INITIAL COMMENTS
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This report is a result of an on-site licensure renewal inspection and buprenorphine waiver inspection conducted on October 27- 28, 2015 by staff from the Division of Drug and Alcohol Program Licensure. Based on the findings of the on-site inspection, Jade Wellness Center, LLC was found not to be in 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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715.14(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 buprenorphine in five of eight patient records. A complete drug screen includes receiving the results from the CLIA and Department of Health approved laboratory.
The findings include:
Eight buprenorphine patient records were reviewed on October 27-28, 2015. All patients are required to complete a drug screen urinalysis prior to the administration of buprenorphine, a narcotic agent. A complete urine drug screen includes receiving the results from the CLIA and Department of Health approved laboratory. The facility failed to obtain a complete drug screen urinalysis prior to the administration of buprenorphine, a narcotic agent and monthly thereafter in records # 3, 4, 5, 6 and 7.
Patient #3 was admitted on 7/30/15. Patient #3 received their first dose of buprenorphine on 7/31/15. The initial urinalysis results were documented on 7/30/15; however, they were not from the laboratory, but an onsite dipstick test.
Patient #4 was admitted on 9/28/15. Patient #4 received their first dose of buprenorphine on 9/29/15. The initial urinalysis results were documented on 9/28/15; however, they were not from the laboratory, but an onsite dipstick test.
Patient #5 was admitted on 4/27/15 and discharged on 8/17/15. Patient #5 received their first dose of buprenorphine on 4/28/15. The initial urinalysis results were documented on 4/28/15; however, they were not from the laboratory, but an onsite dipstick test.
Patient #6 was admitted on 4/15/15 and discharged on 7/16/15. Patient #6 received their first dose of buprenorphine on 4/16/15. The initial urinalysis results were documented on 4/16/15; however, they were not from the laboratory, but an onsite dipstick test.
Patient #7 was admitted on 3/13/15 and discharged on 8/28/15. Patient #7 received their first dose of buprenorphine on 3/1415. The initial urinalysis results were documented on 3/14/15; however, they were not from the laboratory, but an onsite dipstick test.
These findings were reviewed with facility staff during the licensing process.
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Plan of Correction
All potential candidates for buprenorphine services will not be granted initial appointment with the physician for chemotherapy services until results from a CLIA and Department of Health approved laboratory are accessible. Initial onsite Urine Drug screen will be considered presumptuous and utilized in development of treatment plan, plan of cares and not to implement chemotherapy services. Facility Director will monitor compliance of implementation of buprenorphine services to ensure that buprenorphine is not administered or prescribed until CLIA approved laboratory results are accessible. JADE Wellness Center has also submitted an exception to regulation 715.14. JADE Wellness Center will comply with the regulation unless the exception is granted. |
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, the facility's physician failed to adhere to the dosing protocol listed on the medication by ordering that single dose buprenorphine film and / or tablet be halved and quartered in three of eight patient records. The medication packaging identifies this as a single dose medication.
The findings include:
Eight buprenorphine patient records were reviewed on October 27-28, 2015. Medication orders documented in patient records # 2, 4 and 8 instructed that a single dose buprenorphine film and / or tablet by halved and / or quartered.
Patient #2 was admitted on November 17, 2014. For the time period of October 22 - 29, 2015, 6 buprenorphine tablets were ordered and the instructions stated that the patient was to take tablet 1 time per day. For the time period of October 8- 22, 2015. 11 tablets were ordered and the instructions stated that the patient was to take tablet 1 time per day.
Patient #4 was admitted on September 28, 2015. For the time period of October 8 - 15, 2015, 9 buprenorphine films were ordered and the instructions stated that the patient was to take 1 film 1 time per day. For the time period of September 29 - October 9, 15 buprenorphine films were ordered and the instructions stated that that patient was to take 1 film 1 time per day.
Patient #8 was admitted on January 8, 2015 and discharged May 7, 2015. For the time period of March 27 - April 3, 2015, 9 buprenorphine films were ordered and the instructions stated that the patient was to take 1 film 1 time per day. For the time period of March 16-23, 2015, 11 buprenorphine films were ordered and the instructions stated that the patient was to take film 1 time per day. For the time period of March 9-16, 2015, 10 buprenorphine films were ordered and the instructions stated that the patient was to take 1 film 1 time per day. For the time period of March 2-9, 2015, 10 buprenorphine films were ordered and the instructions stated that the patient was to take 1 film 1 time per day. For the time period of February 23 - March 2, 2015, 11 buprenorphine films were ordered and the instructions stated that the patient was to take 1 film 1 time per day. For the time period of February 16 - 23, 2015, 11 buprenorphine films were ordered and the instructions stated that the patient was to take 1 film 1 time per day.
These findings were reviewed with facility staff during the licensing process.
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Plan of Correction
It is the plan of JADE wellness Center and the prescribing physicians to only utilize buprenorphine services in full dosages. Physician will no longer prescribe fractions of a film strip or tablet. Clinical supervisor will train all physicians and educate them on the policy within JADE Wellness Center to ensure all prescribing physicians understand the required dosing protocol. Jade Wellness Center Facility Director will monitor prescriptions through viewing active and inactive medication logs to ensure prescriptions are not indicating the patient to take a fraction of their medication. Front office manager will monitor prescriptions being written and return all prescriptions to the prescribing doctor for modification.
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