Laboratory Director for Florida High Complexity Laboratory

Job description

We are looking for a lab director with a generalist license that can assist in opening our private clinical diagnostic Laboratory in the state of FL. Molecular Licensure is a plus.

Job Summary : The Laboratory Director is responsible for the overall operation and administration of the laboratory, and for assuring compliance with all applicable regulations. The Laboratory Director must meet education and experience requirements to hold the position, and must meet all of the responsibilities associated with the position, including ensuring that there are sufficient personnel with adequate experience and training to conduct the work of the laboratory. He or she must also ensure that every position in the laboratory is filled by an individual qualified to hold the position and able to perform the tasks required of the position.

Job Duties :

The Laboratory Director is responsible for the overall operation of the lab and the competency of all laboratory personnel, and is responsible for the following :

General Responsibilities Must be accessible to the laboratory to provide onsite, telephone, or electronic consultation as needed. Direct no more than five labs. Ensure that the physical facility and environmental conditions are appropriate for the testing performed and provide an environment that is safe from physical, chemical, and biological hazards. Ensure compliance with all applicable regulations. Verify that all of the following responsibilities are properly performed :

Procedural Responsibilities Ensure testing systems provide quality laboratory services for pre-analytic, analytic, and post-analytic phases of testing. Ensure test methods selected have the capability of providing quality results. Ensure verification procedures used are adequate to determine accuracy, precision, and other pertinent performance characteristics of the method. 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. Ensure that an approved procedure manual is available to all personnel. Ensure that laboratory personnel are performing the test methods as required for accurate and reliable results.

Personnel Responsibilities Employ a sufficient number of laboratory personnel with the appropriate education and either experience or training to provide appropriate consultation, properly supervise, and accurately perform tests and report test results. Ensure that prior to testing patient specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of 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-analytic, analytic, and post-analytic phases of testing to verify that they maintain competency to : Process specimens, Perform test procedures, and Report test results promptly and proficiently. Whenever necessary, identify the need for remedial training or continuing education to improve skills. Maintain a written list of responsibilities of each individual in the laboratory that specifies the level of activity each is authorized to perform; whether supervision is required for specimen processing, test performance, or results reporting; and whether consultant or director review is required prior to reporting patient test results. In a high complexity laboratory, ensure that a general supervisor provides on-site supervision of high complexity test performance by minimally qualified testing personnel.

Proficiency Testing (PT) Responsibilities Ensure that the laboratory is enrolled in an approved Proficiency Testing (PT) program. Ensure that PT samples are tested in the same manner as patient samples. Ensure that PT results are returned on time to the PT program. Ensure that PT results are reviewed by the appropriate staff and the corrective action plan is followed when PT results are found to be unsatisfactory. Ensure that PT samples are tested according to COLA and CLIA regulations prohibiting referral of specimens and communication of results.

Quality Control and Quality Assessment Responsibilities Ensure that Quality Control and Quality Assessment programs are established and maintained to identify failures in quality as they occur. Ensure the establishment and maintenance of acceptable levels of analytical performance for each test system. Ensure that remedial actions are taken and documented whenever significant deviations from the laboratory’s established performance characteristics are identified. Ensure that patient test results are reported only when the system is functioning properly.

Qualification, Education and Experience : Education as required by CLIA / CMS regulations. Licensure as required by the Department of Health Board of Laboratory Personnel. Ability to function independently and as a member of a large team; motivate people to achieve excellent work with multiple leadership and staffing levels to achieve quality management goals. Must have QA / QC implementation, recording and troubleshooting experience.

Classification : Full Time, Part Time or Non-Exempt

Job Types : Contract, Part-time, Full-time

Pay : $1,000.00 - $2,000.00 per month

Schedule : On call

Education : Master's (Preferred)

License / Certification :

Directors License (Required)

Work Location : In person

This is a remote position.

Salary : $1,000 - $2,000