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 September 25-27, 2012 by staff from the Division of Drug and Alcohol Program Licensure. Based on the findings of the on-site inspection, Aldie Counseling Center 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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715.17(c)(1)(i-vi)) LICENSURE Medication control
(c) A narcotic treatment program shall develop and implement written policies and procedures regarding the medications used by patients which shall include, at a minimum:
(1) Administration of medication.
(i) A narcotic treatment physician shall determine the patient 's initial and subsequent dose and schedule. The physician shall communicate the initial and subsequent dose and schedule to the person responsible for the administration of medication. Each medication order and dosage change shall be written and signed by the narcotic treatment physician.
(ii) An agent shall be administered or dispensed only by a practitioner licensed under the appropriate Federal and State laws to dispense agents to patients.
(iii) Only authorized staff and patients who are receiving medication shall be permitted in the dispensing area.
(iv) There shall be only one patient permitted at a dispensing station at any given time.
(v) Each patient shall be observed when ingesting the agent.
(vi) Administering and dispensing shall be conducted in a manner that protects the patient from disruption or annoyance from other individuals.
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Observations
Based on the review of patient records, the facility failed to ensure the physician completed a written dosage change in two of three patient records reviewed.
The findings include:
Sixteen patient records were reviewed September 26 and 27, 2012. Three patient records required documentation of the patient's induction into methadone maintenance.
Patient # 13 was admitted December 10, 2011. The physician then wrote a standing order for the initial dose of 60 milligrams to be administered December 10, 2011, 80 milligrams to be administered December 11, 2011, 100 milligrams to be administered December 12, 2011 and 120 milligrams to be administered December 13, 2011. The patient had been administratively discharged from another narcotic treatment facility December 5, 2011. The patient contacted Aldie on December 6, 2011 for a self-referred intake.
Patient # 10 was admitted April 25, 2012. The patient was administered an initial dose of 30 milligrams on May 1, 2012. The physician then wrote a "build up order" for the patient to receive a 5 milligram increase every five days. The documented justification was stated as "pregnant".
This issue of standing orders was addressed September 4, 2007 when the DEPARTMENT OF HEALTH & HUMAN SERVICES Substance Abuse and Mental Health Services Administration addressed all narcotic treatment facilities, stating in part the following:
"In determining the initial dose for each individual patient, the
physician should consider factors such as body weight, size, other substance use and
abuse, diet, co-occurring disorders (check for prescribed SSRIs, benzodiazepines, HIV
medications, anti-seizure medication, etc.) and medical diseases, genetic factors, and
tolerance. The drug labeling states that "methadone's pharmacokinetic properties,
coupled with high inter-patient variability in its absorption, metabolism, and relative
analgesic potency, necessitate a cautious and highly individualized approach to
prescribing." Even though the Treatment Improvement Protocol (TIP #43) and drug
labeling state that a typical first dose of methadone for a patient actively abusing opioids
is 20 to 30 milligrams, some patients may require a much lower dose. According to 42
CFR 8.12 (h) (3) (ii), "...the initial dose of methadone shall not exceed 30 milligrams
and the total dose for the first day shall not exceed 40 milligrams.. .." (emphasis added).
The initial methadone dose should be appropriate for the individual patient, with the
maximum initial dose being 30 mg. Clearly, a 30-mg dose should not be the initial dose
for all patients.
Of note, there has been a rapid increase in the abuse of the opioid-type pain relieving
medications. Typically, hydrocodone and oxycodone are the drugs of choice, and the
resulting addiction is treated by the OTPs. These are short-acting opioids with a half-life
of 2 to 4 hours. However, methadone has an elimination half-life that can vary from 8 to
59 hours depending on the individual being treated. Thus, methadone induction must be
approached cautiously.
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' ."
