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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, 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.

Entity

Medical University Hospital Authority (MUHA)

Worker Type

Employee

Worker Sub-Type​

Regular

Cost Center

CC005201 SYS - Regulatory Affairs and Accreditation

Pay Rate Type

Salary

Pay Grade

Health-28

Scheduled Weekly Hours

40

Work Shift

Job Description

MUSC Minimum Experience and Training Requirements:

A bachelor’s degree and (3) three years of relevant program experience.

Preferred Experience & Additional Skills:

• Bachelor’s degree in a relevant field and 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.

JOB RESPONSIBILITIES

5%-Annual Risk Assessment and Goal Setting – Participate in setting departmental goals and preparation of the Annual Audit Plan.

Success Criteria:

Does Not Meet Expectations – Participates inconsistently/or does not participate in setting departmental goals or preparation of Annual Audit Plan. Meets Expectations – Conduct interviews with institutional administration to identify institutional needs/risks for the annual risk assessment. Documents interview and identified risks. Exceeds Expectations – Criteria at level 2. Document the interview and identify risks within 2 working days of the interview. Substantially Exceeds Expectations – Criteria at levels 2 and 3. Potential review areas identified and forwarded during the year to Director/Assistant Director for considered inclusion in 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. 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.

Success Criteria:

Does Not Meet Expectations – Planning steps are not documented. Meets Expectations – Identify the potential audit criteria needed to evaluate matters under review. Assess risks of fraud or abuse occurring within the context of the audit objective. Consideration of significance is documented in the Audit Planning Memo in accordance with the department’s policy manual. Milestone/target dates are entered in TeamMate during the planning phase. Exceeds Expectations – Criteria at level 2. The draft audit program is prepared and approved prior to fieldwork. Substantially Exceeds Expectations – Criteria at levels 2 and 3. Minimal rework of the Audit Planning is required for its signoff, electronic workpapers are sent to TeamMate+ after the draft audit program is approved

35%-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.

Success Criteria:

Does Not Meet Expectations – Fieldwork is not completed and/or not consistently documented in accordance with department policy. Meets Expectations – Review is completed, including evaluating the effectiveness of related policies and procedures, evaluating risks associated with audit areas and procedures reviews, and; identifying issues. Documentation is completed in accordance with departmental policy and is clearly organized. Results are communicated timely to responsible parties. Diversion investigations are referred as warranted. Exceeds Expectations – Criteria at level 2. Audit documentation/evidence is entered into Internal Audit applications and systems as appropriate. Substantially Exceeds Expectations – Criteria at levels 2 and 3. Documentation is in sufficient detail to enable an experienced auditor to understand from the documentation the nature, timing, extent, and results of audit procedures performed. Corrective action is agreed upon with the audit client during fieldwork prior to reporting.

10%-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.

Success Criteria:

Does Not Meet Expectations – The supervisor is not kept aware at all times of the progress on audits/projects. The appropriate method for reporting/communicating is not used. For written reports, deficient conditions identified are not documented using the 5 elements of a condition: condition, standard, effect, cause, and recommendation. Written reports do not consistently conform to office standard formats. Meets Expectations – The supervisor is kept aware at all times of the progress on audits/projects. Document in workpapers the condition, standard, effect, cause, and recommendation. Written reports and memorandums are prepared in the standard format. The draft audit report is cross-referenced to supporting workpapers prior to the Assistant Director’s review of the draft. Exceeds Expectations – Criteria at level 2. Use authoritative standards (i.e., law, regulation, policy, standard-setting body such as GASB, COSO, COBIT) when applicable. Determine the underlying reason why the condition occurred. Review conditions with the auditee and document their comments prior to issuing the draft report to the auditee. The auditor writes reports to include a perspective on the extent and significance of reported finding(s), such as frequency of occurrence relative to transactions tested. Substantially Exceeds Expectations – Criteria at levels 2 and 3. Request and document auditee input on cause and action plan to correct deficient condition. The recommendation proposed by the auditor is measurable, actionable, and provides accountability. Minimal re-work of comments is required after manager review. Minimal re-work of reports/memorandums is required to meet department reporting standards. Reports are prepared and sent to the appropriate responsible parties timely in accordance with department policy.

