Regulatory and Accreditation Manager

Serves as the USP designated person for the company and remains current in and ensures compliance with USP and other applicable laws, regulations, and standards, including but not limited to The Joint Commission (TJC), Centers for Medicare & Medicaid Services (CMS), and Louisiana Department of Health (LDH).

Completes and prepares mock survey reports, conducts regulatory rounding site visits, and documents review.

Maintains reports of environmental testing and wipe sampling performed and develops and implements action plans responding to environmental testing and wipe sampling results.

Ensures environmental control of the storage and compounding areas, participates in regulatory agency inspections of the compounding facility and oversees and uses internally developed systems and/or commercial vendor software to maintain records of facility monitoring.

Develops and implements appropriate standard operating procedures for risk prevention, updates policies, procedures and other documentation requirements to align with changes in standards, regulations and/or laws and communicates risks that may compromise safety as well as the rationale for prevention policies.

Participates in TJC, LDH/CMS, and/or other accrediting body licensing surveys, and assists and actively participates in the System Environment of Care Committee.

Adds addresses system-level compliance with other regulatory concerns, including laser safety, USP and hazardous waste disposal, reports potentially hazardous situations to the management team, and collaborates with health care professionals to provide training regarding risks to themselves and others resulting from non-compliance.

Ensures personnel competency and uses internally developed systems and/or commercial vendor software to track personnel competency.

Performs other related duties as required.