers
(Rev. 120, Issued: 09-19-14, Effective: 09-19-14, Implementation: 09-19-14)
Sections 5100 - 5130 apply to all deemed providers and suppliers, with the exception
of clinical laboratories subject to the Clinical Laboratory Improvement
Amendments of 1988 (CLIA). See Sections 5500 – 5590 for CLIA information,
including investigation of complaints related to accredited laboratories.
5100.1 - Basis for Investigation
(Rev. 243; Issued: 06-12-26; Effective: 06-12-26; Implementation: 06-12-26)
Sections 1864(c) and 1865 of the Social Security Act (the Act) provide the basis for
conducting substantial allegation validation – i.e., complaint investigation - surveys of
deemed providers/suppliers. Before the SA may conduct a complaint investigation
survey at a deemed provider/supplier, it must receive authorization to do so from the
CMS location. In accordance with 42 CFR 488.7, the CMS location may authorize a
complaint investigation only in response to a “substantial allegation” of noncompliance.
A “substantial allegation of noncompliance” is defined at 42 CFR 488.1 as a complaint
from any of a variety of sources, including complaints submitted in person, by telephone,
through written correspondence, or in news media articles, that, if substantiated, would
have an impact on the health and safety of patients, and that raises doubts as to a
provider’s or supplier’s compliance with any Medicare condition. 	In other words, the
complaint, if verified and uncorrected at the time of the survey, would result in a
condition-level deficiency citation. The SA survey conducted in response to a substantial
allegation is one type of validation survey.
NOTE: Deemed status is irrelevant for EMTALA complaints. Hospitals and CAHs may
not be deemed to be in compliance with EMTALA requirements at 42 CFR 489.24 and
the related requirements at 42 CFR 489.20, since these requirements are not part of an
approved Medicare hospital or CAH Medicare accreditation program. SAs must refer all
EMTALA-related allegations concerning a hospital or CAH to the CMS location,
regardless of whether the hospital or CAH is deemed or not. The provisions of Section
5100 do not apply to EMTALA investigations.
The SA must notify the CMS location of all complaints/incidents it receives which, if
substantiated, would by their manner and degree suggest condition-level noncompliance.
The CMS location authorizes the SA to conduct a complaint investigation if it concurs
that the nature of the allegation, if it were true and uncorrected, suggests condition-level

noncompliance. If the CMS location does not concur that the allegation rises to this
level, either the CMS location will change the prioritization of the intake in ACTS to the
appropriate level or it will instruct the SA to do so. Regardless of who makes the change
in ACTS, the CMS location instructs the SA to refer the complainant to the applicable
accrediting organization, following the procedures in section 5100.2
The CMS location communicates its authorization to conduct a complaint investigation of
the deemed provider/supplier by completing the applicable Form CMS 2802 (See Exhibit
33) in ACTS, indicating which Conditions of Participation or Conditions for Coverage or
Certification are to be investigated by the SA. Absent CMS location authorization, the
SA may not conduct a Federal complaint investigation of the deemed provider/supplier.
The SA may have authority under State law to conduct its own non-Federal investigation.
The CMS location completes the Form CMS 2802 in ACTS even if the SA received an
initial verbal authorization from the CMS location to initiate the complaint survey of a
deemed provider/supplier. Since ACTS allows the CMS location to authorize a
complaint survey electronically it is not necessary for the CMS location to send a signed
hard copy of the Form CMS 2802 to the SA via fax or U.S. Postal Service. Once the SA
receives the authorization, it may begin its complaint investigation of a deemed
provider/supplier. Whether the survey is of one or all Medicare conditions, it will be
treated as a complaint survey under ACTS rather than a re-certification survey, since the
complaint/incident is the basis for the survey.
If the CMS location learns directly of a complaint/incident concerning a deemed
provider/supplier, it will review the complaint/incident to assign a priority consistent with
Section 5075. If the complaint/incident is found to be a substantial allegation of
noncompliance, prioritized for investigation as either immediate jeopardy or non-IJ high,
the CMS location authorizes the SA to conduct a complaint investigation or, in a limited
number of cases, the CMS location conducts the complaint investigation.
There may be occasions during the course of a State-only activity in a deemed
provider/supplier when State surveyors observe a situation they believe may constitute IJ
or other substantial noncompliance with a Medicare condition. In such circumstances,
the State must contact the CMS location by telephone or e-mail, explain the situation, and
request authorization to conduct a Federal complaint survey. CMS authorizes the
investigation as a complaint validation (i.e., substantial allegation validation) survey if it
concurs that there may be condition-level noncompliance. The complaint is entered into
ACTS at the earliest possible opportunity.
5100.2 – Initial Response to Complainant
(Rev. 243; Issued: 06-12-26; Effective: 06-12-26; Implementation: 06-12-26)
• 	If the SA concludes that a complaint represents a substantial allegation of
noncompliance (i.e., it is appropriately triaged as an IJ or non-IJ high), it requests
authorization in ACTS from the CMS location to conduct a survey. If the CMS
location authorizes a survey, the SA acknowledges receipt of the complaint by a letter

to the complainant, and advises that a SA investigation will be initiated. 	The
acknowledgment letter also advises that the complainant may also wish to file a
complaint with the applicable accrediting organization (AO), naming the AO and
attaching a current list of AOs and their contact information. This list may be found
at: https://www.cms.gov/Medicare/Provider-Enrollment-and-
Certification/SurveyCertificationGenInfo/Downloads/Accrediting-Organization-
Complaint-Contacts.pdf
• 	If the SA concludes that a complaint does not represent a substantial allegation of
noncompliance (i.e., it is appropriately triaged as non-IJ medium or low) the SA
sends the complainant a letter indicating that the complaint does not meet the criteria
for a Federal on-site investigation of an accredited health care facility. The letter also
advises the complainant which AO(s) accredit the provider/supplier for Medicare
participation purposes and provides the above AO contact information, should the
individual wish to pursue a complaint with the AO.
If the CMS location directly receives a complaint, it is responsible for sending the
complainant a letter which acknowledges the receipt of the complaint and advises the
complainant in the same manner as indicated above for complaints received by the SA.
5110 - Post-Survey Procedures
(Rev. 88, Issued: 08-27-13, Effective: 07-19-13, Implementation: 7-19-13)
5110.1 - Substantial Compliance
(Rev. 243; Issued: 06-12-26; Effective: 06-12-26; Implementation: 06-12-26)
If a condition-level deficiency is not cited at a survey, the provider/supplier is in
substantial compliance with the Federal requirements. The SA certifies its survey
findings in ACTS within 30 calendar days after the completion of the survey. A Form
CMS 2567 is prepared in all cases. Even if no deficiencies were cited, the Form CMS
2567 is issued with a statement that a survey was conducted to evaluate compliance with
the listed requirements identified on the CMS-2802 and that no deficiencies were
identified in these areas.
The CMS location randomly selects several Form CMS 2567s with standard-level
deficiencies for review to determine if the CMS location concurs with the SA’s finding of
substantial compliance.
• 	For all cases not selected for review of the Form CMS 2567, the CMS location
completes the processing in ACTS of the complaint investigation Form CMS 562
and other applicable items in ACTS, and then, depending on CMS location
practice, either the SA or CMS location uploads the complaint survey package
into CASPER, the CMS National Reporting System.
• 	For cases selected for review of the Form CMS 2567:

• 	If the CMS location concurs with the finding, the CMS location completes
the processing in ACTS of the complaint investigation Form CMS 562
and other applicable items in ACTS, and then, depending on CMS location
practice, either the SA or CMS location uploads the complaint survey
package into CASPER, the CMS National Reporting System.
• 	If the CMS location does not concur with the SA’s findings of substantial
compliance, the CMS location discusses with the SA any revisions needed
on the Form CMS 2567 and, after the revisions are made, follows the
procedures for a survey finding substantial noncompliance. (See Section
5110.2 or 5110.3, as applicable.)
The CMS location either issues a notice or authorizes the SA in ACTS to issue the
provider/supplier a notice of its compliance status. The CMS location or SA, as
applicable, issues this notice to the provider/supplier, along with a copy of the Form CMS
2567containing the survey findings. The notice indicates that the provider/supplier was
found to be in substantial compliance even though there may, or may not, also be
standard-level deficiencies cited. In such circumstances, the provider/supplier is not
required to submit a plan of correction for any cited standard-level deficiencies, but may
choose to do so because the Form CMS 2567 is available to the public. The SA and CMS
location do not review any plan of correction the provider/supplier submits; no revisit
survey is conducted. The CMS location promptly sends a copy of the notice letter and
Form CMS 2567 to the applicable AO(s). At the CMS location’s or SA’s discretion,
the materials may be sent to the AO via e-mail.
5110.2 - Condition-Level, IJ
(Rev. 243; Issued: 06-12-26; Effective: 06-12-26; Implementation: 06-12-26)
1. 	IJ Removed while the SA is On-site
If deficiencies pose an IJ and the IJ is removed while the SA is on-site, deficiency
citations are made at the condition-level. Follow the procedure for condition-level
noncompliance, non-IJ, in Section 5110.3 below.
Note: The Form CMS 2567 must state at the beginning that an IJ was cited, regardless of
the fact that it was removed while the SA was on-site. 	An entry in ASPEN/ACTS must
also be made by the CMS location indicating that there was an IJ citation before the
survey can be uploaded to the national database, the CMS National Reporting System
(CASPER). The ASPEN/ACTS systems will prompt the CMS location whenever a
survey includes condition-level deficiencies to indicate whether there was also an IJ.
Details of the IJ situation and the actions taken by the provider/supplier to remove the IJ
must also be documented on the Form CMS 2567. Even though the IJ was removed
while the SA was on-site, the provider or supplier must still be cited for condition-level
noncompliance for the applicable Condition of Participation, Condition for Coverage, or
Condition for Certification that is cited for non-compliance related to the IJ. The

documentation must also include the date the surveyors verified that the IJ was removed
prior to completion of the survey.
2. 	IJ not Removed while the SA is On-site
If condition-level deficiencies pose an IJ and the IJ is not removed while the SA is on-
site, the SA certifies its findings in ACTS within 2 working days after the completion of
the survey.
If the CMS location concurs with the SA’s findings, the deemed provider/supplier is
placed on a 23 calendar-day termination track. The CMS location sends the
provider/supplier the Form CMS 2567, notifies the provider/supplier of the proposed
termination action and effective date, which is 23 calendar days after the date of the CMS
location’s notice, and requests submission of an acceptable plan of correction to the CMS
location within 5 calendar days of the notice. The provider/supplier is advised it will be
surveyed after receipt of an acceptable plan of correction and prior to the termination
date. The notice also contains a statement that “removes” the “deemed status” of the
provider/supplier and places it under SA jurisdiction.
The CMS location sends a copy of the notice to the SA and a copy of the notice and Form
CMS 2567 to the applicable AO(s). At the CMS location’s discretion, the materials may
be sent to the AO via e-mail.
Note: Although deemed status technically has been removed and the provider/supplier is
placed under SA jurisdiction, because it is expected that deemed status will be restored
once corrections are made and verified, no change is made in ASPEN to the
provider’s/supplier’s deemed status. However, periods during which the
provider/supplier is under SA jurisdiction are entered and tracked in ASPEN. Further,
the AO may also conduct a survey of the facility, so long as it continues to accredit the
provider/supplier under its approved Medicare accreditation program.
When the CMS location receives a timely and acceptable plan of correction from the
provider/supplier, it directs the SA to conduct either a full survey or an IJ follow-up
survey, which is a focused, revisit-type survey, before the scheduled termination date in
order to confirm that the IJ has been removed and that the provider/supplier is in
substantial compliance. See Section 5110.3 for a discussion of factors the CMS location
should consider when deciding whether a full survey is needed. If the CMS location
authorizes a full survey, see Section 5110.4 for procedures to follow, except that the full
survey must be conducted prior to the 23-day termination date.
i. 	No Acceptable Plan of Correction Submitted
No revisit is necessary if the provider/supplier fails to submit a timely and
acceptable plan of correction. CMS will proceed to terminate a provider/supplier
if it does not submit a timely and acceptable POC. See SOM Section 3254F. The

public notice must be published 15 calendar days prior to the termination date.
The CMS location notifies the applicable Medicare Administrative Contractor
(MAC) via the Form CMS 2007 of the termination of the provider/supplier’s
Medicare agreement, including the effective date of the termination.
The CMS location completes the processing in ACTS of the complaint
investigation Form CMS 562 and other applicable items in ACTS and then,
depending on CMS location practice, either the SA or CMS location uploads the
complaint survey package into CASPER, the CMS National Reporting System.
The CMS location sends a copy of the termination letter to the applicable AO(s).
At the CMS location’s discretion, the copy may be sent to the AO via e-mail.
ii. 	Post-IJ First Revisit: IJ Not Removed
At least 5 calendar days in advance of the scheduled termination date, the SA
certifies to the CMS location in ACTs its findings, based on on-site verification,
that the IJ has not been removed, and recommends that the termination action
proceed.
The CMS location reviews the SA’s findings, and if it concurs with the SA’s
recommendation, the CMS location completes the processing in ACTS of the
complaint investigation Form CMS 562 and other applicable items in ACTS and
then, depending on CMS location practice, either the SA or CMS location uploads
the complaint survey package into the CMS National Reporting System
(CASPER). The termination of the provider’s/supplier’s Medicare agreement is
processed in ASPEN.
The CMS location sends the provider/supplier a final termination letter and
publishes a public notice, in accordance with the termination process in Section
3010B. The provider/supplier is terminated from the Medicare program. The
CMS location notifies the applicable Medicare Administrative Contractor (MAC)
via the Form CMS 2007 of the termination of the provider/supplier’s Medicare
agreement, including the effective date of the termination.
The CMS location sends a copy of the termination notice and the Form CMS 2567
to the applicable AO(s). At the CMS location’s discretion, the materials may be
sent to the AO via e-mail.
iii. 	Post-IJ First Revisit: IJ Removed, Substantial Compliance
The termination action is rescinded if the IJ has been removed and substantial
compliance has been achieved prior to the effective date of the termination, i.e.,
there are no condition-level deficiencies identified during the follow-up survey by
the SA. The SA certifies its findings to the CMS location via ACTS at least 5

calendar days in advance of the scheduled termination date, and recommends that
the termination action be rescinded.
The CMS location randomly selects several Form CMS 2567s with standard-level
deficiencies for review, to determine if the CMS location concurs with the SA’s
finding of substantial compliance. If the CMS location concurs, and in all other
cases where the Form CMS 2567 is not reviewed by the CMS location, the CMS
location completes the processing in ACTS of the complaint investigation Form
CMS 562 and other applicable items in ACTS, and then, depending on CMS
location practice, either the SA or CMS location uploads the complaint survey
package into CASPER, the CMS National Reporting System. If the CMS location
does not concur with the SA’s finding, the CMS location discusses with the SA
any revisions needed on the Form CMS 2567 and, after the revisions are made,
follows the procedures for substantial noncompliance.
When substantial compliance is achieved, the CMS location either issues a notice,
or authorizes the SA in ACTS to issue the provider/supplier a notice of its
compliance status, restoring its deemed status. The CMS location or SA, as
applicable, issues this notice to the provider/supplier, along with a copy of the
Form CMS 2567 containing the survey findings.
In addition, the CMS location sends a copy of the notice letter to the applicable
AO(s). At the CMS location’s discretion, the copy may be sent to the AO via e-
mail.
Although the follow-up survey found the provider/supplier to be in substantial
compliance, it may have resulted in citation(s) of standard-level deficiencies of
the Form CMS 2567. Because deemed status has been restored, the
provider/supplier is not obligated to submit a plan of correction to the SA, nor are
any further revisits conducted. The provider/supplier may voluntarily choose to
submit a plan of correction because the Form CMS 2567 will be made available to
the public. 	The SA and CMS location do not review any plan of correction the
provider/supplier submits; no further revisit survey is conducted.
iv. 	Post-IJ First Revisit: IJ Removed, Substantial Noncompliance Remains
If the IJ has been removed but substantial noncompliance (i.e., condition-level
deficiencies), remain, the SA certifies its findings to the CMS location in ACTS
within 10 working days after the survey completion date. The SA certifies that
the IJ has been removed and recommends rescission of the 23 calendar-day IJ
termination action, but continuation of the termination action on a 90 calendar-
day termination track.
The CMS location reviews the SA’s findings, and if it concurs with the SA’s
recommendation, the CMS location gives the provider/supplier up to 67 additional
calendar days, or a total of 90 calendar days (23 plus 67) to achieve substantial

compliance. The resulting revised termination date is 90 calendar days after the
date of the CMS location’s original 23-day notice. The CMS location sends the
CMS Form 2567 from the follow-up survey to the provider/supplier with notice of
the new termination date, and requests that an acceptable POC be provided to the
SA within 10 calendar days of the notice.
Post-IJ Second Revisit: The SA conducts the second revisit survey by the 60th
calendar day after the date of the CMS location’s original 23-day termination notice.
Unlike the post-IJ first revisit survey, advance authorization from the CMS location is
not required.
(i) 	Post-IJ Second Revisit Survey Findings: Substantial Compliance
The termination action is rescinded if substantial compliance (i.e., no
condition-level deficiencies) is achieved and documented through the onsite
verification at the revisit survey. There may or may not be standard-level
deficiencies cited. Within 10 working days after the completion of the revisit
survey, the SA certifies to the CMS location its findings via ACTS and
recommends that the termination action be rescinded.
The CMS location randomly selects some Form CMS 2567s with only
standard-level deficiencies for review, to determine if the CMS location
concurs with the SA’s finding of substantial compliance. If the CMS location
concurs, and in all other cases where the Form CMS 2567 is not reviewed by
the CMS location, the CMS location completes the processing in ACTS of the
complaint investigation Form CMS 562 and other applicable items in ACTS
and then, depending on CMS location practice, either the SA or the CMS
location uploads the complaint survey package into CASPER, the CMS
National Reporting System. If the CMS location does not concur, the CMS
location discusses with the SA revisions needed on the Form CMS 2567 and,
after the revisions are made, follows the procedures for substantial
noncompliance.
The CMS location either issues a notice, or authorizes the SA in ACTS to
issue a notice to the provider/supplier of its compliance status and that its
deemed status is restored. The CMS location or SA, as applicable, issues this
notice to the provider/supplier, along with a copy of the Form CMS 2567 with
the survey findings.
The CMS location sends a copy of the notice and Form CMS 2567 to the
applicable AO(s). 	At the CMS location’s discretion, the materials may be
sent to the AO via e-mail.
i. 	Post-IJ Second Revisit Survey Findings: Substantial Noncompliance

If the second revisit shows that the provider/supplier fails to demonstrate
substantial compliance (i.e., condition-level deficiencies are identified through
on-site verification by the SA), the SA certifies to the CMS location its
findings within 10 calendar days after the survey completion date, and
recommends that the termination action proceed.
The CMS location reviews the SA’s findings, and if it concurs with the SA’s
recommendation, the CMS location sends the provider/supplier a final
termination letter and publishes a public notice 15 calendar days prior to the
termination date. The provider/supplier is terminated from the Medicare
program. The CMS location notifies the applicable Medicare Administrative
Contractor (MAC) via the Form CMS 2007 of the termination of the
provider/supplier’s Medicare agreement, including the effective date of the
termination.
The CMS location completes the processing in ACTS of the complaint
investigation Form CMS 562 and other applicable items in ACTS and then,
depending on CMS location practice, either the SA or CMS location uploads
the complaint survey package into CASPER. The provider’s or supplier’s
Medicare agreement is terminated in ASPEN.
The CMS location sends a copy of the final termination notice and Form CMS
2567 to the applicable AO(s). At the CMS location’s discretion, the materials
may be sent to the AO via e-mail.
5110.3 - Condition-Level, Non-IJ
(Rev. 243; Issued: 06-12-26; Effective: 06-12-26; Implementation: 06-12-26)
If the provider/supplier fails to demonstrate substantial compliance, i.e., condition-level
deficiencies are identified by the SA, but they do not pose an IJ, the SA certifies its
findings to the CMS location via ACTS within 10 working days after the survey
completion date.
The CMS location reviews the SA’s findings, and if it concurs with the SA’s
recommendation, the CMS location either places the deemed provider/supplier on a 90
calendar-day termination track or it requires a full survey after a complaint survey.
In determining whether to exercise its discretion to require a full survey for deemed
providers and suppliers, the CMS location may consider factors including, but not limited
to, the following:
• 	The manner and degree of noncompliance identified as a result of the complaint
investigation;
• 	The provider’s/supplier’s compliance history;

