Laboratory Accreditation Services in Collaboration with Labsci - Oranldo, USA
LabSci Associates have over thirty year’s experience as state and federal laboratory examiners and investigators, and are available to help you prepare for an upcoming inspection, and help with developing a POC (Plan of Correction) that will be acceptable to the inspecting agency, whether it is a state or federal agency or the CAP. Having inspected and approved plans of correction for over a thousand laboratories as government regulatory authorities, we know from experience what policies, procedures, and practices inspectors want to see in place in your lab, and we can help you develop systems that will meet with regulatory requirements.
We offer regulatory compliance consulting to the U.S. and International laboratory communities in the areas of
- CAP standards, including development of policies and procedures, pre- survey inspections, and post-survey remedial actions.
- ISO 15189 including preparation for inspections and remedial action post inspection, and in the design and implementation of effective Quality Assurance (QA) policies, procedures and processes.
- On-site assistance to laboratories undergoing ISO/CAP inspections or examinations.
We also also provide technical consultation in the areas of
- Pre-analytical, analytical, and post-analytical processes, policies, procedures, to ensure compliance with regulatory requirements prior to inspection
- Detailed review of analytical methods, validation, AMR, quality control and quality assurance processes and data prior to inspection
- Development of remedial action plans for any deficiencies identified during inspection
While it is rare for a laboratory to undergo an inspection by government regulators without any deficiencies identified, we can help your lab to minimize the deficiencies cited, and can assist with a timely and thorough plan of correction.
Don’t hesitate to contact us for a free consultation at email@example.com
About Our Inspectors
CLS, JD, CHC: President and Chief Executive Officer
Thomas has been a California licensed Clinical Laboratory Scientist for over 30 years, and retired as the Program Manager of the Clinical Laboratory Complaints and Regulatory Compliance Program at the California Department of Public Health. He has extensive background in clinical laboratory regulation and inspections of clinical laboratories, tissue banks, IVF labs, stem cell and bone marrow transplant labs. He was a commissioned officer of the U.S. Food and Drug Administration for ten years, and is nationally Certified in Healthcare Compliance. He currently resides in Orlando, Florida, where he does consulting and writes books and articles on clinical laboratory compliance and regulatory affairs. He is available nation-wide to advise attorneys (both plaintiff and defendant) on legal and technical issues involved in litigation involving laboratories directly, and where laboratory testing may have bearing on a claim for negligence or a defense to negligence. He is also available to advise attorneys on applicable state and federal laws and technical standards of practice when developing a cause of action or a defense, or determining if laws or standards were adhered to in a laboratory’s technical operations.
Victoria Shahrzad Radahd
CLS, MSc, PhD: Vice President and Chief Financial Officer
Shahrzad has more than 30 years experience in the clinical laboratory field. She retired from the California Department of Public Health in 2009, after spending 15 years as a federal (CLIA) and California state clinical laboratory inspector and manger of the CLS Continuing Education and Medical Laboratory Technician programs. She has traveled world-wide as a clinical laboratory consultant and speaker, and spent a year as Lab Specialist consultant for “Doctors Without Borders”, setting up an HIV testing laboratory for the Nigerian Ministry of Health’s “Comprehensive HIV Program” in Lagos. While she was the manager of the Quality Improvement and Quality Control Programs at Berkeley HeartLab, Inc., a subsidiary of Celera Genomics/Quest Diagnostics, she led CAP inspection teams in performing laboratory inspections under the CAP Laboratory Evaluation Program.