F0605 F605: Prevent the use of unnecessary psychotropic medications or use medications that may restrain a resident's ability to function.
J

Improper Use of Chemical Restraints with Haldol Administration

The Gables Of Pelham Skilled Nursing & RehabGreenville, South Carolina Survey Completed on 02-10-2025

Summary

The facility failed to ensure that a resident was free from chemical restraints, as evidenced by the administration of Haloperidol Deaconate (Haldol) to a resident for exit-seeking behavior and entering patient rooms. The medication was not ordered for an approved indication of use, and the facility did not have systems in place to monitor for chemical restraints. The resident, who was admitted with diagnoses including Alzheimer's disease, type 2 diabetes, chronic obstructive pulmonary disease, and anemia, was given Haldol without a proper diagnosis or monitoring for adverse effects or behaviors. The resident's physician orders included an order for Haldol Deaconate 10 mg intramuscularly as needed for agitation, with a frequency that exceeded the usual recommendation. The medication was administered multiple times over a 17-day period without proper monitoring. Interviews with the Director of Nursing (DON) and the Nurse Practitioner (NP) revealed a lack of awareness and communication regarding the medication's intended use and the necessary diagnosis. The NP confirmed that the wrong medication was given and that the order was intended as a one-time dose only. Further investigation revealed that the pharmacy made a transcription error, leading to the incorrect administration of the medication. The facility's policy on the use of restraints was not followed, and there was a failure to obtain proper consents for psychotropic medications. The facility's systems for monitoring and documenting medication administration and side effects were inadequate, contributing to the deficiency.

Removal Plan

  • The DON, MDS or Designee conducted an audit of residents to identify those residents with potential risk for chemical restraints.
  • The DON, MDS Nurse, Administrator or Designee will conduct nurse and or provider in-service education of Guardian Pharmacy Psychotropic PRN Medication Regulation in LTC and medication Monitoring Management - Policy regarding F758 Psychotropic Medication and PRN use.
  • The Director of MDS Nurse, Administrator or designee will conduct nurse inservice education on (6) rights of Medication Administration.
  • The Director of MDS Nurse, Administrator or designee will conduct in-service/education on AASC Agitation in Alzheimer's Screener for Caregivers.
  • The Director of MDS Nurse, Administrator or designee will conduct in-service/education on Policy for Medication Variance Report.
  • The Director of MDS Nurse, Administrator or designee will conduct in-service/education on New Order Tracking Form.
  • The Director of MDS Nurse, Administrator or designee will conduct in-service/education on CMS Revises Several Regulations in Appendix PP- Chemical Restraints/Unnecessary Psychotropic Medications.

Penalty

Inspection fine: $17,225
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The penalty, as released by CMS, applies to the entire inspection this citation is part of, covering all citations and f-tags issued, not just this specific f-tag. For the complete original report, please refer to the 'Details' section.

Resources

Below are regulatory guidelines relevant to this citation:

See other F0605 citations
Failure to Assess and Monitor Antipsychotic Use
D
F0605 F605: Prevent the use of unnecessary psychotropic medications or use medications that may restrain a resident's ability to function.
Short Summary

Failure to Assess and Monitor Antipsychotic Use: A resident with severe cognitive impairment, dementia, anxiety, and mood disorder received Risperidone for agitation and paranoia, but the EMR did not show an AIMS assessment on admission or timely target behavior monitoring. The RN case manager and DON confirmed that baseline AIMS and ongoing behavior monitoring should have been in place when the antipsychotic was started, but the resident’s record lacked measurable target behaviors and documentation of medication effectiveness.

No penalty information released
tooltip icon
The penalty, as released by CMS, applies to the entire inspection this citation is part of, covering all citations and f-tags issued, not just this specific f-tag. For the complete original report, please refer to the 'Details' section.
Failure to Limit and Re‑Evaluate PRN Psychotropic Medications
D
F0605 F605: Prevent the use of unnecessary psychotropic medications or use medications that may restrain a resident's ability to function.
Short Summary

Two residents receiving PRN anti‑anxiety medications were not protected from potential chemical restraints when PRN lorazepam/Ativan orders lacked required 14‑day stop dates and physician re‑evaluation. One resident with schizoaffective disorder, dementia, and anxiety had a PRN Ativan order without a stop date that was administered multiple times over several months. Another resident with metabolic encephalopathy, heart failure, and peripheral vascular disease had a PRN lorazepam order without a stop date that was still being administered weeks later, with no documented physician reassessment. The DON confirmed that these PRN psychotropic orders should have included 14‑day limitations but did not.

