Laboratory consulting, management, and medical directorship—delivered by an operating CLIA laboratory.
Envision Pathology partners with physician office labs, independent labs, and specialty practices to strengthen quality systems, streamline workflow, and support compliant operations across the testing lifecycle—from accessioning to resulting.
Services can be scoped as a one-time engagement, inspection-readiness sprint, or ongoing monthly support.
- Inspection-ready documentation and quality program structure
- Clear SOPs, training, and competency programs tied to your testing menu
- Improved turnaround time, fewer reworks, and better audit trails
- Systems that unify workflow: accessioning → testing → resulting → reporting
- Director oversight aligned to CLIA Subpart M where applicable
Service offerings
We combine operational expertise with software deployment to reduce friction, raise consistency, and support compliance.
Laboratory consulting
- CLIA readiness assessments and gap analysis
- SOP, policy, and quality program development
- Corrective action plans and documentation remediation
- Workflow mapping and efficiency improvements
Laboratory management services
- Quality program implementation and governance
- Competency, training, and attestation systems
- Incident reporting, CAPA, and trend review
- Operational KPI dashboards and recurring reviews
Medical directorship staffing
- Director coverage planning and documentation
- Oversight structure for nonwaived testing
- Quality review cadence and corrective action participation
- Support aligned to CLIA Subpart M requirements
Software services (LIMS + Laboratory QA)
- Implementation, onboarding, and configuration
- Role-based access, forms/logs, and workflow setup
- Data migration strategy and integration planning
- Audit trails, reporting templates, and training
Inspection readiness & remediation
- Mock inspections and document review
- Deficiency response planning and evidence organization
- Competency record repair and ongoing maintenance
- Quality meeting structure, minutes, and follow-through
Regulatory alignment (CLIA Subpart M)
When services involve director oversight for nonwaived testing, engagements are structured around CLIA personnel and director responsibility requirements in 42 CFR Part 493, including Subpart M. (Informational summary—your counsel/compliance team should confirm applicability.)
42 CFR §493.1403 — Director Qualifications
Defines eligibility pathways and qualifications for laboratory directors supporting nonwaived testing.
42 CFR §493.1407 — Director Responsibilities
Establishes the director’s overarching responsibility for laboratory operation, personnel, quality systems, and reliable results.
42 CFR §493.1441 — Moderate Complexity Director
Applies to moderate complexity settings and defines the scope of oversight responsibilities in those environments.
42 CFR §493.1445 — High Complexity Director
Defines expanded oversight responsibilities appropriate for high complexity testing systems and quality risk.
Contact
Email us to discuss your testing menu, current workflow, compliance goals, and whether you need software, consulting, medical directorship support—or a combined plan.