Laboratory Manager - Big Sandy Health Care : Job Details

RESPONSIBILITIES:

* Ensures that testing systems developed and used for each of the tests performed in the laboratory provide quality laboratory services for all aspects of test performance, which includes the pre-analytic, analytic, and post-analytic phases of testing

* Ensures that the physical and environmental conditions 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

* Ensures that the test methodologies selected have the capability of providing the quality of results required for patient care

* Ensures that verification procedures used are adequate to determine the accuracy, precision, and other pertinent performance characteristics of the method

* Ensures that laboratory personnel are performing the test methods as required for accurate and reliable results

* Ensures that the laboratory is enrolled in an HHS approved proficiency testing program for the testing performed and that-

* The proficiency testing samples are tested as required by regulations

* The results are returned within the timeframes established by the proficiency testing program

* All proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory performance and identify any problems that require corrective actions

* An approved corrective action plan is followed when any proficiency testing results are found to be unacceptable or unsatisfactory

* Ensures that the quality control and quality assurance programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur

* Ensures the establishment and maintenance of acceptable levels of analytical performance for each test system

* Ensures 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

* Ensures that reports of test results include pertinent information required for interpretation

* Ensures 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

* Evaluates the competency of all testing personnel and assures that the staff maintain their competency to perform test procedures and report test results promptly, accurately, and proficiently

* Evaluates and documents the performance of individuals responsible for moderate complexity testing at least semiannually during the first year the individual tests patient specimens. Thereafter, evaluations must be performed at least annually unless test methodology or instrumentation changes, in which case, prior to reporting patient test results, the individual's performance must be reevaluated to include the use of the new test methodology or instrumentation

* Employs a sufficient number of laboratory personnel with the appropriate education and experience or training to provide appropriate consultation, properly supervise and accurately perform tests and report test results in accordance with the personnel responsibilities

* Ensures 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

* Ensures 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 and, whenever necessary, identify needs for remedial training or continuing education to improve skills

* Ensures that an approved procedure manual is available to all personnel for any aspect of the testing process

* Responsible for the technical and scientific oversight of the laboratory

* Ensures that all policies, procedures, record keeping, and overall operation of the laboratory are in compliance with state and federal regulations including CLIA, HCFA, and OSHA

* Performs job duties of all laboratory personnel when necessary

* Adheres to the terms and conditions set forth in the BSHC Corporate Compliance Plan.

* Ensures the confidentiality of electronic protected health information in accordance with BSHC policy and current HIPAA regulations.

JOB SUMMARY:

The Laboratory Manager is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurately, and proficiently and for assuring compliance with the applicable regulations.

REQUIRED QUALIFICATIONS:

* Doctor of Medicine with laboratory training or experience consisting of at least one year directing or supervising non-waived laboratory testing; or have at least 20 continuing medical education credit hours in laboratory practice commensurate with the director responsibilities defined in 42 CFR 493.1407

* Or a Bachelor's degree in medical technology from an accredited institution with at least 2 years of laboratory training or experience, or both in non-waived testing and have at least 2 years of supervisory laboratory experience in non-waived testing and have ASCP certification