Ensures troubleshooting is performed when calibrators/quality controls fail and properly documented.
Performance of delegated tasks as by the Laboratory Director and/or Technical Supervisor, which may include:
Ensuring that remedial actions are taken when test systems deviate from the laboratory’s established performance specifications.
Ensuring that patient test results are not reported until all corrective actions have been taken and the test system functions properly.
Ensuring that orientation is provided to all testing personnel.
Investigation, documentation, and follow up of corrective actions
Ensure that annual personnel performance evaluations are performed and documentation of competency assessments is kept on file.
Drafting and/or revision of standard operating procedures.
Ensuring accuracy and precision of quality control data and patient results.
Provides information regarding test results, methodologies, and validation specifications to clients.
Assists in implementation of new test systems and procedures, including validations.
Ensuring preventative maintenance is performed according to schedule for all laboratory equipment.
Ensuring adequate supplies are available, including PPE, reagents, chemicals, and other consumables, to perform testing safely and within stated turnaround time.
Performing assessments of quality indicators, such as turnaround time, rejected specimens, QC failure rates, and other indicators of quality.
Investigates client complaints and reports any complaints received to Laboratory Director and Client Services.
Ensuring that test reports include pertinent information for results interpretation, and availability for consultation concerning test results and their interpretation as they relate to specific patient conditions.
Appropriate test method selection.
Adequate method verification in order to determine accuracy and precision of test methods.
Enrollment in a CMS-approved Proficiency Testing (PT) program for all tests performed by the laboratory, and that demonstrates:
PT samples are tested in accordance with CLIA requirements.
PT results are submitted within the time frames established by the PT program.
PT reports are reviewed by the appropriate staff.
Corrective action plans are followed when PT results are found to be unacceptable or unsatisfactory.
Review and sign off on PT attestations and evaluation summaries.
Quality Assessment and Quality Control Programs are established and maintained.
Acceptable analytical test performance is established and maintained for each test system.
Personnel have been appropriately trained and demonstrate competency prior to testing patient specimens.
Policies and procedures are established for monitoring personnel competency in all phases (pre-analytic, analytic, and post-analytic) of testing to assure ongoing competency of all individuals who perform testing.
Remedial training or continuing education needs are identified and training provided.
An approved procedure manual is available to all personnel.
Ensuring that patient test results are not reported until all corrective actions have been taken and the test system is properly functioning.
Cooperates and effectively communicates with laboratory personnel.
Participates in and assigns Continuing Education according to schedule.
Participates in and assigns Proficiency Testing according to schedule.
Participates in new employee orientation and training.
Maintains a sterile and organized work area and documents cleaning according to procedure.
Adheres to and enforces all employee and patient safety practices, including all OSHA and HIPAA requirements.
CLIA QUALIFICATIONS (42 CFR 493.1461)
An Associates or bachelor’s degree (Bachelor’s preferred) in Medical Technology, Biochemistry, Chemistry, Biology, or Physics with:
60 semester hours including 24 semester hours of medical lab technology; or
60 semester hours including 24 hours of science that includes 6 hours chemistry, 6 hours biology, and 12 hours chemistry, biology; or
medical lab tech in any combination and laboratory training that includes either:
completion of a clinical lab training program; or
3 months training in each specialty in which high complexity testing is performed.
ADDITIONAL QUALIFICATIONS
At least two years of experience in a CLIA licensed clinical laboratory required
Medical Technologist board certification preferred
At least two years of experience supervising lab personnel preferred
Ability to read and comprehend English and follow instructions
Good communication and critical thinking skills
Understanding of statistics
Ability to creatively think under pressure and handle high stress levels, changing environments, and possible irregular work hours
Ability to recognize potential exposure to bloodborne pathogens and/or hazardous chemicals in the workplace and execute safety protocols in the event of exposure or spill
Must be able to demonstrate competency for all required diagnostic tests and other areas of assignment within 3 months of hire date
WORKING CONDITIONS
Possible exposure to bloodborne pathogens
Possible exposure to hazardous chemicals
PHYSICAL REQUIREMENTS
Ability to climb stairs, lift 35lbs, sit or stand for long periods, and walk/bend down
Visual and auditory acuity and good eye/hand coordination
DIRECT REPORTING
Reports to the Laboratory Director and Operations Leader
Laboratory staff including laboratory assistants and testing personnel report to the Lab Supervisor for the applicable department(s)
Pay starting at $80,000/year
