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 residential detoxification from opioid dependence. This inspection was conducted on July 9 and 10, 2008 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 in compliance with the applicable chapters of 28 PA Code which pertain to the facility. Deficiencies were identified during this inspection and plan of correction is due on August 5, 2008.
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Plan of Correction
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715.6(b)(1-9) LICENSURE Physician Staffing
(b) A narcotic treatment program may employ narcotic treatment physicians to assist the medical director. A narcotic treatment physician 's responsibilities include:
(1) Performing a medical history and physical exam.
(2) Determining diagnosis and determining narcotic dependence.
(3) Reviewing treatment plans.
(4) Determining dosage and all changes in doses.
(5) Ordering take-home privileges.
(6) Discussing cases with the treatment team.
(7) Issuing verbal orders pertaining to patient care.
(8) Assessing coexisting medical and psychiatric disorders.
(9) Treating or making appropriate referrals for treatment of these disorders.
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Observations
Based on a review of policy and procedure, the facility failed to include in the physician's listing of job responsibilities, the responsibility for the determination of diagnosis opioid drug dependence.
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Plan of Correction
Physician job description will be udpated to include the responsibility for determining diagnosis of drug dependence. This will be monitored by the Clinical Director. This will be completed by August 8, 2008. |
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 10 patient records, 3 were reviewed for content regarding determination of opioid dependence. The facility failed to document that the physician had performed face-to-face determinations for patients # 8, 9, and 10 to determine opiate dependency. Patients # 9 & 10 had histories and physicals performed by the certified registered nurse practitioner (CRNP) with no documentation that the physician had performed a face-to-face assessment of the patient.
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Plan of Correction
Physician will document all face to face determinations for all patients prior to administering Suboxone protocol. This will be monitored by the Medical Director. |
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 a review of 10 patient records, the facility failed to obtain a complete urine drug screen prior to the administration of Suboxone, a narcotic agent, for patients # 1, 2, 4, 5, 6, 7, 9 and 10 A complete urine drug screen includes receiving the results from the CLIA and Department of Health approved laboratory.
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Plan of Correction
UDS will be completed prior to administering protocol for all patients. Results will be recieved from the lab prior to administering Suboxone. This process will be monitored by the Director of Nursing.This will occur on August 8, 2008. |
715.14(d) LICENSURE Urine testing
(d) A narcotic treatment program shall ensure that a laboratory that performs the testing required under this section shall be in compliance with applicable Federal requirements, specifically the Clinical Laboratory Improvement Amendments of 1998 (42 U.S.C.A. §§ 201 note, 263 and 263a notes), and State requirements, specifically the Pennsylvania Clinical Laboratory Act (35 P.S. §§ 2151-2165) and Chapter 5 (relating to clinical laboratories).
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Observations
Based upon a review of 20 patient records and staff interviews, the facility failed to utilize an approved laboratory to obtain the urine drug screen results prior to the patient's initial dose of Suboxone. The facility utilized a "dipstick" test for urinalysis results prior to the submission to the laboratory for a confirmatory analysis. Patients were dosed based on the completion of the dipstick analysis and not the results from the approved laboratory.
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Plan of Correction
Lab will be utilized for UDS and not a "dipstick" test and UDS results will be obtained from the Lab prior to administering protocol. This will occur on August 8, 2008. |
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
Three of 10 patient records were reviewed to determine the physician's role in the determination of the proper dosage level. The facility failed to document that the physician who performed the patient evaluation was the physician who made the dose determination. Reviews of patient records # 9 and 10 revealed that the CRNP completed the patient evaluation; there was no record of consultation by the narcotic treatment physician with the CRNP prior to the physician's determination of the patients' dose.
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Plan of Correction
Consultations between CRNP and Physician or Physician and Physician will be documented in the chart regarding all contact prior to physican ordering Suboxone for any patient if ordering physician different from examining physician. This process will be monitored by the Medical Director. |
715.28(c)(1-5) LICENSURE Unusual incidents
(c) A narcotic treatment program shall file a written Unusual Incident Report with the Department within 48 hours following an unusual incident including the following:
(1) Complaints of patient abuse (physical, verbal, sexual and emotional).
(2) Death or serious injury due to trauma, suicide, medication error or unusual circumstances.
(3) Significant disruption of services due to a disaster such as a fire, storm, flood or other occurrence.
(4) Incidents with potential for negative community reaction or which the facility director believes may lead to community concern.
(5) Drug related hospitalization of a patient.
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Observations
Based on review of administrative documentation provided during the inspection and staff interviews, the facility failed to submit documentation of unusual incidents to the Department as required.
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Plan of Correction
Incident Reporting Policy and Procedure has been updated to indicate all incident reports must be forwarded to Department of Health as required. This process will be monitored by Clinical Director. |