INITIAL COMMENTS
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This report is a result of an onsite licensure renewal and buprenorphine monitoring inspection conducted on November 5-6, 2015 by staff from the Division of Drug and Alcohol Program Licensure. Based on the findings of the on-site inspection, Gateway Rehabilitation Center 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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709.32(b) LICENSURE Medication Control
709.32. Medication control.
(b) Verbal medication orders may be accepted but shall be put in writing and signed within 24 hours thereafter by the prescribing physician.
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Observations
Based on a review of client records, the facility failed to ensure that verbal medication orders were authenticated, in writing, within three business days by a physician or other medical professional authorized by State and Federal law to prescribe medication, in one of six client records reviewed.
The findings include:
Twelve client records were reviewed on November 5-6, 2015. One client record reviewed documented a verbal order. The verbal order was not authenticated, in writing, within three business days by a physician or other medical professional authorized in client record # 12.
Client # 12 was admitted on October 6, 2015 and discharged on November 5, 2015. A verbal order was documented on 10/30/15. There was no physician's signature on the verbal order as of November 5, 2015.
These findings were reviewed with facility staff during the licensing process.
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Plan of Correction
All nurses and physicians will be re-educated on the Medication Control Standard. The training shall include the following and will be completed by 12/14/2015:
a. Required authentication of all verbal orders in writing by a physician within 24 hours.
b. The 11p-7am nursing staff will be assigned the task of preparing all medical records that contain verbal orders written within the prior 24 hours. These medical records will be made available to the physician for review and authentication by signature.
c. Compliance will be monitored by the nursing department and the Medical Record analyzers.
d. The Medical Director has reviewed this process and requirement with all physicians.
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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 narcotic treatment program failed to document that a narcotic treatment physician made a face-to face determination of current physiological dependence prior to the administration of a narcotic drug in two of six patient records.
The findings include:
Twelve client records were reviewed on November 5-6, 2015. Six records were reviewed as buprenorphine patient records. Six patient records required a face-to face determination of current physiological dependence of a narcotic drug. There was no documentation of a face to face determination of current physiological dependence of a narcotic drug in patient records # 3, 4 and 5.
Patient # 3 was admitted on November 1, 2015. The physician's assistant had completed the initial physical on November 2, 2015 and was countersigned by a physician on November 5, 2015. The patient's first dose was given on November 2, 2015. There was no documentation that the physician had met face to face with the patient to determine current physiological dependency prior to the administration of Suboxone.
Patient # 4 was admitted on November 1, 2015. The physician's assistant had completed the initial physical on November 2, 2015. The patient's first dose was given on November 2, 2015. There was no documentation that the physician had met face to face with the patient to determine current physiological dependency prior to the administration of Suboxone.
Patient # 5 was admitted on October 19, 2015. The physician had completed the initial physical on October 20, 2015. The patient's first dose was given on October 20, 2015. There was no documentation that the physician determined current physiological dependency prior to the administration of Suboxone.
These findings were reviewed with facility staff during the licensing process.
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Plan of Correction
a. All physicians and nurses will be re-educated on the standards for the Buprenorphine Intake. This education will include the following:
1. The narcotic treatment physician must clearly document the face-to-face determination of whether a patient is currently physiologically dependent upon a narcotic drug and has been physiologically dependent for at least 1 year prior to admission for maintenance treatment.
2. All physicians will be trained on new electronic documentation tool which includes: review of history and physical, determination that patient is physiologically addicted to opiate drugs and that the patient has been addicted to opiate drugs for a period of at least one year prior to the date of the intake. The documentation tool will also include the review of benefits, risks and alternatives to Buprenorphine/Suboxone detox and Maintenance treatment. This training will be completed by 12/14/2015 and implementation of the new tool will begin on 12/15/2015
b. Compliance will be monitored by the nursing department and the Medical Record analyzers.
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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 two of six patient records.
The findings include:
Twelve client records were reviewed on November 5-6, 2015. Six patient records were reviewed as buprenorphine records and required a completed drug screen urinalysis prior to the administration of Suboxone. The facility failed to obtain a completed drug screen urinalysis prior to the administration of Suboxone in patient records # 3 and 6.
Patient # 3 was admitted on November 1, 2015. The initial dose of Suboxone was given on November 2, 2015. The completed drug screen urinalysis results were not reported until November 3, 2015.
Patient # 6 was admitted on October 16, 2015. The initial dose of Suboxone was given on October 17, 2015. The completed drug screen urinalysis results were not reported until October 18, 2015.
These findings were reviewed with facility staff during the licensing process.
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Plan of Correction
a. All prospective patients are ordered and complete an initial Tox-10 drug screen urinalysis.
b. The results of the Tox-10 drug screen urinalysis are obtained and reviewed by the Treating Narcotic Physician. The physician will review the drug screen urinalysis results and attest their signature, date and time prior to the administration of suboxone.
c. The physician review of the drug screen results has also been added to the New Electronic Document titled; Suboxone Initial Evaluation. This electronic form ensures all steps are completed prior to the prescribing of suboxone including the review of urine screen results.
Training and full implementation of the electronic document will be by 12/15/15.
Director of nursing is responsible for training and implementation.
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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 the patient records, the facility failed to document a consultation between the physician ' s assistant and physician prior to determining the initial dose and schedule, and administering the initial dose in one of six patient records.
The findings include:
Twelve client records were reviewed on November 5-6. 2015. Six patient records were reviewed as buprenorphine patients. There was no documentation of a consultation in patient record # 3.
Patient # 3 was admitted on November 1, 2015. The physician's assistant completed an initial physical on November 2, 2015, which was countersigned by the physician on November 5, 2015. The patient was first dosed on November 2, 2015. There was no documentation of a consultation between the physician's assistant, who completed the physical, and the Physician, who wrote the initial dose medication order and schedule, prior to the patient ' s first dose.
These findings were reviewed with facility staff during the licensing process.
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Plan of Correction
a. All physicians will be re-educated on the Medication Dosage standard to include consultation.
b. The narcotic treatment physician shall determine the proper dosage level for patients.
c. If the narcotic treatment physician determining the initial dose is not the physician completing the exam the physician will review the history/physical and consult with medical staff that performed the exam prior to the administration of suboxone and document on the Physician progress note. The new physican progress note that is completed prior to administration requires the physician to review the physical if it was completed by someone other than themselves. the new form will be in effect 12/15/2015 and all physicians will be trained by 12/14/15
d. Compliance will be monitored by the nursing department and the Medical Record analyzers.
Training and implementation of poc will be completed by 12/14/15, the director of nursing is responsible for training and implementation
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