Quality Assurance / Quality Control

Quality Assurance / Quality Control

All samples in the CTRL are initially inspected by a board certified pathologist, typically Dr. Mackinnon or another member of the Department of Pathology at MCW. This is the initial step in the CTRL’s quality assurance (QA) program. Depending upon the downstream application, the sample is further analyzed and specific areas of the specimen are identified and labeled as needed. For example, if an investigator requires microdissection of tumor-rich areas of a specimen, the samples is examined by a board certified pathologist, and appropriate, tumor-rich regions of the specimen are identified and marked. These areas are then isolated either manually or with the assistance of a specialized microscope equipped to perform laser capture microscopy. All samples are subsequently analyzed to ensure that the designated region of interest was in fact isolated.

All samples are accessioned, processed, analyzed, and stored in accordance with conventional laboratory procedures as put forth by the Clinical Laboratory Improvement Amendment (CLIA) of 1988. [The CTRL will initially obtain a CLIA Certificate of Registration, which enables the CTRL to conduct moderate and/or high complexity laboratory testing until it acquires a CLIA Certificate of Accreditation]. Specimens are analyzed and interpreted by Dr. Mackinnon and/or other members of the Department of Pathology.