INITIAL COMMENTS
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This report is a result of an on-site inspection conducted for the approval to use a narcotic agent, specifically Methadone, in the treatment of narcotic addiction. This inspection was conducted on October 7, 2013, through October 11, 2013, by staff from the Division of Drug and Alcohol Program Licensure. Based on the findings of the on-site inspection, Habit OPCO, Inc. was found not to be in compliance with the applicable chapters of 4 PA Code and 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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715.6(a)(2) LICENSURE Physician staffing
(a) A narcotic treatment program shall designate a medical director to assume responsibility for administering all medical services performed by the narcotic treatment program.
(2) When a narcotic treatment program is unable to hire a medical director who meets the qualifications in paragraph (1), the narcotic treatment program may hire an interim medical director. The narcotic treatment program shall develop and submit to the Department for approval a training plan for the interim medical director, addressing the measures to be taken for the interim medical director to achieve minimal competencies and proficiencies until the interim medical director meets qualifications identified in paragraph (1)(i), (ii) or (iii). The interim medical director shall meet the qualifications within 36 months of being hired.
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Observations
Based on a review of personnel records, the facility failed to submit to the Department for approval a training plan for the interim medical director.
The findings included:
The medical director's personnel record was reviewed on October 8, 2013. A review of the experience found the medical director did not meet the qualifications per 715.6(a)(1)(i-iii). This required the medical director to be designated as interim. No documentation was made available during the methadone monitoring indicating the Department approved a training plan, developed by the Narcotic Treatment Program, for the Interim Medical Director.
The findings were reviewed and confirmed with the facility director and clinical director.
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Plan of Correction
The on-site Medical Director personnel file and training will be reviewed by the Project Director and Corporate Medical Director. A previously prepared training plan will also be reviewed and edited accordingly to ensure placement into the personnel file for the Physician. The plan will be forwarded by the project director, to DDAP licensure no later than 12/30/2013. |
715.6(a)(3)(i) LICENSURE Physician staffing
(a) A narcotic treatment program shall designate a medical director to assume responsibility for administering all medical services performed by the narcotic treatment program.
(3) The medical director 's responsibilities include the following:
(i) Supervision of narcotic treatment physicians.
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Observations
Based on a review of personnel records, the facility failed to document all of the required responsibilities for the medical director.
The findings included:
The medical director's personnel record was reviewed on October 8, 2013. No documentation was made available during the methadone monitoring indicating the supervision of narcotic treatment physicians was included in the medical director's responsibilities.
The findings were reviewed and confirmed with the facility director and clinical director.
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Plan of Correction
The Narcotic treatment program physician will be advised of his/her responsibilities via memorandum. The physician will sign off on these, and they will be included in the personnel file. The agency has included these responsibilities in all future contracts. The language has been inserted into a template maintained by corporate legal counsel. |
715.6(b)(1-9) LICENSURE Physician Staffing
(b) A narcotic treatment program may employ narcotic treatment physicians to assist the medical director. A narcotic treatment physician 's responsibilities include:
(1) Performing a medical history and physical exam.
(2) Determining diagnosis and determining narcotic dependence.
(3) Reviewing treatment plans.
(4) Determining dosage and all changes in doses.
(5) Ordering take-home privileges.
(6) Discussing cases with the treatment team.
(7) Issuing verbal orders pertaining to patient care.
(8) Assessing coexisting medical and psychiatric disorders.
(9) Treating or making appropriate referrals for treatment of these disorders.
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Observations
Based on a review of personnel records, the facility failed to document all of the required responsibilities for the narcotic treatment physicians.
The findings included:
The narcotic treatment physicians personnel records were reviewed on October 10, 2013. No documentation was made available during the methadone monitoring indicating the narcotic treatment physicians were informed of their responsibilities.
The findings were reviewed and confirmed with the facility director and clinical director.
