§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 review of clinical records, select facility policy review, and staff interview, it was determined the facility failed to ensure a resident was free of chemical restraints that were not necessary to treat the resident's medical symptoms, were without justification, and did not demonstrate individualized, nonpharmacological approaches to care for one out of 36 residents reviewed (Resident 39).
Findings include:
A review of the facility policy titled "Psychotropic Medication Use," last reviewed by the facility on February 24, 2026, revealed it is the facility policy to ensure residents do not receive psychotropic medication (medications that affect the chemical makeup of the brain and nervous system, altering mood, cognition, and perception) that are not clinically indicated and necessary to treat a specific condition documented in the medical record. The policy also indicates that behavioral and other non-pharmacological approaches (approaches used to manage symptoms or behaviors, such as environmental, behavioral, or comfort measures) are used to minimize or eradicate the need for medications, permit the lowest possible dose if indicated, and support efforts at gradual dose reduction. Psychotropic medication may be considered appropriate when non-pharmacological approaches have been attempted but did not relieve the medical symptoms that are presenting a danger or significant distress.
The clinical record review revealed Resident 39 was admitted to the facility on June 6, 2022, with diagnoses that include cerebral palsy (a group of permanent movement and posture disorders caused by abnormal brain development or damage to the developing brain) and intellectual disabilities (a lifelong condition characterized by significant limitations in both intellectual functioning, such as learning, reasoning, and problem-solving, and adaptive behavior).
A review of Resident 39's quarterly Minimum Data Set assessment (MDS, a federally mandated standardized assessment process conducted periodically to plan resident care) dated January 1, 2026, revealed that Resident 39 was severely cognitively impaired with a BIMS score of 03 (Brief Interview for Mental Status, a tool within the Cognitive Section of the MDS that is used to assess the resident's attention, orientation, and ability to register and recall new information; a score of 00 to 07 indicates severe cognitive impairment).
A review of the comprehensive care plan revealed Resident 39 had a problem with inappropriate verbal and physical behaviors related to cognitive impairment (a condition that affects memory, understanding, and decision-making) and intellectual disability. Documented behaviors included attempting to grab female staff, combative behavior during care, spitting at staff and others, screaming, inappropriate exposure, and striking out at staff and others. The care plan, initiated December 29, 2025, included interventions such as continuous supervision by one staff member, administration of medications as ordered, use of distraction techniques, playing soft music, allowing the resident to calm in his room, and providing visual stimuli such as observing birds.
A review of physician orders revealed lorazepam gel 0.5 mg/ml was prescribed on January 8, 2026, with directions to apply to the posterior neck (back of the neck) every eight hours as needed for anxiety, agitation, or aggression related to anxiety disorder. Lorazepam is a psychotropic medication (a drug that affects the brain and alters mood, behavior, or perception) and is classified as a central nervous system depressant, meaning it slows brain activity and produces calming and sedative effects. The method of administration of lorazepam in topical gel form to the posterior neck allowed for rapid application without the resident's awareness or ability to refuse, particularly given the resident's cognitive impairment. This method limited the resident's opportunity to participate in decision-making. The order was discontinued and reinitiated on January 23, 2026, discontinued again on February 10, 2026, and reinitiated on February 10, 2026, with the same directions.
The clinical record failed to demonstrate that the facility defined Resident 39's specific behavioral expressions of anxiety, agitation, or aggression in measurable and observable terms to guide staff in determining when administration of lorazepam gel was clinically indicated. Without defined parameters, staff lacked objective criteria to ensure the medication was administered appropriately and consistently.
A review of the medication administration record dated January 2026 revealed Resident 39 was administered lorazepam gel 0.5 mg/ml on the following dates:
January 10, 2026, at 08:12 AM
January 12, 2026, at 11:44 AM
January 13, 2026, at 11:09 AM
January 14, 2026, at 10:01 AM
January 15, 2026, at 07:46 AM
January 15, 2026, at 02:09 PM
January 18, 2026, at 02:30 PM
January 19, 2026, at 11:13 AM
January 20, 2026, at 08:03 AM
January 21, 2026, at 08:23 AM
January 30, 2026, at 12:56 PM
A review of the medication administration record dated February 2026 revealed Resident 39 was administered lorazepam gel 0.5 mg/ml on the following dates:
February 1, 2026, at 01:51 AM
February 2, 2026, at 02:01 AM
February 10, 2026, at 02:31 PM
February 15, 2026, at 08:57 AM
February 20, 2026, at 01:02 PM
February 23, 2026, at 08:00 AM
February 24, 2026, at 11:44 AM
Review of Resident 39's medical record revealed no evidence non-pharmacological interventions were attempted and found to be ineffective prior to each use of lorazepam gel 0.5 mg/ml on the 18 aforementioned psychotropic medication administrations.
During an interview on March 13, 2026, at 9:50 AM, the above information was reviewed with the Director of Nursing. The DON could not provide documented evidence that the facility utilized non-pharmacological interventions prior to administering lorazepam gel 0.5 mg/ml 18 times from January 10, 2026, through February 24, 2026. Also, the director of nursing could not provide documented evidence that the facility defined Resident 39's behavioral expression of anxiety, agitation, or aggression that objectively indicated the appropriate use for lorazepam gel 0.5 mg/ml. The facility did not ensure Resident 39 was free of unnecessary psychotropic medication and did not demonstrate that individualized, nonpharmacological approaches were used before administering PRN (as needed) psychotropic medication.
28 Pa. Code 211.2(3) Medical director.
28 Pa. Code 211.5(ii)(xi) Clinical records.
28 Pa. Code 211.8(e) Use of restraints.
28 Pa. Code 211.9(1) Pharmacy services.
28 Pa. Code 211.10 (c) Resident care policies.
28 Pa. Code 211.12 (d)(1)(2)(5) Nursing services.
| | Plan of Correction - To be completed: 03/25/2026
This provider submits the following plan of correction in good faith and to comply with Federal Law. This plan is not an admission of wrongdoing, nor does it reflect agreement with the facts and conclusions stated in the statement of deficiencies
# 1 Resident 39's Lorazepam gel order was clarified with MD and was updated in PCC to have non-pharmacological interventions added . #2 DON/Designee to audit current residents with PRN psychotropic medications ordered to identify non-pharmacological interventions are added; issues identified will be addressed. DON/Designee to review order listing report at morning meeting to identify new PRN psychotropic medications to ensure non-pharmacological are added. #3 DON/Designee to educate nursing staff on Psychotropic medication use policy #4 DON/Designee to conduct random weekly audits on PRN psychotropic medications to verify non-pharmacological interventions are added. Results will be reviewed at monthly QAPI.
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