INITIAL COMMENTS
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This report is a result of an on-site licensure renewal inspection and methadone monitoring inspection conducted on September 14-16, 2021 by staff from the Department of Drug and Alcohol Programs, Bureau of Program Licensure. Based on the findings of the on-site inspection, Pinnacle Treatment Centers PA-II, LLC 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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704.9(c) LICENSURE Supervised Period
704.9. Supervision of counselor assistant.
(c) Supervised period.
(1) A counselor assistant with a Master's Degree as set forth in 704.8 (a)(1) (relating to qualifications for the position of counselor assistant) may counsel clients only under the close supervision of a trained counselor or clinical supervisor for at least the first 3 months of employment.
(2) A counselor assistant with a Bachelor's Degree as set forth in 704.8 (a)(2) may counsel clients only under the close supervision of a trained counselor or clinical supervisor for at least the first 6 months of employment.
(3) A registered nurse as set forth in 704.8 (a)(3) may counsel clients only under the close supervision of a trained counselor or clinical supervisor for at least the first 6 months of employment.
(4) A counselor assistant with an Associate Degree as set forth in 704.8 (a)(4) may counsel clients only under the close supervision of a trained counselor or clinical supervisor for at least the first 9 months of employment.
(5) A counselor assistant with a high school diploma or GED equivalent as set forth in 704.8 (a)(5) may counsel clients only under the direct observation of a trained counselor or clinical supervisor for the first 3 months of employment. For the next 9 months, the counselor assistant may counsel clients only under the close supervision of a lead counselor or a clinical supervisor.
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Observations
Based on one of one counselor assistant personnel record reviewed, the facility failed to provide documentation of the required supervision for a counselor assistant with a Bachelor's degree. Employee # 9 was hired as a counselor assistant on June 14, 2021 and was still in this position at the time of the inspection. Supervision notes for June 20-26, 27-July 3, 4-10, 11-17, August 1-7, 8-14, 15-21, and 22-28 were not documented in the employee's personnel record. These findings were reviewed with facility staff during the licensing process.
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Plan of Correction
It was determined that not all counselor assistants received one hour of direct observation from a trained counselor or clinical supervisor for the first 6-months of employment.
The Facility Director will be responsible for making sure that all counselor assistants are being supervised by a full-time clinical supervisor or clinician who meets the 704.6 or 704.7 qualifications.
Counselor Assistants will receive one hour of weekly direct observation during their first 6 months of employment and this period of weekly direct observation will be documented with the counselor assistants' required weekly supervision.
Company Compliance & Human Resources department will regularly review employee HR files to make sure all staffing regulations are being met.
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709.28 (c) (4) 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:
(4) Dated signature of client or guardian as provided for under 42 CFR 2.14(a) and (b) and 2.15 (relating to minor patients; and incompetent and deceased patients).
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Observations
Based on one of five applicable client records reviewed, the facility failed to obtain an informed and voluntary consent from the client for the disclosure of information contained in the client record to include a dated signature of the client.Client # 7 was admitted on February 9, 2021 and was discharged on August 2, 2021. An informed and voluntary consent from the client for the disclosure of information dated February 9, 2021 to a government agency, emergency contact, funding, and transportation did not have a valid signature by the client but instead had telehealth verbal consent in the signature line.These findings were reviewed with facility staff during the licensing process.
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Plan of Correction
The facility failed to appropriately document informed and voluntary consent including in multiple record that was reviewed, which included incomplete signatures.
The COVID-19 pandemic caused a lot of issues around this regulation. Was difficult with some patients receiving extended exception bottles, doing sessions via telehealth, being quarantined and many other factor brought on by the pandemic.
The facility will ensure that all clinical staff appropriately complete all aspects of the informed and voluntary consent for patients, which includes dated signatures.
Supervisory Staff will meet with program staff in treatment team meeting and review all regulation requirements related to informed and voluntary consent.
The facility did change electronic documentation system in 2020. Facility will research if new system has the ability to make sure all aspects of a form has to be completed before allowing the form to be signed and completed. If this is possible, information will be provided to cooperate for possible implementation.
