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Metabolic Solutions : Quality Assurance

Quality Assurance Program

The cornerstone of the quality assurance program at MSI is the training and expertise of the staff. Our long-standing team of laboratory professionals has unsurpassed laboratory experience that is applied to the operation of our facility every day. Our GLP protocols and facilities along with our status as a high complexity clinical laboratory (CLIA) demonstrate MSI's on-going commitment to quality. We continually strive to provide the best quality data in a timely and cost-effective manner.

Upon receipt of any analytical samples, laboratory personnel will receive, inspect and log those samples into our central computer system using a validated database. Any problems or discrepancies with the samples will be immediately documented and the customer contacted by the Study Director. All shipments are assigned a unique number ("job number") and each sample within that shipment will be identified and labeled with a unique MSI sample number. All pertinent information concerning that sample such as client name, sample name, collection date and time point are entered and permanently associated with the MSI sample number in the validated database.

Batch sheets are generated from the login procedure and verified versus the actual samples by Quality Assurance. The paperwork is forwarded to the Study Director who resolves any conflicts with the client and approves the job to be started. All analytical procedures are carried out using written, current and validated standard operating procedures. The samples are prepared and loaded onto the automated analytical instrumentation using the unique sample number as an identifier.

Each validated assay has specific standards and controls as well as other system suitability checks to assure that every analytical run is acceptable. When the analyst is satisfied, the data is entered into a validated spreadsheet software program and the appropriate validated calculations, as specified in the individual methods, are applied. The raw data, final data and calculations are forwarded along with the original investigator paperwork and receiving documents to the Director of Quality Assurance for final analytical review.

After acceptance by QA, the entire package is forwarded to the Study Director for a review of the data with regard to the individual study endpoints. When the Study Director is satisfied that the data meets the requirements of the study, the results will be forwarded to the client by whatever means specified in the protocol. All data is archived and stored in accordance with GLP standards.

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