Controlled Substance Auditor

Job Description Summary

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, 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.

• 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.

Medical University Hospital Authority (MUHA)

Employee

Regular

CC005201 SYS - Regulatory Affairs and Accreditation

Salary

Health-28

40

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

• 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.

• 5%-Annual Risk Assessment and Goal Setting – Participate in setting departmental goals and preparation of the Annual Audit Plan.
• 10%-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. Audits/projects are primarily related to controlled substances and the 340B Program and include routine audits of pharmacies, nursing units, clinics, registered departments, etc.
• 35%-Audit/Project Fieldwork – Obtain/prepare audit documentation that provides a basis for audit conclusions. Use software to analyze data for accuracy and compliance with laws, regulations, policies, and procedures. Analyze internal controls for effectiveness and ensure proper records and documentation are maintained. Conduct data analysis on an ongoing basis where necessary.
• 10%-Audit/Project Reporting – Communicate results of audits timely to the appropriate parties using department policy. Documentation should follow standard formats and include necessary cross-references.
• 5%-Audit/Project Follow-up Process – Complete the follow-up process on assigned audits in accordance with department policy.
• 5%-DHEC and DEA Inspections – Coordinate with DHEC and/or DEA for site inspections and review of regulations; assist in inspections and investigations; inform supervisor of interactions with regulatory bodies.
• 15%-Timely destruction of contaminated or expired controlled substances – Destruction in accordance with regulations; educate staff on wastage procedures; ensure paperwork is maintained.
• 5%-Conduct CS training – Conduct training on handling, disposition, and documentation of controlled substances and use of the ADM.
• 5%-Communication and Relationships with personnel relevant to the CS…