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 July 17, 2009 by staff from the Division of Drug and Alcohol Program Licensure. Based on the findings of the on-site inspection, Conewago - Pottsville 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 August 9, 2009. .
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Plan of Correction
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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 patient records and a staff interview, the facility failed to document a consultation between the physician's assistant who completed the the physical evaluation and the physician determining the dose in one of eight records.
The findings include:
Eight patient records were reviewed on July 17, 2009. Patient records that contained documentation of a physician's assistant or physician completing the physical evaluation
were required to have a consultation by the physician who determined the dose. In patient record # 5, there was documentation that the physician's assistant performed the patient's physical evaluation. There was no documentation by the prescribing physician that identified that a consultation had taken place prior to the dose determination. The physician did sign patient # 5's physical evaluation that had been completed by the physician's assistant but there was no date documented. A signature by the physician is not sufficient documentation to identify that a consultation took place.
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Plan of Correction
The facility director will meet with the medical director on August 3, 2009 to ensure that effective immediately, when a physician assistant conducts a physical examination, documentation is placed in the client's file stating that the medical director has reviewed all documentation of the physical examination and agrees with the finding and that consultation of such took place. The medical director will then place a note in the client's chart documenting such consultation. Facility director will monitor on a monthly basis in conjunction with the corporate compliance officer by 8/31/09 to ensure compliance. |
715.17(c)(3)(i-v) 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:
(3) Inspection of storage areas. A narcotic treatment program shall inspect all drug storage areas and the dispensing station at least quarterly to ensure that the areas are maintained in compliance with Federal, State and local laws and regulations. A narcotic treatment program shall develop and implement written policies and procedures regarding who performs the inspections, how often, and in what manner the inspections are to be documented. The policies and procedures shall include the following:
(i) Disinfectants and drugs for external use shall be stored separately from oral and injectable drugs.
(ii) Drugs requiring special conditions for storage to insure stability shall be properly stored.
(iii) Outdated and contaminated drugs shall be removed and destroyed according to Federal and State regulations.
(iv) Administration of controlled substances shall be documented.
(v) Controlled substances and other abusable drugs shall be stored in accordance with Federal and State regulations.
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Observations
Based on a review of administrative materials and staff interview, the facility failed to maintain documented records of quarterly inspections of the drug storage areas, as per their written policy.
The findings include:
The facility's policy and procedure manual was reviewed on July 16, 2009. The facility's policy stated that quarterly inspections would be completed and documented in a log book. The log documenting quarterly inspections of the drug storage areas was requested to be reviewed on July 16, 2009. The log documenting quarterly inspections of the drug storage areas included an inspection completed in September 2008 and in December 2008, however, there was no documentation to show that an inspection had been completed in March 2009 or June 2009, as required.
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Plan of Correction
The facility director will review the existing contract with the local pharmacy to ensure that quarterly inspections are conducted and documented as required by the Facility's Policy and Procedure's Manual on August 12, 2009. The facility director will ensure that documentation of the quarterly inspections are kept on file at the facility. The facility director will monitor on a monthly basis in conjunction with the corporate compliance officer by 8/31/09 to ensure compliance |