Quality Assurance Prepared by: RVS Date Prepared: November 29, 2001 Code: MP-009 Reviewed by: KLS Revision #: 1.0 Date Revised: 0.0 Abstract: Quality Assurance procedures for the Heart, Lung, Blood, and Sleep Disorder Phenotyping Group at The Jackson Laboratory are an integral part of the overall sample and data management. The Phenotyping components in our laboratory include blood pressure, EKG, assessment of pulmonary function, hematology, blood chemistries, fibrinogen, prothrombin time (PT) and partial thrombin time (PTT), ultrasound imaging, bone mineral density, and additional parameters as developed by the program. Each of these procedures has specific Quality Control samples specific to the test. These are detailed in the Standard Operating Procedures for each of the Phenotypes. 1.0 Definitions: Quality assurance (QA) is a set of operating principles that, if strictly followed during sample collection and analysis, will produce data of known and defensible quality. (Standard Methods: section 1020A) 2.0 Components: The following elements of our Quality Assurance program are detailed in our Phenotyping Standard Operating Procedures (SOP). These SOPs are posted on the Heart, Lung and Blood web site at (http://pga.jax.org). 1. Certification of Operator Competence - Each operator is trained in the use of the equipment and/or protocol appropriate for the phenotype being tested. Operator training is documented and maintained by the Project Manager. 2. Standard Operating Procedures - Each phenotype being tested is documented for the appropriate sample collection and preservation, reagent preparation, equipment setup, calibration, quality control samples, data collection, and data reduction. These SOPs are reviewed by the Project Manager and by the Principle Investigator appropriate to that Phenotype. 3. Quarterly Control Animals - Each quarter, fifteen (15) male and fifteen (15) female C57BL/6J mice are analyzed through our standard protocol for all phenotypes. This data is reviewed by the Project Manager and the Principle Investigator. 4. Quality Control Charts - Each phenotyping test maintains quality control tables and/or charts for its control parameters. These include but are not limited to Calibration Check Standards, Reagent Blanks, and Duplicates. Each batch of samples contains one or more Quality Control samples that are charted and evaluated as part of the primary review process. Standards for the acceptance of data are included in the Control Charting Standard Operating Procedure. 5. Quality Audits - Quality Audits are conducted quarterly by the Project Manager and/or their designee. A written report is presented to the Principle Investigator detailing the review of the components of the Quality Assurance plan with proposed corrective actions when needed.