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Job Description - Director, Division of Laboratory Information Management Systems (250005DL)

Job Description

Director, Division of Laboratory Information Management Systems - ( 250005DL )

Description

The Massachusetts Department of Public Health (DPH) seeks an experienced leader to serve as our Director, Division of Laboratory Information Management Systems. The Director, Division of Laboratory Information Management Systems position for the State Public Health Laboratory (SPHL) has authority from the SPHL Director to carry out functions of Laboratory informatics described and serves as the senior scientific and Laboratory manager responsible for the SPHLs strategic direction for its Laboratory Information Management System (LIMS), Health Information Exchange, and data security and retention. This position will utilize modern information science and technology as a strategic tool to verify laboratory electronic processes and data compliance to promote public health. The Director, Division of Laboratory Information Management Systems is responsible for ensuring that the interests of the SPHL and that of the LIMS are aligned with the Centers for Disease Control and Preventions (CDCs) national health information technology standards, architecture, and information technology specifically in the areas of electronic messaging and interoperability, as well as laboratory specimen/sample processing, testing workflows, data analysis and result reporting, following CLIA, ISO17025, or other regulatory requirements of the MA SPHL. This position will oversee the electronic management of samples, laboratory data, automated workflows and instrument integration throughout the laboratory and the development and distribution of laboratory information to associated statewide customers through Electronic Laboratory Reporting and will ensure that regulatory requirements for the SPHL LIMS are met and documented during periodic entity audits by CLIA, A2LA for ISO17025: Food and Drug Administration (FDA); Department of Environmental Protection (DEP) and other Federal and state regulations governing clinical and public health Laboratories and as the primary Laboratory Privacy Liaison to report incidents to the DPH Privacy and Security Office with regular consultation with the SPHL Division Director of Quality Assurance. This position will be required to ensure that the security of SPHLs laboratory data related to key federal programs within CDC and Department of Homeland Security (DHS) are maintained on behalf of the SPHL Director/Responsible Official and in coordination with the Executive Office of Health and Human Services (EHS) IT staff.

Duties and Responsibilities (these duties are a general summary and not all inclusive):

• Serve as the Laboratory Data Custodian and grant network access to Laboratory staff to Laboratory network directories and user groups to maintain Protected Health Information (PHI) privacy and confidentiality and prevent unauthorized disclosures. This includes management and auditing of network access and usage, including security group assignment, and reporting to the SPHL Laboratory Director/Associate Director. Supervise the Laboratory LIMS ELR Administrator and ensure appropriate ELR user access is granted per CLIA, DOJ, FDA, DHS or other regulatory authority including provision of ELR user support and training. Write Standard Operating Procedures (SOPs) as needed for approval by the SPHL Director. Monitor Compliance with internal LIMS training. Serve as the Laboratory primary point of contact regarding all ELR issues for MassIT and EHS IT.
• Confirm integrity of reported data across LIMS, ELR, and thru the VPN tunnel to comply with CLIA and other regulatory agencies. Collaborate with CDC and lab staff to ensure that the laboratory test result data reported matches the data received via applications such as PHIN-MS, PHLIP, and ALRN monthly reports.
• Act as the primary laboratory point of contact to collaborate with EHS IT and MassIT network and desktop support staff to ensure that all networked laboratory instrumentation and laboratory applications meet national laboratory standards for federal programs such as SPHERES, ARLN, and PulseNet, as well as EHS IT and MassIT Architecture and Security requirements.
• Oversee laboratory elements of ELR integration and interoperability efforts, including messaging between LIMS, MAVEN, CDC and other hospitals and health care providers. Provide input on the proper selection of Laboratory LOINC and SNOMED.
• Serve as the BIDLS Public Health Laboratory (PHL) interoperability data specialist and in regular consultations with the SPHL Director, lead all laboratory components of Laboratory HL7 messaging, working with EHS-IT.
• Oversee data security of PHI and Personally Identifiable Information (PII) and administration of applicable data use and data retention policies. Includes collaboration with EHS-IT on use of on premises servers and analysis stations and use of all cloud-based infrastructure for Laboratory-specific applications to ensure security and data integrity and compliance.
• Under the direct supervision of the MA SPHL Director and indirect supervision of the Associate Laboratory Director, collaborates with all Laboratory Division Directors, and other BIDLS Division Directors, DPH health programs, and external partners as needed to apply for and meet the requirements of various grants. Collaborate with internal and external partners to implement grant-funded activities, attending meetings/conferences as needed according to the requirements of the funding. Collaborate with other state public health and environmental laboratories and Association of Public Health Laboratories to share informatics expertise. Assist in the preparation of annual goals and objectives and operational budgets.
• May be required to perform other duties as needed, include functions in support of emergency declaration activities.

Preferred Qualifications:

• Clinical laboratory knowledge of testing processes in microbiology, diagnostic immunology, Chemistry and/or molecular diagnostics.
• Technical expertise and educational background to coordinate all aspects of a comprehensive Laboratory Information Management System for a public health laboratory including components of bioinformatics, informatics, and laboratory/clinical experience.
• Experience working in a laboratory setting, preferably a public health environment.
• Working knowledge of chemistry, virology, and microbiology laboratory tests and techniques as well as public health and epidemiology.
• Working knowledge of laboratory information management systems (LIMS) including applications that support sample kit management, sample accessioning, sample analysis, result reporting, QA/QC, inventory and management/statistical reporting.
• Experience with gathering business requirements, familiarity with system development life cycle (SDLC), networking a broad range of laboratory instrumentation, HIPAA security requirements, and data back-up solutions.
• Awareness of Specific LIMS platforms, including but not limited to LabWare, StarLIMs, OpenELis.
• Experience with and/or knowledge of HL7 messaging and LOINC and SNOMED Coding Standards.
• A proven track record successfully facilitating collaboration between end users and technical staff of varying technical aptitudes.
• Ability to keep up with current regulations and develop policies and procedures to comply with any changes.
• Knowledge of CLIA, CAP, and ISO regulations for laboratory quality assurance and quality control for high complexity testing.
• Awareness of the principles and practices of organizational behavior.
• Understanding of the principles and practices of budgeting as it relates to program management.
• Knowledge of the principles and practices of personnel management and supervision.
• Capability to select and develop staff by utilizing participatory management, personnel assessment and performance review.
• Power to give written and oral instructions in a precise, understanding manner.
• Ability to resolve personnel conflicts effectively.
• Means to delegate authority effectively.
• Potential to anticipate and analyze difficult situations and take corrective action to prevent problems from occurring.
• Skilled to supervise, including planning and assigning work according to the nature of the job to be accomplished and the capabilities of subordinates and available resources; controlling work through periodic reviews and/or evaluations; determining subordinates to work effectively; determining the need for disciplinary action and either recommending or initiating disciplinary action.
• Ability to effectively write scientific proposals, grants and manuscripts.
• At least 6 years of relevant laboratory experience including knowledge of instrumentation, study design, method development, data interpretation and Laboratory Information Management Systems (LIMS).
• At least 3 years of technical and supervisory experience to direct and manage all aspects of a comprehensive Laboratory Information Management System (LIMS) for a public health laboratory including components of bioinformatics, and clinical laboratory experience.

Special Requirements:

• Current & valid clearance for the Select Agent registration via the Department of Justice.
• Current & valid certification as a general supervisor required by CLIA, CAP, ISO15189, ISO17025 or other.

As part of the pre-hire process, you will be required to submit transcript(s) for review for theClinical Laboratory Improvement Amendments (CLIA) verification pr]]> <

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