Under general administrative direction, and in compliance with state and federal regulations, plans, organizes, directs, staffs and controls the operations and services of the San Joaquin County Public Health Laboratory, which is both a high-complexity and bio-terrorism reference laboratory certified by the State of California; serves as the laboratory director as required by state and federal law; serves as the County technical and operational resource for public health laboratory issues; maintains a liaison with state and federal agencies regarding public health laboratory activities; and does related work as required.
This is an at-will, single-position management-level class that is exempt from the San Joaquin County Civil Service system. The incumbent oversees and directs the operations of the Public Health Laboratory and has strategic responsibility for planning, developing and implementing laboratory programs, projects and services through the establishment of organizational goals, objectives, policies and priorities. Work is performed in accordance with applicable laws, regulations, policies, and other requirements. The incumbent is expected to model a strong work ethic and leadership skills, including accountability for oneself and others.
This specification is a general guideline for the class. The statements below are not restrictive, and the responsibilities and duties assigned to a position in this class may expand beyond those identified in this specification.
Plans, directs, and administers the operations and programs of the County’s Public Health Laboratory within Public Health Services and serves as the designated laboratory director as required by state and federal law; oversees the work of staff performing a wide variety of general and specialized laboratory testing activities, including those identified as “highly complex” by the federal Centers for Disease Control; consults with departmental staff, private physicians, clinical laboratory scientists, and other related health personnel in the performance and interpretation of laboratory diagnostic testing related to public health; provides technical expertise pertaining to the most difficult tests and procedures; exercises good judgment and makes sound decisions in managing assigned areas and functions.
Participates in department-wide strategic planning activities and the development of goals and objectives; recommends and establishes short- and long-term goals and objectives for the public health laboratory; develops and establishes laboratory program objectives and performance standards; establishes policies and procedures related to laboratory operations and directs their implementation; directs the preparation and maintenance of laboratory procedure manuals.
Develops and directs internal quality control standards, protocols and controls, including mandated equipment preventive maintenance, quality control and quality assurance programs; interprets quality control data related to program operations and activities in order to evaluate overall program effectiveness and compliance; directs process improvements and modifications as necessary; directs operational adjustments in response to changes in program directives and/or client needs; coordinates laboratory services with management staff in other divisions;
Directs the performance of clinical trials and assessments as well as related data development, analysis and reporting; directs and oversees the development and maintenance of laboratory reports and statistical data in order to evaluate the efficiency and effectiveness of laboratory operations, the accomplishment of strategic objectives, and the compliance of laboratory programs with departmental, County, state, and federal codes, regulations, guidelines, policies and procedures and protocols.
Coordinates with local, regional, state and federal officials to meet contractual obligations for regional testing services, the Level B Bioterrorism Response Program, and/or other special programs and activities.
Directs and oversees the development, preparation, and administration of the laboratory operating, capital and special program budgets in accordance with strategic fiscal goals, objectives, and cost efficiency options; directs the preparation of cost estimates/projections and justifications for requested resources and expenditure plans; estimates revenues; oversees the analysis of bids and contracts for supplies, services and equipment and recommends awards for services; directs and administers contractual agreements for laboratory services; approves billings, payments, and laboratory expenditures, including the purchase of equipment and supplies in a manner that ensures efficient inventory control.
Represents the Public Health Laboratory in audits and inspections and ensures that certification and accreditation standards are met.
Selects and supervises subordinate personnel, including management staff; ensures that all laboratory work is accurate, is performed using proper work methods and techniques, and is in compliance with applicable standards and specifications; ensures that staff receive appropriate in-service and other training; initiates, recommends and implements disciplinary actions as necessary; directs the development and utilization of laboratory information systems and the use, operation and maintenance of other laboratory equipment.
Provides technical expertise and consultation to department staff, community physicians, nursing personnel, laboratory technicians, hospitals, schools, businesses and the general public regarding public health diagnostic and other laboratory processes; provides testimony and affidavits as an expert witness as required; responds to complaints or concerns and resolves issues.
Maintains professional knowledge in applicable areas and keeps abreast of changes in job-related rules, statutes, laws and new business trends; makes recommendations for the implementation of changes; reads and interprets professional literature; attends training programs, workshops, meetings and seminars; represents Public Health Services in meetings and participates on task forces, commissions, and other groups as assigned.
Experience: Two years of management experience in an approved public health laboratory.
License: Possession of a valid certificate as a Public Health Microbiologist issued by the California Department of Public Health.
Special Requirement: Must qualify under the federal Clinical Laboratory Improvement Amendments (CLIA) as incorporated into the California Health and Safety Code. These are summarized below:
Either Pattern I
Education: Possession of a Doctorate degree from an accredited university in a chemical, physical, biological, or laboratory science, including all undergraduate and graduate coursework required to meet the requirements to be appointed as a director of a public health laboratory as identified by the State of California, Department of Public Health, Laboratory Field Services (see the California Code of Regulations, Title 17, Chapter 3, Subchapter 1, Article 3.)
a)Possession of a valid certificate by a CLIA-approved board (See the California Health and Safety Code, Division 101, Part 3, Chapter 2, Article 5, Section 101160); OR
b)Before February 24, 2003, must have worked two years as a director supervising or directing in a laboratory performing high complexity testing and must have at least two years of laboratory training.
Or Pattern II
Experience: On or before February 28, 1992, held a position as a laboratory director or could have qualified as a laboratory director under California regulations (42 CFR 493.1415, published March 14, 1990) or federal regulations (55 FR 9538).
Or Pattern III
Experience: On or before February 28, 1992, was qualified under state law to direct a laboratory in the state in which the laboratory is located.
Principles and practices related to the management and administration of public health laboratory, including budgeting, organizational development, supervision and personnel management; current trends, concepts, and methods in public health laboratory science including principles, practices, and testing procedures in bacteriology, serology, mycology, parasitology, virology and other areas of microbiology; state and federal regulations related to the operation of public health laboratories; social, political, and economic issues influencing program administration; causes and methods of transmission of communicable diseases; laboratory research methods, test development and evaluation techniques; work review and methods analysis techniques in a laboratory setting; laboratory quality control principles and techniques; laboratory testing parameters and results yielding positive or negative conclusions; statistical methodologies utilized in quality control procedures; modern office automation technology and pertinent software programs.
Plan, organize, direct, staff and control the programs and activities of a high-complexity public health laboratory; interpret and explain laboratory practices and laws governing public health laboratory operations; administer and oversee public health laboratory testing and operations; provide appropriate and effective leadership and management over diverse staff teams; exercise good judgment and make sound managerial decisions; exercise analytical and critical thinking to analyze complex problems and recommend appropriate solutions; establish and maintain effective working relationships with physicians, public health professional staff, government officials, contractors, vendors and others; perform complex research and analyses on highly technical issues; develop quantitative and qualitative data, draw logical conclusions, and prepare complex statistical and narrative reports; issue oral and written directives of a technical nature; ensure the quality and quantity of laboratory output; maintain accurate records and documentation of actions taken; maintain confidentiality of information; operate computers and related software; communicate effectively, both orally and in writing.
Mobility - Frequent sitting for long periods of time while operating a keyboard. Lifting - Occasional lifting of 30 lbs. or less. Vision - Constant use of overall visual capabilities; frequent need for use of color perception, hand/eye coordination, reading and/or close-up work; Dexterity - Frequent holding, grasping and writing; Hearing/Talking - Constant hearing and talking in person and on the telephone; Special Requirements – may require working weekends/nights; working alone;Emotional/Psychological - Constant concentration and decision‑making duties; frequent emergency situations, public contact and ability to work independently.