Director of Laboratory Informatics - (250002V5)

Company: Sacred Heart University
Location: Boston
Posted on: April 14, 2025

Job Description:

Bureau of Infectious Disease and Laboratory Sciences (DPH)Recruitment began on March 17, 2025 and the job listing Expires on April 16, 2025.The Massachusetts Department of Public Health (DPH) seeks an experienced leader to serve as our Director of Laboratory Informatics. The Director of Laboratory Informatics 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 SPHL's 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 of Laboratory Informatics is responsible for ensuring that the interests of the SPHL and that of the LIMS are aligned with the Centers for Disease Control and Prevention's (CDC's) 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 SPHL's 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:

• Serve as the Laboratory Data Custodian and grant network access to Laboratory staff 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.
• Confirm integrity of reported data across LIMS, ELR, and thru the VPN tunnel to comply with CLIA and other regulatory agencies.
• 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.
• Oversee laboratory elements of ELR integration and interoperability efforts, including messaging between LIMS, MAVEN, CDC and other hospitals and health care providers.
• 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.
• Collaborate 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.
• May be required to perform other duties as needed, including 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.
  • 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.
  • 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.
  • 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.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.This position will require work in the BSL-3 laboratory. In the context of work in a BSL-3 environment the successful candidate must understand the following:
      • All Tier 1 Staff will undergo a security risk assessment (SRA), which includes signing a confidentiality statement, and renewal every three years.
      • Working conditions include potential exposure to infectious agents.
      • All Tier 1 designated staff who may be exposed to Tier 1 Biological Select Agents and Toxins (BSAT) must complete OSHA Respirator Medical Evaluation Questionnaire (29 CFR 1910.134 Appendix C).About the Bureau of Infectious Disease and Laboratory Sciences (BIDLS):The DPH Bureau of Infectious Disease and Laboratory Sciences (BIDLS), predominantly located in Jamaica Plain, provides public health response to infectious disease.Infectious disease response services address concerns of the general public as well as those disproportionately affected by infectious disease through a variety of risk factors.The SPHL provides scientific expertise and capacity to identify infectious agents, chemical agents, and other toxins that cause human disease.BIDLS Vision: Optimize the health of all people in Massachusetts and implement an equitable and just public health response by combatting infections and other public health threats.BIDLS Mission: Use testing, analytical, and direct service capacities, grounded in data-, science-, and equity-driven public health principles, to share accurate information, provide timely guidance, and respond to infections and other public health threats.DPH Mission and Vision:The mission of the Massachusetts Department of Public Health (DPH) is to promote and protect health and wellness and prevent injury and illness for all people, prioritizing racial equity in health.A tax & background check will be completed on the recommended candidate as required by the regulations set forth by the Human Resources Division prior to the candidate being hired.QualificationsMINIMUM ENTRANCE REQUIREMENTS:Applicants must have at least (A) six (6) years of full-time or, equivalent part-time, professional, administrative, supervisory, or managerial experience in a particular specialty and must possess current license and/or registration requirements established for the performance of the position.Substitutions:I. A certificate in a relevant or related field may be substituted for one (1) year of the required (A) experience.II. A Bachelor's degree in a related field may be substituted for two (2) years of the required (A) experience.III. A Graduate degree or higher in a related field may be substituted for three (3) years of the required (A) experience.IV. A Doctorate degree in a related field may be substituted for four (4) years of the required (A) experience.Salary placement is determined by a combination of factors, including the candidate's years of directly related experience and education, and alignment with our internal compensation structure as set forth by the Human Resources Division's Hiring Guidelines.An Equal Opportunity / Affirmative Action Employer. Females, minorities, veterans, and persons with disabilities are strongly encouraged to apply.
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Keywords: Sacred Heart University, Boston , Director of Laboratory Informatics - (250002V5), Healthcare , Boston, Massachusetts