INITIAL COMMENTS
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This report is a result of an on-site complaint investigation. This investigation was conducted on July 5, 2011 by staff from the Division of Drug and Alcohol Program Licensure. Based on the findings of the on-site inspection, A.R.S. of Lancaster, LP was found not to be compliance with the applicable chapters of 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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715.9(a)(3) 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:
(3) Obtain a drug use history and current drug use status of the individual.
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Observations
Based on the review of patient records, the facility failed to obtain a drug use history and current drug status in patient record # 1.
The findings include:
On July 5, 2011, a review of patient record # 1 provided documention of a drug history prepared by facility staff. The drug history documented that the patient's first use of heroin was at age seventeen. The facility's documentation failed to identify the lengths and patterns of the patient's use of heroin, documenting only that the patient used "12 bags daily".
The documentation of patient # 1's drug use history was addressed with the executive director and it was confirmed that lengths and patterns of use are a required component of a drug use history.
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Plan of Correction
ARS will conduct an inservice training with all clinical staff prior to August 15, 2011 to enhance staff's skill at documenting patient drug use history with more detail. Additionally, an inservice training will be conducted for nursing staff responsible for completing nursing assessments to enhance their documentation skills regarding drug use history.
The admitting physician will review drug use history and current drug use as documented within Nursing Assessment and Biopsychosocial assessment prior to admitting the patient. This review will be evidenced by signing and dating both forms. Any drug use histories or current drug use documentation deemed insufficient will be investigated and documented prior to the patient admission.
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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.
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Observations
Based on the review of clinical documentation and an interview with the executive director, the facility, specifically the physician, failed to document the basis for determining current and one year history of dependency in patient record # 1.
The findings include:
Patient record # 1 was reviewed on July 5, 2011. The content of the patient's record was reviewed for documentation of the physician's face-to-face determination of the patient's current physiological status and one year history of dependency. The facility has a specific form that is specifically utilized to assess a patient for current and one year history of dependency. This form, when completed, documents a patient's signs and symptoms of current dependency as well as identifies the physician's determination of at least a one year history of dependency.
In the review of patient record # 1, the form was completed in part by a staff member who is not a physician. A review of the document, and an interview with the executive director, revealed that the handwriting was that of a physician extender and not the physician. It was confirmed that the physician had signed the form but it is unclear that the physician conducted the face-to-face determination of current dependency.
In accordance with the regulations, only the physician can make the determination of current and one year history of dependency. In an interview with the executive director, it was confirmed that the form that the facility used to document the determination of patient # 1's current and one year history of dependence was not completed by the physician.
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Plan of Correction
The Project/Facility Director investigated this deficiency through an in interview with the physician and director of nursing. This investigation concluded that the physician did evaluate the patient face to face and make the diagnosis of physiological dependence. The physician and the physician extender were both present for the entire examination. The physician extender entered the notes based on the physician's dictation during the examination. In the future, the physician will always physically complete the section of the History and Physical form that relates to the diagnosis of physiological dependence for at least 1 year prior to admission. The Director of Nursing or Charge Nurse will incorporate reviewing the History and Physical for completeness prior to dosing the patient.
On an on-going basis, the project/facility director, Clinical Supervisor, Physician Assistant, or Medical Director will review all new admission charts to ensure the DON/Charge Nurse review continues to remain in place.
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715.14(a) LICENSURE Urine testing
(a) A narcotic treatment program shall complete an initial drug-screening urinalysis for each prospective patient and a random urinalysis at least monthly thereafter.
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Observations
Based on a review of patient records and an interview with the facility director, the facility failed to ensure that patient #1 was initially dosed following the completion of a drug-screen urinalysis.
The findings included:
Patient # 1's record was reviewed on July 5, 2011. Per regulation, a narcotic treatment program shall complete an initial drug-screening urinalysis for each prospective patient and a random urinalysis at least monthly thereafter. The facility failed to document the completion of a drug screen urinalysis prior to dosing in patient record # 1.
Patient # 1 was admitted into treatment on March 16, 2010. Patient # 1 received a dose of 30 mg of methadone on March 16, 2010, the same date that the patient had submitted a urine specimen for a drug-screen urinalysis. The results of the urinalysis were made available to the facility on March 17, 2010; the results of this urinalysis revealed that the patient had used benzodiazepines but revealed no opiates. There was no documentation that addressed the fact that the patient's urinalysis results did not reveal content of opiate or methadone. It is typical in urinalysis testing that a patient entering methadone treatment will test positive for opiates or methadone (should the patient be a transfer from another methadone clinic or illicitly using the drug). The fact that a patient's urinalysis results were not indicating opiates were in the patient's system would indicate a need for a physician's written justification to admit a patient into methadone treatment.
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Plan of Correction
The Project/Facility Director investigated this deficiency through an interview with the physician and director of nursing. This investigation concluded that among other things, the physician relied on the urinalysis obtained from the referring treatment facility that showed a positive opiate result at the time of hospitalization for detoxification. In addition to the face-to-face medical exam and history, the hospital medical record was reviewed prior to issuing the methadone induction order.
