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 3, 2011 by staff from the Division of Drug and Alcohol Program Licensure. Based on the findings of the on-site inspection, Caron Treatment Centers 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 and a plan of correction is due on January 23, 2011.
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Plan of Correction
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Observations
Based on review of the patient records and discussion with facility staff, the facility failed to obtain a complete drug screen urinalysis prior to the administration of Subutex, a narcotic agent, in five of five patient records. A complete urine drug screen includes receiving the results from the CLIA and Department of Health approved laboratory.
The findings include:
Five patient records were reviewed on January 3, 2011. Five patient records were required to have a complete drug screen urinalysis prior to the administration of Subutex, a narcotic agent. The facility failed to obtain a complete drug screen urinalysis prior to the administration of Subutex, a narcotic agent in five of the five patient records.
Record #1 - Patient was admitted on June 23, 2010.
The urine for the drug screen was obtained June 23, 2010 and the result was received by the facility June 25, 2010. The first dose of Subutex was given on June 23, 2010 at 11:13 PM.
Record #2 - Patient was admitted on September 8, 2010.
The urine for the drug screen was obtained September 8, 2010 and the result was received by the facility September 15, 2010. The first dose of Subutex was given on September 9, 2010.
Record #3 - Patient was admitted on October 1, 2010.
The urine for the drug screen was obtained October 1, 2010 and the result was received by the facility October 3, 2010. The first dose of Subutex was given on October 2, 2010 at 11:57 AM.
Record #4 - Patient was admitted on December 24, 2010.
The urine for the drug screen was obtained December 25, 2010 and the result was received by the facility December 28, 2010. The first dose of Subutex was given on December 27, 2010 at 9:07 AM.
Record #5 - Patient was admitted on December 23, 2010.
The urine for the drug screen was obtained December 22, 2010 and the result was received by the facility December 24, 2010. The first dose of Subutex was given on December 23, 2010 at 2:09 PM.
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Plan of Correction
When clinically indicated prior to dosing with buprenorphine, a completed drug screen result will be on the chart prior to dosing. Compliance monitoring will be done by the DON on an ongoing basis for quality control purposes.
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