• 	Recent changes in the provider’s/supplier’s ownership or management;
• 	The length of time since the provider’s/supplier’s last accreditation survey;
• 	The availability of SA resources at the time required to conduct a full survey;
and/or
• 	The advantages associated with conducting a more extensive survey compared to
the advantages associated with the faster enforcement (and thus a faster potential
corrective action) that result when proceeding directly to enforcement action after
the complaint survey.
Paragraph a) below discusses the procedures when the CMS location does not
require a full survey after the complaint survey; paragraph b) discusses the
procedures to follow when the CMS location directs the SA to conduct a full survey.
a) 	No full survey – proceed directly to termination track based on the complaint
survey
If the CMS location places the deemed provider/supplier on a 90 calendar-day
termination track as a result of the complaint investigation, it sends the
provider/supplier the Form CMS 2567, notifies the provider/supplier of the proposed
termination action and effective date, which will be 90 calendar days after the date of
the CMS location’s notice. The CMS location requests submission of an acceptable
plan of correction to the SA within 10 calendar days. The notice also contains a
statement that “removes” the “deemed status” of the provider/supplier and places it
under SA jurisdiction.
The CMS location sends a copy of the notice to the SA and a copy of the notice and
Form CMS 2567 to the applicable AO(s). At the CMS location’s discretion, the
materials may be sent to the AO via e-mail.
NOTE: Although deemed status has technically been “removed” and the
provider/supplier is placed under SA jurisdiction, because it is expected that deemed
status will be restored once corrections are made and verified, no change is made in
ASPEN to the provider’s/supplier’s deemed status. However, periods during which
the provider/supplier is under SA jurisdiction are entered and tracked in ASPEN.
Further, the AO may also conduct a survey of the facility so long as it continues to
accredit the provider/supplier.
The SA conducts a complaint survey revisit after the SA has received a timely and
acceptable plan of correction, but no later than the 45th calendar day after the notice
to the provider/supplier.
1) 	No Timely, Acceptable Plan of Correction Submitted

If the provider/supplier fails to submit a timely and acceptable plan of correction
to the SA and as a result the SA is unable to conduct a timely revisit before the
termination date, the SA notifies the CMS location and the CMS location may
proceed with termination. See SOM Section 3254F. The CMS location publishes
a public notice 15 days prior to the termination date. The CMS location notifies
the applicable Medicare Administrative Contractor (MAC) via the Form CMS
2007 of the termination of the provider/supplier’s Medicare agreement, including
the effective date of the termination.
The CMS location approves the complaint investigation Form CMS 562 and other
applicable items in ACTS and then, depending on CMS location practice, either
the SA or CMS location uploads the complaint survey package into the CMS
National Reporting System (CASPER). The provider’s or supplier’s Medicare
agreement is terminated in ASPEN.
Additionally, the CMS location sends a copy of the notice of termination letter to
the applicable AO(s).
2) 	First Revisit Survey Findings: Substantial Compliance
The termination action is rescinded if substantial compliance (i.e., no condition-
level deficiencies) is achieved and documented through the onsite verification at
the first revisit survey. There may or may not be standard-level deficiencies cited.
Within 10 working days after the completion of the revisit survey, the SA certifies
to the CMS location in ACTS its findings and recommends that the termination
action be rescinded.
The CMS location randomly selects several Form CMS 2567s with standard-level
deficiencies for review to determine if the CMS location concurs with the SA’s
finding of substantial compliance.
• 	For all cases not selected for review of the Form CMS 2567, the CMS location
completes the processing in ACTS of the complaint investigation Form CMS
562 and other applicable items in ACTS, and then, depending on CMS
location practice, either the SA or CMS location uploads the complaint survey
package into CASPER, the CMS National Reporting System.
• 	For cases selected for review of the Form CMS 2567:
• 	If the CMS location concurs with the finding, the CMS location
completes the processing in ACTS of the complaint investigation
Form CMS 562 and other applicable items in ACTS, and then,
depending on CMS location practice, either the SA or CMS location
uploads the complaint survey package into CASPER, the CMS
National Reporting System.

• 	If the CMS location does not concur with the SA’s findings of
substantial compliance, the CMS location discusses with the SA any
revisions needed on the Form CMS 2567 and, after the revisions are
made, follows the procedures for a survey finding substantial
noncompliance. (See Section 5110.2 or 5110.3, as applicable.)
The CMS location either issues a notice, or authorizes the SA in ACTS to issue a
notice to the provider/supplier of its compliance status and that its deemed status
is restored. The CMS location or SA, as applicable, issues this notice to the
provider/supplier, along with a copy of the Form CMS 2567 with the survey
findings.
The CMS location sends a copy of the notice and Form CMS 2567 to the
applicable AO(s). At the CMS location’s discretion, the materials may be sent to
the AO via e-mail.
3) 	First Revisit Survey Findings: Substantial Noncompliance
If the SA finds during the first revisit survey that the provider/supplier is not in
substantial compliance with one or more Medicare conditions, the SA consults
with the CMS location on its findings and whether to conduct a second revisit. If
the CMS location agrees that condition-level deficiencies remain, the CMS
location considers whether the survey findings warrant a second revisit or
proceeding immediately to termination. Generally the CMS location authorizes a
second revisit, but the CMS location has discretion to make an exception, based
on the facts of the situation. For example, if the SA and CMS location determine
that an immediate jeopardy was present during the first revisit, the CMS location
might find it prudent to proceed to termination without a second revisit.
If the CMS location agrees that condition-level deficiencies remain and does not
authorize a second revisit, the CMS location and SA follow the procedures
outlined in paragraph 3ii. below.
If a second revisit is authorized by the CMS location, the SA sends the
provider/supplier the Form CMS 2567 for the first revisit with notice that
substantial noncompliance remains, the 90-day termination date remains in effect,
a new acceptable plan of correction is required, and that an additional revisit will
be conducted prior to the termination date. The SA conducts the second revisit no
later than 60 calendar days after the date of the termination notice.
i. 	Second Revisit Survey Findings: Substantial Compliance
If substantial compliance is achieved by the provider/supplier (i.e., no
condition-level deficiencies are identified through the on-site verification by
the SA), the SA certifies its findings to the CMS location via ACTS within 10

working days after the survey completion date, and recommends that the
termination action be rescinded.
The CMS location randomly selects some Form CMS 2567s with only
standard-level deficiencies for review, to determine if the CMS location
concurs with the SA’s finding of substantial compliance. If the CMS location
concurs, and in all other cases where the Form CMS 2567 is not reviewed by
the CMS location, CMS location completes the processing in ACTS of the
complaint investigation Form CMS 562 and other applicable items in ACTS
and then, depending on CMS location practice, either the SA or CMS location
uploads the complaint survey package into CASPER, the CMS National
Reporting System. If the CMS location does not concur, the CMS location
discusses with the SA revisions needed on the Form CMS 2567 and, after the
revisions are made, follows the procedures for substantial noncompliance.
The CMS location either issues a notice, or authorizes the SA in ACTS to
issue the provider/supplier a notice letter of its compliance status and that its
deemed status is restored. The CMS location or SA, as applicable, forwards
this notice to the provider/supplier, along with a copy of the Form CMS 2567
with the survey findings.
Additionally, the CMS location sends a copy of the notice and the Form CMS
2567 to the applicable AO(s). At the CMS location’s discretion, the materials
may be sent to the AO via e-mail.
ii. 	Second Revisit Survey Findings – Substantial Noncompliance
If the second revisit survey shows that the provider/supplier fails to
demonstrate substantial compliance (i.e., condition-level deficiencies are
identified through on-site verification by the SA), the SA certifies its findings
to the CMS location via ACTS within 10 calendar days after the survey
completion date, and recommends that the termination action proceed.
The CMS location reviews the SA’s findings, and if it concurs with the SA’s
recommendation, the CMS location sends the provider/supplier a final
termination letter and publishes a public notice at least 15 calendar days prior
to the termination date, consistent with the requirements of Section 3012. The
provider/supplier is terminated from the Medicare program. The CMS
location notifies the applicable Medicare Administrative Contractor (MAC)
via the Form CMS 2007 of the termination of the provider/supplier’s
Medicare agreement, including the effective date of the termination.
The CMS location completes the processing in ACTS of the complaint
investigation Form CMS 562 and other applicable items in ACTS and then,
depending on CMS location practice, either the SA or CMS location uploads
the complaint survey package into CASPER, the CMS National Reporting

System. The provider’s or supplier’s Medicare agreement is terminated in
ASPEN.
Additionally, the CMS location sends a copy of the termination notice and the
Form CMS 2567 to the applicable AO(s). At the CMS location’s discretion,
the materials may be sent to the AO via e-mail.
b) 	Full Survey After the Complaint Survey
If the CMS location directs the SA to conduct a full survey following the complaint
survey, it sends the Form CMS 2567 for the complaint survey to the provider/supplier
in addition to a notice letter indicating that it is “removing” the provider’s/supplier’s
deemed status and that a full survey will be conducted on an unannounced basis.
The provider/supplier is not required to submit a plan of correction in response to the
complaint survey findings, but may choose to do so.
The CMS location completes the processing in ACTS of the complaint investigation
Form CMS 562 and other applicable items in ACTS and then, depending on CMS
location practice, either the SA or CMS location uploads the complaint survey
package into CASPER, the CMS National Reporting System.
Additionally, the CMS location sends a copy of the notice letter and Form CMS 2567
for the complaint survey to the applicable AO(s). At the CMS location’s discretion,
the materials may be sent to the AO via e-mail.
NOTE: Although deemed status technically has been removed and the
provider/supplier is placed under SA jurisdiction, because it is expected that deemed
status will be restored once corrections are made and verified, no change is made in
ASPEN to the provider’s/supplier’s deemed status. However, periods during which
the provider/supplier is under SA jurisdiction are entered and tracked in ASPEN.
Further, the AO may also conduct a survey of the facility so long as, since it
continues to accredit the provider/supplier.
The full survey must be conducted within 60 calendar days after the CMS
location’s notice to the provider/supplier of the complaint survey results and
removal of deemed status. The CMS location and SA follow the procedures in
Section 5110.4.
5110.4 - Full Survey after Complaint Survey with Condition-level
Deficiencies, When Authorized by the CMS location
(Rev. 243; Issued: 06-12-26; Effective: 06-12-26; Implementation: 06-12-26)
If the CMS location authorizes the SA to conduct a full survey after the complaint survey,
the timeframes and procedures described in this section apply.
Timeframe

The full survey must be conducted within:
• 	23 days after the CMS location’s notice to the provider/supplier, if the complaint
survey involved an IJ that was not removed while the survey team was on-site; or
• 	60 calendar days after the CMS location’s notice to the provider/supplier in all
other cases.
Procedures following the full survey with findings of:
a) Full Survey Findings: Substantial Compliance
If the SA full survey finds the deemed provider or supplier to be in substantial
compliance, the SA and CMS location follow the same procedures and timeline as at
Section 5110.1. In addition, since the CMS location had removed deemed status, the
CMS location either issues a notice, or authorizes the SA to issue a notice to the provider
or supplier of its compliance status and that its deemed status is restored, along with a
copy of the Form CMS 2567 with the survey findings.
The CMS location sends a copy of the notice and Form CMS 2567 to the applicable
AO(s). 	At the CMS location’s discretion, the materials may be sent to the AO via e-
mail.
b) Full Survey Findings: Condition-Level, IJ
1. 	IJ Removed while the SA is On-site
If deficiencies pose an IJ and the IJ is removed while the SA is on-site, deficiency
citations are made at the condition-level. Follow the procedure for condition-
level noncompliance, non-IJ, in Section 5110.4c below.
Note: 	The Form CMS 2567 must state at the beginning that an IJ was cited,
regardless of the fact that it was removed while the SA was on-site. 	An entry in
ASPEN must also be made by the CMS location indicating that there was an IJ
citation before the survey can be uploaded to the national database, the CMS
National Reporting System (CASPER). The ASPEN systems will prompt the
CMS location whenever a survey includes condition-level deficiencies to indicate
whether there was also an IJ.
Details of the IJ situation and the actions taken by the provider/supplier to remove
the IJ must also be documented on the Form CMS 2567. Even though the IJ was
removed while the SA was on-site, the provider or supplier must still be cited for
condition-level noncompliance for the applicable Condition of Participation or
Condition for Coverage that is cited for non-compliance related to the IJ. The

documentation must also include the date the surveyors verified that the IJ was
removed prior to completion of the survey.
2. 	IJ not Removed while the SA is On-site
If condition-level deficiencies pose an IJ and the IJ is not removed while the SA is
on-site, the SA certifies its findings to the CMS location within 2 working days
after the completion of the survey.
If the CMS location concurs with the SA’s findings, the deemed provider/supplier
is placed on a 23 calendar-day termination track. The CMS location sends the
provider/supplier the Form CMS 2567, notifies the provider/supplier of the
proposed termination action and effective date, which is 23 calendar days after the
date of the CMS location’s notice, and requests submission of an acceptable plan
of correction to the CMS location within 5 calendar days of the notice.
The CMS location sends a copy of the notice to the SA and a copy of the notice
and Form CMS 2567 to the applicable AO(s). At the CMS location’s discretion,
the materials may be sent to the AO via e-mail.
When the CMS location receives a timely and acceptable plan of correction from
the provider/supplier, it directs the SA to conduct an IJ follow-up survey before
the rescheduled termination date in order to confirm that the IJ has been removed
and that the provider/supplier complies with the conditions previously cited for
noncompliance.
2.1 First Revisit after Full Survey with IJ
i. 	No Acceptable Plan of Correction Submitted
No revisit is necessary if the provider/supplier fails to submit a timely and
acceptable plan of correction. CMS will proceed to terminate a provider/supplier
if it does not submit a timely and acceptable POC. See SOM Section 3254F. The
public notice must be published 15 calendar days prior to the termination date.
The CMS location notifies the applicable Medicare Administrative Contractor
(MAC) via the Form CMS 2007 of the termination of the provider/supplier’s
Medicare agreement, including the effective date of the termination.
The SA and CMS location complete the processing in ASPEN of the survey kit
and then, depending on CMS location practice, either the SA or CMS location
uploads the complaint survey package into CASPER, the CMS National
Reporting System.
The CMS location sends a copy of the termination letter to the applicable AO(s).
At the CMS location’s discretion, the copy may be sent to the AO via e-mail.

ii. 	First Revisit Survey Findings: IJ Not Removed
At least 5 calendar days in advance of the scheduled termination date, the SA
certifies to the CMS location its findings, based on on-site verification, that the IJ
has not been removed, and recommends that the termination action proceed.
The CMS location reviews the SA’s findings, and if it concurs with the SA’s
recommendation, the SA and CMS location complete the processing of the survey
kit in ASPEN and then, depending on CMS location practice, either the SA or
CMS location uploads the survey package into the CMS National Reporting
System (CASPER). The termination of the provider’s/supplier’s Medicare
agreement is processed in ASPEN.
The CMS location sends the provider/supplier a final termination letter and
publishes a public notice, in accordance with the termination process in Section
3010B. The provider or supplier is terminated from the Medicare program. 	The
CMS location notifies the applicable Medicare Administrative Contractor (MAC)
via the Form CMS 2007 of the termination of the provider/supplier’s Medicare
agreement, including the effective date of the termination.
The CMS location sends a copy of the termination notice and the Form CMS 2567
to the applicable AO(s). At the CMS location’s discretion, the materials may be
sent to the AO via e-mail.
iii. 	First Revisit Survey Findings: IJ Removed, Substantial Compliance
The termination action is rescinded if the IJ has been removed and substantial
compliance has been achieved prior to the effective date of the termination, i.e.,
there are no condition-level deficiencies identified during the first revisit survey
by the SA. The SA certifies its findings to the CMS location at least 5 calendar
days in advance of the scheduled termination date, and recommends that the
termination action be rescinded.
The CMS location randomly selects several Form CMS 2567s with standard-level
deficiencies for review, to determine if the CMS location concurs with the SA’s
finding of substantial compliance. If the CMS location concurs, and in all other
cases where the Form CMS 2567 is not reviewed by the CMS location, depending
on CMS location practice, either the SA or CMS location uploads the survey
package into CASPER, the CMS National Reporting System. If the CMS location
does not concur with the SA’s finding, the CMS location discusses with the SA
any revisions needed on the Form CMS 2567 and, after the revisions are made,
follows the procedures for substantial noncompliance.
When substantial compliance is achieved, the CMS location either issues a notice,
or authorizes the SA to issue the provider/supplier a notice of its compliance

status, restoring its deemed status, along with a copy of the Form CMS
2567containing the survey findings.
In addition, the CMS location sends a copy of the notice letter to the applicable
AO(s). At the CMS location’s discretion, the copy may be sent to the AO via e-
mail.
Although the revisit survey found the provider/supplier to be in substantial
compliance, it may have resulted in citation(s) of standard-level deficiencies of
the Form CMS 2567. Because deemed status has been restored, the provider or
supplier is not obligated to submit a plan of correction to the SA, nor are any
further revisits conducted. The provider or supplier may voluntarily choose to
submit a plan of correction because the Form CMS 2567 will be made available to
the public. 	The SA and CMS location do not review any plan of correction the
provider/supplier submits; no further revisit survey is conducted.
iv. 	First Revisit Survey Findings: IJ Removed, Substantial Noncompliance
Remains
If the IJ has been removed but substantial noncompliance (i.e., condition-level
deficiencies), remains, the SA certifies its findings to the CMS location within 10
working days after the survey completion date. If the CMS location concurs that
the IJ has been removed but that condition-level deficiencies remain, the CMS
location considers whether the survey findings warrant a second revisit or
proceeding immediately to termination. At this point the provider/supplier will
have been surveyed three times, including the preceding complaint survey, with
continued substantial noncompliance found in each survey and at least one IJ.
Generally the CMS location authorizes a second revisit, but the CMS location has
discretion to make an exception, based on the facts of the case, including the risks
to patients associated with the remaining deficiencies versus providing the
provider/supplier further opportunity to correct its problems in a timely manner.
If the CMS location does not authorize a second revisit, it follows the procedures
in paragraph ii above.
If the authorizes a second revisit, the CMS location gives the provider/supplier up
to 67 additional calendar days, or a total of 90 calendar days (23 plus 67) from the
date of the notice of the IJ, to achieve substantial compliance. The resulting
revised termination date is 90 calendar days after the date of the CMS location’s
original 23-day termination notice. The CMS location provides the
provider/supplier the Form CMS 2567 for the revisit with notice of the new
termination date, and requests that an acceptable POC be provided to the SA
within 10 calendar days of the notice.
2.2 Second Revisit after Full Survey with IJ

The SA conducts the second revisit survey no later than 60 calendar days after the date of
the CMS location’s 23-day termination notice to the provider or supplier.
i. Second Revisit Survey Findings: Substantial Compliance
If substantial compliance is achieved by the provider/supplier (i.e., no condition-
level deficiencies are identified through the on-site verification by the SA) during
the second revisit survey, the SA certifies its findings to the CMS location within
10 working days after the survey completion date, and recommends that the
termination action be rescinded.
The CMS location randomly selects some Form CMS 2567s with standard-level
deficiencies for review, to determine if the CMS location concurs with the SA’s
finding of substantial compliance. If the CMS location concurs, and in all other
cases where the Form CMS 2567 is not reviewed by the CMS location, depending
on CMS location practice, either the SA or CMS location uploads the survey kit
into CASPER, the CMS National Reporting System. If the CMS location does
not concur, the CMS location discusses with the SA revisions needed on the Form
CMS 2567 and, after the revisions are made, follows the procedures for
substantial noncompliance.
The CMS location also either issues a notice, or authorizes the SA to issue the
provider/supplier a notice, of its compliance status and that its deemed status is
restored, along with a copy of the Form CMS 2567 with the survey findings.
Additionally, the CMS location sends a copy of the notice and the Form CMS
2567 to the applicable AO(s). At the CMS location’s discretion, the materials
may be sent to the AO via e-mail.
ii. Second Revisit Survey Findings: Substantial Noncompliance
If the second revisit shows that substantial noncompliance (i.e., condition-level
deficiencies) remain, the SA certifies to the CMS location its findings within 10
calendar days after the survey completion date, and recommends that the
termination action proceed.
The CMS location reviews the SA’s findings, and if it concurs with the SA’s
recommendation, the CMS location sends the provider or supplier a final
termination letter and publishes a public notice 15 calendar days prior to the
termination date. The provider or supplier is terminated from the Medicare
program. 	The CMS location notifies the applicable Medicare Administrative
Contractor (MAC) via the Form CMS 2007 of the termination of the
provider/supplier’s Medicare agreement, including the effective date of the
termination.

