INITIAL COMMENTS
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This report is a result of an on-site licensure renewal inspection conducted on November 9, 2015 by staff from the Division of Drug and Alcohol Program Licensure. Based on the findings of the on-site inspection, Gateway Greensburg 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 personnel training records, the facility failed to document the completion of 25 clock hours of annual training required for counselors in one of two personnel training records.
Four personnel training records pertaining to counselors were reviewed on November 2 and November 9, 2015. Two personnel training records were required to include documentation of 25 clock hours of annual training. Two personnel records pertained to newly hired counselors and were not reviewed for annual training hours. The facility failed to document the completion of 25 clock hours of annual training required for counselors in personnel record # 6.
Employee # 6 was hired for the position of counselor on June 27, 2005. The project's training year is from January through December. Employee # 6 had only 22 clock hours of annual training documented for the January 1 - December 31, 2014 training year.
The findings were reviewed with facility staff during the licensing process.
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Plan of Correction
The Clinical 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 a 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 narcotic treatment physician failed to document a face-to-face determination of whether an individual was currently physiologically dependent upon a narcotic drug and has been physiologically dependent for at least 1 year prior to admission for maintenance treatment in three of three patient records.
The findings include:
Ten client records were reviewed on November 9, 2015. Three patients were prescribed Suboxone. These patient records were reviewed for documentation that the physician made a face-to-face determination of whether the individual was currently physiologically dependent upon a narcotic drug and had been physiologically dependent for at least one year prior to admission for maintenance treatment. The narcotic treatment physician failed to document a face-to-face determination in the patient's record including the basis for determination of current dependency and evidence of a one year history of addiction in patient records # 8, 9 and 10.
Patient # 8 was admitted into treatment on February 2, 2015. Patient # 8 was prescribed Suboxone on February 13, 2015. The narcotic treatment physician failed to document a face-to-face determination of whether patient # 8 was currently physiologically dependent upon a narcotic drug and had been physiologically dependent for at least one year prior to admission for maintenance treatment.
Patient # 9 was admitted into treatment on March 23, 2015 and discharged on June 5, 2015. Patient # 9 was prescribed Suboxone on April 10, 2015. The narcotic treatment physician failed to document a face-to-face determination of whether patient # 9 was currently physiologically dependent upon a narcotic drug and had been physiologically dependent for at least one year prior to admission for maintenance treatment.
Patient # 10 was admitted into treatment on August 4, 2015 and discharged on October 23, 2015. The narcotic treatment physician conducted a face-to-face examination of patient # 10 and prescribed Suboxone on August 5, 2015. The narcotic treatment physician failed to document in the patient's record the evidence of a one year history of addiction prior to admission for maintenance treatment.
The findings were reviewed with facility staff during the licensing process.
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Plan of Correction
Since the November 9, 2015 licensing date and the facility acquired this citation for the lack of such physician documentation, two procedures have been established:
1) The Outpatient Director, Medical Records Director and MAT Manager prepared this procedure and the related ?physician progress note?.
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.
(2) The outpatient Director and the MAT Manager prepared this following procedure.
If a patient is induced with Suboxone by a non-Gateway employed physician, and that physician continues to monitor and prescribe Suboxone to the patient while physically at a Gateway facility, that physician will provided copies of the patient medical records which will be included in the Gateway patient chart.
This medical information will include the patient initial medical evaluation, which will also include the physician's statement that the patient was evaluated to have been addicted to opiates for at least one (1) year.
This documentation will also be dated and signed by that physician.
The facility Manager or her designee will review the patient chart and the Physician Progress Note completed by the Gateway physician or the medical record documents from the external physician who will continue to treat the patient at the Gateway facility. This will occur to ensure accuracy and thoroughness of documentation.
This review/monitoring will occur within one work day of the initial patient evaluation by the physician.
Both of the above documentation procedures were established on November 18, 2015.
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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
Based on review of patient records, the facility failed to complete a random drug-screening urinalysis at least monthly in one of three patient records.
The findings include:
Ten client records were reviewed on November 9, 2015. Three patients were prescribed Suboxone. Three patients were required to complete a random urinalysis at least monthly. A complete drug-screening urinalysis includes receiving the results from a CLIA and Department of Health approved laboratory. The facility failed to document a complete drug-screening urinalysis at least monthly in patient record # 8.
Patient # 8 was admitted into treatment on February 2, 2015. Patient # 8 was prescribed Suboxone on February 13, 2015. The facility completed monthly random drug screens using the dipstick method in April, July, August, September and October 2015. There was no documentation these monthly drug screens were sent out to a laboratory for urinalysis.
The findings were reviewed with facility staff during the licensing process.
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Plan of Correction
The day after this facility's licensing visit, the Director informed this facility staff and all other Gateway outpatient facilities, to ensure that each patient receives at least one (1) drug screen per month from a contracted laboratory.
The Director communicated this procedure via e-mail to all OP facility managers and instructed them to immediately inform their respective staffs. This directive was also placed in the facility charting manual for future reference.
Typically when a patient is in an outpatient rehab level of care, i.e., partial hospitalization and intensive outpatient, laboratory drug screens are conducted several times per month. But in recent months, when a Suboxone patient has been transferred to traditional outpatient and has been in treatment for several months, we had been mainly utilizing instant drug screens.
This, however, has been rectified, whereby we now do continue to utilize laboratory drug screens for each Suboxone patient along with using instant drug screens.
The facility Manager and the Administrative Assistant will monitor this by reviewing the patient charts, at least once/month, to ensure that the laboratory drug screens are being done as per regulation.
