|§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 review of facility policies, observations and staff interviews, it was determined that the facility failed to date multi-dose medication vials and failed to dispose of medications after the use by date in two of four medication rooms (200 Unit and 300 Unit).
The facility policy "Medication Storage in the Facility" dated 11/4/19, indicated medications are stored following the manufacturer's recommendations, that multiple dose injectable vials require an expiration date shorter than the manufacturer's expiration date, and that when the original seal of the manufacturer's container or vial is initially broken, it will be dated.
During an observation of the 200 Unit medication room on 11/7/19, at 12:50 p.m. revealed
one Trulicity (injectable diabetic medication) injection pen open, and not labeled with a resident's name,
During an observation of the 300 Unit medication room on 11/7/19, at 1:15 p.m. revealed
one vial of Vancomycin (antibiotic) attached to a 250 ml bag of normal saline, with a pharmacy printed use-by date of 10/22/19,
one opened, and undated bottle of vancomycin liquid, with a manufacturer's label stating that the medication must be used by 14 days after opening, and a pharmacy applied label stating "14 DAY",
one Humulin (insulin to treat diabetes) injection pen, with a use-by date of 10/25/19,
one Humalog (insulin to treat diabetes) vial open, and undated,
one vial of ampicillin and sulbactam (a combination of antibiotics), with an expiration date of 9/2019,
four piston irrigation trays, including sterile sodium chloride, with expirations dates of 11/30/18, and 8/31/19,
During an interview on 8/28/18, at 1:39 p.m. Licensed Practical Nurse (LPN) Employee E12 confirmed that facility staff failed to dispose of expired medications, and accurately label medications as required.
During an observation of the 300B medication cart on 11/7/19, at 1:43 p.m. revealed one Lantus vial open, and undated.
During an interview on 11/7/19, at 1:45 p, at 1:39 p.m. Licensed Practical Nurse (LPN) Employee E12 confirmed that facility staff failed to accurately label medications as required.
During an observation of the 200A medication cart on 11/7/19, at 1:43 p.m. revealed
one Lantus (insulin to treat diabetes) vial open, with a use-by date of 7/2/19,
one Lantus vial open, and undated,
two Humalog vials open, and undated,
one bottle of hemocult solution (liquid used in testing stool for the presence of blood), with a manufacturer's expiration date of 11/2017.
During an interview on 11/7/19, at 1:45 p, at 1:39 p.m. Licensed Practical Nurse (LPN) Employee E13 confirmed that facility staff failed to dispose of expired medications, and accurately label medications as required.
28 Pa. Code 211.9(a)(1) Pharmacy services.
Previously cited 6/2/17.
28 Pa. Code 211.12(d)(1)(5) Nursing services.
Previously cited 6/2/17.
| ||Plan of Correction - To be completed: 01/07/2020|
1. Residents affected on unit 200 and 300 medications not labeled, expired, and/or dated were disposed of properly. New medications reordered after med room audit conducted and resident reordered identified. All residents on 200 and 300 medications were labeled and dated and facility educator provide education to licensed nursing on compliance of labeling and dating medications
2. The Director of Nursing/ Designee will complete a house wide audit of all medication in-house ensuring resident medication labeling meet the requirement for proper labeling, resident identification, dating and expiry dates for all multi-dose vials, inhalers, eye-drops and syringes to facilitate safe administration.
3. Director of Nursing/Designee will have weekly audits performed of all medication carts and medication supply rooms for proper labeling and dating for two months. A random audit will be done monthly by Facility Educator, the Facility Infection Preventionist, and the Clinical Pharmacist (on monthly reviews). Facility Educator will educate licensed nurses on proper labeling, resident identification, dating and expiry dates for all multi-dose vials, inhalers, eye-drops and syringes to facilitate safe administration. Director of Nursing/Designee will have added education on audit requirements and follow-up with nursing administration.
4. Director of Nursing /Designee will report monthly audit findings in Quality Assessment Performance Improvement (QAPI) meeting monthly on-going.
5. Corrective date of completion January 7, 2020