The SA and CMS location complete the processing in ASPEN of the survey kit
and, depending on CMS location practice, either the SA or CMS location uploads
the survey package into CASPER. The provider’s or supplier’s Medicare
agreement is terminated in ASPEN.
The CMS location sends a copy of the final termination notice and Form CMS
2567 to the applicable AO(s). At the CMS location’s discretion, the materials
may be sent to the AO via e-mail.
c) Full Survey Findings: Condition-Level, Non-IJ
If the results of the full survey indicate there is substantial noncompliance (i.e., condition-
level deficiencies), but the deficiencies do not constitute an IJ, the SA certifies its
findings to the CMS location within 10 working days after the survey completion date.
The CMS location reviews the SA’s findings, and if it concurs with the SA’s
recommendation, the CMS location places the provider or supplier on a 90 calendar-day
termination track as a result of the full survey. The CMS location sends the provider or
supplier the Form CMS 2567 and notifies it of the proposed termination action and
effective date, which will be 90 calendar days after the date of the CMS location’s notice.
The CMS location requests submission of an acceptable plan of correction to the SA
within 10 calendar days of the notice.
Additionally, the CMS location sends a copy of the notice of termination letter to the
applicable AO(s).
1. 	First Revisit: The SA conducts the first revisit survey no later than the 45th calendar
day after the date of the CMS location’s termination notice to the provider or supplier.
i. 	First Revisit Survey Findings: Substantial Compliance
The termination action is rescinded if substantial compliance (i.e., no condition-
level deficiencies) is achieved and documented through the onsite verification at
the revisit survey. There may or may not be standard-level deficiencies cited.
Within 10 working days after the completion of the revisit survey, the SA certifies
to the CMS location its findings and recommends that the termination action be
rescinded.
The CMS location randomly selects some Form CMS 2567s with only standard-
level deficiencies for review, to determine if the CMS location concurs with the
SA’s finding of substantial compliance. If the CMS location concurs, and in all
other cases where the Form CMS 2567 is not reviewed by the CMS location, the
CMS location completes the processing of the survey kit in ASPEN and then,
depending on CMS location practice, either the SA or the CMS location uploads
the survey package into CASPER, the CMS National Reporting System. If the
CMS location does not concur, the CMS location discusses with the SA revisions

needed on the Form CMS 2567 and, after the revisions are made, follows the
procedures for substantial noncompliance.
The CMS location either issues a notice, or authorizes the SA to issue a notice to
the provider or supplier of its compliance status and that its deemed status is
restored, along with a copy of the Form CMS 2567 with the survey findings.
The CMS location sends a copy of the notice and Form CMS 2567 to the
applicable AO(s). At the CMS location’s discretion, the materials may be sent to
the AO via e-mail.
ii. 	First Revisit Survey Findings: Substantial Noncompliance
If the SA confirms during the first revisit survey that the provider/supplier is not
in substantial compliance with one or more Medicare conditions, the SA consults
with the CMS location on its findings and whether to conduct a second revisit. If
the CMS location concurs that condition-level deficiencies remain, the CMS
location considers whether the survey findings warrant a second revisit or
proceeding immediately to termination. At this point the provider/supplier will
have been surveyed three times, including the complaint survey, the full survey
and the first revisit, with substantial noncompliance found on each survey.
Generally the CMS location authorizes a second revisit, but the CMS location has
discretion to make an exception, based on the facts of the case, including the risks
to patients associated with the remaining deficiencies versus providing the
provider/supplier further opportunity to correct its problems in a timely manner.
If the CMS location does not authorize a second revisit, the CMS location and SA
will follow the procedures outlined in paragraph 2(ii). below.
If the CMS location authorizes a second revisit, the SA sends the
provider/supplier the Form CMS 2567 for the first revisit with notice that
substantial noncompliance remains, the 90-day termination date remains in effect,
a new acceptable plan of correction is required, and that an additional revisit will
be conducted prior to the termination date.
2. 	Second Revisit: The SA conducts the second revisit survey no later than 60 calendar
days after the date of the termination notice to the provider or supplier.
(i) 	Second Revisit Survey Findings: Substantial Compliance
If substantial compliance is achieved by the provider/supplier (i.e., no
condition-level deficiencies are identified through the on-site verification by
the SA) during the second revisit survey, the SA certifies its findings to the
CMS location within 10 working days after the survey completion date, and
recommends that the termination action be rescinded.

The CMS location randomly selects some Form CMS 2567s with standard-
level deficiencies for review, to determine if the CMS location concurs with
the SA’s finding of substantial compliance. If the CMS location concurs, and
in all other cases where the Form CMS 2567 is not reviewed by the CMS
location, the CMS location completes the processing in ASPEN of the survey
kit and then, depending on CMS location practice, either the SA or CMS
location uploads the complaint and revisit surveys into CASPER, the CMS
National Reporting System. If the CMS location does not concur, the CMS
location discusses with the SA revisions needed on the Form CMS 2567 and,
after the revisions are made, follows the procedures for substantial
noncompliance.
The CMS location also either issues a notice, or authorizes the SA in ACTS to
issue the provider or supplier a notice, of its compliance status and that its
deemed status is restored, along with a copy of the Form CMS 2567 with the
survey findings.
Additionally, the CMS location sends a copy of the notice and the Form CMS
2567 to the applicable AO(s). At the CMS location’s discretion, the materials
may be sent to the AO via e-mail.
(ii) 	Second Revisit Survey Findings: Substantial Noncompliance
If the second revisit shows that the provider or supplier has substantial
noncompliance (i.e., condition-level deficiencies are identified through on-site
verification by the SA), the SA certifies to the CMS location its findings
within 10 calendar days after the survey completion date, and recommends
that the termination action proceed.
The CMS location reviews the SA’s findings, and if it concurs with the SA’s
recommendation, the CMS location sends the provider/supplier a final
termination letter and publishes a public notice 15 calendar days prior to the
termination date. The provider or supplier is terminated from the Medicare
program. The CMS location notifies the applicable Medicare Administrative
Contractor (MAC) via the Form CMS 2007 of the termination of the
provider/supplier’s Medicare agreement, including the effective date of the
termination.
The CMS location completes the processing in ASPEN of the survey kit and
then, depending on CMS location practice, either the SA or CMS location
uploads the survey package into CASPER. The provider’s or supplier’s
Medicare agreement is terminated in ASPEN.
The CMS location sends a copy of the final termination notice and Form CMS 2567 to
the applicable AO(s). At the CMS location’s discretion, the materials may be sent to the
AO via e-mail.

5120 - Life Safety Code Guidance for Deemed Providers/Suppliers
(Rev. 18, Issued: 03-17-06; Effective/Implementation Dates: 03-17-06)
In most States, an engineer or other fire safety specialist surveys for compliance with the
Life Safety Code (LSC) standard and others survey the remaining standards in the
Physical Environment Condition. If the allegation pertains only to LSC requirements, it
is not necessary to survey the remainder of the Physical Environment Medicare
condition.
5130 – Deemed Provider/ Supplier Refusal of Complaint Investigation
Surveys
(Rev. 243; Issued: 06-12-26; Effective: 06-12-26; Implementation: 06-12-26)
The SA informs the provider/supplier that refusal to allow a complaint investigation
survey is a basis for termination and exclusion from the Medicare program, in accordance
with Section 1128(b)(12) of the Social Security Act. The SA notifies the CMS location
immediately of a refusal to allow a complaint investigation survey.
5140 - Complaints Involving HIV-Infected Individuals
(Rev. 243; Issued: 06-12-26; Effective: 06-12-26; Implementation: 06-12-26)
As direct recipients of Federal funds, providers and suppliers are subject to provisions of
Section 504 of the Federal Rehabilitation Act of 1973. Symptomatic and asymptomatic
individuals who are infected with the human immunodeficiency virus (HIV), or “AIDS
virus,” are protected by the Rehabilitation Act as “individuals with handicaps.”
Therefore, HIV-infected individuals who are provided services, are employed, or are to
be employed by providers and suppliers in Federally-conducted or financed programs or
activities would be treated like anyone else in the workforce, so long as these individuals
do not, on a case-by-case basis, pose a substantial health and safety risk to others, or pose
a performance problem, and are “otherwise qualified.”
A provider participating in the Medicare or Medicaid programs cannot discriminate
against individuals who are HIV-infected so long as these individuals do not, on a case-
by-case basis, pose a substantial health and safety risk to others and so long as the
provider provides comparable services and care to non HIV-infected individuals.
The SA or the CMS location refers discrimination complaints to the Office of Civil
Rights (OCR), which is the authority to determine whether Medicare or Medicaid
providers and suppliers comply with this non-discrimination statute.
5150 - Investigating Complaints Involving ESRD Services Provided by
Deemed Hospitals or CAHs
(Rev. 88, Issued: 08-27-13, Effective: 07-19-13, Implementation: 7-19-13)

Many of the hospitals or CAHs participating in the ESRD program are deemed to meet
the Medicare Conditions of Participation on the basis of their accreditation by a CMS-
approved Medicare accreditation program. “Deemed status” applies only to the
hospital’s or CAH’s approval as a provider, not to its status as a supplier of ESRD
transplantation or dialysis services. The SA investigates all complaints and allegations
related solely to ESRD services since ESRD services fall outside the purview of
accreditation.
5160 - Investigating Complaints Against ESRD Suppliers
(Rev. 88, Issued: 08-27-13, Effective: 07-19-13, Implementation: 7-19-13)
1. General
Refer to the guidance for investigation of complaints against non-deemed providers and
suppliers. See SOM §5200.
The ESRD Networks are required to have a complaint /grievance resolution system.
Networks (NW) and the SA are frequently contacted by the same complainant with the
same or similar allegations. If the allegations require an onsite investigation or allege
potential risk to patient health or safety, the SA is responsible for the investigation. If the
allegations are primarily focused on relationship or communication issues, the NW may
assume primary responsibility for the investigation. If the focus of the allegations is a
medical practice issue, the SA and NW may need to collaborate on the investigation. The
NWs and SA are encouraged to communicate and collaborate to reduce or prevent
redundant investigations.
2. Conducting the ESRD Investigation
The SA surveyors must use the ESRD survey protocol in Appendix H to investigate
complaints. The allegations of the complaint will determine the tasks needed. For
example, an allegation of inadequate patient care staffing would require use of the
following tasks, at a minimum:
• 	Pre survey activities;
• 	Entrance Conference: Provide an overview of the complaint allegations and the
planned agenda for your survey time;
• 	Tour and observations;
• 	Patient interviews;
• 	Staff interviews;
• 	Record reviews;

• 	Review of quality management materials; and
• 	Exit conference.
Conduct each of the identified survey tasks in Appendix H, “Guidance to Surveyors:
End-Stage Renal Disease Facilities.”
3. Pre-survey Task for ESRD Complaint Investigations
Review the allegations of the complaint to identify needed survey tasks. Review the
State Outcomes List and the Dialysis Facility Report to determine if there are data
outliers related to the allegations. For example, if the complaint alleges staff members do
not wash their hands, the surveyor should review the facility’s rate of hospitalization and
hospitalizations related to septicemia, and consider this information in the survey process.
To facilitate meeting the requirement of surveying each ESRD facility every 3 years, the
SA evaluates all available information (outcome list rank, Dialysis Facility Report, time
since last survey, complaint history, NW information, etc.) to determine whether a
recertification survey should be conducted at the time of the complaint investigation.
5170 – Hospital Restraints/Seclusion Death Reporting and Investigation
(Rev. 88, Issued: 08-27-13, Effective: 07-19-13, Implementation: 7-19-13)
This section applies to both deemed and non-deemed hospitals, as well as to deemed and
non-deemed CAH distinct part psychiatric and rehabilitation units.
5170.1 - Background
(Rev. 243; Issued: 06-12-26; Effective: 06-12-26; Implementation: 06-12-26)
The Medicare hospital restraint and seclusion requirements are found under the Patients’
Rights provisions at 42 CFR 482.13(e),(f) and (g).
Hospitals are required to report a death associated with the use of restraint/seclusion to
their CMS location in accordance with 42 CFR 482.13(g)(1).
The interpretive guidelines found in the Hospital Appendix A at 42 CFR
482.13(e) – (g) discuss in detail what is considered a restraint or seclusion, the
requirements governing hospital use of restraint or seclusion, and these reporting
requirements.
5170.2 - Responsibilities
(Rev. 243; Issued: 06-12-26; Effective: 06-12-26; Implementation: 06-12-26)
CMS Locations

The CMS location receives Hospital Restraint/Seclusion Death Reports which hospitals
are required to submit in accordance with 42 CFR 482.13(g)(1). 	The CMS location is
responsible for communicating with hospitals in its region whether the required reports
are to be submitted electronically by facsimile and/or e-mail, providing appropriate
addresses or fax numbers, or whether it will also accept mail submissions.
The CMS location is also responsible for data entry of reports received into the
Automated Survey Processing Environment (ASPEN) Complaint Tracking System
(ACTS) Hospital Restraint/Seclusion Death Module and for maintenance in ACTS of
information related to disclosures to Protection and Advocacy Agencies. (See Process
discussion below.)
Each CMS location designates one contact person and a backup person who serves as the
hospital point of contact regarding reporting, and who is responsible for coordinating the
review of reports received, and authorization of complaint surveys when appropriate.
State Agencies (SAs)
Hospitals report patient deaths associated with restraint or seclusion to their CMS
location, not to the SA. Any hospital patient restraint or seclusion death report received
by a SA directly from a hospital (or other source) must be forwarded immediately by the
SA to its CMS location.
The SA conducts a complaint investigation related to a patient death associated with a
hospital’s use of restraints or seclusion only when the CMS location authorizes the
investigation. The investigation must be completed no later than five working days after
CMS location authorization.
SAs assist CMS locations in educating the hospitals in their State about their obligation to
report to their CMS location any death that meets the reporting requirements found at 42
CFR 482.13(g)(1). Upon request, SAs are to provide hospitals with the applicable CMS
location contact information, as well as the hospital reporting procedures contained in
this policy.
The SAs respond to requests from Protection and Advocacy (P&A)
organizations, or any other parties, for information on survey findings related to
specific cases identified by the requestor. The SAs handle these requests in
accordance with standard CMS policy on disclosure of Federal survey
information.
5170.3 - Process
(Rev. 243; Issued: 06-12-26; Effective: 06-12-26; Implementation: 06-12-26)
The CMS location evaluates the information required to be reported by the hospital or
CAH DPU under 42 CFR 482.13(g)(1) to determine whether the situation might involve

a violation of 42 CFR 482.13(e) through 42 CFR 482.13(g) and authorizes an on-site
investigation if there appears to be a possible violation.
Using the information provided by the hospital or CAH DPU in the worksheet, the CMS
location evaluates whether the case warrants an on-site investigation. 	If the CMS
location determines that the restraint/seclusion death report requires on-site investigation,
within two business days of receiving the report, the CMS location enters the reported
information into the ACTS restraint/seclusion module and immediately notifies the SA to
authorize a complaint survey to investigate the hospital’s or CAH DPU’s compliance
with the Patient’s Rights requirement at 42 CFR 482.13(e), (f), and (g), including the
reported case. The SA accesses the ACTS restraint/seclusion module to see the
information reported by the hospital or CAH DPU prior to conducting the on-site
investigation. The SA is expected to be onsite to initiate the investigation within two
business days of receipt of survey authorization from the CMS location.
Notice to Protection and Advocacy Organizations
At the same time that the CMS location notifies the SA that it authorizes the on-site
survey, consistent with the ACTS Notice of a Modified or Altered System of Records
(SOR) (71 FR 29643, May 23, 2006, SOR 09-70-0565), the CMS location also provides
written notification, by mail or email, to the appropriate Protection and Advocacy
Organization (P&A) within the State where the hospital is located, only if the P&A has a
current Data Use Agreement (DUA) with CMS. The CMS location may contact CMS
Central Office for a list of P&A’s with current DUAs. The names and addresses for each
State’s P&A can be located at the following website, at the drop down menu entitled “Get
Help in Your State:” www.ndrn.org . Notification is provided only in those cases for
which an on-site survey is authorized.
The CMS location provides the following information to the P&A: hospital or CAH
DPU name, hospital or CAH DPU address, name of the deceased, and a copy of the
restraint/seclusion death report submitted by the hospital or CAH DPU. An entry must
be made on the intake in ACTS indicating the name of the P&A to which the
restraint/seclusion death report data was sent and the date it was sent.
The P&A must have an approved CMS Data Use Agreement (DUA), Form CMS-R-
0235, (Exhibit 292) in place before restraint/seclusion death report data may be disclosed
to it. In order to get an approved DUA, the P&A must complete and submit a signed
CMS DUA, Form CMS-R-0235, including an initialed DUA ACTS SOR- P&A
Attachment (Exhibit 293) to the Director, Division of Information Security and Privacy
Management (DISPM), Centers for Medicare and Medicaid Services, Mailstop N2-04-27,
7500 Security Boulevard, Baltimore, MD 21244-1850. DISPM will review the DUA,
assign a unique DUA identifier and expiration date to it, and return a signed copy to the
P&A, including an expiration date. CMS Central Office Survey and Certification will
maintain and make available to CMS locations a list of P&As with DUAs.
When completing the Form, P&As must note the following in particular:

• 	Line 5 of the DUA must state “Restraint/Seclusion Hospital Death Reports.” The
“Years” and “System of Record” columns should be left blank;
• 	Line 12 must state “CMS DUA: ACTS SOR Attachment – P&A;”
• 	The DUA must be signed by the P&A official whom the P&A designates as
“Custodian,” i.e., the individual who will have actual possession of and
responsibility for the data released under the DUA; and
• 	A P&A may designate more than one Custodian, but if it does so, each individual
must complete and sign a Multi-Signature Addendum Form (Exhibit 294).
When approved, the DUA will have an expiration date. DISPM will alert an organization
with a DUA of its upcoming expiration date and will give the organization the option of
requesting a one-year DUA extension via e-mail, or to close the DUA with a DUA
destruction certificate. DISPM has set up a DUA resource email box which accepts all
expired DUA resolution requests at DataUseAgreement@cms.hhs.gov.
Custodians may be added or deleted over the life of the primary DUA. To add a new
Custodian under an existing DUA, the P&A must submit the following to CMS/DISPM:
a letter from the P&A describing the activities planned for the new Custodian and the
length of time over which the Custodian will serve, and a Multi-Signature Addendum
signed by the appropriate official from the P&A. The Multi-Signature Addendum must
show the DUA number of the existing primary P&A DUA. The P&A must assign a case
number to all Multi-Signature Addendums beginning with “1” and adding consecutively
thereafter. CMS/DISMP will use this number to track the number of Custodians in each
P&A. When a P&A seeks to delete an existing Custodian, it must send the CMS/DISPM
a letter to this effect. CMS/DISPM will strike out the name of the deleted Custodian
from the DUA or Multi-Signature Addendum that added that Custodian, dating and
initialing the deletion.
The DUA process described in this section applies to disclosure of hospital and CAH
DPU restraint/seclusion death reports by CMS to P&As in those cases where the P&A
did not first make a request specific to an identified patient; a DUA is not required for
other disclosures of information in ACTS to a P&A when permitted in accordance with
the ACTS System of Records Notice.
• 	A P&A may request information about an on-site survey by submitting its request
to the SA. The SA will process this request and release information to the P&A in
accordance with standard CMS policy for disclosure of Form CMS 2567,
Statement of Deficiencies and Plan of Correction.
If the P&A identifies a particular patient, hospital, and approximate date or dates when
the patient was in that hospital or CAH DPU, and if the P&A makes a request for
additional information, beyond the Form CMS 2567, related to use of restraint or
seclusion on that patient, the request is forwarded to the CMS location. The CMS

location may, in accordance with the ACTS System of Records Notice, release additional
information to the P&A.
NOTE: 	Sections 5200 to 5240 relate to all non-deemed
provider/supplier types, excluding nursing homes (SNFs/NFs).
NOTE: 	Sections 5200 to 5240 relate to all non-deemed
provider/supplier types, excluding nursing homes (SNFs/NFs).
5200 - Investigating Complaints for Non-Deemed Providers/Suppliers,
Excluding Nursing Homes (SNFs/NFs)
(Rev. 18, Issued: 03-17-06; Effective/Implementation Dates: 03-17-06)
5200.1 - General Procedures
(Rev. 243; Issued: 06-12-26; Effective: 06-12-26; Implementation: 06-12-26)
For complaint surveys on non-deemed providers/suppliers, the SA uses the appropriate
survey protocol and interpretive guidelines. A focus survey is conducted on the specific
regulatory requirements related to the allegation. Based on an initial assessment or other
observations, if significant problems are identified, the SA expands the scope of review
as necessary to determine compliance or noncompliance. The SA does not refer
complaints regarding non-deemed providers/suppliers to the CMS location.
If deficiencies are cited, the SA documents the deficiencies on Form CMS-2567 and
obtains an acceptable POC. If non-compliance with the Medicare conditions is identified,
the SA will follow the appropriate termination procedures and document and report as
required. (See SOM Chapter 3, §§3010-3028 for termination procedures.)
5200.2 - Special Procedures for Psychiatric Hospitals
(Rev. 243; Issued: 06-12-26; Effective: 06-12-26; Implementation: 06-12-26)
The special conditions for psychiatric hospitals cannot be deemed to meet the Medicare
requirements. The remaining conditions for hospitals apply to psychiatric hospitals, and
a hospital may be deemed to meet those conditions.
When the SA receives a complaint allegation against a psychiatric hospital under the
general conditions of participation, it must determine whether or not the hospital is
deemed. If the hospital is deemed, the SA follows the appropriate survey protocol for
deemed facilities. If the hospital is not deemed, the SA investigates the complaint if
appropriate under these procedures listed above in §5200.1.
If the complaint allegation concerns the special conditions for psychiatric hospitals, the
SA may conduct an investigation if it has appropriate qualified personnel or refer it to the
CMS location. If the complaint is referred to the CMS location, the CMS location will
evaluate and refer it to the CO as required.

