§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.
|
Observations:
Based on observations, review of facility policy/protocols, and interview with staff, it was determined that facility did not ensure to store drugs and biologicals according to professional standards of practice in two of two medication storage rooms observed (2nd floor and 3rd floor units)
Findings include:
Review of facility policy 'Medication Storage,' reviewed December 17, 2024, indicates that "medication preparation and storage areas will have sufficient lighting," and "medications requiring refrigeration will be stored in a refrigerator that is maintained between 2 8 degrees Celsius ( 36 to 46 degrees F) temperatures will be checked daily to ensure it is within the specific range. If temperature is out of range, the refrigerator thermostat will be adjusted."
Review of 'Refrigerator temperature control log,' for month of October 2025, on 3rd floor unit, indicated that "The RN (Registered Nurse) or LPN (Licensed Practical Nurse) will check and record the refrigerator temp. every shift, initial and sign. Temp (F- Fahrenheit) should be between 36 degrees 46 degrees F. If out of range, readjust temp. If still out of range, notify maintenance and document in the maintenance log."
Further review of temperature log on 3rd floor unit, revealed no record that the temperature was monitor and documented on the following dates/shifts: October 1, 2025 day and evening shift, October 2, 2025 day and evening shift, October 6, 2025 through October 23, 2025 day shifts, October 9, 2025 evening shift, October 11, 2025 through October 13, 2025 evening shift, October 15, 2025 through October 23, 2025 evening shift, October 22, 2025 night shift.
Further observations of medication storage room on 3rd floor unit indicated refrigerator temperature out of range at 48F. Finding confirmed by charge nurse, Employee E10 at the time of the observation.
Further review of temperature log in 2nd floor medication storage room revealed missing temperature checks, dates and initials on following dates: October 1, 2025 through October 8, 2025 day shifts, October 11, 2025 through October 22, 2025 day shifts, October 5, 2025 through October 6, 2025 evening shifts, October 11, 2025 through October 12, 2025 evening shifts, October 17, 2025 evening shift, October 20, 2025 through October 22, 2025 evening shifts, October 3, 2025 through October 5th, 2025 night shifts, October 9, 2025 night shift, October 11, 2025 night shift, October 15, 2025 night shift, October 17, 2025 through October 18, 2025 night shift, October 21, 2025 through October 22, 2025 night shift.
Findings confirmed with 2nd floor unit charge nurse, Employee E11 on Thursday, October 23, 2025, at 11:54 am.
28 Pa Code 211.12(d)(5)(e) Nursing services
| | Plan of Correction - To be completed: 12/11/2025
1. Corrective Action: All medication storage rooms inspected to ensure proper storage and fridge function. 3rd floor med room fridge temperature adjusted to proper range. 2. Systemic Changes: Nursing staff re-educated on proper med storage and completion of refrigerator temperature control log by staff educator and/or designee. 3. Monitoring: DON/Designee will complete weekly audits to ensure medication refrigerators are within acceptable temperature range and properly documented x4 weeks, then monthly x2. DON/Designee will present the findings of the audit to the monthly QA committee for review and further recommendations
|
|