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 October 21, 2010 by staff from the Division of Drug and Alcohol Program Licensure. Based on the findings of the on-site inspection, Malvern Institute 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 November 10, 2010.
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Plan of Correction
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Observations
Based on a review of patient records and a discussion with the facility director, the facility failed to ensure that the patient was initially dosed following the completion of a drug-screen urinalysis in one of ten patient records.
The findings included:
Five patient records were reviewed on October 21, 2010. Five patient records were reviewed for drug screen urinalysis results prior to a patient's initial dose. Per regulation, a narcotic treatment program shall complete an initial drug-screening urinalysis for each prospective patient. The facility failed to document the completion of a drug screen urinalysis prior to dosing in patient record # 1 and # 4.
Patient # 1 was admitted into treatment on October 18, 2010. On October 18, 2010, the facility utilized an instant urine drug screen (dipstick) test that is Clinical Laboratory Improvement Amendments of 1998 (CLIA) waived. This is not a completed drug-screening urinalysis in that the laboratory performing the testing is not CLIA approved.
Patient # 4 was admitted into treatment on September 7, 2010. On September 7, 2010, the facility utilized an instant urine drug screen (dipstick) test that is Clinical Laboratory Improvement Amendments of 1998 (CLIA) waived. This is not a completed drug-screening urinalysis in that the laboratory performing the testing is not CLIA approved.
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Plan of Correction
UDS will be complete and reviewed prior to dispensing suboxone. Results may be read and printed from an online system to ensure timliness and accuracy. The prescribing physician will review all UDS results prior to dispensing suboxone. The Medical Director will monitor this process. |