INITIAL COMMENTS
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This report is a result of an on-site licensure renewal inspection conducted on September 27, 2016 by staff from the Division of Drug and Alcohol Program Licensure. Based on the findings of the on-site inspection, Gateway/Greentree 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:
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Plan of Correction
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709.28 (c) LICENSURE Confidentiality
§ 709.28. Confidentiality.
(c) The project shall obtain an informed and voluntary consent from the client for the disclosure of information contained in the client record.
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Observations
In one of twelve client records reviewed during the annual licensing inspection conducted on September 27, 2016, the project exceeded the limitations imposed at 4 Pa. Code 255.5 (b) when releasing information to an insurance company.
Client # 5 was admitted on 6/25/16. The facility faxed Suboxone authorization documents on September 2, 2016 to the insurance company. The project exceeded 4 Pa. Code 255.5 (b) by including a copy of the drug screen test results and the client's psychosocial evaluation.
The findings were reviewed with facility staff during the licensing process.
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Plan of Correction
The Outpatient Services Director met with the Manager of Gateway Greentree, the Manager of Gateway MAT and the Director of Nursing on 10/7/2016 to discuss this citation and action plan.
In turn, the three managers will provide a brief in-service with their respective staffs, informing them of the need to acquire the appropriate signed consent from each patient for their respective funding source, from which an authorization for medication is requested. These managers will conduct their in-services with their staffs by no later than 10/14/2016. Written procedures for consent to insurance companies (funding sources), with the limitations of 4 Pa. Code 255.5 will also be presented to the staffs at their in-service meetings.
Included in the procedures is the directive that the Outpatient and the MAT Managers, or their designee, will monitor all MAT patients to insure the acquisition of appropriate consents to funding sources for medication authorizations; and that only information limited by 4 Pa. Code 255.5 is to be released.
Additionally, the Director of Outpatient Services will meet with the managers of all nine outpatient facilities on 10/28/2016 and will inform them of this issue and will provide them all with the written procedure. In turn, they all will provide a refresher in-service to their respective staffs on this issue/need by 11/4/2016.
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715.14(a) LICENSURE Urine testing
(a) A narcotic treatment program shall complete an initial drug-screening urinalysis for each prospective patient and a random urinalysis at least monthly thereafter.
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Observations
The facility failed to obtain complete drug screen urinalysis prior to the administration of Suboxone, a narcotic agent, and monthly there after, in two of four patient records reviewed during the September 27, 2016 inspection.
Patient #2 was admitted on 6/1/16. The initial urine screen was completed on 5/26/16 using a dip stick. There was no documentation provided that the facility had the required CLIA certificate nor that the urine screen had been sent to a lab. The initial dose of Suboxone was given on 5/26/16.
Patient # 4 was admitted on 7/28/16. The initial urine screen was completed on 7/28/16 using a dip stick. There was no documentation provided that the facility had the required CLIA certificate nor that the urine screen had been sent to a lab. The initial dose of Suboxone was given on 7/28/1616. Urinalysis conducted on August 4, 11 and 18, 2016 were completed using a dip stick. There was no documentation provided that the facility had the required CLIA certificate nor that the urine screen had been sent to a lab.
These findings were reviewed with facility staff during the licensing process.
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Plan of Correction
The Outpatient Services Director met with the Manager of Gateway Greentree, the manager of Gateway MAT and the Director of Nursing on 10/07/2016 to discuss this citation and action plan. Being that Gateway has acquired a CLIA certification, but this location did not have the appropriate certificate, the MAT Manager will investigate and acquire the needed certificate for the facility. The request for the CLIA certificate will occur on 10/10/2016. When the certificate is acquired by the facility, it will be posted. Until then, urine drug specimens for MAT patients will be sent to the laboratory for documented results.
Additionally, the three managers will provide a brief in-service with their respective staffs, informing them of the need to acquire laboratory documented urine drug screens on MAT patients until informed otherwise. These managers will conduct their in-services with their staffs by no later than 10/14/2016.
It was furthermore directed that the Outpatient and the MAT Managers, or their designee, will immediately begin monitor all MAT patient activity to insure the acquisition of laboratory documented drug screens until the appropriate CLIA certificate is acquired.
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