Regulation of Laboratory Genetic Testing

Laboratory regulations provide rules to establish consistency and to evaluate performance. They also set out the qualifications and experience needed for laboratory staff to fulfill regulatory requirements and meet professional standards. Clinical genetic counselors play a significant role in determining which tests to offer patients, which laboratories to consider for testing, and which phenotypic information to provide to the clinical laboratory to improve the interpretation of test results. This chapter discusses laboratory regulations pertinent to the type of genetic testing offered and specimens received in the laboratory. The goal is to help the laboratory genetic counselor understand the regulatory oversight of genetic testing and the quality management of clinical laboratory operations.