F658
(Rev. 229; Issued: 04-25-25; Effective: 04-25-25; Implementation: 04-28-25) 
§483.21(b)(3) Comprehensive Care Plans
The services provided or arranged by the facility, as outlined by the comprehensive care plan, must—
    (i) Meet professional standards of quality.

INTENT §483.21(b)(3)(i)
To assure that ALL services, as outlined by the comprehensive care plan, being provided meet professional standards of quality.
 

GUIDANCE §483.21(b)(3)(i)
“Professional standards of quality” means that care and all services are provided according to accepted standards of clinical practice. Standards may apply to care provided by a particular clinical discipline or in a specific clinical situation or setting. Standards regarding quality care practices may be published by a professional organization, licensing board, accreditation body or other regulatory agency. Recommended practices to achieve desired resident outcomes may also be found in clinical literature. Possible reference sources for standards of practice include:
    • Current manuals or textbooks on nursing, social work, physical therapy, etc.
    • Standards published by professional organizations such as the American Dietetic Association, American Medical Association, American Medical Directors Association, American Nurses Association, National Association of Activity Professionals, National Association of Social Work, etc.
    • Clinical practice guidelines published by the Agency for Healthcare Research and Quality.
    • Current professional journal articles.
 

Although Federal requirements dictate the completion of RAI assessments according to certain time frames, standards of good clinical practice dictate that the clinical assessment process is more fluid and should be ongoing. The lack of ongoing clinical assessment and identification of changes in condition, to meet the resident’s needs between required RAI assessments should be addressed at §483.35 Nursing Services, F726 (competency and skills to identify and address a change in condition), and the relevant outcome tag, such as §483.12 Abuse, §483.24 Quality of Life, §483.25 Quality of Care, and/or §483.40 Behavioral Health.
 

Mental Disorders are diagnosed by a practitioner, using evidence-based criteria and
professional standards, such as the current version of the Diagnostic and Statistical Manual
of Mental Disorders (DSM), and are supported by documentation in the resident’s medical
record. Supporting documentation should include, but is not limited to, evaluation of the
resident’s physical, behavioral, mental, psychosocial status, and comorbid conditions,
ruling out physiological effects of a substance (e.g., medication or drugs) or other
medical conditions, indications of distress, changes in functional status, resident
complaints, behaviors, symptoms, and/or state Preadmission Screening and Resident
Review (PASARR) evaluation.

Examples of insufficient documentation to support a mental health diagnosis would
include:
    • A situation where schizophrenia or another diagnosis is only mentioned as an
indication in medication orders without supporting documentation.
    • The addition of, or request by the facility to a practitioner for, a diagnosis of
schizophrenia or another diagnosis without documentation supporting the
diagnosis.
    • A practitioner’s note or transfer summary from a previous provider stating
“history of schizophrenia,” “schizophrenia,” or another diagnosis without
supporting documentation confirming the diagnosis with a previous practitioner
or family, and the facility failed to to provide evidence that a practitioner
conducted a comprehensive evaluation after admission.
    • A diagnosis list stating schizophrenia or another diagnosis without supporting
documentation.
    • A note of schizophrenia or another diagnosis in an electronic health record
(EHR) without supporting documentation which populates throughout the EHR.
    • A note of schizophrenia or another diagnosis in the medical record by a nurse
without supporting documentation by the practitoner.

Insufficient documentation for a new mental health diagnosis means that the resident’s
medical record does not contain the following:
    • Documentation (e.g., nurses’ notes) indicating the resident has had symptoms,
disturbances, or behaviors consistent with those listed in the DSM criteria, and
for the period of time in accordance with the DSM criteria.
    • Documentation from the diagnosing practitioner indicating that the diagnosis was
given based on a comprehensive assessment, such as notes from a practitioner’s
visit.
    • Documentation from the diagnosing practitioner indicating that the symptons,
disturbances, or behaviors are not attributable to (i.e., ruled out) the effects of a
substance (e.g., a drug of abuse, a medication) or another medical condition
(e.g., UTI or high ammonia levels).
    • Documentation regarding the effect the disturbance is having on the resident’s
function, such as interpersonal relationships, or self-care, in comparison to their
level of function prior to the onset of disturbance.

The medical record must include documentation of ALL of these items, if not, this would
constitute insufficient documentation.

CMS is aware of situations where residents are given a diagnois of schizophrenia without
sufficient supporting documentation that meets the criteria in the current version of the
DSM for diagnosing schizophrenia. For these situations, determine if non-compliance
exists related to the practitioner not adhering to professional standards of practice for
assessing and diagnosing a resident.

Surveyors should investigate this concern through record review and interviews with the
practitioner(s), facility medical director, and other appropriate nursing home staff, as
well as consult with the state agency medical director as needed. Surveyors are not
questioning the practitioner’s medical judgement, but rather, they are evaluating whether
the medical record contains supporting documentation for the diagnosis to verify the
accuracy of the resident assessment.

If the facility is unable to provide practitioner documentation which supports the new
psychiatric diagnosis in question, then non-compliance exists. For example, if a new
diagnosis of schizophrenia is noted in the medical record, the surveyor should verify the
documentation supports the use of accepted standards of practice (e.g. current DSM
criteria) for the diagnosis.

