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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 07/15/2010

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 residential detoxification to treat opioid dependence. This inspection was conducted on July 15, 2010 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 28 PA Code which pertain to the facility. Deficiencies were identified during this inspection and plan of correction is due on August 11, 2010.
 
Plan of Correction

715.17(c)(1)(i-vi))  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: (1) Administration of medication. (i) A narcotic treatment physician shall determine the patient 's initial and subsequent dose and schedule. The physician shall communicate the initial and subsequent dose and schedule to the person responsible for the administration of medication. Each medication order and dosage change shall be written and signed by the narcotic treatment physician. (ii) An agent shall be administered or dispensed only by a practitioner licensed under the appropriate Federal and State laws to dispense agents to patients. (iii) Only authorized staff and patients who are receiving medication shall be permitted in the dispensing area. (iv) There shall be only one patient permitted at a dispensing station at any given time. (v) Each patient shall be observed when ingesting the agent. (vi) Administering and dispensing shall be conducted in a manner that protects the patient from disruption or annoyance from other individuals.
Observations
Based on a review of patient records, the facility failed to document physician determination of the patient's initial and subsequent medication dose in four of six records.



Findings include:



Six records were reviewed on July 15, 2010. The physician's determination of the patients initial and subsequent medication dose was required in six patient records. This was not documented in patient records # 2, 3, 4 and 6. The facility had standing medication orders, which included the use of buprenorphine, for opiate detoxification. The patient records failed to document the physician's determination of the medication doses for patients # 2, 3, 4 and 6.
 
Plan of Correction
The four physicians prescribing buprenorphine will be met with by the Division Director and the Nurse Manager to review this standard by August 1, 2010 and will begin to write out the order accordingly on or by that date. The Nurse Manager will contact the pharmacy and have the buprenorphine protocol order removed from the September and subsequent month's standing order sheet. This will be monitored by the Nurse Manager and reported on in the monthly PI/QI meetings and will be overseen by the Division Director.

 
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