5210- Processing of Complaints Originating with or Investigated by the
CMS location
(Rev. 243; Issued: 06-12-26; Effective: 06-12-26; Implementation: 06-12-26)
The CMS location establishes procedures and clear organizational accountability to
ensure that complaints are properly evaluated, documented, acknowledged, and handled
timely and appropriately. The CMS location uses ACTS to ensure timely and appropriate
action on all allegations originating with or investigated by the CMS location. The extent
and nature of the CMS location involvement with a given complaint varies depending on
the nature of the allegation and the receiving organization.
Most complaints originate through the SA and are recorded and controlled by the SA.
When a complaint is filed directly with the CMS location, the CMS location assumes
those initial SA responsibilities.
5220- Investigation Conducted Directly by the CMS location
(Rev. 243; Issued: 06-12-26; Effective: 06-12-26; Implementation: 06-12-26)
This less frequent class of complaints includes allegations retained by the CMS location
or forwarded to the CMS location by the SA for investigation. The CMS location’s
responsibilities vary based on the type of complaint.
The CMS location uses the appropriate survey protocol and interpretive guidelines for the
provider/supplier. These procedures apply when a direct CMS location investigation is
conducted, such as for Federal facilities, Religious Non-Medical Health Care Institutions
(RNHCIs), or special situations. When directly investigating, the CMS location begins
by ensuring that it or the SA has met all initial data collection and acknowledgement
requirements.
If the allegation involves an IJ, the CMS location investigates within two working days.
Otherwise, the CMS location schedules the investigation based on the severity of the
allegation. (See §5075.9 for time frames related to Federal onsite investigations.)
5230 - Special CMS location Processing
(Rev. 243; Issued: 06-12-26; Effective: 06-12-26; Implementation: 06-12-26)
The following types of allegations are subject to special CMS location handling:
1. 	Over-Utilization or Inappropriate Utilization of Services- The CMS location
refers to the local QIO for investigation, and documents the provider’s files as for
other allegations. The CMS location acts, as necessary, on any findings returned
by the QIO;
2. 	Civil Rights Violations- The CMS location refers to the regional OCR for
investigation. The CMS location documents the provider’s files as for other

allegations. The CMS location acts as necessary on any findings returned by
OCR; and
3. 	Medicare/Medicaid/CLIA fraud- The CMS location refers to the CMS location of
the Inspector General/DHHS for investigation. The CMS location documents the
provider’s files as for other allegations.
In each of the above instances, the CMS location ensures that the complainant and SA are
notified of any findings.
5240 - Complaints - HHA Hotline
(Rev. 18, Issued: 03-17-06; Effective/Implementation Dates: 03-17-06)
Each State has a Medicare home health hotline that can be called by patients who are
dissatisfied with the home health services they are receiving or by other individuals with
a complaint about a specific HHA. Under the Medicare COPs for Patient Rights at 42
CFR 484.10, HHAs are required to provide their patients with the hotline number for
their state. Concerns about an HHA not complying with the COPs, or reports that an
HHA is misinforming beneficiaries or inappropriately terminating care for patients, can
be referred to the SA for investigation via the home health hotline. Concerned consumers
may also call the SA directly. A violation of the COPs or the provider agreement could
lead to termination of the HHA from the Medicare program.
As part of the patient rights COPs, the HHA is required to investigate complaints made
by a patient or the patient’s family or guardian regarding treatment or care that is, or fails
to be, furnished, and to document both the existence of the complaint and resolution of
the complaint.
Surveyors, as part of their investigation of the HHA’s compliance of the COPs, may ask
to review complaints received by the HHA and the resolution of these complaints. The
HHA must permit examination of these records by or on behalf of CMS, or risk
termination from the Medicare program.
NOTE: Sections 5300 to 5390 relate to nursing homes.
5300 - Investigation of Complaints for Nursing Homes
(Rev. 243; Issued: 06-12-26; Effective: 06-12-26; Implementation: 06-12-26)
Section 42 CFR 488.332 provides the Federal regulatory basis for the investigation of
complaints about nursing homes.
The survey agency must review all complaint allegations and conduct a standard or an
abbreviated standard survey to investigate complaints of violations of requirements if its
review of the allegation concludes that:
• 	A deficiency in one or more of the requirements may have occurred; and

• 	Only a survey can determine whether a deficiency or deficiencies exist.
The survey agency does not conduct a survey if the complaint raises issues that are
outside the purview of Federal participation requirements.
Complaint investigations follow, as appropriate, the pertinent survey tasks, and
information gathered is recorded on the appropriate survey worksheets. However, if the
documentation required is minimal, use Form CMS-807 to record information during the
complaint investigation. Record deficiencies on Form CMS-2567 and/or, the “Statement
of Isolated Deficiencies Which Cause No Harm with Only a Potential for Minimal Harm
for SNFs and NFs” . The completed Form CMS-2567 must be made a part of the
complaint record.
If necessary, a specialized team may be used to investigate complaints. Team members
may include, but are not limited to, an attorney, auditor, and appropriate health
professionals. The specialized team is not necessarily composed of qualified surveyors.
However, specialized team members provide unique talents and expertise that assist at
least one qualified surveyor in identifying, gathering, and preserving documented
evidence. Further information regarding the composition of the survey team is provided
in Chapter 7.
The timing, scope, duration and conduct of a complaint investigation are at the discretion
of the SA, except when a determination is made that immediate jeopardy may be present
and ongoing or a higher level of actual harm may be present. If the complaint concerns
conditions on a certain day (e.g., on weekends), or on a certain shift (e.g., 11 p.m. - 7
a.m.), the SA should make an attempt to investigate it at the relevant time. In most cases,
the following tasks, or portion of tasks, should be performed during a complaint
investigation.
Abbreviated surveys must be conducted on two consecutive calendar days from the day of
entrance. Exceptions to this guidance would be an emergency situation as deemed by the
state agency or a competing IJ at another location requiring the survey team’s immediate
attention. 	Additionally, the surveyor or survey team should plan to be onsite for a
minimum of five hours after entrance, unless the investigation can be completed in less
than five hours.
5300.2 - Task 2: Entrance Conference/Onsite Preparatory Activities
(Rev. 18, Issued: 03-17-06; Effective/Implementation Dates: 03-17-06)
Onsite complaint investigations should always be unannounced. Upon entrance, advise
the facility’s Administrator of the general purpose of the visit. The SA explains the
reason for the survey and avoids any impression that a predetermination has been made
as to the validity of the allegation. It is important to let the facility know why you are
there, but protect the confidentiality of those involved in the complaint. Do not release

information that will cause opportunities to be lost for pertinent observations, interviews,
and record reviews required for a thorough investigation. For example, if the complaint
is that food that is intended to be served hot is always served cold, do not tell the facility
the exact complaint. Rather, tell them it is a situation related to dietary requirements.
5300.3 - Task 5: Information Gathering
(Rev. 18, Issued: 03-17-06; Effective/Implementation Dates: 03-17-06)
The order and manner in which information is gathered depends on the type of complaint
that is being investigated. Conduct comprehensive, focused, and/or closed record
reviews as appropriate for the type of complaint. Generally, it is not necessary to review
records and information from more than one year ago. However, the SA is not precluded
from doing so if concerns identified during the investigation indicate it is necessary in
order to determine current compliance. It is very important to remember that the
determination of whether the complaint happened is not enough. The surveyor needs to
determine noncompliant facility practices related to the complaint situation and which, if
any, requirements are not met by the facility.
Perform information gathering in order of priorities, i.e., obtain the most critical
information first. Based on this critical information about the incident, determine what
other information to obtain in the investigation.
Observations, record review and interviews can be done in any order necessary. As
information is obtained, use what has been learned to determine what needs to be
clarified or verified as the investigation continues.
Observe the physical environment, situations, procedures, patterns of care, delivery of
services to residents, and interactions related to the complaint. Also, if necessary,
observe other residents with the same care need. After determining what occurred, i.e.,
what happened to the resident and the outcome, investigate what facility practice(s) or
procedures affected the occurrence of the incident.
EXAMPLE
It was verified through the investigation that a resident developed a pressure sore/ulcer
which progressed to a Stage IV, became infected and resulted in the resident requiring
hospitalization for aggressive antibiotic therapy. Observe as appropriate: dressing
changes, especially to any other residents with Stage III or IV pressure sores; infection
control techniques such as hand washing, linen handling, and care of residents with
infections; care given to prevent development of pressure sores (e.g., turning and
repositioning, use of specialized bedding when appropriate, treatments done when
ordered, keeping residents dry, and provision of adequate nutritional support for wound
healing).
Record Review: If a specific resident is involved, focus on the condition of the resident
before and after the incident. If there are care issues, determine whether the appropriate

assessments, care planning, implementation of care, and evaluations of the outcome of
care have been done as specified by the regulatory requirements.
EXAMPLE
For a complaint of verbal and physical abuse, review the record to determine the
resident’s mood and demeanor before and after the alleged abuse. Determine if there are
any other reasons for the change in the resident’s demeanor and behavior. Determine
whether an assessment has been done to determine the reason for the change in mood and
behavior. Does the record document any unexplained bruises and/or complaints of pain,
and whether they occurred in relation to the alleged incident?
Interviews: Interview the person who made the complaint. If the complainant is not at
the facility at the time of the survey, he/she should be interviewed by telephone, if
possible. Also, interview the person the complaint is about. Then, interview any other
witnesses or staff involved. In order to maintain the confidentiality of witnesses, change
the order of interviews if necessary. It may not always be desirable to interview the
person who made the complaint first, as that may identify the person as the complainant
to the facility. Interview residents with similar care needs at their convenience.
As interviews proceed, prepare outlines needed for other identified witnesses and revise
outlines as new information is obtained.
During information gathering to investigate a complaint about the care and services
provided to residents in a nursing home, findings of past noncompliance may be
identified. Before considering a citation of past noncompliance with a specific regulatory
tag, surveyors must determine if current compliance with the specific regulatory tag
exists. Similar to verifying correction of current noncompliance on a revisit, surveyors
should use a variety of methods to determine whether correction of the past
noncompliance occurred and continues. This may include, but is not limited to, the
following:
• 	Interviews with facility staff, such as the administrator, nursing staff, social
services staff, medical director, quality assessment and assurance committee
members, and/or other facility staff, as indicated, to determine what procedures,
systems, structures, and processes have been changed.
• 	Reviewing through observation, interview and record review, how the facility
identified and implemented interventions to address the noncompliance.
Examples of interventions may include, but are not limited to:
o 	The facility’s review, revision, or development of policies and/or
procedures to address the areas of concerns;
o 	The provision and use of new equipment, as necessary;

o 	The provision of staff training required to assure ongoing compliance for
the implementation and use of new and/or revised policies, procedures,
and/or equipment, especially with new and/or temporary staff;
o 	The provision of additional staffing, changes in assignments or
deployment of staff, as needed; and
o 	The provision of a monitoring mechanism to assure that the changes made
are being supervised, evaluated, and reinforced by responsible facility
staff.
• 	Evaluating whether the facility has a functioning quality assessment and
assurance committee whose responsibilities include the identification of quality
issues; providing timely response to ascertain the cause; implementing corrective
action; implementing monitoring mechanisms in place to assure continued
correction and revision of approaches, as necessary, to eliminate the potential risk
of occurrence to other residents and to assure continued compliance.
A citation of past noncompliance must meet all of the criteria described in Task 6 below.
5300.5 - Task 7: Exit Conference
(Rev. 243; Issued: 06-12-26; Effective: 06-12-26; Implementation: 06-12-26)
Conduct an Exit Conference related to a complaint survey in accordance with the process
described in the Exit Conference section located in the Long-Term Care Survey Process
(LTCSP) Procedure Guide (https://www.cms.gov/Medicare/Provider-Enrollment-and-
Certification/GuidanceforLawsAndRegulations/Nursing-Homes.html). Do not inform
the nursing facility of confidential information unless the individual who provided the
information specifically authorizes you to do so.
If a deficiency is not present now, but was present and has been corrected, notify the
facility orally and in writing that there was noncompliance related to the complaint
because deficiencies existed at the time that the complaint situation occurred. (See SOM
Chapter 7, Survey and Enforcement Process for Skilled Nursing Facilities and Nursing
Facilities, for specific information about citing past noncompliance.)
If there was no noncompliance related to the complaint, notify the facility of this
decision.
5310 - Action on Allegations of Resident Neglect and Abuse, and
Misappropriation of Resident Property for Nursing Homes
(Rev. 212; Issued; 02-10-23; Effective: 10-21-22; Implementation: 10-24-22)
5310.1 - Written Procedures

(Rev. 212; Issued; 02-10-23; Effective: 10-21-22; Implementation: 10-24-22)
The State must develop and implement written procedures for the timely review and
investigation of allegations of resident abuse and neglect, and misappropriation of
resident property, including both complaints and facility-reported incidents. The State’s
policies and procedures must be consistent with Federal requirements as well as with
procedures in the State Operations Manual.
Nursing homes send the following types of incidents to the State Survey Agency:
• 	All alleged violations involving abuse, neglect, exploitation or mistreatment,
including injuries of unknown source and misappropriation of resident property;
• 	The results of all facility investigations involving alleged violations of abuse,
neglect, exploitation or mistreatment, including injuries of unknown source and
misappropriation of resident property; and
• 	Reasonable suspicions of crimes against nursing home residents.
NOTE: If the SA receives information that a suspected crime may have
occurred in a facility and there is indication that it has not been reported or the
SA cannot verify that a report was made to law enforcement, then the SA
forwards the information from the initial report immediately to law
enforcement. The SA must follow applicable laws and regulations related to
information disclosures, privacy and confidentiality, as it makes referrals.
The SA may also contact the CMS Location office for more information.
A. Initial Reporting of Facility-Reported Incidents
The information collected during intake is critical in determining what may be
occurring in a facility and the effect(s) that it may have on residents. While
States have discretion in how they collect information from facilities (e.g.,
through electronic submission), at a minimum, the State Survey Agency must
provide instructions to the facility and collect sufficient information to
determine how the incident should be prioritized. See also Exhibit XX for
sample instructions with examples of information and Appendix PP, Tag
F609. If the facility has not provided sufficient information, the SA should
take this into consideration as it triages the incident.
1. Facility Reported Incidents – Initial Report
The facility must provide in its report sufficient information to describe
the alleged violation and indicate how residents are being protected [See
§483.12(c)(3)]. It is important that the facility provide as much
information as possible, to the best of its knowledge at the time of

submission of the report, so that state agencies can initiate action
necessary to oversee the protection of nursing home residents. See Exhibit
XX for a sample form for initial reporting with examples of information
and see also Appendix PP, Tag F609.
B. Reporting of Investigation Findings for Facility-Reported
Incidents
For alleged violations of abuse, neglect, exploitation or mistreatment,
including injuries of unknown source and misappropriation of resident
property, the facility is required to submit a report of the results of the
investigation within 5 working days to the State Survey Agency (See 42
C.F.R. §483.12(c)(4), Tag F609 of Appendix PP of the State Operations
Manual). While States have discretion in how they collect information from
facilities (e.g., through electronic submission), at a minimum, the State Survey
Agency must provide instructions to the facility and collect sufficient
information to determine how the incident should be prioritized.
5-Day Final Report of Suspected Allegation
Within 5 working days of the incident, the facility must provide in its report
sufficient information to describe the results of the investigation, and indicate
any corrective actions taken, if the allegation was verified. It is important that
the facility provide as much information as possible, to the best of its
knowledge at the time of submission of the report, so that State agencies can
initiate action necessary to oversee the protection of nursing home residents
[see §483.12(c)(4)]. See Exhibit XX for a sample form for the investigation
report with examples of information, and see also Appendix PP, Tag F609.
5310.2 - Review and Triage of Allegations
(Rev. 212; Issued; 02-10-23; Effective: 10-21-22; Implementation: 10-24-22)
The State reviews all allegations of resident neglect and abuse and misappropriation of
resident property regardless of the source.
5310.2A-Immediate Jeopardy Priority
(Rev. 243; Issued: 06-12-26; Effective: 06-12-26; Implementation: 06-12-26)
In cases where the initial report indicates the following, the SA must initiate an onsite
survey within three business days of receipt of the initial report:
1) 	The alleged noncompliance may have caused, or may likely cause, serious injury,
harm, impairment, or death to a resident, and
2) 	The facility has not implemented adequate protection for all residents or the SA
has not received sufficient evidence to conclude that residents are adequately
protected.

For these cases, the SA will enter into iQIES: Intake Type=Incident; Priority = IJ; and
Investigate Within X Days = 3 Working Days.
In cases where the initial report indicates the following, the SA must initiate an onsite
survey within seven business days of receipt of the initial report:
1) 	The alleged noncompliance may have caused, or may likely cause, serious injury,
harm, impairment, or death to a resident, and
2) 	The facility has potentially implemented adequate protection for all residents.
For these cases, the SA will enter into iQIES: Intake Type=Incident; Priority = IJ; and
Investigate Within X Days = 7 Working Days.
NOTE: See Appendix Q of the State Operations Manual for guidance related to
immediate jeopardy situations.
Depending on the nature of the allegation, the facility would be expected to take
immediate action(s) to ensure the protection of residents. Information provided by the
facility may assist the SAs in determining whether there are potentially adequate
protections provided to the resident. 	Examples of such information include, but are not
limited to:
• 	Monitoring of the alleged victim and other identified residents who are at risk,
such as conducting unannounced management visits at different times and shifts;
• 	Evaluation of whether the alleged victim feels safe and if he/she does not feel
safe, taking immediate steps to alleviate the fear, such as a room relocation,
increased supervision, etc.;
• 	Providing social services (e.g., emotional support and counseling) to the resident,
as needed;
• 	Immediate assessment of the alleged victim and provision of medical treatment
as necessary;
• 	Provision of goods and/or services that are necessary to avoid serious injury,
harm, impairment, or death to a resident;
• 	Immediate notification of the alleged victim’s physician and the resident
representative, when there is injury or a change in condition or status;
• 	If the alleged perpetrator is staff- Removal of access by the alleged perpetrator to
the alleged victim and other residents and assurance that ongoing safety and
protection is provided for the alleged victim and other residents

• 	If the alleged perpetrator is a resident or visitor- Removal of access by the
alleged perpetrator to the alleged victim and, as appropriate, other residents and
assurance that ongoing safety and protection is provided for the alleged victim
and other residents
• 	Notification of the alleged violation to other agencies or law enforcement
authorities, within timeframes as specified under Federal or State law or
regulations; and
• 	Whether administrative staff, including the administrator, were informed and
involved as necessary in the investigation.
Below are examples that indicate that a resident(s) may not be protected in the facility:
• 	The alleged perpetrator continues to have access to the alleged victim and/or
other residents;
• 	Retaliation occurs against a resident who reports an alleged violation;
• 	A resident who repeatedly fondles other residents is moved to another unit,
where he/she continues to exhibit the same behaviors to other residents; and
• 	A resident with a history of striking a resident is left unsupervised with a resident
who has been targeted in the past.
The SA may contact the resident/representative to determine whether adequate
protections are provided to the resident
5310.3 - Investigating Allegations
(Rev. 18, Issued: 03-17-06; Effective/Implementation Dates: 03-17-06)
If there is reason to believe, either through oral or written evidence, that an individual
used by a facility to provide services to residents could have abused or neglected a
resident or misappropriated a resident's property, the State must investigate the allegation.
During the investigation, the SA should evaluate how the facility developed policies and
procedures to prevent the abuse, and after the abuse occurred, how the facility took action
to report and investigate the allegations while ensuring the safety of the residents.
5310.4 - Factors Beyond the Control of the Individual
(Rev. 18, Issued: 03-17-06; Effective/Implementation Dates: 03-17-06)
The State must not make a finding that an individual neglected a resident if the individual
demonstrates that such neglect was caused by factors beyond the control of the
individual.

