Clinical Laboratory Manager
28 days ago
Oklahoma City
Job Description Clinical Laboratory Manager: Job Description The clinical laboratory manager plays a pivotal role in the smooth and efficient operation of Elite Pain & Health’s clinical toxicology testing laboratory. This individual will act as the link between the technical operations and administrative leadership, ensuring the accurate and timely delivery of diagnostic information while upholding safety and regulatory standards. Key responsibilities • Overseeing daily laboratory operations: This includes managing workflow, ensuring testing procedures are accurate and efficient, and implementing new programs, tests, and methodologies., • Managing personnel: Hiring, training, supervising, scheduling, and evaluating laboratory staff. The manager also fosters a positive work environment, addresses conflicts, and promotes professional development among the team., • Ensuring quality control and compliance: Developing and implementing quality control (QC) procedures, monitoring testing accuracy, and resolving issues are essential. Compliance with federal, state, and local regulations, including CLIA, CAP, or COLA is paramount., • Financial management: Developing and managing the laboratory budget, optimizing resource allocation, coordinating purchasing, and identifying cost-saving opportunities are all part of the role., • Technology implementation: Assessing new technologies and tools, integrating new systems with existing laboratory information management systems (LIMS), and training staff are important aspects of the job., • Safety and security: Ensuring the laboratory adheres to safety protocols and standards, including managing hazardous materials and equipment, is a critical responsibility., • Reporting and documentation: Analyzing requests for tests and equipment, maintaining records of test examinations, and preparing reports for supervisors, accreditation boards, and other stakeholders are common duties. Skills and qualifications • Education: A bachelor's of science degree in a chemical, biological, clinical laboratory science, or medical technology field is required., • Experience: 4 years’ of experience operating LC/MSMS and Immunoassay Analyzer instrumentation for Presumptive and Confirmatory Urine Drug Screens., • Licensure and certification: One of the following certifications is required; MT (ASCP), MLS (ASCP), CLS, or AMT., • Leadership skills: The ability to inspire and motivate staff, delegate tasks, provide constructive feedback, and lead by example are essential for building a high-performing team., • Communication skills: Clear and effective communication, both written and verbal, is crucial for interacting with staff, healthcare providers, regulatory agencies, and other stakeholders., • Problem-solving abilities: Analytical thinking, critical thinking, and the ability to identify and solve complex problems are vital for addressing issues in laboratory operations., • Technical expertise: A strong understanding of laboratory procedures, equipment, and testing methods is beneficial for overseeing processes and quality control measures., • Organizational skills: Effectively managing multiple tasks, prioritizing responsibilities, delegating effectively, and maintaining an organized laboratory environment are crucial for smooth operations., • Additional skills: Other valuable skills include budgeting, financial management, project management, data analysis, and the ability to adapt to changes in technology and regulations. Technical supervisor qualifications: The laboratory must employ one or more individuals who are qualified by education and either training or experience to provide technical supervision for each of the specialties and subspecialties of service in which the laboratory performs high complexity tests or procedures. • Have at least 2 years of laboratory training or experience, or both, in high complexity testing within the specialty of Chemistry/Toxicology with a minimum of 6 months of experience in high complexity testing within the applicable subspecialty;, • Have earned a bachelor's degree in a chemical, biological, clinical or medical laboratory science, or medical technology from an accredited institution; or (2) Forty-eight (48) semester hours of science courses that include— (i) Twelve (12) semester hours of chemistry, which must include general chemistry and biochemistry or organic chemistry; (ii) Twelve (12) semester hours of biology, which must include general biology and molecular biology, cell biology or genetics; and (iii) Twenty-four (24) semester hours of chemistry, biology, or medical laboratory science or technology in any combination; and (iv) Have at least 4 years of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months of experience in high complexity testing within the applicable subspecialty. Technical supervisor responsibilities: • The technical supervisor is responsible for the technical and scientific oversight of the laboratory., • (a) The technical supervisor must be accessible to the laboratory to provide on-site, telephone, or electronic consultation; and, • (b) The technical supervisor is responsible for—, • (1) Selection of the test methodology that is appropriate for the clinical use of the test results;, • (2) Verification of the test procedures performed and establishment of the laboratory's test performance characteristics, including the precision and accuracy of each test and test system;, • (3) Enrollment and participation in an HHS approved proficiency testing program commensurate with the services offered;, • (4) Establishing a quality control program appropriate for the testing performed and establishing the parameters for acceptable levels of analytic performance and ensuring 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;, • (5) Resolving technical problems and ensuring that remedial actions are taken whenever test systems deviate from the laboratory's established performance specifications;, • (6) Ensuring that patient test results are not reported until all corrective actions have been taken and the test system is functioning properly;, • (7) Identifying training needs and assuring that each individual performing tests receives regular in-service training and education appropriate for the type and complexity of the laboratory services performed;, • (8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. The procedures for evaluation of the competency of the staff must include, but are not limited to—, • (i) Direct observations of routine patient test performance, including patient preparation, if applicable, specimen handling, processing and testing;, • (ii) Monitoring the recording and reporting of test results;, • (iii) Review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventive maintenance records;, • (iv) Direct observation of performance of instrument maintenance and function checks;, • (v) Assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples; and, • (vi) Assessment of problem-solving skills; and, • (9) Evaluating and documenting the performance of individuals responsible for high complexity testing at least semiannually during the first year the individual tests patient specimens. Thereafter, evaluations must be performed 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.
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