§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, manufacturer's guidelines, observations, and staff interview, it was determined that the facility failed to ensure that medications were properly dated when opened, in one of two medication rooms reviewed (A Hall medication room).
Findings include:
Review of a facility policy entitled "Storage of Medications" with a policy review date of 1/5/2026, revealed that, "The facility stores all drugs and biologicals in a safe, secure, and orderly manner. Drug containers that have missing, incomplete, improper, or incorrect labels are returned to the pharmacy for proper labeling before storing. Discontinued, outdated, or deteriorated drugs or biologicals are returned to the dispensing pharmacy or destroyed."
Manufacturer's guidelines for Aplisol PPD (solution used for tuberculosis testing upon admission and for employment), indicated that, "vials in use more than 30 days should be discarded due to possible oxidation and degradation which may affect potency."
Observation on 2/26/26, at 11:35 a.m. of the A hall medication room refrigerator revealed an opened vial of Aplisol PPD without an open date, therefore the staff were unable to determine the discard date.
During an interview at that time, the Licensed Practical Nurse Employee E1 confirmed that the opened Aplisol PPD vial lacked an open date, and staff were unable to determine the discard date.
28 Pa. Code 211.9(a)(1) Pharmacy services
28 Pa. Code 211.10(c) Resident care policies
28 Pa. Code 211.12(d)(1)(3)(5) Nursing services
| | Plan of Correction - To be completed: 04/02/2026
"The Facility submits this Plan of Correction under procedures established by the Department of Health in order to comply with the Department's directive to change conditions which the Department alleges is deficient under State and/or Federal Long Term Care Regulations. This Plan of Correction should not be construed as either a waiver of the facility's right to appeal or challenge the accuracy or severity of the alleged deficiencies or an admission of past or ongoing violation of State or Federal regulatory requirements."
The facility cannot correct that A hall medication room refrigerator had an opened vial of Aplisol PPD without an open date. There were no adverse resident effects.
Licensed nursing staff will be re-educated on the Medication Storage policy by the Director of Nursing/designee.
The Director of Nursing /designee will complete a whole house audit on all medication storage fridges.
The Director of Nursing/designee will audit all medication storage fridges twice weekly for four weeks and monthly for two months to ensure medications are labeled with date and stored per policy.
Outcomes of audits will be reported to the Quality Assurance Performance Improvement Committee for review and recommendations.
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