INITIAL COMMENTS
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This report is a result of an on-site licensure renewal inspection conducted on October 4 - 7, 2021 by staff from the Department of Drug and Alcohol Programs, Bureau of Program Licensure. Based on the findings of the on-site inspection, Gaudenzia Erie Inc./Community House was found not to be in compliance with the applicable chapters of 28 PA Code which pertain to the facility. The following deficiencies were identified during this inspection:
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Plan of Correction
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709.32 (c) (3) (i) - (v) LICENSURE Medication control
§ 709.32. Medication control.
(3) Inspection of storage areas that ensures compliance with State and Federal laws and program policy. The policy must include, but not be limited to:
(i) What is to be verified through the inspection, who inspects, how often, but not less than quarterly, and in what manner it is to be recorded.
(ii) Disinfectants and drugs for external use are stored separately from oral and injectable drugs.
(iii) Drugs requiring special conditions for storage to insure stability are properly stored.
(iv) Outdated drugs are removed.
(v) Copies of drug-related regulations are available in appropriate areas.
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Observations
Based on a physical plant inspection, review of medication documentation and facility staff interviews on October 6, 2021, the facility failed to document quarterly inspections of the medication storage area from January 2021 through September 2021.
The findings were reviewed with facility staff during the licensing process.
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Plan of Correction
Monthly inspection of all medication storage areas will be completed by the Nurse Manager utilizing a specific checklist to be maintained in the medication area. This will begin by 11/12/21.
The Division Director and Program Director will review documentation of this quarterly inspection to ensure that it is completed in a timely manner, and to address any concerns identified.
The Quality Assurance department will conduct at least quarterly reviews of the program, to include medication storage areas, and the Compliance department will conduct a review of all plans of correction within 9 months to ensure full implementation.
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