§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 . . . 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 . . . chemical restraints
imposed for purposes of discipline or convenience and that are not required to treat the resident's medical symptoms.
. . . .
§483.45(c)(3) A psychotropic drug is any drug that affects brain activities associated with mental processes and behavior. These drugs include, but are not limited to, drugs in the following categories:
(i) Anti-psychotic;
(ii) Anti-depressant;
(iii) Anti-anxiety; and
(iv) Hypnotic.
§483.45(d) Unnecessary drugs-General. Each resident's drug regimen must be free from unnecessary drugs. An unnecessary drug is any drug when used-
(1) In excessive dose (including duplicate drug therapy); or
(2) For excessive duration; or
(3) Without adequate monitoring; or
(4) Without adequate indications for its use; or
(5) In the presence of adverse consequences which indicate the dose should be reduced or discontinued; or
(6) Any combinations of the reasons stated in paragraphs (d)(1) through (5) of this section.
§483.45(e) Psychotropic Drugs. Based on a comprehensive assessment of a resident, the facility must ensure that--
§483.45(e)(1) Residents who have not used psychotropic drugs are not given these drugs unless the medication is necessary to treat a specific condition as diagnosed and documented in the clinical record;
§483.45(e)(2) Residents who use psychotropic drugs receive gradual dose reductions, and behavioral interventions, unless clinically contraindicated, in an effort to discontinue these drugs;
§483.45(e)(3) Residents do not receive psychotropic drugs pursuant to a PRN order unless that medication is necessary to treat a diagnosed specific condition that is documented in the clinical record; and
§483.45(e)(4) PRN orders for psychotropic drugs are limited to 14 days. Except as provided in §483.45(e)(5), if the attending physician or prescribing practitioner believes that it is appropriate for the PRN order to be extended beyond 14 days, he or she should document their rationale in the resident's medical record and indicate the duration for the PRN order.
§483.45(e)(5) PRN orders for anti-psychotic drugs are limited to 14 days and cannot be renewed unless the attending physician or prescribing practitioner evaluates the resident for the appropriateness of that medication.
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Observations:
Based on a review of select facility policies and procedures, clinical record review, and staff interview, it was determined that the facility failed to ensure residents' medication regime was free from potentially unnecessary medications for two of five residents reviewed for medication regime concerns (Residents 2 and 4).
.
Findings include:
The facility policy entitled, "Psychotropic Medication Use," last reviewed January 29, 2026, revealed that the purpose of the policy included to provide consistent monitoring of usage of medications to ensure each resident is receiving the medication that he/she needs without being overmedicated. Residents will not receive psychotropic medications unless behavioral programming and/or environmental changes or other non-pharmacological interventions have failed to sufficiently address the resident's target behavioral goals. The facility will monitor psychotropic medications for proper dose, duration, evidence of adequate monitoring for efficacy and adverse consequences and to prevent, identify, and respond to adverse consequences. As needed (PRN) orders for psychotropic medications will be limited to 14 days unless the physician identifies the rationale to extend the medication beyond 14 days. PRN anti-psychotic drugs will be limited to 14 days and will not be renewed unless the physician evaluates the resident for appropriateness of the medication. When selecting medications and non-pharmacological approaches, members of the interdisciplinary team and the resident and resident representative, if applicable, will participate in the care process to identify, assess, advocate for, monitor, and communicate the resident's needs and changes of condition. The indication for any psychotropic medication will be thoroughly documented in the clinical record to include behavioral symptoms being treated. Identified target behaviors will be monitored each shift along with individualized interventions. The care plan will also include the type of psychotropic medications to be monitored for side effects daily. The, "Basic Guidelines for Behavior and Side Effect Monitoring," noted that a medication specific behavior and side effect monitoring system is used for each psychotropic category of medication ordered. At least one individualized behavior will be clearly linked with each antipsychotic, antianxiety, sedative hypnotic, or other psychotropic medication. These targeted behaviors are linked within the behavior monitoring system in such a way that all (staff, physicians, medical consultants, family members, regulatory, etc.) can clearly see the specific targeted behavior(s) treated with each medication prescribed. At least daily monitoring of the specific target behaviors and side effects is documented within this system. The absence of behaviors and side effects is indicated with a zero in the appropriate row. Do not leave these spaces blank as this fails to indicate that monitoring occurred. Additionally, monitoring by exception only is not the best practice since it can lead to underreporting and a lack of trust in the monitoring system. All side effects seen with medications are to be recorded in the monitoring system.
