INITIAL COMMENTS
|
This report is a result of an on-site inspection conducted for the approval to use a narcotic agent, specifically methadone and buprenorphine, in the treatment of narcotic addiction. This inspection was conducted on March 25-26, 2014 by staff from the Division of Drug and Alcohol Program Licensure. Based on the findings of the on-site inspection, Lebanon Treatment 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.
|
Plan of Correction
|
715.9(a)(4) LICENSURE Intake
(a) Prior to administration of an agent, a narcotic treatment program shall screen each individual to determine eligibility for admission. The narcotic treatment program shall:
(4) Have a narcotic treatment physician make a face-to-face determination of whether an individual is currently physiologically dependent upon a narcotic drug and has been physiologically dependent for at least 1 year prior to admission for maintenance treatment. The narcotic treatment physician shall document in the patient 's record the basis for the determination of current dependency and evidence of a 1 year history of addiction.
|
Observations
Based on the review of patient records, the facility failed to document current dependency and one year history of dependency in one of four patient records.
The findings include:
Fifteen patient records were reviewed, four were reviewed for documentation of the physician's face-to-face assessment of a patient at the time of admission. Patient record # 13 included documentation that the patient had recently been incarcerated and a previous patient. The physician's face to face documentation stated the patient had a one year history of opiate dependency, failing to reference the patient's treatment experience and incarceration during the past year.
The finding was reviewed with clinical staff and not disputed.
|
Plan of Correction
Consultation completed with Medical Director. Medical Director will evaluate and document basis of determination of current dependency. |
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.
|
Observations
Based on the review of patient records and a review of policies and procedures, the facility failed to ensure the physician completed a written dosage change four of four patient records reviewed.
The findings include:
Fifteen patient records were reviewed, four were new patients reviewed for induction documentation and the determination of medication dosage. These four records revealed dosing orders pertaining to dose increases. The facility nursing staff were interviewed and explained that there is an induction protocol that instructs nurses to increase a patient's medication 5 or 10 mg without the physician being notified.
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 pharrnacokinetic 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' ."
|
Plan of Correction
Consultation completed with Medical Director. Determination of medication dosage will be completed by the Medical Director. All medical staff will receive training regarding protocol by 5/1/2014. |
715.23(b)(5) LICENSURE Patient records
(b) Each patient file shall include the following information:
(5) The results of all annual physical examinations given by the narcotic treatment program which includes an annual reevaluation by the narcotic treatment physician.
|
Observations
Based on the review of patient records, the facility failed to complete the annual re-evaluation by the physician in two of five patient records.
The findings include:
Fifteen patients were reviewed, five were reviewed for content of the physican's annual review of the patient's treatment. Patient records # 9 and 11 had annual physicals completed by the physician's extender but there was no documentation of the physician's reevaluation of either patient.
The findings were shared with facility staff and not disputed.
|
Plan of Correction
Consultation completed with Medical Director. Medical Director will complete documentation indicating reevaluation of annual physicals. Form will be updated to include Medical Director documentation. |
715.23(b)(6) LICENSURE Patient records
(b) Each patient file shall include the following information:
(6) Results of laboratory tests or other special examinations given by the narcotic treatment program.
|
Observations
Based on a review of patient records, the facility failed to document the results of laboratory tests in three of four patient records.
The findings include:
Fifteen patient records were reviewed, four records contained documentaion of newly admitted patients whose records were reviewed for documentation of laboratory testing.
Patient records #12, 13, 14 and 15 were reviewed.
Patient # 12 was admitted on May 20, 2013. There is no record of Mantoux testing.
Patient # 13 was admitted on December 23, 2013. There was no record of Mantoux or serological testing.
Patient # 15 was admitted on February 12, 2014. There was no record of Mantoux or serological testing.
|
Plan of Correction
Director of Nursing will utilize manual tracking system to ensure laboratory testing completed/documented. |
715.23(b)(15) LICENSURE Patient records
(b) Each patient file shall include the following information:
(15) Psychosocial evaluations of the patient.
|
Observations
Based on a review of patient records, the facility failed to document a psychosocial evaluation in one of four patient records.
The findings include:
Fifteen patient records were reviewed. Four patient records were reviewed for psychosocial evaluations.
Patient # 15 was admitted into treatment on February 12, 2014. There was no documentation of a psychosocial evaluation in the patient record.
|
Plan of Correction
Clinical supervisor will utilize computerized tracking to monitor documentation completion. |
715.23(c)(1-7) LICENSURE Patient records
(c) An annual evaluation of each patient 's status shall be completed by the patient 's counselor and shall be reviewed, dated and signed by the medical director. The annual evaluation period shall start on the date of the patient 's admission to a narcotic treatment program and shall address the following areas:
(1) Employment, education and training.
(2) Legal standing.
(3) Substance abuse.
(4) Financial management abilities.
(5) Physical and emotional health.
(6) Fulfillment of treatment objectives.
(7) Family and community supports.
|
Observations
Based on the review of patient records, the facility failed to complete annual evaluations in accordance with the regulations in two of six patient records.
The findings included:
Fifteen patient records were reviewed, six were reviewed specifically for documentation of an annual evaluation. Patient records # 9 and 11 did not contain documentation of an annual evaluation by the patient's counselor.
Patient # 9 was admitted to treatment on September 24, 2009; the evaluation was to have been completed on or around September 24.
Patient # 11 was admitted to treatment on November 12, 2008; the evaluation was to have been completed on or around November 12.
The findings were addressed with clinical staff and it was confirmed the annual evaluations were not available for review in the specified patient records.
|
Plan of Correction
Clinical Supervisor will utilize computerized tracking system to ensure annual evaluations are completed within required time frame.
Training regarding documentation of annual evaluation completed with staff 4/24/2014. |
715.23(d) 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.
|
Observations
Based on the review of patient records, the narcotic treatment program failed to document comprehensive treatment plans in two of four records reviewed.
The findings include:
Fifteen patient records were reviewed. Four records were reviewed for treatment plans with realistic short and long-term treatment goals. Patient records # 14 and 15 did not contain documentation of comprehensive treatment plans.
Patient # 14 was admitted on January 4, 2014. The comprehensive treatment plan was to have been completed within 30 days of admission.
Patient # 15 was admitted on February 12, 2014. The comprehensive treatment plan was to have been completed within 30 days of admission.
|
Plan of Correction
Clinical Supervisor will utilize computerized tracking system to ensure treatment planning completed within 30 days of admission.
Training regarding documentation requirements will be completed with staff 4/24/14. |