§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 facility policy, clinical record review, medication administration records, physician orders, and staff interview, it was determined the facility failed to document that individualized non-pharmacological interventions were attempted prior to the administration of a PRN (as needed) psychotropic medication and failed to obtain and document the prescribing practitioner's clinical rationale and duration supporting continuation of the PRN psychotropic medication beyond the federally permitted 14-day period for one of 19 residents reviewed (Resident 35).
Findings Include:
Federal requirements for the use of psychotropic medications expect that psychotropic medications are used only when necessary to treat a specific, documented condition. A PRN (as needed) psychotropic medication order is limited to 14 days unless the prescribing practitioner documents the clinical rationale for extending the order and specifies the duration of the extension. Non-pharmacological interventions are approaches that do not involve medications, such as reassurance, redirection, environmental modifications, distraction techniques, or comfort measures. When clinically appropriate, these interventions should be attempted and documented prior to administering a PRN psychotropic medication.
A review of the facility's policy titled "Psychoactive Medication Policy" reviewed June 25, 2026, indicated that all residents receiving psychoactive medications will have their behaviors, effectiveness of interventions (pharmacological and non-pharmacological) and potential for a gradual dose reduction of psychoactive medication monitored and documented. The policy further revealed that individualized non-pharmacological approaches are provided as part of a supportive physical and psychological environment and are directed toward preventing, relieving, or accommodating a resident's distressed behavior.
Clinical record review revealed Resident 35 was admitted on April 2, 2025, with diagnoses including depression (a common, serious mood disorder that causes persistent sadness, loss of interest, and physical fatigue) and anxiety (the body's natural response to stress, characterized by feelings of tension, worried thoughts, and physical changes).
A review of Resident 35's Quarterly Minimum Data Set assessment (MDS, a federally mandated standardized assessment process conducted periodically to plan resident care) dated June 23, 2026, revealed that Resident 35 was moderately cognitively impaired with a BIMS score of 12 (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 8 through 12 indicates moderate cognitive impairment).
Review of physician orders revealed an order dated May 22, 2026, for Hydroxyzine 25 mg (antihistamine that has anxiolytic or anti-anxiety properties. When prescribed to treat anxiety or other behavioral or psychological symptoms, it is considered a psychotropic medication under the federal requirements governing PRN psychotropic medications) administer 1 tablet by mouth at bedtime as needed for anxiety for 14 days.
Review of physician orders further revealed the order was changed on June 19, 2026, to Hydroxyzine 25 mg, administer one tablet by mouth twice daily as needed.
Review of the Medication Administration Record (MAR) revealed the PRN Hydroxyzine was administered on the following occasions:
May 26, 2026, at 12:45 AM
June 1, 2026, at 8:28 PM
June 5, 2026, at 8:41 PM
June 6, 2026, at 10:56 PM
Review of the clinical record failed to identify documentation that non-pharmacological interventions were attempted or ineffective prior to administration of the PRN psychotropic medication on any of the seven occasions. As a result, the facility could not demonstrate that less restrictive interventions were considered before the medication was administered.
Review of the clinical record failed to identify documentation that individualized non-pharmacological interventions were attempted or found to be ineffective before the PRN Hydroxyzine was administered on any of the four identified occasions. Therefore, the facility could not demonstrate less restrictive interventions were considered before administering the psychotropic medication.
Review of the clinical record further failed to identify documentation from the prescribing practitioner providing the clinical rationale for continuing the PRN Hydroxyzine order beyond the 14-day federal limitation. In addition, the record failed to identify documentation specifying the duration of the extension.
During an interview on July 9, 2026, at 12:30 PM, the surveyor reviewed the above findings with facility staff. The facility could not provide documented evidence that non-pharmacological interventions were attempted before the PRN Hydroxyzine was administered on the four identified occasions and no documented clinical rationale or specified duration from the prescribing practitioner supporting continuation of the PRN psychotropic medication beyond 14 days.
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.
| | Plan of Correction - To be completed: 08/04/2026
1. Hydroxyzine has been discontinued for resident 35.
2. To identify resident with the potential to be effected, the DON/designee will complete a 14 day look back for PRN psychotropic medication to ensure a 14 day stop date is in place and NPIs are attached to orders.
3. To prevent from recurring, the DON/designee will educate licensed staff that any PRN (as needed) psychotropic medication orders are limited to 14 days and documentation of NPIs.
4. To monitor and maintain compliance the DON/designee will audit a random selection of 5 residents weekly x 4 then monthly x2, to ensure 14 day stop dates or supporting physician documentation are in place and NPIs are offered prior to administration. All results will be brought to QAPI.
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