Supervisory & Compliance staff will continue to conducted chart reviews which does include this aspect of the patient file.
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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 one of five applicable client records reviewed, the facility failed to obtain an informed and voluntary consent from the client for the disclosure of information to include documentation of a copy of the client consent being offered to the client.Client # 2 was admitted on July 11, 2019 and was still active at the time of the inspection. An informed and voluntary consent from the client for the disclosure of information dated July 7, 2021 to a government agency- prescription authorization did not document a copy of the client consent being offered to the client. These findings were reviewed with facility staff during the licensing process.
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Plan of Correction
The facility failed to appropriately document if copy of completed consent was offered to patient.
The facility will ensure that all clinical staff appropriately complete all aspects of the informed and voluntary consent for patients, which will offering copy to patient and appropriately documenting patient response.
Supervisory Staff will meet with program staff in treatment team meeting and review all regulation requirements related to informed and voluntary consent, which will offering copy to patient and appropriately documenting patient response.
The facility did change electronic documentation system in 2020. Facility will research if new system has the ability to make sure all aspects of a form has to be completed before allowing the form to be signed and completed. If this is possible, information will be provided to cooperate for possible implementation.
Supervisory & Compliance staff will continue to conducted chart reviews which does include this aspect of the patient file.
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715.16(a)(3) LICENSURE Take-home privileges
(a) A narcotic treatment program shall determine whether a patient may be provided take-home medications.
(3) The narcotic treatment physician shall document in the patient record the rationale for permitting take-home medication.
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Observations
Based on one of two applicable patient records reviewed, the facility narcotic treatment physician failed to document the rationale for permitting take-home medication.Patient # 7 was admitted on February 9, 2021 and was discharged on August 2, 2021. An order to rescind 6 take-home bottles was documented on July 9, 2021, but there was no documentation in the record of the rationale permitting the patient 6 take-home bottles. These findings were reviewed with facility staff during the licensing process.
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Plan of Correction
The facility failed to appropriately document patient take-home medication that was being honored during a transfer admission.
The facility physician honored the transfer take-home level by entering the bottle days into the dosing record but provided incorrect documentation on the manual take-home order.
To resolve future errors, the PA and facility medical staff will double check manual physician orders that are utilized when patients transfer in to the facility with honored take-homes.
Medical staff will also verify honored take-home levels when transferring at the same time medical staff contacts transferring facility to verify methadone dosage.
Supervisory & Compliance staff will continue to conducted chart reviews which does include this aspect of the patient file.
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715.17(c)(1)(i-vi)) LICENSURE Medication control
(c) A narcotic treatment program shall develop and implement written policies and procedures regarding the medications used by patients which shall include, at a minimum:
(1) Administration of medication.
(i) A narcotic treatment physician shall determine the patient 's initial and subsequent dose and schedule. The physician shall communicate the initial and subsequent dose and schedule to the person responsible for the administration of medication. Each medication order and dosage change shall be written and signed by the narcotic treatment physician.
(ii) An agent shall be administered or dispensed only by a practitioner licensed under the appropriate Federal and State laws to dispense agents to patients.
(iii) Only authorized staff and patients who are receiving medication shall be permitted in the dispensing area.
(iv) There shall be only one patient permitted at a dispensing station at any given time.
(v) Each patient shall be observed when ingesting the agent.
(vi) Administering and dispensing shall be conducted in a manner that protects the patient from disruption or annoyance from other individuals.
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Observations
Based on one of seven applicable patient records reviewed, the facility failed to have a narcotic treatment physician document a medication order indicating a schedule change granting 6 day take homes.Patient # 7 was admitted on February 9, 2021 and was discharged on August 2, 2021. The initial order on April 1, 2021 did not indicate a take-home schedule. The next order on July 9, 2021 indicated 6 take-home bottles that were provided to the patient be rescinded.These findings were reviewed with facility staff during the licensing process.
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Plan of Correction
The facility failed to appropriately document patient take-home medication that was being honored during a transfer admission.
The facility physician honored the transfer take-home level by entering the bottle days into the dosing record but provided incorrect documentation on the manual take-home order.
