CS-214 Position Description Form



CS-214Rev 11/2013Position CodeSTDDADM1State of MichiganCivil Service CommissionCapitol Commons Center, P.O. Box 30002Lansing, MI 48909POSITION DESCRIPTIONThis position description serves as the official classification document of record for this position. Please complete this form as accurately as you can as the position description is used to determine the proper classification of the position. 2.Employee’s Name (Last, First, M.I.)8.Department/AgencyVacantHealth and Human Services 3.Employee Identification Number9.Bureau (Institution, Board, or Commission)Laboratories4.Civil Service Position Code Description10.DivisionState Administrative Manager 155.Working Title (What the agency calls the position)11.SectionQuality Assurance ManagerQuality Assurance6.Name and Position Code Description of Direct Supervisor12.UnitSandip Shah, State Bureau Administrator, SME 197.Name and Position Code Description of Second Level Supervisor13.Work Location (City and Address)/Hours of WorkDr. Joneigh Khaldun, MD, CME, Chief Deputy Director3350 N. MLK BLVD., Lansing, MI 48909Monday – Friday 8:00 a.m. to 5:00 p.m.14.General Summary of Function/Purpose of PositionThe individual in this position is responsible for the implementation and monitoring of the Quality Management System of the Bureau of Laboratories, oversees process improvement activities throughout the Bureau, and coordinates all activities necessary to comply with requirements under federal CLIA regulations to maintain continuous laboratory accreditation and certification. The position also oversees laboratory operations including the statewide courier system for specimen pickup, the continuous temperature monitoring system, the laboratory water purification system, quality control testing and analysis of microbiological media, glassware washing, processing of outgoing packages and incoming deliveries for the laboratory; and warehouse inventory services. The position supervises three units in the Quality Assurance Section, 1) Quality Control, 2) Laboratory Support, and 3) Data and Specimen Handling (DASH). In this capacity, the position is responsible for the direction, evaluation and verification of employee performance including one first line professional level supervisor for the DASH unit. The Quality Control (QC) Unit monitors compliance of all testing areas with the Bureau quality policies, procedures, and accreditation requirements through internal audits; evaluates all in-house manufactured the performance and acceptability of culture media and reagents prior to use; tracks CLIA-required employee competency assessments and proficiency testing data; and maintains the controlled documents management system. The Laboratory Support unit which includes the dish room and warehouse, handles incoming deliveries and outgoing shipments, maintains inventory and fills orders for reusable glassware, testing and shipping kits, newborn screening specimen cards, laboratory stock items, and STI program pharmaceuticals. The Data and Specimen Handling Unit coordinates the receipt, data entry and distribution of laboratory specimens to the appropriate testing unit; packages hazardous materials (infectious specimens)33 for shipment to other laboratories, and serves as the front-line customer service area for the laboratory including handling of customer complaints.This position also coordinates the activities of local health department laboratories within the Michigan Regional Laboratory System15.Please describe the assigned duties, percent of time spent performing each duty, and what is done to complete each duty.List the duties from most important to least important. The total percentage of all duties performed must equal 100 percent.Duty 1General Summary of Duty 1% of Time 50The individual in this position plans, organizes, and monitors the overall Quality Management System of the Bureau of LaboratoriesIndividual tasks related to the duty.Ensure compliance with CLIA regulations, CAP accreditation, and AIHA-LAP, LLC accreditation requirementsOperate and maintains document control system Bureau-wide, ensures controlled documents are reviewed on a biennial basisWrite and updates policies and procedures in the BOL quality manual Write and updates standard operating procedures (SOP) for DASH, Quality Control and Lab Support units Define quality metrics annuallyMonitor and review results of proficiency testing, route for management review Coordinate Process Improvement activities through Bureau-wide teams and workgroups. Establishes priorities for quality management practices throughout the BureauPrepare quarterly and annual quality reports that summarize the quality activities of the BOL.Assure that any corrective action on the part of the Quality Assurance Section is appropriate, timely and thorough, Maintain records and documentation of quality assurance activities including proficiency testing results, personnel competency evaluations, new test validation reports, response to customer complaints, accreditation inspections, internal audits, Incorporate best practice standards and guidelines in quality policies and procedures (For example -Clinical Laboratory Standards Institute, or CLSI)Duty 2General Summary of Duty 2% of Time 15Direct quality control testing by professional microbiologists on microbiological culture media and reagents used throughout the Bureau of LaboratoriesIndividual tasks related to the duty.Oversee the media quality control activities within the Quality Assurance SectionAssure that current media quality control procedures used to ensures that the Bureau’s testing performance comply with current best practices and manufacturer’s recommendationsOversee and maintains staffing at required levels to meet laboratory testing demands for thorough and timely evaluation of media products either manufactured on-site or purchased from outside vendorsEnsure that all QC procedures are reviewed on a biennial basis through the iPassport document controlCompile and analyze media QC data annually to update the Individual Quality Control plan (IQCP) for commercial mediaEnsure that all Bureau IQCP are reviewed annually by lab directorDuty 3General Summary of Duty 3% of Time 15Prepares and oversees the