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 19, 2011 by staff from the Division of Drug and Alcohol Program Licensure. Based on the findings of the on-site inspection, Livingrin Foundation, 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 and a plan of correction is due on February 16, 2011.
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Plan of Correction
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Observations
Based on a review of patient records and an interview with the administrative staff, the facility failed to document an informed and voluntary consent from the patient for the disclosure of information contained in the patient record, in five of five client records, as required.
The findings include:
Five patient records were reviewed on January 19, 2011. Five patient records were required to include an informed and voluntary consent to release patient identifying information. Per regulation, a narcotic treatment program shall physically secure and maintain the confidentiality of all patient records in accordance with 42 CFR 2.22 (relating to notice to patients of Federal confidentiality requirements and 709.28 (relating to confidentiality). Five patient records included consents to release information that included a revocation statement. This revocation statement indicated that the consent could be revoked upon the patient's written request. This is in violation of 42 CFR 2.31 which states a consent is subject to revocation at any time except to the extent that the program or person which is to make the disclosure has already acted in reliance on it. The facility failed to provide the patients with an informed and voluntary consent including this revocation statement in patient records # 1, 2, 3, 4 and 5.
The administrative staff was interviewed on January 19, 2011 at approximately 1:45 PM. The administrative staff reviewed the consents and confirmed that all of the consents to release information did state the revocation was to be in writing in accordance with HIPAA.
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Plan of Correction
The Director of Total Quality Management will remove the requirement for revocation of consents to be in writing. The amended consents will indicate that a consent is subject to revocation at any time, except to the extent that the program or person which is to make the disclosure has already acted in reliance on it. This action will pertain to all consents. Compliance will be monitored by the Chief Clinical Officer. |