EXAMPLE: A nurse aide could not be found negligent for not providing clean bed and
bath linens to a resident if the facility had no clean bed and bath linens available.
However, the facility is responsible for providing clean bed and bath linens to residents.
5320 – Reporting Findings of Abuse, Neglect, or Misappropriation of
Property to the Nurse Aide Registry
(Rev. 18, Issued: 03-17-06; Effective/Implementation Dates: 03-17-06)
5320.1 - Notification Procedures - Preliminary Determinations
(Rev. 243; Issued: 06-12-26; Effective: 06-12-26; Implementation: 06-12-26)
If the State makes a preliminary determination, based on oral or written evidence and its
investigation, that resident neglect, abuse, or misappropriation of property has occurred,
the State completes the following notification procedures:
1. 	Individuals Notified - The State notifies the following individuals in writing
within 10 working days of the investigation:
a. 	Individual(s) implicated in the investigation; and
b. 	The current administrator of the facility in which the incident occurred.
2. 	Notice Information - The following information is included in the notice:
a. 	Nature of the allegation (specific facts);
b. 	Date and time of the occurrence;
c. 	A statement that the individual implicated in the investigation has a right to a
hearing and must request the hearing within 30 days from the date of the
notice. Provide the individual with the specific information needed to request
a hearing, such as the name and address of a contact in the State to request a
hearing;
d. 	Statement that if the individual fails to request a hearing, in writing, within 30
days from the date of the notice, the findings are reported to the nurse aide
registry or the appropriate licensure authority;
e. 	The intent to report findings upheld by a hearing in writing to the nurse aide
registry and/or to the appropriate licensure authority;
f. 	Consequences of waiving the right to a hearing;
g. 	Consequences of a finding through the hearing process that the resident abuse
or neglect, or misappropriation of property did occur; and

h. 	Right of the accused individual to be represented by an attorney at the
individual’s own expense.
5320.2 - Conduct of Hearing for Nurse Aides
1- Time frame to Complete the Hearing
The State must complete the hearing and the hearing record within 120 days from the day
it receives the request for a hearing.
2 - Hearing Location
The State must hold the hearing in a manner consistent with State practice at a reasonable
place and time convenient for the individual.
5330 - Reporting Abuse to Law Enforcement and the Medicaid Fraud
Control Unit for Nursing Homes
(Rev. 243; Issued: 06-12-26; Effective: 06-12-26; Implementation: 06-12-26)
If the SA receives information that a suspected crime may have occurred in a facility and
there is indication that it has not been reported or the SA cannot verify that a report was
made to law enforcement, the SA must report the suspected crime to law enforcement
immediately.
Verifying that a complainant, facility, and/or covered individual(s) has made a report to
law enforcement would include review and confirmation of the following information:
• 	Who submitted the report to law enforcement, including name and contact
information;
• 	Who did the reporter contact, including law enforcement entity, name, and contact
information;
• 	Date/Time that the report was filed;
• 	Any copies of the report made to law enforcement, if available;
• 	What information was conveyed to law enforcement; and
• 	The police report number provided by law enforcement.
When the SA or CMS location confirms noncompliance related to abuse, the SA or CMS
location must report the cited finding of noncompliance to local law enforcement and, if
appropriate, the Medicaid Fraud Control Unit.

NOTE: “Covered individual” is defined in section 1150B(a)(3) of the Act as anyone who
is an owner, operator, employee, manager, agent or contractor of the facility
(§483.12(b)(5)(i)).
5340 - Post-Survey Certification Actions for Nursing Homes
(Rev. 155, Issued: 06-10-16, Effective: 06-10-16, Implementation: 06-10-16)
Following the investigation, the survey team records any findings on Form CMS-2567,
the SA conducts a supervisory review of the CMS-2567 form and sends the provider a
copy. The SA requests a POC for any uncorrected deficiencies. See §2728.
When Federal deficiencies are identified, the SA initiates certification actions as follows:
1. Noncompliance that Constitutes Immediate Jeopardy to Resident Health
and Safety - The SA initiates procedures in accordance with §§7307 to 7309.
2. 	Noncompliance that Does Not Constitute Immediate Jeopardy to Resident
Health and Safety - The SA initiates procedures in accordance with §§7311 to
7316.
3. 	In Substantial Compliance - The SA initiates procedures in accordance with
§7319.
5350 – Data Entry
(Rev. 243; Issued: 06-12-26; Effective: 06-12-26; Implementation: 06-12-26)
The SA enters survey information into the CMS system, including Forms CMS-670 and
CMS-2567.
5360 - Processing of Complaints Originating with or Investigated by the
CMS location
(Rev. 243; Issued: 06-12-26; Effective: 06-12-26; Implementation: 06-12-26)
The CMS location establishes procedures and clear organizational accountability to
ensure that any complaint is properly evaluated, documented, acknowledged, and handled
timely and appropriately. The CMS location uses ACTS to ensure timely and
appropriated action on all allegations originating with or investigated by the CMS
location.
The extent and nature of CMS location involvement with a given complaint varies
depending on the nature of the allegation and the receiving organization. The following
procedures address the major variants of CMS location involvement.

5370 - Pre-Investigation Actions on Allegations Originating Through
the CMS location
(Rev. 243; Issued: 06-12-26; Effective: 06-12-26; Implementation: 06-12-26)
Most complaints originate through the SA and are recorded and controlled by the SA.
When a complaint is filed directly with the CMS location, however, the CMS location
assumes those initial SA responsibilities.
5380 - CMS location Processing of CMS location Investigated
Complaints
(Rev. 243; Issued: 06-12-26; Effective: 06-12-26; Implementation: 06-12-26)
This less frequent class of complaints includes allegations retained by the CMS location
or forwarded to the CMS location by the SA for investigation or special processing. The
CMS location responsibilities vary based on the type of complaint.
1 - Direct CMS location Investigation
These procedures apply when a direct CMS location investigation is conducted. When
directly investigating, the CMS location begins by ensuring that it or the SA has met all
intake, acknowledgment, and priority assignment requirements in §5010 to §5020.
2 - Conducting the Investigation
The CMS location follows the procedures for investigation in §5300.
3 – CMS location Certification Actions
When Federal deficiencies are identified, the CMS location initiates certification actions
as follows:
a. 	Noncompliance that Constitutes Immediate Jeopardy to Resident Health and
Safety - The CMS location initiates procedures in accordance with §§7307 to
7309. The CMS location performs the SA responsibilities described in these
sections.
b. 	Noncompliance that Does Not Constitute Immediate Jeopardy to Resident Health
and Safety - The CMS location initiates procedures in accordance with §§7311 to
7316.
c. 	In Substantial Compliance - The CMS location initiates procedures in accordance
with §7319.
4 - Reporting

The CMS location should report survey information into the iQIES system , including
Forms CMS-670 and CMS-2567.
5390 – CMS location Oversight of Complaint-Related Processes
(Rev. 243; Issued: 06-12-26; Effective: 06-12-26; Implementation: 06-12-26)
1. The CMS location considers any complaint data in targeting look-behind surveys or
reviews.
2. The CMS location monitors data in summary form - either through a log or data
system. See §5060.
These records should include:
• 	Identification of region or State-wide patterns;
• 	Pinpointing of problem providers or States;
• 	Evaluation of SA processing times, workloads, performance, etc.; and
• 	Identification of overall SA workloads, including review of complaints where
noncompliance was not found and Medicaid-only complaint volumes.
3. Based on needs identified from oversight activities, the CMS location provides SA
training and technical assistance.
NOTE: Sections 5400 to 5480.2 relate to alleged EMTALA violations.
5400 - Investigations Involving Alleged Emergency Medical Treatment
and Labor Act (EMTALA) Violations
(Rev. 18, Issued: 03-17-06; Effective/Implementation Dates: 03-17-06)
Section 1866 of the Act, Agreements with Providers of Services, specifies that for a
hospital, or any provider of services, to qualify for participation in the Medicare program,
it must enter into an agreement with the Secretary of HHS. Effective August 1, 1986,
participating hospitals with emergency departments must comply with the requirements
of §1867 of the Act as a condition of their provider agreement.
The following Medicare provider agreement requirements, which closely parallel
provisions contained in §1866of the Act, must be met by Medicare participating hospitals
with emergency departments:
• 	42 CFR 489.20(l) requires a hospital to comply with the requirements of 42 CFR
489.24. Section 1866(a)(1)(I) of the Act requires a hospital to have and enforce
policies to ensure compliance with the requirements of §1867;

• 	42 CFR 489.20(m) requires a hospital to report to CMS or the SA any time it has
reason to believe it may have received an individual who has been transferred in
an unstable emergency medical condition (EMC) from another hospital in
violation of the requirements of 42 CFR 489.24(e);
• 	42 CFR 489.20(q) requires a hospital to post conspicuously a sign(s) specifying
the rights of individuals, under §1867 of the Act, with respect to examination and
treatment for emergency medical conditions and women in labor and to indicate
whether or not the hospital participates in the Medicaid program. The letters
within the signs must be clearly readable at a distance of at least 20 feet or the
expected vantage point of the emergency department clients. The wording of the
sign(s) must be clear and in simple terms and language(s) that are understandable
by the population served by the hospital;
• 	42 CFR 489.20(r)(1) requires a hospital to maintain medical and other records
related to individuals transferred, including discharges, to or from the hospital for
a period of five years from the date of transfer;
• 	42 CFR 489.20(r)(2) requires a hospital to maintain a list of physicians who are
on call to provide treatment necessary to stabilize an individual with an
emergency medical condition;
• 	42 CFR 489.20(r)(3) requires a hospital to maintain a central log on each
individual who comes seeking assistance and whether he or she refused treatment,
was refused treatment, or whether the individual was transferred, admitted and
treated, stabilized and transferred, or discharged.
When hospitals do not conform to the requirements of §1867 of the Act, the practice is
commonly called “dumping.” A hospital with a dedicated emergency department is
defined in 42 CFR 489.24(b) as a hospital that offers services for emergency medical
conditions within its capacity to do so. The regulations at 42 CFR 489.24 parallel the
provisions of §1867 of the Act and contain the following requirements that a hospital
with a dedicated emergency department must meet:
• 	42 CFR §489.24(a) General. Applicability of provisions of this section.
• 	42 CFR §489.24(b) Definitions. As used in this section.
• 	42 CFR §489.24(c) Use of dedicated emergency department for non-emergency
services.
• 	42 CFR §489.24(d) Necessary stabilizing treatment for emergency medical
conditions.
• 	42 CFR §489.24(d)(1) General. Subject to the provisions of paragraph (d)(2).

• 	42 CFR §489.24(d)(2) Exception: Application to inpatients.
• 	42 CFR §489.24(d)(3) Refusal to consent to treatment.
• 	42 CFR §489.24(d)(4) Delay in examination or treatment.
• 	42 CFR §489.24(d)(5) Refusal to consent to transfer.
• 	42 CFR §489.24(e) Restricting transfer until the individual is stabilized.
• 	42 CFR §489.24(e)(1) General.
• 	42 CFR §489.24(e)(2) Appropriate transfer to another medical facility.
• 	42 CFR §489.24(e)(3) Provides whistleblower protection to physicians and
qualified medical personnel.
• 	42 CFR §489.24(f) Recipient hospital responsibilities.
• 	42 CFR §489.24(g) Termination of provider agreement.
• 	42 CFR §489.24(h) Consultation with Quality Improvement Organization (QIO).
• 	42 CFR §489.24(i) Release of QIO Assessment.
• 	42 CFR §489.24(j) Availability of on-call physicians.
• 	42 CFR §489.24 (j)(1) On-call list.
• 	42 CFR §489.24 (j)(2) Hospital on-call policy and procedures.
If a hospital fails to meet these requirements, CMS may terminate the provider agreement
in accordance with 42 CFR 489.53. The Office of the Inspector General (OIG) has the
responsibility and authority to assess civil monetary penalties (CMPs) or to exclude
physicians from the Medicare program when a hospital or physician violates these
requirements. Additionally, individuals suffering personal harm and medical facilities
suffering financial loss as a result of a violation of these provisions can bring civil action
against the offending hospital and physicians. Filing for such civil action is limited to a
period of 2 years after the date of the alleged violation. This legislation does not preempt
any State or local laws, except to the extent that State or local requirements directly
conflict with a requirement of this legislation.
5410 – EMTALA and Born-Alive Infants Protection Act of 2002
(Rev. 18, Issued: 03-17-06; Effective/Implementation Dates: 03-17-06)

5410.1 - Interaction of the Born-Alive Infant Protection Act and
EMTALA
(Rev. 18, Issued: 03-17-06; Effective/Implementation Dates: 03-17-06)
With the definition of the terms “person” and “individual” codified at 1 U.S.C. §8, it is
clear that there are circumstances where EMTALA protections are applicable to an infant
who is born alive, as that term is defined in 1 U.S.C. §8(b).
For example, assume that a hospital’s labor and delivery department meets the definition
of a “dedicated emergency department.” If an infant was born alive in that dedicated
emergency department, and a request was made on that infant’s behalf for screening for a
medical condition, (or if a prudent layperson would conclude, based on the infant’s
appearance or behavior, that the infant needed examination or treatment for an
emergency medical condition and that a request would have been made for screening) the
hospital and physician could be liable for violating EMTALA for failure to provide such
a screening examination. The born-alive infant is a “person” and an “individual” under 1
U.S.C. § 8(a) and the screening requirement of EMTALA applies to “any individual”
who comes to the emergency department.
Another example is a case of an infant born alive elsewhere on the hospital’s campus
(i.e., not in the hospital’s dedicated emergency department) and a prudent layperson
observer concluded, based on the born-alive infant’s appearance or behavior, that the
infant was suffering from an emergency medical condition. In such a circumstance, the
hospital and its medical staff are required to perform a medical screening examination on
that infant to determine whether or not an emergency medical condition existed. If the
hospital or its medical staff determined that the infant was suffering from an emergency
medical condition, the hospital has an obligation to admit the infant, or to comply with
either the stabilization requirement or the transfer requirement of EMTALA. The born-
alive infant is a “person” and an “individual,” as described above, and the stabilization
and transfer requirements of EMTALA apply to “any individual” who comes to the
hospital.
Finally, a third example is when the hospital admits a born-alive infant. EMTALA does
not apply to inpatients. If a born–alive infant is admitted to the hospital, EMTALA would
not apply to protect the infant in most circumstances. However, the Medicare COPs
would apply to the infant once he or she was admitted to the hospital as an inpatient.
5410.2 - Conduct of Investigations
(Rev. 18, Issued: 03-17-06; Effective/Implementation Dates: 03-17-06)
If a complaint indicates that a born-alive infant has been denied a screening examination,
stabilizing treatment, or an appropriate transfer, the complaint is prioritized as an alleged
EMTALA violation. It is not necessary to determine that the hospital acted with an
improper motive in any failure to provide a screening examination, stabilizing treatment,
or an appropriate transfer in order to conclude that an EMTALA violation has occurred.

The Supreme Court of the United States has held that a finding of improper motive is not
required to conclude that an EMTALA violation has occurred.
5420 - Basis for Investigation
(Rev. 243; Issued: 06-12-26; Effective: 06-12-26; Implementation: 06-12-26)
The SA enters alleged EMTALA violations into ACTS. The CMS location approves or
disapproves requests for EMTALA investigations in ACTS.
5430 - CMS location Direction of Investigation
(Rev. 243; Issued: 06-12-26; Effective: 06-12-26; Implementation: 06-12-26)
5430.1 - Evaluation of Allegation
(Rev. 243; Issued: 06-12-26; Effective: 06-12-26; Implementation: 06-12-26)
The CMS location evaluates all complaints and refers to the SA those that warrant SA
investigation. The SA or the CMS location sends a letter to the complainant
acknowledging the complaint and informing the complainant of whether an investigation
is warranted. The SA’s responsibility is to verify whether a violation of 42 CFR 489.24
and/or the related requirements at 42 CFR 489.20 occurred, and if there were other
violations.
5430.2 - Request for Investigation of Allegations
(Rev. 243; Issued: 06-12-26; Effective: 06-12-26; Implementation: 06-12-26)
The CMS location gives an initial verbal authorization to the SA to investigate the
EMTALA allegation, and then completes Form CMS-1541A in ACTS. If the CMS
location identifies Medicare conditions or standards it wants the SA to survey, related to
the EMTALA allegation at a deemed hospital, the CMS location completes Form CMS-
2802 in ACTS. If the CMS location identifies conditions or standards it wants the SA to
survey related to the EMTALA allegation at a non-deemed hospital, it directs the SA to
conduct a survey by completing Form CMS-1541A in ACTS.
5440 - Conducting an Investigation
(Rev. 18, Issued: 03-17-06; Effective/Implementation Dates: 03-17-06)
5440.1 - Selecting the Team
(Rev. 18, Issued: 03-17-06; Effective/Implementation Dates: 03-17-06)
The SA selects surveyors with a background in the profession or area to be investigated.
Preferably, the surveyors should have acute care training and experience. All surveyors
must be adequately trained in the evaluation of 42 CFR 489.24 cases. Physicians should
have experience in peer review.

