Sections
22 entriesSection 1200Requires every provision of the chapter to be liberally construed to protect the interests of all persons affected. The rule directs how…Section 1201Defines “person” for purposes of the chapter to include a firm, association, partnership, individual, limited liability company, and corporation. The definition expressly…Section 1202Defines “department” for purposes of the chapter as the State Department of Public Health. The definition identifies the agency referred to by…Section 1202.5Defines “CLIA” as the federal Clinical Laboratory Improvement Amendments of 1988 and specified implementing regulations effective January 1, 1994, or a later…Section 1203Defines “clinical laboratory bioanalyst” or “bioanalyst” as a person licensed to engage in clinical laboratory practice and direct a clinical laboratory. Allows…Section 1204Defines “clinical laboratory scientist” as a licensed person, other than a bioanalyst or trainee, who practices under a laboratory director except when…Section 1205Defines “trainee” as a person licensed to receive practical experience and instruction in clinical laboratory procedures or sciences under direct, responsible supervision…Section 1206Defines key clinical-laboratory terms for the chapter, including analyte, biological specimen, clinical laboratory, clinical laboratory science, direct supervision, licensed and registered laboratories,…Section 1206.5Limits performance of waived and moderate-complexity clinical laboratory tests to listed qualified personnel working under the laboratory director’s overall operation and administration,…Section 1206.6Exempts a community-pharmacy pharmacist from the referenced restriction when, at a customer’s request, performing only waived over-the-counter blood glucose, hemoglobin A1c, or…Section 1206.7Allows a person who satisfies federal CLIA requirements for high-complexity testing to analyze samples for SARS-CoV-2 in a clinical laboratory notwithstanding the…Section 1207Defines several limited clinical-laboratory director license categories and confines each to specified specialties or subspecialties. Qualified licensees may perform high-complexity testing and…Section 1208Requires the department to regulate new or modified clinical-laboratory license categories and evaluate later federal CLIA rules with the multidisciplinary committee. Federal…Section 1209Defines who may serve as a laboratory director, including physicians, specified licensed professionals for waived testing, and persons licensed to direct laboratories,…Section 1209.1Defines a histocompatibility laboratory director through specified physician, bioanalyst, or doctoral-science qualifications, including four years of post-graduate immunology experience with two years…Section 1209.5Defines “autoverification” as computer-algorithm review and verification of laboratory test results with automated instrumentation. Requires documented validation and annual revalidation criteria, annual…Section 1210Defines specified clinical laboratory scientist specialty licenses and authorizes qualified licensees to perform high-complexity tests and listed CLIA supervisory duties within their…Section 1211Defines a clinical-laboratory “owner” through ownership or control interests generally reaching 5 percent, specified secured interests, corporate offices or directorships, and partnership…Section 1211.5Defines “cytological slides” for the chapter as cellular materials that are submitted for preliminary cytologic examination. The definition identifies what the term…Section 1212Defines “unlicensed laboratory personnel” as laboratory aides, histocompatibility technicians, cardiopulmonary technicians, and other persons performing activities authorized by the referenced provision. Exempts…Section 1213Defines “school” for the chapter as any place, establishment, or institution organized and operated to offer training for one or more personnel…Section 1214Defines “health fair” as a health-assessment program offered to the general public that may include screening, self-ordered, or diagnostic clinical laboratory tests…