INITIAL COMMENTS
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This report is a result of an on-site licensure renewal inspection conducted on October 4 - 7, 2021 by staff from the Department of Drug and Alcohol Programs, Bureau of Program Licensure. Based on the findings of the on-site inspection, Gaudenzia Erie Inc. 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) (2) 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. The consent must be in writing and include, but not be limited to:
(2) Specific information disclosed.
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Observations
Based on a review of client records, the facility failed to document a written, informed and voluntary consent from the client that included the specific information disclosed in two of seven records.
Client # 6 was admitted July 1, 2021 and discharged August 16, 2021. Consents for the pharmacy, treatment provider, lab, hospital and doctor were completed during intake and did not include the specific information disclosed.
Client # 7 was admitted July 12, 2021 and discharged September 30, 2021. Consents for the pharmacy, relative/friend, lab, hospital and government agency were completed during intake and did not include the specific information.
The findings were reviewed with facility staff during the licensing process.
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Plan of Correction
All consent forms will document the specific information to be disclosed.
An in-service training was conducted on 7/26/21 reviewing this requirement with all staff. This topic will be revisited again by Quality Assurance Staff in collaboration with the Clinical Supervisor in an in-service training by 11/12/21.
The Clinical Supervisor will review charts on at least a monthly basis to ensure compliance using the standard audit tool.
A new consent form is being developed in our electronic health record and is scheduled to be released by 11/12/21. This new form has a mandatory field to indicate the specific information to be released to help ensure that all required areas are addressed.
The Quality Assurance department will conduct at least quarterly reviews of the program, to include proper completion of consent forms, and the Compliance department will conduct a review of all plans of correction within 9 months to ensure full implementation.
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709.28 (c) (3) 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. The consent must be in writing and include, but not be limited to:
(3) Purpose of disclosure.
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Observations
Based on a review of client records, the facility failed to document a written, informed, and voluntary consent from the client that included the purpose of disclosure in two of seven records.
Client # 6 was admitted July 1, 2021 and discharged August 16, 2021. Consents for the pharmacy, treatment provider, lab, hospital, and doctor were completed during intake and did not include the purpose of disclosure.
Client # 7 was admitted July 12, 2021 and discharged September 30, 2021. Consents for the pharmacy, relative/friend, lab, hospital, and government agency were completed during intake and did not include the purpose of disclosure.
The findings were reviewed with facility staff during the licensing process.
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Plan of Correction
All consent forms will document the purpose of the disclosure.
An in-service training was conducted on 7/26/21 reviewing this requirement with all staff. This topic will be revisited again by Quality Assurance Staff in collaboration with the Clinical Supervisor in an in-service training by 11/12/21.
The Division Director, Program Director, and Clinical Supervisor will review charts on at least a monthly basis to ensure compliance using the standard audit tool.
A new consent form is being developed in our electronic health record and is scheduled to be released by 11/12/21. This new form has a mandatory field to indicate the purpose of the disclosure to help ensure that all required areas are addressed.
The Quality Assurance department will conduct at least quarterly reviews of the program, to include proper completion of consent forms, and the Compliance department will conduct a review of all plans of correction within 9 months to ensure full implementation.
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709.28 (d) LICENSURE Confidentiality
§ 709.28. Confidentiality.
(d) A copy of a client consent shall be offered to the client and a copy maintained in the client record.
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Observations
Based on a review of client records and client handbook/orientation materials, the facility failed to document a copy of the client consent was offered to the client in two of seven records.
Client # 6 was admitted July 1, 2021 and discharged August 16, 2021. Consents for the pharmacy, treatment provider, lab, hospital, and doctor were completed during intake and there was no documentation the client was offered a copy of these consents.
Client # 7 was admitted July 12, 2021 and discharged September 30, 2021. Consents for the pharmacy, relative/friend, lab, hospital, and government agency were completed during intake and there was no documentation the client was offered a copy of these consents.
The findings were reviewed with facility staff during the licensing process.
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Plan of Correction
A copy of all consents shall be offered to the client, and their response documented on the form.
An in-service training was conducted on 7/26/21 reviewing this requirement with all staff. This topic will be revisited again by Quality Assurance Staff in collaboration with the Clinical Supervisor in an in-service training by 11/12/21.
The Division Director, Program Director, and Clinical Supervisor will review charts on at least a monthly basis to ensure compliance.
A new consent form is being developed in our electronic health record and is scheduled to be released by 11/12/21. This new form has a mandatory field to indicate that consent was offered to the client help ensure that all required areas are addressed.
The Quality Assurance department will conduct at least quarterly reviews of the program, to include proper completion of consent forms, and the Compliance department will conduct a review of all plans of correction within 9 months to ensure full implementation.
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709.32 (c) (3) (i) - (v) LICENSURE Medication control
§ 709.32. Medication control.
(3) Inspection of storage areas that ensures compliance with State and Federal laws and program policy. The policy must include, but not be limited to:
(i) What is to be verified through the inspection, who inspects, how often, but not less than quarterly, and in what manner it is to be recorded.
