Controlled Substance Auditor

Medical University of South Carolina•Charleston, SC

22h

About The Position

The Program Manager works under limited supervision to conduct the compliance and operational audits primarily in a hospital pharmacy setting; prepares and completes the Audit Programs relating to controlled substances and the 340B drug discount program; determines compliance with policies, regulations, Federal and State laws; determines accuracy and validity of pharmacy and related records; prepares written audit reports in accordance with Internal Auditing standards, Generally Accepted Auditing Standards (GAAS), accounting principles, and department policy; maintains accurate and thorough records of all audit work, and; destroys contaminated and expired controlled substances as allowed by DHEC. This position is responsible for: Verifying proper controls are in place to prevent or deter the diversion of controlled substances from their legal and authorized purpose; Verifying proper controls are in place to facilitate compliance with HRSA’s 340B Drug Discount Pricing Program; Verifying all required legal documents, reports, and records are properly and timely initiated and completed by all disciplines; Educating employees on proper handling, disposition, and documentation of controlled substances and verifying proper security measures are adhered to. Educating employees on 340B Program regulations.

Requirements

MUSC Minimum Experience and Training Requirements: A bachelor’s degree and (3) three years of relevant program experience.

Nice To Haves

Ability to interpret and apply controlled substance and 340B Program regulations and related MUSC policies and procedures.
Experience with Automated Dispensing Machines (ADMs) required.
Professional, concise, and articulate presentation and written communication skills.
Ability to use computer hardware and software, especially word processing, spreadsheet applications, data analytics, and pharmacy and medical records systems.
Relevant professional certification is preferred.
Master’s degree in a related field preferred.
Must be available on pager 24 hours/day, 7 days/week.
Must be able to work flexible hours on occasion.

Responsibilities

Annual Risk Assessment and Goal Setting – Participate in setting departmental goals and preparation of the Annual Audit Plan.
Audit/Project Planning – For assigned audits/projects, plan and document the planning of the work necessary to address the audit objectives in accordance with department policies and relevant regulatory requirements. Assigned audits/projects are primarily related to controlled substances and the 340B Program and include routine audits of pharmacies, nursing units, clinics, registered departments, etc.
Audit/Project Fieldwork – For assigned audits/projects, obtain/prepare audit documentation that provides a basis for audit conclusions. Use available software to analyze data for accuracy and compliance with laws, regulations, policies, and procedures. Analyze audit area internal controls for effectiveness, including verifying proper and accurate records and documentation is maintained. When necessary for audits/projects, including controlled substance activity, conduct data analysis on an ongoing basis.
Audit/Project Reporting – Communicate results of pharmacy, nursing unit, registered department, and 340B Program audits timely to the appropriate parties (supervisor, audit clients, Nurse Manager, Registrant, CNP, Pharmacy Services, 340B Program Management, etc.), using the appropriate method (in person or in writing) according to department policy.
Audit/Project Follow-up Process – Complete the follow-up process on assigned audits in accordance with department policy.
DHEC and DEA Inspections – DHEC has increased its oversight of our campus, thus, requiring more assistance from the department. Coordinate with the DHEC Bureau of Drug Control and/or DEA for the site inspection and review of the controlled substance regulations and recording requirements. Assist DHEC and DEA in conducting inspections and investigations. Inform the supervisor of contact with DEA, DHEC, or other regulatory bodies on a timely basis.
Timely destruction of contaminated or expired controlled substances – Timely destruction of contaminated or expired controlled substances in accordance with Federal and State regulations. Educate research, hospital, and clinic staff on proper procedures for wastage and/or destruction of controlled substances.
Conduct CS training – Conduct training on proper handling, disposition, and documentation of controlled substances and use of the ADM.
Communication and Relationships with personnel relevant to the CS process – Maintain close contact with individuals responsible for ordering, receiving, and distributing controlled substances so possible sources of illegal use or distribution of controlled substances may be detected. Guide and assist Hospital Administration, Pharmacy Services, practitioners, and researchers with the application requirements and proper submission for controlled substance registrations. Monitor application progress and coordinate resolution of any issues that may arise.
Maintain Knowledge of laws, policies, procedures, and automated dispensing machines (ADM) – Maintain up-to-date awareness of Federal and State laws and regulations related to controlled substances, controlled substances registrations (application and submission requirements), and the 340B Program. Maintain full awareness of MUSC, MUHA, and MUSCP policies, procedures, and systems relating to controlled substances and the 340B Program. Understand the capabilities and functions of the ADM used for controlled substances. Perform other duties as assigned.