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 March 6-7, 2014 by staff from the Division of Drug and Alcohol Program Licensure. Based on the findings of the on-site inspection, Pinnacle Treatment Centers PA-V, LLC 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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715.9(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 a review of patient records, the facility failed to document that the narcotic treatment physician completed a face-to-face consultation with the patient prior to admission and prior to increasing her dose in one of one patient records.
The findings include:
Fifteen patient records were reviewed on March 6 & 7, 2014. One of the patient records reviewed was that of a courtesy dosing patient whose dose was increased prior to admission. The facility failed to document a face-to-face consultation with the patient and narcotic treatment physician in patient record #5.
Patient #5 was admitted to treatment on January 27, 2014; however, she had been courtesy dosing at the facility since January 14, 2014. On January 21, 2014, the narcotic treatment physician increased the patient's dose from 30 milligrams of methadone to 40 milligrams of methadone. There was no documentation in the patient record that the patient had met with the doctor prior to her dose increase or admission to the facility.
The findings were confirmed with the clinical supervisor and were not disputed.
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Plan of Correction
The agency will ensure the physician complies with 715.9(a)(4) through a retraining process with the Corporate Medical Director and Facility Director by March 30, 2014. The physician will be retrained on the policies, procedures and regulations of guest dosing / transfer admissions by March 30, 2014. Notes and documentation will be reviewed by the Facility Director and / or Clinical Supervisor to ensure compliance. |
715.15(b) LICENSURE Medication dosage
(b) The narcotic treatment physician shall determine the proper dosage level for a patient, except as otherwise provided in this section. If the narcotic treatment physician determining the initial dose is not the narcotic treatment physician who conducted the patient examination, the narcotic treatment physician shall consult with the narcotic treatment physician who performed the examination before determining the patient 's initial dose and schedule.
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Observations
Based on the review of patient records, the facility failed to comply with Federal laws and regulations regarding the initial dose level for a patient in one of five patient records.
The findings include:
42 CFR (Code of Federal Regulations) Subpart B, (h)(3)(ii) included the following language: "For each new patient enrolled in a program, the initial dose of methadone shall not exceed 30 milligrams....."
Fifteen patient records were reviewed on March 6 & 7, 2014. Five of the fifteen patients reviewed were new admissions. The facility failed to comply with Federal laws and regulations, specifically 42 CFR, Subpart B, (h)(3)(ii) in patient record #1.
Patient #1 was admitted on November 19, 2013. The doctor's order dated November 19, 2013 stated that the patient was to receive an initial dose of 35 milligrams.
The findings were discussed with the clinical supervisor and were not disputed.
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Plan of Correction
The Corporate Medical Director and the Facility Director will review the federal regulations regarding the initial dose not exceeding 30 mgs with the physician by March 30, 2014. The physician will comply with the regulation while using their medical discretion to ensure the patient is beginning treatment at an appropriate dosage. The medical staff at the facility will monitor the admission paperwork prior to the patient receiving their initial medication to ensure compliance with this regulation. The Facility Director will continue to monitor the physician to ensure compliance. |
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 that the narcotic treatment physician determined the proper dosage level and that each medication order and dosage change was written and signed by the narcotic treatment physician in four of five patient records.
The findings include:
Fifteen patient records were reviewed on March 6 & 7, 2014. Five patient records were reviewed for the physician's documentation in determining the initial dose. The facility failed to ensure that the narcotic treatment physician determined the proper dosage level and that each medication order and dosage change was written and signed by the narcotic treatment physician in patient records # 1, 2, 3 and 4. Patient records # 1, 2, 3 and 4 included documentation of a combination verbal and standing order for the initial and subsequent doses.
Patient #1 was admitted on November 19, 2013. The initial order, which was documented as a verbal order, included an initial dose of 35 milligrams on 11/19/13, then an increase to 45 milligrams on 11/20/13 and 55 milligrams on 11/21/13.
Patient #2 was admitted on October 8, 2013. The initial order, which was documented as a verbal order, included an initial dose of 30 milligrams on 10/9/13, then an increase to 35 milligrams on 10/10/13 and 40 milligrams on 10/11/13.
Patient #3 was admitted on August 8, 2013. The initial order, which was documented as a verbal order, included an initial dose of 25 milligrams.
Patient #4 was admitted on October 28, 2013. The initial order, which was documented as a verbal order, included an initial dose of 30 milligrams on 10/28/13, then an increase to 40 milligrams on 10/29/13 and 50 milligrams on 10/30/13.
The findings were confirmed with the clinical supervisor and were not disputed.
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Plan of Correction
The Corporate Medical Director and the Facility Director will review with the physician all policies, procedures and regulation 715.17 by March 30, 2014 to ensure all medication orders are entered into the computer system by the physician. The facility will utilize the new symptom triggered induction protocol established by the company, which will be implemented in the facility by April 30, 2014. The medical staff / physician will maintain documentation which will be monitored by the Facility Director and / or Clinical Supervisor to ensure compliance with regulations. |