Below are excerpts from the DSM (current as of the date of this publication) which
describe diagnostic criteria for schizophrenia, schizophreniform disorder, and
schizoaffective disorder. This list is not all-inclusive and should not be used as a checklist
but rather as a guide when reviewing supporting documentation.

SCHIZOPHRENIA

Diagnostic Criteria
A. Two (or more) of the following, each present for a significant portion of time during a
1-month period (or less if successfully treated). At least one of these must be (1), (2), or
(3):
    1. Delusions.
    2. Hallucinations.
    3. Disorganized speech (e.g., frequent derailment or incoherence).
    4. Grossly disorganized or catatonic behavior.
    5. Negative symptoms (i.e., diminished emotional expression or avolition).

B. For a significant portion of the time since the onset of the disturbance, level of
functioning in one or more major areas, such as work, interpersonal relations, or selfcare,
is markedly below the level achieved prior to the onset (or when the onset is in
childhood or adolescence, there is failure to achieve expected level of interpersonal,
academic, or occupational functioning).

C. Continuous signs of the disturbance persist for at least 6 months. This 6-month period
must include at least 1 month of symptoms (or less if successfully treated) that meet
Criterion A (i.e., active-phase symptoms) and may include periods of prodromal or
residual symptoms. During these prodromal or residual periods, the signs of the
disturbance may be manifested by only negative symptoms or by two or more symptoms
listed in Criterion A present in an attenuated form (e.g., odd beliefs, unusual perceptual
experiences).

D. Schizoaffective disorder and depressive or bipolar disorder with psychotic features
have been ruled out because either 1) no major depressive or manic episodes have
occurred concurrently with the active-phase symptoms, or 2) if mood episodes have
occurred during active-phase symptoms, they have been present for a minority of the
total duration of the active and residual periods of the illness.

E. The disturbance is not attributable to the physiological effects of a substance (e.g., a
drug of abuse, a medication) or another medical condition.

F. If there is a history of autism spectrum disorder or a communication disorder of
childhood onset, the additional diagnosis of schizophrenia is made only if prominent
delusions or hallucinations, in addition to the other required symptoms of schizophrenia,
are also present for at least 1 month (or less successfully treated).

SCHIZOPHRENIFORM
Schizophreniform disorder is characterized by a symptomatic presentation equivalent to
that of schizophrenia except for its duration (less than 6 months) and the absence of a
requirement for a decline in functioning.

Diagnostic Criteria
A. Two (or more) of the following, each present for a significant portion of time during a
1-month period (or less if successfully treated). At least one of these must be (1), (2), or
(3):
    1. Delusions.
     2. Hallucinations.
    3. Disorganized speech (e.g., frequent derailment or incoherence).
    4. Grossly disorganized or catatonic behavior.
    5. Negative symptoms (i.e., diminished emotional expression or avolition).
B. An episode of the disorder lasts at least 1 month but less than 6 months. When the
diagnosis must be made without waiting for recovery, it should be qualified as
“provisional.”
C. Schizoaffective disorder and depressive or bipolar disorder with psychotic features
have been ruled out because either 1) no major depressive or manic episodes have
occurred concurrently with the active-phase symptoms, or 2) if mood episodes have
occurred during active-phase symptoms, they have been present for a minority of the
total duration of the active and residual periods of the illness.
D. The disturbance is not attributable to the physiological effects of a substance (e.g., a
drug of abuse, a medication) or another medical condition.

SCHIZOAFFECTIVE DISORDER

Diagnostic Criteria
A. An interrupted period of illness during which there is a major mood episode (major
depressive or manic) concurrent with Criterion A of schizophrenia.
    Note: The major depressive episode must include Criterion A1: Depressed mood.
B. Delusions or hallucinations for 2 or more weeks in the absence of a major mood
episode (depressive or manic) during the lifetime duration of the illness.
C. Symptoms that meet criteria for a major mood episode are present for the majority of
the total duration of the active and residual portions of the illness.
D. The disturbance is not attributable to the effects of a substance (e.g., a drug of abuse,
a medication) or another medical condition.

When residents are admitted to the facility with a mental health diagnosis, supporting
documentation should include, but is not limited to:
    • The PASARR evaluation and determination report from the State Mental Health
Authority;
    • Facility attempts to obtain documentation regarding the mental health diagnosis
from the previous provider(s);
    • Validation of the resident’s mental health diagnosis by the practitioner in
accordance with professional standards of practice, such as reviewing
information available in the medical record, including information from the
previous provider(s), discussions about the diagnosis and history with the
resident or resident representative, conducting a comprehensive evaluation, the
need for a psychiatric or other consultations if necessary, and their determination of the resident's diagnosis. 