5440.2 - Scheduling the Investigation
(Rev. 243; Issued: 06-12-26; Effective: 06-12-26; Implementation: 06-12-26)
Allegations of EMTALA violation against a non-deemed or deemed hospital or CAH
may represent a probable immediate jeopardy to the next individual who comes to the
hospital requesting examination and treatment for an emergency medical condition.
Therefore, when triaged as IJ by the CMS location, initiate the investigation within two
business days after receipt of the authorization from the CMS location. The onsite
investigation must be conducted on consecutive business days. The survey must be
completed promptly and is not to be interrupted by other activities. DO NOT
ANNOUNCE ANY INVESTIGATIONS.
Based on review of the complaint allegations by the CMS location, the EMTALA
complaint may also be prioritized as Non-IJ High. In these situations, the investigation
must be initiated within 45 business days of CMS location authorization. The onsite
investigation must be conducted on consecutive business days. The survey must be
completed promptly, should not be interrupted by other activities, and must be
unannounced.
5440.3 - Guidelines for Surveyors Conducting Investigations
(Rev. 243; Issued: 06-12-26; Effective: 06-12-26; Implementation: 06-12-26)
Attention to Procedures
The purpose of conducting the investigation is to ascertain whether or not the hospital
violated the EMTALA requirements. The survey must be in accordance with applicable
survey procedures and policies. Review instructions in Appendix V, before beginning
the investigation. The guidelines provide a detailed interpretation of the regulations.
Involvement of Complainants
Complainants, if known, receive a letter of acknowledgment from the SA or CMS
location. Do not disclose the identity of complainants. When information obtained
during the investigation appears to be in conflict with the information supplied by the
complainant, consult with the complainant, if this can be done without disclosing the
person’s identity.
5440.4 - Conducting the Investigation
(Rev. 18, Issued: 03-17-06; Effective/Implementation Dates: 03-17-06)
A complete investigation consists of assessment of the following components:
• 	Completeness, adequacy and enforcement of policies and procedures which
address the provisions of 42 CFR 489.24;

• 	Prompt reports to the SA or CMS of receipt of an improperly transferred
individual by the receiving hospital;
• 	Presence and completeness of signs posted in emergency departments specifying
the rights of individuals under 42 CFR 489.24, and information indicating
whether the hospital participates in the Medicaid program;
• 	Maintenance of medical and other records related to individuals transferred to or
from the hospital for a period of five years from the date of transfer, including
discharged patients;
• 	Maintenance of a list of physicians who are on call to provide necessary
stabilizing treatment;
• 	Maintenance of a central log on each individual who comes to the hospital
seeking emergency services;
• 	Provision of an appropriate medical screening examination sufficient to determine
the presence of an emergency medical condition;
• 	Provision of necessary stabilizing treatment;
• 	Provision of no delay in examination or treatment in order to inquire about
insurance status or capability for payment;
• 	Provision of an appropriate transfer to another medical facility/provider;
• 	Provision of whistleblower protections; and
• 	Adequacy of responsibilities of the recipient hospital with specialized capabilities
(nondiscrimination).
The survey tasks are listed below for easy reference. See Appendix V for detailed
guidance.
• 	Task 1: Entrance Conference;
• 	Task 2: Case Selection Methodology;
• 	Task 3: Record review;
• 	Task 4: Interviews;
• 	Task 5: Exit Conference;

• 	Task 6: Professional Medical Review; and
• 	Task 7: Assessment of Compliance and Completion of the Deficiency Report.
After the investigation is concluded, complete a Form CMS-1541B (Exhibit 137). If one
or more of the provisions of EMTALA are not met, complete Form CMS-2567, using
“Principles of Documentation.” Describe in detail the facts of each individual case. In
addition, specify whether the hospital was aware of the problem and took steps to remedy
it prior to the survey. If a SA physician was a member of the investigation team, include
the medical review of the case. Use the “Physician Review Outline for Emergency Care
Obligations of Medicare Hospitals,” (Exhibit 138) for this purpose. In addition, complete
Form CMS-562. All the forms must be signed, showing the professional titles of all
participating surveyors, and dated.
A hospital may have multiple sites listed under its Medicare provider number. These sites
may not be in close proximity of each other and each site may have its own dedicated
emergency department (DED). In cases where the alleged EMTALA violation is against
a specific site of the hospital, the surveyors should focus their survey investigation at the
hospital site mentioned in the complaint intake. However, the surveyors should review
all EMTALA related Policies and Procedures of all sites of the hospital. The surveyors
need to survey the other sites of the hospital if the survey findings indicate that the
potential EMTALA violation maybe widespread.
5440.5 - Exit Conference
(Rev. 243; Issued: 06-12-26; Effective: 06-12-26; Implementation: 06-12-26)
It is usually desirable and appropriate to conduct an exit conference. The surveyor(s) may
outline the basic facts uncovered during the onsite investigation. However, the
surveyor(s) must inform the hospital that the CMS location makes the final compliance
determination, and the determination is often made with information obtained after the
onsite investigation. Do not reveal the complainant and do not venture an opinion on
what determination the CMS location might make. The exit conference should include a
description of the process that is followed if the CMS location determines that a violation
has occurred.
5450 - Forwarding Report of Investigation to the CMS location
(Rev. 243; Issued: 06-12-26; Effective: 06-12-26; Implementation: 06-12-26)
Transmit the results of the investigation and your recommendations to the CMS location
through ACTS within 10 working days following completion of the onsite survey, if it
appears there may be an EMTALA violation. If there appears to be no violation, this
time frame may be extended to 15 working days, in order to allow the SA additional
processing time.
Transmit the following materials to the CMS location through ACTS:

• 	Form CMS-562,”Medicare/Medicaid/CLIA Complaint Form;”
• 	Form CMS-1541B, “Responsibilities of Medicare Participating Hospitals in
Emergency Cases Investigation Report.” Recommend one or more of the actions
below on the form:
o 	None - This means the complaint was not substantiated;
o 	In Compliance, but Previously Out of Compliance - This means that the
hospital identified the problem on its own and took effective corrective
action prior to the investigation. In addition to this recommendation,
document on the Form CMS-2567 when the hospital identified the
violation or a similar problem, the corrective action taken, and the date of
such action. Also, document that the hospital has had no violations or
similar problems for at least the past 6 months;
o 	Recommend Termination (23 calendar day track) - This means that the
hospital is out of compliance with 42 CFR 489.24 or the related
requirements at 42 CFR 489.20(l), (m), (q) or (r) and the violation presents
an immediate jeopardy to patient health and safety;
o 	Recommend Termination (90 calendar day track) - This means that the
hospital is out of compliance with 42 CFR 489.24 or the related
requirements at 42 CFR 489.20(l), (m), (q) or (r), but the violation does
not present an immediate jeopardy to patient health and safety;
o 	Request Physician Review. This means that it is recommended that the
CMS location obtain a medical review of the case;
o 	Possible Discrimination. This means that it is believed that
discrimination occurred based on financial status, race, color, nationality,
handicap, or diagnosis.
• 	Form CMS-670, “Survey Team Composition and Workload Report;”
• 	Form CMS-2567, “Statement of Deficiencies and POC;”
NOTE: If the hospital had identified the deficiency and took corrective action
prior to the investigation, indicate on the Form CMS-2567 that the
requirement was not met. However, indicate on the Form CMS-2567
and the narrative report that the hospital took corrective action prior to
the investigation, what action was taken, and for how long the hospital
has been in compliance.
• 	Physician Review Outline for Emergency Care Obligations of Medicare Hospital
(if physician review was done by SA);

• 	Complaint investigation narrative;
• 	Copies of pertinent hospital policies and procedures that relate to the identified
deficiencies;
• 	Summary listing of all patients comprising the sample, including an explanation
of how and why the cases were selected for review;
• 	Summary of interviews.
Transmit the following to the CMS location by overnight mail:
• 	Copies of medical records for substantiated cases, medical records of individuals
named in the complaints, and other medical records for which a QIO review is
requested;
• 	Certification of benefits versus risks of the transfer, if this is a transfer case.
5460 - CMS location Review of Investigation
(Rev. 243; Issued: 06-12-26; Effective: 06-12-26; Implementation: 06-12-26)
Upon receiving the case from the SA, the CMS location has 10 working days to review
the investigation findings. The CMS location requests a 5-day advisory medical review
of the case by the QIO to determine if there is an EMTALA violation. The CMS location
has 5 working days to review the case upon return from the QIO. With this information,
and any other additional information, the CMS location determines whether the hospital
complied with the EMTALA requirements and determines whether the violation
constitutes an immediate jeopardy to patient health and safety.
Prior to determining compliance or noncompliance, the CMS location is encouraged to
confer with the State Agency, and may confer with the hospital’s representatives. The
CMS location shares as much data as possible in accordance with current Privacy Act
requirements.
5460.1 - Hospital Is In Compliance - No Past Violation
(Rev. 243; Issued: 06-12-26; Effective: 06-12-26; Implementation: 06-12-26)
If the CMS location determines that the allegation is not substantiated and that the
hospital is in compliance with 42 CFR 489.24 and/or the related requirements at 42 CFR
489.20, the CMS location notifies the hospital and forwards a copy of the letter to the SA.
If the SA received the complaint, it notifies the complainant that the complaint was not
substantiated. If the CMS location received the complaint, the CMS location notifies the
complainant.

5460.2 - Hospital Is In Compliance - Past Violation, No Termination
(Rev. 243; Issued: 06-12-26; Effective: 06-12-26; Implementation: 06-12-26)
If the CMS location determines that the allegation was substantiated, but the hospital had
identified the violation on its own, took effective corrective action prior to the
investigation, and has had no EMTALA violations for at least the past 6 months,
termination action is not initiated. The CMS location notifies the hospital via a “Past
Violation - No Termination Letter.” The SA receives a copy of the letter through ACTS.
The CMS location or SA sends a letter to the complainant regarding the outcome of the
investigation. Although no termination action is taken, the CMS location refers past
violations of 42 CFR 489.24 to the OIG for assessment of civil monetary penalties
(CMPs) if warranted.
5460.3 - Hospital Is Not in Compliance - Immediate Jeopardy to Patient
Health and Safety
(Rev. 243; Issued: 06-12-26; Effective: 06-12-26; Implementation: 06-12-26)
If the CMS location determines that the hospital is not in compliance and the violation
represents an immediate jeopardy to patient health and safety, the CMS location follows a
23 calendar-day termination process. The termination procedures in §3010 are followed.
Uncorrected deficiencies that resulted in a violation of 42 CFR 489.24 may pose an
immediate jeopardy to people seeking emergency care. The CMS location notifies the
complainant that the complaint was substantiated. It also informs the hospital in writing
of the specific violations via a preliminary determination letter, and sends the hospital a
copy of Form CMS-2567. The SA receives a copy of the letter through ACTS.
5460.4 - Hospital Is Not in Compliance - Situation Does Not Pose an
Immediate Jeopardy to Patient Health and Safety
(Rev. 243; Issued: 06-12-26; Effective: 06-12-26; Implementation: 06-12-26)
If the CMS location determines that the hospital is not in compliance with the EMTALA
requirements, but the violation does not pose an immediate jeopardy to patient’s health
and safety, or the hospital took corrective action after the investigation to remove the
immediate jeopardy, the CMS location follows a 90 calendar-day termination process.
The termination procedures in §3012 are followed. The CMS location notifies the
complainant that the complaint was substantiated. The CMS location informs the
hospital, in writing, of the specific violations via a preliminary determination letter and
sends the hospital a copy of Form CMS-2567. The SA receives a copy of the letter
through ACTS.
Examples of noncompliance that usually do not pose an immediate jeopardy:
1. A transfer which was appropriate, but not signed or dated by the physicians;
2. An appropriate, functioning, central log that on one particular day is not fully
completed; and

3. A written hospital policy that is missing, but is nonetheless being implemented.
The fact that the hospital has completed a POC should not be interpreted to mean that the
hospital admits violating the EMTALA requirements. However, the hospital is included
on the log of facilities with EMTALA violations, with the notation that an acceptable
POC was received by CMS, and termination action was stopped.
5465 - Procedures for the 5-day QIO Review of Alleged Violations of 42
CFR 489.24
(Rev. 243; Issued: 06-12-26; Effective: 06-12-26; Implementation: 06-12-26)
Prior to terminating a hospital from the Medicare program because of possible
violation(s) of EMTALA, the CMS location requests the QIO to assess whether the
individual involved was provided an appropriate medical screening examination,
stabilizing treatment, or an appropriate transfer as required by EMTALA.
The QIO 5-day review is mandatory if the CMS location determines that a case involves
a possible violation of 42 CFR 489.24 to support possible termination action against a
hospital if in fact it violated EMTALA. The CMS location is responsible for providing
the QIO with all information relevant to the case that is within its possession and control.
The CMS location sends the “Physician Review Outline for Emergency Care Obligations
of Medicare Hospitals,” (Exhibit 138) to capture this information. The QIO completes the
review within 5 working days upon the receipt of CMS location’s request. The QIO sends
the case file back to the CMS location including a copy of the review report. It is not
required that the physician reviewer give the hospital and/or the physician an opportunity
to respond to the allegations at this time. If the affected physician and/or hospitals have
questions concerning the case, they are to consult with the CMS location.
The QIO Review is not required in cases where a delay in effecting a sanction would
jeopardize the health and safety of individuals or in situations where medical review is
inappropriate (e.g., cases where the individual was denied a medical screening
examination). The QIO 5-day review is required to seek medical expertise on whether
the individual was adequately screened, examined and treated.
The CMS location shall release upon request the 5 day QIO review to the affected
physician and/or hospital, after the CMS location has made a determination as to whether
the hospital violated or is in compliance with EMTALA. In addition, the CMS location
may release the QIO review to the complainant or his/her representative upon request.
The physician reviewer’s identity is confidential, therefore, when releasing the QIO
report the physician’s identity is not to be disclosed unless he or she consents to the
release of their identity in accordance with the disclosure regulations at 42 CFR 480.132
and 480.133.

The cases in which the CMS location determined that the hospital was in compliance with
42 CFR 489.24 but in violation of 42 CFR 489.20 of the EMTALA regulation do not
need to be forwarded to the QIO for review. The CMS location takes action as warranted.
5470 - Termination Procedures for EMTALA Violations
(Rev. 18, Issued: 03-17-06; Effective/Implementation Dates: 03-17-06)
5470.1 - Procedures for Termination when the EMTALA Violation is an
Immediate Jeopardy to Patient Health and Safety
(Rev. 243; Issued: 06-12-26; Effective: 06-12-26; Implementation: 06-12-26)
In cases where the CMS location determined that an immediate jeopardy existed, after a
5-day QIO advisory review has been completed, the CMS location follows the
termination procedures in §3010. The processing timeframes are the maximum allowed.
The termination procedures are not postponed or stopped unless evidence of correction of
the deficiencies or proof that the violation did not exist is provided by the hospital to the
CMS location. The CMS location forwards the supporting documents to the QIO (for a
60 day QIO review) in order to provide a medical opinion on the case. The CMS location
refers the case to the OIG that has the responsibility for assessment of CMPs against the
hospital and/or physician and physician exclusion provisions for violations of 42 CFR
489.24. The case is also referred to the Office for Civil Rights (OCR) because OCR may
take action under the Hill-Burton Subpart G Community Services regulations at 42 CFR
124.603(b) (1).
The termination track starts on the date that the CMS location makes the determination of
noncompliance with 42 CFR 489.24. It is the date of the preliminary determination
letter. The letter is forwarded to the hospital by the fastest method available (fax, e-mail
or telephone). In addition, a written letter follows up by mail. The preliminary
determination letter informs the hospital of:
• 	The CMS location’s findings based on the investigation and the results of medical
review;
• 	The projected termination date (the 23rd calendar day from the date of the
preliminary determination letter);
• 	The date on which the CMS location issues a Notice of Termination Letter and
notifies the public (at least two calendar days, but no more than four calendar
days prior to the termination date); and
• 	That the hospital may avoid the termination action and notice to the public by
either providing acceptable POCs for the deficiencies or by successfully showing
that the deficiencies did not exist. In either case, the necessary information must
be furnished to the CMS location in time for the SA to verify the corrections
before the projected termination date.

If, during the resurvey, the SA finds that the provider had implemented systems and
processes to ensure that the likelihood of further violation is remote and there is adequate
evidence that the provider is in compliance with the requirements, the termination action
is rescinded and the provider is put back in compliance.
If, during the resurvey, the SA finds that the provider has not adequately implemented
systems and processes to ensure compliance, the CMS location gives the hospital an
additional 67 days or a total of 90 days (23 plus 67) to achieve compliance.
This allows the hospital time to prove that the corrective action is good for the long-term
(i.e., the corrective action is adequate to ensure that no further violations will occur). The
CMS location directs the SA to conduct a second survey by the 60th calendar day. On
the resurvey, the surveyor(s) reviews patients’ emergency department (ED) records and
other relevant documents for the period since the last survey to assess continued
compliance. If the hospital fails to achieve compliance, it is terminated from the
Medicare program. The CMS location sends the complainant a letter reporting the final
results of the investigation.
If the termination takes place and the hospital desires to become re-certified as a
Medicare provider, the hospital must provide reasonable assurance that compliance will
be maintained. The procedures at §2016 are followed.
5470.2 - Procedures for Termination When the EMTALA Violation is
Not Immediate Jeopardy to Patient Health and Safety
(Rev. 243; Issued: 06-12-26; Effective: 06-12-26; Implementation: 06-12-26)
In cases where the CMS location determined that a violation existed but not an immediate
jeopardy, after a 5-day QIO advisory review has been completed when it was warranted,
the CMS location follows the termination procedures in §3012 The processing
timeframes are the maximum allowed. The termination procedures are not postponed or
stopped unless evidence of correction of the deficiencies or proof that the violation did
not exist is provided to the CMS location by the hospital. If warranted, the CMS location
forwards supporting documents to the QIO (for a 60 day QIO review) in order to provide
a medical opinion on the case. The CMS location refers the case to the OIG, if warranted,
that has the responsibility for assessment of CMPs against the hospital and/or physician
and physician exclusion provisions for violations of 42 CFR 489.24 The case is also
referred to the Office for Civil Rights (OCR) because OCR may take action under the
Hill-Burton Subpart G Community Services regulations at 42 CFR 124.603(b)(1)
The termination track starts on the date that the CMS location makes the determination of
noncompliance with 42 CFR 489.24 and/or the related requirements at 42 CFR 489.20. It
is the date of the preliminary determination letter.
5480 - Procedures for QIO Review of Confirmed EMTALA Violation
(Rev. 18, Issued: 03-17-06; Effective/Implementation Dates: 03-17-06)

Before imposing sanctions under §1867 of the Act for violations of 42 CFR 489.24, 42
CFR 489.24(h) requires that CMS obtain consultation from the QIO. The OIG holds the
authority to assess CMPs against the hospital or physicians or to exclude physicians from
the Medicare program for violations of 42 CFR 489.24.
5480.1 - Procedures for Coordinating 60 day QIO Review
(Rev. 243; Issued: 06-12-26; Effective: 06-12-26; Implementation: 06-12-26)
The CMS location requests the QIO to provide a medical opinion on EMTALA violation
cases within 60 calendar days. The cases referred for 60-day QIO review are outlined in
§5480B. The CMS location uses the “Model Letter Requesting QIO Review of a
Confirmed Violation of 42 CFR 489.24 for Purposes of Assessing Civil Monetary
Penalties or Excluding Physicians,” (Exhibit 212). 	The QIO provides the physician and
the hospital reasonable notice of its review a reasonable opportunity for discussion, and
an opportunity for the physician and hospital to submit additional information before
issuing its report. (Instructions on notice of review and opportunity for discussion, and
additional information that follow the regulatory requirements in 42 CFR 489.24(h) are
found in §§9100-9150 of the QIO Manual.)
The CMS location is responsible for providing the QIO with all information relevant to
the case that is within its possession and control. The CMS location sends the “Physician
Review Outline for Emergency Care Obligations of Medicare Hospitals,” (Exhibit 138)
to capture this information. This outline is helpful for organizing the review of the
medical record. The specialty of the reviewing physician should be matched to the
specialty of the physician who attended the patient and/or the individual’s medical
condition. If the patient was not seen by a physician, the QIO uses the diagnosis of the
patient or the usual physician assignment practice of the hospital to determine the
specialty of the physician reviewer.
Within 60 calendar days of receiving the case, the QIO must submit to the CMS location
a report on its findings. The report provides an expert medical opinion regarding whether
the individual involved had an emergency medical condition, whether the individual’s
emergency medical condition was stabilized, whether the individual was transferred
appropriately, and whether there are any medical utilization or quality of care issues
involved in the case. Upon request, the CMS location provides copies of the QIO report
to the affected physician and/or hospital after all investigative activity has been
completed.
When there was no screening examination or when a delay would jeopardize the health or
safety of individuals, QIO Review is not required before the OIG may impose CMPs or
exclude a physician from the Medicare program. In addition, if the QIO determines, after
a preliminary review, that there was an appropriate medical screening examination and
the individual did not have an emergency medical condition, the QIO returns the case to
the CMS location with its documented opinion. The CMS location will close the case and
no referral to OIG is necessary.

