Person, Text, Face

 

Every patient sample is a story.

That's why our Lab Ops team is focused on providing physicians with comprehensive genomic information about each person's cancer. Information that's as unique as the patients are. The insights discovered in our labs may help change their story.

 

Senior Licensure and Accreditation Lead, LIS

  • United States
  • Full Time

About the Job

The Senior Licensure and Accreditation Lead, LIS is responsible for coordinating and maintaining continued compliance with all applicable laboratory information system requirements. In this role, the Sr. Licensure and Accreditation Lead, LIS is responsible for meeting current and future business goals by curating and executing an optimization and systems roadmap, and by closely collaborating with leadership across functional teams in collaboration with the Enterprise Quality & Compliance Engineering team. You are responsible for oversight of department processes, team workflows and ensuring adherence to change control best-practices for Laboratory Information Systems. This position assists with LIS software development accreditation compliance activities to ensure adherence to accreditation and regulatory standards, including the College of American Pathologists, NYSDOH, CLIA, CA, and ISO 15189. This role builds and maintains collaboration with the IT team and provides suggestions to current practices for compliance. The Sr Licensure and Accreditation Lead, LIS aids FMI departments in the navigation and interpretation of the requirements and provides ongoing education of laboratory accreditation requirements and standards and collaborates with the IT team in the SDLC process. This position supports the execution of the planning and work of multiple projects.

Key Responsibilities

  • Guide, mentor, and collaborate with the IT team on software development ensuring compliance with all applicable laboratory requirements.
  • Maintain a deep working knowledge of current and future capabilities across laboratory applications.
  • Collaborate with laboratory leadership, cross-functional leads and staff to ensure lab activities and support are integrated into planning for LIS activities and ensure minimal disruption of operations during LIS maintenance or changes.
  • Ensure all documentation and processes are documented to ensure regulatory compliance with national and state accreditation bodies as well as the College of American Pathologists.
  • Monitor security of the LIS system to ensure proper functioning and compliance.
  • Collaborate with system engineers and company IT staff to develop and execute LIS domain strategy, ensuring proper installation and validation of needed packages and domain upgrades.
  • Closely collaborate with operational stakeholders to ensure business needs are met and future projects are properly scoped, resourced and executed.
  • Maintain a strong understanding of laboratory technology and its application to achieve clinical and business objectives.
  • Recommend improvements to the interface QA process to improve quality, reduce project cycle time, and reduce bugs discovered during all phases of the project.
  • Ensures inspection readiness through activities including but not limited to maintenance of personnel records, ongoing document preparation and submission for surveys, conducting mock accreditation audits, and tracking corrective action to resolution.
  • Develops education programs regarding compliance of laboratory regulatory requirements and provides education by utilizing various delivery methods.
  • Educates and updates departments regarding accreditation standards, revisions in accreditation standards, and regulatory standards and requirements as identified through internet, literature review, standard review and conference resources.
  • Educates and updates Laboratory Directors, leadership and staff regarding accreditation standards, revisions in accreditation standards, and regulatory standards and requirements as identified through internet, literature review, standard review and conference resources.
  • Coordinates IT delegation process including personnel record audits to ensure compliance with regulatory qualifications, maintaining and coordinating delegation documentation, and review of delegation submissions.
  • Ensures inspection readiness through activities including, but not limited to, maintenance of complete and accurate records, and appropriateness.
  • Develops/updates regulatory and accreditation policies and procedures in accordance with regulatory requirements including the notation of the checklist requirement for all Quality documents within the Document Control system.
  • Updates regulatory and accreditation policies and procedures in accordance with regulatory requirements, including the notation of the checklist requirement.
  • Aids federal and state regulatory agencies to related queries regarding licensure and accreditation.
  • Suggests changes in working conditions and develops and establishes measures to improve efficiency and performance of the laboratory; strives to make the laboratory a model of efficiency, quality, safety, and service.
  • Assists in root cause analysis and implementation of correction, corrective and preventative actions and verification of effectiveness of actions as periodically required in the identification and resolution of issues.
  • May be involved in coordination and leading of off-site accreditation inspections as required by the terms of conditions.
  • May provide guidance for licensure and regulatory compliance.
  • May coordinate and manage off-site inspections and assist the on-site teams of inspectors.
  • May assist in special projects, including site implementations, and activities as required.
  • Travel periodically (up to 15%) of the time.
  • Other duties as required.

Qualifications

Basic Qualifications

  • Associate degree in science or related field and 5+ years of experience in the clinical laboratory or healthcare industry; OR
  • 12+ years of experience in a clinical laboratory
  • Knowledge of operational workflows for the laboratory and how those workflows apply to lab systems
  • Knowledge of relevant compliance and regulatory requirements related to Laboratory Information Systems
  • Knowledge of common healthcare integration methods and reference lab interfaces

Preferred Qualifications

  • Advanced Degree in the Sciences, Engineering or Business or a related field
  • ASCP or MT(AMT) Certification
  • ASQ Certification
  • Experience supporting a CLIA, QC and device laboratory
  • Experience with next generation sequencing methodology
  • Demonstrated capacity to work in a fast-paced environment with strong attention to detail
  • Working knowledge of Next Generation Sequencing
  • Evidence of knowledge of molecular biology
  • Proficiency in Microsoft Office, Word, Excel, Project and PowerPoint
  • Familiarity with the College of American Pathologists (CAP) accreditation, CMS regulations, California, and NY DOH licensure requirements and compliance standards and practices
  • Strong skills in troubleshooting and problem solving
  • Excellent communication skills and proven ability to work effectively as a member of a multidisciplinary team
  • Understanding of HIPAA and the importance of patient data privacy
  • Commitment to FMI’s values: passion, patients, innovation and collaboration

#LI-Remote

 

Please be aware that Foundation Medicine mandates COVID-19 vaccination of all employees regardless of work location. Accommodations may be made in accordance with applicable law.

 

About Foundation Medicine

Foundation Medicine, Inc. (FMI) began with an idea—to simplify the complex nature of cancer genomics, bringing cutting-edge science and technology to everyday cancer care. Our approach generates insights that help doctors match patients to more treatment options and helps accelerate the development of new therapies. Foundation Medicine is the culmination of talented people coming together to realize an important vision, and the work we do every day impacts real lives.

Confidence, or the belief that we need to check every box before applying for a job, can sometimes hold us back from going after a role that inspires us. At Foundation Medicine there's no such thing as the 'perfect' applicant, and our company is a place where every employee can make an impact and continue to grow whatever background they may have or path they may have taken. So, as long as you meet the basic qualifications for a role, please apply if you see a position that would make you excited to come into Foundation Medicine every day and help us transform cancer care.

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