INITIAL COMMENTS
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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 from opioid dependence. This inspection was conducted on March 22, 2010 by staff from the Division of Drug and Alcohol Program Licensure. Based on the findings of the on-site inspection, Gateway Rehabilitation Center, 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 April 11, 2010.
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Plan of Correction
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715.12(1-5) LICENSURE Informed patient consent
A narcotic treatment program shall obtain an informed, voluntary, written consent before an agent may be administered to the patient for either maintenance or detoxification treatment. The following shall appear on the patient consent form:
(1) That methadone and LAAM are narcotic drugs which can be harmful if taken without medical supervision.
(2) That methadone and LAAM are addictive medications and may, like other drugs used in medical practices, produce adverse results.
(3) That alternative methods of treatment exist.
(4) That the possible risks and complications of treatment have been explained to the patient.
(5) That methadone is transmitted to the unborn child and will cause physical dependence.
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Observations
Based on a review of the patient records, the facility failed to obtain an informed patient consent for the use of buprenorphine in one of four patient records.
The findings include:
Four patient records were reviewed on March 22, 2010. Four patient records were` required to contain documentation of an informed patient consent for the use of buprenorphine.
Record #3 - Patient was admitted on 1-30-10, transferred to residential rehabilitation treatment on 2-2-10 and discharged on 2-12-10. The informed consent was not documented in the patient record. The first dose of Suboxone was given on 2-1-10 at 2:00 PM and the last dose of Suboxone was given on 2-2-10.
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Plan of Correction
After a patient is approved for Suboxone by the physician, a nurse reviews the informed consent with the patient and has the patient sign it. Each nurse is responsible to ensure that the informed consent is signed before each dose of medication is given. The Director will review this process with the nursing staff at the next Staff Meeting and will conduct random checks of the consents to ensure that the informed consent is being signed before Suboxone is administered. |