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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 narcotic treatment physician failed to document a patient examination prior to determining the patient's initial dose and schedule of Suboxone in two of three patient records.
The findings include:
Ten client records were reviewed on November 9, 2015. Six client records pertained to the outpatient activity. Three patients were prescribed Suboxone and were required to receive a patient examination. The narcotic treatment physician failed to document a patient examination prior to determining the patient's initial dose and schedule of Suboxone in client records # 8 and 9.
Client # 8 was admitted into treatment on February 2, 2015. Client # 8 was prescribed Suboxone on February 13, 2015. There was no documentation of a patient examination in client record # 8, as of November 9, 2015. The narcotic treatment physician failed to document a patient examination prior to determining the patient's initial dose and schedule of Suboxone.
Client # 9 was admitted into treatment on March 23, 2015 and discharged on June 5, 2015. Client # 9 was prescribed Suboxone on April 10, 2015. There was no documentation of a patient examination in client record # 9, as of November 9, 2015. The narcotic treatment physician failed to document a patient examination prior to determining the patient's initial dose and schedule of Suboxone.
The findings were reviewed with facility staff during the licensing process.
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Plan of Correction
Since the November 9, 2015 licensing date and the facility acquired this citation for the lack of such physician documentation, the two following procedures have been established. These procedures were prepared by the Director and MAT Manager. The Director communicated these procedures via e-mail to all OP facility managers and instructed them to immediately inform their respective staffs. This directive was also placed in the facility charting manual for future reference.
1) Any patient that had be induce with Suboxone in Gateway's inpatient facility and then transferred to a Gateway outpatient facility for continued treatment, including Suboxone maintenance, Gateway's Medical Records Department will ensure that the initial physician's history and physical exam, the Physician Initial Suboxone Evaluation Progress Note and the medication log will be included in the outpatient medical record;
2) When a non-Gateway physician induces a patient with Suboxone or continues to monitor and prescribe Suboxone to the patient, or both, while in a Gateway facility, that physician will provide the patient's medical record (including the initial evaluation, ongoing medication check notes, medication logs, and physician?s signed statement of diagnosis and that the patient had been addicted to opiates for a minimum of one year) for the patient's Gateway medical record.
The facility Manager or her designee will review the patient chart and the Physician Progress Note by the Gateway physician or the medical record documents form the external physician who will continue to treat the patient at the Gateway facility to ensure accuracy and thoroughness of documentation. This review/monitoring will occur within one work day of the initial patient evaluation by the physician.
Both of the above documentation procedures were established on November 18, 2015.
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709.93(a) 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:
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Observations
Based on a review of client records, the facility failed to document a complete client record on an individual which included information relative to the client's involvement with the project in three of six client records.
The findings include:
Ten client records were reviewed on November 9, 2015. Six client records pertained to the outpatient activity. Six client records were reviewed for medication records. Three clients were prescribed Suboxone. Three client records were reviewed for consent forms for buprenorphine treatment. The facility failed to document medication records in client records # 8, 9 and 10. The facility failed to document a consent form for buprenorphine treatment in client records # 8 and 9.
Client # 8 was admitted into treatment on February 2, 2015. Client # 8 was prescribed Suboxone on February 13, 2015. The facility utilizes a consent to treatment with buprenorphine form for clients receiving Suboxone treatment. There was no documentation of a consent form for buprenorphine treatment in client record # 8, as of November 9, 2015.
Client # 8 receives a prescription for Suboxone biweekly. There was no documentation of the medication record for the following weeks: March 13, March 27, April 10, April 24, May 8, May 22, June 5, June 19, July 3, July 17, July 31, August 14, August 28, September 11, September 25, October 9, October 23 and November 6, 2015.
Client # 9 was admitted into treatment on March 23, 2015 and discharged on June 5, 2015. Client # 9 was prescribed Suboxone on April 10, 2015. The facility utilizes a consent to treatment with buprenorphine form for clients receiving Suboxone treatment. There was no documentation of a consent form for buprenorphine treatment in client record # 9, as of November 9, 2015.
Client # 9 receives a prescription for Suboxone biweekly. There was no documentation of the medication record for the following weeks: April 10, April 24, May 8 and May 22, 2015.
Client # 10 was admitted into treatment on August 4, 2015 and discharged on October 23, 2015. Client # 10 was prescribed Suboxone on August 5, 2015. Client # 10 receives a prescription for Suboxone biweekly. There was no documentation of the medication record for the following weeks: August 28, September 11, September 25, October 9 and October 23, 2015.
The findings were reviewed with facility staff during the licensing process.
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Plan of Correction
As a result of this facility's November 9, 2015 licensing visit, procedures were established with Gateway's medical records department and with the external physician group who treats Suboxone patients on site at Gateway Greensburg.
1) Gateway's medical records department will ensure that a signed consent for Suboxone treatment and the patient's medication log from inpatient will be included in each Suboxone patient's outpatient medical record. The Gateway physician, who continues Suboxone treatment with the patient while in outpatient, will continue to document on the medication log specific to all prescribed medications;
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
2) Any external physician, who induces a patient with Suboxone or continues to treat a patient with Suboxone, or both, and treats that patient at a Gateway facility, will provide a copy of the signed patient consent to treat with Suboxone. That physician will also provide Gateway with, and will continue to document, an ongoing patient medication log, which will be part of the patient's medical record.
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 consent for Suboxone treatment was appropriately completed and signed by the patient and staff member. This review will occur within one work day of the completion of the initial outpatient Suboxone treatment session.
Both of the above documentation procedures were established on November 18, 2015.
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