INITIAL COMMENTS
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This report is a result of an on-site inspection conducted for the approval to use narcotic agent, specifically methadone and buprenorphine, in the treatment of narcotic addiction. This inspection was conducted on February 1 -3, 2011, by staff from the Division of Drug and Alcohol Program Licensure. Based on the findings of the on-site inspection, The Family Center of Thomas Jefferson University MATER) 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 and a plan of correction is due on March 4, 2011.
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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 and a discussion with the facility director and administrative staff the facility failed to restrict the determination of a patient's dose to the physician in 3 of 3 patient records.
The findings include:
Fourteen patient records were reviewed on February 1-3, 2011. Three patient records were reviewed for dose change orders. Patient records # 2, 4 and 12 contained dose change forms that did not clearly document that the physician was ordering dose changes.
Patient record #2 had incomplete documentation on dose change forms dated 5/4/10, 5/21/10 and 8/5/10.
Patient record #4 had incomplete documentation on dose change forms dated 9/21/10, 10/8/10, 10/19/10 and 12/3/10.
Patient record #12 had incomplete documentation on dose change forms dated 8/26/10, 9/9/10, 11/11/10 and 11/29/10.
This was discussed with the facility director and administrative staff and it was confirmed that the form will need to be revised and reviewed to accurately reflect their current practice.
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Plan of Correction
The prescription form has been revised so that the only signature at the bottom on the form is the prescribing physicians. All other signature lines have been moved to the upper part of the form. All old forms have been destroyed. The Clinic Director has provided a training for all staff on the changes including proper completion on the form to indicate any dose changes.
Timeframe for completion: Immediate
Person(s) responsible: Program Director and Clinic Director
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