5%-Audit/Project Follow-up Process – Complete the follow-up process on assigned audits in accordance with department policy.

Success Criteria:

Does Not Meet Expectations – The follow-up process is not consistently followed for assigned audits. Meets Expectations – Inform the auditee of the follow-up process as part of the entrance and exit procedures in assigned audits. Request from the auditee the status of their action plan once all action plan implementation dates are reached or 14 months after the original report is issued. Exceeds Expectations – Criteria at level 2. Review the response and documentation provided by the auditee to determine if further fieldwork is necessary. Compose and distribute a draft follow-up memo to the auditee. Substantially Exceeds Expectations – Criteria at levels 2 and 3. Determine the status/condition of each action plan with minimal re-work required from manager review.

5%-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.

Success Criteria:

Assist DEA or DHEC when requested and as time permits. The supervisor is kept aware at all times of interactions with and progress on audits/projects related to DEA/DHEC.

Does Not Meet Expectations- Does not consistently, reliably, and/or independently “Meet Expectations.” Meets Expectations-Consistently, reliably, and independently meets the needs of situations in terms of quality, quantity, accuracy, timeliness, policy/process/procedure compliance, respect, inclusion, and service delivery. Exceeds Expectations- Consistently, reliably, and independently meets expectations, plus frequently adds additional value by going above and beyond what is required. Substantially Exceeds Expectations- Exceeds expectations and initiates innovations and ongoing improvements to expand the scope and/or value of contributions.

15%-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.

Success Criteria:

Destroy expired controlled substances in each pharmacy area as requested. Destroy contaminated and expired controlled substances within 3 business days of notification by the on-campus nursing units or registered departments. Destroy drugs in outlying clinics/areas within a reasonable time with assurance from the clinic/area that the drugs have been secured. Paperwork is properly completed and maintained in accordance with policy.

Does Not Meet Expectations- Does not consistently, reliably, and/or independently “Meet Expectations.” Meets Expectations-Consistently, reliably, and independently meets the needs of situations in terms of quality, quantity, accuracy, timeliness, policy/process/procedure compliance, respect, inclusion, and service delivery. Exceeds Expectations- Consistently, reliably, and independently meets expectations, plus frequently adds additional value by going above and beyond what is required. Substantially Exceeds Expectations- Exceeds expectations and initiates innovations and ongoing improvements to expand the scope and/or value of contributions.

5%-Conduct CS training – Conduct training on proper handling, disposition, and documentation of controlled substances and use of the ADM.

Success Criteria:

Participate in new employee orientation, staff meetings, and charge nurse workshops. Conduct in-services on nursing units when requested. Conduct in-services for House Staff, physicians, researchers, etc., as needed or requested. Training is conducted timely, professionally, and in accordance with regulations and policies.

Does Not Meet Expectations- Does not consistently, reliably, and/or independently “Meet Expectations.” Meets Expectations-Consistently, reliably, and independently meets the needs of situations in terms of quality, quantity, accuracy, timeliness, policy/process/procedure compliance, respect, inclusion, and service delivery. Exceeds Expectations- Consistently, reliably, and independently meets expectations, plus frequently adds additional value by going above and beyond what is required. Substantially Exceeds Expectations- Exceeds expectations and initiates innovations and ongoing improvements to expand the scope and/or value of contributions.

5%-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.

Success Criteria:

Interact with appropriate personnel on a regular basis. Utilize reports generated by the ADM or other software to determine areas or individuals needing attention or review. Assist personnel with basic questions that arise with the use of the ADM. Duties performed timely in a professional manner. SuccessFactors may vary depending on the assigned duty. Registrations are accurate and received in as timely a manner as possible. Paperwork is completed properly, submitted timely, tracked, and maintained appropriately. Timeliness is somewhat dependent on factors beyond our control (i.e., registrant responsibilities for application completion and security requirements, DHEC and DEA inspection and processing).