When the CMS location determines that a hospital was non-compliant with the
requirements of 42 CFR 489.24, one of its notice requirements is to notify the OIG that
the violation was confirmed and that termination action was initiated. (See Exhibit 208.)
The CMS location completes the notification after receipt of the QIO 60-day review
report. 	If the QIO report does not support an EMTALA violation, the CMS location
closes the case without referring it to the OIG.
The CMS location forwards the following documents to the OIG:
• 	Form CMS-1541B;
• 	Form CMS-2567;
• 	Medical record;
• 	Summary of interviews;
• 	Explanation of sample selection;
• 	Copies of pertinent hospital policies and procedures related to the identified
deficiencies;
• 	Complaint investigation narrative;
• 	Certification of benefits versus risks of the transfer (if this is a transfer case);
• 	Copy of the 5 working-day advisory QIO Review, and
• 	Copy of the 60 calendar-day advisory QIO Review.
The CMS location sends the above information and any other pertinent documentation in
its possession to the OIG at the following address:
Office of Inspector General
Office of Counsel to the Inspector General
Department of Health and Human Services
Room 5527, Cohen Building
330 Independence Avenue SW
Washington, D.C. 20201
5480.2 - EMTALA Case Referral to OIG
(Rev. 18, Issued: 03-17-06; Effective/Implementation Dates: 03-17-06)
CMS refers appropriate cases to the OIG for investigation. Periodically, OIG will advise
us of the criteria they would prefer CMS to use in referring cases. Examples of the types
of cases that may be referred include:

1. 	Financial Screening - The hospital and/or responsible physician refused to
examine or treat a person based on the person’s insurance status or inability to pay
a fee. The financial basis for the decision must be clearly supported by evidence
in the file, e.g., documented policy, interview reports.
2. 	Patient with Trauma or Acute Emergency Condition - The hospital and/or
responsible physician (including an on-call physician who failed to come to the
hospital) failed to screen, stabilize, or appropriately transfer (or, in the case of a
hospital with specialized capabilities or facilities, refused to accept an appropriate
transfer of) a person with trauma, e.g., a severe head injury, or other acute
emergency condition, e.g., heart attack or stroke, requiring immediate and
substantial medical intervention.
3. 	High Risk Event (such as Birth) Occurs Prior to Arrival at Another Hospital
- The hospital and/or responsible physician discharged or refused to screen/treat a
person who gave birth (or is subject to another high risk medical event) prior to
arriving at another hospital (especially if transport is by private vehicle).
4. 	Death or Serious Harm Results from Dump - The evidence in the file
(including the QIO Review) demonstrates that the dumping violation caused
serious medical harm or death to the victim of the violation.
5. 	Egregious Violation Prioritized by CMS - CMS concludes that a CMP is
appropriate because of the seriousness of the violation (the person must have had
an emergency medical condition) and other relevant factors, e.g., long history of
noncompliance, hospital policy resulting in violations, pattern of serious
violations, knowing and willful violation. This category is for those cases that
CMS determines are very serious and merit a CMP but do not fit within other
categories identified by OIG.
5480.3 - Releasing QIO Assessment
(Rev. 243; Issued: 06-12-26; Effective: 06-12-26; Implementation: 06-12-26)
Upon request, the CMS location may release QIO assessment(s) to the physician and/or
hospital or the affected individual, or his/her representative. The QIO physician’s
identity is confidential unless he/she consents to its release. The QIO Review may be
released pursuant to the requirements of 42 CFR 480.132 and 480.133.
Sections 5500 to 5590 relate CLIA
5500 - Complaint Investigations in Non-Accredited, Non-Exempt
Laboratories
(Rev. 234; Issued: 09-12-25; Effective: 09-12-25; Implementation: 09-12-25)
NOTE: This section applies to complaints against laboratories that hold a CLIA

certificate of compliance (CoC), certificate of waiver (CoW), and certificate for Provider-
performed Microscopy (PPM) procedures. See sections 5540-5590 for complaints
regarding accredited laboratories, and sections 5510-5530 for State laboratory licensure
program (SLLP).
A complaint is an allegation that could result in citing noncompliance with CLIA
requirements. A complaint may be substantiated or unsubstantiated as a result of an
investigation or survey.
• 	A substantiated complaint is one resulting in a finding of noncompliance at the
time of the investigation, or a finding that noncompliance was proven to exist,
but was corrected prior to the investigation.
• 	An unsubstantiated complaint is an allegation where sufficient evidence could
not be found to conclude that noncompliance with CLIA requirements existed
during the investigation or at the time of the alleged violation.
A complaint may be received by either the State Agency (SA) or CMS. 	The receiving
organization should follow the procedures outlined below.
The SA or CMS should attempt to obtain the following information for every complaint:
• Complainant’s name, address, and telephone number, unless the
complainant requests anonymity;
• Laboratory’s name and address;
• CLIA number; and
• Description of problem, (e.g., personnel, places, and dates of occurrence).
The SA or CMS should gather as much information as possible to help
focus the complaint survey.
If a laboratory representative refuses to permit a complaint survey, the SA should contact
CMS.
There are several entities that may address laboratory complaints including: CMS, SAs,
SLLPs, and Accreditation Organizations (AO). Each of these entities share a strong
interest ensuring the quality of patient care and the services provided by laboratories.
When the complaint involves more than one of these entities, CMS should coordinate
communication to ensure an effective and timely resolution of the issue.
NOTE: If a SA surveyor identifies potential fraudulent billing activities on a complaint
survey, the surveyor should refer the information to CMS so that the information can be
referred to the State OIG with a copy to CMS. CMS can then refer the laboratory to the
federal OIG.

5500.1 - Control
(Rev. 234; Issued: 09-12-25; Effective: 09-12-25; Implementation: 09-12-25)
The SA establishes a file for the complaint and logs the action into the CLIA Data
System. 	The system may be manual or automated but must facilitate tracking and
control of all complaints.
NOTE: All complaints alleging noncompliance with CLIA requirements must be entered
into the CLIA Data System.
5500.2 - Acknowledgment
(Rev. 234; Issued: 09-12-25; Effective: 09-12-25; Implementation: 09-12-25)
If the complainant is known, the SA promptly issues written acknowledgment, e.g., email
or letter, that the complaint is being investigated. 	The SA should not delay
acknowledgment pending an investigation unless the investigation takes place within
three working days. 	The SA must take appropriate precautions to protect the
complainant’s anonymity and privacy. 	The SA maintains a copy or record of the
notification with the complaint documentation.
5500.3 - Evaluation
(Rev. 234; Issued: 09-12-25; Effective: 09-12-25; Implementation: 09-12-25)
The SA evaluates any complaint to determine whether it should be investigated by the
SA, or whether it should be forwarded to CMS for investigation or referral to the
appropriate authority (e.g., OCR, OSHA, CMS). 	The SA assesses the complaint to
determine if an immediate survey is necessary. While the SA will perform most
complaint surveys, complaints involving State-operated facilities are the responsibility of
CMS. 	When the SA does not have jurisdiction, it should forward the complaint to CMS
within three working days. 	If referral is not necessary, the SA considers whether or not
any special notification is appropriate.
If a complaint is especially significant, sensitive, or attracting public or media attention,
the SA informs CMS immediately.
5500.4 - Scheduling Investigations
(Rev. 234; Issued: 09-12-25; Effective: 09-12-25; Implementation: 09-12-25)
The SA investigates complaints involving possible immediate jeopardy (IJ) within three
working days of receiving the complaint and focuses on the specific problem area. The
SA should notify CMS of a possible IJ complaint. 	Otherwise, the SA follows
procedures for prioritizing and investigating certification-related complaints within 45
days. 	Laboratories with complaints pending are identified and given priority in
scheduling of regular certification surveys.

5510 - Conducting Complaint Investigations in Non-Accredited, Non-
Exempt Laboratories
(Rev. 234; Issued: 09-12-25; Effective: 09-12-25; Implementation: 09-12-25)
The SA may contact CMS for guidance on the type of complaint investigation which may
include one or more of the following: on-site survey, telephone, electronic
communication, letter, or a documentation review depending on the complaint.
Complaint investigations are unannounced.
NOTE: The SA should contact CMS when an unannounced complaint survey is
problematic, such as when a laboratory will not permit an investigation.
For on-site complaint investigations, the SA performs a full or partial survey based on
the allegations. If a complaint alleges generalized inappropriate laboratory practices,
the SA evaluates compliance with applicable requirements or conducts a full survey, as
needed. If the complaint is of a specific nature, the SA performs a survey focused on
areas relevant to the complaint. However, if the SA discovers systemic issues on the
focused survey, the survey may be expanded to a full survey.
5510.1 – Conducting Investigations in a Laboratory with a Certificate of
Waiver
(Rev. 234; Issued: 09-12-25; Effective: 09-12-25; Implementation: 09-12-25)
If the SA receives a complaint on a CoW laboratory, CMS authorizes an unannounced
complaint survey of a laboratory only if it is based on an allegation of noncompliance.
The fact that a deficiency is not at the condition-level does not preclude taking adverse
action based on provisions contained in 42 CFR 493.1775.
As with other laboratories, the SA investigates complaints made against laboratories
with a CoW by means of an on-site survey, by telephone, letter, or by a review of
documents.
The SA performs the on-site investigation based on the allegation and determines
whether a laboratory is performing only waived tests and if the laboratory is following
the manufacturer’s instructions for performing the tests. See SOM Appendix C.
If a survey determines that a laboratory is performing tests that are not waived, the
laboratory should cease testing of the non-waived tests that do not qualify under 42 CFR
493.15(c) and 493.39(a). If the laboratory wants to continue performing non-waived
tests, they must submit a CLIA application for the appropriate level of testing and
designate a qualified laboratory director. The SA should notify CMS so a cease-and-
desist letter and/or notice of other adverse actions for testing outside of the current
CLIA certificate can be sent by CMS to the laboratory.

5510.2 - Conducting Investigations in a Laboratory with a Certificate
for Provider-performed Microscopy Procedures
(Rev. 234; Issued: 09-12-25; Effective: 09-12-25; Implementation: 09-12-25)
If the SA receives a complaint on a certificate for PPM laboratory, CMS authorizes an
unannounced complaint survey of a laboratory only if based on an allegation of
noncompliance. If a survey determines that a laboratory is performing tests that do not
qualify under 42 CFR 493.19(c), the laboratory should cease testing. 	If the laboratory
wants to continue performing non-waived tests, they must submit a CLIA application
for the appropriate level of testing and designate a qualified laboratory director. The
SA should notify CMS so a cease-and-desist letter and/or notice of other adverse
actions for testing outside of the current CLIA certificate can be sent by CMS to the
laboratory in accordance with 42 CFR 493.47(d).
The survey should not differ from a complaint survey done in any other laboratory
performing non-waived testing, as all requirements for moderate complexity testing
apply, except the routine survey. Note that there are separate D-tags for PPM personnel
(D5980-5995). These specific citations should be used for personnel citations in PPM
laboratories. The moderate complexity personnel requirements (D6000-D6075, D6190,
D6191) should not be used for PPM laboratories.
If a PPM laboratory's noncompliance with waived testing is found during the survey and
the laboratory is not following the manufacturer’s instructions when performing the
waived tests, cite D1001.
5510.3 – Conducting Investigations in a Laboratory with Certificate of
Compliance
(Rev. 234; Issued: 09-12-25; Effective: 09-12-25; Implementation: 09-12-25)
The SA is responsible for the review and triage of CoC complaints. This does not include
federal jurisdictional laboratories within its State.
Note for Transfusion-Related Fatality Investigations: CMS or the SA will conduct the
survey within 45 days of the notice from CMS, with notification to CMS when the survey
is complete. A copy of the investigation report should be submitted to CMS within 60
days, including the Form CMS-2567, Statement of Deficiencies, if issued.
Investigations of transfusion-related fatalities are generally announced, since the facility
is aware of the possibility of a follow up after the report is made to the FDA. These
investigations are an exception to the general policy that complaint surveys are not
announced. However, if the report of the fatality originates with any other source, e.g.,
media or anonymous complaint, the SA or CMS conducts an unannounced survey.
Summary and information from the FDA are considered confidential and may only be
shared within CMS or the SA. It may not be shared with any other party, including

AOs. See SOM Chapter 6 section 6040.
5510.4 – Conducting Investigations in a Laboratory with Certificate of
Registration
(Rev. 234; Issued: 09-12-25; Effective: 09-12-25; Implementation: 09-12-25)
Certificates of Registration (CoR), regardless of whether it is a pending CoC or
Certificate of Accreditation (CoA), will be investigated by the SA or CMS. The SA
enters all complaints received into the CLIA Data System and notifies CMS for
approval or denial to perform the survey.
Note for Transfusion-Related Fatality Investigations: CMS or the SA will conduct the
survey within 45 days of the notice from CMS, with notification to CMS when the survey
is complete. A copy of the investigation report should be submitted to CMS within 60
days, including the Form CMS-2567, if issued.
Investigations of transfusion-related fatalities are generally announced, since the facility
is aware of the possibility of a follow up after the report is made to the FDA. These
investigations are an exception to the general policy that complaint surveys are not
announced. However, if the report of the fatality originates with any other source, e.g.,
media or anonymous complaint, the SA or CMS conducts an unannounced survey.
Transfusion-related fatality investigations must not be referred to an AO for action.
However, the AO or multiple AOs, as appropriate, will receive a copy of the Form
CMS-2567 and the accompanying notification letter from CMS when the investigation
is complete. Summary and information from the FDA are considered confidential and
may only be shared within CMS or the SA. 	It may not be shared with any other party,
including AOs. See SOM Chapter 6 section 6040.
5510.5 – Conducting Investigations in a Laboratory with Temporary
Testing Sites, Regardless of Certificate Type
(Rev. 234; Issued: 09-12-25; Effective: 09-12-25; Implementation: 09-12-25)
Complaints with No Known CLIA Number:
If the SA receives a complaint on a Temporary Testing Site (TTS) without a known
CLIA number, it should be entered into the CLIA Data System as a “No CLIA Number
(NOCN).” The TTS location is reviewed and triaged.
The SA performs an on-site complaint survey and gathers evidence about which CLIA
number the TTS is operating under, including testing and reporting results. If no CLIA
number is identified, the SA notifies CMS.
There may be situations where a complaint crosses multiple states. If the NOCN TTS is
operating under a primary site laboratory, the SA contacts CMS. CMS opens an intake
in the CLIA Data System and inserts the deficiencies from the referring states. The SA

that performed the complaint survey completes the Form CMS-2567 and the NOCN
information in the CLIA Data System and notifies CMS when it is complete.
Deficiencies in multiple states are combined on one Form CMS-2567, as applicable.
CMS is responsible for collecting and combining the information to issue and release the
Form CMS-2567. CMS is responsible for any subsequent enforcement actions.
Complaints with Known CLIA Number Operating Under a Primary Site or Home
Base:
If the SA receives a complaint on a TTS, it should be entered into the CLIA Data
System under the primary site/home base. The complaint is reviewed and triaged.
If a complaint is received and the primary site/home base is not located in the state that
receives the complaint, the information should be forwarded by the SA to CMS. CMS
may request that the SA perform a complaint survey on the TTS in its state. In this case
the SA enters the complaint into the CLIA Data System as a NOCN. 	If the TTS is
performing tests outside the scope of its CLIA certificate (e.g., CoW performing
moderate/high complexity tests), the SA notifies CMS. The SA completes the Form
CMS-2567 for the NOCN laboratory and notifies CMS when it is complete.
Deficiencies in multiple states are combined on one Form CMS-2567, as applicable.
CMS is responsible for collecting and combining the information to issue and release the
Form CMS-2567. CMS is responsible for any subsequent enforcement actions.
5520 - Post Complaint Investigation Actions in Non-Accredited, Non-
Exempt Laboratories
(Rev. 234; Issued: 09-12-25; Effective: 09-12-25; Implementation: 09-12-25)
Following the investigation, the SA records any deficiencies on a Form CMS-2567 and
provides it to the facility. 	Subsequent actions depend on the severity and nature of the
deficiencies cited and the facility’s willingness or ability to correct them.
When deficiencies are identified, the SA initiates actions as follows:
1. 	Condition-Level Deficiencies – Immediate Jeopardy – Certifies
noncompliance and initiates procedures to recommend imposing alternative
and/or principal sanctions. An on-site revisit must be performed before
imposing principal sanctions (i.e., limitation, revocation or suspension of the
CLIA certificate).
When IJ is determined, the SA sends the IJ templates, one for each condition-
level deficiency, to the laboratory (on-site or off-site). See SOM Appendix Q
and SOM Chapter 6 section 6284 for enforcement procedures.
2. 	Condition-Level Deficiencies – No Immediate Jeopardy – If an Allegation
of Compliance (AoC) is not submitted or is not credible – Certifies
noncompliance and initiates procedures to recommend imposing alternative

and/or principal sanctions. An on-site revisit must be performed before
imposing principal sanctions (i.e., limitation, revocation or suspension of the
CLIA certificate). See SOM Chapter 6 section 6286 for enforcement
procedures.
3. 	Standard-Level Deficiencies – Facility Provides an Acceptable Plan of
Correction – Certifies compliance based upon an acceptable Plan of Correction
(PoC) and assembles documentation for CMS to review. See SOM Chapter 6
section 6289.
4. 	Standard-Level Deficiencies – Facility Unable or Unwilling to Provide
Acceptable Plan of Correction – If a laboratory fails to submit an acceptable
PoC, and subsequent requests for an acceptable PoC are unsuccessful, CMS may
initiate principal sanctions against the laboratory certificate. See SOM Chapter 6
section 6289.
No Deficiencies - When no deficiencies are identified, no certification action is required.
5530 - Post Complaint Investigation in Non-Accredited, Non-Exempt
Laboratories Resolution/Closeout
(Rev. 234; Issued: 09-12-25; Effective: 09-12-25; Implementation: 09-12-25)
The SA closes out all complaints with a follow-up notice to the complainant noting the
complaint was substantiated or unsubstantiated. 	The SA should send this notice soon
after the investigation is completed and retain a copy with the complaint record.
Complaints are considered closed when an investigation is complete, and the
complainant is notified.
The SA provides follow-up reports, as necessary, to other appropriate parties such as the
State Medicaid agency and/or initial referring agencies. 	The SA must protect the
anonymity and privacy of the complainant.
The SA inputs the investigation information into the CLIA Data System within 45 days of
the completion of the complaint survey.
1 – Unsubstantiated
The SA indicates “unsubstantiated” in the CLIA Data System. 	If no deficiencies are
found, the SA notifies the complainant via written correspondence that the complaint is
unsubstantiated and sends a Form CMS-2567 to the laboratory stating that it is in
compliance. If deficiencies are found that are either related or not related to the
complaint, the SA sends a Form CMS-2567 to the laboratory with the cited deficiencies
along with a request for PoC or AoC.
2 – Substantiated

The SA logs summary information in the CLIA Data System. The SA enters the
“substantiated” in the complaint into the CLIA Data System. The laboratory will be
charged a fee to cover the cost of the survey if noncompliance is documented.
The SA notifies the complainant via written correspondence (e.g., letter, email) that the
complaint is substantiated. The SA reports substantiated complaints using the Form
CMS-2567 and retains any appropriate supporting documentation.
The SA provides follow-up reports, as necessary, to any other appropriate parties such
as the State Medicaid agency and/or initial referring agencies. 	The SA must protect
the anonymity and privacy of the complainant.
The SA inputs the investigation information into the CLIA Data System within 45 days
of the completion of the complaint survey.
5540 - State Laboratory Licensing Program Laboratory (SLLP)
Complaint Investigations– General
(Rev. 234; Issued: 09-12-25; Effective: 09-12-25; Implementation: 09-12-25)
NOTE: State laboratory licensure program is also referred to as exempt state (ES) or
CLIA-exempt laboratory.
Complaints may be from any source, including verbal, written, electronic or in the media.
Complaints are investigated if they meet the following criteria:
• 	If substantiated, would have an impact on the health and safety of the
general public or individuals served by the laboratory, and
• 	Would raise doubt as to the laboratory's compliance with one or more
CLIA conditions and/or requirements.
An attempt to maintain the anonymity of the complainant should always be made.
There are a number of entities that address laboratory complaints including: CMS, SAs,
SLLPs, and AOs. 	Each of these entities shares a strong interest in ensuring the quality
of patient care and the services provided by laboratories.
When the complaint involves more than one of these entities, CMS should be in
coordination and communication to ensure an effective and timely resolution of the
issue.
5540.1 – Review of State Laboratory Licensing Program Laboratory

Complaints
(Rev. 234; Issued: 09-12-25; Effective: 09-12-25; Implementation: 09-12-25)
Complaints received by CMS:
If CMS receives a complaint against a SLLP laboratory, CMS determines what action
is appropriate. CMS may do any of the following:
• 	Determine the severity of the complaint;
• 	Send the information to the approved State for their action;
• 	May conduct a survey (full or partial);
• 	Investigate the complaint during the course of a validation survey (full survey),
if it is conducted within 45 days of the laboratory’s licensure survey and the
complaint does not present IJ concerns.
NOTE: Transfusion-related fatality investigations must be conducted by CMS within 45
days of the notice from CMS, with notification to CMS when the survey is complete.
They may not be delegated to the approved SLLP; however, the approved SLLP may
accompany CMS on the investigation. In either case, there must be coordination and
communication between CMS and the SLLP. Investigations of transfusion-related
fatalities are generally announced, since the facility is aware of the possibility of a
follow up after the report is made to the FDA. These investigations are an exception to
the general policy that complaint surveys are not announced. However, if the report of
the fatality originates with any other source, e.g., media or anonymous complaint, CMS
conducts an unannounced survey. Where State laws apply to transfusion-related
incidents, the approved SLLP should follow its established procedures and coordinate
with CMS. The SLLP, as appropriate, will receive a copy of the Form CMS-2567 from
CMS when the investigation is complete. See SOM Chapter 6 section 6040.
CMS reviews the approved SLLPs complaint activities as part of the overall annual
review. 	CMS has the discretion to maintain its own complaint tracking system for
complaints that have been forwarded to the approved SLLP. However, this information
should be an integral part of the SLLPs annual review.
Complaints received by State Laboratory Licensing Program:
If the approved SLLP receives a complaint against a SLLP laboratory, the approved
SLLP determines what action is appropriate. 	If the approved SLLP sanctions a SLLP
laboratory in any way (e.g., licensure is withdrawn), it must notify CMS within 30 days.
If the laboratory against which the complaint is alleged is accredited, the SA must also
notify the AO.

