Laboratory Information System Specialist, Full Time

The Laboratory Information System (LIS) Specialist is responsible for the configuration, maintenance, validation, security, and ongoing support of the laboratory information system and its interfaces within a CLIA-certified clinical laboratory. The LIS Specialist ensures that the LIS accurately captures, processes, stores, and transmits patient and quality control data in full compliance with the Clinical Laboratory Improvement Amendments (CLIA, 42 CFR Part 493), applicable accreditation standards (e.g., CAP, The Joint Commission, COLA), and HIPAA requirements for privacy and security of protected health information.

Essential Functions

System Administration and Configuration

• Build, configure, and maintain the LIS, including test definitions (orderables/resultables), specimen types, reference (normal) ranges, critical/panic values, units of measure, calculations, and result-reporting rules.
• Specialist user accounts, roles, and security profiles based on the principle of least privilege; manage password policies, access reviews, and timely deactivation of separated users.
• Maintain master files, dictionaries, and code tables (example: Beaker, Soft Bank, etc.) and ensure consistent mapping across instruments, the LIS, and downstream systems.
• Plan, test, and deploy LIS software upgrades, patches, and hotfixes in coordination with the vendor and IT, minimizing disruption to laboratory operations.

Interfaces and Connectivity

• Build, validate, and monitor instrument interfaces, middleware, and HL7/ASTM interfaces to the EHR/HIS, reference labs, and other downstream systems.
• Troubleshoot interface errors, message queues, and connectivity failures; perform root-cause analysis and corrective action to restore data flow.
• Coordinate auto-verification rules and delta checks with technical supervisors to ensure clinically appropriate, validated automatic result release.

CLIA and Regulatory Compliance

• Validation: Conduct and document validation and verification of LIS builds, interfaces, calculations, reference ranges, and auto-verification logic before implementation in the production (live) environment, in accordance with CLIA and CAP requirements.
• Audit trails and data integrity: Ensure the LIS maintains complete, tamper-evident audit trails for result entry, modification, and release, and that historical and revised results are retained per CLIA record-retention requirements (test records retained a minimum of two years; longer for certain specialties).
• Result reporting: Confirm that patient reports contain all CLIA-required elements, including reference intervals, units, specimen source, conditions/disclaimers, and identification of the performing laboratory for referred (send-out) testing.
• Quality control and PT: Support configuration of QC rules, calibration tracking, and proficiency testing handling so that PT samples are treated like patient samples and are not improperly referred or shared.
• LDTs and analytic changes: Coordinate with the Technical Supervisor, Laboratory Manager and Laboratory Director when system changes affect analytic performance, ensuring revalidation as required.
• Inspection readiness: Maintain document control, change logs, and validation records to support CLIA surveys and inspections; respond to inspector and assessor requests for LIS evidence.

Data Security and Privacy (HIPAA)

• Implement and maintain access controls, audit logging, and data-integrity safeguards consistent with the HIPAA Security Rule and organizational policy.
• Participate in risk assessments, downtime/contingency planning, and disaster-recovery testing for the LIS to ensure continuity of laboratory reporting.
• Ensure protected health information (PHI) is appropriately safeguarded in test, training, and production environments.

Validation, Change Control, and Documentation

• Maintain a formal change-control process: document requested changes, testing, approvals, and go-live for all production modifications.
• Author and maintain standard operating procedures (SOPs), build documents, validation plans/reports, and end-user job aids.
• Review and sign off on validation documentation in coordination with the Laboratory Director or designee.

Support, Training, and Continuous Improvement

• Provide tier-1/tier-2 support to laboratory staff for LIS issues; manage the LIS portion of the IT ticket queue and escalate to vendors as needed.
• Train laboratory and phlebotomy staff on LIS workflows, new functionality, and downtime procedures.
• Monitor system performance, generate operational and turnaround-time reports, and recommend workflow and configuration improvements.
• Participate in laboratory and IT projects, instrument implementations, and new-test go-lives.

• Three or more years of experience in a CLIA-certified clinical laboratory, with hands-on LIS build, validation, or administration experience.
• Demonstrated experience with at least one major LIS platform (e.g., Epic Beaker, Cerner/Oracle Health, Sunquest, SCC SoftLab, Orchard, MEDITECH).
• Experience with HL7/ASTM interfacing, middleware, and instrument connectivity.

Skills/Competencies

• Working knowledge of CLIA regulations (42 CFR Part 493), CAP accreditation requirements, and HIPAA privacy/security rules.
• Understanding of laboratory workflows across pre-analytic, analytic, and post-analytic phases.
• Strong analytical and troubleshooting skills, with meticulous attention to data integrity and documentation.
• Effective communication and the ability to collaborate across laboratory, IT, and clinical teams.
• Ability to manage multiple priorities and respond to time-sensitive system issues affecting patient reporting., * Bachelor's degree in Medical Laboratory Science, Clinical Laboratory Science, Health Informatics, Information Systems, or a related field; equivalent experience may be considered., * MLS(ASCP), MT(ASCP), or equivalent within 12-months of hire date.
• LIS/informatics certification (e.g., ASCP qualification in Laboratory Informatics, CAHIMS, or vendor certification).
• Familiarity with CLIA personnel requirements under 42 CFR 493 Subpart MASCP preferred

Cameron Health is a 25-bed, independent, not-for-profit facility that proudly serves Angola and Steuben County. We've been a cornerstone of this community and the surrounding area in northeast Indiana dating back to 1926. Over the years, we've helped generation after generation of area residents enjoy better health and live comfortably. Today, Cameron Hospital has grown into something more than a simple community hospital. Filled with advanced equipment and skilled specialists, Cameron is a modern, high-tech facility that provides advanced diagnostics, a variety of specialties and cutting-edge treatment options that are combined with highly personalized and compassionate care.