§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 observations and staff interviews, it was determined that the facility failed to provide a separately-locked, permanently-affixed compartment in the refrigerator for the storage of controlled drugs in the medication room at Lehman House.
Findings include:
Observations in the facility's medication room refrigerator at Lehman House on March 13, 2024, at 8:40 a.m. revealed two multi-dose bottles of Ativan (a medication used to treat anxiety that is tightly controlled because it may be abused or cause addiction) on the top shelf in the refrigerator. The refrigerator did not contain a locked compartment that was affixed to the inside of the refrigerator to secure the Ativan.
Interview with Registered Nurse 1 on March 13, 2024, at 8:43 a.m. revealed that she was not aware that there was supposed to be a locked compartment affixed to the inside of refrigerator.
Interview with the Director of Nursing on March 13, 2024, at 12:05 p.m. confirmed that the refrigerator should have contained a locked compartment affixed to the inside of the refrigerator to secure controlled substances and it did not.
28 Pa. Code 211.9(a)(1) Pharmacy Services.
| | Plan of Correction - To be completed: 03/29/2024
1. A separate locked permanently affixed compartment in the refrigerator for storage of controlled drugs was provided for the medication room in the Lehman house during the survey on 3/13/24.
2. An audit of refrigerators that would contain controlled drugs was completed to ensure that a separate locked permanently affixed compartment in the refrigerator for storage of controlled drugs was present.
3. A separate locked permanently affixed compartment in the refrigerator for storage of controlled drugs was provided for the medication room in the Lehman house during the survey on 3/13/24.
4. The Director of Nursing or designee will conduct audits of medication room refrigerators for a separately locked permanently affixed compartment in the refrigerator for storage of controlled drugs. Audits will be conducted weekly x4 weeks, Biweekly x4 weeks, and monthly x1 month. A summary of the audits will be presented at the Quality Assurance and Performance Improvement meetings for 3 months for further review and recommendations.
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