Laboratory Director

Integrity Care Group•Carrollton, TX

About The Position

The Laboratory Director is responsible for complete operational, technical, financial, regulatory, and administrative leadership of the organization’s stand-alone clinical laboratory. The role has end-to-end accountability for operating a safe, compliant, efficient, financially responsible, high-performing laboratory and owns the full lifecycle of laboratory services, including test menu strategy, specimen management, testing operations, quality systems, regulatory compliance, staffing, equipment and instrumentation, laboratory information systems, supply chain, vendor management, budgeting, revenue cycle, customer service, performance improvement, and growth. The Laboratory Director works closely with the Laboratory Medical Director, clinical leadership, Compliance, Finance, Revenue Cycle, IT, Human Resources, Operations, and other organizational leaders to ensure laboratory services meet clinical needs and maintain high standards of quality, compliance, patient safety, service, and financial stewardship. This is a hands-on leadership position with complete ownership of the stand-alone laboratory operation, from specimen collection and accessioning through final results, billing, quality oversight, vendor management, financial performance, and continuous improvement. The position requires active management across bench operations, people, processes, systems, compliance, clinical partnerships, financials, and executive-level strategy.

Requirements

Bachelor's degree in Medical Laboratory Science, Clinical Laboratory Science, Medical Technology, biological science, chemical science, or another field meeting applicable regulatory requirements.
Significant progressive leadership experience in clinical laboratory operations, preferably including high-complexity testing.
Demonstrated experience with laboratory regulatory compliance, quality systems, personnel management, instrumentation, testing operations, and financial management.
Working knowledge of CLIA requirements and other regulations applicable to clinical laboratory operations.
Demonstrated ability to lead the full operational and administrative functions of a clinical laboratory.

Nice To Haves

Master's degree in healthcare administration, business administration, laboratory science, or a related field.
MLS(ASCP), MT(ASCP), DLM(ASCP), or other applicable laboratory certification.
Experience leading a stand-alone or independent clinical laboratory.
Experience with CAP or other laboratory accreditation programs.
Experience developing or expanding laboratory services, including implementation of new instrumentation and testing.
Experience with laboratory information systems, instrument interfaces, and electronic health record integrations.
Experience with laboratory revenue cycle, reimbursement, budgeting, and financial analysis.

Responsibilities

Assume end-to-end responsibility for laboratory operations, functions, workflows, and performance, including oversight across shifts and applicable testing disciplines.
Establish operational standards, workflows, policies, procedures, performance expectations, escalation procedures, and business continuity plans.
Oversee the full specimen lifecycle, from ordering and collection through accessioning, processing, testing, reporting, storage, and disposal; monitor specimen integrity, rejection, transportation, and chain of custody as applicable.
Monitor laboratory volume, capacity, productivity, turnaround time, quality, staffing, utilization, and service levels.
Maintain readiness for applicable federal, state, and accreditation requirements, including CLIA; maintain licenses, certifications, permits, registrations, and accreditation documentation.
Partner with the Laboratory Medical Director and Compliance leadership on oversight of high- and moderate-complexity testing; lead inspection preparation and remediation of deficiencies, audit findings, quality events, and compliance risks.
Ensure laboratory policies and practices meet applicable OSHA, HIPAA, infection prevention, safety, biohazard, and record-retention requirements, and implement changes in response to regulatory updates.
Develop and maintain the laboratory Quality Management System, quality assurance and quality control programs, proficiency testing processes, quality indicators, and corrective and preventive actions.
Lead root-cause analysis of significant quality events and ensure critical results and other clinically significant findings are communicated and documented appropriately.
Ensure testing methodologies are validated or verified and maintained appropriately; oversee technical operations, calibration, quality control, instrument maintenance, troubleshooting, and documentation.
Evaluate testing methodologies and oversee implementation of new assays, platforms, instrumentation, and services; partner with the Laboratory Medical Director on test performance, clinical quality, reference ranges, policies, procedure approvals, and utilization.
Lead laboratory managers, supervisors, technologists, technicians, processors, phlebotomy personnel, and other staff as applicable; determine staffing models and oversee recruitment, onboarding, training, scheduling, retention, and development.
Ensure employee education, certification, experience, training, competency, and performance requirements are met; provide coaching, feedback, recognition, accountability, and succession planning, and address conduct or performance issues with Human Resources.
Develop and manage annual operating and capital budgets; monitor financial performance and budget variances; evaluate labor, supplies, reagents, equipment, reference testing, maintenance, courier costs, productivity, testing costs, and other cost drivers.
Develop business cases and ROI analyses for investments and service expansion; identify cost reductions without compromising quality, safety, compliance, or service.
Partner with Revenue Cycle and Finance to monitor reimbursement, payer requirements, denials, medical necessity, coding, billing, documentation, and other revenue-cycle issues; assess test economics and opportunities to bring testing in-house appropriately.
Maintain oversight of laboratory equipment and facilities, including preventive maintenance, calibration, troubleshooting, replacement, lifecycle planning, instrument selection, workflow, safety, security, temperature control, storage, and infection prevention.
Manage inventory controls, par levels, expiration monitoring, lot management, and stockout and waste prevention; manage vendor relationships and participate in contract evaluation and negotiation.
Own laboratory information system workflows and technology operations; partner with IT and vendors on configuration, interfaces, connectivity, result transmission, downtime procedures, cybersecurity, data integrity, validation, and system upgrades.
Develop and maintain laboratory performance dashboards and key performance indicators; identify performance gaps and implement measurable improvement plans using Lean, process improvement, and root-cause analysis methods.
Present laboratory performance, risks, priorities, and recommendations to executive leadership; establish service expectations and resolve concerns with physicians, advanced practice providers, clinical teams, operations leaders, and other laboratory customers.
Lead laboratory expansion, new-service implementation, technology initiatives, and other strategic projects as assigned; remain knowledgeable about emerging technology, regulation, reimbursement, workforce issues, and industry practices.