Clinical Laboratory Consultant Security Clearance

Position: Clinical Laboratory Consultant with Security Clearance
Overview Job specifications are intended to present a descriptive list of the range of duties performed by employees. Specifications are not intended to reflect all duties performed within the job. SUMMARY Serves as the Clinical Laboratory Lead Consultant for laboratories performing high complexity clinical analysis accredited under the Clinical Laboratory Improvement Program (CLIP).

ESSENTIAL DUTIES AND RESPONSIBILITIES:

* Serves as the Clinical Laboratory Consultant for laboratories performing high complexity clinical analysis accredited under the Clinical Laboratory Improvement Program (CLIP).

* Serves as a subject matter expert and provides expert consultation services with technical advice and guidance on matters relating to the quality of the clinical test results reported and their interpretation.

* Ensure that the laboratories' clinical program is in compliance with the CLIP requirements and the laboratories' quality management system.

* Ensure that clinical testing 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.

* Ensure that the quality control (QC) and quality assessment (QA) programs are maintained to assure the quality of laboratory services provided and recommend/develop corrective action plans when necessary to address deviations in the QC/QA program.

* Provide briefings as appropriate upon request within their region.

* Maintains clear lines of communication with the Lab Managers/Directors for awareness and feedback.

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

* The laboratory consultant, if qualified, may perform the duties of the clinical consultant, and assist the testing personnel, or delegate these responsibilities to personnel.

* If the laboratory consultant reapportions performance of his or her responsibilities, he or she remains responsible for ensuring that all duties are properly performed.

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

* Ensure 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.

* 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.

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

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

* Ensure laboratory personnel are performing the test methods as required for accurate and reliable results;

* Ensure 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 under subpart H of this part; the 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 an approved corrective action plan is followed when any proficiency testing result is found to be unacceptable or unsatisfactory.

* Ensure that the 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.

* Ensure the establishment and maintenance of acceptable levels of analytical…