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Plan of Correction
The Medication Dosage policy and procedure was previously revised to stipulate that there shall be a separate physician's order for each dosage change, and that build-up orders for dose changes during induction are no longer allowed. This policy will be amended to include the new directive that build-up orders are not permitted under any circumstances ? even with existing clients. Notification of this new directive was communicated to the program physician/medical director and nursing staff. The program coordinator shall monitor compliance through regular review of all new orders. |
715.21(1)(i-iv) LICENSURE Patient termination
A narcotic treatment program shall develop and implement policies and procedures regarding involuntary terminations. Involuntary terminations shall be initiated only when all other efforts to retain the patient in the program have failed.
(1) A narcotic treatment program may involuntarily terminate a patient from the narcotic treatment program if it deems that the termination would be in the best interests of the health or safety of the patient and others, or the program finds any of the following conditions to exist:
(i) The patient has committed or threatened to commit acts of physical violence in or around the narcotic treatment program premises.
(ii) The patient possessed a controlled substance without a prescription or sold or distributed a controlled substance, in or around the narcotic treatment program premises.
(iii) The patient has been absent from the narcotic treatment program for 3 consecutive days or longer without cause.
(iv) The patient has failed to follow treatment plan objectives.
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Observations
Based on the review of patient records, the facility failed to provide documentation in the form of a letter of termination to indicate the reason for termination in two of three patient records reviewed.
The findings include:
Sixteen patient records were reviewed September 25-26, 2012. Three patient records were reviewed specifically for documentation of the involuntary termination process. Two of the three patient records did not have a letter of termination in the patient record.
Patient # 13 was admitted December 6, 2011. The patient was involuntarily terminated March 9, 2012. The termination letter to describe why the patient was involuntarily terminated was not found in the patient record at the time of the monitoring.
Patient # 14 was admitted July 21, 2010. The patient was involuntarily terminated January 21, 2012. The termination letter to describe why the patient was involuntarily terminated was not found in the patient record at the time of the monitoring.
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Plan of Correction
The program coordinator shall provide additional staff training on State Regulations and Aldie's Policy and Procedure regarding allowable reasons for involuntary termination of clients from the Pharmacotherapy program: written copies of these regulations will be provided as part of a specific training.
All clients at risk of being terminated from the Pharmaco program will be reviewed at the Treatment Team Meeting as a case consult to determine what additional efforts could be implemented in an attempt to retain the client in treatment prior to the Team's final decision to terminate. Case consults addressing involuntary termination will clearly identify only areas allowed by the State regulations and policies prior to the Program Coordinators signature. Documentation of the reason for the termination, such as the Notice to Terminate given to the client, will specify the reason which is allowable according to the applicable regulation. The Program Coordinator shall monitor compliance by ensuring that a letter of termination is included when the Coordinator is signing-off on all client discharge paperwork. |
715.23(b)(14) LICENSURE Patient records
(b) Each patient file shall include the following information:
(14) Case consultation notes regarding the patient.
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Observations
Based on the review of patient records, the facility failed to ensure all required case consultations were completed timely in two of five patient records reviewed.
The findings include:
Sixteen patient records were reviewed September 25-26, 2012. Five patient records were reviewed for documentation of case consultations. Two patient records had annual case consults completed about two months late.
Patient # 8 was admitted May 6, 2005. There was only one case consultation in the patient record and it was dated July 7, 2012. An annual case consult was due by May 6, 2012.
Patient # 9 was admitted May 23, 2007. An annual case consult was due by May 6, 2012, but the annual case consultation was completed on July 17, 2012.
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Plan of Correction
The Program Coordinator will provide Clinicians with a Caseload Spreadsheet and train all Pharmaco Clinicians on how to complete and update this form. Clinicians will be required to bring an updated copy of their Caseload Spreadsheet to monthly supervision for review. Monthly all Pharmaco Clinicians are provided with an order to complete the annual case consult, PCPC and Annual Evaluation for those clients who have achieved their anniversary month. The Program Coordinator will review charts to ensure that this standard is being complied with and case consults are being completed on-time. |
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 the review of patient records and the policy and procedure manual, the facility failed to complete an aftercare plan for those patients who required an aftercare plan.
