Will work on specific projects as available and as requested. Available for large projects and on a retainer for ongoing roles as well as for small projects. Please contact me at 720-440-1436 or firstname.lastname@example.org to discuss your project.
CONSULTING AREAS (List not exhaustive)
- Regulatory Applications & Ongoing Maintenance (CLIA, CAP, CDPH, RI, PA, MD, NY)
- New Lab Start Up
- Quality Program and Quality Management System Development, Implementation and Improvement
- Inspection Preparation and Deficiency Response (CLIA, CAP, CDPH, NY)
- Internal Audit Program Development & Assistance with Auditing
- Quality Management System Assessments & Action Plan Formulation
- ISO 15189 Accreditation Preparation & Ongoing Maintenance
- Culture of Quality Benchmarking
- Authoring Quality & Regulatory Compliance related policies and articles
- Presenting Quality & Regulatory Compliance related talks and training (in person & virtual)
- Compliance due diligence for potential buyers & investors
- Advisor on non-technical CLIA, CAP and state licensure requirements
Specific projects I can help with include (but are not limited to):
· Clinical laboratory due diligence for licensure, Quality Management System audit/evaluation and CLIA/CAP/State licensure compliance.
· CLIA initial certification and change paperwork (lab name/director/ownership change, test menu updates, etc)
· Clinical laboratory state license initial application, renewal and change paperwork (CA, RI, PA, MD, NY).
· CLIA/CDPH initial quality management system set up and inspection preparation.
· Serve as point of contact/liaison for regulatory communications and inspections (CLIA, CAP, state licensure) and other audits by external partners.
· CAP accreditation initial application and ongoing maintenance/changes.
· CAP accreditation initial inspection preparation: gap assessment, formulation of action plan and tracking of corrective actions.
· Lead, coordinate and submit CAP interim self-inspection
· Consulting for CLIA/CAP/states compliance for initial facility set-up
· Write quality manual and policies related to regulatory compliance, HIPAA and Quality Management System.
· Establish manual or electronic systems to comply with regulatory requirements (non-conforming events/issues, complaints, document control, change control, internal audits, etc)
· Participate in the selection of eQMS/compliance software
· Lead eQMS/compliance software implementation
· Review validations for regulatory compliance in collaboration with technical/scientific leadership
· Provide quality and/or regulatory training to staff on specific topics or overall onboarding training
· Write staff qualification checklists (Lab Director, Technical Supervisor, Clinical Consultant and General Supervisor) checklists to ensure compliance.
· Provide template/checklist for or set up employee personnel files with all CLIA/CAP required elements to ensure compliance.
· Write quality staff job descriptions. Participate in writing technical staff job descriptions.
· Perform and document internal audits as requested.
· Perform Quality Management System assessment and formulate action plan for improvement.
· Train, assist and coach existing lab quality management staff.
· Formulate regulatory strategies for new Laboratory Developed Tests (LDTs), including integrated diagnostic tests
· Participate in “sales pitch” meetings to present and explain laboratory’s QMS and compliance.
· Perform gap assessment and lead ISO 15189 implementation.
· Establish compliance committee policies and agenda template. Participate in meetings as requested.
· Assist with proficiency testing and competency assessment program implementation.
· Establish management review program for compliance and effective laboratory management, including establishment of policy, metrics, committees, thresholds and reports.
· Evaluate required retention times and establish laboratory policy.
· Provide guidance, assistance and/or leadership in any non-technical area related to laboratory quality and/or regulatory compliance.