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Plan of Correction
The Narcotic treatment program physician will be advised of his/her responsibilities via memorandum. The physician will sign off on these, and they will be included in the personnel file. The agency has included these responsibilities in all future contracts. The language has been inserted into a template maintained by corporate legal counsel. |
715.6(c) LICENSURE Physician Staffing
(c) A narcotic treatment physician shall be otherwise available for consultation and verbal medication orders at all times when a narcotic treatment program is open and a narcotic treatment physician is not present.
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Observations
Based on a review of personnel records, the facility failed to document a narcotic treatment physician was available for consultation and verbal orders at all times.
The findings included:
The narcotic treatment physicians personnel records were reviewed on October 10, 2013. No documentation was made available during the methadone monitoring indicating the narcotic treatment physicians were providing consultation and verbal orders when the narcotic treatment program was open and a physician was not onsite.
The findings were reviewed and confirmed with the facility director and clinical director.
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Plan of Correction
The Narcotic treatment program physician will be advised of his/her responsibilities via memorandum. The physician will sign off on these, and they will be included in the personnel file. The agency has included these responsibilities in all future contracts. The language has been inserted into a template maintained by corporate legal counsel. |
715.14(b) LICENSURE Urine testing
(b) A narcotic treatment program shall develop and implement policies and procedures to ensure that urine collected from patients is unadulterated. These policies and procedures shall include random observation which shall be conducted professionally, ethically and in a manner which respects patient privacy.
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Observations
Based on a review of policies and procedures manual, the facility failed to develop policies and procedures regarding the collection of urine drug screens.
The findings included:
The narcotic treatment program policies and procedures were reviewed on October 10, 2013. No documentation was made available during the methadone monitoring indicating the narcotic treatment program had developed policies and procedures regarding the collection of urine drug screens.
The findings were reviewed and confirmed with the facility director and clinical director.
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Plan of Correction
A hardcopy of Habit OPCO's UDS policy will be placed in the licensing policy book. The policy is maintained on the company intranet and is accessible by all staff. The hard copy book used for licensing will be reviewed by the clinical director to ensure that the policy is present for audits. This review will occur at least annually each January. |
715.14(c) LICENSURE Urine testing
(c) A narcotic treatment program shall develop and implement policies and procedures to minimize misidentification of urine specimens and to ensure that the tested specimens can be traced to the donor.
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Observations
Based upon review of the policies and procedures manual, the facility failed to develop policies and procedures regarding the chain of custody of urine specimens.
The findings included:
The narcotic treatment program policies and procedures were reviewed on October 10, 2013. No documentation was made available during the methadone monitoring indicating the narcotic treatment program had developed policies and procedures that ensure accurate tracking of the urine specimen from collection to shipment to the laboratory.
The findings were reviewed and confirmed with the facility director and clinical director.
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Plan of Correction
A hardcopy of Habit OPCO's UDS policy will be printed from out intranet and will be placed in the binder provided to licensing inspectors. The hard copy book used for licensing will be reviewed by the clinical director to ensure that the policy is present for audits. This review will occur at least annually each January. |
715.15(f) LICENSURE Medication dosage
(f) The narcotic treatment program shall develop written policies and procedures relating to narcotic treatment medication dosage which includes the requirements of subsections (a)--(e).
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Observations
Based upon review of the policies and procedures manual, the facility failed to develop policies and procedures regarding medication dosage.
The findings included:
The narcotic treatment program policies and procedures were reviewed on October 10, 2013. No documentation was made available during the methadone monitoring indicating the narcotic treatment program had developed policies and procedures that address the review of dosage levels, the physician determining the proper dosage level, medication in oral form and the labeling take home bottles.
The findings were reviewed and confirmed with the facility director and clinical director.
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Plan of Correction
A copy of the medication management policies, and the take home policies specific to medication management will be printed from the HOI intranet and placed in the binder provided to on site licensing auditors. The hard copy book used for licensing will be reviewed by the clinical director to ensure that the policy is present for audits. This review will occur at least annually each January. |