Auditing, Assessment and Consultation

About Auditing, Assessment and Consultation

Get an objective, structured view of performance, efficiency, and compliance across your laboratory and clinical operations. The coLABorative conducts assessments that look beyond checklists to identify what is working, what is introducing risk, and what will drive measurable improvement.

Audits can include review of lab workflows, clinical integration, physical plant efficiency, and operational practices that affect consistency and outcomes. We can also evaluate financial and operational efficiency by reviewing pricing models, vendor contracts, equipment ROI, staffing schedules, and other cost drivers that quietly erode margin or reliability.

For compliance-focused needs, we support inspection preparation, simulated audits, targeted gap analyses, and protocol customization so your team is better prepared and less reactive when audits occur.

What this can cover

  • Operational performance and workflow assessments
  • Clinical-lab integration review
  • Physical plant and efficiency review
  • Financial efficiency audits (contracts, ROI, staffing models)
  • Inspection preparation, mock audits, and protocol updates

The CoLABorative management team includes Dara Berger, PhD, MPH, MS; Charlene Alouf, PhD, HCLD, TS; Gerry Celia, MBA, PhD, HCLD, CC; and Liesl Nel-Themaat, PhD, HCLD, MBA.

Frequently Asked Questions

The coLABorative is a consulting and management company specializing in reproductive laboratory services. We provide comprehensive solutions for in vitro fertilization (IVF) programs, including laboratory design, construction, staffing, accreditation, and ongoing management services.

Our team brings over 60 years of combined experience in assisted reproductive
medicine. Each of our four partners holds a PhD, High Complexity Laboratory Director
(HCLD) certification, and three hold MBAs. We offer a unique multi-tiered service model
that allows us to support you at any stage from initial consultation to complete
laboratory ownership and management.

We work with independent reproductive endocrinologists and physician groups who
want to develop or enhance their laboratory capabilities. Our clients range from
established practices seeking modernization to physicians starting new IVF programs.

We provide a complete spectrum of laboratory solutions:

  •  Laboratory Audits: Comprehensive evaluations for quality assurance, regulatory compliance, or investor due diligence
  •  Design & Build Services: Custom laboratory design, equipment selection, and construction oversight
  • Accreditation Support: Guidance through regulatory requirements and accreditation processes
  •  Staffing Solutions: Recruitment assistance, training programs, and temporary staffing
  • Project Management: Turn-key operations for new laboratory development
  • Laboratory Management: Full-service ongoing management of laboratory operations
  • Consulting Services: Strategic planning, process optimization, and best practice implementation

No. We work with laboratories at all stages—from greenfield projects to established
facilities seeking modernization, expansion, or improved operational efficiency.

Absolutely. Our team has extensive experience navigating regulatory requirements and
securing accreditation from bodies such as the College of American Pathologists (CAP),
The Joint Commission, and state-specific licensing agencies.

Absolutely. Our team has extensive experience navigating regulatory requirements and
securing accreditation from bodies such as the College of American Pathologists (CAP),
The Joint Commission, and state-specific licensing agencies.

Our Team

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