day-to-day operations of the Quality Assurance SectionIndividual tasks related to the duty.Maintain a schedule of timely issues to be reviewed including procedures, equipment contracts, culture media contracts, service agreements, budget, etc., that are critical to the smooth operation of the Bureau of LaboratoriesSchedules work assignments set priorities and direct the work of QA Section employees with knowledge of equal opportunity, diversity and inclusion practices and policies, supervisory techniques, labor relations and employee policies and proceduresEvaluate and verify employee performanceAnalyze budgets and track expenditures in QA SectionDocument problems as they arise, conduct root cause analysis and develop corrective action plans when indicated. Review corrective actions taken and assess for effectiveness. Requires maintaining an extensive knowledge of laboratory techniques, equipment, apparatus and terminologyMonitor the reverse osmosis water treatment system for both the DHHS and EGLE laboratories, including daily readings, weekly testing, troubleshooting, and scheduling the professional contracted vendor for routine maintenance, repair, replacement, etc.Serve as liaison with the contracted vendor for statewide courier service for daily (Sun-Fri) specimen pick up from 75 birthing hospitals and additional local health departments and clinical sitesMaintain the Vaisala continuous temperature monitoring system for temperature controlled lab equipment, including refrigerators, freezers, incubators, etc. Daily monitoring of alarms, replacement of loggers, and scheduling annual calibrations.Oversee the laboratory glassware washing service for the BOL, including maintenance of the 2 laboratory glassware washersCoordinate the distribution of completed test reports for all Divisions of the Bureau as well as provides archival activities for these records. requiring familiarity with State records retention policiesDuty 4General Summary of Duty 4% of Time 10Initiates, performs and approves investigation of new and more efficient laboratory and operation procedures through facilitation of process improvement activities.Individual tasks related to the duty.Utilize standard Lean tools (e.g., value stream mapping, 5S, Kaizen events, etc.) to implement process improvement projectsReview existing procedures and practices in all units in order to identify the need for corrective action or preventive actionAttend pertinent lectures, seminars and workshops on the topics of microbiological analysis, control of human diseases, laboratory instrumentation, Quality Control/Quality Assessment, Quality Management System, laboratory regulation and employee policies and proceduresCoordinate the activities of the BOL Quality Steering Committee and Process Improvement teamDuty 5General Summary of Duty 5% of Time 1Provides leadership and coordination of the Regional Laboratory System to provide standardized and quality testing that meets regulatory and accreditation standards in local public health agencies.Individual tasks related to the duty.Develop quality policies and standard operating procedures for tests used in the Regional Laboratory SystemDevelop quality control intervals and practices appropriate for the testing performed within the SystemDevelop forms, training, and other tools for use by System participants to meet regulatory and accreditation standards Coordinate the online wet mount proficiency testing program Provide regulatory oversight to umbrella public health certificate(s) and high complexity certificate laboratory(ies) as assignedProvide technical and quality consultation to local public health agencies as requested Coordinate and facilitate quarterly meetings of the Regional Laboratory SystemDuty 6General Summary of Duty 6% of Time9 Oversee operation of laboratory warehouse Individual tasks related to the duty.Order and maintain inventory of components for test collection kits and shipping materials Maintain minimum inventory of assembled (ready-to-ship) kitsReceive shipments from commercial carriers and deliver to main lab buildingMaintain standard supply items, fill orders from BOL staff, and deliver to main lab buildingOversee online kit ordering system (MILKOTS)Maintain stock of STI pharmaceuticals and fill orders for STI programCoordinate renewal of pharmaceutical distribution license from LARAMaintain inventory of newborn screening cards and fill orders from birthing hospitals and midwives through online ordering systemResponsible for operation of warehouse equipment including forklift; ensure operators have forklift training and maintain current operator’s permitAnnual inspection of shelving and other warehouse safety items16.Describe the types of decisions made independently in this position and tell who or what is affected by those decisions.Decisions that impact program areas. Decisions regarding submission of unusual specimens for testing, decisions to recommend proposed services, and operation and maintenance of a variety of specialized equipment pertaining exclusively to laboratory operations. These decisions affect the section, bureau, department, and the general public.17.Describe the types of decisions that require the supervisor’s review.Unusual problems or personnel needs, certain types of involvement with Divisions, Bureaus and Agencies outside the Bureau of Laboratories that could have widespread effects on either the Bureau’s programs or those of other Bureaus or Departments within the state.18.What kind of physical effort is used to perform this job? What environmental conditions is this position physically exposed to on the job? Indicate the amount of time and intensity of each activity and condition. Refer to instructions.Physical Activities: standing (25%), sitting (60% - using a computer/telephone) walking (15%) between laboratories, office and buildings. Valid Michigan driver’s licenseConditions/hazards: Odors, fumes, infectious agents, hazardous chemicals19.List the names and position code descriptions of each classified employee whom this position immediately supervises or oversees on a full-time, on-going basis. (If more than 10, list only classification titles and the number of employees in each classification.)NAMECLASS TITLENAMECLASS