INITIAL COMMENTS
|
This report is a result of an on-site provisional license follow-up inspection conducted on April 15, 2021 by staff from the Department of Drug and Alcohol Programs, Bureau of Program Licensure. Based on the findings of the on-site inspection, Polaris Detox LLC dba Innovo Detox was found not to be in compliance with the applicable chapters of 28 PA Code which pertain to the facility. The following deficiencies were identified during this inspection:
|
Plan of Correction
|
709.34 (c) (5) LICENSURE Reporting of unusual incidents
§ 709.34. Reporting of unusual incidents.
(c) To the extent permitted by State and Federal confidentiality laws, the project shall file a written unusual incident report with the Department within 3 business days following an unusual incident involving:
(5) Outbreak of a contagious disease requiring CDC notification.
|
Observations
Based on a review of client records and administrative information, the facility failed to file a written unusual incident report to the Department within 3 business days following an incident involving an outbreak of a contagious disease requiring CDC notification.
Client record #1 documented a positive test on December 19, 2020.
Client record #2 documented a positive test on March 3, 2021.
The findings were reviewed with facility staff during the licensing process.
|
Plan of Correction
The Compliance Specialist or the Director of HR & Compliance will report all required unusual incidents to DDAP within 3 business days. The Compliance Specialist and Director of HR and Compliance are responsible for ensuring the corrective action is implemented. The Nurse Practitioners and the Director of Nursing, who are the staff members that receive patient lab results, were educated on 4/19/2021 to alert the Compliance Team when a reportable incident occurs, specifically a contagious disease requiring CDC notification. Incident reports will be tracked and documented on the DDAP Electronic Reporting System, as well as, in Innovo's Incident Report binder. |
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.
|
Observations
Based on a review of the patient records, the facility failed to document an informed patient consent for the use of buprenorphine which includes all five items.
Four of four buprenorphine patient records reviewed did document an informed patient consent, but the consent did not include: (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.
Patient records # 1, 3, 4, and 5 did not document a patient consent for the use of buprenorphine.
The findings were reviewed with facility staff during the licensing process.
|
Plan of Correction
The Compliance Specialist added the appropriate components to the Buprenorphine Consent with consultation from the Director of Nursing. The consent now clearly contains all 5 required items, and it is hard-coded in the form so this deficiency shall not reoccur. The consent is populated by Nursing in a patient's electronic medical record when applicable. Nursing reviews the Buprenorphine consent with the patient prior to having the patient sign. Additionally, the Compliance Specialist and Director of HR and Compliance will conduct monthly chart audits to ensure the Buprenorphine consents continue to be signed by the applicable patients. |