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 July 6, 2011 by staff from the Division of Drug and Alcohol Program Licensure. Based on the findings of the on-site inspection, Aldie Foundation, 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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Observations
Based on the review of patient records and a discussion with administrative staff, the facility failed to demonstrate the physician made the determination of the patient's dose in 2 of 23 patient records.
The findings include:
Twenty-three patient records were reviewed on January 5-7, 2011. Patient records were reviewed for physician's documentation of the patient's initial and subsequent dose and schedule.
Patient # 19 was admitted 11/8/2010. A standard order was used to order the initial dose and then the increases were left for the nursing staff to implement during the induction phase. The physician's order states: "MMTP build-up order 11/11/10-30 mg, 11/16/10-40 mg, 11/21/10-50 mg, 11/26/10-60 mg, 12/1/11-70 mg and 12/6/10-80 mg."
Patient # 20 was admitted 11/10/10. A standard order was used to order the initial dose and then the increases were left for the nursing staff implement during the induction phase.
The physician's order states: "MMTP build-up order 11/10/10-30 mg, 11/14/10-40 mg, 11/18/10-50 mg."
On September 4, 2007, all narcotic treatment programs were issued a letter regarding the use of standard orders, especially during the induction phase, by the Department of Health & Human Services, Substance Abuse and Mental Health Services Administration: (SAMHSA)
In part, the following is excerpted from the letter:
"Because methadone overdose deaths have occurred in early treatment due to the drug's
cumulative effects of the first several days, it is also important to be cautious when
adjusting the dose. According to the drug labeling, the peak respiratory depressant
effects of methadone typically occur later and persist longer than its peak analgesic effects, which can contribute to cases of iatrogenic overdose, particularly during treatment initiation and dose titration. With repeated dosing, "methadone may be retained in the liver and released slowly, prolonging the duration of action despite low plasma concentrations." The drug labeling also states that "steady-state concentrations are not usually attained until 3 to 5 days of dosing," and that doses "will 'hold' for a longer period of time as tissue stores of methadone accumulate." Therefore, patients should be closely monitored during the induction phase, and the increase in dose should be under the close supervision of a physician as stated in 42 CFR 8.12 (h)(4), ' Dosing and administration decisions shall be made by a program physician familiar with the most up-to-date product labeling'. "
This was still out of compliance at the time of the follow-up conducted on July 7, 2011.
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Plan of Correction
In the NTP induction phase, the program physician will meet with the patient before ordering any changes in the patient's dose, or the nursing staff shall assess the individual patient and communicate with the program physician regarding the assessment findings. The physician shall write a new order or shall give the program nurse a verbal order if a change in dose is warranted; i.e., there shall be a separate physician's order for each dose change. |
Observations
Based on the review of patient records and a discussion with administrative staff, the facility failed to complete the annual physical in two of four patient records as required per regulation.
The findings include:
Twenty-three patient records were reviewed on January 5-7, 2011. Four patient records were reviewed for annual physical examinations. Per regulation each patient file shall include the following information: "The results of all annual physical examinations given by the narcotic treatment program which includes and annual re-evaluation by the narcotic treatment physician."
Patient # 2 was admitted 10/31/03. There was no documentation of an annual physical in the patient record.
Patient # 7 was admitted 3/18/09. There was no documentation of an annual physical in the patient record.
This was still out of compliance at the time of the follow-up conducted on July 7, 2011.
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Plan of Correction
Written Policy and Procedure reflects Federal and State regulations that an annual physical examination take place on or before each patient's anniversary in treatment. The Program Coordinator has reviewed these policies and procedures with the Medical Director. To insure future compliance, the Program Coordinator will generate a monthly report listing all patients due for annual physical, at least 30 days prior to patients' anniversary dates. The Medical Director and Nursing Director will maintain oversight of scheduling and completion of these appointments. Overall agency compliance with this regulation will be maintained by Quality Assurance review of charts by the Program Coordinator. The Program Coordinator will review filing protocols with the Office Manager to assure that all documentation is present in each patient's chart |