§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, facility policy review, and staff interview, it was determined that the facility failed to ensure that medications/biologicals were securely stored in one of one medication storage rooms. (Medication and Treatment Room)
Findings include:
Review of the facility policy entitled, "Controlled Substances," last reviewed on February 25, 2024, revealed that controlled substances listed as Schedule II-V of the Comprehensive Drug Abuse Prevention and Control Act of 1976 are to be separately locked in permanently affixed compartments.
Observation on June 13, 2024, at 11:20 a.m., revealed the Medication and Treatment Room had controlled substances that were stored in a locked box inside a refrigerator. The locked box was not permanently affixed to the refrigerator and contained 35 doses of lorazepam suppositories.
In an interview on June 13, 2024, at 12:23 p.m., the Director of Nursing confirmed that the medication box should have been permanently affixed in the locked refrigerator.
28 Pa. Code 211.12(d)(1)(5) Nursing services.
| | Plan of Correction - To be completed: 07/02/2024
This provider submits the following plan of correction in good faith to comply with federal law. This plan is not an admission of wrongdoing, nor does it reflect agreement with the facts and conclusions stated in the statement of the deficiencies. It is the policy of the facility to ensure that all residents receive care and treatment in accordance with professional standards of practice.
Narcotic boxes will be permanently affixed to the medication refrigerator by Plant Operations Director
Audits will be done weekly for 4 weeks and then monthly for 3 months to ensure boxes maintains Permanently affixed to the medication fridge by DON or designee
DON will report finding of audits during the monthly QA
Administrator is responsible for ongoing oversight.
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