§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 and manufacturer's instructions, observations and staff interview, it was determined that the facility failed to label one multi-dose vial of Aplisol-tuberculin purified protein derivative (PPD-testing solution for tuberculosis) injection with the date it was opened in one of three medication storage rooms observed (Two East Hall).
Findings include:
Review of manufacturer's instructions for Aplisol- tuberculin PPD Vials revealed "Vials in use more than 30 days should be discarded due to possible oxidation and degradation which may affect potency."
Review of facility policy entitled "Storage of Medications," last reviewed 6/27/23, revealed that "Medications and biologicals are stored safely, securely, and properly, following manufacturer's recommendations or those of the supplier."
Observations of the Two East Hall medication room on 6/14/24, at approximately 10:30 a.m. revealed that one multi-dose vial of Aplisol-Tuberculin PPD was opened and was currently in use, but not labeled with the opened date.
At the time of the observation, the Director of Nursing confirmed that the one undated multi-dose vial of Aplisol was opened, in use daily, and should have been labeled with the date opened.
28 Pa. Code 211.10(c)(d) Resident care policies
28 Pa. Code 211.12(d)(1)(3) Nursing services
| | Plan of Correction - To be completed: 07/28/2024
One vial of tubersol which was not dated was disposed of. All med room refrigerators were immediately checked to ensure vials that were opened were dated.
1. Education will be provided to the nursing staff on the policy of medication storage by the DON/designee to ensure the deficient practice does not continue.
2. Random audits will be done by the DON/ Designee to ensure all open vials are dated in each med room and staff have adhered to the Policy on medication storage three times a week for four weeks. Results of audits will be reported at the QAPI meeting. Audits will be completed in all four medication rooms and six med carts randomly and audits will continue according to discussion in qapi.
Quality Life Services, New Castle has adopted internal processes as part of our on-going commitment to provide quality care to the residents we serve. The attached information contains Quality Life Services, New Castle's Plan of Correction which we are submitting in response to specific deficiencies identified by the Pennsylvania Department of Health and is required for purposes of our facility's licensure and certification. The information and responses contained in our Plan of Correction are consistent with our own quality improvement efforts and should not be construed as an admission of or agreement with the deficiencies cited in the Department's findings. This Plan of Correction is not an admission of wrongdoing on the part of Quality Life Services, New Castle.
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