INITIAL COMMENTS
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This report is a result of an on-site licensure renewal and buprenorphine waiver inspection conducted on November 18, 2015 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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704.11(f)(2) LICENSURE Trng Hours Req-Coun
704.11. Staff development program.
(f) Training requirements for counselors.
(2) Each counselor shall complete at least 25 clock hours of training annually in areas such as:
(i) Client recordkeeping.
(ii) Confidentiality.
(iii) Pharmacology.
(iv) Treatment planning.
(v) Counseling techniques.
(vi) Drug and alcohol assessment.
(vii) Codependency.
(viii) Adult Children of Alcoholics (ACOA) issues.
(ix) Disease of addiction.
(x) Aftercare planning.
(xi) Principles of Alcoholics Anonymous and Narcotics Anonymous.
(xii) Ethics.
(xiii) Substance abuse trends.
(xiv) Interaction of addiction and mental illness.
(xv) Cultural awareness.
(xvi) Sexual harassment.
(xvii) Developmental psychology.
(xviii) Relapse prevention.
(3) If a counselor has been designated as lead counselor supervising other counselors, the training shall include courses appropriate to the functions of this position and a Department approved core curriculum or comparable training in supervision.
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Observations
Based on a review of staff training documentation, the facility failed to document 25 clock hours of training for the 2014 training year for one of two counselors reviewed.
The findings include:
Training records for two counselors were reviewed on November 18, 2015. All counselors are required to complete 25 clock hours of training each training year. The projects training year is January through December and the 2014 training year was reviewed during this inspection. Employee #5 did not complete 25 clock hours of training for the 2014 training year.
Employee #5 has been in her current counselor position since January 29, 2013. At the time of the inspection, employee #5 had .75 hours of training documented for the 2014 training year.
These findings were reviewed with facility staff during the licensing process.
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Plan of Correction
The Manager has already created an on-site file for each staff member, which includes copies of training plans & training records/certificates, and other personnel documents
The Manager will review these records at the end of each quarter as an aid to encourage staff to schedule and complete trainings listed on their annual plans. In turn, the Manager will present a quarterly status report to the Director.
To ensure closer monitoring of staff trainings, the facility's Administrative Assistant will assist the manager by also monitoring the staff files quarterly and collaborate with the manager regarding training needs and scheduling.
The Manager will compare these records with HR every 6 months to ensure completeness of both files. This will assist the manager to maintain a more hands-on record of the type and number of training hours for each staff.
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715.9(a)(4) LICENSURE Intake
(a) Prior to administration of an agent, a narcotic treatment program shall screen each individual to determine eligibility for admission. The narcotic treatment program shall:
(4) Have a narcotic treatment physician make a face-to-face determination of whether an individual is currently physiologically dependent upon a narcotic drug and has been physiologically dependent for at least 1 year prior to admission for maintenance treatment. The narcotic treatment physician shall document in the patient 's record the basis for the determination of current dependency and evidence of a 1 year history of addiction.
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Observations
Based on a review of patient records, the facility failed to document that a narcotic treatment physician made a face-to-face determination of whether an individual is currently physiologically dependent upon a narcotic drug and has been physiologically dependent for at least 1 year prior to admission for maintenance treatment. The narcotic treatment physician shall document in the patient 's record the basis for the determination of current dependency and evidence of a 1 year history of addiction.
The findings include:
Four buprenorphine patient records were reviewed on November 18, 2015. All of the patient records reviewed were required to include documentation that a narcotic treatment physician made a face-to-face determination of current physiological dependence and a 1 year history of dependence. Patient records # 5, 6, 7 and 8 did not include documentation of a face-to-face determination of current dependency and/or 1 year history of dependence.
Patient #5 was admitted to treatment at this facility on July 9, 2015. The patient's first dose of buprenorphine was given on 6/15/15, when he/she was in a higher level of care within the project. There was no documentation of a one year history of opiate dependence contained in patient record #5.
Patient #6 was admitted to treatment at this facilty on July 6, 2015. The patient's first dose of buprenorphine was given on 6/11/15, when he/she was in a higher level of care within the project. There was no documentation of a one year history of opiate dependence contained in patient record #6.
Patient #7 was admitted to treatment at this facilty on July 24, 2015. The patient's first dose of buprenorphine was given on 9/10/15. There was no documentation of a face-to-face assessment, current dependency and a one year history of opiate dependence contained in patient record #7.
Patient #8 was admitted to treatment at this facilty on October 14, 2015. The patient's first dose of buprenorphine was given on 9/23/15, when he/she was in a higher level of care within the project. There was no documentation of a one year history of opiate dependence contained in patient record #8.
These findings were reviewed with facility staff during the licensing process.
