Lab Director

Title: Lab Director 

FLSA Status: Exempt 

Reports To: National Director of Physician Services 

Position Summary:  

The Laboratory Director is responsible directing and overseeing the compliance and management of laboratory services; and all components of laboratory services in alignment with the Arizona Department of Health and CLIA guidelines. In collaboration with Theratest leadership, the laboratory director serves as a triad partner to ensure safe handling, testing, quality assurance, and oversight meets all state and federal program guidelines.   

Reasonable Accommodation Statement 

To perform this job successfully, an individual must be able to perform each essential duty listed below satisfactorily. Reasonable accommodations may be made to enable qualified individuals with disabilities to perform the essential functions. 

Job Duties 

• Responsible for the overall administration of all laboratory operations including the duties of the technical supervisor, clinical consultant, general supervisor, and testing personnel as described by Theratest.  
• Directs, plans, organizes, and implements strategies and initiatives to enhance and support the operations of the laboratory to ensure high quality, efficient, and cost-effective operations.  
• Collaborates with Summit Rheumatology administration and Theratest leadership in the planning and implementation of policies and procedures, programs, and initiatives that support the mission, growth and success of the institution. Performs full policy review yearly.  
• Implements standardization of all Laboratory policies, procedures, and work flows within the organization. Maintains administrative functions for training and compliance among specimen processors at satellite locations. Standardizes air and ground transportation processes. Works closely with courier services to ensure seamless specimen transportation.  
• Works closely with clinic managers at satellite locations to ensure optimal laboratory operations. including personnel training, proficiency, compliance and adherence to all laboratory policies and procedures.  
• Provides direction to department personnel to achieve operational and technical objectives including workflow design, service quality, financial performance, regulatory compliance, personnel management, and personnel scheduling.  
• Monitors employee and departmental performance to ensure adherence to policies and procedures, timelines and regulatory requirements. Ensuring all necessary remedial actions are taken and documented whenever significant deviations from the laboratory established performance are identified.  
• Ensures ongoing compliance with federal and state regulations. Maintains all necessary personnel compliance, and training documents. Ensures laboratory enrollment and participation in an HHS approved proficiency testing program and ensures all proficiency results are turned in within an appropriate time frame. Maintains all proficiency records, including addressing any problems that require corrective action and documenting appropriately.  
• Develops or maintains QA process improvement monitoring systems to improve quality; initiates corrective action plans, and monitors results. Must perform yearly Internal Audits to ensure Laboratory is adhering to Quality Assessment Policy.  
• Evaluates existing systems and processes and develops corrective action plans for service/quality trends identified. 

• Ensures prompt and effective resolution of quality or service concerns. 
• Responsible for equipment oversight, maintenance, and functionality in accordance to vendor, state and federal regulatory standards. Maintains all records.  
• In collaboration with Theratest leadership, directs and evaluates staff activities and provides coaching, guidance, delegation opportunities, and on-the-job training and re-training as necessary to ensure operational efficiency and adherence to policies and procedures; fosters open communication by offering, encouraging, and accepting suggestions from staff regarding department operations. 
• Participates in the screening and interviews of qualified individuals for open positions within the department. 
• Assures the implementation of policies and procedures for the laboratory in accordance with national policies, procedures, and standards and according to state and organizational regulatory requirements. 
• Maintains Laboratory Theratest inventory for Gilbert testing laboratory, Gilbert on site phlebotomy. Will work with satellite locations to maintain Theratest required phlebotomy supplies or shipping material as needed.  
• A technical resource to all laboratory personnel within the national organization, including phlebotomy and reference lab sites. Must be accessible to the laboratory and administration to provide onsite, telephone, or electronic consultation as needed.  
• Works with all departments to troubleshoot and resolve issues including but not limited to Theratest leadership, TERIS, eCW, and BlueCore.  
• Performs all duties and roles within the laboratory to ensure flow of testing and results is maintained. 

Competency Statements:  

• Competent in handling, storage, and disposal of blood and body fluid products.
• Competent in handling, storage, and disposal of chemicals, controls, and waste products.
• Competent in laboratory processing techniques.
• Competent in quality assurance processing and control testing.
• Competent in tracking and reporting results accurately for all samples, sites, and patients.

Supervisory Responsibility 

This role supervises: 

• Lab Technicians
• Lab assigned staff
• Oversee all complex medical laboratories at any Summit Rheumatology owned or managed sites.

Work Environment 

This job operates in an indoor laboratory environment. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines. It also routinely uses complex laboratory equipment, analyzers, chemicals, and blood/body fluid components.  

Position Type and Expected Hours of Work 

This is a full time position with typical working hours of Monday through Friday, 8:00 a.m. to 5:00 p.m. Hours and work shift may change in accordance with business needs.

Required Minimum Job Qualifications, Experience, Education and Training