The Compliance Coordinator reflects the mission, vision, and values of Northwestern Medicine, adheres to the organization's Code of Ethics and Corporate Compliance Program, and complies with all relevant policies, procedures, guidelines and all other regulatory and accreditation standards.
The Compliance Coordinator will work with Medical Directors and Managers to assure regulatory compliance of department activities and provides consultation to other hospital departments and committees regarding regulatory requirements in Transfusion Medicine (Blood Bank), the Pathology Laboratories, or the Blood Gas laboratory, as applicable.
The Compliance Coordinator will maintain the highest degree of expertise in quality, compliance, regulatory, and accreditation requirements through attendance at professional, association and scientific meetings, and through continual dialogue with regulators and experts in the field.
- Develops and maintains a quality management system relative to the technical evaluation and improvement of services in relation to physician and patient care requirements. 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 NM 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 NM 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.
- Conducts audits and evaluates and prepares reports recommending improvements in process and workflow for laboratory sections in compliance with DMAIC principles.
- Assures 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.
- Assures that research activities performed in the section are in compliance with Hospital Research policies.
- Maintains departmental quality, accreditation and regulatory records.
- Bachelors Degree
- Minimum 5 years experience in clinical laboratory, Transfusion Medicine, or Blood Gas Laboratory.
- Clinical/professional expertise.
- Knowledge of CAP and TJC Standards; IDOT, OSHA and CLIA regulations; CLSI guidelines.
- Knowledge of AABB standard and FDA regulations (applies to Blood Bank)
- Masters Degree in related field
- Experience with quality systems
- American Society of Quality, CQA
- MT ( ASCP) certification
- Experience as quality inspector or quality assurance officer.