To resolve future errors, the PA and facility medical staff will double check manual physician orders that are utilized when patients transfer in to the facility with honored take-homes.
Medical staff will also verify honored take-home levels when transferring at the same time medical staff contacts transferring facility to verify methadone dosage.
Supervisory & Compliance staff will continue to conducted chart reviews which does include this aspect of the patient file.
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715.19(1) LICENSURE Psychotherapy services
A narcotic treatment program shall provide individualized psychotherapy services and shall meet the following requirements:
(1) A narcotic treatment program shall provide each patient an average of 2.5 hours of psychotherapy per month during the patient 's first 2 years, 1 hour of which shall be individual psychotherapy. Additional psychotherapy shall be provided as dictated by ongoing assessment of the patient.
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Observations
Based on two of five applicable patient records reviewed, the facility failed to provide documentation of a narcotic treatment program providing each patient an average of 2.5 hours of psychotherapy per month during the patient 's first 2 years.Patient # 1 was admitted on June 7, 2021 and was still active at the time of the inspection. A review of progress notes indicates the patient did not receive 2.5 hours of psychotherapy a month. For the month of June 7-July 7 the patient had 0 hours of psychotherapy, August 7-September 7 the patient had 45 minutes of psychotherapy.Patient # 3 was admitted on June 1, 2021 and was still active at the time of the inspection. A review of progress notes indicates the patient did not receive 2.5 hours of psychotherapy a month. For the month of June the patient had 75 minutes of psychotherapy, July the patient had 75 minutes of psychotherapy and August the patient had 75 minutes of psychotherapy.These findings were reviewed with facility staff during the licensing process.
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Plan of Correction
The facility failed to provide 2.5 hours of psychotherapy services for all patient records that were reviewed.
The COVID-19 pandemic has cause a lot of issues around this regulation.
The facility will ensure that all patients receive the required of monthly psychotherapy. Monitoring of ongoing compliance with this regulation will be the responsibility of the Supervisory Staff through regular record review, clinical supervision, and utilization for Electronic Record reports.
Supervisory Staff will meet with program staff in treatment team meeting and review all regulation requirements related to individualized psychotherapeutic needs.
Clinical staff will maintain accurate records of when patients cancel, no-show, or reschedule appointments. Also, if patients continually remain out of compliance with treatment requirements treatment contracts will be utilized. Clinical staff will utilize Electronic Record reports to periodically check counseling compliance for their caseloads.
Open counseling positions will be filled to help ease the burden on current counseling staff and provide additional counseling staff to when other staff are out of the building.
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709.93(a)(11) LICENSURE Client records
709.93. 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 three of three applicable patient records reviewed, the facility failed to provide a complete patient record to include follow-up information in accordance with the facility policy and procedure manual. The facility policy and procedure manual indicate a follow up is to occur within 7 days, 3 months, and 12 months of the patient discharge. A follow-up will occur within 1 week of discharge if the patient is referred to another agency. Patient # 5 was admitted on November 9, 2016 and was discharged on June 16, 2021. There was no documentation of a follow-up in the patient record.Patient # 6 was admitted on August 18, 2017 and was discharged on August 20, 2021. There was no follow-up information documented in the patient record.Patient # 7 was admitted on February 9, 2021 and was discharged on August 2, 2021. There was no documentation of a follow-up in the patient record.These findings were reviewed with facility staff during the licensing process.
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Plan of Correction
The facility failed to complete required patient follow-ups post discharge per facility policies and procedure manual.
Facility moved to a new electronic documentation system towards the end of 2020 which has made it more difficult to tract completed patient documentation, especially when staff leave and patient are assigned to new counselors. This has also effected the scheduling & completion of discharge follow-ups. This issue will continue to be reported to corporate for possible resolution in the new electronic documentation system.
The facility will ensure that all required discharge follow-ups are completed per facility policies/procedure manual.
Supervisory Staff will meet with program staff in treatment team meeting and review all requirements related to scheduling & completion of discharge follow-ups.
Supervisory & Compliance staff will continue to conducted chart reviews which does include this aspect of the patient file.
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