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4253 - Regulatory Compliance & Laboratory Supervisor
at Pima County
- Position Description
This position is in the Health Department. OPEN UNTIL FILLED.
Salary Grade: M2
Researches, coordinates and oversees the Pima County Health Department's compliance with relevant regulatory and statutory requirements, including but no limited to OSHA, HIPAA, CLIA and Pharmaceutical Security. Directs, plans, coordinates and oversees the PCHD medical laboratory activities, ensuring the accuracy and integrity of all tests, examinations and analyses performed in the department's clinical settings.
- (Work assignments may vary depending on the department's needs and will be communicated to the applicant or incumbent by the supervisor.)Evaluates employee performance, makes recommendations on hiring, terminations, and related personnel activities, and initiates progressive discipline process as necessary;
Maintains current knowledge of laws, rules and regulations and relevant legislation governing PCHD, including but not limited to OSHA, HIPAA, CLIA, Outpatient Clinics and Pharmaceutical operations, to ensure that the department's policies, procedures and activities comply with all regulatory requirements and standards;
Coordinates and participates in Department wide training in order to ensure all programs are in compliance with all regulatory requirements and standards including, but not limited to, OSHA, HIPAA, CLIA and relevant pharmacy dispensing laws;
Provides oversight and review to assure program compliance with regulatory requirements and standards (i.e., reviews each program's safety policies and procedures, compliance with departmental pharmacy inventory policies and procedures, etc.);
Performs as a department representative and subject matter expert to other sections of the department, other County departments, private sector and other agencies, entities and other jurisdictions at meetings, on committees, task forces, and boards at the local, and state level;
Reviews proposed legislation and rules and ensures the Department's and the public interests are taken into consideration in the legislative process;
Prepares comprehensive reports in order to satisfy reporting requirements of Federal, State and local regulatory agencies;
Initiates, develops and implements policies and procedures to assure optimal laboratory testing and analyses to obtain data for the use in diagnoses and treatment of disease;
Researches and selects testing methodology and establishes parameters for acceptable levels of analytic performance throughout the testing process including receipt, analyses and reporting;
Oversees and trains clinicians and staff performing waived laboratory testing at PCHD sites and obtaining specimens for hematological, chemical, serologic, urine, microbiological tests by establishing procedures for specimen handling, performance of the test, labeling, etc.;
Develops, implements and monitors the quality assurance and quality control program as required by certification agencies;
Develops, implements and evaluates laboratory in-service and new employee training;
Reviews tests performed by clinician staff to ensure quality and accuracy of tests and results;
Determines, and directs others in, actions to take to resolve testing, analyses and operational problems;
Interacts with medical staff for evaluation of diagnostic data;
Develops record keeping, reporting and communication protocols between different laboratory and clinic functions to assure timely and accurate data transmission and entry;
Identifies potential safety and health issues and develops strategies to effectively respond.
KNOWLEDGE & SKILLS:
- Clinical Laboratory Improvement Amendment (CLIA) laboratory regulations;
- Occupational Safety and Health Administration (OSHA) regulations;
- Health Insurance Portability and Accountability Act (HIPAA) standards, rules and regulations;
- Federal and State laws, rules and regulations governing the practice of pharmaceutical storage and dispensing;
- the principles and practices of medical laboratory technology and supervision.
- developing and implementing policies, procedures, quality control and quality assurance programs related to regulatory compliance;
- training staff in regulatory compliance;
- selecting, developing and testing test methodologies;
- assigning, training and supervising staff;
- using, calibrating and performing operator maintenance on laboratory instruments;
- handling potentially dangerous and infectious substances;
- establishing and maintaining effective working relationships with department staff and employees;
- overseeing and performing all medical laboratory tests, analyses and examinations;
- recognizing abnormal test results and instructing others in taking corrective actions;
- performing all medical laboratory tests, analyses and examinations;
- identifying bacteria and preparing specimens for testing;
- documenting information in and retrieving information from a computer database.
- Minimum Qualifications
A Bachelor of Science degree from an accredited college or university with a major in medical technology, clinical laboratory science, chemical, physical, biological or related science and four year of medical laboratory experience including one year supervisory experience and three years experience overseeing regulatory compliance in a health care setting (which may be concurrent with the required medical laboratory experience).
Qualifying education and experience must be clearly documented in the "Education" and "Work Experience" sections of the application. Do not substitute a resume for your application or write "see resume" on your application.
Preferred Qualifications (Be specific in describing your experience in your application. Ensure the descriptions provided illustrate your competencies, specifically addressing the required and preferred qualifications.):
- Three (3) years or more of documented experience working with CLIA, OSH, HIPAA regulations and regulatory agencies.
- Three (3) years or more of documented experience working with Arizona State regulatory and licensure boards.
- Three (3) years or more of experience working in/with public health departments.
Pima County Human Resources Department reserves the right to admit to the selection process only those candidates that meet the minimum/desired qualifications. All applications will be assessed based on an evaluation of the listed education and experience. Candidates meeting the minimum/desired qualifications may be further evaluated/scored against any advertised Preferred Qualifications. The hiring authority will interview and select the successful candidate from a referral list provided by Human Resources. Additional assessments/testing may be required as part of the selection process.
- Supplemental Information
Licenses and Certificates: Certification as a Medical Technologist with the Registry of Medical Technologists of the American Society of Clinical Pathologists, or equivalent certification by a recognized health agency (e.g. HEW, AMT, NCA) is required at the time of appointment. Valid driver license is required at time of application. Valid AZ driver license is required at time of appointment. The successful applicant will be subject to a 39-month DOT Motor Vehicle Record review to determine applicant's suitability to operate county vehicles in accordance with Pima County administrative procedures. Failure to obtain and maintain the required licenses and certifications shall be grounds for termination. Any offer of employment resulting from this recruitment is contingent upon Fleet Services' review and approval of the candidate's driving record.
Special Notice Items: Department of Labor regulations CFR Part 1910.1030 requires notification that this category may have a high risk of exposure to communicable diseases. Hepatitis B vaccine will be provided. The County requires pre-employment background checks. Successful candidates will receive a post-offer, pre-employment background screening to include verification of work history, education and criminal conviction history. A prior criminal conviction will not automatically disqualify a candidate from employment with the County.
Physical/Sensory Requirements: Ability to distinguish color within normal range and to properly wear safety clothing and/or equipment. Other physical and sensory abilities will be determined by position.