Laboratory Services Manager - Clinical Laboratory - Full Time 8 Hour Days (Exempt) (Non-Union)

The QA, Regulatory and Compliance Manager, manages the Quality Plans for the Clinical Laboratory and Pathology. Coordinates all quality assessment and performance improvement activities for the Department of Pathology/ USC Laboratories. Serves as Laboratory Compliance Officer and manages the Compliance Program to ensure compliance with all Federal, State and accreditation requirements for all laboratory operations and testing performed at all USC Laboratory locations. Researches, monitors, updates and communicates laboratory regulatory issues.

Essential Duties:

• Prepares annual Laboratory Compliance Plan and Key Program Objectives.
• Coordinates operational aspects (agendas, meeting dates, and minutes) of the Laboratory Compliance Committee (LCC).
• Manages laboratory compliance variance reporting process and ensures that identified issues are tracked and resolved in a timely manner.
• Administers and manages activities in the laboratory that support the University’s Compliance Program.
• Monitoring and evaluation of regulatory requirements and changes affecting USC Clinical Laboratory operations.
• Assesses impact to processes requiring revisions or additions to applicable policies and procedures.
• Works with the Patient Business Services to ensure that a comprehensive and effective plan is in place to monitor and audit laboratory claims.
• Compliance training, education, and awareness activities to include HIPAA Privacy and Security requirements.
• Assures that laboratory employees are properly trained in general compliance and where appropriate, in areas specific to their laboratory responsibilities.
• Coordinates all Quality Assessment and Performance Improvement activities. Communicates information and findings to appropriate staff and committees.
• Responsible for development and maintenance of appropriate QA programs for testing.
• Conducts in-service programs as needed. Assures collection of appropriate QA data by consulting with LIS. downloads applicable data from Cerner LIS.
• Acts as QA officer for Blood Bank Quality Unit as defined by AABB. Writes and reviews the annual Blood Bank Quality Plan
• Responsible for writing and reviewing all policies and procedures related to QA&I such as the Annual Lab Quality plan.
• Maintain current knowledge of CLIA, State of California, JCAHO, CAP, FDA, and Bureau of Biologics regulation and requirements. Ensures regulatory compliance of the SCML/Department of Pathology and all testing sites. Communicates with regulatory and accreditation agencies, as necessary, to clarify current state of federal laws/regulations.
• Responsible for coordination of the laboratory’s preparedness for inspections/surveys by CAP, JCAHO, AABB, FDA, and the follow up inspection response activities.
• Prepares applications or other correspondence, as required, with regulatory agencies and ensures timely completion and mailing.
• Maintains complete, organized files of regulatory documents relating to laboratory licensure/accreditations/certifications for all testing sites.
• Coordinates annual purchase order of proficiency testing surveys for all sections of the laboratory, pathology and POCT at USC and other clinic testing sites.
• Serves as key contact with PT providers
• Researches regulatory issues upon request and serves as a regulatory resource for lab management.
• Coordinates and maintains Laboratory General Administration Policy Manual as directed by the Administrative Director and Medical Director.
• Performs other duties as assigned.

Required Qualifications:

• Req Bachelor's degree Undergraduate degree from an accredited university in the U.S. For a degree obtained outside the U.S., a certificate of equivalency with U.S. degree programs
• Req Specialized/technical training 12 CEU continuing education (12 hours) per year, required and approved by the State of California for continued CLS licensure.
• Req 2 years Clinical laboratory as a supervisor, manager or higher.
• Req Comprehensive understanding of State and Federal laws pertaining to clinical laboratory testing and operations, and accreditation standards (JCAHO, CAP, AABB).
• Req Possess strong analytical problem-solving skills and excellent communication skills including effective interpersonal aptitude to interact with a diverse group in a diplomatic manner.
• Req Participation in accreditation (JCAHO, CAP, etc.) inspections.
• Req Understanding of quality assurance requirements of JCAHO, CAP, AABB, FDA, CLIA, and State of California.
• Req Understanding of clinical laboratory quality control, CQI philosophy.
• Req Familiarity with State and federal laws and regulations governing laboratory practice, including physicians’ office testing, hospital bedside testing, scope of practice, Quality Control, Quality Assurance.
• Req Understanding of OIG compliance guidance for laboratories.
• Req Expertise in the use of desktop computer tools, including the Internet, Outlook, Excel, PowerPoint, and Word applications.
• Req Ability to write and implement policies & procedures.

Preferred Qualifications:

• Pref Clinical Laboratory Specialist in Chemistry (ASCP) ASCP certification in Chemistry or Microbiology as an MT.

Required Licenses/Certifications:

• Req Clinical Laboratory Scientist – CLS.
• Req Fire Life Safety Training (LA City) If no card upon hire, one must be obtained within 30 days of hire and maintained by renewal before expiration date. (Required within LA City only).

The annual base salary range for this position is $145,600.00 - $240,240.00. When extending an offer of employment, the University of Southern California considers factors such as (but not limited to) the scope and responsibilities of the position, the candidate’s work experience, education/training, key skills, internal peer equity, federal, state, and local laws, contractual stipulations, grant funding, as well as external market and organizational considerations.