Clinical Laboratory Consultant

Clinical Laboratory Lead Consultant

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 timeframes 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 performance for each test system.
• Ensure that all necessary remedial actions are taken and documented whenever significant deviations from the laboratory's established performance characteristics are identified, and that patient test results are reported only when the system is functioning properly.
• 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 the consultation regarding high complexity test performance by testing personnel qualified under 493.1489(b) (4) as provided.
• Ensure a sufficient number of laboratory personnel with the appropriate education and either experience or training are supporting the lab to provide appropriate consultation, properly oversee and accurately perform tests and report test results in accordance with the personnel responsibilities described in this sub- part. If not, is to bring this to the Government COR attention immediately for potential action.
• Ensure that prior to testing samples, 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.
• 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 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.
• Ensure that an approved procedure manual is available to all personnel responsible for any aspect of the testing process.
• Specify, in writing, the responsibilities and duties of each consultant and each lead, as well as each person engaged in the performance of the pre-analytic, analytic, and post- analytic phases of testing, that identifies which examinations and procedures each individual is authorized to perform, whether supervision is required for specimen processing, test performance or result reporting and whether supervisory or director review is required prior to reporting patient test results.
• The clinical laboratory consultant responsibilities include providing consultation regarding the appropriateness of the testing ordered and interpretation of test results.
• The clinical laboratory consultant must;o Be available to provide consultation to the laboratory's clientso Be available to assist the laboratory's clients in ensuring that appropriate tests are ordered to meet the clinical expectationso Ensure that reports of test results include pertinent information required for specific patient interpretation; ando Ensure that consultation is available and communicated to the laboratory's clients on matters related to the quality of the test results reported and their interpretation concerning specific patient conditions.

Non-Essential Duties and Responsibilities:

• Other duties as assigned.

Requirements/Qualifications:

• Option 1: Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located and be certified in clinical pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification.
• Option 2: Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located and have at least 1 year of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of virology.
• Option 3: Have an earned doctoral degree in a chemical, physical, biological or clinical laboratory science from an accredited institution and have at least 1 year of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of virology.
• Option 4: Have earned a master's degree in a chemical, physical, biological, or clinical laboratory science or medical technology from an accredited institution and have at least 2 years of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of virology.
• Option 5: Have earned a bachelor's degree in a chemical, physical or biological science or medical technology from an accredited institution and have at least 4 years of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of virology.

Reasonable accommodations may be made to enable individuals with disabilities to perform the following essential functions.

Supervisory Responsibilities:

Coordinates, supervises, and/or manages support personnel.

Work Environment:

Work environment characteristics described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is exposed to weather conditions prevalent at the time. The noise level in the work environment is usually moderate.

Physical Requirements:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the