Quality Assurance

The cornerstone of the quality assurance (QA) program at Metabolic Solutions is the training and expertise of the staff. Every step in the process is optimized to provide the best quality data in a timely and cost-effective manner. Our protocols and facilities, along with our status as a high complexity clinical laboratory (CLIA), demonstrate MSI’s on-going commitment to quality. No data will leave our laboratory without independent approval of both the Director of QA and the Study Director.

Sample Control: Unique numbering and database assignment

Upon receipt of samples, laboratory personnel will receive, inspect and log those samples into our central computer system. 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, principal investigator, receipt date, sample number and stable isotope analysis is entered and permanently associated with the MSI job number in our central database.

Process Control: Validated processes lead to reliable results

All analytical procedures are carried out using written, current and approved standard operating procedures. The samples are prepared and loaded onto the automated analytical instrumentation using the unique sample number as an identifier.

Each MSI assay has specific standards and controls as well as other system suitability checks to assure that the stable isotope analysis is accurate. Note: if the stable isotope analysis you are interested in is not on the list, other assays are available from MSI contact us.  When the analyst is satisfied, the data is entered into a spreadsheet and appropriate calculations, as specified in the individual methods, are applied.

Data Control: Checks on every step optimize the data

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. Each sample is checked for its identifier, each process is checked for appropriateness and acceptability according to the written criteria and each data point is checked for entry accuracy.

Final Review:

After acceptance by QA, the entire package is forwarded to the Study Director for a review of the stable isotope analysis 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 written protocols.

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