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
- CLIA compliance, including preparation for inspections and remedial action post inspection, and in the design and implementation of effective Quality Assurance (QA) policies, procedures and processes.
- State Laboratory laws, particularly California state statutes and regulations. We are available to consult on state lab laws in all 50 states
- CAP standards, including development of policies and procedures, pre- survey inspections, and post-survey remedial actions.
- FDA device and laboratory developed test (LDT) validation, and any other lab area in which a client/lab needs help.
- California tissue bank and blood bank laws,
- California stem cell and in-vitro fertility laboratory (IVF) laws
- On-site assistance to laboratories undergoing state and federal inspections or examinations, and civil and criminal investigations.
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 info@labsci.net or by telephone at +01.510.334.6241
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