Clinical laboratory services, software, and professional oversight—built from real lab operations.
Envision Pathology, LLC is an operating CLIA-certified laboratory providing diagnostic services while licensing production-grade LIMS and Quality Management software and delivering laboratory medical directorship, consulting, and compliance services to client laboratories.
We help client laboratories streamline quality management, compliance, workflow, and resulting of test samples with systems and services designed to stand up to inspection.
- Operating laboratory perspective — processes proven in daily production use
- LIMS for accessioning, workflow, and resulting
- Laboratory QA for logs, competency, incidents, CAP-style quality workflows
- Professional services — consulting, implementation, inspection readiness
- Medical directorship staffing aligned to CLIA Subpart M
Technology operated in our lab, delivered to yours
Envision Pathology runs the same platforms we provide to client laboratories—so improvements are driven by real-world workflow and regulatory requirements.
NeoLimsys LIMS — accessioning, workflow, resulting
A production LIMS supporting sample intake, test ordering, audit trails, structured resulting, and operational dashboards.
Laboratory QA — quality, competency, compliance documentation
Web-based quality management designed for inspection-ready documentation: temperature and maintenance logs, competency records, incidents, corrective actions, and attestations.
Laboratory consulting, management & directorship services
We provide hands-on leadership and documentation systems to help laboratories operate efficiently, remain compliant, and deliver reliable results.
Laboratory consulting
Operational assessments, workflow redesign, SOP/program development, inspection preparation, remediation, and ongoing compliance support.
Laboratory management services
Quality program deployment, training/competency structures, incident/CAPA processes, KPI reporting, and implementation governance.
Medical directorship staffing
Qualified oversight aligned to CLIA requirements for nonwaived testing—structured, documented, and designed to withstand inspection review.
CLIA Subpart M: personnel and director responsibilities
For nonwaived (moderate/high complexity) testing, CLIA requires qualified personnel and documented oversight. The following citations are commonly relied upon when defining director and oversight responsibilities. (Informational summary—your counsel/compliance team should review applicability to your laboratory.)
42 CFR §493.1403 — Laboratory Director Qualifications
Establishes education, training, and experience requirements for laboratory directors (and related pathways depending on testing complexity and credentials).
- Defines who may serve as a director for nonwaived testing.
- Used as the baseline when staffing director coverage for client laboratories.
42 CFR §493.1407 — Laboratory Director Responsibilities
Assigns the director overall responsibility for laboratory operation and administration, including ensuring qualified personnel, reliable testing processes, and regulatory compliance.
- Oversight of policies, quality systems, and corrective actions.
- Accountability for accurate and reliable results and compliance readiness.
42 CFR §493.1441 — Director, Moderate Complexity Laboratory
Details director responsibilities specific to moderate complexity testing environments (common in POLs and many routine clinical labs).
- Method selection/verification oversight and QC policy governance.
- Staffing and competency expectations appropriate to the menu.
42 CFR §493.1445 — Director, High Complexity Laboratory
Expands oversight requirements for high complexity testing, including broader quality and personnel responsibilities aligned to complex methodologies and risk.
- Ongoing performance monitoring, competency, and corrective action structure.
- Validation/verification governance and quality improvement expectations.
Talk to us
Tell us about your laboratory’s testing menu, current workflow, and compliance goals. We’ll recommend a plan that combines professional services with the right software components.