Salary Range: 112271 to 124746 (Currency: USD) (Pay period: per-year-salary)

Role Summary

• Laboratory Manager (LM) supports the laboratory with technical instrumentation and assay expertise by facilitating purchase, acquisition, programming, operation, training and troubleshooting of laboratory instruments.  This individual may also assist with managing the daily operation of the laboratory.
• The Laboratory Manager must meet the personnel qualifications and responsibilities per CLIA Sec. 493.1449 and 493.1451 as well as any and all State licensure/certification requirements.
• The Laboratory Manager must be licensed as a Medical Laboratory Scientist (MLS) with the American Society of Clinical Pathology or acceptable equivalent.

Responsibilities:

• Actively contribute to the team effort by volunteering to assist coworkers.
• Maintain a clean and safe working environment.
• Monitor test analyses and specimen examinations to ensure that acceptable levels of analytic performance are maintained.
• Apply scientific and technical knowledge with accuracy and judgment in the completion of tests and procedures.
• Evaluate work in progress, assist and advise staff on procedures, re-tests and result interpretation.
• Monitor and follow daily pending report throughout day to ensure timely reporting of results meeting metrics mandated by Upper Management.
• Ensure adequacy of supplies and appropriate functioning of equipment.
• Administrate and technically supervise the clinical laboratory in a manner conducive to full performance and high morale.
• Plan, assign, coordinate and supervise technical staff ensuring schedules for daily work and departmental coverage are completed and posted timely.
• Assist in all lab areas as needed: answer calls, perform CLS duties in all departments, manage issues; resolve specimen integrity issues.
• Be available for technical issues daily and during after hours, holidays and weekends.
• Ensure the lab is in compliance with all regulatory agencies (e.g. CLIA, COLA, State).
• Liaison between all departments in the laboratory including Pre-Analytic, Analytic, and Post-Analytic.
• Assure all remedial actions are taken whenever test systems deviate from the laboratory’s established performance specifications.
• Perform, review, interpret and record all quality control data from analyzers in all departments as appropriate on a daily, weekly, monthly basis.
• Ensure patient test results are not reported until all corrective actions have been taken and the test system is properly functioning:
• Follow the laboratory’s established policies and procedures whenever test systems are not within the laboratory’s established acceptable levels of performance.
• Identify problems that may adversely affect test performance or reporting of test results and either must correct the problems or immediately notify the upper management and/or lab director.
• Manage human resource related functions in the testing laboratory.
• Interview, hire and maintain staffing.
• Address and document personnel and performance issues.
• Conduct individual performance reviews of laboratory personnel. 
• Maintain absenteeism records.
• Develop an environment for personal growth, development and learning for employees by encouraging continuing education, special projects etc.
• Plan and scale up for surge by ensuring there are adequate supplies and staffing levels.
• Monitor daily performance metrics and daily throughput in accessioning and testing.
• Monitor staffing needs.
• Manage human resource related functions in the testing laboratory.

Duties that may be delegated from the laboratory director to the laboratory manager:

• Internal blind testing samples or external proficiency testing samples.
• Evaluate and document the performance of individuals responsible for high complexity testing at least semiannually during the first year the individual tests patient specimens and thereafter at least annually unless test methodology or instrumentation changes, in which case, prior to reporting patient test results, the individual’s performance must be reevaluated to include the use of the new test methodology or instrumentation.
• Verify the test procedures performed and establish the laboratory’s test performance characteristics, including the precision and accuracy of each test and test system.
• Enroll and participate in an HHS approved (and/or State approved as applicable) proficiency testing program commensurate with the services offered.
• Establish a quality control program appropriate for the testing performed, establish the parameters for acceptable levels of analytic performance and ensure that these levels are maintained throughout the entire testing process from the initial receipt of the specimen, through sample analysis and reporting of test results.
• Identify training needs and assure that each individual performing tests receives regular in-service training and education appropriate for the type and complexity of the laboratory services performed. In some instances, in-service training may be specifically related to an instrument/test or may be very general in nature. The laboratory may establish its own format, content, and schedule or provide training on an as-needed basis which is acceptable provided the laboratory does not have deficiencies related to test performance. 

Duties to collaborate with the laboratory director, director of lab ops, QA and Safety:

• Inspection/Audits/Surveys.
• Coordinate pre-inspection evaluations, post-inspection responses and interim-self inspections with lab management and staff.  Expectation is labs should be prepared and operate on a day to day basis to result in no deficiencies on any scheduled, random or unannounced inspection from any accrediting agency including but not limited to CLIA, COLA, OSHA, Department of Health, State, etc.
• Quality/Safety Program.
• Work with the QA department; attend Committee meetings with Laboratory Director and Director of Lab Ops to implement changes as needed.
• Assist in the development/ongoing continuous quality management for the laboratory.  Review monthly metrics and assist in corrective action/procedural changes to maintain “green light” status per desired/required goal. Participate in the local and national quality/safety committee meetings as requested.  Prepare an annual laboratory quality assessment plan that is evaluated for its effectiveness and assemble new initiatives planned by Laboratory Director and Director of Lab Ops and Quality Committee members.  Work with IT to develop programs to automatically collect and collate data for the committee.
• Process Improvement /Implementation. 
• Assist with lean projects in the laboratory that will improve overall processes to help the company provide quality care in a cost effective and timely manner to its patients.