Quality Specialist, Laboratory Quality Management, Laboratory Administration Department - Days

Job Description

Be a part of a world-class academic healthcare system, UChicago Medicine, as the Quality Specialist, Laboratory Quality Management in the Laboratory Administration department. Here, you will provide support of extensive quality, regulatory, accreditation and compliance requirements for all laboratory testing performed by the Clinical Lab, in Hyde Park, and provide guidance to Orland Park and point-of-care testing performed at the medical center and multiple ambulatory sites, as needed. Our labs are known for providing services to the University of Chicago Medicine and providing care for local patients through a more convenient location. This department is the Laboratory Administration Department. This position requires you to work on-site 3 days per week. You will need to be based in the greater Chicagoland area.

Serves as Quality Specialist for Laboratory Services with primary responsibility to coordinate and support efforts essential to establishing, assessing, improving, and maintaining standards for laboratory quality assurance, safety, licensure, accreditation, and regulatory compliance, in collaboration with the Clinical Laboratories sections and department team. Participates and when appropriate coordinates activities for performance improvement (PI) and transformation initiatives. Collaboratively drives the integration of Clinical Laboratory quality, safety and compliance efforts with improvement activities across the University of Chicago Medical Center.

Essential Job Functions 

• Supports the quality management program for the Clinical Laboratories at Hyde Park and satellite locations, including point of care testing service, in accordance with the mission and strategic goals of UCM and the regulatory/accreditation standards for the hospitals and laboratories
• Collaborates as assigned with other Medical Center departments in specific quality and process improvement activities
• Contributes to the development, integration and collaborative maintenance of standardized quality management systems across the Clinical Laboratories
• Develops and implements actions required to support laboratory strategic, quality and operational goals as assigned
• Guides and collaborates with laboratory section directors and managers in the overall preparation of Clinical Laboratories for inspections by licensing and accrediting agencies (e.g., CAP, JC, State of Illinois, IDPH, City of Chicago). Helps support and coordinate compliance for biannual accreditation and interim reviews by CAP, AABB, tJC, FDA, ASHI, State of New York, COLA and any other regulatory agency, including the registration fees, applications, actual inspections and conferences, and responses to all deficiencies.  
• Manages key software applications required for regulatory compliance including, MediaLab Document Control and Inspection Proof applications, and works with all laboratories to utilize the application for its fullest capacity
• Develops and recommends departmental-wide policies and procedures required for regulatory compliance and optimal operations.  Works with CLIA Medical Director and other directors and managers to drive the review, approval and implementation of departmental policies and procedures
• Manages the online Laboratory Handbook to assure accurate and complete information for all UCMC providers and UCML clients
• Coordinates mock surveys and other audits of regulatory compliance along with follow-up consultation with laboratories to correct deficiencies following an inspection
• Participates in UCMC mock tJC and other organization-wide surveys as assigned
• Manages records of all inspection activities for reference as required by regulatory and accrediting bodies
• Contributes to the development of new processes and monitors that maintain a state of readiness and compliance with regulatory standards
• Monitors, collects, documents and communicates all changes to existing accreditation and licensing standards and ensures laboratories are prepared to respond to changes
• Manages lab-wide proficiency testing program summary; disseminates notices of participation insufficiency or failure including non-acceptable responses; works with lab sections on response and applicable improvement processes 
• Manages water purity and pipet, assessment programs; guides lab sections thermometric device compliance program
• Participates in inter-laboratory surveys, peer review assessments, and other QI initiatives as assigned 
• Manages collection, analysis and collation of laboratory data from laboratory and medical center information systems and applications to provide data-driven support of laboratory quality indicators, improvement initiatives and MDI huddles
• Supports assigned projects to address issues or improve processes
• Represents the Clinical Laboratories on institutional committees as assigned and provides reports on participation  
• Participates in UCMC OE events, meetings, and Kaizens as needed and provides reports on participation
• Manages and provides logistical support of documents, minutes and meetings for the Labs Clinical Laboratory Quality Management meeting.  Provides additional support in collection and evaluation of data to support lab quality efforts
• Communicates Quality Management information regarding performance improvement activities and corrective actions to Clinical Laboratories leadership and other groups as assigned
• Receives problem and event reports, performs initial investigation and triages to both leadership and appropriate lab section for root cause investigation
• Collects and coordinates analysis and summary of event and problem reports on a regular basis to look for trends and opportunities for additional improvement to prevent recurrence
• Collaborates as assigned with involved areas (both inside and outside Clinical Laboratories) to address patient safety issues
• Works with directors, managers and other laboratory leadership as assigned to develop and document feedback to care center providers as related to performance issues and adverse events
• Audits of the tracer methodology for maintaining regulatory preparedness. Documents that corrective actions are identified, implemented and assessed
• Analyzes and evaluates laboratory data and other information to assess methodologies, logistics and strategies designed to optimize laboratory service and utilization and correct recurring problems
• Utilizes the Medical Center’s EMR (Epic), Laboratory Information Systems (Sunquest, CoPath, Histotrac), and other information systems as needed to respond to surveys, troubleshoot problem reports and/or patient events, quality improvement initiatives, and for statistical analysis
• Coordinates laboratory safety progam in collaboration with UCMC Safety Office, Infection Control, Radiation Safety, Emergency Management, Business Continuity and Lab leadership to maintain compliance with federal, state and local requirements and a safe work environment for all laboratory staff
• Serves as Chair to UCMC Laboratory Safety Committee meetings.  Works closely with laboratory safety representatives to ensure all federal, state, city, accreditation and Medical Center policies, procedures, and guidelines are adhered to in each laboratory section
• Guides EOC rounding of laboratory spaces, collects data on observations and develops summary reports to improve Laboratory’s compliance with life-safety, infection control and public safety requirements and directives
• Develops and collaborates with Infection Control and Radiation Safety on policies, procedures and issues related to laboratories and staff
• Participates in UCMC Safety and Environment of Care meetings
• Develops and supports update of Labs safety and business continuity policies and documents in both MediaLab and Sharepoint 