In the future, the facility will not rely on a drug screen analysis from another healthcare provider. During an inservice training with all medical staff held on August 10, 2011, the medical staff were told not to rely on another treatment provider's urinalysis results . The inservice also covered the documentation requirements for circumstances where the physician believes, in his/her professional judgment, that an admission is justifiedfor a patient with a negative opiate drug screen.
The Director of Nursing or Charge Nurse will ensure a completed drug screen analysis has been received prior to medicating the patient.
On an on-going basis, the project/facility director, Clinical Supervisor, Physician Assistant, or Medical Director will review all new admission charts to ensure the DON/Charge Nurse review to ensure the completed drug screen analysis was received prior to medicating the patient.
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715.17(a) LICENSURE Medication control
(a) A narcotic treatment program shall comply with applicable Federal and State statutes and regulations regarding the storing, compounding, administering and dispensing of medication.
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Observations
Based on the review of patient records, the facility failed to demonstrate that the physician made a determination of the patient's initial dose and subsequent orders that was in compliance with all Federal and State regulations and statutes.
The findings include:
Patient record # 1 was reviewed on July 5, 2011. The patient's initial dose and subsequent dosing orders were reviewed.
The patient was admitted into methadone treatment on March 16, 2010. He was subsequently dosed at 30 mg on this same date. The patient had an ordered increase of 10 mg daily on March 17, March 18 and March 19, 2010. He was dosed at 60 mg on March 19, 2010. The patient was pronounced dead in his home on March 19, 2010, at approximately 10:01 pm. The certification of death filed by the Lancaster County Coroner's office specified the cause of death as "acute methadone toxicity".
In reviewing patient record # 1, it was identified that the patient had entered a hospital seeking drug and alcohol treatment on March 11, 2010. The patient was released and referred to this methadone facility on March 16, 2010. The patient was administered 30 mg of methadone on this same date; there was no documentation by the admitting physician that addressed the rationale for admitting this individual into methadone treatment as the individual had reportedly not used heroin since a hospital admission on March 11, 2010. Additionally, there was no documentation to support the initial dose of 30 mg when the patient record indicated the patient had been hospitalized and had not ingested heroin or any other opiate.
A review of patient record # 1 revealed that there was no documentation by the admitting physician that addressed reasons for treatment or the rationale for an increase of 10 mg of methadone daily.
On September 4, 2007, all narcotic treatment programs were issued a letter regarding methadone dose 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'. "
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Plan of Correction
The Project/Facility Director investigated this deficiency through an interview with the physician and director of nursing. This investigation concluded that the medical staff are reviewing previous dose change orders and additional patient information prior to issuing a dosing change order. The investigation also concluded that the documentation of this review should be noted on the physician order.
An inservice training was conducted with the entire medical staff on August 10 to ensure that documentation of the change and reason for the change is implemented uniformly. The inservice covered proper documentation requirements of admission rationale and dose increase conclusions during the induction stage of treatment so as to achieve more complete documentation of the basis for dosing decisions.
When nursing staff enter physician orders into the dosing system, the physician's review of preceding dose amounts and changes will be documented in the "reason" or "nurses' notes" section of the medication order. Physicians will be trained to ensure this documentation is contained on the order before signing the order.
On an monthly basis, the project/facility director
will review a random selection of physician orders to ensure that the new procedures regarding documenting in the "reason" or " nurses' notes" section continues to occur satisfactorily
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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 a review of patient records and a staff interview, the facility failed to provide documentation of the physician's determinations for dose changes for patient # 1.
The findings include:
Patient record # 1 was reviewed on July 7, 2011. The patient was initially dosed at 30 mg of methadone on March 16, 2010. The patient was subsequently increased 10 mg per day on March 17, 2010, March 18, 2010, and March 19, 2010. The patient died on March 19, 2011. The certification of death filed by the Lancaster County Coroner's office specified the cause of death as "acute methadone toxicity".
In the record review, two physicians made dosing orders. Employee A made the initial order of March 16, 2010 for the patient to dose at 30 mg. Employee A ordered an increase of 10 mg to 40 mg on March 17, 2010.
On March 18, 2010, a verbal order to increase patient #1's methadone from 40 mg to 50 mg was entered by a second physician, employee B. A review of patient record #1 revealed that there was no documentation of employee B's medical assessment of the patient prior to ordering a dose increase or of a consult with employee A, the physician who had ordered the patient's initial and all other subsequent dose increases.
An interview with the facility's executive director confirmed there was a second physician involved in the determination of patient # 1's dose changes.
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Plan of Correction
An inservice training will be conducted with the entire medical staff prior to August 15, 2011. This inservice will include training to provide direction regarding more complete documentation of physician orders. This includes documenting physician to physician consults regarding patients prior to physician orders, when appropriate, as well as documenting review of recent orders previously written by other physicians.
When nursing staff enter physician orders into the dosing system, the physician review of preceding dose changes will be documented in the "reason" or "nurses' notes" section of the medication order. Physicians will be trained to ensure this documentation is contained on the order before signing the order.
The Director of Nursing or Charge Nurse will ensure this documentation is completed prior to any induction or dose changes.
On an monthly basis, the project/facility director
will review a random selection of physician orders to ensure that the new procedures regarding documenting in the "reason" or " nurses' notes" section continues to occur satisfactorily.
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