|§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.
Based on facility policy review, observation and staff interview, it was determined that the facility failed to properly store medications and failed to properly label a medication in one of three medication rooms (First Floor medication room).
The facility policy "Medication Distribution System" dated 12/10/19, indicated that refrigerated medications are kept in closed labeled containers, with internal and external medications separated, and separate from fruit juices, applesauce and other foods used in administering medications. Other foods such as refreshments or employee lunches are not stored in this refrigerator.
The facility policy "Expiration Dates" dated 12/10/19, indicated that all multi-dose medications should be labeled by the facility with the date of first use so that expiration dates or date for last use can be determined.
During an observation on 2/11/20, at 10:22 a. m. in the First Floor medication room revealed six containers of nutritional supplements stored in the medication refrigerator next to medications. One vial of Tubersol (a solution injected into the skin to determine the presence of tuberculosis, an infectious bacterial disease of the lungs) that was open and in use without a date opened rendering the expiration date of 6/10/22, inaccurate.
During an interview on 2/11/20, at 10:25 a. m. Licensed Practical Nurse Employee E2 confirmed that the facility failed to properly store and label medications as required.
28 Pa. Code: 211.9 (h) Pharmacy services.
28 Pa. Code: 211.12 (d) (1) (2) (3) (5) Nursing services.
| ||Plan of Correction - To be completed: 03/25/2020|
The six nutritional supplements found in the first-floor medication refrigerator were removed immediately,
The undated Tubersol solution was immediately discarded
Professional nursing staff were re-educated on the facility's policy on the appropriate storage of drugs and biologicals including the dating of all items in the medication refrigerator once opened.
Random audits of the medication refrigerators will be conducted four times per week for three weeks to ensure compliance with the policy will be conducted by the Director of Nursing or designee. Then the audits will be conducted three times per week for three weeks. Any deficient practice will be immediately Any deficient practice will be immediately corrected. All data will be forwarded to the QAPI committee to determine the need for additional education and/or monitoring.
the audits will be conducted by the Unit managers or designee.
the audits will be conducted on all medication refrigerators in the facility.