Laboratory Director

Job Details

Job Location
:
Papillion, NE 68046

Summary:

The Laboratory Director 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.

A:
Job Specific

The laboratory director must be accessible to the laboratory to provide onsite, telephone, or electronic consultation as needed.

The laboratory director must ensure that testing systems are 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.

The laboratory director must ensure that the physical plant 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.

The laboratory director must ensure that the test methodologies selected have the capability of providing the quality of results required for patient care.

The laboratory director must ensure verification procedures used are adequate to determine the accuracy, precision, and other pertinent performance characteristics of the method.

The laboratory director must ensure laboratory personnel are performing the test methods as required for accurate and reliable results.

The laboratory director must ensure 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 CLIA 1988 requirements for proficiency testing. Additionally, the laboratory director must ensure that proficiency testing results are returned within the time frames established by the proficiency testing program, all proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require corrective action and that an approved corrective action plan is followed when any proficiency testing results are found to be unacceptable or unsatisfactory.

The laboratory director must ensure that all quality control and quality assessment programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur.

The laboratory director must ensure the establishment and maintenance of acceptable levels of analytical performance for each test system.

Text Box The laboratory director must ensure 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 he laboratory director shall ensure that reports of test results include pertinent information required for interpretation and 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.

The laboratory director must 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 in accordance with the personnel requirements of CUA 1988, Subpart-M-Personnel.

The laboratory director must ensure 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.

The laboratory director must ensure 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…