(ii) Disinfectants and drugs for external use are stored separately from oral and injectable drugs.
(iii) Drugs requiring special conditions for storage to insure stability are properly stored.
(iv) Outdated drugs are removed.
(v) Copies of drug-related regulations are available in appropriate areas.
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Observations
Based on a physical plant inspection, a review of medication documentation and facility staff interviews on October 6, 2021, the facility failed to document quarterly inspections of the medication storage area from January 2021 through September 2021.
The findings were reviewed with facility staff during the licensing process.
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Plan of Correction
Monthly inspection of all medication storage areas will be completed by the Nurse Manager utilizing a specific checklist to be maintained in the medication area. This will begin by 11/12/21.
The Division Director and Program Director will review documentation of this quarterly inspection to ensure that it is completed in a timely manner, and to address any concerns identified.
The Quality Assurance department will conduct at least quarterly reviews of the program, to include medication storage areas, and the Compliance department will conduct a review of all plans of correction within 9 months to ensure full implementation.
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709.52(a)(2) LICENSURE Tx type & frequency
709.52. Treatment and rehabilitation services.
(a) An individual treatment and rehabilitation plan shall be developed with a client. This plan shall include, but not be limited to, written documentation of:
(2) Type and frequency of treatment and rehabilitation services.
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Observations
Based on a review of client records, the facility failed to document an individual treatment and rehabilitation plan that included the frequency of group counseling services in three of seven records.
The following records included individual treatment plans that indicated the client was participating in group counseling but did not include the frequency of these sessions.
Client # 1 was admitted August 16, 2021. The individual treatment plan was documented August 23, 2021.
Client # 3 was admitted July 19, 2021. The individual treatment plan was documented July 30, 2021.
Client # 5 was admitted May 10, 2021 and discharged August 12, 2021. The individual treatment plan was documented June 4, 2021.
The findings were reviewed with facility staff during the licensing process.
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Plan of Correction
Treatment plans for any clients still active at the program will be updated by 11/12/21 to include frequency of services
Quality Assurance Staff in collaboration with the Clinical Supervisor will conduct an in-service training by 11/12/21 with all clinical staff to ensure that all understand this requirement.
The Division Director, Program Director, and Clinical Supervisor will also review clinical charts at least monthly to ensure compliance.
The Quality Assurance department will conduct at least quarterly reviews of the program, to include treatment plan documentation, and the Compliance department will conduct a review of all plans of correction within 9 months to ensure full implementation.
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709.52(b) LICENSURE TX Plan update
709.52. Treatment and rehabilitation services.
(b) Treatment and rehabilitation plans shall be reviewed and updated at least every 30 days. For those projects whose client treatment regime is less than 30 days, the treatment and rehabilitation plan, review and update shall occur at least every 15 days.
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Observations
Based on a review of client records, the facility failed to document a treatment plan review and update at least every thirty days in two of six client records.
Client # 3 was admitted July 19, 2021. The individual treatment plan was documented July 30, 2021. Only one treatment plan update was documented on August 24, 2021.
Client # 5 was admitted May 10, 2021 and discharged August 12, 2021. The individual treatment plan was documented June 4, 2021. Only one treatment plan update was documented on August 3, 2021.
The findings were reviewed with facility staff during the licensing process.
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Plan of Correction
Treatment plans for any clients still active at the program will be updated by 11/12/21
The Clinical Supervisor will conduct an in-service training in collaboration with the Quality Assurance department by 11/12/21 with all clinical staff to ensure that all understand this requirement.
The Clinical Supervisor will also review upcoming treatment plan due dates during daily treatment team meetings to remind staff of these deadlines, as well as at the end of shifts to ensure that they were completed.
The Division Director, Program Director, and Clinical Supervisor will conduct at least monthly audits to ensure that this is occurring.
The Quality Assurance department will conduct at least quarterly reviews of the program, to include documentation of treatment plan updates, and the Compliance department will conduct a review of all plans of correction within 9 months to ensure full implementation.
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709.53(a)(11) LICENSURE Follow-up information
709.53. Client records.
(a) There shall be a complete client record on an individual which includes information relative to the client's involvement with the project. This shall include, but not be limited to, the following:
(11) Follow-up information.
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Observations
Based on a review of client records, the facility failed to document follow-up information within seven days of discharge, per facility policy, in three of four records.
No follow-up information was documented in the following records.
Client # 4 was admitted February 10, 2021 and discharged June 7, 2021.
Client # 5 was admitted May 10, 2021 and discharged August 12, 2021.
Client # 6 was admitted July 1, 2021 and discharged August 16, 2021.
The findings were reviewed with facility staff during the licensing process.
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Plan of Correction
Follow up will be completed and documented for both of the clients identified by 11/12/21.
Follow up will be documented within 7 days for all clients post-discharge.
The Division Director and Program Director will conduct at least monthly audits of discharged charts to ensure that this is completed.
The Quality Assurance department will conduct at least quarterly reviews of the program, to include documentation of follow up, and the Compliance department will conduct a review of all plans of correction within 9 months to ensure full implementation.
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