§483.45 Pharmacy Services
The facility must provide routine and emergency drugs and biologicals to its residents, or obtain them under an agreement described in §483.70(f). The facility may permit unlicensed personnel to administer drugs if State law permits, but only under the general supervision of a licensed nurse.
§483.45(a) Procedures. A facility must provide pharmaceutical services (including procedures that assure the accurate acquiring, receiving, dispensing, and administering of all drugs and biologicals) to meet the needs of each resident.
§483.45(b) Service Consultation. The facility must employ or obtain the services of a licensed pharmacist who-
§483.45(b)(1) Provides consultation on all aspects of the provision of pharmacy services in the facility.
§483.45(b)(2) Establishes a system of records of receipt and disposition of all controlled drugs in sufficient detail to enable an accurate reconciliation; and
§483.45(b)(3) Determines that drug records are in order and that an account of all controlled drugs is maintained and periodically reconciled.
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Observations:
Based on review of facility policies and clinical records, as well as staff interviews, it was determined that the facility failed to maintain accountability for controlled medications (drugs with the potential to be abused) for one of 6 residents reviewed (Resident 2).
Findings include:
A facility policy related to controlled substances, dated April 7, 2025, indicated that waste and/or disposal of controlled medications are done in the presence of the nurse and a witness who also signs the disposition sheet.
A quarterly Minimum Data Set (MDS) assessment (a mandated assessment of a resident's abilities and care needs) for Resident 2, dated January 15, 2026, indicated that the resident was cognitively impaired, was dependent for care needs, had signs indicating delirium, received controlled medications including antianxiety medications (used to treat anxiety), and had diagnoses that included dementia, anxiety, depression and psychotic disorder.
Physician's orders for Resident 2, dated January 14, 2026, included orders for the resident to receive a 0.5 milligram (mg) tablet of Ativan (a controlled medication used to treat anxiety) twice daily with instructions to cut the pill in half to equal 0.25 mg.
The Medication Administration Record (MAR) for Resident 2, dated January 2026, revealed that the resident was to receive 0.25 mg of Ativan twice daily. Review of a controlled drug count record (tracks each dose of a controlled medication) for Resident 2, revealed that the tablets of Ativan on hand at that time were 0.5 mg tablets and the staff were cutting the tablets in half to administer 0.25 mg of Ativan twice daily. The other 0.25 mg half tablet of Ativan was to be disposed of in the presence of the nurse and a witness who would also sign the disposition sheet. There was no documented evidence on the controlled drug count record that two staff members signed that the other 0.25 mg tablet of Ativan was disposed of on the following dates and times: January 17, 2026, at 7:55 p.m.; January 21, 2026, at 8:12 a.m.; January 23, 2026, at 8:16 p.m.; January 28, 2026, at 7:26 p.m.; and January 31, 2026, at 9:07 p.m.
Interview with the Director of Nursing on February 18, 2026, at 3:11 p.m. confirmed that there was no documented evidence that two staff members witnessed and signed that the other 0.25 mg half tablets of Resident 2's 0.5 mg tablets of Ativan were disposed of on the above-mentioned dates and times.
28 Pa. Code 211.9(a)(1) Pharmacy Services.
28 Pa. Code 211.12(d)(1)(3)(5) Nursing Services.
| | Plan of Correction - To be completed: 03/18/2026
R2 narcotic sheets did not have documentation of wasted medication signed by two licensed nurses. The narcotic sheets are unable to be corrected after the fact. Whole house audit was conducted for proper documentation of wasting medications with two licensed nurse signatures.
Director of Nursing will re-educate licensed nursing staff on requirement to have two licensed nurses signing narcotic sheets to waste narcotic medications. Audits will be conducted of narcotic sheets daily x 10 then x2 per week times 3 weeks. The audit outcomes will be presented to the Quality Assurance Committee for review and recommendations.
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