INVESTIGATIVE PROCEDURES
There is no requirement for the surveyor to cite a reference or source (e.g., current textbooks, professional organizations or clinical practice guidelines) for the standard of practice that has not been followed related to care and services provided within
professional scopes of practice, such as failure of nursing staff to assess a change in the resident’s condition. However, in cases where the facility provides a reference supporting a particular standard of practice for which the surveyor has concerns, the surveyor must provide evidence that the standard of practice the facility is using is not up-to-date, widely accepted, or supported by recent clinical literature. Such evidence
should include a citation for the reference or source (e.g., current textbooks, professional organizations or clinical practice guidelines) for the current standard of practice from
which facility deviated.
 

If a negative or potentially negative resident outcome is determined to be related to the facility’s failure to meet professional standards and the team determines a deficiency has occurred, it should also be cited under the appropriate quality of care or other relevant requirement. For example, if a resident develops a pressure injury because the facility’s
nursing staff failed to provide care in accordance with professional standards of quality, the team should cite the deficiency at both F658 and F686 (Skin Integrity).
 

PROBES
• Do the services provided or arranged by the facility, as outlined in the comprehensive care plan, reflect accepted standards of practice?
• Are the references for standards of practice, used by the facility and/or physician, up to date, and accurate for the service being delivered?
• Does the documentation show how the physician arrived at the diagnosis based on the DSM criteria? For example, for a new diagnosis of schizophrenia, does the medical record contain notes (e.g., from nursing or medical providers) of
symptoms or behaviors consistent with the symptoms from criterion A, and for the period of time in criterion C as listed in the DSM?
• Is there documentation of a physician's visit assessing the resident and concluding a diagnosis of schizophrenia?
 

The following questions may be used to assist the surveyor in discussing a resident’s diagnosis with a physician:
• Who established the mental health diagnosis?
• How did you arrive at the diagnosis according to standards of practice (DSM), and where is this documented? (Documentation should include information on the DSM criteria specified above such as symptoms and behaviors and their duration.)
• Were other underlying conditions excluded, such as medical or psychiatric conditions, progression of an existing condition such as dementia, medication side effects, delirium, etc., prior to diagnosing the resident with schizophrenia?
 

DEFICIENCY CATEGORIZATION
If the surveyor identifies a pattern (e.g., three or more) of residents who have a new diagnosis which lacks sufficient supporting documentation, the surveyor should cite the
scope of the non-compliance at a minimum scope of pattern (e.g., level 2 = "E," Level 3 = "H," or Level 4 = "K"), Additionally, the surveyor should discuss the findings with their state agency to consider referringl a physician, nurse practitioner, clinical nurse specialist, or physician assistant to their respective state board (e.g., state medical board, state nursing board, etc.).
 

A medical record which lacks sufficient documentation, such as a comprehensive evaluation and behavioral documentation, to support a new diagnosis of schizophrenia by a practitioner would represent non-compliance at F658. If the resident is receiving an antipsychotic medication and experienced negative side effects, evaluate compliance with other requirements such as F605. For example:
• While receiving the antipsychotic medication, the resident withdrew from social activities because of difficulty concentrating and carrying on conversations and spends their day isolated in their room, or engages minimally with staff and their family since starting the antipsychotic medication. A lack of documentation to
support a practitioner’s diagnosis of schizoaffective disorder and the use of an antipsychotic medication without an adequate clinical indication represents Immediate Jeopardy at F658 and F605.
• Because of a practitioner diagnosed schizophrenia in a resident (without supporting documentation), the facility did not attempt a gradual dose reduction (GDR) or demonstrate the GDR was contraindicated. There was no indication of a change in the resident’s behavior or function,but the potential for more than minimal harm exists. Therefore, use of the antipsychotic medication without a gradual dose reduction unless contraindicated an adequate clinical indication
and lack of documentation to support the diagnosis would be Level 2 at F658 and F605.
• A resident was diagnosed with schizophrenia after admission to the nursing home and an antipsychotic medication was initiated for agitation and aggressive behaviors. The resident had no prior history of schizophrenia and the medical
record did not contain a comprehensive evaluation to support the new schizophrenia diagnosis by the practitioner and the symptoms for which the antipsychotic was prescribed did not align with schizophrenia symptoms. The medical record demonstrated failed attempts of non-pharmacological
interventions, appropriate monitoring of the antipsychotic medication and an attempted gradual dose reduction. The lack of documentation to support the schizophrenia diagnosis represents level 2 noncompliance at F658 only.
 

When concerns related to a diagnosis of a resident which lacks sufficient supporting documentation are identified, surveyors should also review:
    • F605: to evaluate administration of psychotropic medications based on a comprehensive assessment.
    • F641: to determine if the facility completed an assessment which accurately reflects the resident’s status.
    • F644: to determine if the facility made a referral to the state designated authority when a newly evident or possible serious mental disorder was identified (PASARR).
    • F841: to evaluate the medical director’s oversight of medical care.
 

Surveyors should consider other tags as appropriate depending on the outcome to the resident.

KEY ELEMENTS OF NONCOMPLIANCE:
To cite deficient practice at F658, the surveyor's investigation will generally show that the facility did one or more of the following:
    • Provided or arranged for services or care (including diagnosing a resident) that did not adhere to accepted standards of quality;
    • Provided a service or care when the accepted standards of quality dictate that the service or care should not have been provided;
    • Failed to provide or arrange for services or care that accepted standards of quality dictate should have been provided