§483.45(g) Labeling of Drugs and Biologicals
Drugs and biologicals used in the facility must be labeled in accordance with currently accepted professional principles, and include the appropriate accessory and cautionary instructions, and the expiration date when applicable.
§483.45(h) Storage of Drugs and Biologicals
§483.45(h)(1) In accordance with State and Federal laws, the facility must store all drugs and biologicals in locked compartments under proper temperature controls, and permit only authorized personnel to have access to the keys.
§483.45(h)(2) The facility must provide separately locked, permanently affixed compartments for storage of controlled drugs listed in Schedule II of the Comprehensive Drug Abuse Prevention and Control Act of 1976 and other drugs subject to abuse, except when the facility uses single unit package drug distribution systems in which the quantity stored is minimal and a missing dose can be readily detected.
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Observations:
Based on observation, record review, review of facility policy, interview with staff and residents, it was determined that the facility did not ensure that medications were stored and labeled according to professional standards for one of five residents reviewed. (Resident R1)
Findings include:
Review facility policy for Medication Labeling and Storage revealed that under section Policy Statement: The facility stores all medications and biologicals and locked compartments under proper temperature humidity and light controls only authorized personnel have access to keys. Under section Policy Interpretation and Implementation sub-section Medication Storage #1 Medications and biologicals are stored in the packaging containers or other dispensing systems in which they are received only the issuing pharmacist authorize the transfer medications between containers.#4 Compartments including but not limited to drawers cabinets rooms refrigerators cards and boxes containing medications and biologicals are locked when not in use and trays or carts used to transport such items are not left unattended if open or otherwise potentially available to others. #5 Medications are stored in an orderly manner in cabinets Jewelers carts or automatic dispensing systems its residence medications are assigned to an individual cubicle drawer or other holding area to prevent the possibility of mixing medications of several residents. Under subsection Medication Labeling #1 Labeling of medications and biologicals dispensed by the pharmacy is consistent with applicable federal and state requirements and currently accepted pharmaceutical practices #2 The medication label includes at a minimum: a. medication name, b. prescribed dose, c. strength, d. expiration date when applicable, e. resident's name, e. route of administration and g. appropriate instructions and precautions. #10. Only the dispensing pharmacy may label or alter the label on a medication container or package.
Review of resident R1's clinical record revealed that Resident R1 was admitted to the facility on February 12, 2026, with diagnosis of Acute Respiratory Failure.
Review of Resident R1's MDS (Minimum Data Set, a federally required resident assessment conducted at a specific interval) dated February 18, 2026, revealed that section C500 BIMS (brief interview for mental status) score was "15", suggesting that resident R1 was cognitively intact.
Review of Resident R1 physician's orders revealed that there was no order for fluticasone nasal spray.
Observation during tour of the first-floor unit conducted on March 3, 2026, at 9:30AM revealed that Fluticasone Propionate nasal spray was on Resident R1's bedside table. Further, the Fluticasone Propionate nasal spray did not have a label with resident's name affixed to the bottle. Further, the Fluticasone Propionate nasal spray bottle was full.
Interview conducted with Resident R1 at the time of the observation revealed that the physician gave Resident R1 the Fluticasone Propionate nasal spray the day before.
Interview with Assistant Director of Nursing, Employee 3 conducted on March 5, 2026, at 9:34AM confirmed that Fluticasone Propionate nasal spray was on Resident R1's bedside table.
Interview with Licensed nurse, Employee E4 conducted on March 5, 2025, at 9:40AM revealed that there was no physicians order for Fluticasone Propionate nasal spray for Resident R1.
Follow-up observation of Resident R1's bedside table conducted on March 5, 2026, at 10AM with Director of Nursing Employee E2 revealed an unlabeled Fluticasone Propionate nasal spray bottle was at Resident R1's bedside table. Further, the Fluticasone Propionate nasal spray bottle was full.
Interview with Employee E2 conducted at the time of the observation confirmed that an unlabeled Fluticasone Propionate nasal spray was on resident R1's bedside table. Employee E3 removed the fluticasone from resident R1.
28 Pa. code 211.9 (a)(1)(d) Pharmacy services
28 Pa. Code 211.12(d)(1) Nursing services
| | Plan of Correction - To be completed: 04/09/2026
"This Plan of Correction constitutes this facility's written allegation of compliance for the deficiencies cited. This submission of this plan of correction is not an admission of or agreement with the deficiencies or conclusions contained in the Department's inspection report."
1. All unlabeled medications were discarded at the time of observation in accordance with facility policy.
2. An audit of all residents rooms was completed to identify any additional unlabeled, or improperly stored medications. Variances were addressed at the time of the audit and documented on the facility audit tool.
3. Licensed nurses will receive education regarding medication labeling and storage policies.
4. The DON/Designee will complete random room audits weekly x4 weeks and monthly for 2 months to validate medications are properly labeled, stored, and secured in accordance with facility policy. Audit findings will be addressed and submitted to the Quality Assurance Performance Improvement Committee for further review and recommendations as needed.
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