Description

COVID-19 vaccination NOT required for this position

Job Summary:

The Lab Manager is responsible for the overall operation and functioning of the laboratory.

Duties and Responsibilities:

• Ensure that testing systems developed and used for each of the tests performed in the laboratory provide quality laboratory services of all aspects of test performance, which include the pre-analytic, analytic and post-analytic phases of testing.
• Ensure that the physical plant and environmental condition of the laboratory are appropriate for the testing performed and provide a safe environment in which employees are protected from physical, chemical and biological hazards.
• Ensure that test methodologies selected are capable of providing the quality of results required for patient care.
• Ensure that the laboratory is enrolled in a HCFA-approved proficiency testing program as applicable.
• Ensure that the laboratory complies with CLIA laboratory regulations.
• Ensure that quality control and quality assurance programs are established and maintained to assure the quality of the laboratory services provided and to identify failures in quality as they occur.
• Ensure the establishment and maintenance of acceptable levels of analytical performance of each test system.
• Ensure that all necessary remedial actions are taken and documented whenever significant deviations from the laboratory’s established performance specifications are identified, and that patient test results are reported only when the system is functioning properly.
• Ensure that reports of test results include pertinent information required for interpretation.
• Ensure that consultation is available to the laboratory’s clients on matters relating to the quality of the test results reported and their interpretation concerning specific patient conditions.
• Employ a sufficient number of laboratory personnel with the appropriate educational experience or training required providing appropriate consultation.
• Ensure that prior to testing patients’ specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results.
• Ensure that policies and procedures are established for monitoring individuals who conduct pre-analytical, analytical and post-analytical phases of testing to assure that they are competent and maintain their competency to process specimens, perform test procedures and report test results promptly and proficiently. Also, whenever necessary, identify the need for remedial training or continuing education to improve skills.
• Ensure that an approved procedure manual is available to all personnel responsible for any aspect for the testing process.
• Specify, in writing, the responsibilities and duties of each consultant and each person engaged in the performance of the pre-analytic, analytic and post-analytic phases of testing, identifying which examinations and procedures each individual is authorized to perform.
• Adheres to all safety policies and procedures in performing job duties and responsibilities while supporting a culture of high quality and great customer service.
• Performs other duties that may be necessary or in the best interest of the facility.

The Lab Manager also performs the following functions:

TECHNICAL CONSULTANT

The Technical Consultant is responsible for the technical and scientific oversight of the laboratory. The following represent the duties of the Technical Consultant:

1. Select test methodology appropriate for the clinical use of the test results.
2. Verify test procedures performed and establish laboratory’s test performance characteristics, including the precision and accuracy of each test and test system.
3. Enroll and participate in an HCFA-approved proficiency-testing program.
4. Establish a quality control program acceptable for the testing performed in the laboratory.
5. Resolve technical problems and ensure that remedial actions are taken whenever test systems deviate from the laboratory’s established specifications.
6. Ensure that patient test results are not reported until corrective action has been taken and the test system is functioning properly.
7. Evaluate the competency of all Testing Personnel and assure that staff members maintain their competency to perform test procedures and report test results promptly and accurately.
8. Evaluate and document the performance of individuals responsible for high complexity testing at least semi-annually during the first year the individual test patient specimens. Thereafter, evaluations must be performed at least annually.

CLINICAL CONSULTANT

The Clinical Consultant provides consultation regarding the appropriateness of the testing ordered, They will assist the laboratory’s clients in ensuring the appropriate tests are available to be ordered while meeting clinical expectations.

TESTING PERSONNEL

The testing personnel are responsible for specimen processing, test performance and for reporting test results. The following represent the duties of the Testing Personnel:

1. Follow the laboratory’s procedures for specimen handling and processing, test analyses, reporting and maintaining records of patient test results.
2. Maintain records demonstrating that proficiency-testing samples are tested in the same manner as patient samples.
3. Adhere to the laboratory’s quality control policies. Document all quality control activities, instrument and procedural calibrations, and maintenance performed.
4. Follow the laboratory’s established corrective action policies and procedures.
5. Be capable of identifying problems that may adversely affect test performance or reporting of test results. Must be able to either correct the problem or immediately notify appropriate personnel.
6. Document all corrective actions taken when test systems deviate from the laboratory’s established performance specifications.

Qualifications

Experience Requirements

• Have at least one year experience directing or supervising non-waived testing.

Knowledge, Skills and Abilities Requirements

• Detail oriented, professional attitude, reliable
• Management and organizational skills to support the leadership of this function
• Ability to follow or provide verbal & written instructions with sufficient grammar and spelling skills to avoid mistakes or misinterpretations
• Interpersonal skills to support customer service, functional, and team mate support needs
  • Able to communicate effectively in English, both verbally and in writing
• Mathematical and/or analytical ability for basic to intermediate problem solving
• Basic to intermediate computer operation
  • Proficiency with Microsoft Excel, Word, and Outlook
• Specialty knowledge of systems relating to job function
• Knowledge of state and federal regulations for this position; general understanding of HIPAA guidelines

Supervisory Responsibilities:

• Responsible for the day-to-day supervision of the laboratory operation.
• Responsible for providing day-to-day supervision of high complexity test performance by testing personnel.
• Responsible for monitoring test analyses and specimen examinations to ensure that acceptable levels of analytic performance are maintained.
• Responsible for the annual evaluation and documentation of all laboratory personnel.
• Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws.
• Responsibilities include interviewing, hiring, and training employees, planning, assigning, and directing work; appraising performance, rewarding and disciplining employees, addressing complaints and resolving problems.