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 March 1, 2012 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 in compliance with the applicable chapters of 4 PA Code and 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)(1) 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.
(1) Each test shall be for opiates, methadone, amphetamines, barbiturates, cocaine and benzodiazepines.
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Observations
Based on the review of patient records and discussion with administrative staff, the facility failed to ensure the drug screening urinalysis test included methadone as part of the testing panel. The findings include:Eight patient records were reviewed March 1, 2012. Eight patient records required an initial drug-screening urinalysis testing for opiates, methadone, amphetamines, barbiturates, cocaine and benzodiazepines. Patient records # 1, 2, 3, 4, 5, 6, 7 and 8 each had an initial drug screening urinalysis completed that included opiates, amphetamines, barbiturates, cocaine and benzodiazepines, but did not include testing for methadone.This was discussed with the corporate clinic director and the corporate compliance officer who both agreed that methadone was not on the testing panel as required.
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Plan of Correction
715.14 (a) (1) - Project director revised the drug testing policy # 3-051D to include the six substances mandated in the standard on 3/9/12 and secured governing body approval.
Project director will amend the contract with Schuylkill Medical Center East by 4/16/12 to include the 6 substances listed in the standard and will ensure that the hospital tests for all 6 substances for this date forward.
Facility director will monitor compliance weekly by 4/20/12 to ensure all narcotic treatment clients are drug tested per the standard and the corporate compliance officer will monitor monthly by 5/31/12 to ensure ongoing 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 documentation, the facility failed to ensure at least quarterly inspections of the drug storage and dispensing area during the past 12 months reviewed.The findings include:Administrative documentation that included the quarterly inspection reports completed by the contracted pharmacist for the past twelve months was reviewed March 1, 2012. The documentation demonstrated inspections by the contracted pharmacist dated March 16, 2011, July 7, 2011 and December 22, 2011.Four inspections should have been completed during the twelve months reviewed.
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Plan of Correction
715.17 (c) (3) (i-v) ? Project director will review the applicable licensing standard with the facility director on 3/22/12 to ensure her understanding. Facility director will contact the contracted pharmacy on 3/22/12 to ensure that future quarterly drug storage inspections occur in a timely fashion and will ensure that documentation is placed in the facility inspection binder for department compliance review. Corporate compliance officer will review quarterly beginning 3/30/12 to ensure ongoing compliance. |