No penalty information released
tooltip icon
The penalty, as released by CMS, applies to the entire inspection this citation is part of, covering all citations and f-tags issued, not just this specific f-tag. For the complete original report, please refer to the 'Details' section.
Failure to Perform Regular GDR and Limit PRN Antipsychotic Orders
E
F0605 F605: Prevent the use of unnecessary psychotropic medications or use medications that may restrain a resident's ability to function.
Short Summary

Surveyors determined that the facility failed to consistently manage psychotropic medications for three residents. Two residents with dementia and psychiatric conditions had only one documented psychotropic medication review and gradual dose reduction (GDR) attempt, completed in January, with no evidence of quarterly reviews or additional GDR efforts. Another resident with hemiplegia, psychotic disorder, dementia, and major depressive disorder had a PRN IM haloperidol order written without an end date, which remained active and was administered on multiple occasions beyond 14 days, and the DON confirmed there was no physician documentation justifying the extended PRN antipsychotic order.

No penalty information released
tooltip icon
The penalty, as released by CMS, applies to the entire inspection this citation is part of, covering all citations and f-tags issued, not just this specific f-tag. For the complete original report, please refer to the 'Details' section.
Inadequate Indication for Antipsychotic Use Resulting in Chemical Restraint
D
F0605 F605: Prevent the use of unnecessary psychotropic medications or use medications that may restrain a resident's ability to function.
Short Summary

A resident with moderate dementia and severe cognitive impairment, but no documented psychosis or behavioral symptoms, was started on Zyprexa (olanzapine) 10 mg at bedtime after a mental health NP changed her medication regimen. Physician orders listed varying indications for the antipsychotic, including depression, unspecified psychosis, anxiety, and bipolar disorder, despite the clinical record and MDS lacking corresponding documented diagnoses at the time. Nursing staff reported that they were responsible for entering and clarifying antipsychotic orders and recognized that inappropriate indications for dementia residents could constitute a chemical restraint. The DON could not locate documentation supporting a stated history of schizophrenia, and the facility’s own psychotropic drug policy required a specific, diagnosed, and documented condition for such medications, leading surveyors to find that the antipsychotic was used without an adequate indication.

No penalty information released
tooltip icon
The penalty, as released by CMS, applies to the entire inspection this citation is part of, covering all citations and f-tags issued, not just this specific f-tag. For the complete original report, please refer to the 'Details' section.
PRN Lorazepam Orders Lacked Required Limits and Documentation
D
F0605 F605: Prevent the use of unnecessary psychotropic medications or use medications that may restrain a resident's ability to function.
Short Summary

Two residents received PRN Lorazepam orders without the required 14-day stop date, and the record did not show a documented diagnosed specific condition supporting PRN psychotropic use. One resident had dementia, moderate cognitive impairment, and hospice care with Lorazepam administered on multiple occasions, while the other had dementia with severe cognitive impairment and hospice care with a long-standing PRN Lorazepam order for anxiety and restlessness. The DON and ADM acknowledged PRN psychotropics required review for stop dates, and the facility policy stated PRN psychotropic use must be tied to a documented specific diagnosis and limited to 14 days.

No penalty information released
tooltip icon
The penalty, as released by CMS, applies to the entire inspection this citation is part of, covering all citations and f-tags issued, not just this specific f-tag. For the complete original report, please refer to the 'Details' section.
Failure to Re-Evaluate Prolonged PRN Lorazepam Order
D
F0605 F605: Prevent the use of unnecessary psychotropic medications or use medications that may restrain a resident's ability to function.
Short Summary

A resident with a history of stroke, aphasia, and anxiety, and with severely impaired cognition per BIMS, had a PRN Lorazepam 0.5 mg G-tube order written without a stop date and used for more than 14 days without documented prescriber re-evaluation. The clinical record lacked evidence that the physician or other prescribing practitioner assessed the ongoing appropriateness of this psychotropic medication, even though the care plan identified anti-anxiety drug use and outlined monitoring for adverse reactions.

No penalty information released
tooltip icon
The penalty, as released by CMS, applies to the entire inspection this citation is part of, covering all citations and f-tags issued, not just this specific f-tag. For the complete original report, please refer to the 'Details' section.
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