Clinical record review for Resident 4 revealed her medication regime included the use of the following psychotropic medications per the following schedule:
Buspirone, (Buspar) an antianxiety medication, 15 mg (milligrams) at 8:30 AM, 10 mg at 2:30 PM, and 15 mg at 9:30 PM. Cymbalta, an antidepressant medication, 60 mg at 8:30 AM and 8:30 PM. Elavil, an antidepressant medication, 10 mg three times a day.
The plan of care developed by the facility to address Resident 4's utilization of the psychotropic medications Cymbalta, Elavil, and Buspar for the management of depression, anxiety, and sleep disturbance listed interventions that included:
Document mood, sleep, care participation, and response to interventions per facility protocol
Monitor/document side effects and effectiveness (antidepressant side effects such as dry mouth, dry eyes, constipation, urinary retention, suicidal ideations)
Monitor effectiveness of medications on mood, anxiety, pain, participating in care, and hygiene routines and sleep
Observe and report adverse effects
The plan of care developed by the facility to address Resident 4's symptoms of depression and decreased engagement related to chronic conditions, diagnoses of anxiety, depression and insomnia, and use of psychotropic medications listed interventions that included monitoring sleep patterns.
Review of Resident 4's clinical record did not include evidence that the facility monitored Resident 4's individualized targeted behavior symptoms (e.g. sleep pattern) or potential side effects related to her use of psychotropic medications.
Interview with the Nursing Home Administrator and the Director of Nursing on June 3, 2026, at 10:21 AM confirmed the above findings for Resident 4.
Clinical record review revealed the facility admitted Resident 2 on April 21, 2026. Review of Resident 2's physician orders revealed an order for Hydroxyzine (an antihistamine medication used to treat anxiety) 25 mg, one tablet every 12 hours as needed for relentlessness and agitation-initiated April 27, 2026.
Review of a consultant pharmacy recommendation dated May 4, 2026, noted Resident 2 is currently ordered Hydroxyzine 25 mg every 12 hours as needed and according to CMS regulations there is a 14-day limitation on all as needed antipsychotic orders. The pharmacist noted the Hydroxyzine order may not be extended beyond the 14-day limit, but a new order may be written if the practitioner directly examines and assesses the resident and documents clinical rational for the new order. The pharmacist requested Resident 2's physician reassess the appropriateness of the above therapy and to document the need for continuation every 14 days.
A certified nurse practitioner addressed the May 4, 2026, pharmacy recommendation on May 14, 2026, noting Resident 2's "medication will be reassessed by telePsych and be based on the recommendations."
Further clinical record review revealed that Resident 2's order for Hydroxyzine did not have a 14 day stop date and there was no physician's progress note that provided a rationale for the medication extending past 14 days.
Interview with the Director of Nursing on June 2, 2026, at 2:12 PM confirmed the above noted findings related to Resident 2's Hydroxyzine.
28 Pa. Code 211.12(d)(1)(3)(5) Nursing services
| | Plan of Correction - To be completed: 07/25/2026
1. Resident #2 progress note from the telehealth practitioner, dated 5/12 was uploaded into PCC miscellaneous tab on 5/13. The note recommended continuation of hydroxyzine for anxiety and agitation
2. The NHA educated the DON regarding the PCC miscellaneous tab and the documents maintained within that section
3. The DON obtained a new prescription from a provider for hydroxyzine with a 14- day stop limit on 6/1, initiated on 6/2, with the stop date of 6/16
4. The DON will reeducate all licensed nursing staff regarding regulations governing 14-day stop dates for psychotropic medications and the requirements for timely review and renewal when clinically indicated
5. The DON or designee will audit 14 -day stop- limit medications biweekly x 6 weeks and monthly x 3 months to ensure compliance with regulatory requirements.
6. The DON will report findings in October 2026 and April 2027 QAPI meetings
7. The DON will educate certified nursing assistance on behavior monitoring and intervention documentation requirements for Resident # 4 as she is on psychotropic medications.
8. The DON will demonstrate where to find this behavior monitoring and intervention for Resident # 4 within their PCC tasks.
9. The DON to explain documentation is to be completed each shift, daily, for Residents #2 and 4, as well as all other residents requiring behavior monitoring and intervention
10. The DON or designee will run and review behavior monitoring, and intervention reports weekly x 4, biweekly x 4 and monthly x 1 then as necessary to ensure documentation is completed consistently and interventions are appropriately monitored
9. The DON will report findings in October 2026 and April 2027 QAPI meetings
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