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

Northwestern Memorial Healthcare • Chicago, IL

5d

About The Position

The Compliance Coordinator reflects Northwestern Medicine’s mission, vision, and values and follows its Code of Ethics, Corporate Compliance Program, and applicable policies, procedures, regulations, and accreditation standards. The coordinator works with Medical Directors and Managers to support regulatory compliance in department activities and advises other hospital departments and committees about applicable 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. It develops and maintains quality management systems, supports accreditation inspections, oversees quality and safety processes, audits laboratory operations, maintains records and procedures, and provides staff education and consultation. The coordinator also participates in quality and safety meetings, supports effective communication during critical situations, and pursues 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 responsibilities, as applicable.

Nice To Haves

• Master’s degree in a related field.
• Experience with quality systems.
• American Society of Quality, CQA, or 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 technical evaluation and improvement of services in relation to physician and patient care requirements.
• Document significant activities and recommend corrective action as necessary.
• Facilitate compliance with federal, state, local, TJC, CAP, CLSI, hospital, and other applicable regulations, policies, and procedures.
• Report significant events to NMH management and Medical Directors as required.
• Plan and facilitate departmental preparations for accreditation inspections and conduct inspections related to quality assurance, compliance, and general laboratory policy and practice.
• Review and catalog departmental incident reports, non-conformances, and critical incident reports.
• Prepare reports tracking and trending quality issues 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 NMH Safety, Emergency Management, and Environment of Care departments.
• Train and oversee departmental Safety Officers to help ensure compliance with hospital and regulatory requirements.
• Provide staff training 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.
• Use appropriate resources to provide consultative, educational, technical, or informational services to self, staff, or patients.
• Manage departmental supply recalls in accordance with regulatory requirements.
• Develop and supervise departmental operational audits, communicate results to laboratory management, and conduct audits evaluating processes and workflow in compliance with DMAIC principles.
• Prepare reports recommending improvements to laboratory processes and workflow, and ensure responses to internal and external audits are well documented.
• Author and revise departmental SOPs related to compliance, quality, and general laboratory policies; review and document review of SOPs for regulatory and internal-policy compliance.
• Ensure research activities performed in the section comply with Hospital Research policies.
• Maintain departmental quality, accreditation, and regulatory records.
• Develop expertise in areas of responsibility and participate in and present at laboratory meetings and continuing education programs.
• Participate in 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, consulting a manager or administrator for guidance as needed.
• Facilitate interdepartmental communication about incidents with appropriate personnel and promote the philosophy and objectives of the Hospital, Division, and Department.
• Identify and communicate key issues and trends to the manager.
• Establish and execute personal development objectives, pursue appropriate development opportunities, and assess and communicate staff development needs to the Manager.

Benefits

• Tuition reimbursement
• Loan forgiveness
• 401(k) matching
• Benefits supporting physical, emotional, and financial well-being and protection for unexpected life events

What This Job Offers

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