01/30/2009 32080

LABORATORY EXAMINER

DEFINITION: This is professional examination, investigation and advisory work to determine compliance or to assist in reaching compliance with state and federal laws and regulations pertaining to licensed clinical laboratories in various types of facilities.

An employee in this job is responsible for performing on-site examinations or proficiency testing programs of areas of clinical laboratories including examination of personnel qualifications, instrumentation, quality control, laboratory management practices, or other factors for compliance with the Federal Clinical Laboratory Improvement Amendments of 1988 (CLIA ’88), the Commonwealth’s Clinical Laboratory Act, and Food and Drug Administration (FDA) Blood Bank Regulations. An important aspect of this work involves the responsibility for evaluating the plan of correctionreceived in response to a letter of deficiency to recommend for or against state licensure and certification. Work includes providing individual technical training and guidance to personnel in regulated laboratories. Work also involves investigating various complaints against facilities that originate from regulatory agencies, law enforcement agencies, reimbursement agencies and the general public. An employee may either function independently or serve as a team leader on laboratory examinations and complaint investigations requiring more than one Laboratory Examiner employee. Work assignments are received through the employee’s selection of laboratories from generated lists of facilities due for federal or state examination. General supervision is received through written and oral instructions and the review of survey recommendations.

EXAMPLES OF WORK: Performs on-site examinations of all areas of the clinical laboratory including laboratory personnel qualifications, instrumentation, quality control, laboratory management practices, and other factors to determine compliance with federal and state regulations regarding licensed clinical laboratories.

Participates in the selection and preparation of test specimens to be included in proficiency testing and training evaluation.

Prepares grading ranges, summary analyses and grades reports.

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 recommend for or against federal certification and state licensure, or CLIA ’88 certification.

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

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

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

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

Provides advice 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 requests from laboratories for exceptions to quality control regulations based on statistical analysis of data generated by laboratories or manufacturers and recommends approval or disapproval to section supervisor.

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.

Performs special studies and suggests new approaches to laboratory regulations or section procedures to emphasize more efficient operating mechanisms, or to reduce the regulatory burden on participating laboratories, based upon an analysis of data generated by licensed laboratories, manufacturers or the examiner.

Performs a preliminary analysis of new instruments and diagnostic kits for accuracy and precision or sensitivity and specificity, and provides results to the section supervisor for necessary action.

Schedules monthly activity by selecting facilities to investigate from a geographically based list of laboratories identified by the Division of Laboratory Improvement as 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.

Participates in the planning and conduct of formal workshops, seminars, in-service programs and conferences for laboratory staff pertaining to the laboratory facility survey process.

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.

Performs other related duties as required.

REQUIRED 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 federal and state laws and regulations related to clinical laboratory testing and operations, including record keeping and documentation.

Ability to write technical reports.

Ability to establish and maintain effective working relationships.

Ability to communicate effectively orally.

Ability to communicate effectively in writing.

Ability to read and interpret information.

MINIMUM EXPERIENCE AND TRAINING: Two years of professional laboratory work experience in a clinical laboratory, and bachelor’s degree in a chemical science, biological science, or medical technology;

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One year of professional laboratory work experience in a clinical laboratory, and a master’s degree in a chemical science, biological science, or medical technology.