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Pennsylvania Department of Drug & Alcohol Programs
Inspection Results

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GAUDENZIA, INC.
414 WEST FIFTH STREET
ERIE, PA 16507

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Survey conducted on 04/17/2012

INITIAL COMMENTS
 
This report is a result of an on-site inspection conducted for the approval to use a narcotic agent, specifically buprenorphine, in the treatment of narcotic addiction. This inspection was conducted on April 17, 2012 by staff from the Division of Drug and Alcohol Program Licensure. Based on the findings of the on-site inspection, Gaudenzia Erie, Inc. - Crossroads was found not to be in compliance with the applicable chapters of 4 PA Code and 28 PA Code which pertain to the facility. The following deficiencies were identified during this inspection.
 
Plan of Correction

715.17(c)(2)  LICENSURE Medication control

(c) A narcotic treatment program shall develop and implement written policies and procedures regarding the medications used by patients which shall include, at a minimum: (2) Drug storage areas. A narcotic treatment program shall develop and implement written policies and procedures regarding storage of medications and access to the medication storage area. Agents shall be stored in a locked safe that has been approved by the DEA under 21 CFR 1301.72 and 1301.74 (relating to physical security controls; and other security controls).
Observations
Based on observation, the facility failed to secure the medication area.



The findings include:



On April 17, 2012 at 10:00 AM, the two doors leading to the medication area were completely open leaving the medication area unsecured. The policy states, " The door to the medical office is secured by one knob lock and the medication cart is under a separate lock."



The finding was reviewed with the director and was not disputed.
 
Plan of Correction
All staff will be trained on the medication control policy and the necessity of keeping the medication area secured. The Nurse Manager will monitor.

 
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