Compliance Coordinator - Point of Care Testing, Full-Time, Days

About the role

The Compliance Coordinator position offers a competitive salary range of $37.50 - $50.63 per hour, with placement within the range dependent on relevant work experience and internal equity. Northwestern Medicine provides a comprehensive benefits package including tuition reimbursement, student loan repayment, professional development, and a Wellbeing Fund. The role is part of a community of colleagues dedicated to medical innovation and equity.

Responsibilities

• Develops and maintains a quality management system relative to technical evaluation and improvement of services.
• Documents all significant activities and recommends corrective action as necessary.
• Facilitates compliance with all federal, state, local, TJC, CAP, CLSI, and other multi-disciplinary, hospital regulations, policies, and procedures.
• Reports significant events to NMH management and Medical Directors as required.
• Plans and facilitates departmental preparations for accreditation inspections.
• Responsible for inspections related to quality assurance, compliance, and general laboratory policy and practice.
• Reviews and catalogs departmental incident reports, non-conformances, and critical incident reports.
• Prepares regular reports regarding tracking and trending of quality issues and presents the findings to appropriate management personnel.
• Provides assistance to senior staff in analysis and corrective action plan development in response to incidents.
• Orients, trains, and oversees activities of senior staff responsible for laboratory and departmental document control.
• Serves as, or works in cooperation with, the department primary Safety and Emergency Management Officer, and/or the laboratory liaison with NMH Safety, Emergency Management, and Environment of Care departments.
• Orients, trains, and oversees activities of the departmental Safety Officers to ensure compliance with hospital and regulatory agency requirements.
• Provides training to departmental staff on quality, compliance, and safety issues.
• Authors and maintains their respective Laboratory Quality Plan, as required by applicable regulatory agencies.
• Develops agendas and creates meeting minutes for department and hospital quality meetings.
• Establishes ongoing quality data collection which enables monitoring of testing systems.
• Maintains knowledge and utilizes appropriate resources to provide consultative, educational, technical, or informational services as needed to self, staff, or patients.
• Manages departmental supply recalls in accordance with regulatory requirements.
• Develops and supervises departmental operation audits and communicates results to laboratory management.
• Counsels and evaluates and prepares reports recommending improvements in process and workflow for laboratory sections in compliance with DMAIC principles.
• Affirms that responses to audits, both internal and external, are well documented.
• Authors and revises, as needed, departmental SOPS related to compliance, quality, and laboratory general policies.
• Reviews and documents review of laboratory and departmental SOPS for compliance with regulatory standards and internal policies.
• Affirms that research activities performed in the section are in compliance with Hospital Research policies.
• Maintains departmental quality, accreditation, and regulatory records.

Qualifications

• Education: Bachelors Degree
• Experience: Minimum 5 years experience in clinical laboratory, Transfusion Medicine, or Blood Gas Laboratory. Clinical/professional expertise.
• Behavioral Attributes: Knowledge of CAP and TJC Standards; IDOT, OSHA, and CLIA regulations; CLSI guidelines. Knowledge of AABB standards and FDA regulations (applies to Blood Bank).
• Preferred: Masters Degree in related field. Experience with quality systems. American Society of Quality, CQAMT (ASCP) certification. Experience as quality inspector or quality assurance officer. Experience with the DMAIC quality system.