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

Northwestern Memorial Healthcare • Chicago, IL

7d • $43 - $58

About The Position

The Compliance Coordinator reflects Northwestern Memorial’s mission, vision, and values; follows its Code of Ethics and Corporate Compliance Program; and complies with applicable policies, procedures, regulatory requirements, and accreditation standards. The coordinator works with Medical Directors and Managers to ensure regulatory compliance across department activities and consults with other hospital departments and committees regarding requirements in Transfusion Medicine (Blood Bank), Pathology Laboratories, or the Blood Gas laboratory, as applicable. The role maintains expertise in quality, compliance, regulatory, and accreditation requirements through professional meetings and ongoing dialogue with regulators and subject-matter experts.

The position develops and maintains quality management systems, supports regulatory compliance and accreditation inspections, reviews and reports quality incidents and trends, and assists with analysis and corrective action. It oversees document control and departmental safety activities, trains staff, maintains laboratory quality plans and records, and develops audits and standard operating procedures. The coordinator also supports quality meetings, research compliance, supply recalls, and ongoing quality-data collection, while contributing to interdepartmental communication, leadership, and professional development.

Requirements

• Bachelor’s degree.
• At least 5 years of experience in a clinical laboratory, Transfusion Medicine, or Blood Gas Laboratory.
• Clinical/professional expertise.
• Knowledge of CAP and TJC standards; IDOT, OSHA, and CLIA regulations; and CLSI guidelines.
• Knowledge of AABB standards and FDA regulations for Blood Bank work.

Nice To Haves

• Master’s degree in a related field.
• Experience with quality systems.
• American Society of Quality, CQA qualification.
• MT (ASCP) certification.
• Experience as a quality inspector or quality assurance officer.
• Experience with the DMAIC quality system.

Responsibilities

• Develop and maintain a quality management system for evaluating and improving services in relation to physician and patient care requirements; document significant activities and recommend corrective action.
• Facilitate compliance with federal, state, local, TJC, CAP, CLSI, and other applicable hospital regulations, policies, and procedures; report significant events to management and Medical Directors as required.
• Plan and facilitate departmental preparations for accreditation inspections and be responsible for inspections concerning quality assurance, compliance, and general laboratory policy and practice.
• Review and catalog incident reports, non-conformances, and critical incident reports; prepare regular quality tracking and trending reports and present findings to appropriate management personnel.
• Assist senior staff with incident analysis and corrective-action plan development.
• Orient, train, and oversee senior staff responsible for laboratory and departmental document control.
• Serve as, or work with, the department’s primary Safety and Emergency Management Officer and/or laboratory liaison with hospital safety, emergency management, and environment-of-care departments.
• Orient, train, and oversee departmental Safety Officers to ensure compliance with hospital and regulatory requirements.
• Train departmental staff on quality, compliance, and safety issues.
• Author and maintain the applicable Laboratory Quality Plan.
• Develop agendas and prepare minutes for department and hospital quality meetings.
• Establish ongoing quality-data collection to monitor testing systems and provide consultative, educational, technical, or informational services as needed.
• Manage departmental supply recalls in accordance with regulatory requirements.
• Develop and supervise departmental operational audits and communicate results to laboratory management.
• Conduct audits, evaluate processes and workflow, and prepare reports recommending improvements in compliance with DMAIC principles.
• Ensure responses to internal and external audits are well documented.
• Author and revise departmental SOPs related to compliance, quality, and general laboratory policies; review laboratory and departmental SOPs and document reviews for compliance with regulatory standards and internal policies.
• Ensure research activities performed in the section comply with Hospital Research policies.
• Maintain departmental quality, accreditation, and regulatory records.
• Develop and maintain expertise in the specific areas of responsibility; participate in and present at laboratory meetings and continuing education programs; and attend hospital quality and safety meetings as assigned.
• Adhere to Patients First Management standards for leadership, communication, and visibility; coordinate critical situations involving patients, staff, and visitors and seek guidance as needed.
• Facilitate communication about incidents with appropriate personnel and communicate key issues and trends to the manager.
• Promote the philosophy and objectives of the Hospital, Division, and Department.
• Set and pursue personal development objectives and opportunities, and assess and communicate staff development needs to the Manager.

Benefits

• The employer describes a wide range of benefits supporting physical, emotional, and financial well-being and protection from unexpected life events.
• Tuition reimbursement.
• Loan forgiveness.
• 401(k) matching.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level