§483.10(e) Respect and Dignity.
The resident has a right to be treated with respect and dignity, including:
§483.10(e)(1) The right to be free from any physical or chemical restraints imposed for purposes of discipline or convenience, and not required to treat the resident's medical symptoms, consistent with §483.12(a)(2).
§483.12
The resident has the right to be free from abuse, neglect, misappropriation of resident property, and exploitation as defined in this subpart. This includes but is not limited to freedom from corporal punishment, involuntary seclusion and any physical or chemical restraint not required to treat the resident's medical symptoms.
§483.12(a) The facility must-
§483.12(a)(2) Ensure that the resident is free from physical or chemical restraints imposed for purposes of discipline or convenience and that are not required to treat the resident's medical symptoms. When the use of restraints is indicated, the facility must use the least restrictive alternative for the least amount of time and document ongoing re-evaluation of the need for restraints.
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Observations:
Based on review of clinical records, select facility policy review, and staff interview it was determined that the facility failed to ensure that one resident out of five sampled was free of chemical restraints used to most readily control the resident's behavior and not required to treat the resident's medical symptoms (Resident 1).
Findings include:
A review of the Facility's Policy labeled "Restraint Free Environment" last reviewed by the facility on June 1, 2024, reviewed on April 15, 2025, at approximately 1:30PM defines a chemical restraint as any medication that is used for discipline or staff convenience, and not required to treat medical symptoms. The policy further revealed the resident's medical record must include documentation that less restrictive alternatives were attempted to treat the medical symptom but were ineffective, ongoing re-evaluation of the need for the restraint and the effectiveness of the restraint in treating the medical symptom.
A review of Resident 1's clinical record revealed admission to the facility on March 4, 2024, with diagnoses to include vascular dementia with behavioral disturbance (a condition caused by impaired blood flow, characterized by poor judgement and memory impacting daily functioning) and anxiety disorder (a disorder characterized by excessive worry and fear that can significantly impact daily life.)
A Quarterly Minimum Data Set assessment (MDS- a federally mandated standardized assessment conducted at specific intervals to plan resident care) dated February 11, 2025, revealed the resident was severely cognitively impaired with no BIMS score available (brief interview for mental status, a tool to assess the resident's attention, orientation and ability to register and recall new information).
A review of the resident's clinical record revealed the following orders:
November 22, 2024- Compound lorazepam gel (Ativan a benzodiazepine antianxiety medication topical gel in semisolid form dispensed through a pump mechanism that allows for easy application to the skin for absorption of the medication) apply to wrist topically at 1:00PM daily.
January 3,2025- Compound lorazepam gel apply to wrist topically every 8 hours as needed (PRN) for anxiety, in addition to the lorazepam gel being applied in the afternoon at 1:00 PM.
In addition to these orders the resident was also prescribed Depakote 750 mg (a medication used to manage agitation and other behavioral symptoms) via oral route daily and Zoloft 25mg via oral route daily (a selective Serotonin Reuptake inhibitor medication used to manage mood and behavioral symptoms in people with dementia).
A review of the medication administration record revealed the resident was administered the as needed dose (PRN) lorazepam gel in addition to the 1:00PM dose of lorazepam gel on the following dates without any supporting documentation of increased anxiety or behaviors:
January 6, 2025, at 07:54 AM
January 7, 2025, at 02:40AM
January 9, 2025, at 07:11PM
January 23, 2025, at 07:52PM
January 27,2025 at 6:26 PM
February 8, 2025, at 3:09 PM
February 10, 2025, at 6:27PM
February 15, 2025, at 5:53 PM
A review of the resident's clinical record revealed the resident had no contraindication for taking oral medications. Further record review revealed that all other medications administered to the resident were administered via the oral route.
Observation of the resident on April 15, 2025, at 09:00AM revealed the resident sleeping in the common area of the facility, not easily arousable. A second observation at approximately 10:30AM revealed the same. A third observation at 12:30 PM revealed the resident awake and communicating with other residents.
During an interview with the Director of Nursing (DON) on April 15, 2025, at 09:00AM, the DON stated the lorazepam gel had been initiated in November 2024 due to the resident refusing oral lorazepam. However, the facility failed to provide any documented evidence the resident was unable to tolerate oral medications. The resident's current psychotropic medications, Depakote and Zoloft, were both administered orally without documented difficulty.
The use of lorazepam gel in this case, in the absence of documented behaviors, medical symptoms, or an inability to take oral medications, suggests the medication was not used for the treatment of a specific medical condition, thus constituting a chemical restraint.
Because the resident was assessed as severely cognitively impaired, she lacked the capacity to make informed decisions or express refusal regarding her medication regimen. The lorazepam gel was applied to the resident's skin on the wrist without evidence of consent or objection, despite the absence of documented medical symptoms at the time of administration. This prevented the resident from participating in decisions about her care and eliminated any ability to refuse the medication, further supporting the classification of the lorazepam gel as a chemical restraint.
Further review of a facility policy labeled "Medication Regimen Review" last reviewed by the facility June 1, 2024, revealed PRN (as needed) medications are limited to 14 days. To extend a PRN order past 14 days, the prescriber must document their rationale in the medical record and indicate the duration for the PRN order.
The resident's clinical record failed to contain evidence the prescriber had a documented rationale in the medical record for the extended period of the as needed medication (PRN) administration past 14 days.
An interview with Employee 1 NA (nurse aide) revealed the resident is usually groggy and not easily arousable until around 12:00PM each day. He revealed the resident would display certain behaviors usually in the afternoon.
The facility failed to show evidence a less restrictive alternative treatment was attempted based on an appropriate assessment, care planning by the interdisciplinary team, and physician documentation of the medical symptoms.
The resident's clinical record failed to contain evidence the facility staff and/or physician had identified, to the extent possible, and addressed the potential underlying causes of Resident 1's behavior such as environmental factors and over stimulation.
During an interview with the Director of Nursing (DON) on April 15, 2025, at approximately 12:00PM, the DON confirmed the facility failed to provide documented evidence the resident was experiencing symptoms that would warrant nursing staff to administer the as needed (PRN) medication or the resident was unable to tolerate an oral method of medication administration.
28 Pa. Code 211.12 (d)(1)(2)(5) Nursing Services
28 Pa. Code 211.8 (e) Use of restraints
28 Pa. Code 211.5(i)(ii)(viii)(xi) Clinical records
28 Pa. Code 211.9(b)(2) Pharmacy services
28 Pa. Code 211.2(3) Physician Services
| | Plan of Correction - To be completed: 05/12/2025
Facility cannot retroactively correct deficiency. Resident 1's Ativan Gel was discontinued after review from the physician on 4/29/2025. PRN Ativan was ordered by physician beginning 4/30/2025 while facility completes a seven-day tracker of behaviors. Behavior monitoring ordered at the time of the new PRN medication. Care plan updated to reflect current orders.
2. Current residents reviewed for PRN medications, behavioral monitoring and physician assessments with no corrections required.
3. Education provided to physician assistant and medical director regarding PRN medication orders and required assessment of medication. Education provided to nursing staff on behavior documentation and use of non-pharmacological interventions prior to PRN usage.
4. DON/designee will audit daily order summaries for PRN medications and examine use of PRN medications to ensure the regulations for PRN medications are followed X 2 weeks, then monthly X 2 months. Results to be forwarded to QAPI committee to ensure compliance.
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