Required Qualifications 

• Bachelor’s degree in clinical laboratory science or related field from an accredited college or university
• Certification as Medical Technologist (MT, MLS), or Specialist (S__) through the American Society of Clinical Pathologists required
• Must satisfy CLIA 88 qualification requirements for general supervisor who oversees testing personnel performing high complexity testing
• Five years minimum clinical laboratory work experience required, including experience in clinical laboratory quality management activities
• Experience in performance and evaluation of quality control procedures, preventive maintenance, trouble-shooting and calibration procedures on clinical equipment, and validation of test results required

Preferred Qualifications

• Broad understanding of Laboratory and Medicine quality performance indicators and processes
• Broad understanding of clinical laboratory processes and workflow
• Ability to identify measures or indicators of system performance and the actions needed to improve or correct performance, relative to the goals of the quality system
• Ability to coordinate and lead complex projects and initiatives across all clinical laboratory sub-specialty services
• Understanding of regulatory, accrediting and external reporting requirements as applied to hospitals and laboratories
• Ability to develop and maintain productive working relationships with internal and external departments, staff and leadership
• Ability to apply basic statistical concepts and methods commonly utilized in clinical laboratory science
• Knowledge and ability to use laboratory and hospitals information systems (Epic and Sunquest applications)
• Strong proficiency in the use of word processing, spreadsheet, and graphical computer programs
• Demonstrated awareness of factors that influence test results
• Ability to work independently and exercise sound judgment and experience when working with both small and large groups to complete projects
• Strong written and verbal communication skills appropriate for the needs of the intended audience
• Exceptional organizational ability and attention to detail mandatory and able to meet defined deadlines and timeframes including those with immediate turn-around-times
• Knowledge of lean and six sigma methodologies and statistical process control 

Position Details 

• Job Type/FTE: Full-Time (1.00 FTE)
• Shift: Day Shift, Hybrid (3 days onsite and 2 offsite) Monday - Friday
• Work Location: Hyde Park with travel to offsite locations (Crown Point, Orland Park)
• Unit/Department:  Lab Administration 
• CBA Code: Non-Union

Why Join Us

We’ve been at the forefront of medicine since 1899. We provide superior healthcare with compassion, always mindful that each patient is a person, an individual. To accomplish this, we need employees with passion, talent and commitment… with patients and with each other. We’re in this together: working to advance medical innovation, serve the health needs of the community, and move our collective knowledge forward. If you’d like to add enriching human life to your profile, UChicago Medicine is for you. Here at the forefront, we’re doing work that really matters. Join us. Bring your passion.

UChicago Medicine is growing; discover how you can be a part of this pursuit of excellence at: UChicago Medicine Career Opportunities.

UChicago Medicine is an equal opportunity employer.  We evaluate qualified applicants without regard to race, color, ethnicity, ancestry, sex, sexual orientation, gender identity, marital status, civil union status, parental status, religion, national origin, age, disability, veteran status and other legally protected characteristics.

Must comply with UChicago Medicine’s COVID-19 Vaccination requirement as a condition of employment. If you have already received the vaccination, you must provide proof as part of the pre-employment process. This is in addition to your compliance with the Flu Vaccination requirement as well. Medical and religious exemptions will be considered consistent with applicable law. Lastly, a pre-employment physical, drug screening, and background check are also required for all employees prior to hire.

Compensation & Benefits Overview

UChicago Medicine is committed to transparency in compensation and benefits.  The pay range provided reflects the anticipated wage or salary reasonably expected to be offered for the position.

The pay range is based on a full-time equivalent (1.0 FTE) and is reflective of current market data, reviewed on an annual basis. Compensation offered at the time of hire will vary based on candidate qualifications and experience and organizational considerations, such as internal equity. Pay ranges for employees subject to Collective Bargaining Agreements are negotiated by the medical center and their respective union.

Review the full complement of benefit options for eligible roles at Benefits - UChicago Medicine.