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 February 28-29, 2012 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. 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 four of five patient records reviewed.
The findings include:
Fourteen patient records were reviewed February 28-29, 2012. Five patient records reviewed required documentation of the patient's induction into methadone maintenance.
Patient # 6 was admitted September 1, 2011. The initial dose was to be 30 milligrams with an increase every two days until 60 milligrams. The increase was to be either 5 or 10 milligrams at a time based on the Clinical Opiate Withdraw Scale (COWS), leaving the determination up to the dosing nurse.
Patient # 8 was admitted January 25, 2012. The initial dose was to be 30 milligrams with an increase every two days until 60 milligrams. The increase was to be either 5 or 10 milligrams at a time based on the Clinical Opiate Withdraw Scale (COWS), leaving the determination up to the dosing nurse.
Patient # 11 was admitted June 2, 2011. The initial dose was to be 30 milligrams with an increase every two days until 60 milligrams. The increase was to be either 5 or 10 milligrams at a time based on the Clinical Opiate Withdraw Scale (COWS), leaving the determination up to the dosing nurse.
Patient # 12 was admitted December 24, 2011. The initial dose was to be 30 milligrams with an increase every two days until 60 milligrams. The increase was to be either 5 or 10 milligrams at a time based on the Clinical Opiate Withdraw Scale (COWS), leaving the determination up to the dosing nurse.
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
Induction phase will be more individually monitored by Medical Director. Induction dose will be based on symptoms at presentation, COWS, and stated symptoms. Medical Director will work with Director of Nursing and Physician Extenders to ensure that this is occuring on an individual basis with each patient. This will be effective immediately and is on-going. |
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 administrative documentation, the facility failed to restrict the reasons for involuntary termination to those permitted in the regulations.
The findings include:
Administrative documentation that included a copy of the patient handbook given to patients on admission was reviewed February 28, 2012. Grounds for immediate discharge included "violation of core expectations" which are described in detail elsewhere in the handbook. Some of the core expectations include: #2-possession of a weapon on program premises--#3 - sale, purchase, possession, transfer of drugs on grounds.
The handbook continued on page 9 to list consistent loitering as grounds for involuntary termination.
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Plan of Correction
Campus Director will work with Clinical Supervisor to revise Patient Handbook. The Handbook will be revised in which #2-possession of a weapon, and #3-sale, purchase, possession, transfer of drugs on grounds, will no longer be listed under core expectations. Handbook will also be revised as to not list "consistent loitering" as grounds for involuntary termination. This revision will occur by April 15th, 2012 and is on-going. |
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.
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Observations
Based on the review of patient records, the facility failed to complete the annual physical evaluation with a re-evaluation by the physician in five of six patient records reviewed.
The findings include:
Fourteen patient records were reviewed February 28-29, 2012. Six patient records were reviewed for annual physical exams. Five annual physical exams did not include the re-evaluation by the physician and one patient record did not have the annual physical in the patient record at the time of the review.
Patient # 1 was admitted November 20, 2006. The last annual physical exam was completed on December 6, 2010. The patient had a last dose before discharge on an administrative taper was December 15, 2011.
Patient # 2 was admitted July 19, 2008. The annual physical exam was completed on July 1, 2011 by the Certified Physician Assistant (PAc), but failed to include a re-evaluation by the physician.
Patient # 3 was admitted February 21, 2007. The annual physical exam was completed on March 2, 2011 by the Certified Physician Assistant (PAc), but failed to include a re-evaluation by the physician.
Patient # 5 was admitted July 19, 2006. The annual physical exam was completed on August 3, 2011 by the Certified Physician Assistant (PAc), but failed to include a re-evaluation by the physician.
Patient # 14 was admitted January 16, 2007. The annual physical exam was completed on February 2, 2012 by the Certified Physician Assistant (PAc), but failed to include a re-evaluation by the physician.
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Plan of Correction
Director of Nursing will develop an internal tracking and audit process to ensure that all annual physicals and re-evaluations are conducted within the required time frame. Physician will enter the re-evaluation when physician extender is doing the annual physical. Director of Nursing will audit this on a regular and consistent basis to ensure compliance. This will go into effect by April 15th, 2012 and will be on-going. |
715.28(c)(1-5) LICENSURE Unusual incidents
(c) A narcotic treatment program shall file a written Unusual Incident Report with the Department within 48 hours following an unusual incident including the following:
(1) Complaints of patient abuse (physical, verbal, sexual and emotional).
(2) Death or serious injury due to trauma, suicide, medication error or unusual circumstances.
(3) Significant disruption of services due to a disaster such as a fire, storm, flood or other occurrence.
(4) Incidents with potential for negative community reaction or which the facility director believes may lead to community concern.
(5) Drug related hospitalization of a patient.
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Observations
Based on a review of patient records and administrative documentation, the facility failed to provide written unusual incident reports to the Department within 48 hours following the incident.
The findings include:
Patient records were reviewed on February 28-29, 2012 and the binder with unusual incidents on February 29, 2012. There were several unusual incidents that were not reported as required.
On May 2, 2011 patient # 15 was approved for two travel take home bottles for May 3 and May 4, 2011. On May 3, 2011 an ER physician called the facility and reported the patient came into the ER in a semi-conscious state due to a medical condition. The two take home bottles were not accounted for and Narcan was administered the patient. When the patient returned to the facility, the patient had one take home bottle, but could not account for the second bottle.
On June 30, 2011, a patient was sent to the ER at the patient's request due to having ingested "bath salts."
On August 18, 2011 a patient was sent to the ER for ingesting a benzodiazapene and "bath salts."
On November 15, 2011 patient # 13 was hospitalized for an attempted suicide after having had a disciplinary hearing at the facility.
None of these incidents were reported to the Department as required.
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Plan of Correction
Campus Director will work with Director of Nursing and Clinical Supervisor to ensure that all reportable incidents are completed and submitted within the required timeframe. All Unusual Incidents will remain in a binder in the Campus Directors office for continued audit and review. This process will be effective immediately and is on-going. |