5540.2 - Conducting Complaint Investigations and Surveys for State
Laboratory Licensing Program
(Rev. 234; Issued: 09-12-25; Effective: 09-12-25; Implementation: 09-12-25)
Complaints Performed by CMS:
CMS will enter a complaint it performs on a SLLP laboratory in the CLIA Data System.
When an investigation can be conducted via telephone or electronic communication (e.g.,
personnel credentials), CMS should do so. CMS attempts to obtain the following
information for every allegation:
• 	Complainant’s name and address, unless complainant requests anonymity. 	Do
not disclose the identity of the complainant to the laboratory;
• 	Laboratory’s name and address;
• 	CLIA number; and
• 	Description of problem, involving names, places, and dates.
CMS follows the same procedures for control and acknowledgement indicated in
section 5500. Complaints involving potential IJ will be investigated by CMS within
three working days of receipt. Complaints not involving potential IJ are investigated
within 45 days. All complaint surveys are unannounced.
If a laboratory representative refuses to permit a complaint survey, CMS contacts the
SLLP and requests that it contact the laboratory to explain the protocol and, if necessary,
suggest that the SLLP take enforcement action against the SLLP laboratory. 	CMS
conducts the complaint survey in accordance with the outcome-oriented survey process
(OOSP) found in SOM Chapter 6.
Initially, CMS focuses the survey only on the condition(s) or requirement(s) related to the
complaint area(s). If the complaint is substantiated or if additional deficiencies are found
during the course of the investigation, CMS expands the scope of the survey to include
additional standards, conditions, and other CLIA requirements. If the complaint is not
substantiated, CMS notifies the laboratory that it is in compliance with the CLIA
condition(s). CMS also notifies the approved SLLP of the condition-level compliance.
At the exit conference, CMS informs the laboratory of the deficiencies found. If the
deficiencies pose IJ to the health and safety of individuals served by a laboratory or that
of the general public, CMS notifies the approved SLLP and the laboratory within three
working days by electronic mail and includes a copy of the Form CMS-2567. 	CMS
directs the SLLP to take the appropriate enforcement action. CMS follows-up with the
SLLP within 15 working days of its notification to the laboratory to verify that the

enforcement action has either been taken against the laboratory or that the laboratory
has achieved compliance with CLIA requirements.
5550 - State Laboratory Licensing Program Complaint Post-
Investigation Actions
(Rev. 234; Issued: 09-12-25; Effective: 09-12-25; Implementation: 09-12-25)
If the SLLP fails to take appropriate enforcement action for an IJ case within 23 days of
CMS’ notification, and the laboratory has not achieved condition-level compliance,
CMS may either contact the SLLP or attempt other resolution to eliminate the IJ.
If the deficiencies do not pose IJ to the health and safety of individuals served by a
laboratory or that of the general public, CMS prepares a Form CMS-2567 and forwards
a letter along with the Form CMS-2567 to the laboratory and to the SLLP within 10
working days of completing the survey. The SLLP is responsible for taking any
enforcement action, if necessary, monitoring the correction of the deficiencies, and
providing a report to CMS.
CMS completes a Survey Team Composition and Workload Report (Form CMS-670)
for all complaint surveys and related activity.
5560 - State Laboratory Licensing Program Complaint
Resolution/Closeout
(Rev. 234; Issued: 09-12-25; Effective: 09-12-25; Implementation: 09-12-25)
If the SLLP fails to take appropriate enforcement action in non-immediate jeopardy
situations, CMS documents its files accordingly. Failure to take and document the
necessary enforcement action may subsequently jeopardize the current or future approval
of the SLLP.
5570 – Complaint Investigations and Surveys of Accredited
Laboratories
(Rev. 234; Issued: 09-12-25; Effective: 09-12-25; Implementation: 09-12-25)
The statutory basis for conducting surveys of accredited laboratories based on
allegations of noncompliance is found in §353(e)(2)(D) of the Public Health Service
Act (PHSA).
Since AO requirements are equivalent to CLIA requirements at the condition level, a
complaint may affect the laboratory’s accreditation status as well. Complaints are
investigated if they meet the following criteria:
• 	If substantiated, would have an impact on the health and safety of the
general public or individuals served by the laboratory, and

• 	Would raise doubt as to the laboratory's compliance with one or more
CLIA conditions and/or requirements.
CMS should evaluate the complaint and take appropriate investigatory action. Every
effort should be made to secure a written form of the complaint, while maintaining
anonymity, if requested.
All complaint surveys are unannounced and conducted according to OOSP. See SOM
Chapter 6. If an investigation can be conducted by letter, electronic communication, or
telephone, in lieu of an on-site survey, those means should be utilized.
Upon receipt, all complaints are logged and tracked in the same manner as CMS certified
laboratories is collected, monitored and maintained. See section 5500.
5570.1 - CMS Direction of Complaint Investigation of an Accredited
Laboratory
(Rev. 234; Issued: 09-12-25; Effective: 09-12-25; Implementation: 09-12-25)
CMS has primary responsibility for the coordination of all activities involving complaints
relating to an accredited laboratory when a complaint is received by CMS or SA.
If a laboratory representative refuses to permit a complaint survey, the SA should contact
CMS.
Complaints related to an accredited laboratory must be investigated by CMS or SA, as
directed by CMS.
This includes:
• 	Ensuring that all pertinent information concerning the complaint is obtained;
• 	Assessing the level of severity of the complaint;
• 	Determining actions required for investigation;
• 	Determining whether multiple AOs may be involved; and
• 	Informing and coordinating with all affected parties, including AOs, SAs and
CMS when warranted (e.g., in cases potentially involving media coverage,
Federal/State Congressional or political interest, legal intervention, etc.).
Although CMS has the lead role in directing the investigation of complaints involving
accredited laboratories, all affected entities (i.e., SAs, AOs, CMS) share responsibility in
ensuring timely and effective action is taken.

Complaints received by the SA:
If the SA receives an allegation of noncompliance directly from a complainant about
an accredited laboratory, it promptly acknowledges receipt of the complaint and advises
the complainant that it is being forwarded to CMS for action. The SA forwards a copy
of the acknowledgment letter and the complaint to CMS.
Complaints received by CMS:
If the complaint is received directly by CMS, CMS will promptly send a letter to the
complainant acknowledging the complaint and advising the complainant of the intended
course of action.
In either case (complaint received by SA or CMS), CMS evaluates the complaint and has
the lead in determining the course of action. CMS determines whether CMS, the SA, or
the AO, including multiple AOs if circumstances so warrant, will investigate the
complaint. If CMS determines that the AO will investigate the complaint, CMS promptly
sends a letter to the complainant acknowledging the complaint and informing the
complainant to contact the AO with any further questions.
If CMS determines that the SA should investigate the complaint, CMS approves the SA
performing the complaint survey in the CLIA Data System and forwards the complaint
information electronically, including the approval and notifies the AO when the
investigation is complete. If CMS authorizes the SA to perform a full survey (all
specialties and subspecialties covered by the certificate), and the survey can be performed
within 90 days of the AO’s inspection, the survey can be counted in the SA’s validation
workload.
If CMS determines that the complaint involves a potential IJ to the individuals served
by the laboratory, or to the general public, the SA investigates the complaint within
three working days of receiving it from CMS. 	Otherwise, CMS will direct the SA to
investigate non-immediate jeopardy complaints within 45 days and report their findings
to CMS and AO at the conclusion of the survey.
Complaints investigated by AOs:
If CMS determines that the AO should carry out its own investigation, it promptly
forwards the complaint to the AO for immediate attention. 	CMS will request to be
notified of the results of any investigative action taken. CMS will then notify the SA.
NOTE: Transfusion-related fatality investigations must be conducted by CMS or SA
within 45 days of the notice from CMS, with notification to CMS when the survey is
complete. Investigations of transfusion-related fatalities are generally announced, since
the facility is aware of the possibility of a follow up after the report is made to the FDA.
These investigations are an exception to the general policy that complaint surveys are not
announced. However, if the report of the fatality originates with any other source, e.g.,

media or anonymous complaint, the SA or CMS conducts an unannounced survey.
Transfusion-related fatality investigations must not be referred to an AO for action.
However, the AO or multiple AOs, as appropriate, will receive a copy of the Form CMS-
2567 and the accompanying notification letter from CMS when the investigation is
complete. Summary and information from the FDA are considered confidential and may
only be shared within CMS or the SA. 	It may not be shared with any other party,
including AOs. See SOM Chapter 6 section 6040.
Complaints received by AOs:
Complaints received directly by AOs will be investigated under each AO’s own
standards and procedures. If multiple AOs are potentially impacted, the AO receiving
the complaint will promptly inform the other AOs and a determination should be
reached regarding the need for coordinated action. 	In cases potentially involving media
coverage, Federal/State, Congressional or political interest, legal intervention, etc., CMS
should be promptly alerted by the AO receiving the complaint and consulted concerning
appropriate action.
5570.2 - Conducting Complaint Survey of an Accredited Laboratory
by CMS or State Agency
(Rev. 234; Issued: 09-12-25; Effective: 09-12-25; Implementation: 09-12-25)
If an on-site survey is warranted, CMS or SA will conduct an unannounced survey of an
accredited laboratory based on the allegation of noncompliance. CMS or the SA
conducts the complaint survey in accordance with OOSP. See SOM Chapter 6 section
6100-6101.
If the SA is performing the survey, the SA conducts a focused complaint survey, as
instructed by CMS. CMS will approve Form CMS-2802A in the CLIA Data System
prior to the survey. 	If the SA finds additional deficiencies during the course of the
complaint investigation, it may expand the scope of the survey with CMS approval.
At the exit conference, CMS or the SA informs the laboratory director of the
deficiencies found and the procedures to respond to them. 	If deficiencies are found, a
Form CMS-2567 is prepared. The laboratory is informed that the Form CMS-2567
will be made available to the public under the disclosure of survey information
provisions. The surveyor should advise the laboratory that the official report of
deficiencies is Form CMS-2567.
Standard-level deficiencies: If the deficiencies are at the standard-level, a PoC is
requested. However, it is optional for the laboratory to submit a PoC to CMS. For
standard only deficiencies, responsibility rests with the AO to follow up and pursue
corrective action.
Condition-level deficiencies, non-immediate jeopardy: If the deficiencies are at the
condition- level, the laboratory must submit an AoC to CMS. Condition-level

deficiencies must be corrected. CMS or the SA indicates to the laboratory that the Form
CMS-2567 will be forwarded to the laboratory within 10 working days and that the AoC
must be returned to CMS and the SA within 10 calendar days. Upon receipt of the survey
information and AoC, CMS, in coordination with the SA, determines whether or not the
AoC is credible, and if sanctions will be imposed against the laboratory. CMS notifies
the laboratory and AO.
Condition-level deficiencies, immediate jeopardy found: If the deficiencies are at the
condition-level and pose IJ to the health and safety of individuals served by a laboratory,
or to the general public, an AoC is requested. Condition-level deficiencies must be
corrected, so the accredited laboratory must submit an AoC to CMS. CMS or SA
indicates to the laboratory that the Form CMS-2567 will be forwarded to the laboratory
within three working days of the survey exit date and that the credible AoC and evidence
of correction must be submitted to CMS and the SA within 10 calendar days. The IJ
template should be given to the laboratory at the time that IJ is determined (see SOM
Appendix Q). Upon receipt of the survey AoC and evidence, CMS, in coordination with
the SA, determines whether or not the AoC is credible, and if sanctions will be imposed
against the laboratory. CMS notifies the laboratory and AO.
If CMS determines that the deficiencies pose IJ, an IJ template must be given to the
laboratory at the time IJ is determined (on-site or off-site). See SOM Appendix Q.
5570.3 – Forwarding Investigation Report to CMS by the SA
(Rev. 234; Issued: 09-12-25; Effective: 09-12-25; Implementation: 09-12-25)
If non-immediate jeopardy is found, the SA will submit the appropriate information,
including but not limited to, Form CMS-2567, Form CMS-116, Form CMS-209, and
surveyor notes to CMS, or through an update to the CLIA Data System within 45 days of
completing the survey and notifies CMS of the entry. 	If the laboratory chooses not to
submit a PoC when standard-level deficiencies are found, the SA reports any known
information about the laboratory’s efforts to correct deficiencies to CMS and AO. If the
laboratory does not submit an AoC for condition-level noncompliance, the SA should
refer the case to CMS who may begin enforcement actions.
5570.4 - Accredited Laboratory Found in Compliance Following a
Complaint Survey
(Rev. 234; Issued: 09-12-25; Effective: 09-12-25; Implementation: 09-12-25)
If after review of the documentation, CMS determines that the accredited laboratory is
in compliance with all CLIA condition-level requirements, it officially notifies the
laboratory and forwards a copy of this letter to the SA and the AO. This letter advises
that the AO may contact the laboratory about correcting any deficiencies below
condition-level, i.e., standard-level deficiencies only. If no deficiencies are found, a
Form CMS-2567 should be issued stating that the accredited laboratory is in
compliance with CLIA condition-level requirements.

5570.5 - Accredited Laboratory Found Not in Condition-level
Compliance Following a Complaint Survey
(Rev. 234; Issued: 09-12-25; Effective: 09-12-25; Implementation: 09-12-25)
If the deficiencies found pose an IJ to the health and safety of individuals, the SA
prepares the Form CMS-2567, IJ template, and letter notifying the laboratory of the
condition-level noncompliance with IJ and requests an AoC. The SA copies CMS when
notifying the laboratory and requesting an AoC. The Form CMS-2567 is sent to the
laboratory within three working days. CMS will notify the AO and forward the letter
and Form CMS-2567 to the AO when the investigation is complete. Based on the
laboratory’s submitted AoC and evidence of correction, CMS determines if sanctions
are to be imposed against the laboratory.
For condition-level noncompliance that is not IJ, the same process is followed except
the timeline is 10 working days and no IJ template is required.
5580 - Accredited Laboratories Post Investigation Actions
(Rev. 234; Issued: 09-12-25; Effective: 09-12-25; Implementation: 09-12-25)
CMS will notify the AO about a potential CMS enforcement action.
The laboratory continues to be accredited by its AO and retains its CLIA Certificate of
Accreditation. However, it temporarily comes under the jurisdiction of CMS and
becomes subject to the same CLIA requirements, survey, and enforcement procedures
as applied to non-accredited laboratories found out of compliance. The laboratory
remains under the jurisdiction of CMS until either it comes into condition-level
compliance, or the certificate is revoked.
Should the condition-level deficiencies, including an IJ situation, be corrected before the
adverse action is taken or completed, CMS or the SA will advise the laboratory that it will
perform an on-site revisit it to ensure it is in condition-level compliance, and that IJ has
been removed. In all cases of condition-level noncompliance, an on-site revisit will be
performed before the principal sanctions of revocation or suspension are imposed. This
includes, but is not limited to, a credible AoC is not received, or the laboratory does not
submit an AoC. CMS will notify the AO.
5590 - Accredited Laboratories Resolution/Closeout
(Rev. 234; Issued: 09-12-25; Effective: 09-12-25; Implementation: 09-12-25)
The SA will submit the appropriate information to CMS, or through an update to the
CLIA Data System within 45 days of completing the survey and notifies CMS of the
entry. If the laboratory chooses not to submit an AoC when condition-level deficiencies
are found, CMS will notify the AO that the laboratory is out of compliance, and CMS

will move forward with an enforcement action. A copy of all correspondence, as well
as the Form CMS-2567 and AoC, is provided to the AO by CMS. Complaints are
considered closed when referred to an AO by CMS.
CROSSWALK TO THE OLD CHAPTER 5
A crosswalk from sections of the State Operations Manual Chapter Five published 5-
21-2004 to the revised chapter five is as follows:
Name of Old Section 	Old
Section
Number
New
Section
Number
Name of New Section
Management of Complaints and
Incidents
5000 	5000 	Management of Complaints and
Incidents
Intake Process 	5010 	5010 	Intake Process
Triage and Priority Assignment 	5020 	5070 	Priority Assessment for Nursing
Homes, Deemed and Non-Deemed
Providers/Suppliers, and EMTALA
Priority Definitions 	5030 	5075 	Priority Definitions for Nursing
Homes, Deemed and Non-Deemed
Providers/Suppliers, and EMTALA
Investigation Findings and
Reports
5040 	5080 	Investigation Findings and Reports
CMS Regional Office
Responsibility for Monitoring
SA Management of Complaints
and Incidents
5050 	5050 	CMS Location Responsibility for
Monitoring SA Management of
Complaints and Incidents
Aspen Complaints/Incidents
Tracking System (ACTS)
5060 	5060 	ASPEN Complaints/Incidents
Tracking System (ACTS)
Investigation of Complaints
Against Accredited/Deemed
Providers and Suppliers
5100 	5100 	Investigation of Complaints for
Deemed Providers/Suppliers
Basis for Investigation of
Complaints Against
Accredited/Deemed Providers
and Suppliers
5110 	5100.1 	Basis for Investigation
RO Direction of Accredited
Hospital Complaint Investigation
5120 	5210 	Processing of Complaints
Originating with or Investigated by
CMS Location
Conducting an Accredited
Hospital Complaint Validation
Survey
5130 	5050 	CMS Location Responsibility for
Monitoring SA Management of
Complaints and Incidents
Forwarding Investigation Report
to RO
5140 	5050 	CMS Location Responsibility for
Monitoring 	SA 	Management 	of
Complaints and Incidents
Accredited Hospital Found in
Compliance Following
Complaint Validation Survey
5150 	5100 	Investigation of Complaints for
Deemed Providers/Suppliers

Accredited Hospital Found Not
in Compliance Following
Complaint Validation Survey
5160 	5100 	Investigation of Complaints for
Deemed Providers/Suppliers
Reinstatement to Accreditation
Organization Jurisdiction
5170 	5100.2 	Post-Survey Procedures
Termination of Accredited
Hospital
5180 	5100.2 	Post-Survey Procedures
Investigating Complaints
Involving ESRD Services
Provided by Accredited
Hospitals
5190 	5160 	Investigating Complaints Involving
ESRD Services Provided by
Deemed Hospitals
Investigation of Complaints
Against Other Than
Accredited/Deemed Providers
and Suppliers
5200 	5200 	Investigating Complaints for Non-
Deemed Providers/Suppliers,
Excluding Nursing Homes
SA Processing of General,
Certification-Related Complaints
5210 	5010 	General Intake Process
Hospital Restraints/Seclusion
Death Reporting and
Investigation
5240 	5140 	Hospital Restraints/Seclusion
Death Reporting and Investigation
Complaints Involving HIV-
Infected Individuals
5250 	5150 	Complaints Involving HIV-
Infected Individuals
Investigations Involving Alleged
EMTALA Violations
5300-
5400
5400-
5500
Investigations Involving Alleged
EMTALA Violations
Complaints Involving
Unaccredited Laboratories
5500-
5590
5500-
5590
Complaints Involving
Unaccredited Laboratories

Chapter Five State Operations Manual
Acronyms
(Rev. 243; Issued: 06-12-26)
ACTS 	ASPEN Complaint Tracking System
AIDS 	Auto-immune deficiency syndrome
AO 	Accreditation Organization
the ACT 	Social Security Act
CFC 	Conditions for Coverage
CFR 	Code of Federal Regulations
CLIA 	Clinical Laboratory Improvement Amendments
CMP 	Civil Monetary Penalties
CMS 	Center for Medicare and Medicaid Services
CO 	Central Office
CoP 	Conditions of Participation
COW 	Certificate of Waiver
DED 	Dedicated Emergency Department
DHHS 	Department of Health and Human Services
EMS 	Emergency Medical System
EMTALA 	Emergency Medical Treatment and Labor Act
ESRD 	End-Stage Renal Disease
FDA 	Food and Drug Administration

HHA 	Home Health Agency
HIV 	Human Immunodeficiency Virus
IJ 	Immediate Jeopardy
iQIES 	Internet Quality Improvement & Evaluation System
JCAHO 	Joint Commission on Accreditation of Healthcare Organizations
LSC 	Life Safety Code
NF 	Nursing Facility
NW 	Networks
OCR 	Office of Civil Rights
OIG 	Office of Inspector General
OSHA 	Occupational Safety and Health Administration
P & A 	Protection and Advocacy Group
PHSA 	Public Health Service Act
POC 	Plan of Correction
PPM 	Provider Perform Microscopy (PPM) Procedures
PRTF 	Psychiatric Residential Treatment Facility
QIO 	Quality Improvement Organization
RFP 	Requirements for Participation
RNHCI 	Religious Non-Medical Health Care Institutions
RO 	Regional Office
SA 	State Agency
SMA 	State Medicaid Agency
SNF 	Skilled Nursing Facility

SOM 	State Operations Manual
USC 	United States Code