TITLEMatthew BashoreDepartmental Manager -2Mark WarstlerStorekeeper-AJames ArmelagosMicrobiologist AMary BonifasLaboratory Evaluation Specialist-AAlbert JohnsonLaboratory Technician EJoshua Hall Storekeeper -A20.This position’s responsibilities for the above-listed employees includes the following (check as many as apply):XComplete and sign service ratings.XAssign work.XProvide formal written counseling.XApprove work.XApprove leave requests.XReview work.XApprove time and attendance.XProvide guidance on work methods.XOrally reprimand.XTrain employees in the work.22. Do you agree with the responses for Items 1 through 20? If not, which items do you disagree with and why?23.What are the essential functions of this position?This position is the administrative chief of the Quality Assurance Section that is responsible for ensuring compliance with federal laboratory CLIA certification requirements, CAP laboratory accreditation requirements, and ISO-17025 laboratory accreditation requirements.24.Indicate specifically how the position’s duties and responsibilities have changed since the position was last reviewed.Added the Quality Management System software (iPassport) for document control and preventive maintenance trackingBecame accredited for testing human specimens through the College of American Pathologists (CAP), (previously accredited only by CLIA)Increased scope of ISO-17025 accreditation for testing of non-human (environmental) samples from one analyte (lead) in one laboratory unit to multiple analytes in both Chemistry-Toxicology and Infectious Disease Divisions. Accreditations require preparation for extensive internal assessments in even-numbered years, and comprehensive external assessments in the alternating (odd-numbered) yearsAdded the laboratory warehouse operations, which serves all specimen submitters in the state by maintaining inventory and providing specimen collection and shipping materials, instructions; newborn screening cards and pharmaceuticals for treating sexually transmitted infections. The warehouse also processes all incoming deliveries and outgoing shipments for the Bureau of LaboratoriesAdded operation and maintenance of both software and hardware for the automated continuous temperature monitoring system for all incubators, refrigerators, freezers, heating baths, and similar equipment in the laboratory25.What is the function of the work area and how does this position fit into that function?The Quality Assurance Section provides the framework and support for the laboratory to perform testing to the highest standards of quality. The position oversees activities and maintains all documentation to ensure compliance with federal and state legislation and rules, and laboratory accreditation requirements; evaluates culture media used throughout the clinical laboratories of the bureau; and supports various laboratories within the Bureau through glassware cleaning and maintenance of warehoused laboratory supplies. In addition, the position oversees the receipt of specimens, patient data entry, the distribution of completed test reports for all Divisions of the Bureau, and provides archival activities for these records.This position also coordinates the activities of the Regional Laboratory System to ensure quality of testing within local health departments.26.What are the minimum education and experience qualifications needed to perform the essential functions of this position?EDUCATION:Possession of an earned bachelor’s degree in public health, chemistry, biochemistry, forensic science, microbiology, or a related field.EXPERIENCE:Four years of professional experience, including two years equivalent to the experienced (P11) level or one year equivalent to the responsibility of a Laboratory Scientist 12 or Microbiologist 12 or one year experience equivalent in responsibility to a 13 level specialist or manager in state service, or one year equivalent to the 14 level specialist or manager in state service with an extensive background in quality assurance activities.KNOWLEDGE, SKILLS, AND ABILITIES:Extensive knowledge of the principles of laboratory testing in microbiology and chemistry, including the specialties of bacteriology, parasitology, mycology, virology and serology. Extensive knowledge of CLIA regulations, ISO laboratory standards, CAP accreditation checklists, and CLSI laboratory standards and guidelines; quality management and process improvement; specimen collection and processing; quality control and quality assurance; validation and verification of testing; proficiency testing; competency assessment; equipment operation and preventive maintenance The ability to interpret complex regulations and deal effectively with regulatory agencies is a necessity. Knowledge of the principles and techniques of administrative management including organization, planning, staffing, training, budgeting, and reporting.Ability to solve problems and make decisions, ability to establish and maintain effect relationships with government officials, private industry officials, professional personnel, and others.Professional and technical communication skills (oral and written), and scrupulous attention to detail required.CERTIFICATES, LICENSES, REGISTRATIONS:Hazardous materials transportation certification in Division 6.2 Infectious Substances is desiredNOTE: Civil Service approval of this position does not constitute agreement with or acceptance of the desirable qualifications for this position.I certify that the information presented in this position description provides a complete and accurate depiction of the duties and responsibilities assigned to this position. Supervisor’s SignatureDateTO BE FILLED OUT BY APPOINTING AUTHORITYIndicate any exceptions or additions to statements of the employee(s) or supervisors.I certify that the entries on these pages are accurate and complete. Appointing Authority SignatureDateTO BE FILLED OUT BY EMPLOYEEI certify that the information presented in this position description provides a complete and accurate depiction of the duties and responsibilities assigned to this position. Employee’s SignatureDateNOTE: Make a copy of this form for your records. ................
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