JOB TITLE: LABORATORY EXAMINER SUPERVISOR

JOB CODE: 32100

DEFINITION: This is professional supervisory work evaluating, investigating, and consulting with licensed clinical laboratories for compliance with state and federal laws and regulations.

An employee in this job supervises Laboratory Examiners performing on-site examinations or proficiency testing programs in clinical laboratories, including the examination of personnel qualifications, instrumentation, quality control, management practices, and other factors for compliance with federal and state laws. Work involves supervising the evaluation of plans of correction and recommendations for state licensure or licensure and certification, and supervising the investigation of various complaints against facilities that originate from regulatory agencies, law enforcement agencies, reimbursement agencies, and the general public. Work includes identifying the need for and providing individual technical training for Laboratory Examiner staff and personnel in regulated laboratories. Work assignments are received from the division chief or through the licensure and certification review process. Supervision is received from the division chief through written or oral instruction, and work is reviewed through reports and the completion of work assignments.

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 supervises on-site examinations in all areas of the clinical laboratory to determine compliance with the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and the Commonwealth’s Clinical Laboratory Act regarding licensed clinical laboratories, based on laboratory personnel qualifications, instrumentation, quality control, laboratory management practice, and other factors.

• Supervises the preparation of letters of compliance, deficiency, or adverse action to laboratory directors based on results of on-site visits.

• Supervises staff responsible for examining plans of correction and making recommendations on state licensure or federal certification of laboratories cited for repeated unsatisfactory proficiency testing performance.

• Supervises the individual technical training of private laboratory personnel concerning laboratory procedures and tests of wide ranging complexity as identified during on-site visits or through repeated proficiency testing failures.

• Provides instruction on rules and regulations of various licensure and certification programs.

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

• Supervises investigative laboratory visits in response to complaints from governmental or law enforcement agencies, reimbursement agencies, and the public relating to improper quality assurance practices, inaccurate results, unqualified personnel, or fraud.

• Oversees the scheduling of monthly activities by reviewing the selection of laboratories identified by Laboratory Examiners as requiring on-site visits.

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

• Operates motor vehicles.

• Performs the full range of supervisory duties.

• An employee in this job may participate in the performance of subordinates’ work consistent with operational or organizational requirements.

• Performs related work as required.

ENTRY LEVEL KNOWLEDGES, SKILLS, AND ABILITIES:

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

• 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 accepted methodologies and procedures used in the evaluation of clinical laboratories.

• 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)

• One year as a Laboratory Examiner (Commonwealth title);

or

• Three 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

• 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 master’s degree in chemical science, biological science, or medical technology.

SPECIAL REQUIREMENTS:

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