van Wijk Consulting LLC

We provide Clinical Diagnostics, Laboratory and Medical/Regulatory Affairs Consulting, CLIA Laboratory Directorship for Moderate- and High-Complexity Laboratories, and Medical Writing Services. This includes laboratory start-up consulting; draft and review of policies, logs, and standard operating procedures; help with the CLIA certification process; CLIA/COLA/CAP/FDA regulatory compliance; mock inspections; technical supervisor and clinical consultant services; validation planning and review (LDTs and FDA-cleared/approved); LDT development/validation/compliance; and quality control/quality assessment draft and review. With a wealth of experience in high complexity clinical diagnostic laboratory services, the owner and Principal consultant, Dr. van Wijk is passionate about improving healthcare through innovative solutions. He is board-certified by the American Board of Clinical Chemistry, and by the American Society of Clinical Pathology Board of Certification. His diverse expertise stems from serving as Senior Medical Director at Beckman Coulter Diagnostics where he supported medical strategy, innovation, and new product development & launch, and Assistant Professor of Pathology at the University of Chicago where he oversaw the Clinical Chemistry, Mass Spectrometry, Blood Gas, and Pharmacogenomics Laboratories as an attending clinical chemist. Dr. van Wijk is well-versed in working in regulated environments (CLIA/CAP/COLA, FDA) and has validated numerous laboratory-developed tests in for example molecular diagnostics and mass spectrometry. He has functioned as a high-complexity CLIA laboratory director, technical supervisor and/or clinical consultant for a variety of clinical laboratories. He holds multiple board and leadership positions (e.g., ADLM, CLSI) and has a strong track record of scientific contributions. He has received several recent major national awards & recognitions, including the prestigious ADLM Academy George Grannis Award.