Precision Compliance Infrastructure for High-Complexity Clinical Laboratories
Prescher Consulting Inc. provides specialized consulting support for high-complexity clinical laboratories with focus in molecular diagnostics, validation oversight, regulatory compliance systems, inspection readiness, and operational laboratory infrastructure.Services are designed for startup laboratories, expanding laboratories, ownership transitions, corrective action support, and laboratories requiring operational or regulatory guidance.Experience includes support of multiple high-complexity laboratories across California, Florida, and Texas in molecular, toxicology, chemistry, hematology, serology, immunology, and NGS environments.
Core Services
High-Complexity Laboratory Startup Support
Validation Planning & Oversight
Multiplex RT-PCR LDT Validations
SOP & Compliance Infrastructure
Inspection Readiness, Mock Inspections & Inspection Support
CLIA/COLA/CAP Compliance Support
Corrective Action & Deficiency Response Support
Personnel Competency Programs
QA/QC Systems & IQCP Development
Remote Compliance Oversight
Inspection-Tested Validation & Compliance Experience
Validation systems, SOP infrastructure, and compliance programs developed through Prescher Consulting have supported successful completion of 12+ CLIA, COLA, and state inspection/accreditation events across California, Florida, and Texas high-complexity laboratory environments.Experience includes support of 15+ high-complexity laboratories across molecular, toxicology, chemistry, hematology, serology, immunology, and NGS environments.Prescher Consulting Inc. provides specialized consulting support for:
High-complexity laboratory startup support
Multiplex RT-PCR laboratory-developed test (LDT) validations
SOP and quality systems development
QA/QC systems including IQCP development
CLIA/COLA/CAP inspection readiness and inspection support
Corrective action planning and regulatory response support
Personnel competency and workflow implementation
Remote compliance oversight
Education & Technical Background:
Clinical Genetics & Molecular Biology Scientist (CGMBS) Graduate Program (California State University, Los Angeles)
B.S. Biology, Cellular & Molecular Sciences (University of La Verne)
Consulting Packages
Laboratory Startup Package
Support for new and expanding high-complexity laboratories including compliance infrastructure, SOP systems, workflow planning, quality systems, and operational readiness.Includes:
SOP infrastructure
QA/QC systems
IQCP development
PT workflows
competency systems
startup compliance guidance
Inspection Readiness Package
Preparation and support for CLIA, COLA, CAP, and state inspections.Includes:
Mock inspections
Documentation review
Deficiency identification
Corrective action planning
Inspection support
Validation Package
Validation planning, oversight, and documentation support for high-complexity laboratory assays including multiplex RT-PCR LDTs.Includes:
Validation planning
Validation review
Data analysis
Summary documentation
Regulatory documentation support
Inspection-defensible validation Infrastructure
Compliance Remediation & Corrective Action Support
Support for laboratories requiring operational remediation, corrective action planning, documentation restructuring, or regulatory response support.
Remote Compliance Oversight
Ongoing consulting support for laboratories requiring periodic compliance review, validation oversight, documentation review, or inspection guidance.
Contact
To request deliverables, pricing information, or custom consulting packages, please submit the inquiry form below.