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Pennsylvania Department of Drug & Alcohol Programs
Inspection Results

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ST. LUKE'S PENN FOUNDATION
807 LAWN AVENUE<br>PO Box 32
SELLERSVILLE, PA 18960

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Survey conducted on 01/24/2013

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 January 24, 2013 by staff from the Division of Drug and Alcohol Program Licensure. Based on the findings of the on-site inspection, Penn Foundation For Mental Health, Inc. 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

715.15(b)  LICENSURE Medication dosage

(b) The narcotic treatment physician shall determine the proper dosage level for a patient, except as otherwise provided in this section. If the narcotic treatment physician determining the initial dose is not the narcotic treatment physician who conducted the patient examination, the narcotic treatment physician shall consult with the narcotic treatment physician who performed the examination before determining the patient 's initial dose and schedule.
Observations
Based on a review patient records, the narcotic treatment program failed to document the consultation between the narcotic treatment physician determining the initial dose and the narcotic treatment physician performing the physical examination in six of eight patient records, as required.



The findings include:



Eight patient records were reviewed January 24, 2013.



Patient # 1 was admitted August 14, 2012. A document signed by the physician ordering the medication dose and schedule was dated August 14, 2012. The form contained a pre-printed statement that the history and physical completed by another physician was reviewed. However, the history and physical was not completed until August 15, 2012. In addition, this statement only states the physical was reviewed, not that a consultation had been conducted between the two physicians.



Patient # 3 was admitted December 12, 2012. One physician wrote the order for the patient's dose and schedule on December 12, 2012 without documenting a consultation with the physician conducting the history and physical. The history and physical was completed on December 13, 2012, a day after the medication order was written.



Patient # 4 was admitted January 18, 2013. One physician wrote the order for the patient's dose and schedule on January 18, 2013 without documenting a consultation with the physician conducting the history and physical. The history and physical was completed on January 21, 2013 , three days after the medication order was written.



Patient # 5 was admitted January 15, 2013. One physician wrote the order for the patient's dose and schedule on January 16, 2013 without documenting a consultation with the physician conducting the history and physical. The history and physical was completed on January 16, 2013.



Patient # 6 was admitted January 22, 2013. One physician wrote the order for the patient's dose and schedule on January 22, 2013 without documenting a consultation with the physician conducting the history and physical. The history and physical was completed on January 22, 2013.



Patient # 7 was admitted January 17, 2013. One physician wrote the order for the patient's dose and schedule on January 18, 2013 without documenting a consultation with the physician conducting the history and physical. The history and physical was completed on January 18, 2013.
 
Plan of Correction
It was discovered during the site visit that the consultation between the NTP and the physician completing the physical examination was not consistently occurring and that several times the NTP had written orders for Suboxone prior to the physical exam. To address this, PFRC has implemented a new NTP evaluation form that covers all necessary components of the physical exam and physiological dependence to opiates. No Suboxone orders will be written without this examination completed in its entirety. This form includes a section specifically dedicated to attestation of a consult, if the person completing the physical component is not the NTP. This form will assure no Suboxone is prescribed prior to the examination taking place. NTP's and CRNP developed this form and have been made aware of our new procedure. Executive Director and Medical Director will oversee this POC.

715.17(c)(3)(i-v)  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: (3) Inspection of storage areas. A narcotic treatment program shall inspect all drug storage areas and the dispensing station at least quarterly to ensure that the areas are maintained in compliance with Federal, State and local laws and regulations. A narcotic treatment program shall develop and implement written policies and procedures regarding who performs the inspections, how often, and in what manner the inspections are to be documented. The policies and procedures shall include the following: (i) Disinfectants and drugs for external use shall be stored separately from oral and injectable drugs. (ii) Drugs requiring special conditions for storage to insure stability shall be properly stored. (iii) Outdated and contaminated drugs shall be removed and destroyed according to Federal and State regulations. (iv) Administration of controlled substances shall be documented. (v) Controlled substances and other abusable drugs shall be stored in accordance with Federal and State regulations.
Observations
Based on the review of administrative documentation and discussion with facility staff, the facility failed to complete inspections of the drug storage areas at least quarterly.



The findings include:



The documentation of at least quarterly inspections was reviewed January 24, 2013. The nursing director reported she completed these inspections monthly. In reviewing the documentation, it was noted the last documented entry was dated in September 2012.
 
Plan of Correction
It was discovered during the site visit that our nursing staff failed to document the last quarterly medication inspection. Nursing staff have reviewed our internal policy and procedure requiring quarterly medication inspections and are aware of the need to document the inspection. Nursing Director will oversee this POC.

715.24(3)  LICENSURE Narcotic detoxification

If a narcotic treatment program provides narcotic detoxification services, the narcotic treatment program shall develop and implement narcotic detoxification policies and procedures which include the following: (3) A 1-year physiologic dependence is not required for narcotic detoxification although documentation of current dependency is required.
Observations
Based on the review of clinical documentation, the facility, particularly the physician, failed to accurately document the basis for determining current dependency in four of eight patient records.



The findings include:



Eight patient records were reviewed January 24, 2013. Eight patient records were reviewed for physician documentation of the basis for determining current dependency.

Patient # 4 was admitted January 18, 2013. There was no documentation, prior to the administration of medication, by the physician of current dependency.



Patient # 5 was admitted January 15, 2013. There was no documentation, prior to the administration of medication, by the physician of current dependency.



Patient # 6 was admitted January 21, 2013. There was no documentation, prior to the administration of medication, by the physician of current dependency.



Patient # 7 was admitted January 17, 2013. There was no documentation, prior to the administration of medication, by the physician of current dependency.
 
Plan of Correction
It was discovered during the site visit that a recent update in Suboxone paperwork had excluded the NTP's attestation as to the client's physiological dependence. This deficiency has been resolved with the implementation of our new NTP examination which has an component for the NTP to document the physiologic dependence to opiates. The use of the new form will assure that this dependence is clearly documented for all clients prior to being started on Suboxone. The Executive Director and Medical Director will oversee this POC.

 
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