Hours are Monday through Friday 7:30 a.m. - 4:00 p.m.
The Compliance Coordinator reflects the mission vision and values of Northwestern Memorial adheres to the organizations 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.
Responsibilities:
- 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 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.
- 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.
ADDITIONAL FUNCTIONS
- Develops and maintains a higher level of expertise in the specific areas of responsibility.
- Participates in and presents at laboratory meetings and continuing education programs.
- Participates in hospital quality and safety meetings as assigned.
LEADERSHIP/PROBLEM SOLVING
- Adheres to Patients First Management standards on leadership communication and visibility.
- Coordinates critical situations involving patients staff and visitors and consults with manager or administrator for guidance as needed (e.g. complaints discipline the press etc.).
- Facilitates effective interdepartmental communication of incidents with appropriate personnel (Manager Administrator Medical Staff; etc.).
- Promotes philosophy and objectives of the Hospital Division and Department.
- Identifies and communicates key issues and trends to manager.
PROFESSIONAL/PERSONAL DEVELOPMENT
- Establishes and executes personal development objectives as part of annual objective setting process which complements current position.
- Identifies and pursues activities/development opportunities which are appropriate for position and personal development objectives e.g. participation/leadership in relevant professional groups associations continuing education as participant presenter and planner.
- Assesses and communicates staff development needs to Manager.
Qualifications :
Required:
- 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)
Preferred:
- 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.
- Experience with the DMAIC quality system.
Additional Information :
Northwestern Medicine is an affirmative action/equal opportunity employer and does not discriminate in hiring or employment on the basis of age sex race color religion national origin gender identity veteran status disability sexual orientation or any other protected status.
If we offer you a job we will perform a background check that includes a review of any criminal convictions. A conviction does not disqualify you from employment at Northwestern Medicine. We consider this on a case-by-case basis and follow all state and federal guidelines.
Benefits
We offer a wide range of benefits that provide employees with tools and resources to improve their physical emotional and financial well-being while providing protection for unexpected life events. Please visit our Benefits section to learn more.
Remote Work :
No
Employment Type :
Full-time
Hours are Monday through Friday 7:30 a.m. - 4:00 p.m.The Compliance Coordinator reflects the mission vision and values of Northwestern Memorial adheres to the organizations Code of Ethics and Corporate Compliance Program and complies with all relevant policies procedures guidelines and all other reg...
Hours are Monday through Friday 7:30 a.m. - 4:00 p.m.
The Compliance Coordinator reflects the mission vision and values of Northwestern Memorial adheres to the organizations 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.
Responsibilities:
- 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 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.
- 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.
ADDITIONAL FUNCTIONS
- Develops and maintains a higher level of expertise in the specific areas of responsibility.
- Participates in and presents at laboratory meetings and continuing education programs.
- Participates in hospital quality and safety meetings as assigned.
LEADERSHIP/PROBLEM SOLVING
- Adheres to Patients First Management standards on leadership communication and visibility.
- Coordinates critical situations involving patients staff and visitors and consults with manager or administrator for guidance as needed (e.g. complaints discipline the press etc.).
- Facilitates effective interdepartmental communication of incidents with appropriate personnel (Manager Administrator Medical Staff; etc.).
- Promotes philosophy and objectives of the Hospital Division and Department.
- Identifies and communicates key issues and trends to manager.
PROFESSIONAL/PERSONAL DEVELOPMENT
- Establishes and executes personal development objectives as part of annual objective setting process which complements current position.
- Identifies and pursues activities/development opportunities which are appropriate for position and personal development objectives e.g. participation/leadership in relevant professional groups associations continuing education as participant presenter and planner.
- Assesses and communicates staff development needs to Manager.
Qualifications :
Required:
- 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)
Preferred:
- 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.
- Experience with the DMAIC quality system.
Additional Information :
Northwestern Medicine is an affirmative action/equal opportunity employer and does not discriminate in hiring or employment on the basis of age sex race color religion national origin gender identity veteran status disability sexual orientation or any other protected status.
If we offer you a job we will perform a background check that includes a review of any criminal convictions. A conviction does not disqualify you from employment at Northwestern Medicine. We consider this on a case-by-case basis and follow all state and federal guidelines.
Benefits
We offer a wide range of benefits that provide employees with tools and resources to improve their physical emotional and financial well-being while providing protection for unexpected life events. Please visit our Benefits section to learn more.
Remote Work :
No
Employment Type :
Full-time
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