Description

Laboratory Director (CLIA High Complexity)

Subspecialty (Specialty): General Immunology (Diagnostic Immunology), Routine (Chemistry), and Mycobacteriology (Microbiology)

Remote | Physician Office Laboratory (POL)

Job description

Responsibilities include but are not limited to:

-Be accessible to the laboratory to provide onsite, telephone, or electronic consultation as needed.

-Ensure quality control (QC) and quality assurance (QA) programs are established, implemented, and maintained to monitor laboratory performance and promptly identify quality failures.

-Ensure that testing systems for all assays provide quality laboratory services across the pre-analytic, analytic, and post-analytic phases of testing.

-Ensure the establishment and maintenance of acceptable levels of analytical performance for each test system.

-Ensure verification and validation procedures are adequate to determine accuracy, precision, reportable range, and other pertinent performance characteristics of each method.

-Ensure laboratory facilities, environmental conditions, and safety practices are appropriate for the testing performed and provide a safe working environment for personnel.

-Ensure consultation is available to laboratory clients regarding the quality, interpretation, and clinical relevance of test results for specific patient conditions.

-Ensure that, prior to patient testing, all personnel:

Possess appropriate education and experience
Receive training commensurate with the complexity of testing performed
Demonstrate ongoing competency to reliably perform testing and report accurate results
-Ensure adherence to the Quality Assessment Policies and Procedures by all testing personnel, including:

Ongoing competency assessment
Identification of remedial training needs
Support for continuing education as necessary
-Perform a minimum of two (2) onsite laboratory visits per year, spaced at least four (4) months apart, and document findings as required.

Requirements

Option 1

        Doctor of Medicine (MD) or Doctor of Osteopathy (DO), licensed to practice medicine in the state where the laboratory is located, and

        Certification in Anatomic Pathology, Clinical Pathology, or both by:

        The American Board of Pathology (ABP), or

        The American Osteopathic Board of Pathology (AOBP)

Option 2

        Doctor of Medicine (MD) or Doctor of Osteopathy (DO), licensed to practice medicine in the state where the laboratory is located, and

        At least two (2) years of experience directing or supervising high-complexity testing, and

        Completion of 20 CE credit hours in laboratory practice covering laboratory director responsibilities as defined in 42 CFR §493.1445

Option 3

        Earned doctoral degree in a chemical, biological, clinical, or medical laboratory science (or medical technology) from an accredited institution, and

        Certification by a board approved by HHS, and

        At least two (2) years of laboratory training and/or experience, and

        At least two (2) years of experience directing or supervising high-complexity testing, and

        Completion of 20 CE credit hours in laboratory practice covering laboratory director responsibilities as defined in 42 CFR §493.1445