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 November 1-3, 2010 by staff from the Division of Drug and Alcohol Program Licensure. Based on the findings of the on-site inspection, Habit OPCO, Inc. - Allentown, 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 and a plan of correction is due on December 4, 2010.
|
Plan of Correction
|
Observations
Based on the review of patient record documentation, the facility failed to ensure that the physician documented in the patient record the rationale for granting take-home medication in two of two patient records.
The findings include:
Eighteen patient records were reviewed November 1-3, 2010. Two patient records were reviewed for take home medication documentation. Patient records # 8 and 9 did not have the physician's rationale for granting take-home medication.
This is a repeat deficiency.
|
Plan of Correction
The Program Director met with the Medical Director to review the regulation. The form used by the physician for approving or denying take home applications was revised on November 4, 2010 to clearly specify how the physician is expected to document his/her rationale for approval of take homes. The physician is now using the revised form.
The revision and the related regulation were discussed and explained at the staff meeting held on November 11, 2010. The physician documentation of rationale will be reviewed for all take home applications that are approved between November 12, 2010 and January 12, 2011 to ensure that they are correct. The Program Director will be responsible for reviewing them. Any applications with incorrect documentation will be returned to the physician and will be reviewed by the Nurse Manager and physician together for corrections. |
Observations
Based on the review of patient records, the facility failed to demonstrate the physician made the determination of the patient's dose in six of nine patient records.
The findings include:
Eighteen patient records were reviewed November 1-3, 2010. Nine patient records were reviewed for the physician's documentation of the patient's initial and subsequent dose and schedule.
Patient # 5 was admitted May 3, 2010. A standard order was used to order the initial dose and then the increases were left to the discretion of the nursing staff over the next week of the induction phase. The order did not specify the amount of each increase.
Patient # 6 was admitted June 9, 2010. A standard order was used to order the initial dose and then the increases were left to the discretion of the nursing staff over the next 10 days of the induction phase.
Patient # 10 was admitted on August 1, 2010. A standard order was used to order the initial dose and then the increases were left to the discretion of the nursing staff over the next week of the induction phase.
Patient # 14 was admitted October 8, 2010. A standard order was used to order the initial dose and then the increases were left to the discretion of the nursing staff over the next week of the induction phase.
Patient # 15 was admitted October 8, 2010. A standard order was used to order the initial dose and then the increases were left to the discretion of the nursing staff over the next week of the induction phase.
Patient # 18 was admitted May 19, 2010. A standard order was used to order the initial dose and then the increases were left to the discretion of the nursing staff over the next 10 days of the induction phase.
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'. "
A copy of this letter was offered to the facility director, but it was declined because the facility director reported having a copy.
In addition, eight patient records included documentation by the counselor directing the physician to increase the patient's dose by a specific amount. The physician signed each of these documents.
Patient record # 1 contained documentation by the counselor to increase the patient's dose by 10 milligrams on 4/14/10; 4/222/10; 5/20/10; 6/3/10; 6/11/10; 6/14/10; 7/16/10 and on 5/11/10, a staff other than the physician documented the physician should decrease the dose 4 milligrams per day "until done".
Patient record # 2 contained documentation by the counselor to increase the patient's dose by 10 milligrams on 1/29/10 and 2/12/10 and to decrease by 10 milligrams on 7/14/10.
Patient record # 5 contained documentation by the counselor to increase the patient's dose on two different occasions, 5 milligrams and 10 milligrams.
Patient record # 6 contained documentation by the counselor to increase the patient's dose by 10 milligrams on 6/23/10.
Patient record # 10 contained documentation by the counselor to increase the patient's dose by 10 milligrams on 10/4/10.
Patient record # 11 contained documentation by the counselor to increase the patient's dose by 10 milligrams on 10/4/10 and 10/15/10.
Patient record # 14 contained documentation by the counselor to increase the patient's dose by 10 milligrams on 10/27/10.
Patient record # 17 contained documentation by the counselor to increase the patient's dose by 10 milligrams on 10/14/10 and 10/21/10.
Patient record # 18 contained documentation by the counselor to increase the patient's dose by 10 milligrams on 6/24/10 and 7/6/10.
|
Plan of Correction
The Program Director met with the Medical Director to review the relevant regulations and guidelines. The Medical Director also reviewed this citation with the Medical Director for all the Habit OPCO programs throughout the northeast. The physician is now documenting only the initial order on the form used at admission. The nursing staff has been instructed to contact the physician for any and all dose changes. The nursing staff will not be using their discretion in making dose changes for the induction phase of treatment.
The entire staff, including the Medical Director, was instructed in the proper completion of the Methadone Communication Form at the staff meeting on November 11, 2010. The regulation was also explained and reviewed. The counseling staff will not be requesting specific dose changes.
The recording and ordering of dose changes during the induction phase of treatment will be reviewed for all new admissions from November 15, 2010 through February 15, 2011 to ensure that they are correct. The Program Director will be responsible for reviewing them. Any incorrect entries will be returned to the physician and will be reviewed by the Nurse Manager and physician together. Any continued problems following February 15, 2011 will be referred to the Medical Director for all the Habit OPCO programs, who will be asked to review and supervise the local Medical Director.
The documentation on the Methadone Communication Form will be reviewed for all dose-change requests between November 15, 2010 and January 15, 2011 to ensure that they are correctly submitted and completed. The Program Director and/or Nurse Manager will be responsible for reviewing them. any forms that are incorrectly completed will be returned to the counselor for revision. Any ongoing problems with particular counselors will be addressed in individual supervision by the Clinical Supervisor. |