Does Not Meet Expectations- Does not consistently, reliably, and/or independently “Meet Expectations.” Meets Expectations-Consistently, reliably, and independently meets the needs of situations in terms of quality, quantity, accuracy, timeliness, policy/process/procedure compliance, respect, inclusion, and service delivery. Exceeds Expectations- Consistently, reliably, and independently meets expectations, plus frequently adds additional value by going above and beyond what is required. Substantially Exceeds Expectations- Exceeds expectations and initiates innovations and ongoing improvements to expand the scope and/or value of contributions.

5%- 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.

Success Criteria:

Does Not Meet Expectations – 0 – 29 CPEs earned; Keep abreast of changes in Federal and State laws and MUSC, MUHA, and UMA policies and procedures as they relate to controlled substances; able to assist personnel with basic questions that arise regarding controlled substances, the 340B Program, or the ADM; other duties are performed timely in a professional manner. Meets Expectations – 30 – 39 CPEs earned; Keep abreast of changes in Federal and State laws and MUSC, MUHA, and UMA policies and procedures as they relate to controlled substances; able to assist personnel with basic questions that arise regarding controlled substances, the 340B Program, or the ADM; other duties are performed timely in a professional manner. Exceeds Expectations – 40 CPEs earned; Keep abreast of changes in Federal and State laws and MUSC, MUHA, and UMA policies and procedures as they relate to controlled substances; able to assist personnel with basic questions that arise regarding controlled substances, the 340B Program, or the ADM; other duties are performed timely in a professional manner. Substantially Exceeds Expectations – 41+ CPEs earned; Keep abreast of changes in Federal and State laws and MUSC, MUHA, and UMA policies and procedures as they relate to controlled substances; able to assist personnel with basic questions that arise regarding controlled substances, the 340B Program, or the ADM; other duties are performed timely in a professional manner.

Additional Job Description

NOTE: The following descriptions are applicable to this section: 1) Continuous – 6-8 hours per shift; 2) Frequent – 2-6 hours per shift; 3) Infrequent – 0-2 hours per shift

Ability to perform job functions while standing. (Frequent)

Ability to perform job functions while sitting. (Frequent)

Ability to perform job functions while walking. (Frequent)

Ability to climb stairs. (Infrequent)

Ability to work indoors. (Continuous)

Ability to work from elevated areas. (Frequent)

Ability to work in confined/cramped spaces. (Infrequent)

Ability to perform job functions from kneeling positions. (Infrequent)

Ability to bend at the waist. (Frequent)

Ability to squat and perform job functions. (Infrequent)

Ability to perform repetitive motions with hands/wrists/elbows and shoulders. (Frequent)

Ability to reach in all directions. (Frequent)

Possess good finger dexterity. (Continuous)

Ability to fully use both legs. (Continuous)

Ability to fully use both hands/arms. (Continuous)

Ability to lift and carry 15 lbs. unassisted. (Infrequent)

Ability to lift/lower objects 15 lbs. from/to floor from/to 36 inches unassisted. (Infrequent)

Ability to lift from 36 inches to overhead 15 lbs. (Infrequent)

Ability to maintain 20/40 vision, corrected, in one eye or with both eyes. (Continuous)

Ability to see and recognize objects close at hand or at a distance. (Continuous)

Ability to match or discriminate between colors. (Continuous) *(Selected Positions)

Ability to determine distance/relationship between objects; depth perception. (Continuous)

Ability to maintain hearing acuity, with correction. (Continuous)

Ability to perform gross motor functions with frequent fine motor movements. (Continuous)

Ability to work in a latex safe environment. (Continuous)

*Ability to maintain tactile sensory functions. (Frequent) *(Selected Positions)

*Ability to maintain good olfactory sensory function. (Frequent) *(Selected Positions

*Ability to be qualified physically for respirator use, initially and as required. (Continuous)

(Selected Positions)*

If you like working with energetic enthusiastic individuals, you will enjoy your career with us!

The Medical University of South Carolina is an Equal Opportunity Employer. MUSC does not discriminate on the basis of race, color, religion or belief, age, sex, national origin, gender identity, sexual orientation, disability, protected veteran status, family or parental status, or any other status protected by state laws and/or federal regulations. All qualified applicants are encouraged to apply and will receive consideration for employment based upon applicable qualifications, merit and business need.

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