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 May 6-8, 2013 by staff from the Division of Drug and Alcohol Program Licensure. Based on the findings of the on-site inspection, Pinnacle Treatment Centers PA-V, LLC 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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715.2(a)(b) LICENSURE Relationship of Federal and State Regulations
(a) A narcotic treatment program shall comply with Federal regulations and requirements governing the administration, dispensing and storage of agents.
(b) This chapter is intended to supplement the Federal regulations governing narcotic treatment programs in 21 CFR Chapter II, 1300-1399 (relating to Drug Enforcement Administration, Department of Justice).
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Observations
Based on the review of administrative documentation, the facility failed to comply with Federal laws and regulations regarding documentation of certification.
The findings include:
The administrative material was reviewed on May 6, 2013. The facility is required to comply with Federal laws, specifically, 42 CFR; Chapter 1; Part 8, which includes maintaining current certification with the Substance Abuse and Mental Health Services Administration (SAMHSA). As of May 6, 2013, the SAMHSA certificate was expired as the expiration date was April 30, 2013.
The aforementioned information was confirmed by the facility director.
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Plan of Correction
The Project Director submitted the application on May 7, 2013. The facility has since received the certificate and has a valid CSAT certificate until April 30, 2016. |
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 the review of patient records, the facility failed to comply with Federal laws and regulations regarding the initial dose level for a patient in two of three patient records.
The findings include:
Twenty five patient records were reviewed on May 6-8, 2013. Three of the twenty five patients reviewed were new admissions. The facility failed to comply with Federal laws and regulations, specifically, 42 CFR, Part 8, which states, "For each new patient enrolled in a program, the initial dose of methadone shall not exceed 30 milligrams" in patient records # 14 and 15.
Patient #14 was admitted on September 27, 2012. The doctor's order dated September 27, 2012 stated that the patient was to receive an initial dose of 35 milligrams.
Patient #15 was admitted on July 3, 2012. The doctor's order dated July 3, 2012 stated that the patient was to receive an initial dose of 35 milligrams.
An interview with the facility director took place on May 8, 2013 at which time the aforementioned information was confirmed.
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Plan of Correction
The Facility Director will review the federal regulations regarding the initial dose can not exceed 30mgs with the medical director, as well as the interim doctor. The physician will comply with the regulation while using their medical discretion to ensure that the patient is beginning at an appropriate dose. The facility director will provide additional copies of the federal regulations to the physicians in order to review for compliance. The medical staff will review all initial paperwork prior to the patient receiving their initial dose to insure compliance with this regulation. The physician will comply with the regulation that the patient's initial dose will not exceed 30 mgs. The facility director will continue to monitor the medical director and ensure the maximum initial dose is 30 mgs. |
715.23(b)(22) LICENSURE Patient records
(b) Each patient file shall include the following information:
(22) Aftercare plan, if applicable.
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Observations
Based on a review of patient records, the facility failed to document a completed aftercare plan for patients who completed treatment in three of three patient records.
The findings include:
Twenty five patient records were reviewed on May 6-8, 2013. Three of the patients reviewed completed treatment and were not transferred or referred to any other program. These three patient records required the completion of an aftercare plan with the patient that included: goals with timeframes, support services, contact person and the reentry process. Patient records # 21, 22 and 23 did not include documentation of a complete aftercare plan.
Patient #21 was admitted on February 16, 2010 and discharged on July 12, 2012. There was no documentation of a complete aftercare plan in patient record #21.
Patient #22 was admitted on December 11, 2009 and discharged on October 29, 2012. There was no documentation of a complete aftercare plan in patient record #22.
Patient #23 was admitted on November 23, 2004 and discharged on September 6, 2012. There was no documentation of a complete aftercare plan in patient record #23.
An interview with the clinical supervisor took place on May 8, 2013 at which time the aforementioned information was confirmed.
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Plan of Correction
The Facility Director and Clinical Supervisor will work with the clinical staff to ensure all required documentation is being completed with the patient prior to discharge. The clinical staff will be provided with an in-house training on the completion of the Aftercare Plan and the importance of completing correctly. All patients that are preparing to complete methadone maintenance treatment will work with their counselors to complete the Aftercare Plan prior to their discharge. All aftercare plans will have appropriate time frames to address each goal. The Facility Director and Clinical Supervisor will actively review the clinical records and meet with clinical staff regularly to ensure the plans are being completed. |