§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 review of facility policy, observations, and staff interviews, it was determined that the facility failed to label a multi-dose insulin (medication to treat elevated blood sugar levels) vial with the date it was opened and discard an expired multi-dose insulin vial; and failed to prevent the opportunity for unauthorized access to medications in three of five medication carts (Unit D North, Unit E, and Unit C South); and failed to store Schedule II-V medications in a separately locked, permanently affixed compartment in two of five medication rooms (Unit C North and Unit D South).
Findings include:
A facility policy entitled, "Security of Medication Cart" dated, 1/07/25, revealed that medication carts must be securely locked at all times when out of the nurse's view.
A facility policy entitled, "Storage of Medications" dated, 1/07/25, revealed that unlocked medication carts are not left unattended, and Schedule II-V controlled medications are stored in separately locked permanently affixed compartments.
A facility policy entitled, "Insulin Administration" dated, 1/07/25, revealed to check expiration date, if drawing from an opened multi-dose vial; if opening a new vial, record expiration date and time on the vial (follow manufacturer recommendations for expiration after opening).
Observation on 2/26/25, at 8:52 a.m. of the Unit D North medication cart revealed one multi-dose vial of Lantus (long-acting insulin) labeled with an opened date of 1/22/25, (36 calendar days prior) and a pharmacy label that indicated to discard after 28 days opened.
During an interview at that time, Licensed Practical Nurse (LPN) Employee E6 confirmed that the multi-dose vial was expired and should have been discarded.
Observation on 2/26/25, at 10:13 a.m. of the Unit E medication cart revealed one opened multi-dose vial of insulin glargine (long-acting type of insulin) and lacked an opened date.
During an interview at that time, Registered Nurse Employee E3 confirmed that the vial should contain an opened date and that he/she was unable to determine a discard date.
Observation on 2/26/25, at 1:26 p.m. of the Unit C North medication refrigerator rack contained a locked compartment with two boxes of injectable lorazepam (controlled substance used to treat anxiety disorders). The rack of the refrigerator was not permanently affixed.
During an interview at that time, the Assistant Director of Nursing confirmed that the refrigerator rack was not permanently affixed.
Observation on 2/26/25, at 1:37 p.m. of the Unit S South medication refrigerator rack contained a locked compartment with one box of injectable lorazepam. The rack of the refrigerator was not permanently affixed.
During an interview at that time, LPN Employee E1 confirmed that the refrigerator rack was not permanently affixed.
Observation on 2/27/25, at 11:04 a.m. revealed the Unit C South medication cart was unsecured and unattended outside of a resident room (approximately 25 feet from nurse's station and was unable to be seen from nurse's station). Several staff and residents walked by the unsecured cart, and LPN Employee E4 approached the medication cart from nurse's station area.
During an interview at that time, LPN Employee E4 confirmed that the medication cart should have been locked.
During an interview on 2/27/25, at 11:35 a.m. the Director of Nursing confirmed the medication cart should have been locked when not attended to and/or in view.
28 Pa. Code 201.18(b)(1) Management
28 Pa. Code 201.14(a) Responsibility of licensee
28 Pa. Code 211.9(a)(1) Pharmacy services
28 Pa. Code 211.10(c) Resident care policies
| | Plan of Correction - To be completed: 04/03/2025
Immediately upon discovery, the Maintenance team permanently affixed the racks containing the locked controlled substance box to the locked refrigerators in the locked medication rooms. When the Registered Nurse Supervisor is checking refrigerator temperatures, he/she will audit that all controlled substances are accounted for in the refrigerators. All outdated and undated insulin was removed from service at the time of discovery. Immediate education was provided to all nursing staff regarding the proper dating and storage of insulin, as well as the requirement to lock medication carts when not attended or within view. To ensure continued compliance, the Director of Nursing (DON) or designee will perform three medication cart audits per week for two weeks, followed by one audit per week for four weeks, and then one audit per month for two months for outdated or undated insulin rotating carts to ensure all 5 carts are audited. The results of these audits will be reviewed during Quality Assurance and Performance Improvement (QAPI) meetings, and any identified concerns will be addressed with additional education or corrective actions as needed. Additionally, the DON or designee will conduct random observational audits to ensure medication carts are being locked when not attended or within view, performing these checks three times per week for two weeks, once per week for four weeks, and once per month for two months.
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