CLINICAL LABORATORY EVALUATOR 4

Definition

Under the direction of the Director, Clinical Laboratory Improvement Service or other supervisory official in the Department of Health and Senior Services has responsibility for the provision of programmatic services in the areas of blood bank licensing and inspection, state licensing and inspection of clinical laboratories, proficiency testing, or federal CLIA contract obligations which involves the supervision of clinical laboratory evaluators to ensure compliance with applicable state and federal statutes, rules and regulations by licensed and/or certified clinical laboratories and blood banks; does other related duties as required.

Examples of work

• Supervises staff involved in the licensing, inspection and/or provision of proficiency testing surveys to licensed or certified clinical laboratories and blood banks.
• Develops and implements policies and procedures for programmatic operations including, but not limited to: Licensing, enrollment in proficiency testing, survey procedures, report writing including documentation of deficiencies, recommendations for enforcement action, review of corrective action plans, and complaint investigations.
• Establishes programmatic criteria for evaluating the quality assurance plans and activities of clinical laboratories and/or blood banks to determine that provisions are in place and are monitored at established frequencies in order to ensure the accuracy and reliability of test results and to protect the health and safety of blood donors and recipients.
• Develops and revises program policies and procedures governing licensing, inspections, complaint investigations and guidelines for regulated facilities.
• Participates as a member of rulemaking advisory committees for the licensing and operation of blood banks, clinical laboratories and proficiency testing and reviews existing rules to determine their adequacy and appropriateness to changing technologies and guidelines issued by federal agencies or accreditation organizations.
• Supervises the collection of revenue from licensing, proficiency testing and enforcement actions to ensure that all fees are collected and deposited.
• Participates in the preparation of annual budget, evaluation data and revenue projections and monitors and reconciles licensing and fee collections with budget projections.
• Reviews licensing surveys, proficiency testing performance and complaint findings and prepares recommendations for enforcement action against blood banks and clinical laboratories to include warning notices, monetary penalties, suspension of testing and closure when appropriate.
• Develops guidelines to assist regulated facilities in complying with applicable state and federal statutes, rules and regulations and evolving technologies which are not addressed by existing standards.
• Assesses staff training needs and provides access to appropriate training and resources necessary to maintain the knowledge, skills and competency of clinical laboratory evaluators involved in evaluating blood banks and clinical laboratories.
• Prepares monthly and annual reports addressing the number of licenses issued, inspections performed, proficiency testing surveys issued and reviewed with laboratory performance (i.e. satisfactory or unsatisfactory) complaints investigated enforcement actions and revenues collected.
• Participates with the unit director in planning, organizing and prioritizing program services and activities.
• Coordinates with and provides technical consultation to other units/divisions involved in regulating blood banks and clinical laboratories.
• Provides assistance, guidance and consultation to blood banks or clinical laboratories to improve performance and compliance with regulatory provisions.
• Interprets current state and federal statute, rules and regulations applicable to blood banks and clinical laboratories and consults with federal agencies and accrediting organizations when appropriate.
• Supervises the maintenance of records, reports and files.
• Prepares materials for legal action against clinical laboratories and blood banks.
• Supervises work operations and/or functional programs and has responsibility or effectively recommending the hiring, firing, promotion, demotion and discipline of employees.
• Will be required to learn to utilize various types of electronic and/or manual recording and information systems used by the agency, office or related units.

Education

Graduation from an accredited college or university with a Bachelor's degree in Medical Technology or a biological or chemical science which shall have included at least sixteen (16) semester credit hours in chemistry, sixteen (16) semester credit hours in the biological sciences, and three (3) semester hour credits in mathematics.

NOTE: Possession of qualifications of a Medical Technologist as required under Federal Medicare Regulations Subpart M part 405:1315, Chapter 3, Title 20 of the Code of Federal Regulations for coverage of services of independent laboratories or under N.J.A.C. 8:44-2.6 may be substituted for the above education.

Experience

Five (5) years of experience as a medical technologist in specialties including but not limited to chemistry, microbiology, hematology, immunology, and cytology in a private/public/hospital clinical laboratory which shall have included training responsibilities, one (1) year of which must have been related to quality control standards and two (2) years of which shall have been in a supervisory capacity.

NOTE: A Master's degree in Medical Technology or the biological or chemical sciences may be substituted for one (1) year of indicated nonsupervisory experience.

License

Appointees will be required to possess a driver's license valid in New Jersey only if the operation of vehicle, rather than employee mobility, is necessary to perform essential duties of the position.

American Society of Clinical Pathology (ASCP) certification as a medical technologist may be required for federally funded positions.

Knowledge, skills and abilities

• Knowledge of the science and practice of medical technology and its related scientific areas.
• Knowledge of procedures/techniques employed in making/interpreting standard as well as special diagnostic tests in the clinical laboratory and/or blood bank.
• Knowledge of theory, function, maintenance, and use of clinical laboratory and blood bank equipment/instruments.
• Knowledge of statistical methods which are employed in the clinical laboratory and/or blood bank.
• Ability to interpret federal/state statutes relating to qualifications of laboratory or blood bank personnel and quality control programs.
• Ability to evaluate the work flow in any size clinical laboratory or blood bank and to ensure that the design flow is functional for that individual facility.
• Ability to give appropriate assignments/instructions to individuals and supervise the performance of their work.
• Ability to analyze and make recommendations for the correction of laboratory and blood bank problems.
• Ability to organize and administer the various functions of a laboratory licensure and inspection program.
• Ability to write scientific/technical reports and articles and to take active part in local/state/national meetings and conferences.
• Ability to prepare and supervise preparation of clear scientifically sound, and accurate reports of tests and survey results to include findings, conclusions, and recommendations.
• Ability to prepare reports for administrative hearings.
• Ability to prepare and/or edit technical correspondence in the course of official duties.
• Ability to review and analyze existing work procedures, evaluate their appropriateness, and recommend changes to improve operating efficiency.
• Ability to supervise the maintenance of records, reports and files.
• Ability to utilize various types of electronic and/or manual recording and information systems used by the agency, office or related units.
• Ability to read, writes, speak, understand, and communicate in English sufficiently to perform duties of this position. American Sign Language or Braille may also be considered as acceptable forms of communication.
• Persons with mental or physical disabilities are eligible as long as they can perform essential functions of the job after a reasonable accommodation is made to their known limitations. If the accommodation cannot be made because it would cause the employer undue hardship, such persons may not be eligible.
• CODES: 29/S29 - MCK 04/30/05

Note

The examples of work for this title are for illustrative purposes only. A particular position using this title may not perform all duties listed in this job specification. Conversely, all duties performed on the job may not be listed.