Attachment 1
An allegation is an assertion of improper care or treatment against a Medicare, Medicaid or CLIA participating program that could result in the citation of a Federal deficiency. The point of receipt of the allegation is a critical fact-finding and decision-making point. Information regarding the care, treatment and services provided to beneficiaries can come from a variety of sources and in a number of formats. Allegations may come directly from beneficiaries themselves, beneficiaries' family members, health care providers, concerned citizens, public agencies, or in published or broadcast media reports. Report sources may be verbal or written. In some instances, the complainant may request anonymity.
Information To Collect From Complainant
To the extent possible, the SA captures complete information necessary to make important decisions about the allegations. In instances where written allegations are received, either subsequent verbal and/or written communication may be necessary to obtain comprehensive information. In the case of allegations received verbally (telephone or face-to-face meetings), an important opportunity exists to obtain complete information to assist with the decision-making and investigative processes.
Comprehensive information should be collected during the intake process to allow for proper triage to occur. This information includes the following:
Information To Provide To
Complainant
An effective complaint intake process provides information to assist the complainant in resolving his/her conflicts. The information provided to the complainant may be communicated verbally during initial or subsequent telephone discussions or through written correspondence when acknowledging receipt of the allegation. In either case, the following elements, at a minimum, are provided as part of the intake:
A complaint is a report made to the SA or RO by anyone other than the administrator or authorized official for a provider or supplier that alleges noncompliance with Federal and/or State laws and regulations. If, based on the intake information received, the SA determines that the allegation(s) falls within the authority of the SA, the SA triages the intake to determine 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 each complaint. This structure needs to include response time lines and an orderly process to document actions taken by the SA in responding to every allegation. If a State’s triage 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 time frames. The SA is expected to be able to share the logic and rationale that was utilized in triage and prioritization of the allegation for investigation. The SA response must be designed to protect the health and safety of all residents, patients and clients.
An assessment of each intake must be made by an individual who is professionally qualified to evaluate the nature of the problem based upon his/her knowledge of current clinical standards of practice and Federal requirements. In situations where a determination is made that immediate jeopardy may be present and ongoing, the SA is required to investigate within two working days of receipt of the information. For all non-immediate jeopardy situations, the complaint/incident is to be prioritized within two working days of its receipt, unless there are extenuating circumstances that impede the collection of relevant information. There are circumstances when a provider/supplier is required to report information to the SA. This is defined as an incident - an official notification to the SA or RO from a self-reporting provider or supplier (i.e., the administrator or authorized official for the provider or supplier), or from a separate agency that is providing information about a provider or supplier. The reported incident intake is prioritized after sufficient information is gathered and evaluated. The SA response is expected to protect the health and safety of all residents, patients and clients.
An investigation is a review to determine if a deficient practice is or was present, and to assess the degree of harm to any resident(s), patient(s) or client(s). To assist in planning the investigation, the SA reviews any information about the provider that would be helpful to know. This may include the provider’s compliance history, the provider's quality indicators, 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. For non-deemed providers and suppliers, CMS expects the SA to investigate allegations of violations of the Federal participation requirements.
For deemed providers and suppliers, if the SA receives a substantial allegation of noncompliance, an appropriate investigation is initiated, if one is warranted, once RO approval has been obtained. (In 1997 CMS, then HCFA, issued “Guidelines for Complaint Investigation.” These guidelines continue to serve as a generic, supplementary document to assist SAs with investigative protocols.)
Generally,
allegations about nonrecurring events that occurred more than twelve months
prior to the intake date will not require the SA to conduct an
investigation. However, the SA is not
precluded from conducting an investigation to determine current compliance
status based on concerns identified during the intake or triage process. More specifically for nursing homes, if there
is sufficient evidence that the facility does not have continuing
noncompliance, as evidenced by a systemic problem, and the intake reported
relates to an event that occurred before the last standard survey, an onsite
survey may not be required.
PRIORITY DEFINITIONS
Immediate Jeopardy - Section 42 CFR 489.3 defines 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." Intakes are assigned this priority if the intake information indicates immediate corrective action is necessary because a provider’s or supplier’s alleged noncompliance with one or more conditions or requirements may have caused, or is likely to cause, serious injury, harm, impairment or death to a resident, patient or client. Immediate jeopardy, immediate and serious threat, and serious and immediate threat are interchangeable terms.
In situations where a determination is made that immediate jeopardy may be present and ongoing, the SA is required to investigate within two working days of receipt of the information except: 1) For all Medicare deemed providers/suppliers complaint and incident intakes, the SA investigates a complaint within two working days of receipt of the Form CMS-2802, Request for Validation of Accreditation Survey, from the RO if the RO determines that the complaint involves potential immediate jeopardy to patient health and safety; 2) For hospital EMTALA complaints, the investigation is completed within five working days after receipt of the authorization from the RO; 3) For restraint/seclusion death reports, the SA completes the investigation within five working days of receipt of telephone authorization from the RO. (Appendix Q of the State Operations Manual (SOM) contains the Guidelines for Determining Immediate Jeopardy.)
Non-Immediate Jeopardy - High – (harm that impairs mental, physical and/or psychosocial status) Intakes are assigned this priority if a provider’s or supplier’s alleged noncompliance with one or more requirements or conditions may have caused harm that negatively impacts the individual’s mental, physical and/or psychosocial status and is 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.
