We have produced and maintained a number of procedures where specific methodologies are maintained to include the dedicated equipment and instrumentation utilized by LEGEND. SOPs are produced, updated, and/or maintained to include new equipment and instrumentation and to conform to all regulatory requirements. Existing SOPs are reviewed on an annual basis or as needed. The Quality Assurance Manager maintains all official copies and distributes copies to all applicable personnel.

To provide clients with the production of quality data, proper calibration and maintenance of all laboratory equipment and analytical instruments is incorporated into the daily process. LEGEND has implemented a preventative maintenance program to ensure that routine maintenance procedures are performed to prevent failure of instrumentation during use. The continual calibration process assures that equipment and instruments are within prescribed accuracy and precision limits. Utilizing manufacturers guidelines along with regulatory stipulations, analysts perform and document calibration and maintenance activities on all appropriate equipment and instruments.

One of LEGEND’s quality control mechanisms is a validation and review process based on acceptance/rejection criteria. This process involves critical review of the data searching for the questionable values relative to the measuring tools available along with an evaluation of the quality control information relative to the sample data.

Training is an integral part of the QAP in the operation of an analytical laboratory. It is vital to ensure that all employees are knowledgeable in their areas of responsibility on a continuing basis. To accomplish this goal, the laboratory has a formal training program that covers all aspects of LEGEND’s operations, with strong emphasis on quality assurance, safety, and analytical procedures.

In addition to external audits conducted by regulatory agencies and clients, the QAP sets forth steps, procedures, and documentation for insuring the quality of analytical data. The system uses an Internal Audit Program, where the QA Manager performs periodic audits of records. Internal auditing procedures exist to identify areas of improvement in the QAP for continuous improvements.

In order to validate the performance of an analytical laboratory, an ongoing program of blind performance evaluation (PE) samples are prescribed. The external PE sample program involves the analysis of blind samples to assess the continuing capability of each parameter for which samples are available. The blind samples are processed as a routine sample.

LEGEND participates in the CDC ELITE Legionella PT program which is conducted by the Wisconsin State Laboratory of Hygiene University.