"Congress passed the Clinical Laboratory Improvement Amendments (CLIA) in 1988 establishing quality standards for all laboratories testing to ensure the accuracy, reliability, and timeliness of patient test results, regardless of where the test was performed. The CLIA regulations are based on the complexity of the test method; thus, the more complicated the test, the more stringent the requirements." The standards are focused on four areas: the qualifications of the lab director; physical facilities and safety; quality control and performance improvement; and inspection. ("Clinical Laboratories." Centers for Medicare & Medicaid Services. Accessed May 9, 2018). See also CLIA.
Laboratory Standards and Accreditation
"A legally enforceable claim on the assets of a business or property of an individual. In business, liability results from a breach of duty or obligation by act or failure to act." (Legal Information Institute. Cornell Law School. Accessed May 9, 2018). For the purposes of the LawSeqSM project, liability "includes tort and contract exposure of clinicians, laboratory personnel, and their institutions and describes the standard of care while protecting innovation in sequencing. Liability also applies to return of results and incidental findings, including duty to hunt, duty to return, and duty to warn." (LawSeqSM Methodology. Accessed May 9, 2018).