§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, a review of select facility policy, and staff interview, it was determined that the facility failed to adhere to acceptable storage and use by dates for multi-dose diabetes medication on two of four medication carts observed (Spruce 400 hall, Willow 800 hall medication cart - Resident's 107, 6, 27, 147, 34, 57, and M1).
Findings include:
A review of facility policy entitled "Multi-Dose Vials" last reviewed by the facility April 17, 2024, revealing once opened and used, the vials needs to be stored in the body of the refrigerator when not in use, be dated when opened, and it expires 30 days after opening.
Observation of the Spruce 400 hall medication cart on June 4, 2024, at approximately 9:08 AM, in the presence of Employee 3, Licensed Practical Nurse (LPN), revealed the following opened multi-dose diabetes medications:
One (1) Novolin N Flex Pen opened and available for use, not dated when initially opened, Two (2) Insulin Lispro vials, both opened and available for use, the first was dated April 20, 2024, and the second not dated when initially opened, belonging to Resident 107.
One (1) Fiasp vial, opened and available for use, dated April 20, 2024, belonging to Resident 6.
One (1) Fiasp Kwik pen, and One (1) Novolog flex pen, opened and available for use, not dated when initially opened, belonging to Resident 27.
One (1) Lantus Solo Star flex pen, opened and available for use, dated April 22, 2024, and one (1) Insulin Aspart pen, opened and available for use, dated May 1, 2024, belonging to Resident 147.
One (1) Insulin Degludec pen, and one (1) Insulin Aspart pen, opened and available for use, not dated when initially opened, belonging to Resident 34.
One (1) Humalog Kwik pen, opened and available for use, not dated when initially opened, belonging to Resident 57.
Interview at that time with Employee 3, Licensed Practical Nurse (LPN), confirmed the above findings and that the medications should have been dated when initially opened.
Observation of the Willow 800 hall medication cart on June 4, 2024, at approximately 9:37 AM, in the presence of Employee 4, Licensed Practical Nurse (LPN), revealed the following opened multi-dose diabetes medications:
One (1) Humalog vial, opened and available for use, not dated when initially opened, belonging to Resident M1.
Interview at that time with Employee 4, Licensed Practical Nurse (LPN), confirmed the above finding and that the medication should have been dated when initially opened.
Interview with the Director of Nursing (DON) on June 5, 2024, at approximately 12:55 PM, confirmed the that the facility failed to date multi-dose medications when opened to assure acceptable storage times.
28 Pa. Code 211.9 (a)(1)(k) Pharmacy Services
28 Pa. Code 211.12 (c)(d)(3)(5) Nursing services
| | Plan of Correction - To be completed: 07/30/2024
F 0761 Label/Store Drugs and Biologicals 1. Medication carts of Spruce 400 hall, Willow 800 hall (- Resident's 107, 6, 27, 147, 34, 57, and M1) with diabetic medications were reviewed to ensure proper storage and use by dates for multi-dose vials were identified. 2. Medication carts on all units were audited to ensure that diabetic medications were stored properly and used by dates for multi-dose vials were identified. 3. Staff educator/designee will educate Licensed Nursing Staff on the importance of storing and identifying Use by date on diabetic medications when opened. 4. Audits will be done by -unit managers/designees on medication carts of Diabetic meds to ensure that they are stored properly and use by dates for multi dose vials are identified. Audits will be done weekly x4 then monthly x2 then quarterly until compliance is achieved. Results will be presented in QAPI committee meeting. 5. Date of compliance: July 30, 2024
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