Regarding allegations pertaining to residents in nursing homes, if the SA makes the determination that a higher level of actual harm may be present, the investigation is to be initiated within 10 working days of its receipt. The initiation of these types of investigations is generally defined as the SA beginning an onsite survey. It is often difficult to distinguish between those allegations that would require an investigation within two working days (immediate jeopardy) from those that would require an investigation within 10 working days (higher level of actual harm). The following are some examples of allegations that indicate that a higher level of actual harm may be present:
Attachment 2 describes examples to assist the SAs in distinguishing between the priorities of Immediate Jeopardy and Non-Immediate Jeopardy - High.
Non-Immediate Jeopardy - Medium – (harm or potential of more than minimal harm that does not significantly impair mental, physical and/or psychosocial status) Intakes are assigned this priority if a provider’s or supplier’s alleged noncompliance with one or more requirements or conditions has caused or may cause harm that is of limited consequence and does not significantly impair the individual’s mental, physical and/or psychosocial status to function. An onsite survey should be scheduled to review these intakes.
Non-EMTALA, and non-immediate jeopardy complaints for providers/suppliers with deemed status require an onsite survey within 45 calendar days after approval by the RO.
Non-Immediate Jeopardy – Low (discomfort) Intakes
are assigned this priority if a provider’s or supplier’s alleged noncompliance
with one or more requirements or conditions may have caused physical, mental
and/or psychosocial discomfort that does not constitute injury or damage. An onsite investigation may not be scheduled,
but the allegation would be reviewed at the next onsite survey.
Administrative Review/Offsite Investigation - This priority is used for complaint and incident intakes triaged as not needing an onsite investigation. However, further investigative action (written/verbal communication or documentation) initiated by the SA or RO to the provider is gathered and the additional information is adequate in scope and depth to determine that an onsite investigation is not necessary; however, the SA has the discretion to review the information at the next onsite survey.
Referral – Immediate - Complaints/incidents
are assigned this priority if the seriousness of a complaint/incident and/or
State procedures requires referral or reporting to another agency, board, or
network without delay for investigation.
Referral – Other - Complaints/incidents assigned this priority indicate referral to another agency, board, or network for investigation or for informational purposes.
When the SA refers the complaint 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. Regardless of who conducts the investigation,
the SA has the responsibility to assess the provider’s or supplier’s compliance
with Federal conditions or requirements and the time frames for investigation
are not altered by the referral to another agency. (Expressed requests by law enforcement that
the SA defer an onsite investigation would be discussed with the CMS RO, as
appropriate.)
No action necessary - Adequate information has been received about the complaint or incident intake such that the SA can determine with certainty that no further investigation, analysis, or action is necessary.
For all cases except EMTALA, that do not allege immediate
jeopardy, and at the SAs discretion an intake may not require a new onsite
investigation if, at a previously completed survey, the same events were
investigated; the previously completed survey evaluated the appropriate
individuals, including those identified in the intake; and the situation did
not worsen.
INVESTIGATION FINDINGS AND REPORTS
Each SA establishes reporting policies, procedures and formats including report language targeted to specific audiences. The SA/RO provides the complainant and the investigated provider 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:
ADDITIONAL INSTRUCTIONS
For Deemed Providers and Suppliers
Before the SA
conducts a complaint investigation survey against an accredited hospital or
deemed provider/supplier, it must receive authorization from the RO. It is the RO's responsibility to determine
whether the complaint alleges one or more Condition-levels of
non-compliance. If the complaint
identifies one or more Condition-levels of non-compliance, the RO must
authorize the complaint investigation by completing the applicable CMS-2802. If the RO does not authorize the complaint
investigation, the SA may conduct a complaint investigation should it determine
that the accredited hospital or deemed provider/supplier is non-compliant with
its State regulations (i.e., State licensure laws). RO authorization is not required when the
SA's basis for conducting the complaint investigation is related to a State
regulation.
The RO must forward a
completed CMS-2802 to the SA via ACTS even when the SA received an initial
verbal authorization from the RO to initiate the complaint validation survey of
a deemed provider/supplier. Since ACTS
allows the RO to authorize a complaint validation survey electronically by
completing the RO Signature box on the deemed tab, it is not required to send a
signed hard copy of the CMS-2802 to the SA via fax or US Postal Mail. Once the SA receives the authorization
through ACTS it may begin its complaint investigation of an accredited hospital
or 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 is
the basis for the survey.
CMS Regional Office Responsibility
CMS ROs 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 State Operations Manual (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 ROs should accept State requirements that meet or exceed the intent of the Federal requirements. However, 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 ACTS.
State Operations Manual References
This guidance supports data entry into ACTS and supplements existing procedures contained in the SOM in Chapter 3 and in Chapter 7 and Appendix P for nursing homes. There are different procedures for conducting complaint investigations for deemed and non-deemed facilities. The SAs and ROs follow the procedures outlined in the SOM at §§3280-3298 for non-deemed providers/suppliers, at §§3260-3276 for deemed provider/suppliers and at §§3400-3413 for EMTALA.
Data Entry
From the effective date of this memorandum to the effective date for full implementation of ACTS, SAs must continue to upload data to the OSCAR Complaint System either by using the Quick Entry 562 feature in ACTS or by entering all intake and investigation information in ACTS.
ACTS must be used for the intake of all allegations received on or after January 1, 2004 for skilled nursing facilities, nursing facilities, home health agencies, end stage renal disease facilities, hospitals, suppliers of portable X-ray services, providers of outpatient physical therapy or speech pathology services, rural health clinics, and comprehensive outpatient rehabilitation facilities. 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.
SAs and ROs are required to enter into ACTS:
The information is entered into ACTS regardless of the entity within a State carrying out this function. The information recorded in ACTS reflects the facts furnished by the complainant at the time of the intake. 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, at a minimum.
Where 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 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.
Attachment 3 defines the required fields in ACTS.