The clinical laboratory shall employ a sufficient number of properly qualified technical personnel, including a sufficient number of technicians and technologists (10 NYCRR Subpart 58-1.5, MA 105 CMR 180.180) to meet the workload demands of the laboratory. Clinical laboratory scientists shall be present in sufficient number to adequately supervise the work of technicians and trainees.
Clinical Laboratory Scientist means a clinical laboratory practitioner who, in accordance with approved protocols of Boston Heart Diagnostics, performs clinical laboratory procedures and examinations and any other tests or procedures conducted by a clinical laboratory which require the exercise of independent judgment and responsibility (as determined by the department), with minimal supervision by the director or supervisor, in only those specialties or subspecialties in which they are qualified by education, training and experience. With respect to specialties in which the medical technologist is not qualified by education, training or experience, the individual shall function only under direct supervision and perform only tests which require limited technical skill and responsibility.
Level I – Minimum
- Follow the laboratory's procedures for specimen handling and processing, and maintaining records of test examinations.
- Perform ancillary tasks to ensure a smooth operation, including but not limited to preparation and qualification of reagents and materials required for test processes, as well as label, retrieve, re-file, and properly store specimens for testing/repeat testing/long term storage.
- Take an active role in cleaning, organizing, and restocking duties.
- Operate, calibrate and maintain all laboratory equipment and instruments according to standard operating procedures to ensure quality results.
- Maintain records that demonstrate that proficiency testing samples are tested in the same manner as patient specimens.
- Adhere to the laboratory's quality control policies, document all quality control activities, instrument and procedural calibrations and maintenance performed.
- 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 immediately correct the problems or notify the supervisor, manager, director or designee.
- Adhere to established processing timelines.
- Ensures follow-up and demonstrates an understanding of actions taken to resolve problems.
- Demonstrate strong teamwork skills by effectively communicating, knowledge sharing and adequately prioritizing tasks to efficiently complete daily activities.
- Maintain adequate inventory of supplies, reagents and material – notify supervisor, manager or director immediately when faced with shortage of supplies.
- Document all corrective actions taken when test systems deviate from the laboratory's established performance specifications.
- Participate on special projects or assignments as requested by management.
- Trains other technicians on key aspects of the laboratory assay(s), proficient with the performance of competency assessments.
- Plays an active role in process improvement projects with potential for significant improvement in quality, efficiency, and/or reduction in cost of testing.
- Possess critical thinking skills and is able to actively troubleshoot when even the slightest deviations are observed.
Level II – Fully meets the responsibilities of Level I plus the following:
- General knowledge of Standard Operating Procedure writing, assay theory, and instrumentation.
- Orient, mentor and teach clinical laboratory methods, procedures, and techniques to new Associates.
- Demonstrate effective teamwork skills by knowledge sharing.
- Take on formally assigned additional duties, such as training, as a part of routine job performance.
- Participate in special project teams as requested by supervisory staff.
Level III – Fully meets the responsibilities of Level II plus the following:
- Obtain advanced knowledge of Viracor Eurofins standard operating procedures, assays, and instrumentation.
- Participate in troubleshooting activities in conjunction with Technical Supervisor.
- Volunteer to serve on various committees and panels to the benefit of the laboratory or company in general (e.g., Safety Committee).
- Performs train the trainer and Qualified Personnel responsibilities as assigned.