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 buprenorphine, in the treatment of narcotic addiction. This inspection was conducted on April 14, 2010 by staff from the Division of Drug and Alcohol Program Licensure. Based on the findings of the on-site inspection, Malvern Institute was found not to be compliance with the applicable chapters of 28 PA Code which pertain to the facility. Deficiencies were identified during this inspection and a plan of correction is due on May 1, 2010. .
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Plan of Correction
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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 review of the patient records, the facility failed to obtain a complete drug screen urinalysis prior to the administration of Suboxone, a narcotic agent in three of seven patient records.
The findings include:
Seven patient records were reviewed on April 14, 2010. Prior to the administration of Suboxone, the facility was required to complete a drug screen urinalysis for all patients. A complete drug screen urinalysis included the receipt of the results from a CLIA and Department of Health approved laboratory. The facility failed to obtain a completed drug screen urinalysis prior to the administration of Suboxone, a narcotic agent in three of seven records.
Record # 4 - Patient # 4 was admitted on 3/3/10 and was administered the first dose of Suboxone on 3/4/10 at 7:00 PM. The urinalysis drug screen was not initiated until 3/5/10; the results were made available 3/5/10.
Record # 5 - Patient # 5 was admitted on 1/19/10 and was administered the first dose of Suboxone on 1/19/10 At 9:30 PM. The urinalysis drug screen was not initiated until 1/20/10; the results were made available 1/20/10.
Record # 6 - Patient # 6 was admitted on 2/12/10 and was administered the first dose of Suboxone on 2/12/10 at 9:00 PM. The urinalysis drug screen was not initiated until 2/15/10; the results were made available until 2/15/10.
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Plan of Correction
UDS results will be faxed back to Malvern Institute Nursing department for doctor review prior to dispensing Suboxone. Labs will be asked to fax back results on the same day it is sent out. This will be monitored by Nursing Supervisor under direction of Executive Director. |
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 a review of patient records and a staff interview, the narcotic treatment program failed to document the consultation between the narcotic treatment physician determining the initial dose and the certified registered nurse practitioner (CRNP) performing the physical examination in 7 of 7 patient records.
The findings include:
Seven patient records were reviewed on April 14, 2010. The documentation contained in the patient records revealed that all patients were given a physical examination by the CRNP and all records were required to document that the physician consulted with the CRNP prior to the the determination of initial dose of Suboxone.
In patient records #1, 2, 3, 4, 5, 6 and 7 the physician determining the initial dose failed to document that the consultation with the CRNP had occurred prior to the dose determination.
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Plan of Correction
A consult note will be written by the ordering physician as part of the face to face evaluation to ensure acknowledgement of the H&P and any other interaction that other staff have. The consult will ensure acknowledgement of the ordering physician and the CRNP or other medical staff who does the H&P. This will be monitored by the Medical Director.
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