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Plan of Correction
1 1/2 weeks before Gateway Greentree's licensing date, another Gateway outpatient facility acquired this same citation. Immediately the Outpatient Director and the Medical Records Director developed the following procedure and a progress note form for Gateway physicians to use when evaluating a patient for treatment with buprenorphine:
1) If a patient is induced with buprenorphine by a Gateway staff physician, that physician will complete a specific progress note, called "Physician Progress Note Initial Suboxone Evaluation". This progress note format guides the physician to complete documentation on a variety of important and required clinical information, and includes the statement, "Based on my face to face evaluation, it is my best judgment as a physician, that this patient shows evidence of current physiologic addiction to heroin or other opiate drugs and has a history of at least one year addiction as documented above (in the progress note)."
Completing this specific documentation form will ensure a thorough physician evaluation of each buprenorphine patient and will ensure it is documented that the patient has been involved with, at least one year of opiate addiction. This evaluation and included statement will be signed and dated by the physician.
The Manager of the facility or the Administrative Assistant will review each patient record, for those who have been prescribed buprenorphine, to ensure that the ?Physician Progress Note Initial Suboxone Evaluation? was appropriately completed and signed by the evaluating physician. This review will occur within one work day of the completion of the evaluation.
This procedure and progress note form was implemented on 11/18/2015
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715.10(f) LICENSURE Pregnant patients
(f) The narcotic treatment program shall ensure that each female patient is fully informed of the possible risk to her or her unborn child from continued use of illicit drugs and from use of, or withdrawal from a narcotic drug administered or dispensed by the program in comprehensive maintenance or detoxification treatment.
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Observations
Based on a review of patient records, the facility failed to document that each female patient is fully informed of the possible risk to her or her unborn child from continued use of illicit drugs and from use of, or withdrawal from a narcotic drug administered or dispensed by the program in comprehensive maintenance or detoxification treatment in one of two patient records.
The findings include:
Two female buprenorphine patient records were reviewed on November 18, 2015. One of the female patients reviewed started buprenorphine at a higher level of care at a different facility within the project and had signed a buprenorphine consent to treatment. The other female buprenorphine patient reviewed, patient #7, started buprenorphine while at this facility and was required to be informed of risk to her or her unborn child from continued use of illicit drugs and from use of, or withdrawal from a narcotic drug administered or dispensed by the program in comprehensive maintenance or detoxification treatment.
Patient #7 was admitted to treatment at this facilty on July 24, 2015. Patient #7 was prescribed buprenorphine on September 10, 2015. There was no buprenorphine consent to treatment documented for patient #7, nor was there any type of signed document provided to patient #7 to inform her of the risk to her or her unborn child.
These findings were reviewed with facility staff during the licensing process.
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Plan of Correction
Since this licensing visit, the Outpatient Director, the Director of Medical Records and the MAT Manager rewrote the patient consent form, specific to buprenorphine and Suboxone treatment. It is now called ?Buprenorphine/Suboxone Consent for Medication Assisted Treatment & Patient Information?.
It serves as the consent for treatment with these medications and it details information about Suboxone and the possible risks associated with taking the medication, including risks to women who are pregnant or who plan to become pregnant.
The staff person who assists the patient to complete the consent form will review the medication information, including the risks associated with taking the medication
This new consent/information form has been implemented as of this date, 12/07/15.
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715.15(b) LICENSURE Medication dosage
(b) The narcotic treatment physician shall determine the proper dosage level for a patient, except as otherwise provided in this section. If the narcotic treatment physician determining the initial dose is not the narcotic treatment physician who conducted the patient examination, the narcotic treatment physician shall consult with the narcotic treatment physician who performed the examination before determining the patient 's initial dose and schedule.
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Observations
Based on a review of patient records, the facility's physician failed to adhere to the dosing protocol listed on the medication by ordering that single dose buprenorphine film be halved in one of four patient records. The medication packaging identifies this as a single dose medication.
The findings include:
Four buprenorphine patient records were reviewed on November 18, 2015. Medication orders documented in patient records # 7 instructed that a single dose buprenorphine film be halved.
Patient #7 was admitted on July 24, 2015. A prescription written on 9/10/15 stated that the patient was to take 1/2 of an 8 milligram film b.i.d.
These findings were reviewed with facility staff during the licensing process.
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Plan of Correction
On December 7, 2015, Gateway?s Medical Director clarified, in writing, the appropriate protocol for dosing Suboxone. Then the Director further in-serviced each of the staff physicians in regards to the regulation and the procedure for dosing.
The MAT Manager will monitor the dosing on each patient?s medication logs. The Manager will report any errors or incorrect dosing to the prescribing physician, the Medical Director, the Program Director and the Vice-President of Treatment Programs.
The Vice-President will then collaborate with the Medical Director regarding any action that may need to take place regarding the prescribing physician and h/her credentialing rights with Gateway.
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