Laboratory Quality and Systems Manager

Astrana Health, Inc.•Tustin, CA

7d•$145,000•Onsite

About The Position

The Laboratory Quality and Systems Manager is responsible for the design, implementation, and oversight of the clinical laboratory’s quality management program, Point-of-Care Testing (POCT) and laboratory information systems (LIS) for a 177-bed acute care hospital. This role ensures that laboratory services are accurate, timely, compliant, and efficiently integrated into hospital operations, in alignment with CLIA, The Joint Commission, and applicable state and federal regulations. The manager serves as a key link between the Laboratory Director, technical staff, hospital IT, Revenue Integrity/Charge Audit, and clinical departments (e.g., ED, inpatient units, respiratory, POCT) to optimize turnaround times (TAT), specimen quality, automation, and information flow across all phases of testing.

Requirements

Bachelor’s degree in Clinical/Medical Laboratory Science or related field required.
Current, valid Clinical Laboratory Scientist (CLS) license in the State of California required.
Minimum 3–5 years of experience in an acute care hospital clinical laboratory.
Demonstrated experience in quality management, SOP development, and participation in regulatory/accreditation surveys (The Joint Commission, CLIA, etc.).
Proficiency with LIS/HIS systems, analyzers, and middleware, including troubleshooting and validation activities.
Ability to analyze data and present findings in clear dashboards and reports to support operational decisions.
Excellent communication, organization, and problem-solving skills; able to lead cross-functional initiatives and manage multiple priorities.
Demonstrated ability to work collaboratively with diverse stakeholders (lab staff, physicians, nursing, IT, finance/revenue cycle).

Nice To Haves

Master’s degree in Healthcare Administration, Clinical Laboratory Science, or related field preferred (or in progress).
National certification (e.g., ASCP) strongly preferred.
Experience with LIS, instrument interfaces, and/or analytics tools; prior role as LIS super-user or quality lead strongly preferred.
Experience collaborating with IT, Revenue Integrity/Charge Audit, and/or POC programs is highly desirable.

Responsibilities

Lead and maintain the laboratory Quality Management Plan, in collaboration with the Laboratory Director and section leads/ supervisors.
Oversee the full lifecycle (creation, review, revision, and approval) of Standard Operating Procedures (SOPs) across all sections, including hematology, chemistry, urinalysis, coagulation, microbiology, immunohematology, specimen management, and general laboratory policies.
Validate new or revised tests and methodologies ensuring appropriate correlation studies, reportable ranges, reference intervals, and documentation.
Develop and revise quality and operational forms and logs to align with CLIA and hospital standards (e.g., downtime forms, blood bank work cards, temperature logs, emergency release forms, transfusion reaction investigation forms).
Monitor and analyze key quality indicators, including specimen rejection, redraws, add-on requests, and other pre-analytic/analytic/post-analytic issues; implement corrective and preventive actions (CAPA).
Support internal audits and external surveys (e.g., The Joint Commission, CLIA, state), including preparation, participation, and follow-up on any findings.
Perform Monthly QA in the Laboratory.
Serve as a primary operational lead and/or super-user for LIS and middleware, collaborating with IT and vendors to implement and optimize analyzer-to-host and host-to-HIS/LIS interfaces.
Coordinate, validate, and troubleshoot LIS changes related to test builds, CPT/LOINC code mapping, result comments, reflex rules, and automation of result reporting (including outreach and reference lab interfaces).
Work closely with IT to resolve interface issues, manage downtimes, and ensure accuracy and integrity of data flow between analyzers, LIS, HIS, and POC systems.
Design, maintain, and continuously improve quality and operations dashboards (e.g., TAT, specimen rejection, redraws, send-outs, QC failures) to provide actionable information for leadership and section supervisors.
Produce routine LIS–billing reconciliation reports that compare LIS orders/results to billed CPT/LOINC codes, identifying missed charges, mapping errors, and duplicate billing in coordination with Revenue Integrity/Charge Audit.
Plan and contribute to annual LIS and analytics strategic initiatives, including upgrades, new interfaces, and enhancements to reporting and automation.
Monitor and analyze daily TAT reports for ED and in-house patients; identify trends, bottlenecks, and improvement opportunities across shifts and testing areas.
Collaborate with ED, nursing, respiratory therapy, and laboratory staff to streamline workflows.
Oversee or support processes related to specimen management, including monitoring of pending tests (in-house and send-outs), specimen routing, and pre-analytic quality.
Develop and maintain forms and tools that improve laboratory communication and workflow (e.g., daily lab communication logs, reagent monitoring logs, send-out tracking).
Assist the Laboratory Director with staffing, scheduling, coaching, counseling, and management of staff.
Ensure laboratory policies, procedures, and practices are compliant with CLIA, The Joint Commission, and applicable state regulations.
Support and maintain documentation required for compliance, including maintenance logs (e.g., analyzers, microscopes, POCT devices), QC logs, and temperature logs for laboratory and blood bank equipment.
Oversee or coordinate monthly compilation of logs and ensure readiness for inspections and internal reviews.
Assist in risk assessments and IQCP (Individualized Quality Control Plan) documentation and updates to mitigate potential failures in testing processes.
In charge of the POCT program.
Collaborate with POC vendors and hospital IT to support seamless connectivity, on-boarding of new meters/devices, and system migrations (e.g., user migration between EHR platforms or POC management systems).
Monitor POC connectivity, QC compliance, operator lockouts, and result transmission rates via POC dashboards, ensuring results are accurately and promptly integrated into LIS/HIS.
Support POC SOP review, competency tracking, and access control in collaboration with nursing/respiratory leadership and POCT staff.
Provide training and orientation to new hires and existing staff on SOP changes, LIS workflows, downtime procedures, and quality documentation.
Develop concise education and analytics training modules, tip sheets, and guides to help supervisors and leads interpret dashboards, generate reports, and use data for staffing and workflow decisions.
Maintain effective communication with interdepartmental partners (ED, nursing, respiratory, Revenue Integrity, IT, reference laboratories) to align lab operations with clinical and business needs.
Participate in relevant hospital committees and quality initiatives as assigned (e.g., quality council, POC, transfusion, or data analytics workgroups).