JOB TITLE: LABORATORY EXAMINER

JOB CODE: 32080

DEFINITION: This is professional work in examining, investigating, and advising licensed clinical laboratories in various types of facilities to determine and assist with compliance of state and federal laws and regulations.

An employee in this job performs on-site examinations and proficiency testing programs in clinical laboratories. Work involves examining personnel qualifications, instrumentation, quality control, laboratory management practices, and other factors for compliance with federal and state laws. Work includes evaluating plans of correction and making recommendations for state licensure and certification; providing individual technical training and guidance to personnel in regulated laboratories; and investigating various complaints against facilities that originate from regulatory agencies, law enforcement agencies, reimbursement agencies, and the general public. Employees in this job may serve as a team leader on laboratory examinations and complaint investigations requiring more than one Laboratory Examiner. Work assignments are received through selection of laboratories from generated lists of facilities due for federal or state examination. Supervision is received from a Laboratory Examiner Supervisor through written and oral instructions and the review of survey recommendations.

EXAMPLES OF WORK: (NOTE: The examples of work are representative of the work, but every position classified to this job may not perform all examples of work listed. Conversely, this is not an all-inclusive list of work examples.)

• Travels to licensed clinical laboratories throughout the state and conducts on-site examinations of all areas of clinical laboratories, including laboratory personnel qualifications, instrumentation, quality control, laboratory management practices, and other factors to determine compliance with the federal Clinical Laboratory Improvement Amendments of 1988 (CLIA) and the Commonwealth’s Clinical Laboratory Act regarding licensed clinical laboratories.

• Prepares letters of compliance deficiency or adverse action to laboratory directors based on results of the on-site visit.

• Evaluates the plans of correction submitted by laboratories cited for repeated unsatisfactory proficiency testing performance to make recommendations regarding federal certification and state licensure, or CLIA certification.

• Monitors the results of state and private proficiency testing programs to determine competency of laboratories for all categories of licensure.

• Provides individual technical training to licensed clinical laboratory personnel concerning laboratory procedures and tests of wide-ranging complexity identified during on-site visits or through repeated proficiency testing failures.

• Functions as a team leader on laboratory examination reviews and complaint investigations, coordinating the work of other Laboratory Examiners.

• Provides guidance in response to requests for federal and state regulatory, technical, and reimbursement information, including the criteria to establish a laboratory, add an additional testing service, or change personnel.

• Reviews and evaluates data from alternative laboratory monitoring protocols, cites deficiencies, and evaluates plans of correction.

• Investigates licensed clinical laboratories in response to complaints originating from governmental or law enforcement agencies, reimbursement agencies, and the public relating to improper quality assurance practices, inaccurate results, unqualified personnel, or fraud.

• Schedules monthly activity by selecting facilities to investigate from a geographically based list of laboratories requiring on-site visits.

• Reviews records of previous visits, including personnel examinations, proficiency testing results, and correspondence in preparation for the on-site examination and to identify potential problem areas to be addressed.

• Provides technical assistance and guidance to new employees in the laboratory survey process and procedures.

• Appears as a witness in court proceedings or as a specialized witness.

• Drafts correspondence and technical responses to licensed laboratories and outside agencies, including manufacturers, approved proficiency testing agencies, and other regulatory offices.

• Operates motor vehicles.

• Performs related work as required.

ENTRY LEVEL KNOWLEDGES, SKILLS, AND ABILITIES:

• Knowledge of chemistry, microbiology, hematology, immunology, immunohematology, pathology, histocompatibility, or cytogenics.

• Knowledge of the principles and procedures of clinical laboratory testing.

• Knowledge of statistical methods of data analysis.

• Knowledge of the function and proper use of clinical laboratory equipment.

• Knowledge of laws and regulations related to clinical laboratory testing and operations, including record keeping and documentation.

• Knowledge of the use and functionality of Microsoft Office Suite software.

• Ability to write technical reports.

• Ability to read and interpret written information.

• Ability to read and interpret numerical data.

• Ability to operate motor vehicles.

• Ability to communicate effectively orally.

• Ability to communicate effectively in writing.

• Ability to establish and maintain effective working relationships.

MINIMUM EXPERIENCE AND TRAINING: (NOTE: Based on the Entry Level Knowledges, Skills, and Abilities)

• Two years of professional laboratory work experience examining and performing testing on human specimens in a Clinical Laboratory Improvement Amendments of 1988 (CLIA) certified clinical laboratory, and a bachelor’s degree in chemical science, biological science, or medical technology;

or

• One year of professional laboratory work experience examining and performing testing on human specimens in a Clinical Laboratory Improvement Amendments of 1988 (CLIA) certified clinical laboratory, and a master’s degree in chemical science, biological science, or medical technology.

SPECIAL REQUIREMENTS:

• All positions require possession of an active motor vehicle license.