The findings include:
Sixteen patient records were reviewed September 25-26, 2012. Two patients required an aftercare plan be completed prior to discharge.
Patient # 15 was admitted December 5, 2005 and discharged January 31, 2012 as completed treatment. While there was an aftercare plan documented in the patient record, there were no recovery goals, objectives or time frames listed.
Patient # 16 was admitted June 26, 2009 and discharged April 30, 2012 as completed treatment. While there was an aftercare plan documented in the patient record, there were no recovery goals, objectives or time frames listed, and the patient did not sign. The policy states the aftercare plan will be started four weeks prior to the planned discharge. This patient was tapering and the discharge was planned. Therefore, the patient should have signed the aftercare plan and received a copy.
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Plan of Correction
The Program Coordinator will provide training to program staff on how to appropriately complete Aftercare Plans, including specific time-frames, objectives and recovery goals. Clinicians will receive training on transitioning clients off the program for those clients who are planning to disengage from this program within a month. The Program Coordinator will monitor compliance when signing-off on all client discharge forms. |
715.23(b)(23) LICENSURE Patient records
(b) Each patient file shall include the following information:
(23) Discharge summary.
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Observations
Based on a review of patient records, the facility failed to document discharge summaries within 7 days of discharge in 2 of 7 patient records reviewed.
The findings include:
Sixteen patient records were reviewed September 25-27, 2012. Seven patient records were reviewed for complete discharge summaries.
Patient # 7 was admitted February 7, 2008 and transferred to another narcotic treatment facility and began dosing June 8, 2012. The discharge summary was not completed until July 16, 2012 as a transfer.
Patient # 13 was admitted December 6, 2011. The patient was involuntarily terminated on March 9, 2012. The discharge summary was not completed until May 2, 2012.
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Plan of Correction
The Program Coordinator will train Clinicians on discharge procedures with specific attention to appropriate time-frames, within 7-days of termination or notification of acceptance to another clinic, for completion and necessary documentation, including such items as motivation and progress in treatment and prognosis. A discharge report will be reviewed monthly by the Program Coordinator for timely completion of discharges and all discharge paperwork will be reviewed for compliance prior to the Program Coordinator co-signing the document. |
715.23(d)(2) LICENSURE Patient records
(d) A narcotic treatment program shall prepare a treatment plan that outlines realistic short and long-term treatment goals which are mutually acceptable to the patient and the narcotic treatment program.
(2) The narcotic treatment physician or the patient 's counselor shall review, reevaluate, modify and update each patient 's treatment plan as required by Chapters 157, 709 and 711 (relating to drug and alcohol services general provisions; standards for licensure of freestanding treatment activities; and standards for certification of treatment activities which are a part of a health care facility).
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Observations
Based on a review of patient records, the facility failed to document the progress or lack of progress in achieving the goal statements from the prior treatment plan in three of four patient records.
The findings include:
Sixteen patient records were reviewed September 25-27, 2012. Four patient records were reviewed for treatment plan update documentation.
Patient # 8 was admitted May 6, 2005. Only three total treatment plan updates were found in patient record. The updates were signed but not dated. The last update was completed July 17, 2012. The treatment plan updates did not include a reflection of the patient's progress on the stated goals.
Patient # 9 was admitted May 23, 2007. Treatment plan updates are required at least every 60 days. There was no update for the time frame of May 25, 2012 to July 16, 2012. The last update was dated July 17, 2012. The treatment plan updates did not include a reflection of the patient's progress on the stated goals.
Patient # 10 was admitted April 25, 2012. The master treatment plan was completed June 20, 2012. Treatment plan updates are required at least every 60 days. There was no treatment plan update completed at the time of the inspection.
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Plan of Correction
In conjunction with ongoing Treatment Plan training, the staff will receive training from the Program Coordinator and Clinical Director on how to reflect measurable progress in response to stated goals. Treatment Plan updates, moving forward, will clearly identify the client's progress in relationship to the stated goals in the previous Treatment Plan. The Program Coordinator will review Treatment Plans prior to applying signature to insure that this protocol is maintained. |